Safety Standard for Toys: Requirements for Toys Containing Button Cell or Coin Cell Batteries, 65791-65815 [2024-17472]
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65791
Proposed Rules
Federal Register
Vol. 89, No. 156
Tuesday, August 13, 2024
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1250
[CPSC Docket No. CPSC–2024–0023]
Safety Standard for Toys:
Requirements for Toys Containing
Button Cell or Coin Cell Batteries
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
The U.S. Consumer Product
Safety Commission (Commission or
CPSC) proposes to address the risk of
injury and death associated with
children ingesting button cell or coin
cell batteries obtained from toys by
adding performance and labeling
requirements for battery-operated toys
containing such batteries. The proposed
requirements would provide the highest
level of safety feasible, and are
consistent with the Commission’s recent
Reese’s Law rulemaking and
international standards for electronic
toys. The Commission also proposes to
amend CPSC’s list of notice of
requirements (NORs) to include toys
containing button cell or coin cell
batteries.
SUMMARY:
DATES:
Submit comments by October 15,
2024.
Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature requirements of the NPR
should be directed to the Office of
Information and Regulatory Affairs, the
Office of Management and Budget, Attn:
CPSC Desk Officer, FAX: 202–395–6974,
or emailed to: oira_submission@
omb.eop.gov.
Submit all other comments, identified
by Docket No. CPSC–2024–0023, by any
of the following methods:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Do not submit through this website:
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ADDRESSES:
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confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public. CPSC
typically does not accept comments
submitted by email, except as described
below.
Mail/Hand Delivery/Courier/
Confidential Written Submissions: CPSC
encourages you to submit electronic
comments by using the Federal
eRulemaking Portal. You may, however,
submit comments by mail, hand
delivery, or courier to: Office of the
Secretary, Consumer Product Safety
Commission, 4330 East-West Highway,
Bethesda, MD 20814; telephone: (301)
504–7479. If you wish to submit
confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public, you
may submit such comments by mail,
hand delivery, or courier, or you may
email them to: cpsc-os@cpsc.gov.
Instructions: All submissions must
include the agency name and docket
number. CPSC may post all comments
without change, including any personal
identifiers, contact information, or other
personal information provided, to
https://www.regulations.gov. Do not
submit through this website:
Confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public. If you
wish to submit such information, please
submit it according to the instructions
for mail/hand delivery/courier/
confidential written submissions.
Docket: For access to the docket to
read background documents or
comments received, go to: https://
www.regulations.gov, and insert the
docket number, CPSC–2024–0023, into
the ‘‘Search’’ box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT:
Benjamin Mordecai, Project Manager,
Division of Mechanical Engineering,
Directorate for Laboratory Sciences,
Consumer Product Safety Commission,
5 Research Place, Rockville, MD 20850;
Telephone 301–987–2506; email:
bmordecai@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
In 2008, Congress passed the
Consumer Product Safety Improvement
Act of 2008 (CPSIA) providing the CPSC
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with new regulatory and enforcement
tools, particularly for the purpose of
protecting the safety of children. Among
other things, section 106(a) of the CPSIA
made ASTM International’s voluntary
standard for toys, ASTM F963–07,
Standard Consumer Safety
Specification for Toy Safety (except
sections 4.2 and Annex 4) a mandatory
standard beginning 180 days after the
enactment date of the CPSIA, on
February 10, 2009. 15 U.S.C. 2056b(a).
Section 106 also directs the Commission
to promulgate toy safety standards that
are ‘‘more stringent than’’ the applicable
voluntary standard if the Commission
determines that more stringent
requirements would further reduce the
risk of injury associated with the
product, as well as to periodically
review and revise the rules set forth
under section 106 to ensure that such
rules provide the highest level of safety
for such products that is feasible. 15
U.S.C. 2056b(c) and (d).
The CPSIA states that ASTM F963
shall be considered a consumer product
safety standard issued by the
Commission under section 9 of the
Consumer Product Safety Act (CPSA; 15
U.S.C. 2058). Id. Since 2009, CPSC has
enforced ASTM F963 as a mandatory
standard for toys.1 In 2017, the
Commission codified the mandatory toy
standard in 16 CFR part 1250, Safety
Standard Mandating ASTM F963 for
Toys, and incorporated by reference the
newly revised ASTM standard at that
time, ASTM F963–16. 82 FR 8989 (Feb.
2, 2017). Most recently, on January 18,
2024, the Commission updated part
1250 to incorporate by reference a 2023
revision, ASTM F963–23. 89 FR 3344.
Some toys within the scope of ASTM
F963 and 16 CFR part 1250 contain, or
are designed to use, button cell or coin
cell batteries.2 Accordingly, section 4.25
of ASTM F963–23 contains
1 Since the CPSIA’s enactment in 2008, ASTM
revised F963 five times: ASTM F963–08, ASTM
F963–11, ASTM F963–16, ASTM F963–17, and
ASTM F963–23 (approved August 1, 2023).
2 In this notice of proposed rulemaking (NPR) we
define the phrase ‘‘toy containing button cell or
coin cell batteries’’ consistent with the definition of
a ‘‘consumer product containing button cell or coin
batteries’’ in Reese’s Law. 15 U.S.C. 2056e Notes
(Definition 4). A ‘‘toy containing button cell or coin
cell batteries’’ means a toy containing or designed
to use one or more button cell or coin batteries,
regardless of whether such batteries are intended to
be replaced by the consumer or are included with
the product or sold separately. Id., proposed
§ 1250.3(b).
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Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
requirements for ‘‘battery-operated
toys,’’ including requirements for toys
containing button cell or coin cell
batteries. The ASTM requirements are
intended to address hazards related to
battery overheating, leakage, explosion,
fire, and children choking on or
swallowing batteries. The 2023 updates
to ASTM F963 include improvements to
safety requirements for toys that contain
button cell or coin cell batteries, such as
expanding the application of use and
abuse testing of toys and labeling
requirements that enhance battery
accessibility requirements. However, as
discussed in section IV of this preamble,
ASTM F963–23 does not establish
adequate requirements for toys
containing button cell or coin cell
batteries because the existing
requirements do not address all of the
identified hazards and are not as
stringent as requirements for non-toy
consumer products that are found in 16
CFR part 1263, Safety Standard for
Button Cell or Coin Batteries and
Consumer Products Containing Such
Batteries.
Part 1263 implements Reese’s Law,
Public Law 117–171, a law that protects
children 6 years old and younger against
hazards associated with the ingestion of
button cell or coin batteries. 15 U.S.C.
2056e. Reese’s Law, however, excludes
children’s toys subject to requirements
in 16 CFR part 1250 from its scope. 15
U.S.C. 2056e Note. Specifically, the law
states, ‘‘The standards promulgated
under this Act shall not apply with
respect to any toy product that is in
compliance with the battery
accessibility and labeling requirements
of part 1250 of title 16, Code of Federal
Regulations[.]’’ 3 Therefore, the current
part 1250 standard implementing ASTM
F963 does not provide the highest level
of safety feasible for such toys.
Accordingly, this notice of proposed
rulemaking (NPR) proposes to amend
the requirements in part 1250 specific to
battery compartments for toys
containing button cell or coin cell
batteries to align the requirements more
closely with the Commission’s new rule
for consumer products containing
button cell or coin batteries, codified at
part 1263. Further, this NPR proposes
revising the title of part 1250 from
‘‘Safety Standard Mandating ASTM
F963 for Toys’’ to ‘‘Safety Standard for
Toys,’’ to reflect the inclusion of
proposed requirements that do not
incorporate by reference existing
requirements in ASTM F963.4
The Commission is authorized to
issue this NPR pursuant to both sections
106(c) and (d) of the CPSIA, 15 U.S.C.
2056b(c) and (d). Section 106(d) of the
CPSIA, 15 U.S.C. 2056b(d)(2), requires
the Commission to: (1) examine and
assess the effectiveness of ASTM F963,
in consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts; and (2)
promulgate consumer product safety
standards for such toys. Standards
issued under section 106(d) are to be
‘‘more stringent than’’ the applicable
voluntary standard if the Commission
determines that more stringent
requirements would further reduce the
risk of injury associated with the
product. 15 U.S.C. 2056b(d)(2)(B). Since
before the CPSIA, CPSC staff has
consulted with stakeholders regarding
provisions in the toy standard through
the ASTM process. Since the passage of
Reese’s Law in 2022, CPSC staff has
been corresponding with the relevant
ASTM Subcommittee and task group,
discussing the incident data associated
with child battery ingestions, staff’s
testing of toy battery compartments, and
staff’s recommendations to update the
performance and labeling requirements
in the toy standard to adequately
address the ingestion hazard associated
with children accessing button cell or
coin cell batteries from toys.5
Section 106(c) of the CPSIA, 15 U.S.C.
2056b(c), requires the Commission to
periodically review and revise the rules
set forth under section 106, to ensure
that such rules provide the highest level
of safety for such products that is
feasible. The NPR proposes to add
performance requirements and revise
Many toys contain or are designed to
use button cell or coin cell batteries like
those shown in figure 1. Generally,
button cell batteries are small,
disposable, single-cell batteries that
range from 5 mm to 32 mm (0.2 inches
to 1.3 inches) in diameter and are 1 mm
to 6 mm (0.04 inches to 0.24 inches) in
thickness. Common anode materials are
zinc or lithium while common cathode
materials are manganese dioxide, silver
oxide, carbon monofluoride, cupric
oxide, or oxygen from the air.6 Button
cell batteries tend to be manganese
dioxide (alkaline) (1.5 volt) or silver
oxide (1.55 volt). Lithium coin batteries,
also shown in figure 1, were originally
developed as a 3-volt power source for
low-drain and battery-backup
applications because of their highenergy density, correspondingly small
size, and long shelf life. Lithium coin
batteries are commonly approximately
20 mm (0.787 inch) in diameter.
3 Consistent with 16 CFR part 1250, Reese’s Law
defines a ‘‘toy product’’ as ‘‘any object designed,
manufactured, or marketed as a plaything for
children under 14 years of age.’’ 15 U.S.C. 2056e
Notes (Definition 5).
4 On July 19, 2024, the Commission voted
unanimously (5–0) to publish this NPR.
5 See, e.g., August 19, 2022, Letter from Benjamin
Mordecai, Project Manager for ASTM F963 to
ASTM Subcommittee and Task Group Chair,
regarding increasing number of incidents involving
children gaining access to button and coin cell
batteries in battery-operated toys, and requesting
the toy safety F15.22 subcommittee to review the
data and develop more stringent performance
requirements to address these incidents in the next
few months (available at: (https://www.cpsc.gov/
s3fs-public/8-19-2022-Letter-to-ASTM-BatteryOperated-Toys.pdf?VersionId=PgFoeCeb0
BYz0kyg6z87tbwHKv3x9W0y); and March 20, 2023,
Letter from Daniel Taxier, Children’s Product
Program Manager, and Benjamin Mordecai, Project
Manager for ASTM F963, to ASTM Subcommittee
and Task Group Chair, regarding Reese’s Law, CPSC
staff’s toy testing to F963 and UL–4200A, and
recommendations for updates to F963 to align with
the Commission’s then-proposed NPR to implement
Reese’s Law (available at: https://www.cpsc.gov/
s3fs-public/Letter-to-ASTM-F15-22-Reeses-LawNPR-230320.pdf?VersionId=6ZGPs5nSLh
BGlFdoz1IWHF1wo.oOgarH).
6 Anodes and cathodes are the positive or
negative posts of a battery. The different materials
allow the battery to lose or gain electrons
dependent on the intended function.
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labeling requirements for toys
containing button cell or coin cell
batteries that are more stringent than the
existing requirements in ASTM F963,
which are incorporated by reference
into 16 CFR part 1250, and that also
provide the highest level of safety
feasible, aligning with the requirements
in 16 CFR part 1263.
This NPR provides an overview of
staff’s assessment and analysis, and it
discusses the Commission’s basis for
issuing this NPR. Based on the
information and analysis in this NPR,
the Commission preliminarily
determines that the proposed
performance and labeling requirements
for toys containing button cell or coin
cell batteries are more stringent than the
existing requirements in ASTM F963–
23, would further reduce the risk of
injury associated with products within
the scope of the NPR, and would
provide the highest level of safety for
such products that is feasible.
II. Description of Toys Within the Scope
of the Rule
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LR44 button ce11,
11.6mm (0.45 inch) diameter,
5.4
ick
LR754 button ce11,
7.9 mm (0.31 inch) diameter,
5.4
ick
LR626 button ce11,
6.8 mm (0.26 inch) diameter,
2.6
thick
CR2032,
20mm 0. 787 inch diameter
CR2025,
20mm 0. 787 inch diameter
CR2450,
24mm 0.945 inch diameter
65793
Figure 1. Example Button Cell and Coin Cell Batteries
Section 3.1.9 of ASTM F963–23
defines ‘‘battery, button cell’’ as a
‘‘small round non-lithium battery, in
which the overall height is less than the
diameter’’ while section 3.1.10 of ASTM
F963–23 defines a ‘‘battery, coin cell’’ as
a ‘‘small, round lithium battery in
which the overall height is less than the
diameter.’’ Generally, button cell and
coin cell batteries are uniformly defined
across safety standards. For example,
section 5 of Reese’s Law defines ‘‘button
cell or coin battery’’ similarly to the
ASTM F963–23 definitions, in relevant
part, as ‘‘. . . a single cell battery with
a diameter greater than the height of the
battery. . . .’’ 15 U.S.C. 2056e Notes
(Definition 1).
A button cell or coin cell battery (also
referred to by industry and consumers
as a cell or disc/disk battery) stores
chemical energy which is converted to
electrical energy when the battery is
connected to a circuit. A button cell or
coin cell battery consists of an anode, a
cathode, and a separator and electrolyte
between the anode and cathode, as
shown in figure 2. When connected
with a conductive material, such as
when the battery is pressed into moist
human tissue (i.e., when swallowed),
the connected battery terminals form an
electric circuit, and electric current
flows through the conductive material
and between the terminals. As already
described, button cell or coin cell
batteries come in many shapes and sizes
and are composed of different materials
and chemicals. Requirements for power
(voltage and capacity) and size are the
main driver of battery shape, chemical
composition, and the number of
batteries required to operate a toy.
Figure 2. Components of a Button Cell or Coin Cell Battery
but are not limited to, light up toys,
talking dolls, remote controlled
vehicles, stuffed animals, science kits,
musical toys, do-it-yourself light up
craft kits, electronic board games, and
learning tablets/games.
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‘‘toy having at least one function
dependent on electricity and powered
by batteries.’’ Figure 3 provides
examples of toys containing button cell
or coin cell batteries that fall within the
scope of this NPR. Such toys include,
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Section 3.1.92 of ASTM F963–23
defines a ‘‘toy’’ as ‘‘any object designed,
manufactured, or marketed as a
plaything for children under 14 years of
age.’’ Section 3.1.11 of ASTM F963–23
defines a ‘‘battery-operated toy’’ as a
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Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
Figure 3. Examples of Toys Containing Button Cell or Coin Cell Batteries
Within the Scope of this Notice of Proposed Rulemaking
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III. Incident Data and Hazard Patterns
CPSC staff searched two CPSCmaintained databases to identify
incidents and hazard patterns associated
with button cell and coin cell batteries
in toys using product code 0884 for
batteries: the Consumer Product Safety
Risk Management System (CPSRMS) 7
and the National Electronic Injury
Surveillance System (NEISS).8 The
7 CPSRMS includes data primarily from three
groups of sources: incident reports, death
certificates, and in-depth follow-up investigation
reports. A large portion of CPSRMS consists of
incident reports from consumer complaints, media
reports, medical examiner or coroner reports,
retailer or manufacturer reports (incident reports
received from a retailer or manufacturer involving
a product they sell or make), safety advocacy
groups, law firms, and Federal, State, or local
authorities, among others. It also contains death
certificates that CPSC purchases from all 50 states,
based on selected external cause of death codes
(ICD–10). The third major component of CPSRMS
is the collection of in-depth follow-up investigation
reports. Based on the incident reports, death
certificates, or NEISS injury reports, CPSC field staff
conduct in-depth investigations (on-site, telephone,
or online) of incidents, deaths, and injuries, which
are then stored in CPSRMS.
8 NEISS is the source of the injury estimates; it
is a statistically valid injury surveillance system.
NEISS injury data are gathered from emergency
departments of a sample of hospitals with 24-hour
emergency departments and at least six beds,
selected as a probability sample of all U.S.
hospitals. The surveillance data gathered from the
sample hospitals enable the CPSC to make timely
national estimates of the number of injuries
associated with specific consumer products.
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incidents considered were reported as
occurring between January 1, 2016, and
December 31, 2022. For this period staff
identified incidents associated with
battery insertions and ingestion, or the
risk of ingestion, involving children
who were able to access button cell or
coin cell batteries from toy battery
compartments. Specifically, staff
identified one fatal incident and 46 nonfatal incidents in CPSRMS, and 185
NEISS reported hospital emergency
department (ED)-treated incidents,
associated with children accessing a toy
battery compartment. Of the 47
CPSRMS incidents, all but one incident
involved children younger than 9 years
old, while 170 of the NEISS incidents
involved children aged 6 years old or
younger.
A. Overview of Button Cell and Coin
Cell Battery Hazards
1. Ingestion
Children may be able to access button
cell or coin cell batteries when playing
with toys that are operated by such
batteries. Children may access such
batteries if a toy breaks apart and the
batteries become exposed or if a battery
compartment remains open while a
caregiver is changing the batteries. Once
exposed, children may remove and
ingest the batteries. For example, in
CPSC’s In-Depth Investigation (IDI)
171024HCC1059, a 20-month-old male
ingested a button battery from an
electronic toy; the battery was removed
surgically, but the child later died from
injury. Medical literature details how
death and serious injury are associated
with button cell or coin cell battery
ingestion. Such injuries including
choking, internal chemical burns,
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chemical leakage, pressure necrosis
(tissue damage), the creation of
hazardous chemicals (such as sodium
hydroxide and hydrochloric acid), and
related hazards.9 Because of the nature
of the risk of injury, as described in this
section, it is important to identify a
battery ingestion in a timely manner and
remove the button cell or coin cell
battery from the body to prevent serious
injury or death.
CPSC staff reviewed medical
literature related to battery-ingestion
injuries that confirms ingested button
cell or coin batteries can lodge in the
esophagus and cause severe tissue
damage after only a few hours, as
discussed in Tab B of the Reese’s Law
NPR Staff Briefing Package (SBP).10 The
conductive soft tissue in the digestive
tract can form a circuit between the
battery terminals, creating an electric
current. When lodged in the esophagus,
button cell or coin batteries can cause
damage to the esophagus, burning
nearby tissue and creating perforations.
The battery current generates hydroxide
when in contact with tissue in the
digestive tract. Hydroxide can create
9 See, supra n.3, citing Tab B of Staff’s Reese’s
Law NPR Briefing Package.
10 The information in this proposed rule is based
in part on information and analysis provided in the
January 11, 2023, Staff Briefing Package: Draft
Proposed Rule to Establish a Safety Standard and
Notification Requirements for Button Cell or Coin
Batteries and Consumer Products Containing Such
Batteries (Staff’s Reese’s Law NPR Briefing
Package), available at: https://www.cpsc.gov/s3fspublic/NoticeofProposedRulemakingSafety
StandardandNotificationRequirementsforButton
CellorCoinBatteriesandConsumerProducts
ContainingSuchBatteries.pdf?Version
Id=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl. Tab B
and its appendices contain staff’s review of the
medical literature and battery ingestion data from
the National Capitol Poison Center (Poison.Org).
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Toys containing or designed to use
other types of batteries, where the
diameter is less than the height, such as
AAA or AA batteries, or non-cylindrical
batteries, are out of the scope of this
NPR because their size and shape does
not pose the same type or degree of
ingestion hazard as button cell or coin
cell batteries.
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chemical burns. Lithium coin batteries
pose a particular threat of chemical burn
if ingested because such batteries have
a higher voltage and capacity than nonlithium batteries. Other injuries
associated with button cell or coin
battery ingestion include alkaline
electrolyte leakage from alkaline button
cell batteries or pressure necrosis from
extended contact of the battery with
tissue.
While ingested button cell or coin
batteries may be able to pass through the
digestive tract without complications,
ingestion complications can occur,
usually when such batteries become
stuck (impacted) in the esophagus.11
The primary injury from impaction is
from the transmission of electric current
eliciting the production of sodium
hydroxide (NaOH) and hydrochloric
acid (HCl) in tissues adjacent to the
cathode and anode terminals,
respectively.12 After only a few hours of
a battery maintaining contact with moist
tissue, tissue pH on either side of the
battery increases, causing substantial
tissue damage. The erosive and
perforating effects of esophageal
impaction may continue even after
removing the battery.13 Another
mechanism of injury involves an
electrical burn created by electric
current passing between the anode and
the cathode.
An imperfectly sealed alkaline button
cell battery may leak electrolyte solution
when ingested, causing injury or death.
The large concentration of potassium
hydroxide (KOH) in the electrolyte
solution is particularly corrosive to
human tissue. Alkalis penetrate deep
into the tissue layers, which may cause
extensive tissue damage.
Another mechanism of injury
common to foreign body impaction is
pressure necrosis, which creates
ischemic,14 blackened areas of tissue
damage.15 Impaction of a button cell or
coin battery in the esophagus leads to
esophagus burns in as little as two
hours. A burn in the esophagus may
cause a perforation of the esophagus or
an esophageal stricture (a narrowing of
11 Sigalet D, Laes G, Tracheo-esophageal injury
secondary to disc battery ingestion, American
Journal of Otolaryngology 23 (1988) 996–998.
12 Hamilton JM, Schraff SA, Notrica DM. Severe
injuries from coin cell battery ingestions: 2 case
reports. Journal of Pediatric Surgery (2009) 44, 644–
647.
13 Gao Y, Wang J, Ma J, Gao Y, Zhang T, Lei P,
Xiong X. Management of button batteries in the
upper gastrointestinal tract of children. Medicine
(2020) 99:42.
14 Ischemia is a condition where blood flow is
blocked or reduced, depriving oxygen and
nutrients.
15 Alvi A, Bereliani A, Zahtz GN. Miniature disc
battery in the nose: a dangerous foreign body. Clin
Pediatr (Phila). 1997 Jul;36(7):427–9.
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the esophagus). Perforation or stricture
of the esophagus can make eating
difficult, requiring use of a feeding tube
in the stomach or dilations of the
esophagus to expand the stricture to
allow normal swallowing.
A button battery that burns through
the esophagus can also burn through
nearby tissues, creating a fistula, which
is an abnormal connection between the
esophagus and the other surrounding
tissues. When fistulas are created in the
esophageal area, they are commonly
found with the trachea
(tracheoesophageal fistulas or TEF) and
with the aorta (aortoesophageal fistulas
or AEF). Both of these fistulas are life
threatening injuries because they can
lead to an open artery and, thus,
excessive blood loss. Researchers report
that esophageal burns and fistulas
sometimes require multiple surgeries to
repair.16 These injuries could require
weeks of treatment in a hospital.17
Diagnosing an ingested button cell or
coin battery requires an x-ray because
physical examination after ingestion
does not always confirm a battery was
ingested. Symptoms of button cell or
coin battery ingestion, such as
respiratory distress, can be mistaken for
other ailments, like an asthma attack.18
As an example, a child who ingested a
button cell or coin cell battery may have
a fever but no other evidence of having
ingested a button cell or coin battery.
Alternatively, the physical examination
can be normal, making an ingestion
diagnosis difficult.19
Lithium button cell or coin battery
ingestions have become more common
as such batteries are used in more
household products, including toys,
than they were historically.20 As noted,
lithium batteries pose a significant
16 Slamon NB, Hertzog JH, Penfil SH, Raphaely
RC, Pizarro C, Derby CD. An unusual case of button
battery-induced traumatic tracheoesophageal
fistula. Pediatric Emergency Care. Volume 24,
Number 5, May 2008.
17 Liao W, Wen G, Zhang X. Button battery intake
as foreign body in Chinese children. Review of case
reports and the literature. Pediatr Emer Care
2015;31: 412–415; Kimball SJ, Park AH, Rollins II
MD, Grimmer JF, Muntz H. A review of esophageal
disc battery ingestions and a protocol for
management. Arch Otolaryngology Head Neck
Surg/Vol 136 (NO. 9), SEP 2010. 866–871.
18 Takahashi T, Teramoto Y, Aoyama T,
Sahakibara H, Hara M, Maseki M. Yamaguchi S.
Anesthetic management of a child with an
esophageal foreign body with was misdiagnosed as
asthma. MASUI. THE JAPANESE JOURNAL OF
ANESTHESIOLOGY. 2009 Feb;58(2):199–201. 199–
201.
19 Cruz CI, Patel D. (2013). Impacted ButtonBattery Masquerading as Croup. The Journal of
Emergency Medicine, Vol.45, No. 1, pp. 30–33.
20 Dawe N, Puvanendran M, flood L. Unwitnessed
lithium-ion disc battery ingestion: case report and
review of best practice management of an increasing
clinical concern. The Journal of Laryngology &
Otology (2013), 127, 84–87.
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65795
safety hazard when ingested because
lithium batteries generate a relatively
high voltage, causing rapid local injury,
even when partially discharged (used).
Therefore, even partially discharged
batteries can cause life-threatening
injuries when ingested. Medical
literature confirms that caregivers only
have approximately two hours to
remove a lithium battery from a child’s
esophagus to prevent injury.21
2. Nasal Insertion
Not only do children ingest button
cell or coin cell batteries, but children
also insert such batteries into the nasal
cavity. For example, in NEISS case
170555849, a 2-year-old male put into
his nose a button battery that was likely
liberated from a toy, as batteries were
later found to be missing from a toy. A
proportion of nose insertions ultimately
become ingestions or aspirations
because such batteries travel through
the nasal passage and enter the digestive
tract or airways. Button cell or coin
batteries impacted in the nose can lead
to severe damage to the endonasal
mucous membranes (tissue inside the
nasal passage), necrosis (tissue damage)
of the nasal septum cartilage (the tissue
that separates the left and right nostril),
and nasal septum perforation.
When the battery is not removed
immediately, most children experience
long-term effects, such as saddle nose;
saddle nose is a flattening of the nose
after a battery has damaged the nasal
septum to the point of disintegration by
burning a hole in the tissue.
Reconstructive surgery is required to
artificially recreate a septum inside the
child’s nose. The severity of nasal
insertion complications depends on the
duration of impact (longer duration can
lead to more damage), the type of button
cell or coin battery (a higher voltage can
cause more damage), and in which part
of the nasal cavity the battery gets
lodged (the septum is most susceptible
to damage because it is the thinnest
tissue in the nose). Septum perforation
complications can result in lifelong
consequences, such as facial
deformity.22 A button cell or coin
battery that becomes dislodged inside
the nose can be ingested, causing
21 Gao Y, Wang J, Ma J, Gao Y, Zhang T, Lei P,
Xiong X. Management of button batteries in the
upper gastrointestinal tract of children. Medicine
(2020) 99:42.
22 Bakshi SS, Coumare VN, Priya M, Kumar S.
Long-term complications of button batteries in the
nose. The Journal of Emergency Medicine, Vol. 50,
No. 3, pp. 485–487, 2016.
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damage not only to the nasal structure
but to the digestive tract as well.23
Tab B, Appendix B of the Reese’s Law
NPR SBP shows 56 cases from medical
literature of nasal insertion with button
cell or coin batteries from 1985 to 2015.
The most severe injury is septal
perforation after a battery burned a hole
in the tissue. Sometimes the battery
remained lodged in the nose for long
periods of time, sometimes for months,
leading to extensive damage to the
nose.24 Sometimes an impaction
occurred for only a few hours and led
to septal perforation of the nose.25
3. Ear Insertion
Button cell or coin batteries inserted
into the ear canal cause injuries similar
to that of nasal insertions when they
become impacted. A button cell or coin
battery that is inserted into the ear canal
may cause ear drum perforation or
destruction, marked erosion of the ear
canal with exposed bone, hearing
impairment, facial nerve paralysis, and
destruction of the small bones in the
middle ear.26 Like nose insertions, the
severity of ear insertion complications
depends on the duration of impact, the
voltage of the button cell or coin battery,
and in which part of the ear canal the
battery gets lodged. Appendix C of the
Reese’s Law NPR SBP shows 10 cases
from medical literature of button cell or
coin batteries having been inserted into
the ear canal.
B. Incident Data Hazard Scenarios—
How Children Accessed Batteries
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1. Durability
Fifty reported nonfatal incidents
between 2016 and 2022, including 20
CPSRMS and 30 NEISS incidents,
involve a toy battery compartment
breaking apart or opening
unintentionally, allowing children to
access and potentially ingest or insert
button cell or coin cell batteries. Reports
describe battery compartment failures
where the toy was dropped (nine
incidents), thrown or smashed (two
incidents), crushed by foot (one
incident), or manipulated by a child’s
hands or mouth to open the battery
23 Alvi A, Bereliani A, Zahtz GN. Miniature disc
battery in the nose: a dangerous foreign body. Clin
Pediatr (Phila). 1997 Jul;36(7):427–9.
24 Fosarelli P, Feigelman S, Pearson E, CalimanoDiaz A. An unusual intranasal foreign body.
Pediatric Emergency Care. Vol 4 No 2. 1988.117–
118.
25 Liao W, Wen G, Zhang X. Button battery intake
as foreign body in Chinese children. Review of case
reports and the literature. Pediatr Emer Care
2015;31: 412–415.
26 Bhisitkul DM and Dunham MD. An
unsuspected alkaline battery foreign body
presenting as malignant otitis external. Pediatric
Emergency Care. Vol 8 No 3. 141–142. 1992.
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compartment in a manner that defeated
the locking mechanism (nine incidents).
These incident reports demonstrate that
some toy battery compartments are not
strong enough to withstand reasonably
foreseeable use or abuse to prevent
children from accessing batteries. For
example, incident I17B0493A describes
an 8-year-old male who dropped a lightup spinner toy that easily broke apart;
the child swallowed the battery, which
required surgery to remove and caused
tissue damage to his esophagus. Further,
incident I1910003A describes a 3-yearold male who was playing with an
action figure when the battery
compartment unexpectedly broke open;
the consumer indicated they were only
able to locate two of three batteries.
The NPR proposes to address these
incidents by improving the durability of
battery compartments through
performance tests. The NPR proposes to
require sequential use and abuse testing
that aligns with use and abuse testing in
part 1263, adopting similar use and
abuse performance requirements.
