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Rule2025-22643

Safety Standard for Toys: Requirements for Water Beads

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Published

December 12, 2025

Effective

March 12, 2026

Issuing agencies

Consumer Product Safety Commission

Abstract

Section 106(a) of 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. Under this statutory authority, the U.S. Consumer Product Safety Commission (CPSC or Commission) is issuing a safety standard for water bead toys and toys that contain water beads.

Full Text

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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Rules and Regulations]
[Pages 57820-57859]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22643]

[[Page 57819]]

Vol. 90

Friday,

No. 237

December 12, 2025

Part II

Consumer Product Safety Commission

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16 CFR Parts 1112 and 1250

Safety Standard for Toys: Requirements for Water Beads; Final Rule

Federal Register / Vol. 90 , No. 237 / Friday, December 12, 2025 /
Rules and Regulations

[[Page 57820]]

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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: Final rule.

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SUMMARY: Section 106(a) of the Consumer Product Safety Improvement Act
of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety
standard. This safety standard sets forth requirements for water bead
toys and toys that contain water beads. Under this statutory authority,
the U.S. Consumer Product Safety Commission (CPSC or Commission) is
issuing a safety standard for water bead toys and toys that contain
water beads.

DATES: The rule is effective on March 12, 2026. The incorporation by
reference of the publication listed in this rule is approved by the
Director of the Federal Register as of March 12, 2026. The
incorporation by reference of certain other material listed in this
rule was approved for use by the Director of the Federal Register as of
April 20, 2024.

FOR FURTHER INFORMATION CONTACT: Sara E. Brown, Compliance Officer,
Office of Compliance, Consumer Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814-4408; telephone: 240-749-0572; email:
<a href="/cdn-cgi/l/email-protection#53203631213c243d13302320307d343c25">[email&#160;protected]</a> or 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: <a href="/cdn-cgi/l/email-protection#c9a4a2bbacbabaac89aab9baaae7aea6bf">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

A. Background

Section 106(a) of the 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 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 the 2023 revision, ASTM F963-23. 89 FR 3344.
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\1\ Since 2009, ASTM has revised F963 five times: ASTM F963-08,
ASTM F963-11, ASTM F963-16, ASTM F963-17, and ASTM F963-23 (approved
August 1, 2023).
\2\ Section 3.1.91 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 are insufficient to address all known water bead
toy hazards. Potential hazards for expanding materials in general
include gastrointestinal tract blockage if a child ingests a product
comprised of expanding materials. The hazard mitigation provisions in
ASTM F963-23 include performance requirements but do not include
warnings or instructional literature specifically tailored to the
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 bead toys 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 the preamble of the NPR and 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 bead
toys, described in the preamble of the NPR, further demonstrates that
tested water beads that pass the performance requirements in ASTM F963-
23 can still pose safety hazards. Accordingly, this rule under section
106 of the CPSIA creates additional requirements in part 1250 to
establish mandatory requirements specifically for water bead toys.
Further, this rule revises the title of part 1250 from ``Safety
Standard Mandating ASTM F963 for Toys'' to ``Safety Standard for
Toys,'' to reflect the inclusion of requirements that do not
incorporate by reference existing requirements in ASTM F963.

B. Statutory Authority

The Commission is authorized to issue this final rule 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 to promulgate consumer product safety
rules that are more stringent than the existing standards if the
Commission determines that more stringent standards would further
reduce the risk of injury associated with such toys. Consistent with
the consultation requirement in section 106(d)(1) of the CPSIA, staff
has worked with the ASTM F15.22 Subcommittee Task Group since 2009 to
update the toy standard and discuss hazards associated with water bead
toys. This consultation, including the sharing of staff's assessment of
hazards and staff's suggested additional performance and labeling
requirements, continued through the revision and publication of ASTM
F963-23.

C. Notice of Proposed Rulemaking (NPR)

On September 9, 2024, the Commission published an NPR to address
four identified hazard patterns associated with water bead toys that
are not adequately addressed by the current mandatory standard
provisions addressing expanding materials: (1) ingestion of water bead
toys, (2) insertion of water bead toys into the nose or ear, (3)
aspiration due to water bead toys, and (4) choking due to water bead
toys. 89 FR 73024. The Commission proposed adding additional
performance requirements to part 1250 to better address these risks.
The NPR also proposed establishing acrylamide level limits for water
bead toys in response to toxicity hazards when water bead toys
containing acrylamide enter the body, and implementing new testing
requirements for acrylamide in water bead toys under part 1250.
Finally, the Commission proposed labeling requirements for water bead
toys under part 1250, including mandating warnings and

[[Page 57821]]

instructional literature on products within scope of the proposed rule.

D. Final Rule Overview

Pursuant to section 106 of the CPSIA, 15 U.S.C. 2056b, the
Commission is issuing a mandatory standard for water bead toys based on
the proposed requirements in the NPR, with certain modifications in
response to public comments and other clarifications, which are
discussed in detail in sections V and VI of the preamble.\4\ The final
rule defines a ``water bead'' as ``a various shaped liquid absorbent
polymer, composed of materials such as, but not limited to,
polyacrylamide and polyacrylate, which expands when soaked in liquid.''
This rule is intended to reduce the risk of injury or death associated
with children ingesting, inserting into their ear or nose, aspirating,
or choking on water bead toys by setting a maximum expansion size limit
for water bead toys. The rule also is intended to reduce the risks of
acrylamide exposure from water bead toys, by setting limits on the
amount of allowable acrylamide in water bead toys. Finally, the rule
requires strongly worded, conspicuous warnings.
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\4\ On August 21, 2025, the Commission voted (2-0) to publish
this final rule.
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Based on comments received on the NPR and clarifications found to
be necessary to the rule, the following changes have been made in the
final rule:
<bullet> The references to ``water'' in the definition of water
bead in proposed section 1250.4(b) has been revised to the broader term
``liquid'' in the final rule.
<bullet> In section 1250.4(c)(1) of the final rule, the proposed
funnel test gauge diameter has been reduced from 9.0 mm to 5.0 mm; the
50 percent expansion limit has been removed; and an additional test
option allowing for the use of a sieve test gauge for testing multiple
water beads has been added. Corresponding changes have been made to the
test method to reflect these changes.
<bullet> In section 1250.4(c)(2), the extractable acrylamide limit
has been changed from 65 [mu]g to 325 [mu]g per 100 small water beads
or per 1 large water bead.
<bullet> In section 1250.4(c)(2), the proposed definitions for
small and large water beads describing acrylamide testing, have been
changed from ``across the smallest diameter'' to ``in all dimensions''
for small water beads, and from ``across the smallest diameter'' to
``in any dimension'' for large water beads in the final rule.
<bullet> In section 1250.4(d), Figures 3 (``Warning for Water Bead
Toys and Packaging'') and 4 (``Toys That Contain Water Beads'') of the
proposed rule have been renumbered in the final rule as Figures 4 and
5, respectively, and the figure captions have been revised for clarity.
The Figure 4 caption now reads, ``Warning for Water Bead Toys and their
Packaging,'' and the Figure 5 caption now reads, ``Warning for Toys
with Contained Water Beads and their Packaging.'' In addition, both
figures have been revised to reflect changes in warning content made in
response to public comments and other clarifications. All changes
described below apply to both figures unless otherwise specified.
[cir] The first sentence of each warning has been changed from
``This product contains water beads that grow larger,'' to ``Contains
water beads that can grow larger when swallowed or inserted in the ear
or nose.''
[cir] The sentence, ``Discard if beads are coming out,'' in Figure
4 of the proposed rule, has been changed to, ``Discard product if beads
start to come out,'' and this revised sentence has been moved into the
bullet list of precautionary statements in Figure 5 (renumbered from
Figure 4) of the final rule.
[cir] The sentence, ``Children have DIED after swallowing water
beads because the beads blocked their intestines,'' has been changed to
``Children have DIED when the beads blocked their intestines.''
[cir] The sentence, ``Your child can die too,'' has been deleted.
[cir] The sentence, ``Inserted beads have resulted in surgeries,''
has been added to the warnings.
[cir] The sentence, ``Watch older children during use,'' has been
added to the warning after the statement about keeping water beads away
from babies and toddlers.
[cir] The sentence, ``Never use as a sensory toy or bath toy,'' has
been deleted.
[cir] The sentence, ``Seek immediate medical attention if you think
your child swallowed beads or inserted beads into their nose, ears, or
other part of the body,'' has been changed to, ``Get medical help right
away if you think your child swallowed or inserted beads.'' The phrase,
``Get medical help right away,'' has also been highlighted using
boldface type.
<bullet> In section 1250.4(d)(1)(vi)(C), the language ``section X
of'' has been deleted and missing quotation marks have been added at
the beginning of the phrase ``safety white.''
For the reasons explained in this preamble, the Commission
determines that the water bead toy requirements comply with section 106
of the CPSIA because they are more stringent than the current
requirements in ASTM F963-23 and would further reduce the risk of
injury and death associated with products within the scope of the rule,
and they would provide the highest level of safety that is feasible for
such products.

II. The Product

A. Description of the Product

Water beads are various shaped, multi-colored or clear beads
composed of liquid absorbing polymers, such as, but not limited to,
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. Water 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 liquid such as water, which allows the
beads to absorb the liquid and expand. After being soaked in liquid for
periods as short as a few hours for smaller water beads or two to three
days for larger water beads, water beads increase 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 diameter. 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 57822]]

[GRAPHIC] [TIFF OMITTED] TR12DE25.001

Water bead toys 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
products are not marketed as children's toys and are outside of the
scope of this rule.
As noted above, CPSC currently regulates water bead toys 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 bead,'' but it
defines an ``Expanding Material'' in section 3.1.28 as ``any material
used in a toy which expands greater than 50 percent 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. This final rule
defines ``water bead'' under part 1250 as ``a various shaped liquid
absorbent polymer, composed of materials such as, but not limited to,
polyacrylamide and polyacrylate, which expands when soaked in liquid.''
The final rule's test procedures incorporate ASTM's process for
conditioning water bead toys.

B. Scope of Products Subject to the Rule

This rule applies to both 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 designed, manufactured, or marketed as a plaything for children
under 14 years of age (consistent with the definition of ``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 water bead toy
guns designed to shoot water bead projectiles (Figure 6). Each product
would be subject to the rule and would need to meet the requirements of
the rule.
BILLING CODE 6355-01-P

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[GRAPHIC] [TIFF OMITTED] TR12DE25.002

BILLING CODE 6355-01-C
Examples of products outside of the scope of this 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 57824]]

III. Incident Data and Hazard Patterns

Staff searched two CPSC-maintained databases to identify incidents
and hazard patterns associated with water beads: the Consumer Product
Safety Risk Management System (CPSRMS) \5\ and the National Electronic
Injury Surveillance System (NEISS).6 7 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. The incident data and hazard
patterns cited in support of the NPR support this final rule and are
unchanged from the NPR. For further discussion of the incident data and
hazard patterns, see the preamble of the NPR (89 FR at 73031), which
describes the incident and hazard patterns associated with water bead
toys in further detail.
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\5\ 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.
\6\ 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.
\7\ 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

Staff identified 64 incidents in CPSRMS from 2017 through 2023
associated with the use of water bead toys. Staff identified the
following incident data hazard patterns associated with water bead
toys: ingestion, ear insertion, nose insertion, aspiration, and
choking. The CPSRMS incident data relied upon for the rule is unchanged
from the NPR.

B. National Injury Estimates From NEISS

Based on NEISS data, staff 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.\8\ Of the 250 sample NEISS cases, none were fatal. The NEISS
incident data relied upon for the rule is unchanged from the NPR.
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\8\ The estimated injuries for this final rule are less than the
estimate presented in the public guidance on water beads that can be
found on the Commission's website at <a href="http://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center">www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center</a>. The
difference is mainly due to 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 rule.
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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, 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.\9\ 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 but before the child was 2 years old.\10\
Consumers reasonably may be unaware that water bead toys are hazardous,
particularly because they are marketed for children's play.
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\9\ 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.
\10\ 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 non-food items is a normal part of
children's exploratory behavior that contributes to incidents of
choking and poisoning.\11\ 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.\12\ Children are prone to ingest or insert small,
smooth, colorful objects, like water beads or toy parts.\13\
Unintentional foreign body ingestion is a leading cause of nonfatal
emergency department (ED) visits in children younger than 9 years
old.\14\ Management and treatment for childhood accidental ingestion is
well documented in pediatric medical literature.\15\
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\11\ 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.
\12\ A-Kader. (2010) Foreign body ingestion: children like to
put objects in their mouth. World J Pediatrics, Vol 6 No 4. November
15, 2010. <a href="http://www.wjpch.com">www.wjpch.com</a>; 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.
\13\ 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.
\14\ 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:
<a href="http://www.cdc.gov/ncipc/wisqars">www.cdc.gov/ncipc/wisqars</a>. [10/1/2022].
\15\ 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: <a href="https://www.ncbi.nlm.nih.gov/books/NBK430915/">https://www.ncbi.nlm.nih.gov/books/NBK430915/</a> (accessed 4/12/22) Pediatric
Foreign Body Ingestion--StatPearls--NCBI Bookshelf (<a href="http://nih.gov">nih.gov</a>).
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D. 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 regarding water bead toy products.
The announcements involved one death and five reported injuries and
affected approximately 166,000 units. There have been no additional
recalls of water

[[Page 57825]]

bead toy products since the publication of the NPR. See the preamble of
the NPR for additional details about the above recalls.

IV. Review of Voluntary Standards--ASTM F963 and EN 71-1

A. Background

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 material'' 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, that are composed of expanding materials
and fit entirely within the small parts cylinder (16 CFR part 1501)
while in the toy's as-received size condition, must, after expansion,
completely pass through a 20.0 mm diameter gauge while a force of up to
4.5 lbf (pound-force) is applied.
Water beads that expand up to 20.0 mm diameter would meet the ASTM
F963-23 expanding materials requirements because they would pass
through the gauge, but water beads that expand larger than 20.0 mm
diameter would likely fail the requirements because the water beads
would not pass through the gauge. Incident data show that water beads
that expand to a size larger than 20.0 mm diameter are hazardous, but
many water beads that expand to a size smaller than 20.0 mm and would
pass the ASTM F963-23 test are also hazardous, as explained in section
III of this preamble.
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 the small parts cylinder from 16 CFR part 1501, 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 that
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--Part 9: Organic Chemical Compounds--Requirement \16\ provides a
test method and a concentration limit for acrylamide, a hazardous
chemical found in toys.
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\16\ 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.
---------------------------------------------------------------------------

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 for a significant amount of
time, such as teethers and rattles. In contrast, water bead toys
addressed in this rule are not intended to be mouthed for a significant
amount of time. This rule is intended to address ingestion, insertion,
choking, and aspiration hazards, not mouthing. Therefore, this rule
mandates a different acrylamide limit and test method, intended to
address the hazards discussed in section V of the NPR preamble.

B. 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
expanded size. The product is then tested to determine 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, when a force of 4.5 lbf (pound-
force) is applied to the water bead in the direction of the hole via a
rod having a hemispherical end diameter of 10.0 mm.
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 by the
body 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 generally causes
fragmentation of the water bead (Figure 7), which would be considered a
``pass'' pursuant to the ASTM test standard. However, incident data
shows water beads remain whole after being swallowed, thus creating a
gastrointestinal tract blockage.\17\ Because the force that the rod
exerts can damage the expanded water bead and cause fragmentation,
staff have assessed that the current ASTM test method is inadequate to
effectively test water beads for an ingestion and blockage hazard.
---------------------------------------------------------------------------

\17\ Examples include the following IDIs: 230727CBB1846,
230707CBB1698, 230613CBB1591, 170802CCC3140 and 221107CFE0002.

