Home/Federal/Federal Register/2023-02356

Proposed Rule2023-02356

Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

February 9, 2023

Issuing agencies

Consumer Product Safety Commission

Abstract

As required by Reese's Law, to eliminate or adequately reduce the risk of injury from ingestion of button cell or coin batteries by children 6 years old and younger, the U.S. Consumer Product Safety Commission (CPSC or Commission) proposes a rule to establish performance requirements for battery compartments on consumer products that contain, or are designed to use, one or more button cell or coin batteries. The proposed rule also requires warning labels on the packaging of button cell or coin batteries, as well as on the packaging, battery compartments, and accompanying instructions and manuals of consumer products containing button cell or coin batteries. In addition to implementing Reese's Law, the proposed rule requires manufacturers and importers of button cell or coin batteries, and consumer products containing such batteries, to notify consumers of performance and technical data related to the safety of such batteries at the point of sale, both online and in stores. If the rule is finalized, consumer products subject to the rule must be tested and certified as compliant with the rule.

Full Text

<html>
<head>
<title>Federal Register, Volume 88 Issue 27 (Thursday, February 9, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Proposed Rules]
[Pages 8692-8727]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02356]

[[Page 8691]]

Vol. 88

Thursday,

No. 27

February 9, 2023

Part V

Consumer Product Safety Commission

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

16 CFR Parts 1112 and 1263

Safety Standard and Notification Requirements for Button Cell or Coin
Batteries and Consumer Products Containing Such Batteries; Proposed
Rule

Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 /
Proposed Rules

[[Page 8692]]

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

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1263

[CPSC Docket No. 2023-0004]

Safety Standard and Notification Requirements for Button Cell or
Coin Batteries and Consumer Products Containing Such Batteries

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking (NPR).

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

SUMMARY: As required by Reese's Law, to eliminate or adequately reduce
the risk of injury from ingestion of button cell or coin batteries by
children 6 years old and younger, the U.S. Consumer Product Safety
Commission (CPSC or Commission) proposes a rule to establish
performance requirements for battery compartments on consumer products
that contain, or are designed to use, one or more button cell or coin
batteries. The proposed rule also requires warning labels on the
packaging of button cell or coin batteries, as well as on the
packaging, battery compartments, and accompanying instructions and
manuals of consumer products containing button cell or coin batteries.
In addition to implementing Reese's Law, the proposed rule requires
manufacturers and importers of button cell or coin batteries, and
consumer products containing such batteries, to notify consumers of
performance and technical data related to the safety of such batteries
at the point of sale, both online and in stores. If the rule is
finalized, consumer products subject to the rule must be tested and
certified as compliant with the rule.

DATES: Submit comments by March 13, 2023.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the testing and certification, and the marking, labeling, and
instructional literature requirements of the proposed mandatory
standard, 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
<a href="/cdn-cgi/l/email-protection#4b2422392a14383e29262238382224250b242629652e243b652c243d">[email&#160;protected]</a>.
You may submit all other comments, identified by Docket No. CPSC-
2023-0004, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
instructions for submitting comments. CPSC typically does not accept
comments submitted by electronic mail (email), except as described
below. CPSC encourages you to submit electronic comments by using the
Federal eRulemaking Portal.
Mail/Hand Delivery/Courier/Confidential Written Submissions: 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: <a href="/cdn-cgi/l/email-protection#3c5f4c4f5f11534f7c5f4c4f5f125b534a">[email&#160;protected]</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>, and insert the
docket number, CPSC-2023-0004, into the ``Search'' box, and follow the
prompts.

FOR FURTHER INFORMATION CONTACT: Daniel Taxier, Project Manager,
Division of Mechanical and Combustion Engineering, Consumer Product
Safety Commission, 5 Research Place, Rockville, MD 20850; (301) 987-
2211, or by email to: <a href="/cdn-cgi/l/email-protection#f79383968f9e9285b794878494d9909881">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority \1\
---------------------------------------------------------------------------

\1\ On January 25, 2023, the Commission voted (4-0) to publish
this notice of proposed rulemaking. Chair Hoehn-Saric and
Commissioners Boyle and Trumka issued statements in connection with
their vote; statements are available at: <a href="https://www.cpsc.gov/s3fs-public/RCA-NPR-Safety-Standard-and-Notification-Requirements-for-Button-Cell-or-Coin-Batteries-and-Consumer-Products-Containing-Such-Batteries.pdf?VersionId=b9niiZNO11I3MDqWW4JRIkEcBY3Dxp3z">https://www.cpsc.gov/s3fs-public/RCA-NPR-Safety-Standard-and-Notification-Requirements-for-Button-Cell-or-Coin-Batteries-and-Consumer-Products-Containing-Such-Batteries.pdf?VersionId=b9niiZNO11I3MDqWW4JRIkEcBY3Dxp3z</a>.
---------------------------------------------------------------------------