2. Fastener Engagement
Twenty reported nonfatal incidents,
including 18 CPSRMS and two NEISS
incidents, involve a toy battery
compartment fastener, such as a screw,
that did not adequately secure or close
the compartment, potentially allowing
children to access and ingest or insert
the button cell or coin cell batteries
inside. Incident reports describe failing
fasteners as not being long enough to
engage the threads (four incidents),
fasteners continuously spinning, or
threads being stripped (four incidents).
These incidents demonstrate that some
fasteners do not adequately secure toy
battery compartments and that the
engagement of the fastener can degrade
over time. For example, incident
I6C0676A describes a 4-year-old male
who was found playing with a light up
toy in his room with the battery
compartment cover off the toy; the
batteries were all located, but the screw
intended to secure the battery
compartment continuously spun when a
caregiver attempted to tighten it.
Consistent with part 1263 fastener
requirements, and to ensure more
durable fastener engagement, the NPR
proposes minimum requirements for
battery compartment thread attachment
as well as a test to simulate repeated
battery replacement.
3. Sibling Interaction
Twenty-four (24) reported nonfatal
incidents, including seven CPSRMS and
17 NEISS incidents, describe a button
cell or coin cell battery becoming
accessible from a toy when, for example,
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two or more siblings played with a toy
together, or a younger sibling played
with an older sibling’s toy. Incident
reports demonstrate that basing
performance requirements for the
durability of toy battery compartments
on the intended user’s age does not
adequately address typical use and
abuse scenarios leading to the ingestion
hazard. For example, incident
I1910347A describes a 2-year-old female
who played with her 4-year-old male
sibling’s toys; the 2-year-old dropped
the toys on the floor and the toys fell
apart; three button batteries fell out of
the toys. The NPR proposes to address
these incidents by improving the
durability of battery compartments
through performance tests with limited
reliance on age grading. The NPR
proposes to require sequential use and
abuse testing that aligns with testing in
part 1263, incorporating UL 4200A–23
performance requirements.
4. Changing Batteries
Seven reported nonfatal incidents, all
from NEISS, describe a child accessing
a button cell or coin cell battery while
a parent or caregiver was changing
batteries in a toy. All children involved
in these incidents were taken to a
hospital for treatment. For example,
NEISS case 190447495 describes an
incident where a babysitter was
changing a button battery in a toy when
an 8-month-old male was able to
swallow one battery. The NPR proposes
to address these incidents by improving
required product warning labels for toy
battery compartments to better warn
consumers about battery ingestion
hazards while the consumer is
interacting with the compartment.
5. Easily Accessed Battery
Compartments
Four reported nonfatal incidents, all
from CPSRMS, involve a child who was
able to open a toy battery compartment
without the use of a tool. For example,
IDI 170623CFE0001 describes a 9-yearold boy who opened a battery
compartment by pulling a battery
compartment access tab with his teeth.
The remaining three incidents describe
toys that lacked battery compartment
securing mechanisms or that opened
easily without a tool. The NPR proposes
to better address the hazard of easily
accessed battery compartment incidents
by mandating minimum performance
requirements for battery compartment
threaded attachments.
C. National Estimates From NEISS
Based on NEISS data, CPSC staff
estimates that over the seven-year
period from 2016 through 2022 there
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were 4,500 U.S. hospital emergency
department visits (sample size = 185,
coefficient of variation = 0.1705)
associated with a person (generally a
child) accessing a button cell or coin
cell battery from a toy.27 An estimated
81 percent of victims ingested or
swallowed a button cell or coin cell
battery or put a button cell or coin cell
battery in their mouth. An estimated 92
percent of the victims were children
between the ages of 6 months and 5
years old. An estimated 58 percent of
the victims were male, while an
estimated 42 percent were female. An
estimated 81 percent were treated at the
hospital emergency department and
released, 16 percent were admitted for
hospitalization, and 3 percent were held
for observation. Of the 185 sample cases
supporting these estimates, none were
fatal. To ensure that only button cell
and coin cell battery incidents involving
toys are captured, CPSC staff’s estimates
do not include cases that failed to
identify battery source or battery type.
Accordingly, the injury estimates based
on NEISS data are conservative and
represent a lower bound for actual EDtreated injuries associated with button
cell and coin cell batteries in children’s
toys.
D. Availability of Incident Data
Upon publication of this NPR in the
Federal Register, CPSC will make
available for review and comment, to
the extent allowed by applicable law,
the CPSRMS and NEISS incident reports
relied upon and discussed, along with
the associated IDIs. The data can be
obtained by submitting a request to:
https://forms.office.com/g/kSefsxqT3X.
You will receive a website link to access
the data at the email address you
provided. If you do not receive a link
within two business days, please
contact bmordecai@cpsc.gov.
E. Child Supervision and Behavior
Battery compartment security is
important for toys containing button cell
or coin cell batteries because children
often play with these types of toys while
unsupervised, and infants or toddlers
often mouth objects, leading to
incidents of battery ingestion or
insertion.
Research by Morrongiello and
colleagues (2006) 28 indicates that older
toddlers and preschool children (ages 2
through 5 years old) typically are out of
view of a supervising parent for about
20 percent of their awake time at home
and are not within visual range or
hearing distance for about 4 percent of
awake time in the home because
caregivers reasonably allow young
children to be unsupervised for a few
minutes in a presumably safe room.
Most caregivers recognize hazards such
as a hot stove and actively guard against
them; however, items such as toys
reasonably do not present a high level
of concern. Therefore, consumers may
not be aware that certain toys contain
button or coin cell batteries and that
such products pose a hazard. Often,
caregivers notice that a toy is missing a
battery only after a child has already
accessed it.
Mouthing and ingestion of non-food
items is a normal part of children’s
exploratory behavior that contributes to
incidents of choking and poisoning.29
Because of this, CPSC has banned small
65797
parts for toys intended for children
younger than 3 years of age and
mandates small-parts warnings for toys
and games intended for children ages 3
to 6 years old.30 Still, toys containing
button or coin cell batteries pose a
similar danger. Unintentional foreign
body ingestion is one of the top five
leading causes for nonfatal emergency
department visits in children under the
ages of 9 years old.31 Medical literature
indicates that children most commonly
ingest or insert foreign objects found in
the home environment that are small,
round, shiny, and relatively smooth, as
are button cell and coin batteries.32 33
Children develop rapidly, both
physically and cognitively, in the first
few years of life, learning to grasp
object, bring object to their mouth,
stand, and often walk all during the first
year.34 Between the ages of 12 to 18
months of age, children progress from
walking, to running and climbing.
Increased mobility, physical strength,
and coordination, combined with an
inherent predisposition towards
curiosity and exploration can lead to
dangerous situations for young children
who may discover hazardous items.35
F. Recalls
From January 1, 2011, through March
19, 2024, CPSC’s Office of Compliance
and Field Operations conducted six
recalls of toys containing button cell or
coin cell batteries. Table 1 below
summarizes the recalls, including the
press release date, firm, hazard,
approximate number of recalled units,
number of incidents and injuries
reported, and press release number.
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TABLE 1—RECALLS OF TOYS CONTAINING BUTTON CELL OR COIN CELL BATTERIES JANUARY 1, 2011 TO MARCH 19,
2024
Approximate number
of recalled units
Press release date
Firm
Hazard
October 10, 2016 ........
Target ...................
The gel clings can separate and expose the inner decal and LED/button battery compartment, posing
choking and button battery ingestion
hazards to children.
27 One instance involving an 18-year-old who
ingested batteries from a toy is included. Two other
cases involve 15-year-old children, although the
majority of this data includes substantially younger
aged children.
28 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.
29 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.
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About 172,000 units
Halloween LED Gel
Clings.
30 16
CFR part 1501; 16 CFR 1500.19.
for Disease Control and Prevention.
Web-based Injury Statistics Query and Reporting
System (WISQARS) [Online]. (2003). National
Center for Injury Prevention and Control, Centers
for Disease Control and Prevention. Available from:
URL: www.cdc.gov/ncipc/wisqars. [10/1/2022].
32 Kay, M., & Wyllie, R. (2005). Pediatric foreign
bodies and their management. 7(3):212–8; Lee, J.H.,
(2018) Foreign Body Ingestion in Children. Clinical
Endoscopy, 51:129–136; Kramer et al., 2015;
Conners GP, & Mohseni M. Pediatric Foreign Body
Ingestion. [Updated 2021 Jul 18]. In: StatPearls
[internet]. Treasure Island (FL): StatPearls
Publishing; 2022 Jan-. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK430915/
31 Centers
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Number of incidents & injuries
reported 36
No Injuries Reported ...........................
Press
release
No.
37 17–020
-.(accessed 4/12/22) https://www.ncbi.nlm.nih.gov/
books/NBK430915/.
33 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.
34 Frankenburg, W.K., Dodds, J., Archer, P. (1990).
The DENVER II Technical Manual 1990, Denver
Developmental Materials, Denver, CO.
35 https://www.cpsc.gov/content/2020-AgeDetermination-Guidelines.
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TABLE 1—RECALLS OF TOYS CONTAINING BUTTON CELL OR COIN CELL BATTERIES JANUARY 1, 2011 TO MARCH 19,
2024—Continued
Press release date
Firm
Hazard
Approximate number
of recalled units
May 23, 2017 ..............
Hobby Lobby ........
December 19, 2019 ....
Toysmith ...............
About 43,400 units
Easter and July 4ththemed Light-Up
Spinner Toys.
About 58,000 units
Light-Up Magic
Wands.
May 12, 2021 ..............
K & M International.
December 1, 2021 ......
Halo Brand Solutions.
The battery cover can detach and expose the small coin cell batteries,
posing choking and ingestion hazards to young children.
The battery cover can detach and expose the button-cell batteries, posing choking and ingestion hazards
to young children.
The coin cell battery inside the slap
watches can fall out, posing battery
ingestion and choking hazards to
young children.
A child can disassemble the projector
flashlight and access the button cell
batteries, posing ingestion and
choking hazards.
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IV. Voluntary Standard Development
ASTM F963 includes performance
requirements and test methods for
children’s toys, as well as requirements
for warning labels and instructional
literature, to reduce or prevent death of
children or injury to children from
mechanical, chemical, and other
hazards associated with toys. Similar to
other ASTM standards, ASTM F963
contains the following sections: scope,
terminology, referenced documents,
safety requirements, labeling
requirements, instructional literature,
producer’s markings, test methods, and
additional sections appropriate for toys,
such as age grading and flammability
testing of certain types of toys. Since
passage of the CPSIA in 2008, the
voluntary standard has been revised five
times: ASTM F963–08, ASTM F963–11,
ASTM F963–16, ASTM F963–17, and
ASTM F963–23. Pursuant to the update
procedures in section 106 of the CPSIA,
the Commission has accepted the
sequential revisions as the mandatory
standard. 15 U.S.C. 2056b(g).
Section 4.25 of ASTM F963–23
addresses the safety of all battery36 When the recall press release delineates the
approximate number of recalled units, number of
incidents, or number of injuries by country, this
summary only includes the reported United States
values.
37 https://www.cpsc.gov/Recalls/2017/TargetRecalls-Halloween-LED-Gel-Clings.
38 https://www.cpsc.gov/Recalls/2017/hobbylobby-recalls-easter-and-july-4th-light-up-spinnertoys.
39 https://www.cpsc.gov/Recalls/2020/ToysmithRecalls-LightUp-Magic-Wands-Due-to-Choking-andIngestion-Hazards.
40 https://www.cpsc.gov/Recalls/2021/K-MInternational-Recalls-Slap-Watches-Due-to-CoinCell-Battery-Ingestion-and-Choking-Hazards.
41 https://www.cpsc.gov/Recalls/2022/HaloRecalls-Promotional-Childrens-ProjectorFlashlights-Due-to-Button-Battery-Ingestion-andChoking-Hazards.
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About 463,000 units
Wild Republic Slap
Watches.
About 82,500 units
Projector Flashlights.
operated toys. Sections 4.25.4 addresses
the hazards of choking or swallowing
batteries. Section 4.25.4.1 addresses the
accessibility of batteries from toy battery
compartments for children less than 3
years old, while section 4.25.4.2
addresses the accessibility of small part
batteries (i.e., batteries that fit within the
small parts cylinder described in 16
CFR 1501.4, including button cell or
coin cell batteries). The 2023 update to
ASTM F963 included changes to
strengthen requirements associated with
children accessing batteries, such as
adding the definition of a ‘‘tool’’ that
may be used to access the battery,
strengthening labeling requirements
associated with battery accessibility,
and improving safety requirements by
expanding the application of use and
abuse testing of toys, including toys
containing small part batteries.
Still, ASTM F963–23 does not
establish adequate performance
requirements for toys containing button
cell or coin cell batteries.42 Incident
data described in section III of this
preamble and staff’s toy testing in
section V of this preamble demonstrate
weaknesses in the ASTM toy standard.
For example, existing requirements in
ASTM F963–23 are not as stringent as
performance requirements in part 1263
for non-toy consumer products, which
incorporate UL 4200A. Therefore,
ASTM F963–23 fails to adequately
address children accessing toy battery
compartments, leading to children
ingesting or inserting button cell or coin
batteries, and fails to provide the
highest level of safety feasible.
42 The Commission issues a direct final rule on
September 21, 2023, codifying 16 CFR part 1263,
and found that some provisions of ASTM F963
were inadequate to address button cell or coin cell
battery hazards. 88 FR 65278, Table 1a.
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Number of incidents & injuries
reported 36
Press
release
No.
Received one report of a 14-monthold child who ingested the battery.
38 17–166
One report of a child swallowing one
of the batteries removed from the
toy. Medical attention was required
to remove the battery.
None reported ......................................
39 20–045
Received two reports of children accessing the button cell batteries
from the flashlight, and in one case,
a child required surgery to remove a
swallowed battery.
41 22–024
40 21–134
V. Description and Explanation of the
NPR
To address the risk of injury described
in section III of this preamble, this NPR
proposes to add performance and
labeling requirements for toys
containing button cell or coin cell
batteries. The NPR proposes to add test
requirements for captive fasteners,
minimum requirements for threaded
fasteners, and sequential use and abuse
testing (stress relief, battery
replacement, impact, crush, torque,
tension, compression, and compliance
verification tests), and to update
marking and labeling requirements. The
additional requirements are more
stringent than the existing requirements
in part 1250 to further reduce the risk
of injury from these batteries and
represent the highest level of safety
feasible to address child ingestion of
button cell or coin cell batteries from
toys. The additions also are intended to
align the requirements for such toys
with the requirements for consumer
products subject to part 1263, which
could promote design and
manufacturing efficiencies. This section
of the preamble describes the proposed
additions in new § 1250.3,
Requirements for Toys Containing
Button Cell or Coin Cell Batteries.
A. Performance Requirements
Section 106(c) requires that the
Commission periodically review and
revise the rules for children’s toys,
including battery-operated toys, to
ensure that such rules provide the
highest level of safety for such products
that is feasible. Section 106(d) requires
the Commission promulgate safety
standards for toys that are more
stringent than ASTM F963 if the
Commission determines that more
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stringent standards would further
reduce the risk of injury.
In the direct final rule by which the
Commission implemented Reese’s Law
(DFR), CPSC staff evaluated the
requirements of both ASTM F963–23
and the UL 4200A standard the
Commission incorporated by reference
pursuant to that statute. 88 FR 65274
(Sept. 21, 2023). Tables 1a and 1b of the
DFR that established part 1263 evaluate
and compare those two standards. 88 FR
65278–89. Table 1a of the DFR explains
that UL 4200A–23 sets requirements for
products that require a tool to open the
battery compartment, a captive fastener,
a minimum number of fastener threads,
or two independent motions to open the
battery compartment. An accessibility
test measures the adequacy of the
requirements. Table 2, below,
summarizes CPSC staff’s review of
ASTM F963–23’s relevant provisions
and whether a higher level of safety
than that provided in ASTM F963–23 is
feasible for toys containing button cell
65799
or coin cell batteries, based on the
existing performance requirements in
UL 4200A–23 (as incorporated by
reference for non-toy consumer
products in part 1263) and other
international voluntary standards for
electrical toys and other products,
including IEC 62115—Electric toys—
Safety (IEC 62115) and IEC 62368–
1:2023—Audio/video, information and
communication technology
equipment—Part 1: Safety requirements
(IEC 62368–1).
TABLE 2—SUMMARY OF ASSESSMENT OF ASTM F963–23 PERFORMANCE REQUIREMENTS IN COMPARISON TO OTHER
SAFETY STANDARDS
ASTM F963–23
(section No.—assessment)
Requirement category
Safety Requirements:
Battery Accessibility—Use and Abuse Testing.
Battery Accessibility—Probe .......................
Captive screws ............................................
Threaded fastener securement requirements.
Use and Abuse Testing:
Pre-conditioning in oven ..............................
Simulated battery replacement (×10) ..........
Normal Use Testing ....................................
Abuse Testing .............................................
Drop test—based on product weight/type ...
Drop test—based on age grading ...............
Battery Compartment Impact Test ..............
Crush Test (big surface area) .....................
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Torque Test .................................................
Tension Test ...............................................
Compression Test (little surface area) ........
As summarized in table 2, and based
on staff’s assessment described below, a
higher level of safety is feasible for toys
containing button cell or coin cell
batteries. In fact, only one section of the
ASTM standard that is deemed
inadequate does not have a comparable
UL or International Electrotechnical
Commission (IEC) standard. This unique
provision, Section 8.5 of ASTM F963–
23, addresses normal use testing, which
is ‘‘intended to simulate normal use
conditions so as to ensure that hazards
are not generated through normal wear
and deterioration. . . . The tests are
intended to uncover hazards rather than
to demonstrate the reliability of the
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Reference
(standard—section No.)
4.25.4—higher level of safety is feasible .........
UL 4200A–23—6.
4.25.4.2—higher level of safety is feasible ......
4.25.4.3—higher level of safety is feasible ......
Not Addressed—higher level of safety is feasible.
UL 4200A–23—6.3.5.1.
IEC 62115—13.4.6.
UL 4200A–23—5.5a.
Not Addressed—higher level of safety is feasible.
Not Addressed—higher level of safety is feasible.
8.5—Inadequate ...............................................
8.6—higher level of safety is feasible ..............
8.7.1—higher level of safety is feasible ...........
8.7.1—higher level of safety is feasible ...........
Not Addressed—higher level of safety is feasible.
Not Addressed—higher level of safety is feasible.
8.8—higher level of safety is feasible ..............
8.9—higher level of safety is feasible ..............
8.10—higher level of safety is feasible ............
UL 4200A–23—6.2.1a,
IEC 62368–1:2023—4.8.4.2.
UL 4200A–23—6.2.1b.
toy.’’ This section does not define any
specific test procedures; for example, it
provides only that toys with wheels
should be ‘‘operated repeatedly.’’
Accordingly, CPSC preliminarily finds
that this section is inadequate to
consistently identify hazards and that
the abuse testing located elsewhere in
ASTM F963–23, UL 4200A–23, and
other voluntary standards, as discussed
below, is better suited to addressing the
risks associated with accessible button
cell or coin cell batteries.
The NPR proposes the following
performance requirements and test
methods to improve safety by
addressing the hazards of children
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N/A.
UL 4200A–23—6.
UL 4200A–23—6.3.2.
UL 4200A–23—6.3.2.
UL 4200A–23—6.3.3.
UL 4200A–23—6.3.4.
UL 4200A–23—6.3.4A.
UL 4200A–23—6.3.4B.
UL 4200A–23—6.3.4C.
ingesting button cell or coin cell
batteries that have been accessed from
toys.
1. Captive Fasteners
One hazard related to children
ingesting button cell or coin cell
batteries is that consumers permanently
remove or lose the fastener securing the
battery compartment cover, thereby
exposing the button cell or coin cell
battery and allowing child access.
Section 4.25.4.3 of ASTM F963–23
requires that fasteners used to secure toy
battery compartments shall remain
attached to the toy or battery
compartment cover before and after
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testing in accordance with sections 8.5–
8.10. CPSC staff understands that when
conducting use and abuse testing of a
battery-operated toy in accordance with
sections 8.5–8.10 of ASTM F963–23,
test laboratories visually inspect any
fastener used to secure the battery
compartment both before and after
testing to verify that the fastener
remains attached to the toy or battery
compartment cover.
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Section 13.4.6 of IEC 62115—Electric
toys—Safety, contains a similar
requirement for use and abuse testing of
fasteners but specifies to verify
compliance by both inspection and
through testing: ‘‘A force of 20 N is
applied to the screw or similar fastener
without jerks for a duration of 10 s in
any direction.’’ Under the IEC 62115
requirements, to pass the test the
fastener must remain with the toy or
battery compartment cover after
compliance verification testing,
meaning after using a force to make sure
that the fastener does not fall off if
pushed or pulled. This test method is
more stringent than the ASTM F963 test
method that allows purely visual
inspection, and improves safety by
better ensuring that battery cover
fasteners remain attached to the
product.
To improve compliance verification,
the NPR proposes to incorporate into
part 1250 a compliance test for batteryoperated toys similar to the IEC
requirement. The proposed requirement
clarifies how to confirm compliance
with the requirement in section 4.25.4.3
of ASTM F963–23 and establishes a
minimum threshold of attachment force
for the fastener. Therefore, to verify the
fastener cannot be easily pulled out by
a child, and to align with a similar
requirement in the international
standard IEC 62115, the NPR proposes
to add a sentence to section 4.25.4.3,
stating that after use and abuse testing,
the battery compartment fastener will be
subject to 4.5 lbf (20 N) of force,
increasing from 0 lbf to 4.5 lbf, within
5 seconds, which should be maintained
for a duration of 10 seconds in any
direction likely to remove the fastener.
The fastener must remain attached to
the battery compartment to pass the test.
Such functional testing will help further
reduce the risk of injury from accessible
button cell or coin cell batteries because
it works to ensure fasteners cannot be
lost or removed completely, thereby
keeping batteries better contained.
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2. Minimum Battery Compartment
Threaded Attachment Requirements
Another hazard related to children
ingesting button cell or coin cell
batteries is battery compartments being
unsecured because the screws intended
to keep the door or cover secure were
either too short to remain attached to
the toy or did not engage the threads.
ASTM F963–23 currently does not have
performance requirements addressing
the minimum battery compartment
fastener length or the removal torque for
the door or cover for toys containing
batteries.
Section 5.5(a) of UL 4200A–23
includes specific requirements
addressing threaded fastener
securement and twist-on battery
compartment cover securement. In the
DFR, the Commission determined that
two requirements in UL 4200A–23
adequately ensure battery compartment
securement: (1) screws or similar
fasteners must engage at least two full
threads (i.e., the fasteners must screw
into the product for at least two full
turns), and (2) battery compartment
twist-on access covers shall require a
minimum torque of 0.5 Nm (4.4 in-lbf)
and a minimum of 90 degrees of rotation
to open the compartment. 88 FR 65274.
To ensure that toy battery
compartment fasteners are just as secure
as non-toy consumer product battery
compartment fasteners subject to part
1263, § 1250.3(c)(2)(i) through (iii) of the
NPR proposes to add sections 4.25.4.5,
.6, and .7 to ASTM F963–23,
incorporating requirements consistent
with these two UL 4200A–23
provisions. These more stringent
requirements work to address incidents
of children gaining access to batteries
because fasteners had an insufficient
length and could be easily removed
when the threads did not engage
strongly, or twist-on battery
compartments were easily opened
because minimal force was needed to
remove the cover.
3. Sequential Use and Abuse Test
Requirements
To address the hazard of button cell
or coin cell batteries becoming
accessible when a toy breaks, falls apart,
or the battery compartment opens
unexpectedly, the NPR proposes to add
requirements to ensure that batteries
remain inaccessible to children during
reasonably foreseeable use and misuse
of toys. Currently, most of the tests in
ASTM F963–23 do not require
sequential testing on a battery-operated
toy sample. Section 4.25.4 of ASTM
F963–23 requires that the accessibility
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of button cell or coin cell batteries in
toys be determined before and after
testing in accordance with the
applicable use and abuse test
requirements in sections 8.5–8.10. The
test requirements include normal use
testing, abuse testing, impact testing
(including drop testing), torque and
tension testing, and compression
testing. Each individual test may be
performed on a toy or component that
has not yet been subjected to the abuse
testing, in accordance with section 8.1.
The Commission preliminarily
determines that sequential testing better
addresses real-world scenarios of toys
experiencing different uses and abuses
over time, such as a drop followed by
a crush force. It is foreseeable that a toy
will endure multiple and varied uses
and abuses over time. Therefore,
ensuring that a toy battery compartment
can withstand various tests sequentially
improves safety.
In contrast to the ASTM test method,
section 6 of UL 4200A–23 requires that
products containing button cell or coin
cell batteries have all use and abuse
tests conducted sequentially on the
same sample. This sequence of tests
includes pre-conditioning of plastic
products in the oven, simulated battery
replacement, drop testing, battery
compartment impact testing, crush
testing, torque testing, tension testing,
compression testing, and compliance
verification testing. The sequential
testing in UL 4200A–23 means that each
test can affect the results of subsequent
testing, which results in a more
comprehensive and more stringent
series of tests as compared to ASTM
F963–23.
Illustratively, prior to the 2023
versions of the ASTM F963 and UL
4200A standards, CPSC staff compared
the performance of eight toy products
when tested to section 4.25.5 of ASTM
F963–17 (equivalent to testing to section
4.25.4.2 of ASTM F963–23) and section
6 of UL 4200A–20.43 Seven of the eight
toy products tested were associated with
incidents known to CPSC where a child
gained access to the toy battery.44 Six
43 See March 20, 2023, Letter from Daniel Taxier,
Children’s Product Program Manager, and Benjamin
Mordecai, Project Manager for ASTM F963, to
ASTM Subcommittee and Task Group Chair,
regarding Reese’s Law, CPSC staff’s toy testing to
F963 and UL–4200A, and recommendations for
updates to F963 to align with the Commission’s
then-proposed NPR to implement Reese’s Law
(available at: https://www.cpsc.gov/s3fs-public/
Letter-to-ASTM-F15-22-Reeses-Law-NPR-230320.
pdf?VersionId=6ZGPs5nSLhBGlFdoz1IWHF1wo.
oOgarH).
44 Refer to the ‘‘Incident’’ column in table 1 of the
March 20, 2023 letter.
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out of the eight toy products passed
ASTM F963 performance requirements
and failed the sequential performance
requirements in UL 4200A, meaning the
battery became accessible. Five of these
six toy products failed the simulated
battery replacement test in UL 4200A.
Two of these six toy products also failed
during the drop test, the impact test,
and the compliance verification
(accessibility) test. This testing further
indicates that the performance
requirements in UL 4200A better
address known hazard patterns for
children accessing battery
compartments than requirements in
ASTM F963 because they better ensure
toy battery compartments remain intact
when exposed to foreseeable uses and
abuses.
To provide a more stringent toy
requirement that improves the safety of
toys and aligns with the requirement for
non-toy consumer products,45 the NPR
proposes to require similar sequential
use and abuse testing for toys containing
button cell or coin cell batteries by
adding to part 1250 a sequence of tests
based on UL 4200A–23: stress relief;
battery replacement; drop or tip-over;
impact; crush; torque, tension, and
compression; and compliance
verification.
a. Stress Relief Test
The NPR proposes requiring a preconditioning test to account for thermal
stress. Thermoplastics, or polymer
materials used in certain molding or
forming manufacturing processes (such
as acrylic, nylon, Polylactic Acid, and
polycarbonate), are susceptible to
change when subjected to thermal
stresses or heat. In particular, the
manufacturing process will leave parts
of a molded or formed component
stressed after it has cooled to room
temperature; then, when exposed to
heat, the stress will relax, causing the
dimensions and strength of the
component to change.
Toys containing button cell or coin
cell batteries are regularly exposed to
thermal stresses, including during
shipping, when left in a hot car or in the
sun, and from the battery(ies). To ensure
that plastic button cell or coin cell
battery compartments in toys are
designed and manufactured in a manner
that adequately accounts for the effects
of heat on the material, the NPR
proposes stress relief test requirements
that pre-condition the battery
compartment, and are intended to
ensure that any potential relaxation or
45 This standard has been incorporated by
reference in 16 CFR part 1263 as a safety standard
for non-toy consumer products.
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warping of molded or formed
thermoplastic components does not
affect the mechanical integrity of the
battery compartment as determined
through the subsequent tests in the
sequence.
ASTM F963–23 does not require any
pre-conditioning testing of batteryoperated toys prior to use and abuse
testing. The proposed test method is
based on the UL 4200A–23 requirement
that the entire toy or toy component be
placed in an oven at 70 °C, or 10 °C
higher than the maximum operating
temperature of the battery compartment,
if that temperature would be greater
than 70 °C, if any part of the battery
compartment is made of molded or
formed thermoplastic materials.
The proposed test also incorporates
some clarifications based on a similar
test in IEC 62368–1:2023, allowing
battery compartments and the
supporting framework to be removed
from large and bulky toys and placed in
the oven, without the remainder of the
product. This clarification allows
components of large and bulky toys to
be tested in smaller ovens without
compromising the test with a large and
bulky object interfering with use of the
appropriate test oven. The proposed
requirement also clarifies that the
batteries may be removed from the
compartment during the test, which will
not affect the outcome. The proposed
pre-conditioning test ensures that
battery compartments of toys containing
button cell or coin batteries withstand
potential thermal stressors that may
weaken the compartment and allow
children’s access to batteries, risking
ingestion, or insertion.
b. Battery Replacement Test
The NPR proposes testing
requirements for toys with a replaceable
battery to address the hazard of battery
compartments becoming unsecure after
a user replaced the battery and the
fastener or battery compartment threads
became stripped, thereby preventing
proper securement of the battery
compartment, allowing a child to access
the battery. The data described above
includes four such nonfatal incidents.
ASTM F963–23 does not require any
simulated battery replacement tests.
However, repeated opening and closing
of a battery compartment locking
mechanism has the potential to reduce
the strength of the lock. This is
particularly true when threaded
fasteners are used and threads of
different hardness engage with each
other (such as a metal screw into a
plastic toy), creating the potential for
the harder material to damage or strip
the threads from the softer material.