---------------------------------------------------------------------------

[[Page 57826]]

[GRAPHIC] [TIFF OMITTED] TR12DE25.003

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 size should be reduced. The 20.0 mm diameter gauge used in
ASTM F963 was selected based on the dimension of the pyloric sphincter
\18\ within the gastrointestinal tract of an 18-month-old child,
because at the time the ASTM F963 expanding materials requirements were
created, the pyloric sphincter was thought by the drafters to be the
most likely site where a gastrointestinal blockage would occur. As
explained below, objects that can cause a gastrointestinal blockage are
more likely to cause a blockage at either the gastric outlet part of
the stomach or the ileocecal valve at the end of the small
intestine.\19\
---------------------------------------------------------------------------

\18\ 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.
\19\ 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).
---------------------------------------------------------------------------

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.
Staff evaluated the relevant recent incident data and concluded that
because the ileocecal valve is often the site of a 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 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,20 21 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 of the preamble of the NPR (89 FR 73035), the
Commission has based the diameter size of the test gauge through which
water bead toys must pass on incident data.
---------------------------------------------------------------------------

\20\ 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.
\21\ 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,
referenced section 4.6, 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 intended to minimize choking,
ingestion, or inhalation hazards. Most water bead toy products are
intended for children older than 36 months of age and therefore are not
required to comply with the small objects requirements in section 4.6
of ASTM F963-23.
Finally, to address the potential presence of toxic chemicals in
toys, section 4.3, Toxicology of ASTM F963-23 requires that all toys
must comply with the Federal Hazardous Substances Act (FHSA) toxicity
and hazardous substances standards. Although there is a 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 in expanding materials. Water beads are
composed of absorbent polymers, which can contain acrylamide monomer--a
chemical that can be hazardous when ingested.\22\ ASTM F963-23 does not
have a limit or a test method for acrylamide monomer in water bead
toys. Therefore, the current ASTM standard is inadequate to provide the
highest level of safety feasible to ensure that the chemicals in water
bead toys are non-toxic. Because water bead toys containing high levels
of acrylamide monomer are toxic, the rule establishes content limits
and test methods to address the toxicity hazard presented by
acrylamide.
---------------------------------------------------------------------------

\22\ Per the Federal Hazardous Substances Act (FHSA) (16 CFR
1500.3(c)(2)(i)(A)), a substance with a median lethal dose
(LD<INF>50</INF>) between 50 and 5000 mg/kg in rats is ``toxic'' for
acute toxicity. The reported oral LD<INF>50</INF> values for
undiluted acrylamide in rats range from 150 to 413 mg/kg. See ATSDR
Toxicological Profile for Acrylamide, available at <a href="https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf">https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf</a>.
---------------------------------------------------------------------------

C. Assessment of Current ASTM F963-23 Labeling Requirements

Section 5.0 of ASTM F963-23, Labeling Requirements contains general
labeling requirements that apply to toys, including water bead toys or
toys containing water beads. However, 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

[[Page 57827]]

general choking hazards, they do not address or inform about injuries
(e.g., gastrointestinal blockage) or deaths that have occurred when
water bead toys expand after being swallowed or inserted. The primary
U.S. voluntary consensus standard for product safety signs and labels,
ANSI Z535.4, Product Safety Signs and Labels, and other literature and
guidelines on warnings, consistently recommend that warnings include
information about the consequences of exposure to the hazard. Warnings
research has shown that providing explicit information about the
consequences of a hazard can increase perceived hazardousness, which
has been shown to increase warning effectiveness.\23\
---------------------------------------------------------------------------

\23\ 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.
---------------------------------------------------------------------------

D. 2024 Proposed Draft Revisions to ASTM F963

On January 22, 2024, and March 25, 2024, 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 bead toys. As
explained in the preamble of the NPR (89 FR 73037), staff and ASTM
discussed incident information and the ASTM 20.0 mm diameter test gauge
compared to CPSC's proposed funnel test gauge. On July 9, 2024, ASTM
shared a draft proposal to revise section 4.40 of ASTM F963-23 to
include water bead toy-specific requirements. On July 18, 2024, ASTM
submitted a ballot for a vote on the proposal, which was available
until August 19, 2024.
Staff reviewed the 2024 draft proposal, finding it inadequate to
address all known water bead toy hazards. In the draft proposal, water
bead would be defined 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 bead toys intended to be accessible
in dehydrated state and water bead toys in the expanded state. If the
water bead toy is already expanded, the water bead toy would be given
time to dehydrate before testing. These draft requirements would not
apply to water bead toys that are not intended to be accessible, such
as water beads within a squeeze ball.
ASTM's draft performance test proposal would require first
measuring the diameter of a dehydrated water bead toy 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 toy will be placed in
the funnel test gauge to determine whether it can pass through the
gauge under a certain external pressure. If the maximum expansion of
the water bead toy is less than or equal to 50 percent in diameter, no
further testing is required. Based on incident data, the ASTM draft
proposed 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 toy, the proposed test includes applying a force of 0.1 lbf
to the water bead toy in the direction of the 12.0 mm diameter hole
using a 10.0 mm diameter rod having a flat end. The ASTM draft stated
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 test gauge, the product would
still meet the draft requirement even if the unbroken water bead toy
was larger than 12.0 mm. The draft did not include acrylamide limits or
revised labeling requirements.
Staff reviewed the draft ASTM proposal and found that a gauge size
diameter of 12.0 mm is inadequate to address known hazards from water
bead toys. The draft proposed 12.0 mm diameter is based on one
incident,\24\ which describes a 13-month-old female who was unable to
pass through her body a water bead toy presumed to be as small as 13.0
mm diameter. However, while staff knows based on the incident a 13.0 mm
diameter water bead toy can cause a blockage in a child, this incident
by itself does not establish the size of the largest water bead toy
that can safely pass. Further, the draft ASTM requirements would not
require testing for a dehydrated water bead toy of 13.0 mm diameter,
which is capable of expanding to 19.5 mm diameter, because the water
bead toy would not have expanded to more than 50 percent of its
original size. As explained in section IV.B of this preamble,
fragmentation of the water bead toy during testing is not
representative of incident data, and as explained in section V.C.1 of
the NPR preamble, testing of water beads contained within toys, such as
squeeze balls, is necessary to address incidents of children biting
into a squeeze ball and swallowing the water beads within.\25\
Therefore, while the draft ASTM proposal may be an improvement on the
current ASTM F963 expanding materials requirements, it would not
adequately address known water bead hazards, even if adopted.
---------------------------------------------------------------------------

\24\ IDI 170802CCC3140.
\25\ Such as incident 20230601-3657B-2147347238 found on
<a href="http://saferproducts.gov">saferproducts.gov</a>. 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.
---------------------------------------------------------------------------

Since publication of the NPR on September 9, 2024, the subcommittee
held meetings on January 15, 2025, and February 10, 2025, to discuss
the negative votes on the proposed ballot and what modifications should
be made. Two additional task groups have been formed: one task group
for discussing potential sampling sizes for water bead toy testing and
the other task group for discussing potential warning label
requirements. The task group discussing sampling size met on March 13,
2025, May 28, 2025, and August 5, 2025. The task group discussing
warning label requirements met on April 2, 2025.

E. 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
toy, that fits entirely in a small parts cylinder first be measured,
using calipers,\26\ 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 toy 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 toy has expanded more than 50 percent,
then it fails the expanding material requirements.
---------------------------------------------------------------------------

\26\ An instrument used to measure certain dimensions of an
object.
---------------------------------------------------------------------------

The Commission determines that the current EN 71-1 expanding
material requirement is inadequate as a stand-alone requirement. For
example, staff assessed that a maximum size requirement is necessary
because the EN 71-1 standard would permit a water bead toy having a
dehydrated 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 and compliant with the EN 71-1 expanding material
requirements, the expanded water bead would likely cause a
gastrointestinal blockage if a child ingested it. Indeed, as described
in section III of the preamble of the NPR (89 FR 73028), a water bead
with 13.0 mm diameter is known to have caused a gastrointestinal block
in a 13-month-old female. If the

[[Page 57828]]

only requirement on water beads is that they do not expand to more than
50 percent of the original size, the ingestion hazard would still be
present.

V. Response to Public Comments

CPSC received 135 public comments during the NPR comment period.
The comments are available on <a href="http://www.regulations.gov">www.regulations.gov</a>, by searching under
docket number CPSC-2024-0027. This section describes the significant
issues raised in the comments and CPSC's responses to them. Commenters
include two gel blaster manufacturers, That Water Bead Lady, the Toy
Association, Alan Kaufman, China World Trade Organization/Trade
Barriers to Trade, two third party laboratories, consumer advocacy
groups, pediatric gastroenterologists and surgeons, daycare workers,
parents, and a class of law students.

A. General

1. Scope
Comment: Gel Blaster Inc., SplatRball, and Michael Ravnitzky
suggest water bead guns marketed towards adults and used in activities
like paintball or airsoft should not be considered children's toys.
Instead, they belong in the sporting goods and recreational equipment
category. Two of these commenters, Gel Blaster Inc. and SplatRball,
argue that water bead guns are not consistent with the types of
projectile toys identified in CPSC's 2020 Age Determination Guidelines
as being intended for children 9 through 12 years old. Connor Mitchell
expressed concern about limiting the rule to toys, because he believes
water bead guns are intended for ages 14 and older, and therefore would
fall outside the scope of the rule. Albert Tacornal states that more
advanced water bead guns should not be subject to the rule and asserts
that most water bead guns are marketed to children under age 14 based
on their quirky designs and colorful patterns. American Academy of
Pediatrics (AAP) suggest all water bead guns marketed to children
should be in scope of the rule.
Response: Water bead guns that are designed, manufactured, and
marketed to adults (i.e., marketed for ages 14+ years old) for use in
activities similar to paintball or air soft are outside the scope of
this rule because they are not toys as defined by ASTM F963. However,
some water bead guns are designed, manufactured, or marketed for
children younger than age 14, as indicated by commenters, and these
products are within the scope of the rule and subject to its
requirements. Although some commenters note that water beads differ
from other types of air-propelled projectiles intended for children 9
through 12 years old, they also acknowledge that water beads are not
``penetrating'' projectiles of the type identified by the CPSC 2020 Age
Determination Guidelines as being inappropriate for this age group. As
noted earlier, some water bead guns are designed, manufactured, or
marketed for children who are young enough for these products to be
within the scope of the rule. In addition, if water beads used as
projectiles were not appropriate for children up to age 12, there could
still be some water bead guns (e.g., those designed, manufactured, or
marketed for children as young as age 13) that fall within the scope of
the rule.
Comment: Consumer Reports asserts that manufacturers and retailers
of water beads that were previously marketed as toys or for use by
children may attempt to evade the proposed rule by re-marketing their
products for other uses such as decorative or agricultural purposes. If
these repurposed and remarketed water bead products continue to include
images of children and other fun descriptive language, it could be
mistaken by a caregiver as a product suitable for use by children.
Response: CPSC assesses product packaging and marketing materials
to determine whether certain water bead products are marketed for ages
14+ years old, and therefore, would not be within the scope of this
rule. If CPSC finds water bead products that include images of children
and other fun descriptive language, CPSC may determine those water bead
products are toys within scope of the rule.
Comment: Jacob Lowe states that a ban on all toys that use
acrylamide and are likely to be orally inserted would be reasonable.
Response: This comment is outside of the scope of the rulemaking.
However, if the Commission finds evidence of hazards presented by
acrylamide in toys other than water bead toys in the future, then
regulatory activity may be considered.
2. Definitions
Comment: Brianna Zimmerman, Jared Shelton, and Christian Beasley
suggest modifications to the definition of water bead, such as
replacing the term ``water'' within the definition, with the term
``liquid'' or ``water-based liquid'' because while water is an
appropriate term, it may be too narrow. Similarly, AAP and Consumer
Federation of America (CFA) suggest modifications to the definition of
water bead, such as not limiting the definition to only ``water'' but
instead including ``water and other fluids'' that can be absorbed.
Response: Based on these comments, the language in the definition
of water bead in section 1250.4(b) in the final rule has been amended
from ``water absorbent polymer'' to ``liquid absorbent polymer.'' This
change to the broader term ``liquid'' is intended to include within the
definition water bead, water beads that can potentially absorb liquids
other than water that could potentially present the same risk of
injury. Thus, the amended definition of water bead in section 1250.4(b)
of the final rule reads ``a various shaped liquid absorbent polymer,
composed of materials such as, but not limited to, polyacrylamide and
polyacrylate, which expands when soaked in liquid.''
Comment: Emily Threatt contends the scope of the regulation should
explicitly cover toys that are not commonly called ``water beads,''
because water beads are not the only water absorbent polymer toys that
are hazardous. Other water absorbent polymer toys pose a hazard as
well, specifically, those in a non-uniform shape.
Response: The commenter's assertion that the definition of ``water
bead'' in the rule does not cover other products that are not commonly
called water beads and other water absorbent polymer toys, such as
those in non-uniform shape, is incorrect. As defined in the rule, a
water bead is a ``various shaped liquid absorbent polymer.'' Therefore,
the definition does include the examples noted by the commenter,
including those with a non-uniform shape.
Comment: Michael Ravnitzky states the definition of water beads
could be expanded to include specific examples of polymers and their
chemical compositions. This would help in clearly identifying what
constitutes a water bead and avoid ambiguity.
Response: The definition of water bead in the rule states that they
are an ``absorbent polymer, such as, but not limited to, polyacrylamide
and polyacrylate. . . .'' Therefore, it is unnecessary to include
specific examples of other polymers or their chemical compositions
because the phrases ``such as'' and ``not limited to'' in the
definition indicate that various types of polymers and their chemical
compositions fall within the definition of water bead and thus are not
limited to just polyacrylamide and polyacrylate. Additionally, any such
list of specific examples of polymers and their chemical compositions
would necessarily be incomplete and only cover certain examples.

[[Page 57829]]

Comment: Gel Blaster Inc. suggests the water bead definition should
specify polymers to only include polyacrylamides or polyacrylates and
to avoid bundling in natural polymers like starch and cellulose. The
commenter asserts that there is no evidence that there are currently
water beads on the market that are not polyacrylamides or polyacrylates
that have been involved in ingestion issues.
Response: While there is currently no incident data involving water
beads that are not made of polyacrylamides or polyacrylates, natural
polymers such as starch and cellulose expand just like polyacrylamides
and polyacrylates, thus presenting the same hazards from expansion as
other types of polymers. The use of the term ``polymer'' in the
definition of water bead is inclusive of natural polymers such as
starch and cellulose and the language is clear, as it is not intended
to include only polyacrylamides or polyacrylates, as noted by the use
of ``such as'' after ``polymer.'' Therefore, the Commission declines to
explicitly exclude natural polymers such as starch and cellulose from
the definition of water bead in the rule.
Comment: Christian Beasley asserts that the term ``soaked'' is too
constrictive for the proposed definition and the amount of fluid
necessary for a water bead to expand. Even though ``soaked'' accurately
represents that the water bead expands if it is immersed in water or
other water-based fluid, it is too narrow as it implies that the water
bead must be immersed in something to expand. The commenter states that
the more appropriate term would be ``exposed'' because, by definition,
``exposed'' means ``open to view, not shielded or protected.''
Therefore, the proposed definition should be altered to define a water
bead as ``various shaped water absorbent polymers, composed of
materials such as, but not limited to, polyacrylamides and
polyacrylates, which expand when exposed to water or water-based
fluid.''
Response: The term ``exposed'' is an inaccurate word because a
water bead will not noticeably expand if only a drop of water is placed
on the water bead (e.g., the water bead is exposed to a drop of water).
The water bead must be soaked in water for a lengthy period to expand,
and thus potentially present a hazard. Therefore, the Commission
declines to make the commenters recommended change to replace ``soaked
in water'' with ``exposed to water'' in the definition of water bead.
Comment: The Toy Association contends the proposed definition of
water bead is missing the parameter for expansion that is used for the
defined term `expanding materials' in ASTM F963.\27\ Without reference
to the term `expanding materials,' the commenter asserts that the
proposed definition conflicts with established and commonly applied
definitions for all expanding materials (in addition to the NPR
proposal requiring that the water bead does not expand in a manner
consistent with expanding materials, which is more than 50 percent its
original size).
---------------------------------------------------------------------------

\27\ ASTM F963 section 3.1.28: expanded material means ``any
material used in a toy which expands greater than 50% in any
dimension from its as-received state.''
---------------------------------------------------------------------------

Response: It is unnecessary for the definition of water bead in the
rule to reference the definition of ``expanding materials'' from ASTM
F963-23. By removing the 50 percent expansion limit from the final
rule, for the reasons described below in the mechanical requirements
section, water beads can still be classified as an expanding material
because they will grow more than 50 percent of their original size.
Finally, the definition and requirements for water beads in this rule
will be a subsection to the currently existing general ``expanding
materials'' requirements in section 4.40 of ASTM F963-23.
3. Color of Water Beads
Comment: Elenor Grundberg, Brianna Zimmerman, AAP, Mollie Price,
CFA, and the Toy Association do not believe the color of water beads
should factor into whether water beads are toys. By contrast, Bindi
Naik-Mathuria, Christian Beasley, U.S. Public Interest Research Group
(PIRG), and That Water Bead Lady contend the color of water beads
should be restricted to neutral or clear colors, so they don't look
like candy or other edible items.
Response: This rule does not regulate the color of water beads.
Colorful water beads and non-colorful (i.e., clear) water beads both
present the same hazard and thus both are within the scope of the rule.
While colorful water beads may be more appealing to children, as noted
by commenters, non-colorful water beads may be harder to locate if lost
or dropped and later found by a young child and ingested. Non-colorful
water beads are also just as likely as colorful water beads to pose a
hazard. Therefore, both colorful and non-colorful water beads are
subject to the rule.
4. Adhesion
Comment: North American Society for Pediatric Gastroenterology,
Hepatology and Nutrition (NASPGHAN) states they are not familiar with
water bead products sticking together. However, they suggest there is a
likelihood that water beads could aggregate with each other or with
other substances and cause an obstruction. The commenter cited a study
by Pasman et al.\28\ that found 12 cases of care escalation reported
when multiple water beads were ingested. That Water Bead Lady indicates
that in a case in Pakistan, a child died after ingesting water beads,
which upon examination, had turned into a mushy, fragmented mass inside
the gastrointestinal tract. That Water Bead Lady also provides a case
study by Kim et al., 2020,\29\ which described water beads that became
impacted with food in the small bowel. Brad Bergeron, Sarah Desousa,
Anonymous, Marianne L'Abbate, Jane Miller, CFA, and American Academy of
Pediatric Surgeons (AAPS) assert that water beads can stick together
and that multiple medical professionals have shared anecdotal evidence
indicating that is the case.
---------------------------------------------------------------------------

\28\ Pasman EA, Khan MA, Kolasinski NT, Reeves PT. Water bead
injuries by children presenting to emergency departments 2013-2023:
An expanding issue. J Pediatr Gastroenterol Nutr. 2024
Sep;79(3):752-757. doi: 10.1002/jpn3.12333. Epub 2024 Jul 24. PMID:
39045753.
\29\ <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7808832">https://pmc.ncbi.nlm.nih.gov/articles/PMC7808832</a>.
---------------------------------------------------------------------------