A. Explanation of Reese's Law

President Biden signed Reese's Law, Public Law 117-171, into law on
August 16, 2022. 15 U.S.C. 2056e. The purpose of Reese's Law is to
protect children 6 years old and younger against hazards associated
with the ingestion of button cell or coin batteries. Based on a review
of the medical literature, CPSC incident data, and data from the
National Capital Poison Center (NCPC), an ingestion hazard is
associated with swallowing or inserting a button cell or coin battery
that becomes lodged (impacted) in the body (typically in the esophagus
but potentially in the airways or gastrointestinal tract), which can
cause death or serious injury through choking, generation of hazardous
chemicals, leaking of hazardous chemicals, electrical burns, pressure
necrosis (tissue damage), or other means. See Tab B of Staff's NPR
Briefing Package.\2\
---------------------------------------------------------------------------

\2\ The information in this proposed rule is based 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 NPR Briefing
Package), available at: <a href="https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl">https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl</a>.
---------------------------------------------------------------------------

Although this proposed rule is primarily intended to address
hazards associated with oral ingestion of button cell or coin batteries
by children 6 years old or younger, the performance and labeling
requirements in the proposed rule will likely also reduce insertion of
these batteries in the nose. The data on button cell or coin batteries
demonstrate that insertions of batteries into the nose can be aspirated
into the trachea and become an ingestion that lodges in the esophagus.
This scenario presents the same hazard as an oral ingestion of a button
cell or coin battery. Accordingly, the proposed labeling requirements
include warnings regarding ingestion and insertion.
To address ingestion of button cell or coin batteries, section 2(a)
of Reese's Law requires the Commission to publish a final consumer
product safety standard for button cell or coin batteries, and consumer
products containing button cell or coin batteries, not later than 1
year after the date of enactment, meaning by August 16, 2023. 15 U.S.C.
2056e(a). A ``button cell or coin battery'' is broadly defined in
section 5 of Reese's Law as ``(A) a single cell battery with a diameter
greater than the height of the battery; or (B) any other battery,
regardless of the technology used to produce an electrical charge, that
is determined by the Commission to pose an ingestion hazard.'' \3\
Thus, the

[[Page 8693]]

definition of an in-scope product does not depend on the battery
chemistry, but rather the shape of the battery (which contributes to
the ingestion-related risk) and, as stated in part (B), whether the
battery otherwise is associated with an ingestion hazard, which is
consistent with the stated purpose in section 2(a)(1) of Reese's Law.
15 U.S.C. 2056e(a)(1).
---------------------------------------------------------------------------

\3\ Definitions in section 5 of Reese's Law are codified in the
Notes to 15 U.S.C. 2056e.
---------------------------------------------------------------------------

This proposed rule focuses on addressing button cell and coin
batteries under part (A) of the definition because other batteries
where the diameter is less than the height, such as AAA cylindrical
batteries, do not pose the same type or degree of ingestion hazard as
button cell or coin batteries. Cylindrical batteries can pose a choking
hazard, and CPSC is aware that consumers have ingested cylindrical
batteries. However, the medical literature shows that injury or death
due to ingestion of a cylindrical battery is rare. See Staff's NPR
Briefing Package at Tab B, Section II.B. Consequently, the Commission
is not including cylindrical batteries in the proposed rule at this
time. If CPSC becomes aware of a serious ingestion hazard associated
with another battery type, section 2(g) of Reese's Law allows the
Commission to undertake additional rulemaking to address the hazard at
any time. 15 U.S.C. 2056e(g).
Reese's Law defines a ``consumer product containing button cell or
coin batteries'' as ``a consumer product 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.'' \4\ We preliminarily construe
this definition to include products that are not sold with a battery,
if they are designed to use a button cell or coin battery.
---------------------------------------------------------------------------

\4\ 15 U.S.C. 2056e Notes. The term ``consumer product'' has the
same meaning as that in section 3(a) of the Consumer Product Safety
Act (CPSA). 15 U.S.C. 2052(a).
---------------------------------------------------------------------------