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65801
UL 4200A–23 addresses this hazard in
section 6.2.1b by requiring that the
battery compartment is opened; the
battery is removed and replaced; and
the battery compartment is closed and
secured 10 times. If the battery
compartment is secured with a fastener,
the screw must be loosened and
tightened using a suitable screwdriver
and a continuous linear torque in
accordance with the table in § 1250.3,
which is the same as table 20 of UL
60065 Standard for Audio, Video and
Similar Electronic Apparatus—Safety
Requirements.46
The proposed test method is based on
UL 4200A–23, but similar requirements
can be found in the international
standards IEC 62115 and IEC/UL 62368–
1. The test requires that the battery
compartment door or cover be opened,
the battery removed and replaced, and
the battery compartment door closed 10
times. If the battery compartment is
secured with one or more screws, then
the screws are to be loosened and
tightened using a suitable screwdriver,
and a continuous linear torque must be
used in accordance with the table in
§ 1250.3, which is the same as the
Torque to be Applied to Screws table,
table 20, of UL 60065, Standard for
Audio, Video and Similar Electronic
Apparatus—Safety Requirements.
c. Drop Test and Tip Over Test
Drop testing has long been used to
assess the durability of toys, yet the data
contains reports of 50 nonfatal incidents
where a toy’s battery compartment
broke apart or opened unintentionally,
including nine incidents specifically
describing the toy as having been
dropped. Staff’s testing, along with the
incident reports, illustrates the need for
rigorous drop testing to ensure the
integrity of the battery compartment.
Section 8.7.1 of ASTM F963–23
outlines drop test requirements based
on the age grading of the toy and
specific weight limits. The age grading
of the toy determines the maximum
weight of the toy subject to the test; the
number of drops; and the drop height.
For example, a toy for a child age 18
46 UL 60065 8th Edition (2015) is an adoption of
IEC 60065 Audio, video, and similar electronic
apparatus—Safety requirements 8th Edition (2014).
IEC has granted CPSC permission to reproduce
Table 20, Test Probe 11, and Test Probe B with the
following disclaimer: ‘‘The author thanks the
International Electrotechnical Commission (IEC) for
permission to reproduce Information from its
International Standards. All such extracts are
copyright of IEC, Geneva, Switzerland. All rights
reserved. Further information on the IEC is
available from www.iec.ch. IEC has no
responsibility for the placement and context in
which the extracts and contents are reproduced by
the author, nor is IEC in any way responsible for
the other content or accuracy therein.’’
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months or less must weigh 3.01 lbs. (1.4
kg) or less to be subject to the drop test,
and it would be dropped 10 times from
a height of 4.5 ft; a toy for a child age
over 36 months to 96 months must
weigh 10.01 lbs. (4.5 kg) or less to be
subject to the test, and it would be
dropped four times from a height of 3
ft. Toys are dropped in a random
orientation onto 1⁄8-inch-thick vinyl tile
over concrete with the batteries in place.
Large and bulky toys, defined as toys
with a projected base area of more than
400 square inches (0.26 m2) or a volume
of more than 3 cubic feet (0.08 m3), are
subject to the tip-over test in section
8.7.2 instead of the drop test. These toys
are tipped over three times onto the
same test surface as used in the drop
test.
Comparatively, section 6.3.2 of UL
4200A–23 varies the number of drops
for each product based on the weight of
the product and how the product is
used. A portable device, which is
reasonably foreseeable to be routinely
carried or lifted but not operated during
transit with a mass not exceeding 19 kg
(39.7 lbs.), is dropped three times. A
hand-held product, which is reasonably
foreseeable to be used or misused while
being held in one or both hands, with
a mass not exceeding 4.5 kg (10 lbs.), is
dropped 10 times. Products are dropped
in positions likely to produce the
maximum force on the battery
compartment from a height of 1.0 m (3
ft 3.4 in) onto a hardwood surface.
The application of both the ASTM
F963–23 drop test and the UL 4200A–
23 depend on characteristics of the
product intended to be dropped to
determine the appropriate test protocol,
and as a result, which of the tests is
more stringent than the other depends
on what product is being tested. For
example, the impact surface used in
ASTM F963–23 is harder than the
surface used in UL 4200A–23 and is
therefore expected to produce greater
impact forces on the toy. Meanwhile, all
hand-held products weighing 10 lbs. or
less are dropped 10 times in UL 4200A–
23, while many toys weighing 10 lbs. or
less are subject to only four drops or are
not dropped at all pursuant to ASTM
F963–23 test requirements.
Additionally, the drop test in UL
4200A–23 targets the button cell or coin
cell battery compartment for failure,
while the drop test in ASTM F963–23
is intended to identify ingestion hazards
and other hazards, such as small parts,
sharp edges, or other hazards generally
created by the test.
47 CPSC
Because aspects of the drop test in UL
4200A–23 are more stringent than the
drop test in ASTM F963–23 and better
ensure the integrity of the battery
compartment, the proposed test
combines aspects of the drop test in UL
4200A–23 with the drop test in ASTM
F963–23 to achieve the highest level of
safety feasible for toys containing button
cell or coin cell batteries. The proposed
test surface is vinyl tile on concrete,
consistent with the test surface
currently used for toy drop testing in
ASTM F963–23. The vinyl on concrete
test surface will absorb less energy and
produce a harder impact as compared to
the wood test platform used in UL
4200A–23. The proposed test also uses
minimum drop heights based on the
specifications in table 5 of ASTM F963–
23: 4.5 ft (137 cm) for toys for children
aged 0 to 18 months, and 3.0 ft (91 cm)
for all other toys. The drop height
specified in UL 4200A–23 is 1.0 m (100
cm, 3.3 ft). While the UL 4200A–23
drop height is greater than the proposed
drop height for toys for children ages
over 18 months, the Commission
expects that the harder test platform in
the proposed drop test will ultimately
make the test at least as stringent as the
UL 4200A–23 drop test. This
expectation is based on testing of a
product which failed both the ASTM
F963–23 drop test and the UL 4200A–
23 drop test (see section V.A.3. of this
preamble).
Establishing separate weight tiers
based on age grading is not appropriate
for this test given known incidents
where sibling interaction could have
contributed to the incident, including
cases where younger siblings were
playing with an older sibling’s toy.47
Instead, the proposed test method uses
a 10 lbs. product weight criteria for all
toys to establish a maximum weight for
the drop test. The proposed weight limit
is consistent with the weight limit for
hand-held products in UL 4200A–23,
which uses a lesser number of drops for
portable devices weighing up to 18 kg
(39.7 lbs.) that are carried or lifted but
not operated during transit as part of
their foreseeable use or misuse. The
proposed test adapts the drop test for
such portable products in UL 4200A–23
for toys weighing at least 10.01 lbs. up
to 39.7 lbs., and it also adds the existing
tip-over test for large and bulky toys
from section 8.7.2 of ASTM F963–23.
CPSC staff anticipates that most toys
weighing at least 10.01 lbs. would be
subject to the proposed tip-over test,
rather than the proposed drop test. The
Commission seeks comment on whether
there are toys for which the proposed
drop test for toys weighing at least 10.01
lbs. up to 39.7 lbs. would ever be
applicable instead of the proposed tipover test, and whether the drop test
should be removed for these heavier
toys.
d. Impact Test
The Commission is aware of 50
reported nonfatal incidents where a
toy’s battery compartment broke apart or
opened unintentionally, including two
incidents where the toy was described
as having been thrown or smashed. To
address this hazard, the NPR proposes
mandating an impact test directly on the
battery compartment. The proposed test
is based on the test in UL 4200A–23 and
simulates impacts directly to the toy
battery compartment.
ASTM F963–23 does not adequately
address direct impacts to battery
compartment enclosures that can occur
when children throw, punch, kick, or
smash toys together or against another
surface (such as furniture). The drop test
in section 8.7.1 simulates random
impacts from flat surface contact and
the compression test in section 8.10
applies a static load on surfaces not
contacted by the flat surface in the drop
test, but neither of these tests adequately
tests to protect against batteries
becoming unintentionally accessed from
toy battery compartments because these
tests do not simulate direct impacts
against the battery compartment.
To address direct impacts to battery
compartment enclosures that can occur
when children throw, punch, kick, or
smash toys together or against another
surface (such as furniture), the proposed
test adopts the impact test used in UL
4200A–23 and in several other
voluntary standards, such as IEC/UL
62368–1, which subjects the battery
enclosure or compartment door/cover to
three impacts with an energy of 1.5-ft·lbf
(2–J). The impacts are produced by
either dropping or swinging a 2.00 in.
(50.8 mm) diameter steel sphere,
weighing approximately 1.1 lbs. (0.5 kg),
from the height necessary to produce
the specified kinetic energy at impact,
as shown in figures 6 and 7. The sphere
must strike the battery enclosure or
compartment door/cover perpendicular
to the surface to ensure the impact has
the maximum amount of energy
possible.
staff has identified 24 such incidents.
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65803
Start
Position
Height
Impact
Position
Figure 6. Example impact test with a dropped steel sphere
The NPR proposes requiring a test to
account for crushing forces exerted on
toys during normal use and abuse, such
as if a person steps on a toy, to ensure
the battery compartment remains intact
and does not break open. ASTM F963–
23 does not include a test to address this
hazard pattern. Staff has reviewed
incident data demonstrating that a
battery can become accessible when a
child crushes a toy that is required to
comply with ASTM F963 as
incorporated in 16 CFR part 1250. The
NPR therefore proposes adopting a
crush test based on the test in section
6.3.4 of UL 4200A–23 for all toys subject
to the rule. This test simulates a
crushing force, such as the force exerted
on a toy from a child or adult stepping
or sitting on it, to ensure the toy does
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not split open and allow access to the
battery. The crush test involves placing
the toy sample on a fixed rigid
supporting surface (such as the floor or
a flat rigid table), in stable positions
likely to produce the most adverse
results. The test applies a crushing force
of 74.2 lbf ± 1.1 lbf (330 N ± 5 N) for
a period of 10 seconds to exposed
surfaces using a flat surface measuring
approximately 3.9 in by 9.8 in (100 mm
by 250 mm). The more stringent
requirements directly address one
scenario in which children have
accessed batteries, as shown in the
incident data.
f. Torque, Tension, and Compression
Tests
The NPR proposes including torque,
tension, and compression tests to
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address the hazard of children
manipulating a toy with their hands or
mouth to open the battery compartment.
The data includes nine nonfatal
incidents where children were able to
open the compartment in this manner.
Sections 8.8, 8.9, and 8.10 of ASTM
F963–23 include torque, tension, and
compression use and abuse tests that
simulate a child grasping a component
(with at least a thumb and forefinger, or
with teeth). Testing involves use of a
clamp to grab the toy component, and
then the part is twisted (torque) or
pulled (tension). The compression test
is applied to any area on the surface of
a toy that is accessible to a child and not
exposed to flat surface contact during
the impact (drop) test. A flat metal disk
with a diameter of 1.125 inches (28.58
mm) and a thickness of 0.375 inches
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e. Crush Test
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Figure 7. Example impact test with a swinging steel sphere
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(9.52 mm) is pressed into the surface.
Like the drop test, the forces and
torques applied in these tests depend on
the age grading of the toy. Torques range
from 1.8 in·lbf to 4.2 in·lbf (0.20 Nm to
0.47 Nm); tensile forces range from 9.5
lbf to 15.5 lbf (42 N to 69 N); and
compression forces range from 19.5 lbf
to 30.5 lbf (86.7 N to 135.7 N). The
torque and tension tests are conducted
in sequence with each other, but these
tests are otherwise not conducted in
sequence with the other ASTM tests.
In contrast, all of the use and abuse
tests outlined in UL 4200A–23 are
conducted in sequence. UL 4200A–23
requires the same torque, tension, and
compression tests as ASTM F963–23 but
applies the tests specifically to the
battery compartment and has higher
minimum torque and force values.
Under the UL standard, the minimum
torque is 0.5 Nm (4.4 in·lbf); 48 the
minimum tensile force is 72.0 N (16.2
lbf); and the minimum compression
force is 136 N (30.6 lbf). These higher
forces and torques in the UL test are
better able to ensure the integrity of the
battery compartment than the ASTM
test. Accordingly, the proposed torque,
tension, and compression test sequence
are based on the existing methods in
sections 8.8–8.10 of ASTM F963–23 and
must be conducted in the same order in
which they appear, while the proposed
minimum values align with UL 4200A–
23 to achieve the highest feasible level
of safety to best address unintended
access to toy battery compartments.
g. Compliance Verification Test
CPSC staff is aware of incidents of
children gaining access to button cell or
coin cell batteries from toy battery
compartments without the use of a tool,
such as a screwdriver. Section 4.25.4.2
of ASTM F963–23, Battery Accessibility,
requires that batteries which fit
completely within the small parts test
cylinder (including button cell and coin
cell batteries), shown in figure 4 from 16
CFR 1501.4, shall not be accessible
without requiring the use of a common
household tool.49 Any area of the toy
that can be contacted by any portion
forward of the collar of the probes
shown in figure 5 is considered to be
accessible.50 Per section 4.25.4.4,
specialty fasteners may also be used to
secure the battery compartment.51
Because the accessibility probes have
hinges, they reflect the bending
functionality of a finger, however the
probes cannot be applied with force like
that of a real finger because of
limitations associated with hinging
ability.
UL 4200A–23 uses a rigid finger probe
to determine battery accessibility.
Section 5.3 of UL 4200A–23 requires
application of a test probe, Test Probe
11 of IEC 61032 Standard for Protection
of Persons and Equipment by
Enclosures—Probes for Verification,
with minimum force before testing to
determine accessibility and, per section
6.3.5, application of the probe with 50
N (newtons) to 60 N (11.2 lbf to 13.4 lbf)
after testing to verify the battery
compartment enclosure remains
functional. The data described above
includes incidents where children were
able to access toy battery compartments
by manipulating the product with hands
or teeth. To address this hazard,
application of a finger probe with force
after testing is necessary to verify the
secureness of toy battery compartments.
This cannot be accomplished with the
accessibility probe in ASTM F963–23
but can be accomplished with the
accessibility probe in UL 4200A–23.
Therefore, the use of the accessibility
probe in UL 4200A–23 is necessary to
further reduce the risk of injury from
accessible button cell or coin cell
batteries. To address this hazard, the
proposed test uses the design of Test
Probe 11 of the Standard for Protection
of Persons and Equipment by
Enclosures—Probes for Verification, IEC
61032.52 The probe is used to apply 11.2
lbf + 2.2/¥0 lbf (50 N + 10/¥0 N) for
10 seconds at the most unfavorable
place and in the most unfavorable
direction to ensure that the battery
compartment door/cover does not open
and remains functional, while also
verifying that the battery is not touched
or made accessible.
1.25 in
31.7mm
A
rn~....--1--7
25.4 mm
48 This minimum torque aligns with the required
torque for twist-on access covers.
49 By definition, common household tools
include straight-blade or Phillips screwdrivers,
pliers, coins, or other objects commonly found in
most households.
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50 Probe A is for toys age graded for children 0–
36 months, and Probe B is for toys age graded for
children 37–96 months.
51 Specialty fasteners (such as with Torx or Hex
drivers) may be used to secure battery
compartments, so long as the tool is included with
the toy and specific instructional material is
included.
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52 IEC 61032, Figure 7—Test Probe 11 directs
readers to review Test Probe B for dimensions of
the fingertip and tolerances. The proposed
additions to § 1250.3 include Test Probe B, to
ensure readers may easily review the proposed
dimensions and tolerances.
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Figure 4. Small Parts Cylinder (16 CFR 1501.4)
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
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abcdef
~"1~m;
I • .:11-{i!i •
' I
Figure 5. Accessibility Probes
The proposed test method addresses
50 reported nonfatal incidents where
the toy battery compartment broke apart
or opened unintentionally, including
nine nonfatal incidents where children
accessed batteries from the battery
compartment while playing with the toy
with their hands and mouth.53 This test
verifies that the battery compartment
enclosure remains secure and functional
beyond the use of the accessibility probe
currently referenced in ASTM F963–23.
B. Marking, Warning, Labeling, and
Instructional Literature Requirements
During the Reese’s Law rulemaking
process, staff evaluated required
warnings for battery-operated toys in
ASTM F963–17, the previous version of
ASTM F963. Tab C, Appendix A,
Reese’s Law NPR SBP. Warning
requirements for battery-operated toys
have not changed between the 2017
version of ASTM F963 and ASTM
F963–23. ASTM F963 sets forth uniform
methods of addressing mechanical and
chemical safety hazards and associated
safety messaging in toys that are
intended for children. Table 3
summarizes CPSC’s review of marking
and labeling requirements in ASTM
F963–23 and whether a higher level of
safety is feasible for toys containing
button cell or coin batteries based on
requirements in other safety standards.
Detail of staff’s analysis follows.
TABLE 3—SUMMARY OF ASSESSMENT OF ASTM F963–23 MARKING AND LABELING REQUIREMENTS IN COMPARISON TO
UL 4200A–23
Requirement category
ASTM F963–23
(section No.—assessment)
On Toy Product Packaging .......................................
Warnings:
On Toy Products .......................................................
In Accompanying Instructions ...................................
5.14.2—higher level of safety is feasible ........................
UL 4200A–2023—7B.
4.25.1—higher level of safety is feasible ........................
5.14.2—higher level of safety is feasible ........................
UL 4200A–2023—7C.
UL 4200A–2023—9.
Packaging—Section 5.14.2. of ASTM
F963–23 requires that toys powered by
‘‘button or coin cell batteries that are 1.5
volts or greater, regardless of chemistry,
and are greater than 15mm in diameter
and fit within the small parts cylinder’’
Comparison
(standard—section No.)
must have the following warning on the
toy packaging:
• A
1263.1(d). Both ASTM F963–23 and UL
4200A–23 require similar warning
formats with a signal word, safety alert
symbol (e.g., exclamation mark in a
triangle), and message statement noting
the presence of button cell or coin cell
batteries. The UL 4200A–23 warning
label improves safety compared to the
ASTM warning, however, because it
also provides an explicit hazard
statement and detailed hazard
information, the severity and
consequences if the warning is
disregarded, and appropriate hazardavoidance behaviors. The warning
additionally instructs the consumer to
take appropriate action should they
suspect a button cell or coin cell battery
was ingested. Specifically, the warning
53 In one of these incidents, Y214K670A, the
battery compartment opened while the fastener
remained in place. This failure mode may not be
detected using ASTM F963–23’s existing
accessibility probe because the probe cannot be
applied with force due to its joints.
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Products with batteries subject to the
packaging requirements specified in UL
4200A–23 are not limited by battery
voltage or diameter; all consumer
products containing button cell or coin
cell batteries are included (with the
exception of toys and zinc-air batteries).
The Commission has determined that
zinc-air button cell or coin batteries do
not present an ingestion hazard. 16 CFR
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WARNING: "Contains button or coin cell battery. Hazardous if swallowed see instructions" (§ 5.14.2.1 (1) ).
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label shall have the following
statements,
• INGESTION HAZARD: This product
contains a button cell or coin battery.
• DEATH or serious injury can occur if
ingested.
• A swallowed button cell or coin battery
can cause Internal Chemical Burns in as little
as 2 hours.
• KEEP new and used batteries OUT OF
REACH OF CHILDREN.
• Seek immediate medical attention if a
battery is suspected to be swallowed or
inserted inside any part of the body.
The UL warning label format uses a
bulleted list, capitalization, and bolding
that aligns with industry best practices
as outlined in ANSI Z535.4 (American
National Standard for Product Safety
Signs and Labels) and ASTM’s Ad Hoc
Language Task Group
recommendations. Additionally, UL
4200A–23 incorporates the use of a
safety icon accompanying the text to
quickly attract the reader’s attention to
the label. Either the ‘‘Keep out of
Reach’’ icon or the internationally
Additionally, the location of onproduct safety labeling is dependent on
the size of the product, as determined
WARNING: This product contains a Button or Coin Cell Battery. A
swallowed Button or Coin Cell Battery can cause internal chemical burns in as
little as two hours and lead to death. Dispose of used batteries immediately.
Keep new and used batteries away from children. If you think batteries might
have been swallowed or placed inside any part of the body, seek immediate
medical attention.
If the toy does not come with
instructions, the above warning must be
on the packaging or on a paper insert
inside the toy packaging. Products with
accessible (with the use of a coin,
screwdriver or household tool), nonreplaceable batteries must contain a
statement that the batteries are not
replaceable. UL 4200A–23 has the same
requirement for non-replaceable button
cell or coin cell batteries. As previously
discussed, the UL 4200A–23 warning
label requires detailed warning message
statements and a safety icon to capture
the reader’s attention; these
requirements are not dependent on
battery voltage or diameter. This same
warning must be printed on the
instructions or manual if provided.
Similar to the ASTM F963–23 standard,
should no instructions or manual be
provided, UL 4200A–23 requires the
warning to be on the packaging, or it
must be on a hangtag or sticker label if
the product does not include packaging.
UL 4200A–23 requires additional
battery safety information on the
product packaging or in the
instructions/manual as applicable.
VerDate Sep<11>2014
• ‘‘Do not mix old and new batteries.’’
• ‘‘Do not mix alkaline, standard (carbonzinc), or rechargeable batteries.’’
• ‘‘Battery is not replaceable’’ (if
applicable).
by the manufacturer. If the product is
too small, the above information must
be included in the toy instructions.
Button cell or coin cell battery-operated
toys are not required to be marked if the
toy is so small that marking is not
feasible. UL 4200A–23 on-product
marking requirements include a
warning label identifying an ingestion
hazard and the presence of a button cell
or coin cell battery. If the toy’s small
size limits the ability to print a warning
on the product, the warning can be
replaced with an internationally
recognized warning icon. If a toy’s small
size does not allow inclusion of an onproduct warning or icon, UL 4200A–23
requires that a hangtag or sticker label
be included with the toy.
Instructions—ASTM F963–23
requires toys powered by ‘‘button or
coin cell batteries that are 1.5 volts or
greater, regardless of chemistry, and are
greater than 15mm in diameter and fit
within the small parts cylinder’’ to have
the following instructions:
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These statements address battery
replacement and disposal, compatibility
with the product, securement of the
battery compartment, and electrical or
fire hazards associated with misused
batteries.
Section 1263.4, which implements
Reese’s Law for consumer products
generally, establish warning label
requirements for the packaging of button
cell or coin batteries, while § 1263.3
incorporates the labeling requirements
in UL 4200A–23, which establish
warnings for the consumer product
packaging, battery compartment, and
accompanying instructional materials.
To provide the highest level of safety
feasible, this NPR seeks to align
required warnings for toy packaging, toy
battery compartments, and
accompanying instructional literature,
with part 1263 because such
requirements are worded and formatted
in a manner that better warns of hazards
identified in the incident data and better
captures reader’s attention.
The proposed formatting
requirements taken from part 1263 are
based largely on warning label research
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and ANSI Z535.4, which is the primary
voluntary consensus standard providing
guidelines for the design of safety signs
and labels for application to consumer
products. ANSI Z535.4 includes
recommendations for the design,
application, use, and placement of
warning labels, such as having the
signal word ‘‘WARNING’’ and the safety
alert symbol of an equilateral triangle
surrounding an exclamation mark. Tab
C, Reese’s Law NPR SBP. Children’s
juvenile product standards, as well as
standards involving common household
items that may be hazardous to
children, commonly rely on the warning
formatting specifications in ANSI’s
Z535.4.
Spare batteries included with toys not
contained in child-resistant packaging
present an ingestion hazard to children.
Pursuant to section 3 of Reese’s Law, the
Commission already requires that
button cell or coin cell batteries
included separately within toy
packaging meet child resistant
packaging requirements to address the
possibility of children opening and
accessing the contents of retail toy
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.A.
recognized ‘‘Warning: Contains coin
battery’’ icon may be used depending on
applicability.
Product—ASTM F963–23 safety
labeling requirements for toys that use
batteries must specify the type of
battery, the size of the battery, and the
number of batteries used within the toy.
Section 4.25.1 of ASTM F963–23
requires that the toy be marked with
battery polarity, size, and voltage,
although size and voltage may be
provided in the instructions. It also
requires additional on-product markings
if the toy is powered by more than one
battery per circuit. Pursuant to section
6.5 and 5.14 of ASTM F963, the toy or
instructions must state the following:
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
packaging. As such, the Commission
already requires that button cell or coin
cell battery packaging, including button
cell or coin cell batteries sold separately
along with a toy, meet § 1263.4,
Requirements for labeling of button cell
or coin battery packaging.
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VI. Feasibility of Proposed
Requirements
Pursuant to section 106(c) of the
CPSIA, Congress directed the
Commission to ‘‘periodically review and
revise the rules set forth under this
section to ensure that such rules provide
the highest level of safety for such
products that is feasible.’’ 15 U.S.C.
2056b(c). The safety hazards identified
in section III of this preamble can
feasibly be addressed by the
requirements proposed in this NPR.
Many toys on the market already
comply with the proposed
requirements. The technology to comply
is already available (e.g., threaded
fasteners), and the proposed
requirements align with existing,
already-required performance
requirements applicable to non-toys
products in part 1263, which are
currently on the market. Third party
labs are already International
Organization for Standardization (ISO)
accredited and CPSC-accepted to test to
UL 4200A; complying with the
proposed requirements for toys would
use the same or similar testing and test
equipment.
Nor will the proposed rule present
insurmountable economic challenges.
Staff estimates that only 20 percent of
the manufacturers and importers/
wholesalers (approximately 3,775)
would incur any costs related to
redesign required by the proposed rule.
As stated in section IX of this preamble,
the maximum cost expected per firm to
redesign a battery compartment is
$6,586, which equates to a maximum
total cost to the industry of
approximately $25 million. Estimates of
U.S. children’s toys sales revenue in
2023, published by Circana,54 equate to
a total industry size of $28 billion.
Maximum cost estimates are 0.09
percent of revenue.
VII. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). The rule would apply
to all toys containing button cell or coin
54 2023 US Toy Industry Sales Analysis—Circana.
https://www.circana.com/intelligence/pressreleases/2024/us-toy-industry-sales-decline-8-in2023-while-remaining-5-7-billion-above-2019-salescircana-reports/.
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cell batteries manufactured after the
effective date. 15 U.S.C. 2058(g)(1).
Although many toys may already
comply with the proposed
requirements, some toys would need to
be redesigned, and all toys containing
button cell or coin cell batteries would
require third-party testing to the new
requirements. 15 U.S.C. 2063(a)(3).55
Accordingly, to provide time to comply
with the rule, to ensure adequate lab
capacity to test and certify toys, and to
spread the cost of compliance over
approximately six months, the
Commission proposes to make this rule
effective 180 days after publication of
the final rule in the Federal Register.
Although the NPR proposes to add
performance requirements, 180 days
should be sufficient to come into
compliance, because battery-operated
toys already must satisfy third party
testing, and because the proposed new
test methods and test equipment are
consistent with the testing required in
part 1263, incorporating ANSI/UL
4200A–23, which utilizes similar
methods and equipment. For example,
currently 142 third party laboratories
are CPSC-accepted to test to part 1250’s
requirements for battery-operated toys,
and 35 labs are CPSC-accepted to test to
part 1263. Accordingly, CPSC expects
that these laboratories are competent to
conduct the required testing and can
have their ISO accreditation and CPSCacceptance updated in the normal
course. The Commission invites
comments, particularly from small
businesses, regarding the proposed
testing and the amount of time needed
to come into compliance with a final
rule.
VIII. Regulatory Flexibility Act (RFA)
The RFA requires agencies to review
each proposed rule’s potential economic
impact on small entities, including
small businesses. Section 603 of the
RFA generally requires that agencies
prepare an initial regulatory flexibility
analysis (IRFA) and make the analysis
available to the public for comment
when the agency publishes an NPR,
unless the rule would not have a
significant economic impact on a
substantial number of small entities. 5
U.S.C. 603, 605(b).
If the proposed rule is finalized, CPSC
staff does not expect a significant
impact to a substantial number of small
businesses. Small manufacturers may
incur a one-time redesign cost and
ongoing component costs (i.e., screws
and threads) to comply with the rule for
product lines that currently do not meet
55 Section 14(a)(3) specifies laboratories must
have at least 90 days to test for compliance.
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65807
the proposed requirements. However,
CPSC does not expect small firms to
incur a cost that exceeds 1 percent of
the annual revenue of the firm (nor 1
percent of the retail price of the
product). Therefore, the Commission
certifies that the rule will not, if
promulgated, have a significant
economic impact on a substantial
number of small entities.
A. Reason for Agency Action, NPR
Objectives, Product Description, and
Market Description
Section I of this preamble explains
why CPSC proposes to establish
mandatory requirements for toys
containing button cell or coin cell
batteries to prevent access to battery
compartments by children aged 6 years
old and younger and provides a
statement of the objectives of, and legal
basis for, the proposed rule. Section II
of this preamble describes the types of
products within the scope of the NPR,
the market for button cell and coin cell
batteries in toys, and the use of such
batteries in toys in the U.S. The
requirements in the NPR are more
stringent than ASTM F963–23, which
was incorporated into the mandatory
rule 16 CFR part 1250, as described in
sections IV and V of this preamble. The
NPR addresses the known ingestion
hazard, discussed in section III of this
preamble, that the current rule does not
adequately address.
B. Small Entities to Which the Rule
Would Apply
Section II of this preamble describes
the products within the scope of the
rulemaking and provides an overview of
the market for toys containing button
cell or coin cell batteries. This section
of the preamble provides additional
details on the market for products
within the scope of the rulemaking.
The North American Industry
Classification System (NAICS) 56 defines
product codes for U.S. firms. Firms that
manufacture button cell or coin cell
battery-powered children’s toys may list
their businesses under various NAICS
product codes, as these toys include a
variety of children’s products, such as
dolls and musical instruments. Most of
these firms likely fall under NAICS code
339930 Doll, Toy, and Game
Manufacturing, but some may also fall
under code 339992 Musical Instrument
56 The NAICS is the standard used by Federal
statistical agencies in classifying business
establishments for the purpose of collecting,
analyzing, and publishing statistical data related to
the U.S. business economy. For more information,
see https://www.census.gov/naics/. Some programs
use 6-digit NAICS codes, which provide more
specific information than programs that use more
general 3- or 4-digit NAICS codes.
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Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
Manufacturing or 339999, All Other
Miscellaneous Manufacturing. Importers
of battery-operated toys containing
button cell or coin cell batteries also fall
under multiple NAICS codes, with a
majority of the firms following under
NAICS codes as wholesalers: 423920
Toy and Hobby Goods and Supplies
Merchant Wholesalers, 423910 Sporting
and Recreational Goods and Supplies
Merchant Wholesalers, and 423990
Other Miscellaneous Durable Goods
Merchant Wholesalers.