Response: None of the commenters provide convincing evidence that
water beads stick together within the human digestive tract. Staff
agrees that, as indicated in the study by Pasman et al. and the case
from Pakistan, provided by the commenters, that water beads can be
found aggregated together with food and other substances in any area of
the intestine where an expanded water bead cannot pass naturally,
causing an obstruction. However, CPSC is unaware of any incidents of
water beads sticking to each other or clumping together to cause an
intestinal obstruction.
Based on further CPSC testing, CPSC has found that water beads can
clump together when soaked in whole milk or baby formula, depending on
the mixture type. Water beads will partially grow by absorbing the
water available within the milk or baby formula, leaving a sticky milky
substance consisting of the leftover fats and proteins, which cause
instances of clumping. However, once the clumps are immersed in water,
the water beads will fully expand and separate. Any clumped mass of
milk and water beads ingested or that may form in the stomach will
separate in the aqueous environment of the small intestine. Therefore,
water beads clumping together in milk or baby formula that have been
ingested should

[[Page 57830]]

not present an obstruction hazard due to clumping or sticking together.
Comment: Brianna Zimmerman, AAPS, and AAP note that while it
appears that traditional expanding water beads do not have a strong
tendency to stick together, there are similar products that are
designed to stick together such as Aquabeads. The product Aquabeads
``is a bead toy that magically sticks together with water'' according
to their website.
Response: Aquabeads are not within scope of this rule because they
are not a liquid absorbent polymer and do not expand when soaked in
liquid, but rather they are composed of a rigid material that allows
them to stick together when exposed to water. In fact, they dissolve
when soaked in water for several hours. Thus, Aquabeads do not present
the expanding material hazard that water beads do.
5. IDI Issues
Comment: The Toy Association asserts the example presented for
water bead aspiration incidents does not support the position taken in
the NPR. For the IDI 201130CCC3196, the aspiration occurred after the
child vomited water beads that were in the stomach. This hazard
potential is not specific to water beads, and relates to any object,
including food and other matter, since aspiration from vomiting is a
known hazard in any situation.
Response: Staff disagrees with the commenter's assertion that the
aspiration incident does not support the position taken in the NPR. In
the IDI referenced by the commenter, there is no evidence that supports
the assertion that the child aspirated ingested water beads only after
vomiting. Instead, according to the IDI, the victim aspirated water
beads in addition to ingesting water beads. In any case, vomiting is a
common symptom after water bead ingestion and aspiration of water beads
into the airways by any means will result in a water bead in a victim's
airway that may continue to expand. This expansion can lead to injury
or death.
Comment: The Toy Association asserts that the IDI 180104CBB1236
listed in the NPR as an example for the hazard pattern for choking
relates to a nasal obstruction instead of a choking hazard.
Additionally, the commenter asserts that the NPR outlines the hazard
associated with large, expanded water beads without addressing whether
these water beads would conform to the existing ASTM F963 requirement.
Response: As stated in the preamble of the NPR (89 FR 73031), staff
are aware of one choking incident. In that incident, the size of the
water bead is not known. However, a 20.0 mm diameter expanded water
bead that meets the current ASTM F963 expanding material requirement,
which allows for passage through a 20.0 mm diameter gauge, is still
large enough to pose a choking hazard. The 5.0 mm gauge size diameter
and expansion limits in the rule address a potential choking hazard.
IDI 180104CBB1236 does not describe a choking incident, but it was
provided as an example to demonstrate how caregivers commonly place
water beads in water within reach of children for prolonged periods of
time so the water beads can fully expand in advance of a child's
playtime. The expanded water beads may then pose a choking hazard
because they are accessible to children.
Comment: The Toy Association states IDI 230613CBB1591 presents a
circumstance relating to an intestinal obstruction resulting after
water beads were released from a ball, like a stress ball received from
a party goodie bag, and which was described by CPSC as being expected
to be used as a toy. Without information to confirm whether the product
was designed, intended, marketed, and sold as a toy, the commenter
asserts that it is not reliable to assume that the product was actually
a toy.
Response: The commenter suggests that the product involved in IDI
230613CBB1591 may not have been a toy. While the evidence included in
the IDI does not provide information to allow definitive identification
regarding whether the product is a toy, it does describe the product as
a clear ball containing water beads and pink and blue glitter that was
provided in a goodie bag from a birthday party, and therefore, likely a
toy. Based on the description of the product in the incident, the
description indicates that it was likely a toy stress ball containing
water beads that released water beads presenting an ingestion and
insertion hazards to children. CPSC is aware of at least six other
incidents involving toy squeeze balls releasing water beads. However,
if CPSC determines that a product is properly designed, manufactured or
marketed for ages 14+ years old, then the product is outside the scope
of this rule.
Comment: The Toy Association notes the basis for the proposed
maximum water bead size requirement in the NPR is based on IDI
230707CBB1698. Firstly, the commenter notes this incident did not
result in an intestinal obstruction; although an enema was
prophylactically applied since the child intentionally ingested a large
number of water beads, it is not clear whether the enema was required
to pass the water beads. Secondly, the commenter states that in the
absence of any scientific basis for determination, staff are applying
the smallest recorded size of water bead in a set where all water
beads, up to 15 mm diameter, passed through the child's intestinal
tract without obstruction. Thirdly, the commenter asserts that since
the 9.0 mm diameter is based on the smallest water bead in this set,
the value observed could have been any value which can and will depend
on the variation in the product assessed versus any other set obtained
(i.e., the set could have had water beads down to 10 mm or 11 mm
diameter).
Response: The incident referred to by the commenter is IDI
230707CBB1698, which describes a 3-year-old female who ingested
approximately 1,200 small water beads (approximately 1 tablespoon
before expansion). The child successfully passed all the water beads
through her digestive system with the aid of a mineral oil enema. The
sizes of those specific expanded water beads were not provided in the
IDI. However, samples of the same product purchased and collected by
CPSC showed full expansion of water beads after being soaked in
deionized water, with expansion ranging between 9.32 mm and 15.20 mm in
diameter.
To achieve the highest level of safety feasible, the NPR originally
proposed requiring the use of a 9.0 mm diameter test gauge based on the
size of the smallest water bead that was known to pass through the body
without causing an intestinal obstruction. However, based on further
information provided by commenters, as explained below in section B,
Mechanical Requirements, the final rule uses a 5.0 mm diameter test
gauge.

B. Mechanical Requirements

1. Size Requirement for Water Beads Should be Smaller
Comment: That Water Bead Lady asserts that a 9.0 mm diameter size
limit for water beads is too large to ensure safety. Due to the
swelling properties of water beads, the risk of impingement within the
nasal cavity or ear canal will not be mitigated at this size. Reviewing
Sterling et al.'s paper, ``Destructive Otologic Foreign Body: Dangers
of the Expanding Bead,'' \30\ the commenter indicated that the external
auditory canal (EAC) of their patient measured only 5.9 mm in diameter.
A water bead as small as 4.5 mm diameter could still enter this space
and expand.

[[Page 57831]]

Additionally, CFA provided a study which included data showing the
average diameter of a child's airway varies but it is smaller than the
airway of an adult.\31\ This study shows the average diameter of the
cricoid cartilage of a 0-1 year old is 6 mm, a 1-2 year old is 7.5 mm,
a 2-4 year old is 8.0 mm, and a 4-5 year old is 9.0 mm.
---------------------------------------------------------------------------

\30\ <a href="https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2541395">https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2541395</a>.
\31\ Iowa Head and Neck Protocols ``Pediatric Airway--Cross
sectional area.'' <a href="https://medicine.uiowa.edu/iowaprotocols/pediatric-airway-cross-sectional-area#:%7E:text=The%20average%20diameter%20of%20the,3%20mm%20to%202%20mm">https://medicine.uiowa.edu/iowaprotocols/pediatric-airway-cross-sectional-area#:%7E:text=The%20average%20diameter%20of%20the,3%20mm%20to%202%20mm</a>.
---------------------------------------------------------------------------

AAPS states the 9.0 mm diameter limit is too big to prevent hazards
regarding aspiration. Jared Shelton, Petia Paneff, and Elizabeth Berdan
suggest that since the rule is based on limited data, the 9.0 mm
diameter performance requirement may not be adequate, and further
investigation would be beneficial.
Marianne L'Abbate, Brad Bergeron, Sarah Desousa, Anonymous, Connor
Mitchell, AAPS, AAP, and Jame Miller contend that even at 9.0 mm
diameter, water beads could obstruct the intestines of small children,
especially if they have had previous intestinal surgery and have narrow
intestines (stricture) or a medical condition that causes thickened
intestines.
Christopher Cochran suggests a size limit of 7.0 mm, instead of 9.0
mm diameter, may better protect safety hazards for infants. AAPS and
AAP recommend limiting the size to 2.0 mm or 3.0 mm diameter.
Response: That Water Bead Lady provides incident information
involving a young girl having a water bead inserted past her EAC, which
measured 5.9 mm in diameter. After the water bead expanded to 9.8 mm
diameter, profound sensorineural hearing loss was present on audiogram,
and labyrinthitis ossificans of the cochlea and semicircular canals
were observed on imaging after surgery. CFA provided an additional
study from the Iowa Carver College of Medicine regarding pediatric
airways that indicated the average diameter of the cricoid cartilage of
a 0-1 year old is 6.0 mm.
While the Sterling et al. paper indicates a young girl having an
EAC measuring 5.9 mm diameter, the age of the girl is unclear.
Additionally, when revising the gauge size diameter, a safety factor
should be included as a buffer to account for additional uncertainties.
Based on this information, the gauge size diameter in the final rule is
being reduced from 9.0 mm to 5.0 mm diameter to account for the
possible variation in EAC sizes due to age and to include a safety
factor. Therefore, as a result of the smaller final expansion size
limit, the 50 percent expansion limit is no longer necessary and is
being removed from the final rule, as explained below in section 2, 50
Percent Expansion Limit.
Regarding potential children having narrow intestines and a higher
risk of blockage, the revised gauge size of 5.0 mm diameter should
account for more narrow intestines.
While other commenters also provide suggestions on what the gauge
size should be, such as 7.0 mm, 3.0 mm or 2.0 mm diameter, those
commenters do not provide relevant data or information to support using
those specific gauge size diameters to revise the limit in the final
rule.
2. 50 Percent Expansion Limit
Comment: Erin Brennan, the Toy Association, and Gel Blaster Inc.
assert the new performance requirements for these products essentially
regulate water beads out of existence. A 50 percent expansion limit
corresponds to an absorption rate of about 3x, while sodium
polyacrylate, the super absorbent polymer used in hydrogel projectiles,
has a minimum absorption rate of 10x. Thus, they argue that a 50
percent growth limit would essentially be a ban on water beads as toys.
The commenters suggest, based on the proposed 50 percent expansion
limit, that a water bead with a 1.0 mm diameter that expands to more
than 1.5 mm diameter would fail the proposed rule, but doesn't appear
to be a hazardous size. Additionally, Alan Kaufman states the
independent 50 percent expansion limit proposed by the agency has no
valid supporting rationale. Also, he expressed concern CPSC may have
inadvertently increased the likelihood of choking and ear and nose
insertions and increased the likelihood of these water beads being lost
and later ingested.
Response: Based on comments, as described above, the Commission is
removing the 50 percent expansion limit from the final rule and
reducing the gauge size to 5.0 mm diameter to reduce the severity of
injuries resulting from ear and nose insertions. The Commission agrees
with the Toy Association's assertion that a 1.0 mm diameter water bead
that can expand to 1.5 mm diameter is unlikely to be hazardous but
would still fail to comply with the proposed 50 percent expansion
limit. Staff concludes reducing the gauge size diameter from 9.0 mm to
5.0 mm in the final rule will improve the safety of water beads and
improve medical and health outcomes verses combining the proposed 50
percent expansion limit with a larger size limit of 9.0 mm diameter.
Staff notes removing the 50 percent expansion limit means that super
absorbent polymers such as sodium polyacrylate could still be used in
water bead toys, as long as the other requirements of this rule are
met.
Comment: The Toy Association states the NPR has made a preliminary
determination that the current 50 percent expansion limit in EN71-1
(European Toy Safety Standard) is inadequate as a stand-alone
requirement for expanding water beads, apparently on the basis that a
theoretical water bead that expands less than 50 percent would present
an obstruction hazard since it could expand from 9.0 mm to 13.5 mm
diameter, and then likely cause a gastrointestinal blockage if a child
ingested it, while apparently not considering that the same would be
true of any other non-expanding material that has a diameter of 13 mm
or greater.
Response: Staff consider the current 50 percent expansion limit in
EN71-1 to be inadequate as a stand-alone requirement because a
dehydrated water bead of 9.0 mm diameter could expand to 13.5 mm
diameter and still comply with the 50 percent expansion limit despite
potentially causing an intestinal blockage.
The commenter suggests that non-expanding material with a diameter
of 13.0 mm could cause an intestinal blockage. As stated in the
preamble of the NPR (89 FR 73028), objects of this size, such as
marbles, do not grow after being swallowed. Unlike water beads, marbles
and other smooth, solid objects can frequently be located and
identified by x-ray due to their density. Once located, marbles can be
removed endoscopically if detected early enough, especially if they
appear to be too large to pass through the stomach or the remainder of
the digestive tract. By contrast, water beads can remain small within
the stomach and proximal small intestine, eventually growing larger as
they move into the distal small intestine and causing a small bowel
obstruction that frequently requires surgery to resolve.
3. Consequence of Reducing Allowable Expanded Size for Water Beads
Comment: Patricia Rowell and Craig Farrow contend that downsizing
the size of water beads only makes them more dangerous to children and
thus easier to choke on.
Response: The commenters do not provide evidence to support their
claim that reducing the expansion size of water beads makes them more
dangerous and easier to choke on.

[[Page 57832]]

However, the physical characteristics of objects that pose a choking
hazard include large size, round shape, and smooth texture. For
example, an expanded water bead with a diameter of 5.0 mm or less is
less likely to present a choking risk to children than a bead with a
larger diameter, solely due to the smaller diameter of the water bead.
Comment: Jake Peterson states that reducing the allowable expansion
size creates a situation where the lack of enlargement might prevent
any detection. So, if a child were to place a water bead in their ear/
nose, and it does not enlarge, then it is possible for the water bead
to go fully undetected for a long time. The commenter asks: how long
could a water bead stay in an ear canal or nasal cavity without
enlarging; if the water bead never enlarges, how long would it stay
there before other symptoms develop; and are those symptoms potentially
worse than if the water bead did enlarge and was detected relatively
quicker.
Response: If a water bead doesn't expand after being inserted into
the ear or nose, it could stay undetected for an undetermined amount of
time (hours, days, weeks, months). However, if a water bead does not
expand within the ear or nose, the physical injuries or health outcomes
from an unexpanded water bead would be more like the injuries and
health outcomes from insertion of a standard bean, or round toy part,
or other bead-like object that a child might insert into their ear or
nose. No expansion, or limited expansion, reduces the injury to the ear
or nose that CPSC has seen from water beads in incident data where the
expanded water bead leads to a more severe injury due to the expansion
damaging the tissues of the nose and ears. Larger expanded beads lead
to increased nasal and ear injury.
4. Size Requirement for Water Beads Should be Larger
Comment: The Toy Association asserts the NPR misrepresents the
basis for the ASTM proposed 12.0 mm diameter gauge by stating the 12.0
mm proposed diameter was based on consideration of one incident. They
note that this value is 1.0 mm smaller than the smallest confirmed size
(13.0 mm diameter) of a water bead that resulted in an intestinal
obstruction based on the incident data provided by CPSC. The basis for
the proposed size was also extensively discussed in the ASTM F963 water
bead work group meetings. Gel Blaster Inc. and SplatRball support the
ASTM F963 water bead work group's proposal of a 12.0 mm diameter
restriction for water beads. They support CPSC postponing the
development of this final rule to allow the ASTM group to continue
refining revisions that can enhance water bead safety.
Response: Regarding the ASTM proposed 12.0 mm diameter threshold,
as stated in the preamble of the NPR (89 FR 73038), staff are aware of
an incident in which a 13.0 mm diameter expanded water bead caused an
intestinal obstruction in a 13-month-old female. However, this incident
only confirms that a 13.0 mm diameter water bead can cause an
intestinal obstruction. This incident did not involve slightly smaller
water beads, so it does not demonstrate that a slightly smaller water
bead, such as 12.0 mm diameter, could safely pass through the
intestinal tract of the 13-month-old female. Additionally, neither the
incident information nor ASTM's proposed 12.0 mm diameter threshold
account for children younger than 13-months-old, who may have smaller
intestines than older children.
Instead, the NPR cited IDI 230707CBB1698 to establish an
appropriate size to mitigate the hazards associated with water beads.
This incident describes a 3-year-old female who successfully passed
approximately 1,200 water beads. After purchasing and testing a sample
of these water beads, CPSC noted the expanded size ranged from 9.32 mm
and 15.20 mm diameter. Therefore, to ensure the highest level of safety
feasible, the proposed rule limited the gauge size diameter to 9.0 mm,
which was based on the size of the smallest water bead that was known
to pass without causing an intestinal obstruction. However, as
discussed above, based on the response to comments, the gauge size
diameter has been reduced from 9.0 mm to 5.0 mm in the final rule.
Gel Blaster Inc. and SplatRball also request that CPSC postpone the
development of this final rule to allow the ASTM group to continue
refining revisions that can enhance water bead safety. However, to
date, no voluntary standard has been published by ASTM that addresses
the hazards presented by water bead toys. Therefore, the Commission is
issuing this final rule to address the hazards presented by water bead
toys.
5. Further Research Needed on Size Requirement
Comment: Kirksey Croft notes it is crucial to recognize that the
9.0 mm gauge diameter differs significantly from established diameters
for testing choking hazards in other children's products. For example,
the ASTM F963 Toy Safety Standard uses a small parts cylinder with a
31.7 mm diameter opening. Internationally, the European Toy Safety
Standard EN 71-1 covers expanding materials like water beads and
specifies a testing diameter of 31.7 mm. Even the current standard for
expanding materials such as water beads, section 4.40 Expanding
Materials of ASTM F963-23, prescribes a larger 20.0 mm diameter gauge
with applied force, which is already significantly smaller than the
referenced 31.7 mm diameter.
Response: The commenter correctly cites the ASTM F963 Toy Safety
Standard, which uses a small parts cylinder with a 31.7 mm diameter
opening. However, this small parts cylinder is used as a gauge to
simulate the throat size of a child under 3-years-old and determine
what objects or pieces they can potentially choke on. Whereas the 9.0
mm gauge diameter, proposed in the NPR, is based on incident data
showing gastrointestinal blockages caused by water bead toys.
The commenter correctly cites the European Toy Safety Standard EN
71-1 as regulating expanding materials such as water beads, but
incorrectly claims the standard specifies a testing diameter of 31.7
mm. Instead, EN 71-1 specifies that expanding materials, such as water
beads, that when dehydrated fit in the small part cylinder, shall not
expand more than 50 percent of its original size, in any dimension.
The commenter also points out ``even the current standard for
expanding materials such as water beads, section 4.40 Expanding
Materials of ASTM F963-23, prescribes a larger 20.0 mm diameter gauge
with applied force, which is already significantly smaller than the
referenced 31.7 mm diameter.'' However, this 20.0 mm diameter gauge was
developed based on the size of the pyloric sphincter, which leads from
the stomach to the small intestine, within the gastrointestinal tract
of an 18-month-old child. At the time the expanding materials
requirement was created, the pyloric sphincter was thought by the
drafters to be the most likely site where gastrointestinal blockages
would occur. However, as explained in the preamble of the NPR (89 FR
73034), incident data show water beads successfully passing through the
pyloric sphincter before expanding and creating blockages at the
ileocecal valve, which leads from the small intestine to the large
intestine. Therefore, the 9.0 mm diameter gauge proposed in the NPR was
justified based on this incident data, to prevent blockages at the
ileocecal valve, which is a more appropriate anatomical structure on

[[Page 57833]]

which to base the diameter of the test gauge than the pyloric
sphincter.
Lastly, as explained above, additional incident information and
studies from commenters have convinced CPSC to modify the gauge size
diameter from 9.0 mm to 5.0 mm for the final rule.
6. Mechanical Test Should Mirror Intestines
Comment: Brianna Zimmerman is doubtful that only exposing water
beads to gravitational force during the gauge test is replicative of
the forces of a child's digestive tract. Typical esophageal peristalsis
pressure is variable and dependent on multiple factors. To truly be
representative of an ingestion scenario, the gauge test should account
for the wide range of pressures that water beads will experience in the
gastrointestinal tract.
Response: Although placing the expanded water bead in a gauge and
only relying upon the force of gravity to verify if the water bead
passes through is not representative of what happens to water beads
within the digestive tract, it is the most stringent test and therefore
achieves the highest level of safety feasible. Applying other forces to
the water bead as described in the comment could assist a water bead in
passing through the gauge or by breaking the bead into smaller
fragments that pass through the gauge, and if such forces were included
in the test, it would not achieve the highest level of safety feasible.
Comment: Savannah Mesel notes the proposed gauge test for water
beads to be expanded in deionized water prior to the water beads being
tested, but the commenter contends deionized water is vastly different
from the harsh environment of the stomach and intestines. Additionally,
Brianna Zimmerman states that distilled water is used for testing,
which is vastly different from the harsh environment of the stomach and
intestines.
Response: Deionized water is being used for the gauge test to be
consistent with the test methods specified in section 4.40 Expanding
Materials of ASTM F963-23. As noted in the preamble of the NPR (89 FR
73037), the largest expansion occurs in deionized water. Distilled
water is not used in testing. Additionally, the stomach is a more
acidic environment, in which water beads will not expand to their full
potential. In contrast, the small intestine is a more neutral
environment (similar to water) in which water beads will expand to
their full potential. Water beads spend more time in the small
intestine than in the stomach, and so grow in a more neutral
environment, compared to the stomach.
7. Caliper Measurements
Comment: Brianna Zimmerman asserts the proposed rule does not state
with specificity how the standardized caliper measurements are to be
taken to determine the size increase between the dehydrated and
hydrated form. The commenter asserts that instructions in the proposed
rule are not sufficiently specific to ensure all operators are
measuring water beads using the same method.
Response: The issue raised by the commenter concerning caliper
measurements in the proposed rule is now moot because of the removal of
the 50 percent expansion limit from the final rule and the test method
will no longer include a step requiring the use of calipers to measure
and calculate expansion amount. Instead, the expanded water bead will
be tested using the 5.0 mm diameter gauge after full expansion has been
achieved.
8. Accessibility Test Questions
Comment: Intertek Shenzhen asks what the rule means by ``water
beads removed from a toy.'' Does it mean to apply the 16 CFR 1500.50-53
use and abuse tests of toys which tests for accessibility.
Response: Use and abuse testing under 16 CFR 1500.50-53, which is
used to determine accessibility, is also required by ASTM F963-23, and
includes various impact, tension and torque tests to determine
accessibility of toy components. However, this use and abuse testing
does not apply to this rule. This rule applies to all water bead toys
and other toys that contain water beads, regardless of accessibility of
the water beads. The rule is more stringent than mandating use and
abuse testing for accessibility because the rule requires any water
beads contained within a toy to be removed from the toy to test and
measure expansion per the requirements in the rule.
Comment: The Toy Association asserts the NPR would require that all
water beads, even those contained within a toy, to meet the performance
requirements, but existing CPSC standards for products that pose
similar hazards rely on ensuring inaccessibility as a primary
safeguard. The commenter asserts that CPSC has not provided any reason
why maintaining inaccessibility cannot be an effective requirement
here. Similar to water beads, high-powered magnets and button cell
batteries pose specific hazards if ingested. In both of those cases, if
they are contained within a toy, standards apply to test for
accessibility. The NPR contends that water beads contained within toys
may become accessible by a child biting into the product and liberating
the water beads. The commenter states that there is no explanation as
to why this risk is any different from that posed by a high-powered
magnet or a button cell battery.
Response: The commenter suggests that there should be an
accessibility test performed before subjecting water beads contained
within a toy to the proposed requirements. However, CPSC is aware of
multiple incident reports stating that toy squeeze and stress balls
have had their internal water beads pop out over time and other
incident reports of children biting into the toy ball and ingesting
water beads. These incidents could potentially be addressed through
test procedures to represent long-term cyclic squeezing and tests to
represent biting of these toy squeeze and stress balls. However, ASTM
F963-23 currently has only impact, tension and torque test procedures
for toys to determine accessibility, but it does not currently have
test procedures to adequately address the long-term cyclic squeezing
and occasional biting of toy squeeze and stress balls. Rather than
creating additional use and abuse testing requirements, the rule
applies a uniform test for water beads that ensures that water beads in
a toy are not hazardous. Therefore, the rule requires that water beads
contained within a toy, such as a squeeze or stress ball, be subject to
the rule to achieve the highest level of safety feasible.

C. Acrylamide Requirements

1. Acrylamide Limit Should be Higher or Removed
Comment: Alan Kaufman and the Toy Association assert that CPSC has
mistakenly adopted the Agency for Toxic Substances and Disease
Registry's (ATSDR) acute-duration exposure limit of 0.01 mg/kg-day,
which calculates to 65 [micro]g based on the body weight of a small 6-
to 8-month-old female. Alan Kaufman and the Toy Association state there
are numerous issues with the ATSDR exposure limit, as noted below:

1. The commenters both state that it appears that ATSDR relied
almost entirely on data from one study to derive the minimal risk
level (MRL), Sublet, et al. (1989). These data were derived from
feeding male rats acrylamide in distilled water for five days at
varying doses in two separate experimental runs. These males were
then allowed to mate with untreated females, which were sacrificed
at 15 days post-mating and the fetuses examined for developmental
and implantation anomalies, a toxic endpoint that has limited
applicability to children. These raw data were fed into a
Physiologically

[[Page 57834]]

Based Pharmacokinetic (PBPK) model developed by Sweeney, et al.
(2010) to estimate blood levels. This derivation utilized
uncertainty factors of three for extrapolation from animals to
humans with dosimetric adjustment and 10 for human variability,
which collectively have the effect of arbitrarily reducing the MRL
by a factor of 30.
2. The commenters both state CPSC is mistakenly using ATSDR's
derived acute-duration exposure limit of 0.01 mg/kg-day; ATSDR
defines acute-duration oral exposure as daily or continuous dosing
for up to 14 days. However, several studies have dosed humans at up
to 3 mg/kg as a single oral dose with no ill effects. The commenters
state that one single oral exposure is what needs to be addressed
for risk of ingestion by a child. A level approximating 3 mg/day, or
more, is a more appropriate limit (reference: Fennell and Friedman,
2005).
3. The commenters both state that ATSDR's exposure limit is
based on rodent studies, and that acrylamide metabolism differs
significantly between rodents and humans. Rodents metabolize
acrylamide largely via the CYP 2E1 oxidation pathway to glycidamide,
and humans metabolize acrylamide via conjugation with glutathione to
a much greater extent.
4. The commenters both explain that acrylamide is also known to
occur in many foods at levels that can create higher exposures than
the proposed acrylamide limit in water beads. Both commenters
provided several examples of acrylamide in food, with potato chips
having up to 8440 ppb acrylamide per U.S. FDA or up to 9670 ppm per
ATSDR. Alan Kaufman also noted that vegetarians and vegans have much
higher blood levels of metabolites due to their plant-based diets.
5. In addition, both commenters assert that there is evidence
that a significant amount of acrylamide is produced by the body
itself. The German Federal Institute for Risk Assessment (BfR) has
studied this issue and found that up to 48 percent (blood) and 25
percent (urine) of C13-labeled acrylamide metabolites are generated
by the body itself (reference: Monien, et al., 2024).

The commenters contend that the above points indicate that CPSC's
proposed acrylamide limit is several orders of magnitude too low. The
commenters also assert it is clear that ingestion and endogenous
production of significant amounts acrylamide is a daily event for most
humans, and the human body has evolved mechanisms to rapidly metabolize
and excrete acrylamide without apparent adverse health effects.
Response: The responses below are presented in the same order as
the issues raised in the comment above.
1. The commenters' description of the derivation of the ATSDR acute
exposure MRL of acrylamide appears to be accurate. Their concern about
the reproductive toxicity endpoint not being relevant to children is
noted. However, the ``no observed adverse effect level'' (NOAEL) in the
Sublet et al. (1989) study was 5 mg/kg-day. Other acute or short-term
studies described in the ATSDR Toxicological Profile of Acrylamide
included Burek et al. (1980) and Tyl et al. (2000b), and both of these
studies reported dose-dependent health effects in acrylamide-treated
animals as low as the 15 to 20 mg/kg-day range with NOAELs of 5 mg/kg-
day, the same as NOAEL in the Sublet study. The Burek et al. (1980)
study reported behavioral and histological signs of neurotoxicity in
dose groups above 5 mg/kg-day. The Tyl et al. (2002b) study reported
reduced body weight in animals given 15 mg/kg/day acrylamide for 5
consecutive days, which could be related to neurological effects. Staff
notes that these studies with neurological effects have the same NOAEL
value as the critical Sublet et al. (1989) study. ATSDR applied PBPK
and benchmark dose modeling to data from the Sublet et al. (1989) study
to derive the acute-duration oral exposure MRL, using more advance
techniques than a traditional point of departure and uncertainty
factors approach. Staff do not currently have the resources to perform
PBPK modeling, and the Burek et al. (1980) and Tyl et al. (2000b) study
reports did not provide enough quantitative data for staff to apply
benchmark dose methods. Therefore, applying a traditional approach,
staff derived an acute oral acceptable daily intake (ADI) for
acrylamide by using the 5 mg/kg-day NOAEL from Burek et al. (1980) and
Tyl et al. (2000b) and an uncertainty factor of 10x for interspecies
variability and 10x for within species variability. The resulting acute
oral ADI is 0.050 mg/kg-day or 50 [micro]g/kg-day. This value is five
times the MRL used in the originally proposed acrylamide extraction
limit, which was 0.01 mg/kg-day. Adjusting for the chosen body weight
of 6.5 kg, the revised acrylamide extraction limit for the final rule
is 325 [micro]g (50 [micro]g/kg-day x 6.5 kg = 325 [micro]g/day). Staff
understand the commenters' concerns that reproductive toxicity as the
critical effect in the Sublet et al. (1989) study may be of limited
relevance to young children ingesting water beads. The acrylamide limit
for the final rule is based on neurotoxicity endpoints for which
relevance to children is more apparent.
2. While the commenters suggest that there are several human
studies of acute high-dose exposure to acrylamide, they only cited one
study. The Fennell and Friedman (2005) paper cited was a toxicokinetics
study conducted in adult male subjects and did not measure the
sensitive health effects that could affect children. Although it is
CPSC's policy to favor quality human data over animal studies in
evaluating dose-response and risk, the available human data for acute
acrylamide exposure does not address the exposure and hazard scenario
for acrylamide in water beads.
3. The commenters are correct that there are differences in the
dominant pathways by which humans and rats metabolize acrylamide. The
CYP2E1 pathway converts acrylamide into the active metabolite
glycidamide, which is the active component in many of the toxic effects
of acrylamide. The enzyme glutathione S-transferase (GST) conjugates
acrylamide to detoxify and promote urinary excretion. Rats and humans
have both pathways, and GST is the primary pathway in adult humans.
However, young children have lower GST activity than adults, and staff
do not have enough data to compare the relative GST and CYP2E1 activity
levels between toddler-age human children versus adult rats. ATSDR
stated, ``It is not known whether children are more susceptible than
adults to the effects of acrylamide.'' Given the uncertainty in the
limited available data, staff errs on the side of caution and consider
the rat studies appropriate for assessing the risk of acute acrylamide
exposure to children.
4. Staff are aware of food as a chronic exposure source for
acrylamide. CPSC's objective in the rule is to limit the additional
acute exposure to acrylamide (above baseline daily exposures from other
sources) to children who ingest water beads. The animals used in the
toxicity studies were likely exposed to dietary acrylamide in their
commercially produced rodent feed, which is typically made of grains
that are dehydrated by exposure to heat (conditions that produce
acrylamide). Because of this, the animal study already accounts for
dietary acrylamide exposure, although staff concedes that the amount of
daily dietary acrylamide exposure may be variable in both humans and
lab animals. Staff have taken note of Alan Kaufman's statement about
plant-based diets leading to greater acrylamide exposure than mixed
(omnivorous) diets in one study, but this information of different diet
types is not relevant to setting the limit for acrylamide in water
beads for this rule.
5. After staff's review of recent literature on endogenous
acrylamide (e.g., Goempel, et al., 2017), including the Monien et al.
(2024) and BfR (2024) reports cited by the commenter, it appears that
the endogenous production of acrylamide metabolites is a proposed
hypothesis with no known or confirmed

[[Page 57835]]

biochemical process or pathway. The Monien et al. (2024) and BfR (2024)
reports described potential confounding exogenous sources of acrylamide
in the ``raw food'' subject meant to represent an acrylamide-free diet.
Monien et al. (2024) reported that the estimated amounts of
endogenously produced acrylamide corresponded to dietary acrylamide
doses of 0.2 to 0.4 [micro]g/kg-day, which is less than 1 percent of
the 50 [micro]g/kg-day acute oral ADI used to derive the acrylamide
limit in the final rule.
Comment: The Toy Association contends that the NPR is misleading in
stating that ``ASTM F963 does not specifically mandate testing for
hazardous chemicals,'' and then stating an acrylamide testing mandate
is required. While the Federal Hazardous Substances Act (FHSA) does not
mandate acrylamide testing specifically, FHSA does mandate that
materials must comply with the requirements of FHSA, as is required in
section 4.3.1 Hazardous Substances of ASTM F963-23. As such, the
commenter asserts that the statement that an acrylamide test mandate is
missing is not a basis for arguing a need for the proposed acrylamide
test.
Response: As noted in the preamble of the NPR (89 FR 73034), under
section 4.3 of ASTM F963-23, there is a general FHSA toxicity and
hazardous substances compliance requirement for all toys. However,
specific levels of compliance are not identified in section 4.3. Also,
as noted in the preamble of the NPR (89 FR 73034), 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. While CPSC does not have incident data
reflecting acute acrylamide poisoning from water beads, the presence of
acrylamide in several water bead products that CPSC tested demonstrates
a potential chemical hazard. For example, in March 2024 CPSC announced
unilateral warnings 32 33 for two water bead toy products
that contained levels of acrylamide in violation of the FHSA. If those
water beads were ingested, it does pose a risk of acute toxicity to
children from acrylamide exposure.
---------------------------------------------------------------------------