Retailers of toys containing button
cell or coin cell batteries similarly
include a variety of retailer types, from
large ‘‘big box’’ retailers to smaller
specialized product firms. CPSC staff
estimates that a majority of these
products fall under NAICS codes
459120 Hobby, Toy, and Game Stores,
451110 Sporting Goods Stores, 459140
Musical Instrument and Supplies
Stores, 455110 Department Stores, and
455211 Warehouse Clubs and
Supercenters. Some of these products
may also be sold in stores coded as
445110 Grocery Stores, 445121
Convenience Stores, and 443142
Electronic Stores, among other outlets;
however, CPSC expects the number of
such toys sold at these stores to be
negligible.
Under U.S. Small Business
Administration (SBA) guidelines, a
manufacturer, importer, and retailer of
toys containing button cell or coin cell
batteries is categorized as ‘‘small’’ based
on the SBA’s size thresholds associated
with each NAICS code. SBA uses the
number of employees to determine
whether a manufacturer or importer is a
small entity, while SBA uses annual
revenues to consider a retailer. Based on
the U.S. Census Bureau’s 2021 and 2017
Statistics of U.S. Businesses (SUSB)
data, CPSC staff estimated the number
of firms classified as small for the most
relevant NAICS codes. Tables 4 and 5
provide the estimated number of small
firms by each NAICS code.57 Staff
estimates a total of 18,968 small
manufacturers and importers, and
28,619 small retailers.
TABLE 4—ESTIMATED NUMBER OF SMALL MANUFACTURERS AND IMPORTERS
NAICS code
339930
339992
339999
423920
423910
.........
.........
.........
.........
.........
423990 .........
SBA size standard
for firms
(No. of employees)
Description
Doll, Toy, and Game Manufacturing .....................................................
Musical Instrument Manufacturing .........................................................
All Other Miscellaneous Manufacturing .................................................
Toy and Hobby Goods and Supplies Merchant Wholesalers ...............
Sporting and Recreational Goods and Supplies Merchant Wholesalers.
Other Miscellaneous Durable Goods Merchant Wholesalers ...............
Number of firms
that meet size standard
(based on SUSB data)
700
1000
550
175
100
485
587
2,951
1,846
4,432
100
8,567
TABLE 5—ESTIMATED NUMBER OF SMALL RETAILERS
Description
452210 .........
452310 .........
Department Stores .................................................................................
General Merchandise Stores, Including Warehouse Clubs and Supercenters.
Sporting Goods Retailers ......................................................................
Hobby, Toy, and Game Stores ..............................................................
Musical Instrument and Supplies Stores ...............................................
451110 .........
451120 .........
451140 .........
C. Compliance Requirements of the
NPR, Including Reporting and
Recordkeeping Requirements
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SBA size standard
for firms
(annual revenue)
millions $
NAICS code
The NPR would improve the
performance and labeling requirements
applicable to toys containing button cell
or coin cell batteries. Under section 14
of the CPSA, manufacturers, importers,
and private labelers of toys containing
button cell or coin cell batteries would
be required to certify, based on testing
by an ISO-accredited, CPSC-accepted
third party conformity assessment body,
that their toy complies with the
requirements of the proposed rule. Each
certificate of compliance must identify
the third-party conformity assessment
57 Some discrepancies exist between the
published SBA size standard NAICS code and the
SUSB code. Staff used the code description to
match the size standard to the correct value.
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Number of firms
that meet size standard
(based on SUSB data)
$40.0
47.0
15
8,006
26.5
35.0
22.5
13,751
4,660
2,187
body on whose testing the certificate
depends. The certificate must be legible
and in English and include the date and
place of manufacture, the date and place
where the product was tested, including
the full mailing address and telephone
number for each party, and the contact
information for the person responsible
for maintaining records of the test
results. The certificates may be in
electronic format and must be provided
to each distributor or retailer of the
product. Upon request, the certificates
must be provided to CPSC and/or U.S.
Customs and Border Protection. 15
U.S.C. 2063(a) and (g); 16 CFR part
1110.
D. Costs of NPR That Would Be Incurred
by Small Manufacturers
Retailer size determination is made using 2017
SUSB data by applying the ratio of firms that meet
the standard to the 2021 data values.
58 Re-tooling costs are not expected from the
changes in the draft proposed rule.
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Toys containing button cell or coin
cell batteries may require minor
redesign to comply with the proposed
rule. CPSC anticipates one likely
method of redesign is to replace plastic
screw thread inserts with metal inserts
to strengthen fastener attachment and
prevent easy stripping of screws. The
potential costs of this modification are
the incremental cost to incorporate the
screw thread insert and make that
material change, and the one-time
design changes to battery
compartments.58
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CPSC estimates that the incremental
costs to modify the screw thread are
negligible (less than $0.01) per product.
CPSC estimates a range of one to two
weeks of labor for an electrical engineer
to redesign a toy battery compartment.
Data from the Bureau of Labor Statistics
(BLS) indicates that the average full
hourly compensation rate of an
electrical engineer, which includes
wages 59 and benefits,60 in the U.S. is
$84.87.61 Because battery compartment
designs are very similar across product
models and firms, CPSC assesses that
firms would be able to incorporate the
updated battery compartment designs
across all children’s products lines that
the manufacturer offers without
additional effort required for each
product line. Considering this equates to
a range of possible design costs of
$3,395 to $6,791 per firm.62
Some additional costs might be
incurred related to updating and/or
adding labels. Generally, the costs
associated with modifying or adding
warning labels are low on a per unit
basis and all manufacturers of children’s
products are already required to provide
warning labels with their product.
Therefore, CPSC expects the
incremental cost related to the labeling
provision to be negligible.
Manufacturers would likely incur
additional costs to certify that their toys
containing button cell or coin cell
batteries meet the rule, if finalized, as
required by section 14 of the CPSA, 15
U.S.C. 2063. Certification of children’s
products must be completed by a CPSCaccepted, third party conformity
assessment body (i.e., third party
laboratory). Based on quotes from
testing laboratories for ASTM F963
mechanical services, the cost of the
certification testing will range from
$130 to $250 per product sample.
Because toys containing button cell or
coin cell batteries are already tested to
part 1250, CPSC does not expect the
additional testing proposed in this rule
to materially increase the cost of thirdparty testing.
59 The mean hourly wage of an electrical engineer
is $56.58 per hour as of May 2023 according to BLS,
available at: https://www.bls.gov/oes/current/
oes172071.htm.
60 The ratio of full compensation to wages for
someone in Professional and related occupations in
the Manufacturing industry is 1.50 ($68.94
compensation per hour ÷ $46.02 wage per hour) as
of March 2024. See table 4 at: https://www.bls.gov/
news.release/ecec.t04.htm.
61 $84.87 per hour = $56.58 wage per hour × 1.50
compensation factor.
62 Calculated as work hours in a week times
compensation rate. (40 × $84.87 = $3,394.80 and 80
× $84.87 = $6,789.60).
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E. Impact on Small Manufacturers
If the rule is finalized, small
manufacturers would incur a one-time
redesign cost and continuous
component costs (i.e., screws and
threads) to comply with the rule for
product lines that currently do not meet
the proposed requirements. Retail prices
for toys containing button cell or coin
cell batteries vary greatly, with the least
expensive toys costing approximately
$3. CPSC does not expect small firms to
incur a cost that exceeds 1 percent of
the annual revenue of the firm (nor 1
percent of the retail price of the
product).
Generally, CPSC considers an impact
to be potentially significant if it exceeds
1 percent of a firm’s revenue. CPSC does
not expect a potentially significant
impact on small firms that manufacture
toys containing button cell or coin cell
batteries. CPSC does not expect that
small businesses will incur costs that
exceed 1 percent of their annual
revenue. The high end of CPSC’s cost
estimate range is $6,791. Any firm with
annual revenues less than $678,100
could potentially incur a significant
impact, however, CPSC is unaware of
any firms with revenues of this amount
that have costs at the highest end of the
cost estimate range. The Commission
seeks comments from firms stating their
annual revenue and estimated redesign
and continuous component costs.
F. Alternatives for Reducing the Adverse
Impact on Small Entities
CPSC considered three alternatives to
the NPR that could reduce the impact
on small entities: (1) not taking any
action regarding toys containing button
cell or coin cell batteries, (2)
establishing an information and
education campaign for these batteries,
and (3) providing a later effective date.
In addition, although the statute allows
CPSC to provide ‘‘small batch’’
exemptions to testing requirements or
alternative requirements for small
providers of certain products, allowing
no testing or alternate testing would
undermine the Commission’s effort to
require battery accessibility testing in
ASTM F963–23 the same as for non-toy
consumer products. 15 U.S.C.
2063(d)(4).
1. No Action Alternative
Under this alternative the status quo
would be maintained, and no firm
would incur a rule-based cost. While
not promulgating a mandatory standard
for toys containing button cell or coin
cell batteries would have no impact on
U.S. small businesses, it would also
allow hazardous products to remain on
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65809
the market and ignore a known
ingestion hazard to children. Further,
impact on small U.S. businesses if the
Commission took no action would be
limited because of the low cost for small
businesses to comply with the rule.
Taking no action to address the risk
of button cell or coin cell battery child
ingestion by making the requirements
for securing toy battery compartments
more stringent, to ensure that they
provide the highest level of safety
feasible, would be inconsistent with the
Commission’s statutory mandate
described in section I of this preamble.
15 U.S.C. 2056b(c) and (d). After
preliminarily determining that the
existing requirements in ASTM F–963
are inadequate to address the risk of
potential ingestion, the Commission is
moving forward with this rulemaking to
comply with the statutory mandate and
to prioritize the safety of children by
mitigating potential child ingestions of
button cell or coin cell batteries
obtained from toys.
2. Information and Education Campaign
The Commission could create an
information and education campaign to
better alert parents and caregivers
regarding the risks associated with
children ingesting button cell or coin
cell batteries. This would require
consumer outreach efforts like
advertising and marketing related to the
hazards. This alternative could be
implemented independent of any
regulatory action. Although information
campaigns may be helpful, standing
alone they are inadequate to address the
ingestion hazard associated with these
batteries.
3. Later Effective Date
To reduce burden on small
businesses, the Commission considered
an effective date later than 180 days
after Federal Register publication, to
spread the cost of compliance over a
longer period. Although many toys may
already comply with the proposed
requirements, some toys would need to
be redesigned, and all toys containing
button cell or coin cell batteries would
require third-party testing to the new
requirements. In this case, as described
above, 180 days is reasonable for firms
to comply with the rule, the cost of
compliance is low, and many labs are
already CPSC-accepted to conduct the
same or similar testing. Providing a 180day effective date is consistent with
section 106(g) of the statute and
addressing this known health hazard
associated with children’s toys.
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IX. Environmental Consideration
The Commission’s regulations address
whether the agency is required to
prepare an environmental assessment or
an environmental impact statement.
Under these regulations, certain
categories of CPSC actions normally
have ‘‘little or no potential for affecting
the human environment,’’ and therefore
do not require an environmental
assessment or an environmental impact
statement. Safety standards providing
performance and labeling requirements
for consumer products come under this
categorical exclusion. 16 CFR
1021.5(c)(1). The NPR falls within the
categorical exclusion.
X. Paperwork Reduction Act (PRA)
This NPR for toys containing button
cell or coin cell batteries contains
information collection requirements that
are subject to public comment and
review by the Office of Information and
Regulatory Affairs (OMB) under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3521). Toys are children’s
products. Accordingly, CPSC proposes
to update the PRA estimate for toys
containing button cell or coin cell
batteries into a new control number, and
then include this updated estimate in
the Children’s Product OMB Control
Number in the next update. In this
document, pursuant to 44 U.S.C.
3507(a)(1)(D), we set forth:
• A title for the collection of
information;
• A summary of the collection of
information;
• A brief description of the need for
the information and the proposed use of
the information;
• A description of the likely
respondents and proposed frequency of
response to the collection of
information;
• An estimate of the burden that shall
result from the collection of
information; and
• Notice that comments may be
submitted to the OMB.
Title: Safety Standard for Toys:
Requirements for Toys Containing
Button Cell or Coin Cell Batteries.
Description: As described in section V
of this preamble, the proposed rule
would require each toy containing a
button cell or coin cell battery to
comply with the performance and
labeling requirements in 16 CFR 1250.3.
CPSC will seek a new OMB control
number for this update. Sections 5, 6,
and 7 of ASTM F963–23 contain
requirements for marking, labeling, and
instructional literature. These
requirements fall within the definition
of ‘‘collection of information,’’ as
defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons
who manufacture or import toys
containing one or more button cell or
coin cell batteries, as defined in
proposed § 1250.3(b).
Estimated Burden: We estimate the
burden of this collection of information
as follows:
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TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN
Burden type
Number of
respondents
Frequency
of response
Total
annual
responses
Hours per
response
Total burden
hours
Labeling and instructions .............................................................
18,868
2
37,736
2
75,472
This estimate is based on the
following: CPSC estimates that 18,868
respondents would provide labeling and
instructional literature annually, based
on the number of identified small firms
that manufacture or import toys
containing cell or coin cell batteries. We
exclude retailers from our estimate
because we assume that labeling and
instructional literature would be
provided by manufacturers and
importers, but not retailers. While the
number of responses per respondent
would vary, we estimate that on
average, each respondent will respond
twice annually for products that are
updated and brought to market, for a
total of 37,736 annual responses (18,868
respondents × 2 responses per year).
CPSC assumes that on average it will
take 1 hour for each respondent to
create the required label and one hour
for them to create the required
instructions, for an average response
burden of 2 hours per response.
Therefore, the total burden hours for the
collection are estimated to be 75,472
hours annually (37,736 responses × 2
hours per response = 75,472 total
burden hours).
We estimate the hourly compensation
for the time required to create and
update labeling and instructions is
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$41.55 (U.S. Bureau of Labor Statistics,
‘‘Employer Costs for Employee
Compensation,’’ December 2023, table 4,
total compensation for all sales and
office workers in goods-producing
private industries: https://www.bls.gov/
news.release/archives/ecec_
03132024.pdf). Therefore, the estimated
annual cost of the burden requirements
is $3,135,862 ($41.55 per hour × 75,472
hours = $3,135,861.60). No operating,
maintenance, or capital costs are
associated with the collection. Based on
this analysis, the proposed revisions to
the standard would impose a burden to
industry of 75,472 hours at a cost of
$3,135,862 annually.
In compliance with the PRA (44
U.S.C. 3507(d)), we have submitted the
information collection requirements of
this rulemaking to the OMB for review.
Interested persons are requested to
submit comments regarding information
collection by October 15, 2024, to the
OMB (see the ADDRESSES section at the
beginning of this document). Pursuant
to 44 U.S.C. 3506(c)(2)(A), we invite
comments on:
• Whether the collection of
information is necessary for the proper
performance of CPSC’s functions,
including whether the information will
have practical utility;
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• The accuracy of CPSC’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
• Ways to enhance the quality, utility,
and clarity of the information to be
collected;
• Ways to reduce the burden of the
collection of information on
respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology; and
• The estimated burden hours
associated with the update and
modification of labels and instructions,
including any alternative estimates.
XI. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), states that when a consumer
product safety standard is in effect and
applies to a product, no State or
political subdivision of a State may
either establish or continue in effect a
standard or regulation that prescribes
requirements for the performance,
composition, contents, design, finish,
construction, packaging, or labeling of
such product dealing with the same risk
of injury unless the State requirement is
identical to the Federal standard.
Section 106(f) of the CPSIA deems rules
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issued under that provision ‘‘consumer
product safety standards.’’ Therefore,
once a rule issued under section 106 of
the CPSIA takes effect, it will preempt
in accordance with section 26(a) of the
CPSA.
XII. Certification and Notice of
Requirements
Section 14(a) of the CPSA imposes the
requirement that products subject to a
consumer product safety rule under the
CPSA, or to a similar rule, ban,
standard, or regulation under any other
act enforced by the Commission, must
be certified as complying with all
applicable CPSC-enforced requirements.
15 U.S.C. 2063(a). Section 14(a)(2) of the
CPSA requires that certification of
children’s products subject to a
children’s product safety rule be based
on testing conducted by a CPSCaccepted third party conformity
assessment body. Section 14(a)(3) of the
CPSA requires the Commission to
publish an NOR for the accreditation of
third-party conformity assessment
bodies (or laboratories) to assess
conformity with a children’s product
safety rule to which a children’s product
is subject. The proposed rule for 16 CFR
1250.3, Requirements for Toys
Containing Button Cell or Coin Cell
Batteries, if issued as a final rule, would
be a children’s product safety rule that
requires the issuance of an NOR.
Title 16, part 1112 of the CFR
establishes requirements for
accreditation of third-party conformity
assessment bodies to test for conformity
with a children’s product safety rule in
accordance with section 14(a)(2) of the
CPSA. Part 1112 also codifies all of the
NORs issued previously by the
Commission. To meet the requirement
that the Commission issue an NOR for
the proposed standard, the Commission
proposes as part of the NPR to add
§ 1250.3, Requirements for Toys
Containing Button Cell or Coin Cell
Batteries, to the list of children’s
product safety rules for which CPSC has
issued an NOR.
Testing laboratories applying for
acceptance as a CPSC-accepted third
party conformity assessment body to
test to the new standard for button cell
and coin cell batteries in toys would be
required to meet the third-party
conformity assessment body
accreditation requirements in part 1112.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to CPSC to have 16
CFR 1250.3, Requirements for Toys
Containing Button Cell or Coin Cell
Batteries, included within the
laboratory’s scope of accreditation listed
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for the laboratory on the CPSC website
at: https://www.cpsc.gov/cgi-bin/
labsearch/.
XIII. Request for Comments
The Commission requests comments
on all aspects of this NPR, including the
effective date. Submit comments in
accordance with the instructions in the
ADDRESSES section at the beginning of
this document.
CPSC specifically requests comment
on the following topics:
A. Proposed Performance Requirements
for Toys Containing Button Cell or Coin
Cell Batteries
1. Do the proposed performance
requirements align with the
requirements in part 1263? If not, what
requirements should the Commission
add or remove to align the two
standards?
2. Are the proposed performance
requirements adequate to address the
risk of ingestion and insertion from
children accessing button cell or coin
batteries from toys? Please provide
details of any additional requirements
proposed.
3. Are there any toys weighing over 10
lbs. and up to 39.7 lbs., that would not
be considered large and bulky (as
defined in ASTM F963–23), and should
a separate drop test for such toys be
included?
B. Proposed Warning Label
Requirements for Toys Containing
Button Cell or Coin Cell Batteries
1. Are the proposed warnings
adequate to address the hazards
associated with toys containing button
cell or coin cell batteries?
2. Should CPSC consider additional
warnings on toy packaging, on toys, or
on instructional literature
accompanying toys?
3. Should CPSC consider other
warning formats?
C. Regulatory Flexibility Analysis
1. Significant impact. Is CPSC’s
estimated cost of redesign to achieve
compliance appropriate? If not, please
provide additional information and
support for your proposed correction.
Also, do the estimated costs represent
more than one percent of annual
revenue for individual small U.S.
manufacturers and importers?
2. Testing costs. Will third party
testing costs for toys containing button
cell or coin cell batteries increase as a
result of the requirements in this NPR,
and if so, by how much?
3. Effective date of 180 days after
Federal Register publication. How
much time is required to come into
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65811
compliance with a final rule (including
product compliance and third-party
testing)? Please provide supporting data
with your comment supporting a 180day period or other effective date,
particularly for small businesses.
4. Alternatives to reduce the impact
on small businesses. Are there any
alternatives to the rule not discussed in
this NPR that could reduce the impact
on small businesses without reducing
safety? Please provide supporting data
with your comment, particularly
addressing small businesses.
D. Feasibility
1. Are the proposed requirements in
this NPR feasible, both technically and
economically?
2. What would be the total cost to
industry of implementing this rule?
Please be specific about labor and/or
materials costs to redesign products,
and costs of third-party testing.
3. Will complying with this rule
increase the costs of production or the
retail price of toys containing button
cell or coin cell batteries? Why? By how
much?
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1250
Consumer protection, Incorporation
by reference, Infants and children,
Labeling, Law enforcement, Toys.
For the reasons discussed in the
preamble, the Commission proposes to
amend 16 CFR parts 1112 and 1250 as
follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
■
Authority: 15 U.S.C. 2063.
2. Amend § 1112.15 by adding
paragraph (b)(32)(ii)(LL) to read as
follows:
■
§ 1112.15 When can a third-party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
*
*
*
(b) * * *
(32) * * *.
(ii) * * *
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*
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(LL) 16 CFR 1250.3, Requirements for
Toys Containing Button Cell or Coin
Cell Batteries.
*
*
*
*
*
PART 1250—SAFETY STANDARD FOR
TOYS
4. The authority citation for part 1250
continues to read as follows:
■
Authority: 15 U.S.C. 2056b.
5. Revise the heading to part 1250 to
read as set forth above.
■ 6. Revise § 1250.1 to read as follows:
■
§ 1250.1
Scope.
This part establishes a consumer
product safety standard for toys.
■ 7. Add § 1250.3 to read as follows:
§ 1250.3 Requirements for toys containing
button cell or coin cell batteries.
(a) Scope and purpose. This section
establishes additional performance and
labeling requirements for toys
containing button cell or coin cell
batteries to prevent child access to such
batteries during reasonably foreseeable
use and abuse of battery-operated toys.
This section is intended to eliminate or
adequately reduce the risk of injury or
death to children 6 years old and
younger from ingesting button cell or
coin cell batteries accessed from toy
battery compartments.
(b) Definitions. In addition to the
definitions incorporated by reference in
§ 1250.2(a), the following definitions
apply for purposes of this section:
Product display panel means the
surface area on, near, or in the battery
component of the toy using or
containing button or coin cell batteries
that is visible while replacing the
batteries.
Secondary display panel means the
side opposite or next to the principal
display panel of the retail package of a
toy using or containing button or coin
cell batteries.
Toy(s) containing button cell or coin
cell battery(ies) means a toy or toys
containing or designed to use one or
more button cell or coin cell batteries,
regardless of whether such batteries are
intended to be replaced by the
consumer or are included with the
product or sold separately.
(c) Performance and labeling
requirements. Each toy containing
button cell or coin cell batteries must
comply with applicable provisions of
the version of ASTM F963 incorporated
by reference in § 1250.2(a), with the
following additions and exclusions to
that ASTM standard:
(1) Add the following sentence to the
end of section 4.25.4.3: ‘‘Confirm
compliance after testing by opening the
battery door or cover and applying a
force of at least 4.5 lbf (20 N) to the
fastener evenly within 5 s and
maintained for an additional duration of
10 s in any direction likely to remove
the fastener.’’
(2) Add the following paragraphs to
section 4.25.4:
(i) 4.25.4.5 For all toys with battery
compartments using replaceable button
cell or coin cell batteries secured by a
screw or similar fastener, a minimum of
two full rotations of the screw or
fastener shall be required to open or
remove the battery compartment, door,
or cover.
(ii) 4.25.4.6 For all toys with battery
compartments using replaceable button
cell batteries or coin cell batteries
secured by a rotating or twist-on access
cover, a minimum torque of 4.4 in-lbf
(0.5 Nm) shall be required to unlock the
cover, and a minimum angle of 90
degrees of rotation shall be required to
remove the cover.
(iii) 4.25.4.7 All toys containing
button cell or coin cell batteries shall be
tested in accordance with section 8.31.
(3) Instead of complying with section
5.14.2, comply with the following:
(i) 5.14.2 Button Cell or Coin Cell
Batteries.
(ii) 5.14.2.1 For each toy containing
button cell or coin cell batteries, each
toy, toy packaging, and toy instructions
shall meet the requirements in 16 CFR
1263.3, Packaging Markings, Product
Markings, and General Instructions.
(4) Add the following paragraphs as
section 8.31.
(i) 8.31 Button Cell or Coin Cell
Battery Use and Abuse Testing—All
testing in this section shall be
performed in series on each unique toy
or toy component containing button cell
or coin cell batteries. Manufacturer
recommended batteries shall be in place
during the testing unless otherwise
specified. No button cell or coin cell
batteries shall become accessible
without the use of a tool as a result of
testing.
(ii) 8.31.1 Stress Relief Test—Subject
all toys with a battery compartment that
utilizes molded or formed thermoplastic
materials to this test. The sample shall
consist of either the entire toy or toy
component, or for large and bulky toys
or toy components, at least the complete
battery compartment enclosure together
with any supporting framework.
Batteries may be removed during this
test.
(A) Place the sample in a circulating
air oven for a period of 7 hours. Set the
oven temperature to the higher of:
(1) 70 °C; or
(2) 10 °C higher than the maximum
temperature of thermoplastic
enclosures, battery compartment door/
covers, or battery compartment door/
cover mechanisms, during the most
stringent normal operation of the
sample.
(B) After removal from the oven,
permit the sample to cool to room
temperature.
(iii) 8.31.2 Battery Replacement
Test—Subject all toys or toy
components containing replaceable
button cell or coin cell batteries to this
test.
(A) The battery compartment door/
cover shall be opened, the battery
removed and replaced, and the battery
compartment door/cover shall be
closed, for a total of ten cycles. The test
procedure shall simulate battery
replacement according to the
manufacturer’s instructions.
(B) If the battery compartment is
secured with a screw(s), loosen and then
tighten the screw(s) by means of a
suitable screwdriver, applying a
continuous linear torque according to
table 1.
TABLE 1 TO PARAGRAPH (c)(4)(iii)(B)—TORQUE TO BE APPLIED TO SCREWS 1
Torque
Nm
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Nominal diameter of screw
mm
I
Up to and including 2.8 ...........................................................................................................................
Over 2.8 up to and including 3.0 .............................................................................................................
Over 3.0 up to and including 3.2 .............................................................................................................
Over 3.2 up to and including 3.6 .............................................................................................................
Over 3.6 up to and including 4.1 .............................................................................................................
Over 4.1 up to and including 4.7 .............................................................................................................
Over 4.7 up to and including 5.3 .............................................................................................................
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II
0.2
0.25
0.3
0.4
0.7
0.8
0.8
13AUP1
III
0.4
0.5
0.6
0.8
1.2
1.8
2.0
0.4
0.5
0.6
0.6
0.6
0.9
1.0
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TABLE 1 TO PARAGRAPH (c)(4)(iii)(B)—TORQUE TO BE APPLIED TO SCREWS 1—Continued
Torque
Nm
Nominal diameter of screw
mm
I
Over 5.3 up to and including 6.0 .............................................................................................................
....................
II
III
2.5
1.25
(iv) 8.31.3 Drop Test.
—(A) Except for large and bulky toys,
toys intended for children aged 0 to 18
months that weigh less than 10.01 lbs.
(4.5 kg) shall be dropped at least 4.5 ft
(137 cm) onto the test surface specified
in section 8.7.1 in positions likely to
produce maximum force on the battery
enclosure or compartment.
(B) Toys intended for children aged
over 18 months that weigh less than
10.01 lbs. (4.5 kg) shall be dropped 10
times from a height of at least 3.0 ft (91
cm) onto the test surface specified in
section 8.7.1 in positions likely to
produce maximum force on the battery
enclosure or compartment.
(C) Regardless of the intended child
age, all toys that weigh at least 10.01 lbs.
(4.5 kg) up to 39.7 lbs. (18 kg), shall be
dropped three times from a height of at
least 3.0 ft (91 cm) onto the test surface
specified in section 8.7.1 in the
positions likely to produce maximum
force on the battery enclosure or
compartment.
(v) 8.31.3.1 Tipover Test—Large and
bulky toys shall not be subject to the
drop test in section 8.31.3, instead
subject such toys to the Tipover Test for
Large, Bulky Toys in accordance with
the procedure in section 8.7.2.1.
(vi) 8.31.4 Impact Test.
(A) Subject the battery enclosure or
compartment door/cover to three, 1.5-
(C) Add figure 51 to section 8.31.4:
Figure 51. Example Impact Test With a
Swinging Steel Sphere
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ft·lbf (2–J) impacts. Produce the impact
by dropping a steel sphere, 2.00 in (50.8
mm) in diameter, and weighing
approximately 1.1 lbs. (0.5 kg), from the
height required to produce the specified
impact, as shown in figure 50, or the
steel sphere is to be suspended by a
cord and swung as a pendulum,
dropping through the vertical distance
required to cause it to strike the surface
with the specified impact as shown in
figure 51. The steel sphere is to strike
the battery enclosure or compartment
door/cover perpendicular to the
enclosure surface.
(B) Add figure 50 to section 8.31.4:
Figure 50. Example Impact Test With a
Dropped Steel Sphere
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I—For metal screws without heads, if the screw, when tightened, does not protrude from the hole.
II—For other metal screws and for nuts.
II—For screws of insulating material:
• Having a hexagonal head with the dimension across flats exceeding the overall thread diameter, or
• With a cylindrical head and a socket for a key, the socket having a dimension across flats not less than 0.83 times the overall thread diameter, or
• With a head having a slot or cross slots, the length of which exceeds 1.5 times the overall thread diameter.
III—For other screws of insulating material.
1 Reproduced, with permission, from IEC 60065 ed.8.0 Copyright © 2014 IEC Geneva, Switzerland. www.iec.ch.
65814
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
(vii) 8.31.5 Crush Test—Support the
sample by a fixed rigid supporting
surface in positions likely to produce
the most adverse results, so long as the
position can be self-supported. Apply a
crushing force of 74.2 lbf ± 1.1 lbf (330
N ± 5 N) for a period of 10 s to the
exposed surfaces. Apply the force using
a flat surface measuring approximately
3.9 in by 9.8 in (100 mm by 250 mm).
(viii) 8.31.67 Torque Test—If a child
can grasp any part of the battery
compartment enclosure on a toy or toy
component, including the door or cover,
with at least the thumb and forefinger,
or using teeth, apply the Torque Test for
Removal of Components in section 8.8
to the battery compartment enclosure,
using a torque of at least 4.4 in-lbf (0.50
Nm).
(ix) 8.31.7 Tension Test—If a child
can grasp any part of the battery
compartment enclosure on a toy or toy
component, including the door or cover,
with at least the thumb and forefinger,
or using teeth, apply the Tension Test
for Removal of Components from
section 8.9 to the battery compartment
enclosure, using a force of at least 16.2
lbf (72.0 N).
(x) 8.31.8 Compression Test—If any
surface of the battery compartment
enclosure is accessible to a child and
inaccessible to a flat surface contact
during the Drop Test in section 8.7.1,
apply the Compression Test from
section 8.10 to the surface of the battery
compartment enclosure, using a force of
at least 30.5 lbf (135.7 N).
(xi) 8.31.9 Compliance.