\32\ <a href="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-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com</a>.
\33\ <a href="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">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</a>.
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Comment: The Toy Association and China World Trade Organization
(WTO)/Technical Barriers to Trade (TBT) National Notification & Enquiry
Center notes that the only water beads that were deemed as having
dangerous levels of acrylamide by CPSC are those sizes that would not
comply with the proposed rule's size limits. This is the case using
either the 9.0 mm diameter limit proposed in the NPR or the 12.0 mm
diameter limit proposed in the ballot by the ASTM F963 water beads
working group. The commenters state that these large water beads,
having high levels of acrylamide, would be removed from consideration
because they would not meet either of the proposed size requirements.
Therefore, they assert that the test data does not support the
assertion that an acrylamide test for all water beads is necessary.
Response: CPSC is not aware of any data that supports the
commenters assertion that all water beads in compliance with the size
requirement would also necessarily comply with the acrylamide limit,
making the acrylamide test unnecessary. While CPSC found hazardous
levels of acrylamide in two water bead toy products that would not meet
the proposed size limits, there is no evidence to suggest that smaller
water beads could not possess toxic levels of acrylamide. Therefore,
because CPSC is aware of hazardous levels of acrylamide in water bead
toys, the acrylamide requirement in the rule is necessary to address
the hazard and achieve the highest level of safety feasible.
2. Acrylamide Limit Should Be Lower
Comment: That Water Bead Lady, Petia Paneff, Sara Desousa, and Jane
Miller state the minimal risk level (MRL), cited in the rule for the
acrylamide limit, is based on fertility testing conducted on male Long
Evans hooded rats in a 1989 study. The commenters note, use of that
study is highly questionable when applied to the exposure levels
expected in infants and toddlers. Additionally, CFA notes that the
ATSDR describes in its toxicological profile of acrylamide: ``children
are not small adults. They differ from adults in their exposures and
may differ in their susceptibility to hazardous chemicals.'' The
commenters recommend that CPSC consider adopting the more stringent
intermediate/chronic oral MRL of 0.001 mg/kg-day instead of the acute
oral MRL of 0.01 mg/kg-day. The commenters assert that the
intermediate/chronic exposure model will better account for the fact
that many cases of consumption of water beads remain unnoticed and may
continue beyond acute exposure.
Response: As noted in the preamble of the NPR (89 FR 73038),
``children's possible exposure to acrylamide after ingesting water
beads would likely be a single, infrequent event (possibly including
multiple water beads in a single event). Therefore, the appropriate
exposure scenario would be acute rather than intermediate/chronic.''
Additionally, the original proposed acrylamide limit of 65 [micro]g was
based on an acute-duration MRL of 0.01 mg/kg-day. However, due to
information provided by other commenters and as explained above, the
updated acrylamide limit in the final rule is set at 325 [micro]g which
is based on an acute oral acceptable daily intake (ADI) of 0.05 mg/kg-
day.
3. Justification for Acrylamide Requirements
Comment: The Toy Association notes superabsorbent polymers are
usually made of either polyacrylate, polyacrylamide, or a combination
of the two. The Toy Association states that there is no mention in the
NPR that unreacted monomers present a small percentage of the resulting
polymer, which is bound within the polymer matrix. Furthermore, they
state that while polyacrylate is a common material for water beads, its
polymerization process does not utilize acrylamide monomer. The Toy
Association asserts that a significant proportion of water beads either
do not have acrylamide monomer present as a contaminant at all, or have
it present in very low amounts. Gel Blaster Inc. also asserts that
acrylamide, if present at all, would be present well below the proposed
acrylamide limit.
Response: CPSC recognizes that not all water bead products are
manufactured using acrylamide. However, CPSC has found extractable
acrylamide at hazardous levels in two water bead samples, necessitating
acrylamide testing for all water bead products, regardless of
manufacturing, in order to ensure product compliance with the
guidelines described in this final rule. Any water bead toys that do
not contain acrylamide or that contain extractable acrylamide less than
325 [micro]g per one large water bead or per 100 small water beads,
meet the acrylamide limit requirement in the rule.
Comment: China WTO/TBT National Notification & Enquiry Center notes
that separating water beads into small and large sizes and testing 100
small water beads or one large water bead, and the general test method,
are different than the European Toy Safety Standard EN

[[Page 57836]]

71-9. The commenter states, the U.S. is required, by the principle of
transparency, to provide scientific evidence of the sampling method and
experimental approach.
Response: The NPR was transparent and provided incident information
and support for the separation of small and large water beads in the
test method. As noted in the preamble of the NPR (89 FR 73038), the
quantities of small and large water bead toys assumed to be ingested
are based on water bead toy ingestion incidents and published case
reports. Incident data indicate that children tend to ingest only one
or two large water beads, while there is evidence of children ingesting
hundreds of small water beads.\34\
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\34\ 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.
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Regarding the 4.0 mm dimension cut-off between ``small'' and
``large'' water beads, CPSC found that water beads tested by staff, and
water beads noted in incident data, tend to fall into two size ranges:
either from 1.5 mm to 3.0 mm diameter, or from 5.0 mm to 8.0 mm
diameter. This was the basis for staff defining any water bead less
than 4 mm in all dimensions as a ``small water bead'' and any water
bead having any dimension of 4 mm or greater as a ``large water bead.''
Therefore, the test method covers testing for both scenarios.
Finally, the acrylamide limits from the European Toy Safety
Standard EN 71-9 were developed to address acrylamide exposure
following long-term licking, sucking, and chewing of toys that are
intended to be mouthed for a significant amount of time. In contrast,
water bead toys have not been found to be mouthed, sucked, or chewed
for long periods of time, and are also not intended to be. Therefore,
the rule does not adopt the acrylamide testing procedures and limits of
EN 71-9.
Comment: Emily Threatt contends that due to the high number of
ingestion incidents and the hazards of long-term acrylamide exposure,
the more stringent standard for acrylamide requirements of the European
Toy Safety Standard EN 71-9 should be adopted. The NPR states that EN
71-9 is not appropriate because it was designed to address acrylamide
exposure following the long-term licking, sucking, and chewing of toys
intended to be mouthed. The NPR also states water beads are not likely
to be mouthed for a significant amount of time. The commenter states,
although water beads are not intended to be mouthed, they are mouthed,
and the water bead regulation should reflect this reality.
Response: As stated in the preamble of the NPR (89 FR 73033), the
European Toy Safety Standard EN 71-9 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 of such products that are mouthed for a significant
amount of time are teethers, rattles, and other hand-held soft plastic
toys for young children. In contrast, water bead toys are not intended
to be mouthed, nor are they likely to be mouthed for a significant
amount of time. According to incident information, water beads are
typically ingested relatively quickly and are not mouthed for a
significant amount of time; thus, EN 71-9 is not appropriate to use for
the acrylamide requirements in the rule.
4. Acrylamide Test Recommendations and Questions
Comment: The Toy Association contends that it is highly unlikely
for younger children, such as 6-8 months of age, which was used to
estimate the body weight and determine the acrylamide limit, to be
physically or developmentally able to obtain 100 small water beads in
one instance. The Toy Association states that the 100 small water bead
value relates to older children. The Toy Association asserts that it is
not appropriate to use a chosen test value of 100 small water beads
while also using the selected body weight.
Response: The Commission agrees that children 6- to 8-months of age
are less likely than older children to obtain and consume 100 small
water beads in a single incident. However, the number of 100 small
water beads used in the rule is within the range of documented
ingestion incidents, and because of the extremely small size of some
dehydrated water bead toys, it is foreseeable that some children in the
6-to 8-month age range who have repeated access to small water beads
could consume this many over multiple exposures during the course of a
day. Additionally, this value includes a safety factor as a buffer to
account for additional uncertainties. Therefore, the number of 100
small water beads used in the test method for small water beads is a
more stringent standard for the testing quantity that would further
reduce the risk of injury from acute acrylamide exposure in water bead
toys to achieve the highest level of safety feasible for water bead
toys.
Comment: Max Williams asserts that the test procedure for
acrylamide testing proposed in the NPR, which involves a pH neutral
solution, does not account for the variations in pH levels that might
be present in the stomach or the small intestine.
Response: Although the test method in the rule does not account for
pH variation, data gathered by CPSC supports the use of a simplified
extraction solution with one pH level as opposed to a testing protocol
involving solutions with different pH levels. CPSC previously performed
testing designed to simulate water beads traveling through the human
digestive tract. Water beads were extracted in a pH-neutral solution to
mimic the pH of saliva, followed by a 0.07 N hydrochloric acid solution
to mimic the pH of stomach acid, and finally followed by a slightly
basic solution to mimic the pH of small intestinal fluid. During this
testing, it was noted that of the total amount of acrylamide that was
extracted, most leached within the first 24 hours of testing. For
simplicity, CPSC tested a 24-hour extraction of water beads in
deionized water and observed acrylamide extraction on the same order of
magnitude as the multi-day extractions performed across various pH
levels. Based on this testing, staff determined that a 24-hour
extraction in deionized water is sufficient to estimate acrylamide
exposure.
Comment: Petia Paneff and Austin Woods assert a 0.1 mm difference
in the diameter of a water bead is unlikely to have any meaningful
impact on the potential consumption of the number of water beads. They
argue that a child would be just as likely to ingest a handful of 4.0
mm diameter water beads as they would 3.9 mm diameter water beads,
potentially resulting in a significant increase in acrylamide exposure.
Austin Woods suggests creating additional size designations with
different numbers of water beads tested in each designation, while
Petia Paneff recommends that acrylamide content in water beads should
be evaluated based on the dehydrated weight of the beads.
Response: The commenters are correct that a 0.1 mm difference in
the diameter of a water bead is unlikely to have any meaningful impact
on the potential consumption of the number of water beads and are
calling into question the reasoning of the 4.0 mm diameter size cutoff
between testing one large water bead (4.0 mm diameter or greater) and
100 small water beads (less than 4.0 mm diameter). Based on the
products tested by CPSC, staff observed that size differences between
``small'' and ``large'' water beads of water bead toys currently on the
market were distinct enough that

[[Page 57837]]

the size categorization could be rationally made. All small water beads
tested measured, at or below, 3.0 mm diameter (prior to hydration),
while all large water beads tested measured well over 4.0 mm in
diameter (prior to hydration). The cutoff size of 4.0 mm diameter was
chosen because all small water beads were well below this size, while
all large water beads were well above it. Practically speaking, it is
very unlikely there will be many 3.9 mm diameter water beads, which are
on the edge of 4.0 mm diameter small vs large water bead threshold,
because virtually all of the water beads are significantly over or
under the 4.0 mm. The decision to test a certain number of water beads
was based on incident data, which found that children would typically
only swallow one or two large water beads, while small water beads
could be ingested in much larger numbers. Regarding the suggestion to
test water beads based on dehydrated weight, determining the amount of
water beads that a child can grasp is more appropriately based on
volume and not dehydrated weight because the smaller water beads have a
very low mass, and weight is not a limiting factor on the number of
water beads that can be grasped by a child. Basing the extraction
parameters on incident data allowed staff to better model and determine
the possible acrylamide hazard presented by a product.
Additionally, because not all water beads are spherical when
dehydrated and can be different shapes such as cubes and stars, as
explained in section VI.C of this preamble, section 1250.4(c).2 of the
final rule has been revised to define a small water bead as a water
bead being ``less than 4 mm in all dimensions prior to hydration'' and
define a large water bead as a water bead being ``greater than or equal
to 4 mm in any dimension prior to hydration.''
Comment: That Water Bead Lady and CFA state CPSC should investigate
whether water beads break apart within the digestive tract releasing
additional acrylamide. Max Williams and AAP also suggest investigating
how much acrylamide is released when water beads are chewed and break
apart before ingestion.
Response: CPSC has investigated whether water beads break apart
within the digestive tract. According to incident data reviewed by
staff, and as discussed in the preamble of the NPR (89 FR 73033),
ingested water beads do not break apart in the stomach or small
intestine but instead remain whole when successfully passing through
the digestive tract or when creating a blockage. CPSC has not found
evidence of children chewing water beads before or after expansion.
Comment: That Water Bead Lady states CPSC should investigate the
effects of acrylamide on the enteric nervous system, mucosa, gut flora,
bacteria, and gastrointestinal tissue under simulated conditions of
both non-obstruction and obstruction.
Response: The acrylamide limit requirement in the rule is intended
to limit the amount of acrylamide intake due to acute acrylamide
exposure when water bead toys are ingested. By preventing this exposure
in the first instance, it is unnecessary to further research the
effects of acrylamide on the enteric nervous system, mucosa, gut flora,
bacteria, and gastrointestinal tissue. The Commission considers the
acrylamide limit requirement in this rule adequate to address the
hazards associated with acute exposure from acrylamide in water bead
toys without a need for the type of study suggested by the commenter,
which could take years to complete while injuries and death continue to
occur.
Comment: SGS seeks clarification on the following language in the
NPR: ``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.'' The commenter asks if the volume of remaining water means
``the volume of water remaining after the water beads absorb water'' or
if it means ``the water volume added to the dehydrated water beads
before the water extraction.'' The commenter also asks if the volume of
remaining water is used as the final volume in the calculation of
acrylamide content, or if the volume of water added to the dehydrated
water beads, before the water extraction, is used as the final volume
in the calculation.
Response: The ``volume of remaining water'' refers to the volume of
water that remains in the container after the water beads have absorbed
water during the 24-hour extraction period. It does not refer to the
volume of water initially added to the dehydrated water beads. The
``volume of remaining water'' is used in the final calculation. It is
measured and then multiplied by the measured acrylamide concentration,
given by the analytical instrument used to measure acrylamide
concentration, to determine the mass of acrylamide extracted. The
volume of water originally added to the dehydrated water beads is not
used in the calculation of extracted acrylamide.
Comment: SGS inquires if CPSC has official guidelines on how to
completely separate water beads after absorbing water from the
remaining water.
Response: While there are no official guidelines regarding the
separation of the water beads from the remaining water following the
extraction, any means may be used so long as the full volume of
remaining water can be separated and measured, and so long as the
method used for separation would not add or remove acrylamide from the
water to be analyzed. Care should be taken to avoid any losses of the
remaining water during separation, as an accurate volume measurement is
crucial for calculating an accurate mass of extracted acrylamide.
Comment: SGS asks a question regarding the following language in
the NPR: ``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 water bead growth without unnecessarily diluting the
concentration of extracted acrylamide.'' The commenter asks if CPSC has
any official guidelines on how to determine the volume as the water
volume may affect the result of the acrylamide extraction.
Response: Due to large variations in water bead type, size, and
growth potential, CPSC does not have official guidelines on the volume
of water to use for extractions, as there is no volume of water that
will be appropriate for all water bead toys. Staff recommend first
performing a test trial for each type of water bead from each product
to determine an appropriate volume of water to use for those water bead
extractions. However, these test trials would not be used for the
analysis of acrylamide but rather are used to determine the appropriate
volume of water that will allow for full growth of the water beads
while ensuring that they remain fully submerged in water during the
entire 24-hour extraction period. Care should be taken to choose an
appropriate volume when using this approach while also minimizing
unnecessary dilution of any acrylamide that may be extracted. Test
trials should be conducted under the same extraction conditions
required in the rule (water bath at 37 [deg]C, 30 revolutions per
minute, 24 hours) which are unchanged from the NPR.

[[Page 57838]]

D. Marking, Labeling, and Instructional Literature Requirements

1. Warning Content: Hazard and Consequences
a. Clarifications About Water Bead Growth
Comment: Ayden White, Christian Beasley, Mollie Price, Albert
Tacornal, Austin Watson, Zach Gilbert, AAP, and U.S. PIRG suggest
revisions to the warning to clarify or add details about the growth of
water beads. Ayden White, Mollie Price, Albert Tacornal, Zach Gilbert,
AAP, and U.S. PIRG suggest that the warning state more explicitly that
water beads can expand over time or can grow after ingestion. Some
commenters, such as U.S. PIRG, suggest adding descriptions of the
amount of growth by stating how large water beads can get, while Zach
Gilbert suggests adding statistics to describe how the beads can expand
to multiple times their original size (e.g., percentage increase).
Christian Beasley and Austin Watson suggest that the warning include
language explaining that products can grow by absorbing water, other
liquids, or body moisture, with one commenter, Austin Watson, stating
that consumers might not recognize the potential for expansion after
ear insertions, relative to ingestions, because the ear environment is
seemingly dryer. Three commenters offer specific revisions to the
initial sentence of the warning to address one or more of these growth-
related issues. Christian Beasley suggests, ``This product contains
water beads that can grow larger when exposed to water or water-based
fluids.'' Mollie Price suggests, ``This product contains water beads
that [can] grow larger within the [human] body.'' AAP suggests, ``This
product contains water beads that can grow much, much larger when
the[sic] absorb water or any liquid. This includes bodily fluids if the
beads are swallowed or placed in the nose or ears.''
Response: The Commission agrees that the first sentence of the
warning labels in the proposed rule (Figures 3 and 4), which describe
the growth of water beads, should be revised to clarify that the
expansion of these beads can occur within the body, specifically, after
ingestion or insertion. To address the comments related to this
concern, the final rule has revised this sentence in Figures 4 and 5
(renumbered) from ``This product contains water beads that grow
larger,'' to, ``Contains water beads that can grow larger when
swallowed or inserted in the ear or nose.'' The Commission does not
agree that specifying the precise amount by which the beads can grow is
necessary, given that the subsequent sentence already communicates this
information qualitatively by stating that they have blocked intestines.
The Commission also concludes that specifying that growth can occur
when exposed to liquids other than pure water or to body moisture is
unnecessary, because the warning labels' revised language now
explicitly states that growth can occur ``when . . . inserted in the
ear or nose.'' The lack of this information in the NPR warnings was the
basis for the commenters' suggestions for including information about
other bodily fluids. By adding ear and nose insertions to the hazard
identification sentence, the Commission also addresses concerns from
commenters that references to ear and nasal insertions were not
sufficiently prominent by being mentioned only at the end of the
warning labels.
b. References to Death
Comment: Max Williams, Ryan Jernigan, Kirksey Croft, and one
anonymous commenter express concerns about the warning labels'
reference to death and use of the phrase, ``Your child can die too.''
Max Williams and Kirksey Croft suggest that emphasizing deaths in the
warnings is inappropriate, especially in comparison to warnings for
other hazards, such as choking, that are associated with more
fatalities but do not explicitly refer to death. Max Williams also
notes that deaths are very rare, with only one known death involving
water beads. Max Williams and Ryan Jernigan describe the phrase, ``Your
child can die too,'' using terms such as paternalistic, inflammatory,
alarmist, and fearmongering, and claim that this phrase could lead
consumers to either ignore the statement or to no longer take warnings
seriously. An anonymous commenter states that the phrase, ``Your child
can die too,'' is redundant with the preceding sentence, which already
addresses the potential for death. Generally, commenters on the phrase,
``Your child can die too,'' recommend its removal. However, Eleanor
Grundberg refers to this phrase in more positive terms, stating that it
will likely grab the attention of consumers, and Daniel Mendoza
suggests that this phrase ``emphasizes the urgency of the hazard and is
likely to resonate with caregivers.''
Response: The warning labels' reference to death is appropriate
given the known potential consequences of ingesting water beads.
However, the use of the phrase, ``Your child can die too,'' is
unnecessary given the already-explicit reference to death in the
warnings and the relative rarity of fatalities, which presumably will
become even more rare as the performance requirements of the rule go
into effect. The phrase, ``Children have DIED,'' already emphasizes the
urgency of the hazard and is likely to motivate consumers to act. Thus,
the phrase, ``Your child can die too,'' has been removed from the
warnings shown in Figures 4 and 5 of the final rule. Additionally, the
sentence describing how children have died has been revised in Figures
4 and 5 to be more concise by changing the phrase, ``after swallowing
water beads because the beads blocked,'' to ``when the beads blocked,''
because the initial sentence of the final rule's warnings already
identify swallowing explicitly.
c. Additional Ingestion-Related Information
Comment: Eleanor Grundberg, Ryan Jernigan, Zach Gilbert, and U.S.
PIRG suggest that the warning include additional details related to the
ingestion hazard. Ryan Jernigan, Zach Gilbert, and U.S. PIRG suggest
that the warning refer to hospital-related treatments, such as
hospitalization statistics or the potential for emergency surgery.
Eleanor Grundberg suggests that the warning include the following
language about the symptoms of intestinal blockages, to reduce the
potential for misdiagnosis by parents: ``This product may cause
lethargy, distress, dehydration, loss of appetite, fever, fatigue, and
abdominal pain when an expanded water bead blocks the small
intestine.'' Jacob Lowe suggests that all toys that have acrylamide
should have a warning label.
Response: We disagree with commenters suggesting that the warnings
refer to hospital-related treatments resulting from ingestions.
Although ingestion-related hospitalizations and other non-fatal
consequences are more common than fatalities, the potential for death
from ingestions is likely to be a stronger motivator for consumers and
is highlighted in the warning labels. However, we agree that there
would be value in addressing the potential for hospital-related
treatments in the context of ear and nose insertions, and this is
discussed below in response to comments about non-ingestion hazards.
The Commission appreciates the comments about adding language
regarding the symptoms of intestinal blockages but concludes that
adding this information to the warning is not appropriate at this time.
The intent of the warning labels is to identify the

[[Page 57839]]

ingestion and insertion hazards and to instruct consumers about how to
avoid them. Prioritizing and limiting the information to be included on
a warning label is important to hold, or maintain, a consumer's
attention after the warning has been noticed, and the symptoms of
intestinal blockages are not especially diagnostic, in that they do not
point consumers to a single, unambiguous cause (i.e., ingested water
beads). Thus, although additional information about potential symptoms
could be useful, this information would be more appropriate for
manufacturers to consider including within the instructional literature
rather than on the warning labels. Finally, regarding Jacob Lowe's
suggestion of applying warning labels to all toys containing
acrylamide, this comment is outside of the scope of the rulemaking.
However, if the Commission finds evidence of hazards presented by
acrylamide in toys other than water beads in the future, then
regulatory activity may be considered.
d. Non-Ingestion Hazards
Comments: Kayla O'Connor, Caitlin Slusarski, Kayla O'Connor,
Christian Beasley, Jake Peterson, John Oldham, Albert Tacornal, Austin
Watson, Zach Gilbert, Consumer Reports, and four anonymous commenters
suggest not limiting the hazard and consequence information in the
warnings to the ingestion hazard, and to include information related to
other water-bead hazards. Many comments emphasize the need for
information on ear and nose insertions and on inhalations or
aspirations. Mollie Price and Austin Watson identify particular
consequences of interest related to insertions, including deafness or
permanent hearing loss, invasive surgery, and seizures. Another
commenter, John Oldham, suggests the following language about the
insertion and inhalation hazards: ``If inhaled into the lung, this
product can cause unconsciousness and the inability to deliver oxygen
to the brain; if inserted into the ear, this product can damage ear
structure or hearing loss; and if inserted into the nose, this product
can cause bleeding, fever, or nasal swelling.'' Caitlin Slusarski,
Austin Watson and Zach Gilbert suggest that the warnings address other
hazards such as the choking hazard and the toxicity of water beads. An
anonymous commenter suggests adding language to describe the water
beads' carcinogenic properties or the potential for acrylamide
toxicity. Christian Beasley also suggests the following warning:
``Water beads are composed of absorbent polymers, which can contain
acrylamide monomer--a chemical that can be hazardous when ingested.''
Consumer Reports suggests restricting the ability of manufacturers to
use the term ``non-toxic'' in their labeling.
Response: The Commission agrees with commenters that the hazard
description in the warnings for water beads should not be limited to
the ingestion hazard, given the frequency and potential severity of the
insertion hazard. As discussed earlier, the final rule has revised the
initial sentence of the warnings in Figures 4 and 5 (renumbered from
Figures 3 and 4 in the proposed rule) to state that beads also can grow
when ``inserted in the ear or nose.'' In addition, the warnings in the
final rule add information describing the potential consequences of the
insertion hazard. Specifically, after the sentence describing the
potential for death from ingestions, the warnings in Figures 4 and 5 of
the final rule add the sentence, ``Inserted beads have resulted in
surgeries.'' This addition is consistent with commenters' request for
information pertaining to the other primary hazards and is broad enough
to encompass different types of insertions without adding unnecessarily
lengthy text. As noted previously, prioritizing and limiting the
information presented on a warning label is important to improve the
likelihood that consumers will fully read and attend to the most
important safety information in the warning. The Commission assesses
that including information about aspirations would be more appropriate
to include in the instructions, rather than in the warning labels. The
Commission also finds it unnecessary to add language about the beads'
carcinogenic properties or the potential for acrylamide toxicity
because of the limit in the rule on the amount of allowable acrylamide
in water bead toys--a limit that is intended to address the toxicity
hazard directly.
e. X-Ray Visibility
Comment: Elizabeth Berdan, CFA, That Water Bead Lady, and one
anonymous commenter suggest adding language to the warning labels
stating that water beads often do not appear on an x-ray. Elizabeth
Berdan recommends the following specific language: ``This product is
not visible on x-rays, which may delay diagnosis and treatment.'' As
noted later, in the summary and response to comments related to
instructional literature, That Water Bead Lady and NASPGHAN suggest
that the package insert, or instructional literature, include
information about water beads not appearing on an x-ray.
Response: The Commission acknowledges that it might be helpful for
consumers who suspect that their child has ingested water beads to know
that water beads are not easily visible on x-rays. However, the
Commission disagrees with adding this information to the warning labels
in the final rule. This information, like the information on ingestion
symptoms described earlier, would be more appropriate provided within
the instructional literature. This approach allows the warning labels
to focus on and highlight the most critical safety information about
water beads, increasing the likelihood that consumers will fully read
and understand this warning information.
2. Additional Hazard-Related Revisions
Comment: Three commenters offered the following specific revisions
to the initial sentences that describe the hazard and consequences.
Elizabeth Berdan suggests: ``DANGEROUS IF SWALLOWED. This product
contains water beads that can cause life-threatening bowel
obstructions, especially at narrow points like the ileocecal valve.''
Albert Tacornal suggests: ``This product uses water beads, a known
hazard. Water beads expand and, if ingested, can cause serious injury
or death.'' Ryan Jernigan suggests: ``Water Beads Expand When Ingested
and May Shatter--Potentially Fatal.''
Response: As discussed earlier, the Commission has revised the
warning language in Figures 4 and 5 of the final rule to clarify the
hazards and consequences associated with water bead products. These
revisions address most of the commenters' specific suggestions and
concerns about water beads expanding within the body and the potential
for death. The Commission disagrees with adding language that
explicitly identifies the ``ileocecal valve,'' as this term is unlikely
to be understood by the general population and is not necessary for
consumers to understand the ingestion hazard. In response to the
comment suggesting warning language about water beads shattering, there
is no evidence that the hazard associated with water beads stems from
the beads breaking down or ``shattering'' within the body. Rather,
consistent with the final rule warnings, the primary hazard involves
intact, expanded water beads being unable to pass naturally through the
gastrointestinal tract and causing an obstruction.

[[Page 57840]]

3. Warning Content: Hazard Avoidance
a. Discard Statement
Comment: Jared Shelton, Briana Zimmerman, Eleanor Grundberg,
Christian Beasley, Albert Tacornal, Austin Watson, AAP, and CFA express
concerns about, or proposed clarifying revisions to, the warning
statement to discard the product if the water beads are coming out.
Jared Shelton, Eleanor Grundberg, Christian Beasley, AAP, and CFA
assert that the current statement is vague, open to interpretation, or
confusing, and requires clarification. Jared Shelton, Eleanor
Grundberg, and Christian Beasley focus on the phrase ``coming out,''
stating that it is unclear how many beads need to have exited, whether
the beads must be continually leaving or flowing out of the product, or
whether the beads are coming out of the product or the child. Christian
Beasley suggests changing the phrase ``coming out'' to ``exposed,''
which purportedly emphasizes that the beads are unshielded or
unprotected. Other commenters offer the following specific revisions to
the discard statement. Jared Shelton suggests: ``If internal beads
become accessible for any reason discard the product immediately.''
Briana Zimmerman suggests: ``Discard if beads become separated from the
body of the toy,'' or ``Discard if beads are no longer within the toy
cavity.'' AAP suggests: ``Discard if the beads are leaking out of this
product''; alternatively, ``leaking out'' could be replaced with
``exposed,'' ``visible,'' ``dislodged,'' or ``accessible.'' CFA
suggests: ``Discard if the beads are or become accessible.''
Albert Tacornal and Austin Watson suggest that in addition to
discarding the product, consumers should be told to search for loose
water beads that children could ingest. Albert Tacornal suggests the
following language in their comment: ``. . . ensure no loose beads can
be picked up and swallowed by children.''
Response: The Commission agrees with commenters that the statement,
``Discard if beads are coming out,'' in Figure 4 of the proposed rule,
is open to interpretation and potentially confusing. For improved
clarity, the Commission has revised this statement in Figure 5
(renumbered from Figure 4) of the final rule to say, ``Discard product
if beads start to come out.'' This revision clarifies that the
statement is referring to the beads coming out of the product--thus,
the need to discard the product, not just the beads--and that the
product should be discarded as soon as any beads start to come out,
rather than the beads having to be flowing out of the product. The
Commission concludes that adding language that instructs consumers to
seek out loose water beads is not needed, as this would increase the
length of the warning, without presenting a clear additional benefit.
Calling attention to beads coming out of the product, combined with the
earlier information in the warning about the hazardousness of the beads
and the potential for death, should be sufficient to motivate consumers
to look for loose beads in the environment.
b. Minimum Age
Comment: Elizabeth Berdan, Porter Spell, Han Lemberg and Caroline
Divver suggest adding more specific age-related information to the
warnings, either in terms of what ages should be prohibited from
playing with these products or the age at which play with these
products would be appropriate, but the recommendations varied. For
example, Elizabeth Berdan suggests, ``DO NOT ALLOW CHILDREN UNDER 9
YEARS TO HAVE ACCESS TO THIS PRODUCT.'' Han Lemberg suggests,
``Children ages 0-3 should never play with water bead toys.'' Caroline
Divver suggests that the warnings state that children under 3 should
never be permitted to play with water bead toys.
Response: The warning labels in Figures 4 and 5 of the final rule
already include qualitative age-related information in the form of the
statement, ``Keep away from babies and toddlers,'' to highlight those
children most at risk. The commenters have not provided a basis for
more specific numeric age recommendations, and there appears to be no
consensus among these commenters about the appropriate age. Thus, the
Commission declines to add more specific age-related information to the
warning labels in the final rule.
c. Sensory Toys
Comment: Briana Zimmerman and Max Williams express concern about
the NPR warning's reference to sensory toys, stating that it is unclear
what constitutes, or what uses would classify a product as, a ``sensory
toy,'' or that the reference to sensory toys could confuse or mislead
consumers. Briana Zimmerman states that the common use of sensory toys
by neurodivergent children, and the marketing of these products for
these children, could lead consumers to conclude that water beads do
not pose a danger to neurotypical children. Max Williams suggests the
following possible revisions to the warning statement about sensory
toys: ``Do not use in sensory toys for children under 5 years of age,''
or ``Not for use in sensory toys that are put in the mouth.''
Response: The Commission shares commenters' concerns about
potential confusion surrounding what constitutes a sensory toy. In
addition, staff's concerns about the use of water beads as sensory toys
or bath toys were based on such uses being common among young children.
The warning labels in the rule already explicitly warn to keep water
beads away from babies and toddlers, making the precaution against the
use of these products as sensory or bath toys redundant. Thus, to
improve the likelihood of consumers reading the full warning content by
further limiting the length of the warnings and the amount of
potentially unnecessary content that could distract from the most
important safety information, the final rule removes the bullet
statement, ``Never use as a sensory toy or bath toy,'' from the warning
labels in Figures 4 and 5.
d. Supervision
Comment: Daniel Mendoza, Max Williams, Mollie Price, and Austin
Watson suggest adding content about monitoring or supervising the child
during play with or while in the presence of water beads, with Max
Williams adding that supervision is especially important for children
who are on the cusp of toddlerhood.
Response: Supervision is one method of preventing childhood
injuries. However, there is agreement in the literature \35\ that
caregivers cannot be perfectly attentive during their child's entire
awake time, particularly if multiple children are present. Ingestion
and insertion incidents can happen in a matter of seconds, meaning
consumers might be unaware that an incident has occurred. Consumers
also might witness an ingestion and not act, believing that the water
bead will simply pass through the digestive tract. Thus, the Commission
assesses that adding supervision to the warning label is unlikely to be
very effective at preventing incidents.
---------------------------------------------------------------------------

\35\ 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: Morrongiello,
B.A., Corbett, M., McCourt, M., & Johnston, N. (2006). Understanding
unintentional injury-risk in young children II. The contribution of
caregiver supervision, child attributes, and parent attributes.
Journal of Pediatric Psychology, 31(6): 540-551; Wickens, C.D., &
Hollands, J.G. (2000). Engineering Psychology and Human Performance
(3rd Ed.). Upper Saddle River, NJ: Prentice Hall (pp. 714-715).
---------------------------------------------------------------------------