(A) Apply a force of 11.2 lbf + 2.2/¥0
lbf (50 + 10/¥0 N) for 10 s to the battery
compartment door/cover or enclosure
with a rigid test finger probe, Test Probe
11 of IEC 61032, Standard for Protection
of Persons and Equipment by
Enclosures—Probes for Verification
(figure 52). Apply the probe at the most
unfavorable place and in the most
unfavorable direction. Apply force in
only one direction.
(B) To pass, the battery compartment
door/cover shall not open and shall
remain functional, and the battery shall
not be touched by the probe or made
accessible.
(C) Add figure 52 to section 8.31.9.
Figure 52—Test Probe 11 1
5±0,5
80
20
050
- - - 012
Metal
Insulating material
For dimensions of the fingertip and tolerances: see Test Probe B.
1 Reproduced, with permission, from IEC 61032 ed.2.0 Copyright© 1997 IEC Geneva, Switzerland.
vvww. iec.ch.
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EP13AU24.037</GPH>
Dimensions in millimetres
EP13AU24.036</GPH>
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F- - -:::3-e-
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Proposed Rules
65815
(D) Add figure 53 to section 8.31.9.
Figure 53—Test Probe B 1
;
"'
.
---
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'fOilfflnO!t o n ~ 1llfltn i'IO ~ ~ i i giile;
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• <ml!nW~U,loflM:
-=-
ffll!\;owrllii'iffl:'i:l.2u,
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to +tO• tofleruott.
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1 Reproduced, with permission, from IEC 61032 ed.2.0 Copyright© 1997 IEC Geneva, Switzerland.
www.iec.ch.
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2024–17472 Filed 8–12–24; 8:45 am]
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BILLING CODE 6355–01–P
]]>Agencies
[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Proposed Rules]
[Pages 65791-65815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17472]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 /
Proposed Rules
[[Page 65791]]
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1250
[CPSC Docket No. CPSC-2024-0023]
Safety Standard for Toys: Requirements for Toys Containing Button
Cell or Coin Cell Batteries
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The U.S. Consumer Product Safety Commission (Commission or
CPSC) proposes to address the risk of injury and death associated with
children ingesting button cell or coin cell batteries obtained from
toys by adding performance and labeling requirements for battery-
operated toys containing such batteries. The proposed requirements
would provide the highest level of safety feasible, and are consistent
with the Commission's recent Reese's Law rulemaking and international
standards for electronic toys. The Commission also proposes to amend
CPSC's list of notice of requirements (NORs) to include toys containing
button cell or coin cell batteries.
DATES: Submit comments by October 15, 2024.
ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature requirements of the
NPR should be directed to the Office of Information and Regulatory
Affairs, the Office of Management and Budget, Attn: CPSC Desk Officer,
FAX: 202-395-6974, or emailed to: [email protected].
Submit all other comments, identified by Docket No. CPSC-2024-0023,
by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. Do not submit through this
website: confidential business information, trade secret information,
or other sensitive or protected information that you do not want to be
available to the public. CPSC typically does not accept comments
submitted by email, except as described below.
Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC
encourages you to submit electronic comments by using the Federal
eRulemaking Portal. You may, however, submit comments by mail, hand
delivery, or courier to: Office of the Secretary, Consumer Product
Safety Commission, 4330 East-West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479. If you wish to submit confidential business
information, trade secret information, or other sensitive or protected
information that you do not want to be available to the public, you may
submit such comments by mail, hand delivery, or courier, or you may
email them to: [email protected].
Instructions: All submissions must include the agency name and
docket number. CPSC may post all comments without change, including any
personal identifiers, contact information, or other personal
information provided, to https://www.regulations.gov. Do not submit
through this website: Confidential business information, trade secret
information, or other sensitive or protected information that you do
not want to be available to the public. If you wish to submit such
information, please submit it according to the instructions for mail/
hand delivery/courier/confidential written submissions.
Docket: For access to the docket to read background documents or
comments received, go to: https://www.regulations.gov, and insert the
docket number, CPSC-2024-0023, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Benjamin Mordecai, Project Manager,
Division of Mechanical Engineering, Directorate for Laboratory
Sciences, Consumer Product Safety Commission, 5 Research Place,
Rockville, MD 20850; Telephone 301-987-2506; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
In 2008, Congress passed the Consumer Product Safety Improvement
Act of 2008 (CPSIA) providing the CPSC with new regulatory and
enforcement tools, particularly for the purpose of protecting the
safety of children. Among other things, section 106(a) of the CPSIA
made ASTM International's voluntary standard for toys, ASTM F963-07,
Standard Consumer Safety Specification for Toy Safety (except sections
4.2 and Annex 4) a mandatory standard beginning 180 days after the
enactment date of the CPSIA, on February 10, 2009. 15 U.S.C. 2056b(a).
Section 106 also directs the Commission to promulgate toy safety
standards that are ``more stringent than'' the applicable voluntary
standard if the Commission determines that more stringent requirements
would further reduce the risk of injury associated with the product, as
well as to periodically review and revise the rules set forth under
section 106 to ensure that such rules provide the highest level of
safety for such products that is feasible. 15 U.S.C. 2056b(c) and (d).
The CPSIA states that ASTM F963 shall be considered a consumer
product safety standard issued by the Commission under section 9 of the
Consumer Product Safety Act (CPSA; 15 U.S.C. 2058). Id. Since 2009,
CPSC has enforced ASTM F963 as a mandatory standard for toys.\1\ In
2017, the Commission codified the mandatory toy standard in 16 CFR part
1250, Safety Standard Mandating ASTM F963 for Toys, and incorporated by
reference the newly revised ASTM standard at that time, ASTM F963-16.
82 FR 8989 (Feb. 2, 2017). Most recently, on January 18, 2024, the
Commission updated part 1250 to incorporate by reference a 2023
revision, ASTM F963-23. 89 FR 3344.
---------------------------------------------------------------------------
\1\ Since the CPSIA's enactment in 2008, ASTM revised F963 five
times: ASTM F963-08, ASTM F963-11, ASTM F963-16, ASTM F963-17, and
ASTM F963-23 (approved August 1, 2023).
---------------------------------------------------------------------------
Some toys within the scope of ASTM F963 and 16 CFR part 1250
contain, or are designed to use, button cell or coin cell batteries.\2\
Accordingly, section 4.25 of ASTM F963-23 contains
[[Page 65792]]
requirements for ``battery-operated toys,'' including requirements for
toys containing button cell or coin cell batteries. The ASTM
requirements are intended to address hazards related to battery
overheating, leakage, explosion, fire, and children choking on or
swallowing batteries. The 2023 updates to ASTM F963 include
improvements to safety requirements for toys that contain button cell
or coin cell batteries, such as expanding the application of use and
abuse testing of toys and labeling requirements that enhance battery
accessibility requirements. However, as discussed in section IV of this
preamble, ASTM F963-23 does not establish adequate requirements for
toys containing button cell or coin cell batteries because the existing
requirements do not address all of the identified hazards and are not
as stringent as requirements for non-toy consumer products that are
found in 16 CFR part 1263, Safety Standard for Button Cell or Coin
Batteries and Consumer Products Containing Such Batteries.
---------------------------------------------------------------------------
\2\ In this notice of proposed rulemaking (NPR) we define the
phrase ``toy containing button cell or coin cell batteries''
consistent with the definition of a ``consumer product containing
button cell or coin batteries'' in Reese's Law. 15 U.S.C. 2056e
Notes (Definition 4). A ``toy containing button cell or coin cell
batteries'' means a toy containing or designed to use one or more
button cell or coin batteries, regardless of whether such batteries
are intended to be replaced by the consumer or are included with the
product or sold separately. Id., proposed Sec. 1250.3(b).
---------------------------------------------------------------------------
Part 1263 implements Reese's Law, Public Law 117-171, a law that
protects children 6 years old and younger against hazards associated
with the ingestion of button cell or coin batteries. 15 U.S.C. 2056e.
Reese's Law, however, excludes children's toys subject to requirements
in 16 CFR part 1250 from its scope. 15 U.S.C. 2056e Note. Specifically,
the law states, ``The standards promulgated under this Act shall not
apply with respect to any toy product that is in compliance with the
battery accessibility and labeling requirements of part 1250 of title
16, Code of Federal Regulations[.]'' \3\ Therefore, the current part
1250 standard implementing ASTM F963 does not provide the highest level
of safety feasible for such toys.
---------------------------------------------------------------------------
\3\ Consistent with 16 CFR part 1250, Reese's Law defines a
``toy product'' as ``any object designed, manufactured, or marketed
as a plaything for children under 14 years of age.'' 15 U.S.C. 2056e
Notes (Definition 5).
---------------------------------------------------------------------------
Accordingly, this notice of proposed rulemaking (NPR) proposes to
amend the requirements in part 1250 specific to battery compartments
for toys containing button cell or coin cell batteries to align the
requirements more closely with the Commission's new rule for consumer
products containing button cell or coin batteries, codified at part
1263. Further, this NPR proposes revising the title of part 1250 from
``Safety Standard Mandating ASTM F963 for Toys'' to ``Safety Standard
for Toys,'' to reflect the inclusion of proposed requirements that do
not incorporate by reference existing requirements in ASTM F963.\4\
---------------------------------------------------------------------------
\4\ On July 19, 2024, the Commission voted unanimously (5-0) to
publish this NPR.
---------------------------------------------------------------------------
The Commission is authorized to issue this NPR pursuant to both
sections 106(c) and (d) of the CPSIA, 15 U.S.C. 2056b(c) and (d).
Section 106(d) of the CPSIA, 15 U.S.C. 2056b(d)(2), requires the
Commission to: (1) examine and assess the effectiveness of ASTM F963,
in consultation with representatives of consumer groups, juvenile
product manufacturers, and independent child product engineers and
experts; and (2) promulgate consumer product safety standards for such
toys. Standards issued under section 106(d) are to be ``more stringent
than'' the applicable voluntary standard if the Commission determines
that more stringent requirements would further reduce the risk of
injury associated with the product. 15 U.S.C. 2056b(d)(2)(B). Since
before the CPSIA, CPSC staff has consulted with stakeholders regarding
provisions in the toy standard through the ASTM process. Since the
passage of Reese's Law in 2022, CPSC staff has been corresponding with
the relevant ASTM Subcommittee and task group, discussing the incident
data associated with child battery ingestions, staff's testing of toy
battery compartments, and staff's recommendations to update the
performance and labeling requirements in the toy standard to adequately
address the ingestion hazard associated with children accessing button
cell or coin cell batteries from toys.\5\
---------------------------------------------------------------------------
\5\ See, e.g., August 19, 2022, Letter from Benjamin Mordecai,
Project Manager for ASTM F963 to ASTM Subcommittee and Task Group
Chair, regarding increasing number of incidents involving children
gaining access to button and coin cell batteries in battery-operated
toys, and requesting the toy safety F15.22 subcommittee to review
the data and develop more stringent performance requirements to
address these incidents in the next few months (available at:
(https://www.cpsc.gov/s3fs-public/8-19-2022-Letter-to-ASTM-Battery-Operated-Toys.pdf?VersionId=PgFoeCeb0BYz0kyg6z87tbwHKv3x9W0y); and
March 20, 2023, Letter from Daniel Taxier, Children's Product
Program Manager, and Benjamin Mordecai, Project Manager for ASTM
F963, to ASTM Subcommittee and Task Group Chair, regarding Reese's
Law, CPSC staff's toy testing to F963 and UL-4200A, and
recommendations for updates to F963 to align with the Commission's
then-proposed NPR to implement Reese's Law (available at: https://www.cpsc.gov/s3fs-public/Letter-to-ASTM-F15-22-Reeses-Law-NPR-230320.pdf?VersionId=6ZGPs5nSLhBGlFdoz1IWHF1wo.oOgarH).
---------------------------------------------------------------------------
Section 106(c) of the CPSIA, 15 U.S.C. 2056b(c), requires the
Commission to periodically review and revise the rules set forth under
section 106, to ensure that such rules provide the highest level of
safety for such products that is feasible. The NPR proposes to add
performance requirements and revise labeling requirements for toys
containing button cell or coin cell batteries that are more stringent
than the existing requirements in ASTM F963, which are incorporated by
reference into 16 CFR part 1250, and that also provide the highest
level of safety feasible, aligning with the requirements in 16 CFR part
1263.
This NPR provides an overview of staff's assessment and analysis,
and it discusses the Commission's basis for issuing this NPR. Based on
the information and analysis in this NPR, the Commission preliminarily
determines that the proposed performance and labeling requirements for
toys containing button cell or coin cell batteries are more stringent
than the existing requirements in ASTM F963-23, would further reduce
the risk of injury associated with products within the scope of the
NPR, and would provide the highest level of safety for such products
that is feasible.
II. Description of Toys Within the Scope of the Rule
Many toys contain or are designed to use button cell or coin cell
batteries like those shown in figure 1. Generally, button cell
batteries are small, disposable, single-cell batteries that range from
5 mm to 32 mm (0.2 inches to 1.3 inches) in diameter and are 1 mm to 6
mm (0.04 inches to 0.24 inches) in thickness. Common anode materials
are zinc or lithium while common cathode materials are manganese
dioxide, silver oxide, carbon monofluoride, cupric oxide, or oxygen
from the air.\6\ Button cell batteries tend to be manganese dioxide
(alkaline) (1.5 volt) or silver oxide (1.55 volt). Lithium coin
batteries, also shown in figure 1, were originally developed as a 3-
volt power source for low-drain and battery-backup applications because
of their high-energy density, correspondingly small size, and long
shelf life. Lithium coin batteries are commonly approximately 20 mm
(0.787 inch) in diameter.
---------------------------------------------------------------------------
\6\ Anodes and cathodes are the positive or negative posts of a
battery. The different materials allow the battery to lose or gain
electrons dependent on the intended function.
---------------------------------------------------------------------------
[[Page 65793]]
[GRAPHIC] [TIFF OMITTED] TP13AU24.026
Section 3.1.9 of ASTM F963-23 defines ``battery, button cell'' as a
``small round non-lithium battery, in which the overall height is less
than the diameter'' while section 3.1.10 of ASTM F963-23 defines a
``battery, coin cell'' as a ``small, round lithium battery in which the
overall height is less than the diameter.'' Generally, button cell and
coin cell batteries are uniformly defined across safety standards. For
example, section 5 of Reese's Law defines ``button cell or coin
battery'' similarly to the ASTM F963-23 definitions, in relevant part,
as ``. . . a single cell battery with a diameter greater than the
height of the battery. . . .'' 15 U.S.C. 2056e Notes (Definition 1).
A button cell or coin cell battery (also referred to by industry
and consumers as a cell or disc/disk battery) stores chemical energy
which is converted to electrical energy when the battery is connected
to a circuit. A button cell or coin cell battery consists of an anode,
a cathode, and a separator and electrolyte between the anode and
cathode, as shown in figure 2. When connected with a conductive
material, such as when the battery is pressed into moist human tissue
(i.e., when swallowed), the connected battery terminals form an
electric circuit, and electric current flows through the conductive
material and between the terminals. As already described, button cell
or coin cell batteries come in many shapes and sizes and are composed
of different materials and chemicals. Requirements for power (voltage
and capacity) and size are the main driver of battery shape, chemical
composition, and the number of batteries required to operate a toy.
[GRAPHIC] [TIFF OMITTED] TP13AU24.027
Section 3.1.92 of ASTM F963-23 defines a ``toy'' as ``any object
designed, manufactured, or marketed as a plaything for children under
14 years of age.'' Section 3.1.11 of ASTM F963-23 defines a ``battery-
operated toy'' as a ``toy having at least one function dependent on
electricity and powered by batteries.'' Figure 3 provides examples of
toys containing button cell or coin cell batteries that fall within the
scope of this NPR. Such toys include, but are not limited to, light up
toys, talking dolls, remote controlled vehicles, stuffed animals,
science kits, musical toys, do-it-yourself light up craft kits,
electronic board games, and learning tablets/games.
[[Page 65794]]
[GRAPHIC] [TIFF OMITTED] TP13AU24.028
Toys containing or designed to use other types of batteries, where
the diameter is less than the height, such as AAA or AA batteries, or
non-cylindrical batteries, are out of the scope of this NPR because
their size and shape does not pose the same type or degree of ingestion
hazard as button cell or coin cell batteries.
III. Incident Data and Hazard Patterns
CPSC staff searched two CPSC-maintained databases to identify
incidents and hazard patterns associated with button cell and coin cell
batteries in toys using product code 0884 for batteries: the Consumer
Product Safety Risk Management System (CPSRMS) \7\ and the National
Electronic Injury Surveillance System (NEISS).\8\ The incidents
considered were reported as occurring between January 1, 2016, and
December 31, 2022. For this period staff identified incidents
associated with battery insertions and ingestion, or the risk of
ingestion, involving children who were able to access button cell or
coin cell batteries from toy battery compartments. Specifically, staff
identified one fatal incident and 46 non-fatal incidents in CPSRMS, and
185 NEISS reported hospital emergency department (ED)-treated
incidents, associated with children accessing a toy battery
compartment. Of the 47 CPSRMS incidents, all but one incident involved
children younger than 9 years old, while 170 of the NEISS incidents
involved children aged 6 years old or younger.
---------------------------------------------------------------------------
\7\ CPSRMS includes data primarily from three groups of sources:
incident reports, death certificates, and in-depth follow-up
investigation reports. A large portion of CPSRMS consists of
incident reports from consumer complaints, media reports, medical
examiner or coroner reports, retailer or manufacturer reports
(incident reports received from a retailer or manufacturer involving
a product they sell or make), safety advocacy groups, law firms, and
Federal, State, or local authorities, among others. It also contains
death certificates that CPSC purchases from all 50 states, based on
selected external cause of death codes (ICD-10). The third major
component of CPSRMS is the collection of in-depth follow-up
investigation reports. Based on the incident reports, death
certificates, or NEISS injury reports, CPSC field staff conduct in-
depth investigations (on-site, telephone, or online) of incidents,
deaths, and injuries, which are then stored in CPSRMS.
\8\ NEISS is the source of the injury estimates; it is a
statistically valid injury surveillance system. NEISS injury data
are gathered from emergency departments of a sample of hospitals
with 24-hour emergency departments and at least six beds, selected
as a probability sample of all U.S. hospitals. The surveillance data
gathered from the sample hospitals enable the CPSC to make timely
national estimates of the number of injuries associated with
specific consumer products.
---------------------------------------------------------------------------
A. Overview of Button Cell and Coin Cell Battery Hazards
1. Ingestion
Children may be able to access button cell or coin cell batteries
when playing with toys that are operated by such batteries. Children
may access such batteries if a toy breaks apart and the batteries
become exposed or if a battery compartment remains open while a
caregiver is changing the batteries. Once exposed, children may remove
and ingest the batteries. For example, in CPSC's In-Depth Investigation
(IDI) 171024HCC1059, a 20-month-old male ingested a button battery from
an electronic toy; the battery was removed surgically, but the child
later died from injury. Medical literature details how death and
serious injury are associated with button cell or coin cell battery
ingestion. Such injuries including choking, internal chemical burns,
chemical leakage, pressure necrosis (tissue damage), the creation of
hazardous chemicals (such as sodium hydroxide and hydrochloric acid),
and related hazards.\9\ Because of the nature of the risk of injury, as
described in this section, it is important to identify a battery
ingestion in a timely manner and remove the button cell or coin cell
battery from the body to prevent serious injury or death.
---------------------------------------------------------------------------
\9\ See, supra n.3, citing Tab B of Staff's Reese's Law NPR
Briefing Package.
---------------------------------------------------------------------------
CPSC staff reviewed medical literature related to battery-ingestion
injuries that confirms ingested button cell or coin batteries can lodge
in the esophagus and cause severe tissue damage after only a few hours,
as discussed in Tab B of the Reese's Law NPR Staff Briefing Package
(SBP).\10\ The conductive soft tissue in the digestive tract can form a
circuit between the battery terminals, creating an electric current.
When lodged in the esophagus, button cell or coin batteries can cause
damage to the esophagus, burning nearby tissue and creating
perforations. The battery current generates hydroxide when in contact
with tissue in the digestive tract. Hydroxide can create
[[Page 65795]]
chemical burns. Lithium coin batteries pose a particular threat of
chemical burn if ingested because such batteries have a higher voltage
and capacity than non-lithium batteries. Other injuries associated with
button cell or coin battery ingestion include alkaline electrolyte
leakage from alkaline button cell batteries or pressure necrosis from
extended contact of the battery with tissue.
---------------------------------------------------------------------------
\10\ The information in this proposed rule is based in part on
information and analysis provided in the January 11, 2023, Staff
Briefing Package: Draft Proposed Rule to Establish a Safety Standard
and Notification Requirements for Button Cell or Coin Batteries and
Consumer Products Containing Such Batteries (Staff's Reese's Law NPR
Briefing Package), available at: https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl. Tab B and its
appendices contain staff's review of the medical literature and
battery ingestion data from the National Capitol Poison Center
(Poison.Org).
---------------------------------------------------------------------------
While ingested button cell or coin batteries may be able to pass
through the digestive tract without complications, ingestion
complications can occur, usually when such batteries become stuck
(impacted) in the esophagus.\11\ The primary injury from impaction is
from the transmission of electric current eliciting the production of
sodium hydroxide (NaOH) and hydrochloric acid (HCl) in tissues adjacent
to the cathode and anode terminals, respectively.\12\ After only a few
hours of a battery maintaining contact with moist tissue, tissue pH on
either side of the battery increases, causing substantial tissue
damage. The erosive and perforating effects of esophageal impaction may
continue even after removing the battery.\13\ Another mechanism of
injury involves an electrical burn created by electric current passing
between the anode and the cathode.
---------------------------------------------------------------------------
\11\ Sigalet D, Laes G, Tracheo-esophageal injury secondary to
disc battery ingestion, American Journal of Otolaryngology 23 (1988)
996-998.
\12\ Hamilton JM, Schraff SA, Notrica DM. Severe injuries from
coin cell battery ingestions: 2 case reports. Journal of Pediatric
Surgery (2009) 44, 644-647.
\13\ Gao Y, Wang J, Ma J, Gao Y, Zhang T, Lei P, Xiong X.
Management of button batteries in the upper gastrointestinal tract
of children. Medicine (2020) 99:42.
---------------------------------------------------------------------------
An imperfectly sealed alkaline button cell battery may leak
electrolyte solution when ingested, causing injury or death. The large
concentration of potassium hydroxide (KOH) in the electrolyte solution
is particularly corrosive to human tissue. Alkalis penetrate deep into
the tissue layers, which may cause extensive tissue damage.
Another mechanism of injury common to foreign body impaction is
pressure necrosis, which creates ischemic,\14\ blackened areas of
tissue damage.\15\ Impaction of a button cell or coin battery in the
esophagus leads to esophagus burns in as little as two hours. A burn in
the esophagus may cause a perforation of the esophagus or an esophageal
stricture (a narrowing of the esophagus). Perforation or stricture of
the esophagus can make eating difficult, requiring use of a feeding
tube in the stomach or dilations of the esophagus to expand the
stricture to allow normal swallowing.
---------------------------------------------------------------------------
\14\ Ischemia is a condition where blood flow is blocked or
reduced, depriving oxygen and nutrients.
\15\ Alvi A, Bereliani A, Zahtz GN. Miniature disc battery in
the nose: a dangerous foreign body. Clin Pediatr (Phila). 1997
Jul;36(7):427-9.
---------------------------------------------------------------------------
A button battery that burns through the esophagus can also burn
through nearby tissues, creating a fistula, which is an abnormal
connection between the esophagus and the other surrounding tissues.
When fistulas are created in the esophageal area, they are commonly
found with the trachea (tracheoesophageal fistulas or TEF) and with the
aorta (aortoesophageal fistulas or AEF). Both of these fistulas are
life threatening injuries because they can lead to an open artery and,
thus, excessive blood loss. Researchers report that esophageal burns
and fistulas sometimes require multiple surgeries to repair.\16\ These
injuries could require weeks of treatment in a hospital.\17\
---------------------------------------------------------------------------
\16\ Slamon NB, Hertzog JH, Penfil SH, Raphaely RC, Pizarro C,
Derby CD. An unusual case of button battery-induced traumatic
tracheoesophageal fistula. Pediatric Emergency Care. Volume 24,
Number 5, May 2008.
\17\ Liao W, Wen G, Zhang X. Button battery intake as foreign
body in Chinese children. Review of case reports and the literature.
Pediatr Emer Care 2015;31: 412-415; Kimball SJ, Park AH, Rollins II
MD, Grimmer JF, Muntz H. A review of esophageal disc battery
ingestions and a protocol for management. Arch Otolaryngology Head
Neck Surg/Vol 136 (NO. 9), SEP 2010. 866-871.
---------------------------------------------------------------------------
Diagnosing an ingested button cell or coin battery requires an x-
ray because physical examination after ingestion does not always
confirm a battery was ingested. Symptoms of button cell or coin battery
ingestion, such as respiratory distress, can be mistaken for other
ailments, like an asthma attack.\18\ As an example, a child who
ingested a button cell or coin cell battery may have a fever but no
other evidence of having ingested a button cell or coin battery.
Alternatively, the physical examination can be normal, making an
ingestion diagnosis difficult.\19\
---------------------------------------------------------------------------
\18\ Takahashi T, Teramoto Y, Aoyama T, Sahakibara H, Hara M,
Maseki M. Yamaguchi S. Anesthetic management of a child with an
esophageal foreign body with was misdiagnosed as asthma. MASUI. THE
JAPANESE JOURNAL OF ANESTHESIOLOGY. 2009 Feb;58(2):199-201. 199-201.
\19\ Cruz CI, Patel D. (2013). Impacted Button-Battery
Masquerading as Croup. The Journal of Emergency Medicine, Vol.45,
No. 1, pp. 30-33.
---------------------------------------------------------------------------
Lithium button cell or coin battery ingestions have become more
common as such batteries are used in more household products, including
toys, than they were historically.\20\ As noted, lithium batteries pose
a significant safety hazard when ingested because lithium batteries
generate a relatively high voltage, causing rapid local injury, even
when partially discharged (used). Therefore, even partially discharged
batteries can cause life-threatening injuries when ingested. Medical
literature confirms that caregivers only have approximately two hours
to remove a lithium battery from a child's esophagus to prevent
injury.\21\
---------------------------------------------------------------------------
\20\ Dawe N, Puvanendran M, flood L. Unwitnessed lithium-ion
disc battery ingestion: case report and review of best practice
management of an increasing clinical concern. The Journal of
Laryngology & Otology (2013), 127, 84-87.
\21\ Gao Y, Wang J, Ma J, Gao Y, Zhang T, Lei P, Xiong X.
Management of button batteries in the upper gastrointestinal tract
of children. Medicine (2020) 99:42.
---------------------------------------------------------------------------
2. Nasal Insertion
Not only do children ingest button cell or coin cell batteries, but
children also insert such batteries into the nasal cavity. For example,
in NEISS case 170555849, a 2-year-old male put into his nose a button
battery that was likely liberated from a toy, as batteries were later
found to be missing from a toy. A proportion of nose insertions
ultimately become ingestions or aspirations because such batteries
travel through the nasal passage and enter the digestive tract or
airways. Button cell or coin batteries impacted in the nose can lead to
severe damage to the endonasal mucous membranes (tissue inside the
nasal passage), necrosis (tissue damage) of the nasal septum cartilage
(the tissue that separates the left and right nostril), and nasal
septum perforation.
When the battery is not removed immediately, most children
experience long-term effects, such as saddle nose; saddle nose is a
flattening of the nose after a battery has damaged the nasal septum to
the point of disintegration by burning a hole in the tissue.
Reconstructive surgery is required to artificially recreate a septum
inside the child's nose. The severity of nasal insertion complications
depends on the duration of impact (longer duration can lead to more
damage), the type of button cell or coin battery (a higher voltage can
cause more damage), and in which part of the nasal cavity the battery
gets lodged (the septum is most susceptible to damage because it is the
thinnest tissue in the nose). Septum perforation complications can
result in lifelong consequences, such as facial deformity.\22\ A button
cell or coin battery that becomes dislodged inside the nose can be
ingested, causing
[[Page 65796]]
damage not only to the nasal structure but to the digestive tract as
well.\23\
---------------------------------------------------------------------------
\22\ Bakshi SS, Coumare VN, Priya M, Kumar S. Long-term
complications of button batteries in the nose. The Journal of
Emergency Medicine, Vol. 50, No. 3, pp. 485-487, 2016.
\23\ Alvi A, Bereliani A, Zahtz GN. Miniature disc battery in
the nose: a dangerous foreign body. Clin Pediatr (Phila). 1997
Jul;36(7):427-9.
---------------------------------------------------------------------------
Tab B, Appendix B of the Reese's Law NPR SBP shows 56 cases from
medical literature of nasal insertion with button cell or coin
batteries from 1985 to 2015. The most severe injury is septal
perforation after a battery burned a hole in the tissue. Sometimes the
battery remained lodged in the nose for long periods of time, sometimes
for months, leading to extensive damage to the nose.\24\ Sometimes an
impaction occurred for only a few hours and led to septal perforation
of the nose.\25\
---------------------------------------------------------------------------
\24\ Fosarelli P, Feigelman S, Pearson E, Calimano-Diaz A. An
unusual intranasal foreign body. Pediatric Emergency Care. Vol 4 No
2. 1988.117-118.
\25\ Liao W, Wen G, Zhang X. Button battery intake as foreign
body in Chinese children. Review of case reports and the literature.
Pediatr Emer Care 2015;31: 412-415.
---------------------------------------------------------------------------
3. Ear Insertion
Button cell or coin batteries inserted into the ear canal cause
injuries similar to that of nasal insertions when they become impacted.
A button cell or coin battery that is inserted into the ear canal may
cause ear drum perforation or destruction, marked erosion of the ear
canal with exposed bone, hearing impairment, facial nerve paralysis,
and destruction of the small bones in the middle ear.\26\ Like nose
insertions, the severity of ear insertion complications depends on the
duration of impact, the voltage of the button cell or coin battery, and
in which part of the ear canal the battery gets lodged. Appendix C of
the Reese's Law NPR SBP shows 10 cases from medical literature of
button cell or coin batteries having been inserted into the ear canal.
---------------------------------------------------------------------------
\26\ Bhisitkul DM and Dunham MD. An unsuspected alkaline battery
foreign body presenting as malignant otitis external. Pediatric
Emergency Care. Vol 8 No 3. 141-142. 1992.