Nevertheless, the Commission agrees that there is value in adding a
brief

[[Page 57841]]

statement about supervision, given its important role in injury
prevention. Thus, the warning labels in Figures 4 and 5 of the final
rule add the new statement, ``Watch older children during use,''
immediately after the statement, ``Keep away from babies and
toddlers,'' a phrase that already identifies a vulnerable population
and implies that careful attention is warranted. The additional
statement, ``Watch older children during use,'' not only emphasizes the
importance of monitoring children's use of water beads, but the
reference to older children avoids the potential for consumers to
conclude that only infants and toddlers are at risk.
e. Limiting Access
Comment: Ayden White and Daniel Mendoza suggest adding information
related to limiting children's access to water beads. Ayden White
suggests adding instructions for proper water bead storage. Daniel
Mendoza suggests that the warning could instruct consumers to keep
water beads out of children's reach.
Response: The Commission agrees with limiting young children's
access to water beads. However, the warning statement, ``Keep away from
babies and toddlers,'' in Figures 4 and 5 of the rule, already clearly
communicates this information. Adding information about storage and the
use of child-proof containers to the warning label would potentially
distract consumers from the most critical safety information about
water beads, thereby reducing the likelihood that consumers will fully
read and understand the warnings, and is not appropriate, as consumers
are unlikely to have child-resistant containers readily available for
this use.
f. Teach Not to Mouth
Comment: Daniel Mendoza suggests adding an instruction to the
warnings that directs consumers to teach children not to place objects
in their mouths.
Response: Children place non-food items into their mouths for
several developmentally appropriate reasons. For example, young
children learn about texture, shape, and taste through mouthing, and
during teething, children naturally attempt to soothe the discomfort of
tooth eruption by mouthing objects. Mouthing objects is a form of
childhood education by teaching children what is safe to place in the
mouth, and it is a natural part of a child's curiosity and imitation
play. Through mouthing, children learn what items they can or cannot
eat. In light of this, it is unrealistic to expect warning language
that instructs caregivers to teach children not to put objects into
their mouths to be effective in preventing water bead ingestions.
Therefore, the Commission declines to add such an instruction to the
warnings.
4. Warning Content: Pictograms or Graphics
Comments: Michael Ravnitzky, Han Lemberg, Christian Beasley,
Caroline Divver, Christopher Cochran, and Zach Gilbert suggest adding
pictograms, icons, or similar graphical elements to the warning to
convey the hazard. The commenters suggest that these graphics would
help to capture attention and would improve understanding of the hazard
among non-English-speaking households or those who cannot read,
including children. Christopher Cochran suggests that ANSI Z535.4
emphasizes the use of such graphics, paired with text. Han Lemberg
specifically recommends adding a graphic depicting the ingestion risk.
Zach Gilbert suggests the use of a visual representation of a water
bead growing and obstructing the intestines.
Response: The use of pictograms and icons is one common method of
communicating safety information and enhancing attention to warnings,
and the Commission acknowledges that, in principle, the use of such
graphics could help those not capable of reading English. However,
staff are not aware of any pictograms or similar graphics that
accurately and effectively portray the hazards associated with water
beads. Designing effective graphics to address a specific hazard can be
challenging. Even seemingly obvious or intuitive graphics may be
misunderstood and lead to misinterpretation, including the possibility
of interpretations that are the opposite of the intended meaning. To
minimize confusion, warning pictograms should be developed based on
empirical research and thoroughly tested with the intended audience.
Based on the above, the Commission declines to add pictograms to the
warning labels in the final rule.
5. Warning Content: Multilingual Labels
Comment: Han Lemberg asserts that warnings should be provided in
both English and Spanish to ensure that the largest number of consumers
can understand the warning.
Response: The warnings on products sold in the United States must
be written in English. There are no mandatory requirements for warnings
and packaging information to be presented in multiple languages, but
the Commission acknowledges that this is a common practice within the
industry. The Commission recognizes the potential usefulness of
providing warnings in multiple languages and does not discourage their
use if the language is first presented in English. However, the
Commission will not impose a mandatory requirement that departs from
the traditional approach of only requiring warnings in the English
language.
However, consistent with the commenter's expressed goal of ensuring
that the largest number of consumers can understand the warnings,
several changes to the warning language for the final rule that have
been discussed previously (e.g., changes to the hazard descriptions and
consequences, changes to the ``discard'' statement) have simplified and
clarified the content of the warning language. To further improve the
likelihood that most consumers, including those with limited English
literacy, will be capable of understanding and acting on the warnings,
the warning labels in Figures 4 and 5 of the final rule revise the
phrase, ``Seek immediate medical attention,'' to the simpler and more
plain-language wording, ``Get medical help right away.'' This change
should assist in ensuring that the largest number of consumers can
understand the warning.
6. Warning Format
a. Highlighting Specific Text
Comment: Kayla O'Connor, Jake Peterson, Caroline Divver, and Austin
Watson suggest formatting changes to highlight certain text in the
warning. Kayla O'Connor and Jake Peterson suggest using boldface text
to highlight references to ear insertion, nasal insertion, and
aspiration. Caroline Divver suggests using boldface text for the
statement ``seek immediate medical attention.'' Jake Peterson and
Austin Watson suggest moving certain text, with Jake Peterson
suggesting moving the bullet item about insertions and aspirations
earlier, and Austin Watson suggesting moving the statement about
discarding products with water beads into the bullet list. The latter
commenter states that this change was needed because the statement is a
hazard-avoidance statement, and its current placement, in non-boldface
text, interrupts the descriptions of the hazard and its consequences,
making it less likely to be read.
Response: The Commission agrees with commenters about the
importance of highlighting key information in warnings and has
formatted select text in Figures 4 and 5 of the final rule, such as the
phrases, ``Discard product'' (Figure 5 only), and ``Get medical help

[[Page 57842]]

right away'' (both figures) in boldface. As discussed earlier, the
Commission has relocated information about the hazards associated with
ear and nose insertions to earlier in the warning. The statement about
discarding water beads has been moved into the bullet list of the
warning label shown in Figure 5 of the final rule, with other
preventative, or hazard-avoidance, behaviors.
b. Size of Label Elements
Comment: Zach Gilbert suggests increasing the overall size of the
label, enlarging the type sizes, and increasing the size of the
``warning marker,'' which the Commission interprets as meaning the
signal word panel, to better capture consumer attention.
Response: The warning labels in the final rule are designed to be
consistent with ANSI Z535.4, the primary U.S. voluntary standard for
the design of product safety signs and labels, to attract consumers'
attention using features such as color, a safety alert symbol and
signal word ``WARNING,'' a surrounding border, and key information
highlighted in boldface type. The size of the signal word panel follows
requirements outlined in section 5.3 of ASTM F963 and is consistent
with other toy warning labels. Thus, the warnings' visual elements
should be readily visible and noticeable to consumers, particularly
given the requirement for the warnings to be located on the principal
display panel of the product package. The Commission declines to make
changes to the size of the warnings or their individual elements in the
final rule based on this comment.
7. Warning Placement
Comment: Christian Beasley and Jake Peterson assert that the
warning should appear in a prominent location on the front of the
package, while Jake Peterson contends that the warnings also should be
available online where the products are purchased. Albert Tacornal
recommends that warnings appear on containers of water beads, not on
products that use water beads, because the containers are the source of
the risk and the products that use them will likely be discarded
without the warning being read.
Response: The final rule requires warning labels to be on the
principal display panel of the toy packaging, where it is most likely
to be seen by consumers. If the water beads are packaged in a separate
container, the warning label is required on its principal display
panel. Additionally, if there is not enough space available on the
packaging, or there is no packaging, manufacturers can use a hangtag
containing the required warning label as permitted in section
1250.4(d)(1)(iii) of the rule. Regarding online warning labels, section
105 of the CPSIA requires cautionary statements for small parts,
balloons, marbles and small balls on any advertisements including
internet websites, catalogs, or other printed material where a toy is
offered for purchase. CPSC supports online warning labels generally for
toys but is not requiring them in this rule because a holistic approach
to developing online warning label requirements for toys would be more
efficient than just addressing the issue in this rule. Therefore, staff
plans to recommend that the ASTM F15.22 Subcommittee's Emerging Hazards
Task Group consider the development of general requirements for online
warning labels for toys for inclusion in ASTM F963.
8. Warning Effectiveness
Comment: Eleanor Grundberg notes that the NPR acknowledges the
lesser effectiveness of warnings compared to designing out a hazard or
guarding consumers from a hazard. The Toy Association asserts that
warnings for water bead toy products are neither appropriate nor
required because the performance requirements address the potential for
intestinal obstruction. Albert Tacornal argues that warnings are
unlikely to be effective in dissuading consumers from purchasing these
products and are unlikely to increase supervision, and that previously
issued warnings about these products appear to be ineffective because
incidents continue. Albert Tacornal also states consumers may be
indifferent to yet another warning because they are already inundated
with warnings. Savannah Mesel asserts that warnings are not effective
in preventing accidents among young children who lack the ability to
understand the danger. This commenter further explains that although
warnings can help parents or caregivers understand, they cannot prevent
child exposure, even with supervision, as demonstrated by current
supervision practices in the incident data and research that shows
toddlers are often out of sight for brief periods during play. The
commenter also notes that caregivers also may underestimate the danger,
particularly if the products are marketed as safe for children's
sensory play. Eleanor Grundberg states that the proposed warnings may
offer a benefit by reducing the time between ingestion and treatment.
Response: The Commission agrees that providing warnings and
instructions about hazards is less effective at eliminating or reducing
exposure to hazards than either designing the hazard out of a product
or guarding the consumer from the hazard. This is the basis for the
performance requirements in the final rule that are intended to reduce
the likelihood of intestinal obstructions if water beads are ingested.
Nevertheless, the Commission recognizes that the performance
requirements alone may not fully address the potential for intestinal
blockages after ingestion, given anatomical variations among children
and the likelihood of variance in water bead sizes during
manufacturing. The rule's performance requirements are engineered to
minimize injury associated water beads being inserted in the ears,
nose, or other parts of the body. By contrast, the warning labels and
instructions are intended to supplement the performance requirements by
increasing consumer awareness of the hazards associated with water
beads and potentially reducing young children's exposure to these
products. Therefore, performance requirements and warning labels and
instructions are complementary, not an exclusive way to address a
hazard.
9. Instructional Literature
Comment: Consumer Reports and one anonymous commenter express
support for the proposed instructional literature requirements, with
one of the anonymous commenters stating that they are adequate and
efficient. Daniel Mendoza suggests that the instructional materials
follow ANSI Z535.4. Other commenters suggest that various information
be included in packaging inserts, or instructional literature.
Specifically, NASPGHAN and That Water Bead Lady suggest including
information stating that ingested water beads will not appear on x-
rays, which will enable consumers to convey this information to health
care providers. Caitlin Slusarski suggests including information about
all the hazards associated with water beads. An anonymous commenter
suggests including information about the use and storage of water
beads. An anonymous commenter suggests including information about what
to do if water beads are accidentally ingested. Mollie Price suggests
including information about supervision, if not included in the warning
itself. The Toy Association suggests including cautionary information
about ear and nose insertions.
Response: The rule requires the instructional literature, when
provided, to include the same warnings that must appear on the product
packaging, which

[[Page 57843]]

is required to be formatted consistent with certain sections of ANSI
Z535.4-2023, with modifications. Instructional literature is required
to meet those same formatting requirements, but without the use of
color, provided the warnings contrast with the background of the
instructional literature. The revised warning labels in the final rule
include more comprehensive and explicit information about the ingestion
and insertion hazards, so the instructional literature will include
this more detailed information. As suggested by commenters and
mentioned previously, the instructions are an appropriate place to add
additional product safety information, such as water beads not being
easily visible on x-rays, ear insertions leading to hearing loss, nose
insertions leading to surgical extraction, and storage instructions.
For reasons discussed previously, the Commission is not requiring such
information to be required on the warning label in the final rule.
However, manufacturers may choose to include such information, if
desired. Additionally, the Commission notes the warning label in the
final rule already includes some of the information being sought by
commenters, such as information about supervision and the need to
``[s]eek medical attention'' if water beads are ingested, and as noted
earlier, this information is required to be in the instructional
literature that accompanies these products.
10. Labeling Exemption
Comment: Intertek Shenzhen asks if the size of the toy is too
small, could the labeling requirement on toy be exempted.
Response: As noted in the preamble of the NPR (89 FR 73049) and
Sec. 1250.4(d)(1)(iii) of the rule, if there is not enough space
available on the packaging, or there is no packaging, manufacturers can
use a hangtag containing the required warning label.

E. Other Recommendations

1. Proposed Language Changes to Codified Text
Comment: Michael Ravnitzky contends there are several areas where
the rule could be improved or clarified by increasing the use of plain
language. He notes, in the NPR Sec. 1250.4(a) says: ``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
commenter suggests instead: ``This section sets performance and
labeling rules for water bead toys to reduce the risk of children
swallowing, inhaling, or choking on water beads.'' The commenter also
makes several other suggested modifications to definitions, where
modifying language would improve clarity.
Regarding aspiration hazard, the NPR proposes: ``Aspiration hazard
means 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.'' The commenter suggests instead:
``Aspiration hazard: This occurs when a child inhales a water bead. The
bead can get stuck in the respiratory tract, causing injury or death.''
Regarding choking hazard, the NPR proposes: ``Choking hazard means
a hazard caused 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.'' The commenter suggests instead: ``Choking
hazard: This occurs when a child tries to swallow a water bead. The
bead can get stuck in the throat, causing injury or death.''
Regarding ingestion hazard, the NPR proposes: ``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.'' The commenter suggests instead: ``Ingestion
hazard: This occurs when a child swallows a water bead. The bead can
get stuck in the digestive tract, causing injury or death.''
Regarding insertion hazard, the NPR proposes: ``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.'' The commenter suggests instead: ``Insertion hazard: This
occurs when a child puts a water bead in the ear or nose. The bead can
cause injury or death.''
Response: None of the commenter's suggestions improve clarity.
Instead, these suggestions only repeat the proposed language, but with
reduced and synonymous language. Therefore, the Commission is not
modifying the language in the final rule based on the comment.
2. Bitterants
Comment: Bindi Naik-Mathuria, Porter Spell, Brianna Zimmerman, John
Oldham, Ryan Jernigan, Connor Mitchell, AAPS, and That Water Bead Lady
suggest requiring water beads be made unpalatable, with the use of a
bitterant. The commenters assert that although adding a bitterant would
not prevent children from putting the water beads in their mouth
initially, it may prompt them to reject the water bead.
Response: The Commission declines to add a bitterant requirement to
the final rule. The Commission concludes that bitterants generally are
not effective in deterring ingestions. Real world investigations have
not demonstrated that bitterants are effective at preventing
ingestions.\36\ Bitterants do not deter initial ingestion because the
user has not yet tasted the bitterant. This makes bitterants
ineffective at protecting users from harm that can result from a single
ingestion. A single water bead can result in an intestinal obstruction
that requires medical intervention to resolve. Researchers also found
that in adults, between 15 percent to 30 percent do not detect the
taste of bitter compounds.37 38 39 Additionally, bitterants
would not prevent ear and nose insertions.
---------------------------------------------------------------------------

\36\ (CPSC, 1992). CPSC (1992) Final Report Study of Aversive
Agents.
\37\ Id.
\38\ (NIDCD, 2010). Global Variation in Sensitivity to Bitter-
Tasting Substances (PTC or PROP) [verbar] NIDCD (<a href="http://nih.gov">nih.gov</a>).
\39\ (NIDCD, 2019). Quick Statistics About Taste and Smell
[verbar] NIDCD (<a href="http://nih.gov">nih.gov</a>).
---------------------------------------------------------------------------

3. BPA Limits
Comment: Consumer Reports states that CPSC should consider whether
limits for bisphenol A (BPA), a known endocrine disruptor that has been
linked to certain cancers and fertility issues, should be included in
the final rule. The violative level would have to be determined to be
included. In 2023, Consumer Reports tested several brands of water
beads for known toxic chemicals, including lead, phthalates, and BPA,
and found BPA in six brands of water beads.
Response: A BPA limit was not proposed in the NPR and is not
included in the final rule. Proposing a limit on BPA would not be
warranted at this time for the following reasons: (1) CPSC is not aware
of any incidents involving or alleging BPA as an acute health hazard in
water beads; (2) staff have no information on the levels of BPA found
in the 2023 Consumer Reports study or the methods that were used to
measure BPA; (3) staff have not established a method for measuring
extractable BPA from water beads; (4) the toxicity concerns for BPA are
associated with long-term, repeated or continuous exposure, which is
not how incident data indicates children are exposed to water beads;
(5) the acute toxicity of BPA appears to be relatively low; and (6)
currently no federal agency has established an acute toxicity reference
value for BPA. Additionally,

[[Page 57844]]

CPSC has not committed resources to research and derive an acute
acceptable daily intake for BPA. If staff find evidence of hazards
presented by BPA contained in water beads in the future, then
regulatory activity may be considered.
4. Child Resistant Packaging
Comment: Elizabeth Berdan and John Oldham recommend that toy
manufacturers should be required to use child-resistant packaging to
minimize the risk of accidental ingestion by young children.
Response: Staff does not expect child-resistant packaging
requirements to be an effective deterrent because the hazard pattern
for water beads shows they can be lost and picked up off the ground and
ingested at a later time. Additionally, once water beads are expanded,
it is unlikely that adults would reuse the same child-resistant package
because the expanded water beads would no longer fit in the child-
resistant package. Before expanded water beads would fit in the child-
resistant package, they would need several hours to dehydrate and
shrink back to their original size.
5. Regulate Marketing
Comment: Elizabeth Berdan and U.S. PIRG suggest prohibiting the
marketing of expanding water beads for children's use. Consumer Reports
urges the agency to monitor how water bead products are marketed as
they expect manufacturers to repurpose and remarket water bead products
as non-toys. Porter Spell and Jannah Hancock recommend a minimum age be
set for any item containing water beads.
Response: This rulemaking is being conducted pursuant to CPSIA
section 106, and CPSC does not have the authority to prohibit the
specific marketing of water beads to children or to enforce minimum age
requirements. However, if CPSC finds non-toy water bead products that
are designed, manufactured or marketed for children under age 14 years
old, then the water bead product will be considered a toy and within
scope of this rule, and thus subject to its requirements.
6. Ship Water Beads Fully Saturated
Comment: Ryan Jernigan asserts that the Commission should mandate
manufacturers fully saturate water beads during production. While the
Commission proposes implementing standards that limit the ability of
water beads to expand, saturating the water beads fully before they
reach the market may prove to be a simpler and more effective solution.
Response: The commenter's suggestion would not be effective. Over
time, when not immersed in water, water beads shrink back to their
original size. If manufacturers ship the water bead toys fully
saturated, so the water beads arrive fully expanded, the consumer will
likely take the water beads out for play and the water beads will
eventually dehydrate and shrink. The shrunken water beads would then
pose a hazard to a child if a child were to swallow one of the shrunken
water beads. There is no guarantee that the water beads would be placed
back in water, to keep them expanded, when not in use. Thus, the
commenter's recommendation would not be effective in mitigating the
hazards that water beads pose to children.
7. Make Ingested Water Beads Detectable
Comment: Porter Spell and Christopher Cochran suggest making water
beads detectable by doctors such as making water beads able to show up
on x-ray technology or other imaging techniques.
Response: Staff are unaware of methods of making water beads
detectable through x-ray scans due to their composition. As stated in
the preamble of the NPR (89 FR 73029), 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 water bead. Incident data and medical
literature report children requiring serial x-rays, computer tomography
(CT) scans, and ultrasounds to diagnose a water bead bowel obstruction.
8. Durability Testing
Comment: Christopher Cochran and Emily Threatt suggest the
Commission should consider including stricter tests for durability.
Stricter durability testing would likely ensure that water beads do not
break into smaller, more ingestible pieces. Ryan Jernigan recommends a
reevaluation of materials used in making water beads, if water beads
shatter upon compression.
Response: The ingestion hazard pattern presented by water beads is
children ingesting whole water beads, not water beads breaking up and
then children ingesting those pieces. Additionally, if fully expanded
water beads were to break into pieces, those pieces do not have the
potential to grow any further. In other words, testing the whole, fully
grown water bead is the most stringent test, so testing the expansion
of detachable pieces is not necessary. Therefore, durability testing is
not necessary.
9. Information and Education Campaigns
Comment: Ryan Jernigan and Medical Toxicology LLC suggest that CPSC
should explore or engage in educational campaigns about the dangers of
water beads to increase awareness and allow consumers to make informed
decisions. Ryan Jernigan opines that public education can complement
regulatory efforts by informing parents about the risks involved with
these toys and encouraging vigilant supervision. Consumer Reports notes
that such campaigns may help to educate consumers but are not enough.
Response: The Commission supports information and education
campaigns about the dangers of water beads and agrees that such
campaigns are important and useful. However, CPSC has provided public
service announcements regarding the hazard presented by this product
and has issued unilateral warnings,40 41 safety
warnings,\42\ public safety bulletins 43 44 45 and social
media graphics.46 47 CPSC Commissioners have issued
statements related to the topic.48 49 50 In addition,
several health