---------------------------------------------------------------------------
B. Incident Data Hazard Scenarios--How Children Accessed Batteries
1. Durability
Fifty reported nonfatal incidents between 2016 and 2022, including
20 CPSRMS and 30 NEISS incidents, involve a toy battery compartment
breaking apart or opening unintentionally, allowing children to access
and potentially ingest or insert button cell or coin cell batteries.
Reports describe battery compartment failures where the toy was dropped
(nine incidents), thrown or smashed (two incidents), crushed by foot
(one incident), or manipulated by a child's hands or mouth to open the
battery compartment in a manner that defeated the locking mechanism
(nine incidents). These incident reports demonstrate that some toy
battery compartments are not strong enough to withstand reasonably
foreseeable use or abuse to prevent children from accessing batteries.
For example, incident I17B0493A describes an 8-year-old male who
dropped a light-up spinner toy that easily broke apart; the child
swallowed the battery, which required surgery to remove and caused
tissue damage to his esophagus. Further, incident I1910003A describes a
3-year-old male who was playing with an action figure when the battery
compartment unexpectedly broke open; the consumer indicated they were
only able to locate two of three batteries.
The NPR proposes to address these incidents by improving the
durability of battery compartments through performance tests. The NPR
proposes to require sequential use and abuse testing that aligns with
use and abuse testing in part 1263, adopting similar use and abuse
performance requirements.
2. Fastener Engagement
Twenty reported nonfatal incidents, including 18 CPSRMS and two
NEISS incidents, involve a toy battery compartment fastener, such as a
screw, that did not adequately secure or close the compartment,
potentially allowing children to access and ingest or insert the button
cell or coin cell batteries inside. Incident reports describe failing
fasteners as not being long enough to engage the threads (four
incidents), fasteners continuously spinning, or threads being stripped
(four incidents). These incidents demonstrate that some fasteners do
not adequately secure toy battery compartments and that the engagement
of the fastener can degrade over time. For example, incident I6C0676A
describes a 4-year-old male who was found playing with a light up toy
in his room with the battery compartment cover off the toy; the
batteries were all located, but the screw intended to secure the
battery compartment continuously spun when a caregiver attempted to
tighten it. Consistent with part 1263 fastener requirements, and to
ensure more durable fastener engagement, the NPR proposes minimum
requirements for battery compartment thread attachment as well as a
test to simulate repeated battery replacement.
3. Sibling Interaction
Twenty-four (24) reported nonfatal incidents, including seven
CPSRMS and 17 NEISS incidents, describe a button cell or coin cell
battery becoming accessible from a toy when, for example, two or more
siblings played with a toy together, or a younger sibling played with
an older sibling's toy. Incident reports demonstrate that basing
performance requirements for the durability of toy battery compartments
on the intended user's age does not adequately address typical use and
abuse scenarios leading to the ingestion hazard. For example, incident
I1910347A describes a 2-year-old female who played with her 4-year-old
male sibling's toys; the 2-year-old dropped the toys on the floor and
the toys fell apart; three button batteries fell out of the toys. The
NPR proposes to address these incidents by improving the durability of
battery compartments through performance tests with limited reliance on
age grading. The NPR proposes to require sequential use and abuse
testing that aligns with testing in part 1263, incorporating UL 4200A-
23 performance requirements.
4. Changing Batteries
Seven reported nonfatal incidents, all from NEISS, describe a child
accessing a button cell or coin cell battery while a parent or
caregiver was changing batteries in a toy. All children involved in
these incidents were taken to a hospital for treatment. For example,
NEISS case 190447495 describes an incident where a babysitter was
changing a button battery in a toy when an 8-month-old male was able to
swallow one battery. The NPR proposes to address these incidents by
improving required product warning labels for toy battery compartments
to better warn consumers about battery ingestion hazards while the
consumer is interacting with the compartment.
5. Easily Accessed Battery Compartments
Four reported nonfatal incidents, all from CPSRMS, involve a child
who was able to open a toy battery compartment without the use of a
tool. For example, IDI 170623CFE0001 describes a 9-year-old boy who
opened a battery compartment by pulling a battery compartment access
tab with his teeth. The remaining three incidents describe toys that
lacked battery compartment securing mechanisms or that opened easily
without a tool. The NPR proposes to better address the hazard of easily
accessed battery compartment incidents by mandating minimum performance
requirements for battery compartment threaded attachments.
C. National Estimates From NEISS
Based on NEISS data, CPSC staff estimates that over the seven-year
period from 2016 through 2022 there
[[Page 65797]]
were 4,500 U.S. hospital emergency department visits (sample size =
185, coefficient of variation = 0.1705) associated with a person
(generally a child) accessing a button cell or coin cell battery from a
toy.\27\ An estimated 81 percent of victims ingested or swallowed a
button cell or coin cell battery or put a button cell or coin cell
battery in their mouth. An estimated 92 percent of the victims were
children between the ages of 6 months and 5 years old. An estimated 58
percent of the victims were male, while an estimated 42 percent were
female. An estimated 81 percent were treated at the hospital emergency
department and released, 16 percent were admitted for hospitalization,
and 3 percent were held for observation. Of the 185 sample cases
supporting these estimates, none were fatal. To ensure that only button
cell and coin cell battery incidents involving toys are captured, CPSC
staff's estimates do not include cases that failed to identify battery
source or battery type. Accordingly, the injury estimates based on
NEISS data are conservative and represent a lower bound for actual ED-
treated injuries associated with button cell and coin cell batteries in
children's toys.
---------------------------------------------------------------------------
\27\ One instance involving an 18-year-old who ingested
batteries from a toy is included. Two other cases involve 15-year-
old children, although the majority of this data includes
substantially younger aged children.
---------------------------------------------------------------------------
D. Availability of Incident Data
Upon publication of this NPR in the Federal Register, CPSC will
make available for review and comment, to the extent allowed by
applicable law, the CPSRMS and NEISS incident reports relied upon and
discussed, along with the associated IDIs. The data can be obtained by
submitting a request to: https://forms.office.com/g/kSefsxqT3X. You
will receive a website link to access the data at the email address you
provided. If you do not receive a link within two business days, please
contact [email protected].
E. Child Supervision and Behavior
Battery compartment security is important for toys containing
button cell or coin cell batteries because children often play with
these types of toys while unsupervised, and infants or toddlers often
mouth objects, leading to incidents of battery ingestion or insertion.
Research by Morrongiello and colleagues (2006) \28\ indicates that
older toddlers and preschool children (ages 2 through 5 years old)
typically are out of view of a supervising parent for about 20 percent
of their awake time at home and are not within visual range or hearing
distance for about 4 percent of awake time in the home because
caregivers reasonably allow young children to be unsupervised for a few
minutes in a presumably safe room. Most caregivers recognize hazards
such as a hot stove and actively guard against them; however, items
such as toys reasonably do not present a high level of concern.
Therefore, consumers may not be aware that certain toys contain button
or coin cell batteries and that such products pose a hazard. Often,
caregivers notice that a toy is missing a battery only after a child
has already accessed it.
---------------------------------------------------------------------------
\28\ 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.
---------------------------------------------------------------------------
Mouthing and ingestion of non-food items is a normal part of
children's exploratory behavior that contributes to incidents of
choking and poisoning.\29\ Because of this, CPSC has banned small parts
for toys intended for children younger than 3 years of age and mandates
small-parts warnings for toys and games intended for children ages 3 to
6 years old.\30\ Still, toys containing button or coin cell batteries
pose a similar danger. Unintentional foreign body ingestion is one of
the top five leading causes for nonfatal emergency department visits in
children under the ages of 9 years old.\31\ Medical literature
indicates that children most commonly ingest or insert foreign objects
found in the home environment that are small, round, shiny, and
relatively smooth, as are button cell and coin
batteries.32 33
---------------------------------------------------------------------------
\29\ 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.
\30\ 16 CFR part 1501; 16 CFR 1500.19.
\31\ Centers for Disease Control and Prevention. Web-based
Injury Statistics Query and Reporting System (WISQARS) [Online].
(2003). National Center for Injury Prevention and Control, Centers
for Disease Control and Prevention. Available from: URL:
www.cdc.gov/ncipc/wisqars. [10/1/2022].
\32\ Kay, M., & Wyllie, R. (2005). Pediatric foreign bodies and
their management. 7(3):212-8; Lee, J.H., (2018) Foreign Body
Ingestion in Children. Clinical Endoscopy, 51:129-136; Kramer et
al., 2015; Conners GP, & Mohseni M. Pediatric Foreign Body
Ingestion. [Updated 2021 Jul 18]. In: StatPearls [internet].
Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available
from: https://www.ncbi.nlm.nih.gov/books/NBK430915/ -.(accessed 4/
12/22) https://www.ncbi.nlm.nih.gov/books/NBK430915/.
\33\ 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.
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Children develop rapidly, both physically and cognitively, in the
first few years of life, learning to grasp object, bring object to
their mouth, stand, and often walk all during the first year.\34\
Between the ages of 12 to 18 months of age, children progress from
walking, to running and climbing. Increased mobility, physical
strength, and coordination, combined with an inherent predisposition
towards curiosity and exploration can lead to dangerous situations for
young children who may discover hazardous items.\35\
---------------------------------------------------------------------------
\34\ Frankenburg, W.K., Dodds, J., Archer, P. (1990). The DENVER
II Technical Manual 1990, Denver Developmental Materials, Denver,
CO.
\35\ https://www.cpsc.gov/content/2020-Age-Determination-Guidelines.
---------------------------------------------------------------------------
F. Recalls
From January 1, 2011, through March 19, 2024, CPSC's Office of
Compliance and Field Operations conducted six recalls of toys
containing button cell or coin cell batteries. Table 1 below summarizes
the recalls, including the press release date, firm, hazard,
approximate number of recalled units, number of incidents and injuries
reported, and press release number.
Table 1--Recalls of Toys Containing Button Cell or Coin Cell Batteries January 1, 2011 to March 19, 2024
----------------------------------------------------------------------------------------------------------------
Number of
Approximate incidents & Press
Press release date Firm Hazard number of injuries release
recalled units reported \36\ No.
----------------------------------------------------------------------------------------------------------------
October 10, 2016......... Target............... The gel clings About 172,000 No Injuries \37\ 17-
can separate units Reported. 020
and expose the Halloween LED
inner decal and Gel Clings.
LED/button
battery
compartment,
posing choking
and button
battery
ingestion
hazards to
children.
[[Page 65798]]
May 23, 2017............. Hobby Lobby.......... The battery About 43,400 Received one \38\ 17-
cover can units Easter report of a 14- 166
detach and and July 4th- month-old
expose the themed Light- child who
small coin cell Up Spinner ingested the
batteries, Toys. battery.
posing choking
and ingestion
hazards to
young children.
December 19, 2019........ Toysmith............. The battery About 58,000 One report of a \39\ 20-
cover can units Light-Up child 045
detach and Magic Wands. swallowing one
expose the of the
button-cell batteries
batteries, removed from
posing choking the toy.
and ingestion Medical
hazards to attention was
young children. required to
remove the
battery.
May 12, 2021............. K & M International.. The coin cell About 463,000 None reported.. \40\ 21-
battery inside units Wild 134
the slap Republic Slap
watches can Watches.
fall out,
posing battery
ingestion and
choking hazards
to young
children.
December 1, 2021......... Halo Brand Solutions. A child can About 82,500 Received two \41\ 22-
disassemble the units reports of 024
projector Projector children
flashlight and Flashlights. accessing the
access the button cell
button cell batteries from
batteries, the
posing flashlight,
ingestion and and in one
choking hazards. case, a child
required
surgery to
remove a
swallowed
battery.
----------------------------------------------------------------------------------------------------------------
IV. Voluntary Standard Development
---------------------------------------------------------------------------
\36\ When the recall press release delineates the approximate
number of recalled units, number of incidents, or number of injuries
by country, this summary only includes the reported United States
values.
\37\ https://www.cpsc.gov/Recalls/2017/Target-Recalls-Halloween-LED-Gel-Clings.
\38\ https://www.cpsc.gov/Recalls/2017/hobby-lobby-recalls-easter-and-july-4th-light-up-spinner-toys.
\39\ https://www.cpsc.gov/Recalls/2020/Toysmith-Recalls-LightUp-Magic-Wands-Due-to-Choking-and-Ingestion-Hazards.
\40\ https://www.cpsc.gov/Recalls/2021/K-M-International-Recalls-Slap-Watches-Due-to-Coin-Cell-Battery-Ingestion-and-Choking-Hazards.
\41\ https://www.cpsc.gov/Recalls/2022/Halo-Recalls-Promotional-Childrens-Projector-Flashlights-Due-to-Button-Battery-Ingestion-and-Choking-Hazards.
---------------------------------------------------------------------------
ASTM F963 includes performance requirements and test methods for
children's toys, as well as requirements for warning labels and
instructional literature, to reduce or prevent death of children or
injury to children from mechanical, chemical, and other hazards
associated with toys. Similar to other ASTM standards, ASTM F963
contains the following sections: scope, terminology, referenced
documents, safety requirements, labeling requirements, instructional
literature, producer's markings, test methods, and additional sections
appropriate for toys, such as age grading and flammability testing of
certain types of toys. Since passage of the CPSIA in 2008, the
voluntary standard has been revised five times: ASTM F963-08, ASTM
F963-11, ASTM F963-16, ASTM F963-17, and ASTM F963-23. Pursuant to the
update procedures in section 106 of the CPSIA, the Commission has
accepted the sequential revisions as the mandatory standard. 15 U.S.C.
2056b(g).
Section 4.25 of ASTM F963-23 addresses the safety of all battery-
operated toys. Sections 4.25.4 addresses the hazards of choking or
swallowing batteries. Section 4.25.4.1 addresses the accessibility of
batteries from toy battery compartments for children less than 3 years
old, while section 4.25.4.2 addresses the accessibility of small part
batteries (i.e., batteries that fit within the small parts cylinder
described in 16 CFR 1501.4, including button cell or coin cell
batteries). The 2023 update to ASTM F963 included changes to strengthen
requirements associated with children accessing batteries, such as
adding the definition of a ``tool'' that may be used to access the
battery, strengthening labeling requirements associated with battery
accessibility, and improving safety requirements by expanding the
application of use and abuse testing of toys, including toys containing
small part batteries.
Still, ASTM F963-23 does not establish adequate performance
requirements for toys containing button cell or coin cell
batteries.\42\ Incident data described in section III of this preamble
and staff's toy testing in section V of this preamble demonstrate
weaknesses in the ASTM toy standard. For example, existing requirements
in ASTM F963-23 are not as stringent as performance requirements in
part 1263 for non-toy consumer products, which incorporate UL 4200A.
Therefore, ASTM F963-23 fails to adequately address children accessing
toy battery compartments, leading to children ingesting or inserting
button cell or coin batteries, and fails to provide the highest level
of safety feasible.
---------------------------------------------------------------------------
\42\ The Commission issues a direct final rule on September 21,
2023, codifying 16 CFR part 1263, and found that some provisions of
ASTM F963 were inadequate to address button cell or coin cell
battery hazards. 88 FR 65278, Table 1a.
---------------------------------------------------------------------------
V. Description and Explanation of the NPR
To address the risk of injury described in section III of this
preamble, this NPR proposes to add performance and labeling
requirements for toys containing button cell or coin cell batteries.
The NPR proposes to add test requirements for captive fasteners,
minimum requirements for threaded fasteners, and sequential use and
abuse testing (stress relief, battery replacement, impact, crush,
torque, tension, compression, and compliance verification tests), and
to update marking and labeling requirements. The additional
requirements are more stringent than the existing requirements in part
1250 to further reduce the risk of injury from these batteries and
represent the highest level of safety feasible to address child
ingestion of button cell or coin cell batteries from toys. The
additions also are intended to align the requirements for such toys
with the requirements for consumer products subject to part 1263, which
could promote design and manufacturing efficiencies. This section of
the preamble describes the proposed additions in new Sec. 1250.3,
Requirements for Toys Containing Button Cell or Coin Cell Batteries.
A. Performance Requirements
Section 106(c) requires that the Commission periodically review and
revise the rules for children's toys, including battery-operated toys,
to ensure that such rules provide the highest level of safety for such
products that is feasible. Section 106(d) requires the Commission
promulgate safety standards for toys that are more stringent than ASTM
F963 if the Commission determines that more
[[Page 65799]]
stringent standards would further reduce the risk of injury.
In the direct final rule by which the Commission implemented
Reese's Law (DFR), CPSC staff evaluated the requirements of both ASTM
F963-23 and the UL 4200A standard the Commission incorporated by
reference pursuant to that statute. 88 FR 65274 (Sept. 21, 2023).
Tables 1a and 1b of the DFR that established part 1263 evaluate and
compare those two standards. 88 FR 65278-89. Table 1a of the DFR
explains that UL 4200A-23 sets requirements for products that require a
tool to open the battery compartment, a captive fastener, a minimum
number of fastener threads, or two independent motions to open the
battery compartment. An accessibility test measures the adequacy of the
requirements. Table 2, below, summarizes CPSC staff's review of ASTM
F963-23's relevant provisions and whether a higher level of safety than
that provided in ASTM F963-23 is feasible for toys containing button
cell or coin cell batteries, based on the existing performance
requirements in UL 4200A-23 (as incorporated by reference for non-toy
consumer products in part 1263) and other international voluntary
standards for electrical toys and other products, including IEC 62115--
Electric toys--Safety (IEC 62115) and IEC 62368-1:2023--Audio/video,
information and communication technology equipment--Part 1: Safety
requirements (IEC 62368-1).
Table 2--Summary of Assessment of ASTM F963-23 Performance Requirements
in Comparison to Other Safety Standards
------------------------------------------------------------------------
ASTM F963-23 Reference (standard--
Requirement category (section No.-- section No.)
assessment)
------------------------------------------------------------------------
Safety Requirements:
Battery Accessibility-- 4.25.4--higher level UL 4200A-23--6.
Use and Abuse Testing. of safety is
feasible.
Battery Accessibility-- 4.25.4.2--higher UL 4200A-23--
Probe. level of safety is 6.3.5.1.
feasible.
Captive screws.......... 4.25.4.3--higher IEC 62115--13.4.6.
level of safety is
feasible.
Threaded fastener Not Addressed-- UL 4200A-23--5.5a.
securement requirements. higher level of
safety is feasible.
Use and Abuse Testing:
Pre-conditioning in oven Not Addressed-- UL 4200A-23--6.2.1a,
higher level of IEC 62368-1:2023--
safety is feasible. 4.8.4.2.
Simulated battery Not Addressed-- UL 4200A-23--6.2.1b.
replacement (x10). higher level of
safety is feasible.
Normal Use Testing...... 8.5--Inadequate..... N/A.
Abuse Testing........... 8.6--higher level of UL 4200A-23--6.
safety is feasible.
Drop test--based on 8.7.1--higher level UL 4200A-23--6.3.2.
product weight/type. of safety is
feasible.
Drop test--based on age 8.7.1--higher level UL 4200A-23--6.3.2.
grading. of safety is
feasible.
Battery Compartment Not Addressed-- UL 4200A-23--6.3.3.
Impact Test. higher level of
safety is feasible.
Crush Test (big surface Not Addressed-- UL 4200A-23--6.3.4.
area). higher level of
safety is feasible.
Torque Test............. 8.8--higher level of UL 4200A-23--6.3.4A.
safety is feasible.
Tension Test............ 8.9--higher level of UL 4200A-23--6.3.4B.
safety is feasible.
Compression Test (little 8.10--higher level UL 4200A-23--6.3.4C.
surface area). of safety is
feasible.
------------------------------------------------------------------------
As summarized in table 2, and based on staff's assessment described
below, a higher level of safety is feasible for toys containing button
cell or coin cell batteries. In fact, only one section of the ASTM
standard that is deemed inadequate does not have a comparable UL or
International Electrotechnical Commission (IEC) standard. This unique
provision, Section 8.5 of ASTM F963-23, addresses normal use testing,
which is ``intended to simulate normal use conditions so as to ensure
that hazards are not generated through normal wear and deterioration. .
. . The tests are intended to uncover hazards rather than to
demonstrate the reliability of the toy.'' This section does not define
any specific test procedures; for example, it provides only that toys
with wheels should be ``operated repeatedly.'' Accordingly, CPSC
preliminarily finds that this section is inadequate to consistently
identify hazards and that the abuse testing located elsewhere in ASTM
F963-23, UL 4200A-23, and other voluntary standards, as discussed
below, is better suited to addressing the risks associated with
accessible button cell or coin cell batteries.
The NPR proposes the following performance requirements and test
methods to improve safety by addressing the hazards of children
ingesting button cell or coin cell batteries that have been accessed
from toys.
1. Captive Fasteners
One hazard related to children ingesting button cell or coin cell
batteries is that consumers permanently remove or lose the fastener
securing the battery compartment cover, thereby exposing the button
cell or coin cell battery and allowing child access. Section 4.25.4.3
of ASTM F963-23 requires that fasteners used to secure toy battery
compartments shall remain attached to the toy or battery compartment
cover before and after
[[Page 65800]]
testing in accordance with sections 8.5-8.10. CPSC staff understands
that when conducting use and abuse testing of a battery-operated toy in
accordance with sections 8.5-8.10 of ASTM F963-23, test laboratories
visually inspect any fastener used to secure the battery compartment
both before and after testing to verify that the fastener remains
attached to the toy or battery compartment cover.
Section 13.4.6 of IEC 62115--Electric toys--Safety, contains a
similar requirement for use and abuse testing of fasteners but
specifies to verify compliance by both inspection and through testing:
``A force of 20 N is applied to the screw or similar fastener without
jerks for a duration of 10 s in any direction.'' Under the IEC 62115
requirements, to pass the test the fastener must remain with the toy or
battery compartment cover after compliance verification testing,
meaning after using a force to make sure that the fastener does not
fall off if pushed or pulled. This test method is more stringent than
the ASTM F963 test method that allows purely visual inspection, and
improves safety by better ensuring that battery cover fasteners remain
attached to the product.
To improve compliance verification, the NPR proposes to incorporate
into part 1250 a compliance test for battery-operated toys similar to
the IEC requirement. The proposed requirement clarifies how to confirm
compliance with the requirement in section 4.25.4.3 of ASTM F963-23 and
establishes a minimum threshold of attachment force for the fastener.
Therefore, to verify the fastener cannot be easily pulled out by a
child, and to align with a similar requirement in the international
standard IEC 62115, the NPR proposes to add a sentence to section
4.25.4.3, stating that after use and abuse testing, the battery
compartment fastener will be subject to 4.5 lbf (20 N) of force,
increasing from 0 lbf to 4.5 lbf, within 5 seconds, which should be
maintained for a duration of 10 seconds in any direction likely to
remove the fastener. The fastener must remain attached to the battery
compartment to pass the test. Such functional testing will help further
reduce the risk of injury from accessible button cell or coin cell
batteries because it works to ensure fasteners cannot be lost or
removed completely, thereby keeping batteries better contained.
2. Minimum Battery Compartment Threaded Attachment Requirements
Another hazard related to children ingesting button cell or coin
cell batteries is battery compartments being unsecured because the
screws intended to keep the door or cover secure were either too short
to remain attached to the toy or did not engage the threads. ASTM F963-
23 currently does not have performance requirements addressing the
minimum battery compartment fastener length or the removal torque for
the door or cover for toys containing batteries.
Section 5.5(a) of UL 4200A-23 includes specific requirements
addressing threaded fastener securement and twist-on battery
compartment cover securement. In the DFR, the Commission determined
that two requirements in UL 4200A-23 adequately ensure battery
compartment securement: (1) screws or similar fasteners must engage at
least two full threads (i.e., the fasteners must screw into the product
for at least two full turns), and (2) battery compartment twist-on
access covers shall require a minimum torque of 0.5 Nm (4.4 in-lbf) and
a minimum of 90 degrees of rotation to open the compartment. 88 FR
65274.
To ensure that toy battery compartment fasteners are just as secure
as non-toy consumer product battery compartment fasteners subject to
part 1263, Sec. 1250.3(c)(2)(i) through (iii) of the NPR proposes to
add sections 4.25.4.5, .6, and .7 to ASTM F963-23, incorporating
requirements consistent with these two UL 4200A-23 provisions. These
more stringent requirements work to address incidents of children
gaining access to batteries because fasteners had an insufficient
length and could be easily removed when the threads did not engage
strongly, or twist-on battery compartments were easily opened because
minimal force was needed to remove the cover.
3. Sequential Use and Abuse Test Requirements
To address the hazard of button cell or coin cell batteries
becoming accessible when a toy breaks, falls apart, or the battery
compartment opens unexpectedly, the NPR proposes to add requirements to
ensure that batteries remain inaccessible to children during reasonably
foreseeable use and misuse of toys. Currently, most of the tests in
ASTM F963-23 do not require sequential testing on a battery-operated
toy sample. Section 4.25.4 of ASTM F963-23 requires that the
accessibility of button cell or coin cell batteries in toys be
determined before and after testing in accordance with the applicable
use and abuse test requirements in sections 8.5-8.10. The test
requirements include normal use testing, abuse testing, impact testing
(including drop testing), torque and tension testing, and compression
testing. Each individual test may be performed on a toy or component
that has not yet been subjected to the abuse testing, in accordance
with section 8.1. The Commission preliminarily determines that
sequential testing better addresses real-world scenarios of toys
experiencing different uses and abuses over time, such as a drop
followed by a crush force. It is foreseeable that a toy will endure
multiple and varied uses and abuses over time. Therefore, ensuring that
a toy battery compartment can withstand various tests sequentially
improves safety.
In contrast to the ASTM test method, section 6 of UL 4200A-23
requires that products containing button cell or coin cell batteries
have all use and abuse tests conducted sequentially on the same sample.
This sequence of tests includes pre-conditioning of plastic products in
the oven, simulated battery replacement, drop testing, battery
compartment impact testing, crush testing, torque testing, tension
testing, compression testing, and compliance verification testing. The
sequential testing in UL 4200A-23 means that each test can affect the
results of subsequent testing, which results in a more comprehensive
and more stringent series of tests as compared to ASTM F963-23.
Illustratively, prior to the 2023 versions of the ASTM F963 and UL
4200A standards, CPSC staff compared the performance of eight toy
products when tested to section 4.25.5 of ASTM F963-17 (equivalent to
testing to section 4.25.4.2 of ASTM F963-23) and section 6 of UL 4200A-
20.\43\ Seven of the eight toy products tested were associated with
incidents known to CPSC where a child gained access to the toy
battery.\44\ Six
[[Page 65801]]
out of the eight toy products passed ASTM F963 performance requirements
and failed the sequential performance requirements in UL 4200A, meaning
the battery became accessible. Five of these six toy products failed
the simulated battery replacement test in UL 4200A. Two of these six
toy products also failed during the drop test, the impact test, and the
compliance verification (accessibility) test. This testing further
indicates that the performance requirements in UL 4200A better address
known hazard patterns for children accessing battery compartments than
requirements in ASTM F963 because they better ensure toy battery
compartments remain intact when exposed to foreseeable uses and abuses.
---------------------------------------------------------------------------
\43\ See March 20, 2023, Letter from Daniel Taxier, Children's
Product Program Manager, and Benjamin Mordecai, Project Manager for
ASTM F963, to ASTM Subcommittee and Task Group Chair, regarding
Reese's Law, CPSC staff's toy testing to F963 and UL-4200A, and
recommendations for updates to F963 to align with the Commission's
then-proposed NPR to implement Reese's Law (available at: https://www.cpsc.gov/s3fs-public/Letter-to-ASTM-F15-22-Reeses-Law-NPR-230320.pdf?VersionId=6ZGPs5nSLhBGlFdoz1IWHF1wo.oOgarH).
\44\ Refer to the ``Incident'' column in table 1 of the March
20, 2023 letter.
---------------------------------------------------------------------------
To provide a more stringent toy requirement that improves the
safety of toys and aligns with the requirement for non-toy consumer
products,\45\ the NPR proposes to require similar sequential use and
abuse testing for toys containing button cell or coin cell batteries by
adding to part 1250 a sequence of tests based on UL 4200A-23: stress
relief; battery replacement; drop or tip-over; impact; crush; torque,
tension, and compression; and compliance verification.
---------------------------------------------------------------------------
\45\ This standard has been incorporated by reference in 16 CFR
part 1263 as a safety standard for non-toy consumer products.
---------------------------------------------------------------------------
a. Stress Relief Test
The NPR proposes requiring a pre-conditioning test to account for
thermal stress. Thermoplastics, or polymer materials used in certain
molding or forming manufacturing processes (such as acrylic, nylon,
Polylactic Acid, and polycarbonate), are susceptible to change when
subjected to thermal stresses or heat. In particular, the manufacturing
process will leave parts of a molded or formed component stressed after
it has cooled to room temperature; then, when exposed to heat, the
stress will relax, causing the dimensions and strength of the component
to change.
Toys containing button cell or coin cell batteries are regularly
exposed to thermal stresses, including during shipping, when left in a
hot car or in the sun, and from the battery(ies). To ensure that
plastic button cell or coin cell battery compartments in toys are
designed and manufactured in a manner that adequately accounts for the
effects of heat on the material, the NPR proposes stress relief test
requirements that pre-condition the battery compartment, and are
intended to ensure that any potential relaxation or warping of molded
or formed thermoplastic components does not affect the mechanical
integrity of the battery compartment as determined through the
subsequent tests in the sequence.
ASTM F963-23 does not require any pre-conditioning testing of
battery-operated toys prior to use and abuse testing. The proposed test
method is based on the UL 4200A-23 requirement that the entire toy or
toy component be placed in an oven at 70 [deg]C, or 10 [deg]C higher
than the maximum operating temperature of the battery compartment, if
that temperature would be greater than 70 [deg]C, if any part of the
battery compartment is made of molded or formed thermoplastic
materials.
The proposed test also incorporates some clarifications based on a
similar test in IEC 62368-1:2023, allowing battery compartments and the
supporting framework to be removed from large and bulky toys and placed
in the oven, without the remainder of the product. This clarification
allows components of large and bulky toys to be tested in smaller ovens
without compromising the test with a large and bulky object interfering
with use of the appropriate test oven. The proposed requirement also
clarifies that the batteries may be removed from the compartment during
the test, which will not affect the outcome. The proposed pre-
conditioning test ensures that battery compartments of toys containing
button cell or coin batteries withstand potential thermal stressors
that may weaken the compartment and allow children's access to
batteries, risking ingestion, or insertion.
b. Battery Replacement Test
The NPR proposes testing requirements for toys with a replaceable
battery to address the hazard of battery compartments becoming unsecure
after a user replaced the battery and the fastener or battery
compartment threads became stripped, thereby preventing proper
securement of the battery compartment, allowing a child to access the
battery. The data described above includes four such nonfatal
incidents. ASTM F963-23 does not require any simulated battery
replacement tests. However, repeated opening and closing of a battery
compartment locking mechanism has the potential to reduce the strength
of the lock. This is particularly true when threaded fasteners are used
and threads of different hardness engage with each other (such as a
metal screw into a plastic toy), creating the potential for the harder
material to damage or strip the threads from the softer material.