[[Page 57845]]

organizations and social media advocates have brought attention to the
issue. Despite such campaigns, incidents continue, demonstrating that
such campaigns are not sufficient on their own. The Commission agrees
with Ryan Jernigan that information and education campaigns can
complement regulatory efforts that include performance and labeling
requirements to reduce the incidence of ingestion and insertion
incidents with water beads.
---------------------------------------------------------------------------

\40\ <a href="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-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com</a>.
\41\ <a href="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">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</a>.
\42\ CPSC Warns that Narcotics and Water Beads Are Growing Risks
Facing Young Children (March 19, 2024) <a href="https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-that-Narcotics-and-Water-Beads-Are-Growing-Risks-Facing-Young-Children">https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-that-Narcotics-and-Water-Beads-Are-Growing-Risks-Facing-Young-Children</a>.
\43\ Water Bead Safety Education Page <a href="https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center">https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center</a>.
\44\ Water Beads: A Danger to Young Children & Can Be Deadly if
Swallowed Graphic <a href="https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-A-Danger-to-Young-Children-Can-Be-Deadly-if-Swallowed">https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-A-Danger-to-Young-Children-Can-Be-Deadly-if-Swallowed</a>.
\45\ Water Beads Can Be Deadly If Swallowed Graphic <a href="https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-Can-Be-Deadly-If-Swallowed">https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-Can-Be-Deadly-If-Swallowed</a>.
\46\ Instagram @USCPSC <a href="https://www.instagram.com/p/C4rVCGANJyS/?utm_source=ig_web_button_share_sheet">https://www.instagram.com/p/C4rVCGANJyS/?utm_source=ig_web_button_share_sheet</a>.
\47\ <a href="http://X.com">X.com</a> @USCPSC <a href="https://x.com/USCPSC/status/1702341499604648310">https://x.com/USCPSC/status/1702341499604648310</a>.
\48\ Water Beads Can Cause Intestinal Obstruction and Lead to
Death: Get Them Out of Your Home (Sept 13 2023) <a href="https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Water-Beads-Can-Cause-Intestinal-Obstruction-and-Lead-to-Death-Get-Them-Out-of-Your-Home">https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Water-Beads-Can-Cause-Intestinal-Obstruction-and-Lead-to-Death-Get-Them-Out-of-Your-Home</a>.
\49\ Chair Hoehn-Saric Statement on the Dangers that Water Beads
Pose to Young Children (Sept 14 2023) <a href="https://www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Chair-Hoehn-Saric-Statement-on-the-Dangers-that-Water-Beads-Pose-to-Young-Children">https://www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Chair-Hoehn-Saric-Statement-on-the-Dangers-that-Water-Beads-Pose-to-Young-Children</a>.
\50\ Statement of Commissioner Peter A. Feldman on Buffalo
Games, LLC, Water Beads Recall (Sept 14 2023) <a href="https://www.cpsc.gov/About-CPSC/Commissioner/Peter-A-Feldman/Statement/Statement-of-Commissioner-Peter-A-Feldman-on-Buffalo-Games-LLC-Water-Beads-Recall">https://www.cpsc.gov/About-CPSC/Commissioner/Peter-A-Feldman/Statement/Statement-of-Commissioner-Peter-A-Feldman-on-Buffalo-Games-LLC-Water-Beads-Recall</a>.
---------------------------------------------------------------------------

10. Collaboration With Manufacturers
Comment: Ryan Jernigan and Daniel Mendoza opine that it might be
beneficial for CPSC to consider a collaborative approach with
manufacturers to develop safer alternatives to water beads. CPSC could
also establish workshops or webinars that provide practical guidance on
compliance strategies, product redesign, and best practices for
ensuring safety while maintaining product integrity. Encouraging
innovation in toy design could lead to the creation of expanding
materials that do not pose similar risks, thereby maintaining consumer
interest while prioritizing safety.
Response: CPSC has been collaborating with manufacturers and other
members of the public in a voluntary standard development setting for
years to address the hazards of water bead toys. As stated in the
preamble of the NPR (89 FR 73025), since 2009, CPSC has worked with the
ASTM F15.22 Subcommittee Emerging Hazards Task Group to update the toy
standard to address the hazards of water bead toys. The task group has
discussed specific incident data and potential expansion limits for
water bead toys, as well as the issue of acrylamide toxicity and water
bead toys potentially containing high levels of acrylamide. The
subcommittee has not, to date, published a standard that addresses the
hazards presented by water bead toys. This includes the hazards
presented due to expansion and acrylamide exposure.
11. Ban Water Beads Bills
Comment: Jake Peterson and NASPGHAN note that two bills have been
introduced to Congress: H.R. 6468 (Ban Water Beads Act) \51\ and S.
4298 (Esther's Law) \52\ and that these are the best course of action
to ensure children's safety.
---------------------------------------------------------------------------

\51\ <a href="https://www.congress.gov/bill/118th-congress/house-bill/6468/text">https://www.congress.gov/bill/118th-congress/house-bill/6468/text</a>.
\52\ <a href="https://www.congress.gov/bill/118th-congress/senate-bill/4298/text">https://www.congress.gov/bill/118th-congress/senate-bill/4298/text</a>.
---------------------------------------------------------------------------

Response: To date, neither of the two bills referenced by the
commenters have been enacted into law. Therefore, as indicated by
incident data, this rule is necessary in order to protect children from
the risks of injuries from water bead toys.

F. Environmental Impact

Comment: Connor Mitchell asks whether CPSC is concerned that non-
compliant water beads might be thrown away, further exacerbating the
issues that plastic causes in our environment.
Response: As stated in the preamble of the NPR (89 FR 73045), there
is little to no potential for affecting the human environment from the
rule, and therefore, no environmental impact assessment is required for
this rule. Additionally, non-compliant water beads do not have to be
thrown away. Manufacturers and sellers can repackage water bead toys to
be sold for various non-toy purposes such as decorative purposes, air
freshener products or deodorizers for cat litter, and in first-aid cold
packs.

G. Data

Comment: Erin Brennan notes that the NPR suggests that there were
6,300 water bead related injuries seen in emergency departments from
2017 through 2022, but this number fails to differentiate between cases
where actual harm to the child was recorded and visits that were merely
precautionary, where no medical intervention was even necessary. The
commenter asserts that if there were 6,300 cases of death or serious
injury from these beads, then regulation may be necessary, but this is
certainly not the case. Considering the actual risks involved in
allowing children to play with water beads, the proposed regulations of
these water beads are not justified.
Response: As stated in the preamble of the NPR (89 FR 73031), based
on NEISS data, CPSC estimates 6,300 injuries related to water beads
were treated in U.S. hospital emergency departments over the six-year
period from 2017 through 2022. The disposition of those visits were as
follows: 95 person treated by a medical professional and released; 2
percent admitted for hospitalization; 3 percent held for observation;
and less than 1 percent left without being seen. Given that 95 percent
of these visits are categorized as being treated and released, staff
cannot assume that these were all merely precautionary, where no
medical intervention was necessary, as suggested by the commenter.
Treatment could include multiple types of treatment depending on level
of severity, including the administration of a scope or laxative.

H. Economic Impact

Comment: Corey Lee proposes the Commission reevaluate the per unit
cost of the new packaging and labeling requirements. In his estimation,
the unit cost seems to be arbitrarily set. The commenter asserts that
no formula or methodology was presented as to how the Commission came
to the figure. He states that one can assume the Commission is relying
on older data and may be unaware of the complexities in the graphic
production process. He states that the new label could require a new
graphics plate which can cost up to $1,000. More costing data needs to
be assessed from various packaging and labeling suppliers. Also, the
estimation needs to include discussions about the potential production
consequences and potential financial risks posed by the new labeling
requirement.
Response: As stated in the NPR, firms might incur a small one-time
additional cost from updating existing labels and/or adding labels. The
preamble of the NPR (89 FR 73044) stated that 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. In the preamble of the NPR (89 FR 73044) staff estimated that the
additional costs related to updating labels are less than $0.01 per
unit of product sold, which is a typical industry assumption with minor
changes to labeling. However, staff did consider the commenter's high-
end cost estimate for $1,000 for a new graphics plate in its updated
economic feasibility assessment for the final rule given the complexity
for moisture resistant packaging with this product that the commenter
described. Therefore, the main conclusion of economic feasibility
assessment remains that the final rule is economically feasible but
could incur significant costs to small businesses that may either drop
out of the market or stop marketing their products as toys.
Comment: The Toy Association contends that the assertion that firms
might incur a small, one-time additional cost from updating existing
labels and/or adding labels is incorrect. While the incremental cost
estimated in the NPR for an over label (separately applied

[[Page 57846]]

stick-on label) might be at or close to the estimated cost for the
application only, staff's estimates do not take into account the real
costs associated with having to redesign the packaging to accommodate
the additional label footprint, as well as the scrap costs for
packaging already printed above and beyond the over label rework for
product that is already contained in the previous packaging version.
Stating that all manufacturers of children's products are already
required to provide labels with their product pursuant to section
14(a)(5) of the CPSA is also misleading, since the labels being
referenced are not separate components as staff appear to be implying,
but instead integrated labeling elements incorporated into the design
and positioning of the printed packaging layouts. Any such change
requires a redesign to re-align and re-arrange all the packaging layout
elements, especially when the new label is large and in such cases, the
entire sizing of the package layout may well need to be enlarged to
accommodate the label, resulting in additional scrap costs as well as
increased shipment costs since the physical volume of the packages
increase accordingly.
Response: While the Toy Association did not provide specific cost
information for staff consideration, staff did account for labeling
cost to be as high as a one-time purchase of a graphic plate of $1,000
in the economic feasibility assessment based on another comment.
However, that cost estimate is likely an overestimate for manufacturers
as the labeling requirements may be met in less expensive ways. If
there is not enough space available on the packaging for the new label,
manufacturers can use a hangtag warning label. In the preamble of the
NPR (89 FR 73044), staff estimated the additional costs related to
updating labels are less than $0.01 per unit of product sold. Staff
continue to expect the incremental cost related to the labeling
provisions to be generally low for firms. 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. Firms might incur a small one-time additional cost from updating
existing labels and/or adding labels. Even with the consideration of
higher labeling costs, the main conclusion of the economic feasibility
assessment remains that the final rule is economically feasible but
could impose significant costs on small businesses that may either drop
out of the market or stop marketing their products as toys.
Comment: Jake Peterson notes that small businesses can be
disproportionately affected by an overbroad regulatory environment. A
recent study by the American Enterprise Institute found that more
regulation yields more profits for larger firms while crushing smaller
ones.\53\ Therefore, it is likely that large toy companies may benefit
from this regulation.
---------------------------------------------------------------------------

\53\ Timothy Carney, More Regulation Yields More Profits for
Large Firms While Crushing Small Ones: Study Op-ed, Washington
Examiner (2023).
---------------------------------------------------------------------------

Response: The commenter's assertions are not specific to water
beads and are not substantiated with data. Instead, the commenter
references an op-ed article by Timothy P. Carney that discusses the
results of a working paper by Shikhar Singla. Neither of these
references are about the toy industry. The referenced working paper
does not review any regulations from the CPSC to estimate regulatory
costs by regulatory agencies, nor does it rely on data from any large
toy companies. The author of the working paper reviewed data from the
Environmental Protection Agency, National Highway Traffic Safety
Administration, Energy Department, Interior Department, Justice
Department, Health and Human Services Department, Labor Department,
Agriculture Department, Defense Department, and Homeland Department.
The working paper references commercial package air conditioning and
heating equipment, commercial warm air furnaces, automobile
manufacturing, and light truck/utility vehicle manufacturing, which are
not similar to the topic of the NPR.
In the preamble of the NPR (89 FR 73042) and unchanged for the
final rule, staff assessed the rule likely would have a significant
economic impact on a substantial number of small entities supplying the
water bead toy market, primarily from redesign costs in the first year
that the rule would be effective. Specifically, a significant impact
likely would occur for small companies whose products do not meet the
requirements of the rule. However, it is important to note that CPSC
has enforced ASTM F963 as a mandatory standard for toys since 2009 and
the existing section 4.40 Expanding Materials of ASTM F963-23 includes
requirements for toys, including but not limited to water beads, that
are made of expanding materials. Therefore, certain costs, as mentioned
in the preamble of the NPR (89 FR 73042), should not be new significant
costs for most small firms, given suppliers should already test to the
current mandatory standard. As stated in the preamble of the NPR (89 FR
73044), staff expect that small manufacturers likely would incur
significant costs from redesign, retooling, loss of product sales, and
material changes to comply with the rule.
Comment: Connor Mitchell asserts that the NPR suggests small firms
can alleviate compliance costs by replacing non-compliant water beads
with smaller ones that fulfill the size requirement. However, the
commenter states that the NPR also says that the growth requirement
will likely require the redesign of all water beads, as no known water
bead products comply with the rule. Therefore, the commenter questions
how firms can alleviate costs in the manner advocated above. Finally,
the commenter asserts firms could replace non-compliant water beads
with ones that conform to the size regulations, these smaller water
beads are still non-compliant with the proposed regulation because they
do not meet the limits on water bead growth.
Response: Staff are aware of water bead toys that meet the rule's
size limit requirement, which is being able to pass through a 5.0 mm
diameter gauge. Additionally, staff note the proposed 50 percent growth
limit has been removed from the rule. However, nearly all products
staff reviewed exceed the updated size limit requirement. Staff expect
manufacturers will incur retooling costs to ensure compliance and this
could be a significant one-time cost, incurred by the manufacturer.
Manufacturers also have the option of re-marketing their non-compliant
water beads for non-toy uses such as 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 for use in
first-aid cold packs.
Comment: Connor Mitchell asks on what basis does CPSC believe that
firms can sell non-compliant water beads in alternative non-toy
markets. It fails to cite any market analysis or knowledge that would
convince me that manufacturers or sellers could sell their non-
compliant product into the non-toy water bead market. The commenter
asks if the demand is already met in the non-toy water bead market,
what is there to show that the non-compliant water beads would fulfill
additional demand.
Response: As stated in the preamble of the NPR (89 FR 73027) there
are several examples of non-toy water bead products. For example,
products outside of the scope of this rule include water beads used 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

[[Page 57847]]

hydration, as air freshener products or deodorizers for cat litter, and
in first-aid cold packs. Also, additional demand is not required to
sell products in already existing markets. Manufacturers would only
make the transition if it was profitable to do so and as such would be
creating an additional supply of the product. Generally, an increase in
the supply of a product, given a stable product demand, results in a
more competitive market.
Comment: The Toy Association asserts that staff estimate that
``water beads over the size limit are less than 5 percent of the market
based on the range of sizes from the descriptions and an assumed
distribution'' appears to be incorrect, since a significant portion of
the hydrated water beads are larger than the proposed 9.0 mm diameter.
A cursory review of water bead products on e-commerce sites illustrates
water beads that are stated to expand to a size larger than the
proposed 9.0 mm diameter threshold.
Response: Many of the water bead products available on the market
that the commenter likely found in their cursory review are sold on e-
commerce sites that are out of scope of this rule. Water bead toys are
water beads designed, manufactured or marketed as a plaything for
children under 14 years of age (consistent with the definition of a
``toy'' in ASTM F963). However, the commenter is correct that water
beads over the size limit of 5.0 mm diameter (including the 9.0 mm
diameter proposed in the NPR) likely do constitute more than 5 percent
of the water bead toy market. Only some water bead toys are produced at
sizes under the water bead diameter limit. Water bead toys that do not
meet the proposed size limit would require modification.

I. Effective Date

Comment: Corey Lee and the Toy Association recommend the Commission
extend the proposal's effective date from 90 days to 360 days. Kirksey
Croft agrees the compressed time frame of 90 days will not give small
businesses enough time to implement all the requirements set forth and
asserts that many small businesses will be effectively shut out of the
market due to compliance costs. Also, the packaging and labeling costs
associated with transitioning products to other markets will inhibit
many transitions

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