UL 4200A-23 addresses this hazard in section 6.2.1b by requiring
that the battery compartment is opened; the battery is removed and
replaced; and the battery compartment is closed and secured 10 times.
If the battery compartment is secured with a fastener, the screw must
be loosened and tightened using a suitable screwdriver and a continuous
linear torque in accordance with the table in Sec. 1250.3, which is
the same as table 20 of UL 60065 Standard for Audio, Video and Similar
Electronic Apparatus--Safety Requirements.\46\
---------------------------------------------------------------------------
\46\ UL 60065 8th Edition (2015) is an adoption of IEC 60065
Audio, video, and similar electronic apparatus--Safety requirements
8th Edition (2014). IEC has granted CPSC permission to reproduce
Table 20, Test Probe 11, and Test Probe B with the following
disclaimer: ``The author thanks the International Electrotechnical
Commission (IEC) for permission to reproduce Information from its
International Standards. All such extracts are copyright of IEC,
Geneva, Switzerland. All rights reserved. Further information on the
IEC is available from www.iec.ch. IEC has no responsibility for the
placement and context in which the extracts and contents are
reproduced by the author, nor is IEC in any way responsible for the
other content or accuracy therein.''
---------------------------------------------------------------------------
The proposed test method is based on UL 4200A-23, but similar
requirements can be found in the international standards IEC 62115 and
IEC/UL 62368-1. The test requires that the battery compartment door or
cover be opened, the battery removed and replaced, and the battery
compartment door closed 10 times. If the battery compartment is secured
with one or more screws, then the screws are to be loosened and
tightened using a suitable screwdriver, and a continuous linear torque
must be used in accordance with the table in Sec. 1250.3, which is the
same as the Torque to be Applied to Screws table, table 20, of UL
60065, Standard for Audio, Video and Similar Electronic Apparatus--
Safety Requirements.
c. Drop Test and Tip Over Test
Drop testing has long been used to assess the durability of toys,
yet the data contains reports of 50 nonfatal incidents where a toy's
battery compartment broke apart or opened unintentionally, including
nine incidents specifically describing the toy as having been dropped.
Staff's testing, along with the incident reports, illustrates the need
for rigorous drop testing to ensure the integrity of the battery
compartment.
Section 8.7.1 of ASTM F963-23 outlines drop test requirements based
on the age grading of the toy and specific weight limits. The age
grading of the toy determines the maximum weight of the toy subject to
the test; the number of drops; and the drop height. For example, a toy
for a child age 18
[[Page 65802]]
months or less must weigh 3.01 lbs. (1.4 kg) or less to be subject to
the drop test, and it would be dropped 10 times from a height of 4.5
ft; a toy for a child age over 36 months to 96 months must weigh 10.01
lbs. (4.5 kg) or less to be subject to the test, and it would be
dropped four times from a height of 3 ft. Toys are dropped in a random
orientation onto \1/8\-inch-thick vinyl tile over concrete with the
batteries in place. Large and bulky toys, defined as toys with a
projected base area of more than 400 square inches (0.26 m\2\) or a
volume of more than 3 cubic feet (0.08 m\3\), are subject to the tip-
over test in section 8.7.2 instead of the drop test. These toys are
tipped over three times onto the same test surface as used in the drop
test.
Comparatively, section 6.3.2 of UL 4200A-23 varies the number of
drops for each product based on the weight of the product and how the
product is used. A portable device, which is reasonably foreseeable to
be routinely carried or lifted but not operated during transit with a
mass not exceeding 19 kg (39.7 lbs.), is dropped three times. A hand-
held product, which is reasonably foreseeable to be used or misused
while being held in one or both hands, with a mass not exceeding 4.5 kg
(10 lbs.), is dropped 10 times. Products are dropped in positions
likely to produce the maximum force on the battery compartment from a
height of 1.0 m (3 ft 3.4 in) onto a hardwood surface.
The application of both the ASTM F963-23 drop test and the UL
4200A-23 depend on characteristics of the product intended to be
dropped to determine the appropriate test protocol, and as a result,
which of the tests is more stringent than the other depends on what
product is being tested. For example, the impact surface used in ASTM
F963-23 is harder than the surface used in UL 4200A-23 and is therefore
expected to produce greater impact forces on the toy. Meanwhile, all
hand-held products weighing 10 lbs. or less are dropped 10 times in UL
4200A-23, while many toys weighing 10 lbs. or less are subject to only
four drops or are not dropped at all pursuant to ASTM F963-23 test
requirements. Additionally, the drop test in UL 4200A-23 targets the
button cell or coin cell battery compartment for failure, while the
drop test in ASTM F963-23 is intended to identify ingestion hazards and
other hazards, such as small parts, sharp edges, or other hazards
generally created by the test.
Because aspects of the drop test in UL 4200A-23 are more stringent
than the drop test in ASTM F963-23 and better ensure the integrity of
the battery compartment, the proposed test combines aspects of the drop
test in UL 4200A-23 with the drop test in ASTM F963-23 to achieve the
highest level of safety feasible for toys containing button cell or
coin cell batteries. The proposed test surface is vinyl tile on
concrete, consistent with the test surface currently used for toy drop
testing in ASTM F963-23. The vinyl on concrete test surface will absorb
less energy and produce a harder impact as compared to the wood test
platform used in UL 4200A-23. The proposed test also uses minimum drop
heights based on the specifications in table 5 of ASTM F963-23: 4.5 ft
(137 cm) for toys for children aged 0 to 18 months, and 3.0 ft (91 cm)
for all other toys. The drop height specified in UL 4200A-23 is 1.0 m
(100 cm, 3.3 ft). While the UL 4200A-23 drop height is greater than the
proposed drop height for toys for children ages over 18 months, the
Commission expects that the harder test platform in the proposed drop
test will ultimately make the test at least as stringent as the UL
4200A-23 drop test. This expectation is based on testing of a product
which failed both the ASTM F963-23 drop test and the UL 4200A-23 drop
test (see section V.A.3. of this preamble).
Establishing separate weight tiers based on age grading is not
appropriate for this test given known incidents where sibling
interaction could have contributed to the incident, including cases
where younger siblings were playing with an older sibling's toy.\47\
Instead, the proposed test method uses a 10 lbs. product weight
criteria for all toys to establish a maximum weight for the drop test.
The proposed weight limit is consistent with the weight limit for hand-
held products in UL 4200A-23, which uses a lesser number of drops for
portable devices weighing up to 18 kg (39.7 lbs.) that are carried or
lifted but not operated during transit as part of their foreseeable use
or misuse. The proposed test adapts the drop test for such portable
products in UL 4200A-23 for toys weighing at least 10.01 lbs. up to
39.7 lbs., and it also adds the existing tip-over test for large and
bulky toys from section 8.7.2 of ASTM F963-23. CPSC staff anticipates
that most toys weighing at least 10.01 lbs. would be subject to the
proposed tip-over test, rather than the proposed drop test. The
Commission seeks comment on whether there are toys for which the
proposed drop test for toys weighing at least 10.01 lbs. up to 39.7
lbs. would ever be applicable instead of the proposed tip-over test,
and whether the drop test should be removed for these heavier toys.
---------------------------------------------------------------------------
\47\ CPSC staff has identified 24 such incidents.
---------------------------------------------------------------------------
d. Impact Test
The Commission is aware of 50 reported nonfatal incidents where a
toy's battery compartment broke apart or opened unintentionally,
including two incidents where the toy was described as having been
thrown or smashed. To address this hazard, the NPR proposes mandating
an impact test directly on the battery compartment. The proposed test
is based on the test in UL 4200A-23 and simulates impacts directly to
the toy battery compartment.
ASTM F963-23 does not adequately address direct impacts to battery
compartment enclosures that can occur when children throw, punch, kick,
or smash toys together or against another surface (such as furniture).
The drop test in section 8.7.1 simulates random impacts from flat
surface contact and the compression test in section 8.10 applies a
static load on surfaces not contacted by the flat surface in the drop
test, but neither of these tests adequately tests to protect against
batteries becoming unintentionally accessed from toy battery
compartments because these tests do not simulate direct impacts against
the battery compartment.
To address direct impacts to battery compartment enclosures that
can occur when children throw, punch, kick, or smash toys together or
against another surface (such as furniture), the proposed test adopts
the impact test used in UL 4200A-23 and in several other voluntary
standards, such as IEC/UL 62368-1, which subjects the battery enclosure
or compartment door/cover to three impacts with an energy of 1.5-
ft[middot]lbf (2-J). The impacts are produced by either dropping or
swinging a 2.00 in. (50.8 mm) diameter steel sphere, weighing
approximately 1.1 lbs. (0.5 kg), from the height necessary to produce
the specified kinetic energy at impact, as shown in figures 6 and 7.
The sphere must strike the battery enclosure or compartment door/cover
perpendicular to the surface to ensure the impact has the maximum
amount of energy possible.
[[Page 65803]]
[GRAPHIC] [TIFF OMITTED] TP13AU24.029
[GRAPHIC] [TIFF OMITTED] TP13AU24.030
e. Crush Test
The NPR proposes requiring a test to account for crushing forces
exerted on toys during normal use and abuse, such as if a person steps
on a toy, to ensure the battery compartment remains intact and does not
break open. ASTM F963-23 does not include a test to address this hazard
pattern. Staff has reviewed incident data demonstrating that a battery
can become accessible when a child crushes a toy that is required to
comply with ASTM F963 as incorporated in 16 CFR part 1250. The NPR
therefore proposes adopting a crush test based on the test in section
6.3.4 of UL 4200A-23 for all toys subject to the rule. This test
simulates a crushing force, such as the force exerted on a toy from a
child or adult stepping or sitting on it, to ensure the toy does not
split open and allow access to the battery. The crush test involves
placing the toy sample on a fixed rigid supporting surface (such as the
floor or a flat rigid table), in stable positions likely to produce the
most adverse results. The test applies a crushing force of 74.2 lbf
1.1 lbf (330 N 5 N) for a period of 10
seconds to exposed surfaces using a flat surface measuring
approximately 3.9 in by 9.8 in (100 mm by 250 mm). The more stringent
requirements directly address one scenario in which children have
accessed batteries, as shown in the incident data.
f. Torque, Tension, and Compression Tests
The NPR proposes including torque, tension, and compression tests
to address the hazard of children manipulating a toy with their hands
or mouth to open the battery compartment. The data includes nine
nonfatal incidents where children were able to open the compartment in
this manner. Sections 8.8, 8.9, and 8.10 of ASTM F963-23 include
torque, tension, and compression use and abuse tests that simulate a
child grasping a component (with at least a thumb and forefinger, or
with teeth). Testing involves use of a clamp to grab the toy component,
and then the part is twisted (torque) or pulled (tension). The
compression test is applied to any area on the surface of a toy that is
accessible to a child and not exposed to flat surface contact during
the impact (drop) test. A flat metal disk with a diameter of 1.125
inches (28.58 mm) and a thickness of 0.375 inches
[[Page 65804]]
(9.52 mm) is pressed into the surface. Like the drop test, the forces
and torques applied in these tests depend on the age grading of the
toy. Torques range from 1.8 in[middot]lbf to 4.2 in[middot]lbf (0.20 Nm
to 0.47 Nm); tensile forces range from 9.5 lbf to 15.5 lbf (42 N to 69
N); and compression forces range from 19.5 lbf to 30.5 lbf (86.7 N to
135.7 N). The torque and tension tests are conducted in sequence with
each other, but these tests are otherwise not conducted in sequence
with the other ASTM tests.
In contrast, all of the use and abuse tests outlined in UL 4200A-23
are conducted in sequence. UL 4200A-23 requires the same torque,
tension, and compression tests as ASTM F963-23 but applies the tests
specifically to the battery compartment and has higher minimum torque
and force values. Under the UL standard, the minimum torque is 0.5 Nm
(4.4 in[middot]lbf); \48\ the minimum tensile force is 72.0 N (16.2
lbf); and the minimum compression force is 136 N (30.6 lbf). These
higher forces and torques in the UL test are better able to ensure the
integrity of the battery compartment than the ASTM test. Accordingly,
the proposed torque, tension, and compression test sequence are based
on the existing methods in sections 8.8-8.10 of ASTM F963-23 and must
be conducted in the same order in which they appear, while the proposed
minimum values align with UL 4200A-23 to achieve the highest feasible
level of safety to best address unintended access to toy battery
compartments.
---------------------------------------------------------------------------
\48\ This minimum torque aligns with the required torque for
twist-on access covers.
---------------------------------------------------------------------------
g. Compliance Verification Test
CPSC staff is aware of incidents of children gaining access to
button cell or coin cell batteries from toy battery compartments
without the use of a tool, such as a screwdriver. Section 4.25.4.2 of
ASTM F963-23, Battery Accessibility, requires that batteries which fit
completely within the small parts test cylinder (including button cell
and coin cell batteries), shown in figure 4 from 16 CFR 1501.4, shall
not be accessible without requiring the use of a common household
tool.\49\ Any area of the toy that can be contacted by any portion
forward of the collar of the probes shown in figure 5 is considered to
be accessible.\50\ Per section 4.25.4.4, specialty fasteners may also
be used to secure the battery compartment.\51\ Because the
accessibility probes have hinges, they reflect the bending
functionality of a finger, however the probes cannot be applied with
force like that of a real finger because of limitations associated with
hinging ability.
---------------------------------------------------------------------------
\49\ By definition, common household tools include straight-
blade or Phillips screwdrivers, pliers, coins, or other objects
commonly found in most households.
\50\ Probe A is for toys age graded for children 0-36 months,
and Probe B is for toys age graded for children 37-96 months.
\51\ Specialty fasteners (such as with Torx or Hex drivers) may
be used to secure battery compartments, so long as the tool is
included with the toy and specific instructional material is
included.
---------------------------------------------------------------------------
UL 4200A-23 uses a rigid finger probe to determine battery
accessibility. Section 5.3 of UL 4200A-23 requires application of a
test probe, Test Probe 11 of IEC 61032 Standard for Protection of
Persons and Equipment by Enclosures--Probes for Verification, with
minimum force before testing to determine accessibility and, per
section 6.3.5, application of the probe with 50 N (newtons) to 60 N
(11.2 lbf to 13.4 lbf) after testing to verify the battery compartment
enclosure remains functional. The data described above includes
incidents where children were able to access toy battery compartments
by manipulating the product with hands or teeth. To address this
hazard, application of a finger probe with force after testing is
necessary to verify the secureness of toy battery compartments. This
cannot be accomplished with the accessibility probe in ASTM F963-23 but
can be accomplished with the accessibility probe in UL 4200A-23.
Therefore, the use of the accessibility probe in UL 4200A-23 is
necessary to further reduce the risk of injury from accessible button
cell or coin cell batteries. To address this hazard, the proposed test
uses the design of Test Probe 11 of the Standard for Protection of
Persons and Equipment by Enclosures--Probes for Verification, IEC
61032.\52\ The probe is used to apply 11.2 lbf + 2.2/-0 lbf (50 N + 10/
-0 N) for 10 seconds at the most unfavorable place and in the most
unfavorable direction to ensure that the battery compartment door/cover
does not open and remains functional, while also verifying that the
battery is not touched or made accessible.
---------------------------------------------------------------------------
\52\ IEC 61032, Figure 7--Test Probe 11 directs readers to
review Test Probe B for dimensions of the fingertip and tolerances.
The proposed additions to Sec. 1250.3 include Test Probe B, to
ensure readers may easily review the proposed dimensions and
tolerances.
[GRAPHIC] [TIFF OMITTED] TP13AU24.031
[[Page 65805]]
[GRAPHIC] [TIFF OMITTED] TP13AU24.032
The proposed test method addresses 50 reported nonfatal incidents
where the toy battery compartment broke apart or opened
unintentionally, including nine nonfatal incidents where children
accessed batteries from the battery compartment while playing with the
toy with their hands and mouth.\53\ This test verifies that the battery
compartment enclosure remains secure and functional beyond the use of
the accessibility probe currently referenced in ASTM F963-23.
---------------------------------------------------------------------------
\53\ In one of these incidents, Y214K670A, the battery
compartment opened while the fastener remained in place. This
failure mode may not be detected using ASTM F963-23's existing
accessibility probe because the probe cannot be applied with force
due to its joints.
---------------------------------------------------------------------------
B. Marking, Warning, Labeling, and Instructional Literature
Requirements
During the Reese's Law rulemaking process, staff evaluated required
warnings for battery-operated toys in ASTM F963-17, the previous
version of ASTM F963. Tab C, Appendix A, Reese's Law NPR SBP. Warning
requirements for battery-operated toys have not changed between the
2017 version of ASTM F963 and ASTM F963-23. ASTM F963 sets forth
uniform methods of addressing mechanical and chemical safety hazards
and associated safety messaging in toys that are intended for children.
Table 3 summarizes CPSC's review of marking and labeling requirements
in ASTM F963-23 and whether a higher level of safety is feasible for
toys containing button cell or coin batteries based on requirements in
other safety standards. Detail of staff's analysis follows.
Table 3--Summary of Assessment of ASTM F963-23 Marking and Labeling
Requirements in Comparison to UL 4200A-23
------------------------------------------------------------------------
ASTM F963-23 Comparison
Requirement category (section No.-- (standard--section
assessment) No.)
------------------------------------------------------------------------
On Toy Product Packaging. 5.14.2--higher level UL 4200A-2023--7B.
of safety is
feasible.
Warnings:
On Toy Products.......... 4.25.1--higher level UL 4200A-2023--7C.
of safety is
feasible.
In Accompanying 5.14.2--higher level UL 4200A-2023--9.
Instructions. of safety is
feasible.
------------------------------------------------------------------------
Packaging--Section 5.14.2. of ASTM F963-23 requires that toys
powered by ``button or coin cell batteries that are 1.5 volts or
greater, regardless of chemistry, and are greater than 15mm in diameter
and fit within the small parts cylinder'' must have the following
warning on the toy packaging:
[GRAPHIC] [TIFF OMITTED] TP13AU24.033
Products with batteries subject to the packaging requirements
specified in UL 4200A-23 are not limited by battery voltage or
diameter; all consumer products containing button cell or coin cell
batteries are included (with the exception of toys and zinc-air
batteries). The Commission has determined that zinc-air button cell or
coin batteries do not present an ingestion hazard. 16 CFR 1263.1(d).
Both ASTM F963-23 and UL 4200A-23 require similar warning formats with
a signal word, safety alert symbol (e.g., exclamation mark in a
triangle), and message statement noting the presence of button cell or
coin cell batteries. The UL 4200A-23 warning label improves safety
compared to the ASTM warning, however, because it also provides an
explicit hazard statement and detailed hazard information, the severity
and consequences if the warning is disregarded, and appropriate hazard-
avoidance behaviors. The warning additionally instructs the consumer to
take appropriate action should they suspect a button cell or coin cell
battery was ingested. Specifically, the warning
[[Page 65806]]
label shall have the following statements,
INGESTION HAZARD: This product contains a button cell
or coin battery.
DEATH or serious injury can occur if ingested.
A swallowed button cell or coin battery can cause
Internal Chemical Burns in as little as 2 hours.
KEEP new and used batteries OUT OF REACH OF CHILDREN.
Seek immediate medical attention if a battery is
suspected to be swallowed or inserted inside any part of the body.
The UL warning label format uses a bulleted list, capitalization,
and bolding that aligns with industry best practices as outlined in
ANSI Z535.4 (American National Standard for Product Safety Signs and
Labels) and ASTM's Ad Hoc Language Task Group recommendations.
Additionally, UL 4200A-23 incorporates the use of a safety icon
accompanying the text to quickly attract the reader's attention to the
label. Either the ``Keep out of Reach'' icon or the internationally
recognized ``Warning: Contains coin battery'' icon may be used
depending on applicability.
Product--ASTM F963-23 safety labeling requirements for toys that
use batteries must specify the type of battery, the size of the
battery, and the number of batteries used within the toy. Section
4.25.1 of ASTM F963-23 requires that the toy be marked with battery
polarity, size, and voltage, although size and voltage may be provided
in the instructions. It also requires additional on-product markings if
the toy is powered by more than one battery per circuit. Pursuant to
section 6.5 and 5.14 of ASTM F963, the toy or instructions must state
the following:
``Do not mix old and new batteries.''
``Do not mix alkaline, standard (carbon-zinc), or
rechargeable batteries.''
``Battery is not replaceable'' (if applicable).
Additionally, the location of on-product safety labeling is
dependent on the size of the product, as determined by the
manufacturer. If the product is too small, the above information must
be included in the toy instructions. Button cell or coin cell battery-
operated toys are not required to be marked if the toy is so small that
marking is not feasible. UL 4200A-23 on-product marking requirements
include a warning label identifying an ingestion hazard and the
presence of a button cell or coin cell battery. If the toy's small size
limits the ability to print a warning on the product, the warning can
be replaced with an internationally recognized warning icon. If a toy's
small size does not allow inclusion of an on-product warning or icon,
UL 4200A-23 requires that a hangtag or sticker label be included with
the toy.
Instructions--ASTM F963-23 requires toys powered by ``button or
coin cell batteries that are 1.5 volts or greater, regardless of
chemistry, and are greater than 15mm in diameter and fit within the
small parts cylinder'' to have the following instructions:
[GRAPHIC] [TIFF OMITTED] TP13AU24.034
If the toy does not come with instructions, the above warning must
be on the packaging or on a paper insert inside the toy packaging.
Products with accessible (with the use of a coin, screwdriver or
household tool), non-replaceable batteries must contain a statement
that the batteries are not replaceable. UL 4200A-23 has the same
requirement for non-replaceable button cell or coin cell batteries. As
previously discussed, the UL 4200A-23 warning label requires detailed
warning message statements and a safety icon to capture the reader's
attention; these requirements are not dependent on battery voltage or
diameter. This same warning must be printed on the instructions or
manual if provided. Similar to the ASTM F963-23 standard, should no
instructions or manual be provided, UL 4200A-23 requires the warning to
be on the packaging, or it must be on a hangtag or sticker label if the
product does not include packaging. UL 4200A-23 requires additional
battery safety information on the product packaging or in the
instructions/manual as applicable. These statements address battery
replacement and disposal, compatibility with the product, securement of
the battery compartment, and electrical or fire hazards associated with
misused batteries.
Section 1263.4, which implements Reese's Law for consumer products
generally, establish warning label requirements for the packaging of
button cell or coin batteries, while Sec. 1263.3 incorporates the
labeling requirements in UL 4200A-23, which establish warnings for the
consumer product packaging, battery compartment, and accompanying
instructional materials. To provide the highest level of safety
feasible, this NPR seeks to align required warnings for toy packaging,
toy battery compartments, and accompanying instructional literature,
with part 1263 because such requirements are worded and formatted in a
manner that better warns of hazards identified in the incident data and
better captures reader's attention.
The proposed formatting requirements taken from part 1263 are based
largely on warning label research and ANSI Z535.4, which is the primary
voluntary consensus standard providing guidelines for the design of
safety signs and labels for application to consumer products. ANSI
Z535.4 includes recommendations for the design, application, use, and
placement of warning labels, such as having the signal word ``WARNING''
and the safety alert symbol of an equilateral triangle surrounding an
exclamation mark. Tab C, Reese's Law NPR SBP. Children's juvenile
product standards, as well as standards involving common household
items that may be hazardous to children, commonly rely on the warning
formatting specifications in ANSI's Z535.4.
Spare batteries included with toys not contained in child-resistant
packaging present an ingestion hazard to children. Pursuant to section
3 of Reese's Law, the Commission already requires that button cell or
coin cell batteries included separately within toy packaging meet child
resistant packaging requirements to address the possibility of children
opening and accessing the contents of retail toy
[[Page 65807]]
packaging. As such, the Commission already requires that button cell or
coin cell battery packaging, including button cell or coin cell
batteries sold separately along with a toy, meet Sec. 1263.4,
Requirements for labeling of button cell or coin battery packaging.
VI. Feasibility of Proposed Requirements
Pursuant to section 106(c) of the CPSIA, Congress directed the
Commission to ``periodically review and revise the rules set forth
under this section to ensure that such rules provide the highest level
of safety for such products that is feasible.'' 15 U.S.C. 2056b(c). The
safety hazards identified in section III of this preamble can feasibly
be addressed by the requirements proposed in this NPR.
Many toys on the market already comply with the proposed
requirements. The technology to comply is already available (e.g.,
threaded fasteners), and the proposed requirements align with existing,
already-required performance requirements applicable to non-toys
products in part 1263, which are currently on the market. Third party
labs are already International Organization for Standardization (ISO)
accredited and CPSC-accepted to test to UL 4200A; complying with the
proposed requirements for toys would use the same or similar testing
and test equipment.
Nor will the proposed rule present insurmountable economic
challenges. Staff estimates that only 20 percent of the manufacturers
and importers/wholesalers (approximately 3,775) would incur any costs
related to redesign required by the proposed rule. As stated in section
IX of this preamble, the maximum cost expected per firm to redesign a
battery compartment is $6,586, which equates to a maximum total cost to
the industry of approximately $25 million. Estimates of U.S. children's
toys sales revenue in 2023, published by Circana,\54\ equate to a total
industry size of $28 billion. Maximum cost estimates are 0.09 percent
of revenue.
---------------------------------------------------------------------------
\54\ 2023 US Toy Industry Sales Analysis--Circana. https://www.circana.com/intelligence/press-releases/2024/us-toy-industry-sales-decline-8-in-2023-while-remaining-5-7-billion-above-2019-sales-circana-reports/.
---------------------------------------------------------------------------
VII. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). The rule would apply to all toys
containing button cell or coin cell batteries manufactured after the
effective date. 15 U.S.C. 2058(g)(1).
Although many toys may already comply with the proposed
requirements, some toys would need to be redesigned, and all toys
containing button cell or coin cell batteries would require third-party
testing to the new requirements. 15 U.S.C. 2063(a)(3).\55\ Accordingly,
to provide time to comply with the rule, to ensure adequate lab
capacity to test and certify toys, and to spread the cost of compliance
over approximately six months, the Commission proposes to make this
rule effective 180 days after publication of the final rule in the
Federal Register.
---------------------------------------------------------------------------
\55\ Section 14(a)(3) specifies laboratories must have at least
90 days to test for compliance.
---------------------------------------------------------------------------
Although the NPR proposes to add performance requirements, 180 days
should be sufficient to come into compliance, because battery-operated
toys already must satisfy third party testing, and because the proposed
new test methods and test equipment are consistent with the testing
required in part 1263, incorporating ANSI/UL 4200A-23, which utilizes
similar methods and equipment. For example, currently 142 third party
laboratories are CPSC-accepted to test to part 1250's requirements for
battery-operated toys, and 35 labs are CPSC-accepted to test to part
1263. Accordingly, CPSC expects that these laboratories are competent
to conduct the required testing and can have their ISO accreditation
and CPSC-acceptance updated in the normal course. The Commission
invites comments, particularly from small businesses, regarding the
proposed testing and the amount of time needed to come into compliance
with a final rule.
VIII. Regulatory Flexibility Act (RFA)
The RFA requires agencies to review each proposed rule's potential
economic impact on small entities, including small businesses. Section
603 of the RFA generally requires that agencies prepare an initial
regulatory flexibility analysis (IRFA) and make the analysis available
to the public for comment when the agency publishes an NPR, unless the
rule would not have a significant economic impact on a substantial
number of small entities. 5 U.S.C. 603, 605(b).
If the proposed rule is finalized, CPSC staff does not expect a
significant impact to a substantial number of small businesses. Small
manufacturers may incur a one-time redesign cost and ongoing component
costs (i.e., screws and threads) to comply with the rule for product
lines that currently do not meet the proposed requirements. However,
CPSC does not expect small firms to incur a cost that exceeds 1 percent
of the annual revenue of the firm (nor 1 percent of the retail price of
the product). Therefore, the Commission certifies that the rule will
not, if promulgated, have a significant economic impact on a
substantial number of small entities.
A. Reason for Agency Action, NPR Objectives, Product Description, and
Market Description
Section I of this preamble explains why CPSC proposes to establish
mandatory requirements for toys containing button cell or coin cell
batteries to prevent access to battery compartments by children aged 6
years old and younger and provides a statement of the objectives of,
and legal basis for, the proposed rule. Section II of this preamble
describes the types of products within the scope of the NPR, the market
for button cell and coin cell batteries in toys, and the use of such
batteries in toys in the U.S. The requirements in the NPR are more
stringent than ASTM F963-23, which was incorporated into the mandatory
rule 16 CFR part 1250, as described in sections IV and V of this
preamble. The NPR addresses the known ingestion hazard, discussed in
section III of this preamble, that the current rule does not adequately
address.
B. Small Entities to Which the Rule Would Apply
Section II of this preamble describes the products within the scope
of the rulemaking and provides an overview of the market for toys
containing button cell or coin cell batteries. This section of the
preamble provides additional details on the market for products within
the scope of the rulemaking.
The North American Industry Classification System (NAICS) \56\
defines product codes for U.S. firms. Firms that manufacture button
cell or coin cell battery-powered children's toys may list their
businesses under various NAICS product codes, as these toys include a
variety of children's products, such as dolls and musical instruments.
Most of these firms likely fall under NAICS code 339930 Doll, Toy, and
Game Manufacturing, but some may also fall under code 339992 Musical
Instrument
[[Page 65808]]
Manufacturing or 339999, All Other Miscellaneous Manufacturing.
Importers of battery-operated toys containing button cell or coin cell
batteries also fall under multiple NAICS codes, with a majority of the
firms following under NAICS codes as wholesalers: 423920 Toy and Hobby
Goods and Supplies Merchant Wholesalers, 423910 Sporting and
Recreational Goods and Supplies Merchant Wholesalers, and 423990 Other
Miscellaneous Durable Goods Merchant Wholesalers.
---------------------------------------------------------------------------
\56\ The NAICS is the standard used by Federal statistical
agencies in classifying business establishments for the purpose of
collecting, analyzing, and publishing statistical data related to
the U.S. business economy. For more information, see https://www.census.gov/naics/. Some programs use 6-digit NAICS codes, which
provide more specific information than programs that use more
general 3- or 4-digit NAICS codes.
---------------------------------------------------------------------------
Retailers of toys containing button cell or coin cell batteries
similarly include a variety of retailer types, from large ``big box''
retailers to smaller specialized product firms. CPSC staff estimates
that a majority of these products fall under NAICS codes 459120 Hobby,
Toy, and Game Stores, 451110 Sporting Goods Stores, 459140 Musical
Instrument and Supplies Stores, 455110 Department Stores, and 455211
Warehouse Clubs and Supercenters. Some of these products may also be
sold in stores coded as 445110 Grocery Stores, 445121 Convenience
Stores, and 443142 Electronic Stores, among other outlets; however,
CPSC expects the number of such toys sold at these stores to be
negligible.
Under U.S. Small Business Administration (SBA) guidelines, a
manufacturer, importer, and retailer of toys containing button cell or
coin cell batteries is categorized as ``small'' based on the SBA's size
thresholds associated with each NAICS code. SBA uses the number of
employees to determine whether a manufacturer or importer is a small
entity, while SBA uses annual revenues to consider a retailer. Based on
the U.S. Census Bureau's 2021 and 2017 Statistics of U.S. Businesses
(SUSB) data, CPSC staff estimated the number of firms classified as
small for the most relevant NAICS codes. Tables 4 and 5 provide the
estimated number of small firms by each NAICS code.\57\ Staff estimates
a total of 18,968 small manufacturers and importers, and 28,619 small
retailers.
---------------------------------------------------------------------------
\57\ Some discrepancies exist between the published SBA size
standard NAICS code and the SUSB code. Staff used the code
description to match the size standard to the correct value.
Retailer size determination is made using 2017 SUSB data by applying
the ratio of firms that meet the standard to the 2021 data values.
Table 4--Estimated Number of Small Manufacturers and Importers
----------------------------------------------------------------------------------------------------------------
SBA size standard for Number of firms that meet
NAICS code Description firms (No. of size standard (based on
employees) SUSB data)
----------------------------------------------------------------------------------------------------------------
339930.................... Doll, Toy, and Game 700 485
Manufacturing.
339992.................... Musical Instrument 1000 587
Manufacturing.
339999.................... All Other Miscellaneous 550 2,951
Manufacturing.
423920.................... Toy and Hobby Goods and 175 1,846
Supplies Merchant Wholesalers.
423910.................... Sporting and Recreational 100 4,432
Goods and Supplies Merchant
Wholesalers.
423990.................... Other Miscellaneous Durable 100 8,567
Goods Merchant Wholesalers.
----------------------------------------------------------------------------------------------------------------
Table 5--Estimated Number of Small Retailers
----------------------------------------------------------------------------------------------------------------
SBA size standard for Number of firms that meet
NAICS code Description firms (annual revenue) size standard (based on
millions $ SUSB data)
----------------------------------------------------------------------------------------------------------------
452210.................... Department Stores............. $40.0 15
452310.................... General Merchandise Stores, 47.0 8,006
Including Warehouse Clubs and
Supercenters.
451110.................... Sporting Goods Retailers...... 26.5 13,751
451120.................... Hobby, Toy, and Game Stores... 35.0 4,660
451140.................... Musical Instrument and 22.5 2,187
Supplies Stores.
----------------------------------------------------------------------------------------------------------------
C. Compliance Requirements of the NPR, Including Reporting and
Recordkeeping Requirements
The NPR would improve the performance and labeling requirements
applicable to toys containing button cell or coin cell batteries. Under
section 14 of the CPSA, manufacturers, importers, and private labelers
of toys containing button cell or coin cell batteries would be required
to certify, based on testing by an ISO-accredited, CPSC-accepted third
party conformity assessment body, that their toy complies with the
requirements of the proposed rule. Each certificate of compliance must
identify the third-party conformity assessment body on whose testing
the certificate depends. The certificate must be legible and in English
and include the date and place of manufacture, the date and place where
the product was tested, including the full mailing address and
telephone number for each party, and the contact information for the
person responsible for maintaining records of the test results. The
certificates may be in electronic format and must be provided to each
distributor or retailer of the product. Upon request, the certificates
must be provided to CPSC and/or U.S. Customs and Border Protection. 15
U.S.C. 2063(a) and (g); 16 CFR part 1110.
D. Costs of NPR That Would Be Incurred by Small Manufacturers
Toys containing button cell or coin cell batteries may require
minor redesign to comply with the proposed rule. CPSC anticipates one
likely method of redesign is to replace plastic screw thread inserts
with metal inserts to strengthen fastener attachment and prevent easy
stripping of screws. The potential costs of this modification are the
incremental cost to incorporate the screw thread insert and make that
material change, and the one-time design changes to battery
compartments.\58\
---------------------------------------------------------------------------
\58\ Re-tooling costs are not expected from the changes in the
draft proposed rule.
---------------------------------------------------------------------------
[[Page 65809]]
CPSC estimates that the incremental costs to modify the screw
thread are negligible (less than $0.01) per product. CPSC estimates a
range of one to two weeks of labor for an electrical engineer to
redesign a toy battery compartment. Data from the Bureau of Labor
Statistics (BLS) indicates that the average full hourly compensation
rate of an electrical engineer, which includes wages \59\ and
benefits,\60\ in the U.S. is $84.87.\61\ Because battery compartment
designs are very similar across product models and firms, CPSC assesses
that firms would be able to incorporate the updated battery compartment
designs across all children's products lines that the manufacturer
offers without additional effort required for each product line.
Considering this equates to a range of possible design costs of $3,395
to $6,791 per firm.\62\
---------------------------------------------------------------------------
\59\ The mean hourly wage of an electrical engineer is $56.58
per hour as of May 2023 according to BLS, available at: https://www.bls.gov/oes/current/oes172071.htm.
\60\ The ratio of full compensation to wages for someone in
Professional and related occupations in the Manufacturing industry
is 1.50 ($68.94 compensation per hour / $46.02 wage per hour) as of
March 2024. See table 4 at: https://www.bls.gov/news.release/ecec.t04.htm.
\61\ $84.87 per hour = $56.58 wage per hour x 1.50 compensation
factor.
\62\ Calculated as work hours in a week times compensation rate.
(40 x $84.87 = $3,394.80 and 80 x $84.87 = $6,789.60).
---------------------------------------------------------------------------
Some additional costs might be incurred related to updating and/or
adding labels. Generally, the costs associated with modifying or adding
warning labels are low on a per unit basis and all manufacturers of
children's products are already required to provide warning labels with
their product. Therefore, CPSC expects the incremental cost related to
the labeling provision to be negligible.
Manufacturers would likely incur additional costs to certify that
their toys containing button cell or coin cell batteries meet the rule,
if finalized, as required by section 14 of the CPSA, 15 U.S.C. 2063.
Certification of children's products must be completed by a CPSC-
accepted, third party conformity assessment body (i.e., third party
laboratory). Based on quotes from testing laboratories for ASTM F963
mechanical services, the cost of the certification testing will range
from $130 to $250 per product sample. Because toys containing button
cell or coin cell batteries are already tested to part 1250, CPSC does
not expect the additional testing proposed in this rule to materially
increase the cost of third-party testing.
E. Impact on Small Manufacturers
If the rule is finalized, small manufacturers would incur a one-
time redesign cost and continuous component costs (i.e., screws and
threads) to comply with the rule for product lines that currently do
not meet the proposed requirements. Retail prices for toys containing
button cell or coin cell batteries vary greatly, with the least
expensive toys costing approximately $3. CPSC does not expect small
firms to incur a cost that exceeds 1 percent of the annual revenue of
the firm (nor 1 percent of the retail price of the product).
Generally, CPSC considers an impact to be potentially significant
if it exceeds 1 percent of a firm's revenue. CPSC does not expect a
potentially significant impact on small firms that manufacture toys
containing button cell or coin cell batteries. CPSC does not expect
that small businesses will incur costs that exceed 1 percent of their
annual revenue. The high end of CPSC's cost estimate range is $6,791.
Any firm with annual revenues less than $678,100 could potentially
incur a significant impact, however, CPSC is unaware of any firms with
revenues of this amount that have costs at the highest end of the cost
estimate range. The Commission seeks comments from firms stating their
annual revenue and estimated redesign and continuous component costs.
F. Alternatives for Reducing the Adverse Impact on Small Entities
CPSC considered three alternatives to the NPR that could reduce the
impact on small entities: (1) not taking any action regarding toys
containing button cell or coin cell batteries, (2) establishing an
information and education campaign for these batteries, and (3)
providing a later effective date. In addition, although the statute
allows CPSC to provide ``small batch'' exemptions to testing
requirements or alternative requirements for small providers of certain
products, allowing no testing or alternate testing would undermine the
Commission's effort to require battery accessibility testing in ASTM
F963-23 the same as for non-toy consumer products. 15 U.S.C.
2063(d)(4).
1. No Action Alternative
Under this alternative the status quo would be maintained, and no
firm would incur a rule-based cost. While not promulgating a mandatory
standard for toys containing button cell or coin cell batteries would
have no impact on U.S. small businesses, it would also allow hazardous
products to remain on the market and ignore a known ingestion hazard to
children. Further, impact on small U.S. businesses if the Commission
took no action would be limited because of the low cost for small
businesses to comply with the rule.
Taking no action to address the risk of button cell or coin cell
battery child ingestion by making the requirements for securing toy
battery compartments more stringent, to ensure that they provide the
highest level of safety feasible, would be inconsistent with the
Commission's statutory mandate described in section I of this preamble.
15 U.S.C. 2056b(c) and (d). After preliminarily determining that the
existing requirements in ASTM F-963 are inadequate to address the risk
of potential ingestion, the Commission is moving forward with this
rulemaking to comply with the statutory mandate and to prioritize the
safety of children by mitigating potential child ingestions of button
cell or coin cell batteries obtained from toys.
2. Information and Education Campaign
The Commission could create an information and education campaign
to better alert parents and caregivers regarding the risks associated
with children ingesting button cell or coin cell batteries. This would
require consumer outreach efforts like advertising and marketing
related to the hazards. This alternative could be implemented
independent of any regulatory action. Although information campaigns
may be helpful, standing alone they are inadequate to address the
ingestion hazard associated with these batteries.
3. Later Effective Date
To reduce burden on small businesses, the Commission considered an
effective date later than 180 days after Federal Register publication,
to spread the cost of compliance over a longer period. Although many
toys may already comply with the proposed requirements, some toys would
need to be redesigned, and all toys containing button cell or coin cell
batteries would require third-party testing to the new requirements. In
this case, as described above, 180 days is reasonable for firms to
comply with the rule, the cost of compliance is low, and many labs are
already CPSC-accepted to conduct the same or similar testing. Providing
a 180-day effective date is consistent with section 106(g) of the
statute and addressing this known health hazard associated with
children's toys.
[[Page 65810]]
IX. Environmental Consideration
The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, certain categories of CPSC actions
normally have ``little or no potential for affecting the human
environment,'' and therefore do not require an environmental assessment
or an environmental impact statement. Safety standards providing
performance and labeling requirements for consumer products come under
this categorical exclusion. 16 CFR 1021.5(c)(1). The NPR falls within
the categorical exclusion.
X. Paperwork Reduction Act (PRA)
This NPR for toys containing button cell or coin cell batteries
contains information collection requirements that are subject to public
comment and review by the Office of Information and Regulatory Affairs
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Toys are children's products. Accordingly, CPSC proposes to update the
PRA estimate for toys containing button cell or coin cell batteries
into a new control number, and then include this updated estimate in
the Children's Product OMB Control Number in the next update. In this
document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth:
A title for the collection of information;
A summary of the collection of information;
A brief description of the need for the information and
the proposed use of the information;
A description of the likely respondents and proposed
frequency of response to the collection of information;
An estimate of the burden that shall result from the
collection of information; and
Notice that comments may be submitted to the OMB.
Title: Safety Standard for Toys: Requirements for Toys Containing
Button Cell or Coin Cell Batteries.
Description: As described in section V of this preamble, the
proposed rule would require each toy containing a button cell or coin
cell battery to comply with the performance and labeling requirements
in 16 CFR 1250.3. CPSC will seek a new OMB control number for this
update. Sections 5, 6, and 7 of ASTM F963-23 contain requirements for
marking, labeling, and instructional literature. These requirements
fall within the definition of ``collection of information,'' as defined
in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import toys
containing one or more button cell or coin cell batteries, as defined
in proposed Sec. 1250.3(b).
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 6--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total
Burden type Number of Frequency of annual Hours per Total burden
respondents response responses response hours
----------------------------------------------------------------------------------------------------------------
Labeling and instructions........ 18,868 2 37,736 2 75,472
----------------------------------------------------------------------------------------------------------------
This estimate is based on the following: CPSC estimates that 18,868
respondents would provide labeling and instructional literature
annually, based on the number of identified small firms that
manufacture or import toys containing cell or coin cell batteries. We
exclude retailers from our estimate because we assume that labeling and
instructional literature would be provided by manufacturers and
importers, but not retailers. While the number of responses per
respondent would vary, we estimate that on average, each respondent
will respond twice annually for products that are updated and brought
to market, for a total of 37,736 annual responses (18,868 respondents x
2 responses per year).
CPSC assumes that on average it will take 1 hour for each
respondent to create the required label and one hour for them to create
the required instructions, for an average response burden of 2 hours
per response. Therefore, the total burden hours for the collection are
estimated to be 75,472 hours annually (37,736 responses x 2 hours per
response = 75,472 total burden hours).
We estimate the hourly compensation for the time required to create
and update labeling and instructions is $41.55 (U.S. Bureau of Labor
Statistics, ``Employer Costs for Employee Compensation,'' December
2023, table 4, total compensation for all sales and office workers in
goods-producing private industries: https://www.bls.gov/news.release/archives/ecec_03132024.pdf). Therefore, the estimated annual cost of
the burden requirements is $3,135,862 ($41.55 per hour x 75,472 hours =
$3,135,861.60). No operating, maintenance, or capital costs are
associated with the collection. Based on this analysis, the proposed
revisions to the standard would impose a burden to industry of 75,472
hours at a cost of $3,135,862 annually.
In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted
the information collection requirements of this rulemaking to the OMB
for review. Interested persons are requested to submit comments
regarding information collection by October 15, 2024, to the OMB (see
the ADDRESSES section at the beginning of this document). Pursuant to
44 U.S.C. 3506(c)(2)(A), we invite comments on:
Whether the collection of information is necessary for the
proper performance of CPSC's functions, including whether the
information will have practical utility;
The accuracy of CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
Ways to enhance the quality, utility, and clarity of the
information to be collected;
Ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques,
when appropriate, and other forms of information technology; and
The estimated burden hours associated with the update and
modification of labels and instructions, including any alternative
estimates.
XI. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a
consumer product safety standard is in effect and applies to a product,
no State or political subdivision of a State may either establish or
continue in effect a standard or regulation that prescribes
requirements for the performance, composition, contents, design,
finish, construction, packaging, or labeling of such product dealing
with the same risk of injury unless the State requirement is identical
to the Federal standard. Section 106(f) of the CPSIA deems rules
[[Page 65811]]
issued under that provision ``consumer product safety standards.''
Therefore, once a rule issued under section 106 of the CPSIA takes
effect, it will preempt in accordance with section 26(a) of the CPSA.
XII. Certification and Notice of Requirements
Section 14(a) of the CPSA imposes the requirement that products
subject to a consumer product safety rule under the CPSA, or to a
similar rule, ban, standard, or regulation under any other act enforced
by the Commission, must be certified as complying with all applicable
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the
CPSA requires that certification of children's products subject to a
children's product safety rule be based on testing conducted by a CPSC-
accepted third party conformity assessment body. Section 14(a)(3) of
the CPSA requires the Commission to publish an NOR for the
accreditation of third-party conformity assessment bodies (or
laboratories) to assess conformity with a children's product safety
rule to which a children's product is subject. The proposed rule for 16
CFR 1250.3, Requirements for Toys Containing Button Cell or Coin Cell
Batteries, if issued as a final rule, would be a children's product
safety rule that requires the issuance of an NOR.
Title 16, part 1112 of the CFR establishes requirements for
accreditation of third-party conformity assessment bodies to test for
conformity with a children's product safety rule in accordance with
section 14(a)(2) of the CPSA. Part 1112 also codifies all of the NORs
issued previously by the Commission. To meet the requirement that the
Commission issue an NOR for the proposed standard, the Commission
proposes as part of the NPR to add Sec. 1250.3, Requirements for Toys
Containing Button Cell or Coin Cell Batteries, to the list of
children's product safety rules for which CPSC has issued an NOR.
Testing laboratories applying for acceptance as a CPSC-accepted
third party conformity assessment body to test to the new standard for
button cell and coin cell batteries in toys would be required to meet
the third-party conformity assessment body accreditation requirements
in part 1112. When a laboratory meets the requirements as a CPSC-
accepted third party conformity assessment body, the laboratory can
apply to CPSC to have 16 CFR 1250.3, Requirements for Toys Containing
Button Cell or Coin Cell Batteries, included within the laboratory's
scope of accreditation listed for the laboratory on the CPSC website
at: https://www.cpsc.gov/cgi-bin/labsearch/.
XIII. Request for Comments
The Commission requests comments on all aspects of this NPR,
including the effective date. Submit comments in accordance with the
instructions in the ADDRESSES section at the beginning of this
document.
CPSC specifically requests comment on the following topics:
A. Proposed Performance Requirements for Toys Containing Button Cell or
Coin Cell Batteries
1. Do the proposed performance requirements align with the
requirements in part 1263? If not, what requirements should the
Commission add or remove to align the two standards?
2. Are the proposed performance requirements adequate to address
the risk of ingestion and insertion from children accessing button cell
or coin batteries from toys? Please provide details of any additional
requirements proposed.
3. Are there any toys weighing over 10 lbs. and up to 39.7 lbs.,
that would not be considered large and bulky (as defined in ASTM F963-
23), and should a separate drop test for such toys be included?
B. Proposed Warning Label Requirements for Toys Containing Button Cell
or Coin Cell Batteries
1. Are the proposed warnings adequate to address the hazards
associated with toys containing button cell or coin cell batteries?
2. Should CPSC consider additional warnings on toy packaging, on
toys, or on instructional literature accompanying toys?
3. Should CPSC consider other warning formats?
C. Regulatory Flexibility Analysis
1. Significant impact. Is CPSC's estimated cost of redesign to
achieve compliance appropriate? If not, please provide additional
information and support for your proposed correction. Also, do the
estimated costs represent more than one percent of annual revenue for
individual small U.S. manufacturers and importers?
2. Testing costs. Will third party testing costs for toys
containing button cell or coin cell batteries increase as a result of
the requirements in this NPR, and if so, by how much?
3. Effective date of 180 days after Federal Register publication.
How much time is required to come into compliance with a final rule
(including product compliance and third-party testing)? Please provide
supporting data with your comment supporting a 180-day period or other
effective date, particularly for small businesses.
4. Alternatives to reduce the impact on small businesses. Are there
any alternatives to the rule not discussed in this NPR that could
reduce the impact on small businesses without reducing safety? Please
provide supporting data with your comment, particularly addressing
small businesses.
D. Feasibility
1. Are the proposed requirements in this NPR feasible, both
technically and economically?
2. What would be the total cost to industry of implementing this
rule? Please be specific about labor and/or materials costs to redesign
products, and costs of third-party testing.
3. Will complying with this rule increase the costs of production
or the retail price of toys containing button cell or coin cell
batteries? Why? By how much?
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1250
Consumer protection, Incorporation by reference, Infants and
children, Labeling, Law enforcement, Toys.
For the reasons discussed in the preamble, the Commission proposes
to amend 16 CFR parts 1112 and 1250 as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(32)(ii)(LL) to read as
follows:
Sec. 1112.15 When can a third-party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(b) * * *
(32) * * *.
(ii) * * *
[[Page 65812]]
(LL) 16 CFR 1250.3, Requirements for Toys Containing Button Cell or
Coin Cell Batteries.
* * * * *
PART 1250--SAFETY STANDARD FOR TOYS
0
4. The authority citation for part 1250 continues to read as follows:
Authority: 15 U.S.C. 2056b.
0
5. Revise the heading to part 1250 to read as set forth above.
0
6. Revise Sec. 1250.1 to read as follows:
Sec. 1250.1 Scope.
This part establishes a consumer product safety standard for toys.
0
7. Add Sec. 1250.3 to read as follows:
Sec. 1250.3 Requirements for toys containing button cell or coin cell
batteries.
(a) Scope and purpose. This section establishes additional
performance and labeling requirements for toys containing button cell
or coin cell batteries to prevent child access to such batteries during
reasonably foreseeable use and abuse of battery-operated toys. This
section is intended to eliminate or adequately reduce the risk of
injury or death to children 6 years old and younger from ingesting
button cell or coin cell batteries accessed from toy battery
compartments.
(b) Definitions. In addition to the definitions incorporated by
reference in Sec. 1250.2(a), the following definitions apply for
purposes of this section:
Product display panel means the surface area on, near, or in the
battery component of the toy using or containing button or coin cell
batteries that is visible while replacing the batteries.
Secondary display panel means the side opposite or next to the
principal display panel of the retail package of a toy using or
containing button or coin cell batteries.
Toy(s) containing button cell or coin cell battery(ies) means a toy
or toys containing or designed to use one or more button cell or coin
cell batteries, regardless of whether such batteries are intended to be
replaced by the consumer or are included with the product or sold
separately.
(c) Performance and labeling requirements. Each toy containing
button cell or coin cell batteries must comply with applicable
provisions of the version of ASTM F963 incorporated by reference in
Sec. 1250.2(a), with the following additions and exclusions to that
ASTM standard:
(1) Add the following sentence to the end of section 4.25.4.3:
``Confirm compliance after testing by opening the battery door or cover
and applying a force of at least 4.5 lbf (20 N) to the fastener evenly
within 5 s and maintained for an additional duration of 10 s in any
direction likely to remove the fastener.''
(2) Add the following paragraphs to section 4.25.4:
(i) 4.25.4.5 For all toys with battery compartments using
replaceable button cell or coin cell batteries secured by a screw or
similar fastener, a minimum of two full rotations of the screw or
fastener shall be required to open or remove the battery compartment,
door, or cover.
(ii) 4.25.4.6 For all toys with battery compartments using
replaceable button cell batteries or coin cell batteries secured by a
rotating or twist-on access cover, a minimum torque of 4.4 in-lbf (0.5
Nm) shall be required to unlock the cover, and a minimum angle of 90
degrees of rotation shall be required to remove the cover.
(iii) 4.25.4.7 All toys containing button cell or coin cell
batteries shall be tested in accordance with section 8.31.
(3) Instead of complying with section 5.14.2, comply with the
following:
(i) 5.14.2 Button Cell or Coin Cell Batteries.
(ii) 5.14.2.1 For each toy containing button cell or coin cell
batteries, each toy, toy packaging, and toy instructions shall meet the
requirements in 16 CFR 1263.3, Packaging Markings, Product Markings,
and General Instructions.
(4) Add the following paragraphs as section 8.31.
(i) 8.31 Button Cell or Coin Cell Battery Use and Abuse Testing--
All testing in this section shall be performed in series on each unique
toy or toy component containing button cell or coin cell batteries.
Manufacturer recommended batteries shall be in place during the testing
unless otherwise specified. No button cell or coin cell batteries shall
become accessible without the use of a tool as a result of testing.
(ii) 8.31.1 Stress Relief Test--Subject all toys with a battery
compartment that utilizes molded or formed thermoplastic materials to
this test. The sample shall consist of either the entire toy or toy
component, or for large and bulky toys or toy components, at least the
complete battery compartment enclosure together with any supporting
framework. Batteries may be removed during this test.
(A) Place the sample in a circulating air oven for a period of 7
hours. Set the oven temperature to the higher of:
(1) 70 [deg]C; or
(2) 10 [deg]C higher than the maximum temperature of thermoplastic
enclosures, battery compartment door/covers, or battery compartment
door/cover mechanisms, during the most stringent normal operation of
the sample.
(B) After removal from the oven, permit the sample to cool to room
temperature.
(iii) 8.31.2 Battery Replacement Test--Subject all toys or toy
components containing replaceable button cell or coin cell batteries to
this test.
(A) The battery compartment door/cover shall be opened, the battery
removed and replaced, and the battery compartment door/cover shall be
closed, for a total of ten cycles. The test procedure shall simulate
battery replacement according to the manufacturer's instructions.
(B) If the battery compartment is secured with a screw(s), loosen
and then tighten the screw(s) by means of a suitable screwdriver,
applying a continuous linear torque according to table 1.
Table 1 to Paragraph (c)(4)(iii)(B)--Torque To Be Applied to Screws \1\
------------------------------------------------------------------------
Torque Nm
Nominal diameter of screw mm --------------------------------------
I II III
------------------------------------------------------------------------
Up to and including 2.8.......... 0.2 0.4 0.4
Over 2.8 up to and including 3.0. 0.25 0.5 0.5
Over 3.0 up to and including 3.2. 0.3 0.6 0.6
Over 3.2 up to and including 3.6. 0.4 0.8 0.6
Over 3.6 up to and including 4.1. 0.7 1.2 0.6
Over 4.1 up to and including 4.7. 0.8 1.8 0.9
Over 4.7 up to and including 5.3. 0.8 2.0 1.0
[[Page 65813]]
Over 5.3 up to and including 6.0. ........... 2.5 1.25
------------------------------------------------------------------------
I--For metal screws without heads, if the screw, when tightened, does
not protrude from the hole.
II--For other metal screws and for nuts.
II--For screws of insulating material:
Having a hexagonal head with the dimension across flats
exceeding the overall thread diameter, or
With a cylindrical head and a socket for a key, the socket
having a dimension across flats not less than 0.83 times the overall
thread diameter, or
With a head having a slot or cross slots, the length of which
exceeds 1.5 times the overall thread diameter.
III--For other screws of insulating material.
\1\ Reproduced, with permission, from IEC 60065 ed.8.0 Copyright
(copyright) 2014 IEC Geneva, Switzerland. www.iec.ch.
(iv) 8.31.3 Drop Test.
--(A) Except for large and bulky toys, toys intended for children
aged 0 to 18 months that weigh less than 10.01 lbs. (4.5 kg) shall be
dropped at least 4.5 ft (137 cm) onto the test surface specified in
section 8.7.1 in positions likely to produce maximum force on the
battery enclosure or compartment.
(B) Toys intended for children aged over 18 months that weigh less
than 10.01 lbs. (4.5 kg) shall be dropped 10 times from a height of at
least 3.0 ft (91 cm) onto the test surface specified in section 8.7.1
in positions likely to produce maximum force on the battery enclosure
or compartment.
(C) Regardless of the intended child age, all toys that weigh at
least 10.01 lbs. (4.5 kg) up to 39.7 lbs. (18 kg), shall be dropped
three times from a height of at least 3.0 ft (91 cm) onto the test
surface specified in section 8.7.1 in the positions likely to produce
maximum force on the battery enclosure or compartment.
(v) 8.31.3.1 Tipover Test--Large and bulky toys shall not be
subject to the drop test in section 8.31.3, instead subject such toys
to the Tipover Test for Large, Bulky Toys in accordance with the
procedure in section 8.7.2.1.
(vi) 8.31.4 Impact Test.
(A) Subject the battery enclosure or compartment door/cover to
three, 1.5-ft[middot]lbf (2-J) impacts. Produce the impact by dropping
a steel sphere, 2.00 in (50.8 mm) in diameter, and weighing
approximately 1.1 lbs. (0.5 kg), from the height required to produce
the specified impact, as shown in figure 50, or the steel sphere is to
be suspended by a cord and swung as a pendulum, dropping through the
vertical distance required to cause it to strike the surface with the
specified impact as shown in figure 51. The steel sphere is to strike
the battery enclosure or compartment door/cover perpendicular to the
enclosure surface.
(B) Add figure 50 to section 8.31.4:
Figure 50. Example Impact Test With a Dropped Steel Sphere
[GRAPHIC] [TIFF OMITTED] TP13AU24.035
(C) Add figure 51 to section 8.31.4:
Figure 51. Example Impact Test With a Swinging Steel Sphere
[[Page 65814]]
[GRAPHIC] [TIFF OMITTED] TP13AU24.036
(vii) 8.31.5 Crush Test--Support the sample by a fixed rigid
supporting surface in positions likely to produce the most adverse
results, so long as the position can be self-supported. Apply a
crushing force of 74.2 lbf 1.1 lbf (330 N 5
N) for a period of 10 s to the exposed surfaces. Apply the force using
a flat surface measuring approximately 3.9 in by 9.8 in (100 mm by 250
mm).
(viii) 8.31.67 Torque Test--If a child can grasp any part of the
battery compartment enclosure on a toy or toy component, including the
door or cover, with at least the thumb and forefinger, or using teeth,
apply the Torque Test for Removal of Components in section 8.8 to the
battery compartment enclosure, using a torque of at least 4.4 in-lbf
(0.50 Nm).
(ix) 8.31.7 Tension Test--If a child can grasp any part of the
battery compartment enclosure on a toy or toy component, including the
door or cover, with at least the thumb and forefinger, or using teeth,
apply the Tension Test for Removal of Components from section 8.9 to
the battery compartment enclosure, using a force of at least 16.2 lbf
(72.0 N).
(x) 8.31.8 Compression Test--If any surface of the battery
compartment enclosure is accessible to a child and inaccessible to a
flat surface contact during the Drop Test in section 8.7.1, apply the
Compression Test from section 8.10 to the surface of the battery
compartment enclosure, using a force of at least 30.5 lbf (135.7 N).
(xi) 8.31.9 Compliance.
(A) Apply a force of 11.2 lbf + 2.2/-0 lbf (50 + 10/-0 N) for 10 s
to the battery compartment door/cover or enclosure with a rigid test
finger probe, Test Probe 11 of IEC 61032, Standard for Protection of
Persons and Equipment by Enclosures--Probes for Verification (figure
52). Apply the probe at the most unfavorable place and in the most
unfavorable direction. Apply force in only one direction.
(B) To pass, the battery compartment door/cover shall not open and
shall remain functional, and the battery shall not be touched by the
probe or made accessible.
(C) Add figure 52 to section 8.31.9.
Figure 52--Test Probe 11 1
[GRAPHIC] [TIFF OMITTED] TP13AU24.037
[[Page 65815]]
(D) Add figure 53 to section 8.31.9.
Figure 53--Test Probe B 1
[GRAPHIC] [TIFF OMITTED] TP13AU24.038
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-17472 Filed 8-12-24; 8:45 am]
BILLING CODE 6355-01-P