Section 2 of Reese's Law requires the Commission to issue a rule
containing performance requirements for consumer products that contain
button cell or coin batteries, and labeling requirements. Any rule
issued under section 2(a) of Reese's Law will be considered a consumer
product safety rule promulgated under section 9 of the Consumer Product
Safety Act (CPSA). 15 U.S.C. 2056e(c); 15 U.S.C. 2058. CPSC's rule
under section 2 of Reese's Law must be issued in accordance with the
notice and comment provisions of the Administrative Procedure Act
(APA). 5 U.S.C. 553; 15 U.S.C. 2056e(a). Insofar as this proposed rule
is based on section 2 of Reese's Law, it sets forth provisions
implementing the statute's required performance and labeling
requirements--and ``only'' those requirements, as specified in section
2(a). The standard promulgated under section 2(a) of Reese's Law shall
apply to consumer products and battery packaging manufactured or
imported after the effective date of the standard. See 15 U.S.C. 2056e
Notes.
Section 2(a)(1) of Reese's Law mandates that the rule must include
performance requirements for button cell or coin battery compartments
on consumer products to secure them in a manner that eliminates or
adequately reduces the risk of injury from the ingestion of button cell
or coin batteries by children who are 6 years old or younger, during
reasonably foreseeable use or misuse of the product. 15 U.S.C.
2056e(a)(1).
Section 2(a)(2) of Reese's Law mandates warning label requirements
in a rule. Warnings are required:
<bullet> On the packaging of button cell or coin batteries (15
U.S.C. 2056e(a)(2)(A));
<bullet> On the packaging of consumer products containing button
cell or coin batteries (15 U.S.C. 2056e(a)(2)(A));
<bullet> In any literature, such as a user manual, that accompanies
a consumer product containing button cell or coin batteries (15 U.S.C.
2056e(a)(2)(B));
<bullet> As practicable, directly on a consumer product that
contains button cell or coin batteries in a manner visible to the
consumer upon installation or replacement of the button cell or coin
battery (15 U.S.C. 2056e(a)(2)(C)(i));
<bullet> As practicable, in the case of a product for which the
battery is not intended to be replaced or installed by the consumer, to
be included directly on the consumer product in a manner that is
visible to the consumer upon access to the battery compartment, except
that if it is impracticable to label the product, this information
shall be placed on the packaging or instructions (15 U.S.C.
2056e(a)(2)(C)(ii)).
Warning labels required by section 2(a) of Reese's Law must: (1)
clearly identify the hazard of ingestion; and (2) instruct consumers,
as practicable, to keep new and used batteries out of the reach of
children, to seek immediate medical attention if a battery is ingested,
and to follow any other consensus medical advice. 15 U.S.C. 2056e(b).
Section 4 of Reese's Law specifically exempts from the performance
and labeling requirements in section 2 of the law, any toy product \5\
that is in compliance with the battery accessibility and labeling
requirements in 16 CFR part 1250, Safety Standard Mandating ASTM F963
for Toys. 15 U.S.C. 2056e Notes. However, children's products that
contain button cell or coin batteries and that are not a ``toy
product,'' would be required to meet the performance and labeling
requirements in this proposed rule. An example of such products would
be children's apparel, such as shoes, that light up and use a button
cell or coin battery as a power source.
---------------------------------------------------------------------------

\5\ Consistent with 16 CFR part 1250, a ``toy product'' is
defined as ``any object designed, manufactured, or marketed as a
plaything for children under 14 years of age.'' Notes to 15 U.S.C.
2056e.
---------------------------------------------------------------------------

Section 2(d) of Reese's Law (15 U.S.C. 2056e(d)(1)) requires the
Commission to rely on the provisions in a voluntary standard if, before
promulgating a final rule, the Commission determines that: (A) a
voluntary standard exists that meets the requirements for a standard
promulgated under section 2(a) of Reese's Law with respect to any
consumer product, and (B) the voluntary standard is in effect at the
time of the determination by the Commission, or will be in effect not
later than the date that is 180 days after the date of the enactment of
Reese's Law (i.e., February 12, 2023). The Commission must publish in
the Federal Register, any determination regarding a voluntary standard
under this provision. 15 U.S.C. 2056e(d)(2).
As set forth in section IV.A and V.A of this preamble, the
Commission preliminarily determines that no existing voluntary standard
fully meets the requirements in section 2(a) of Reese's Law.
Accordingly, the Commission is proposing a rule that would meet the
requirements of Reese's Law for all consumer products within the scope
of the rule that is based on modifications to several existing
voluntary standards. Because the Commission is proposing its own rule
under Reese's Law, the procedural requirements in sections 2(e) and
2(f) of Reese's Law for relying upon a voluntary standard are not
applicable. 15 U.S.C. 2056e(e) and (f).
Section 3 of Reese's Law requires special packaging for button cell
or coin batteries. These requirements, codified in the Notes to 15
U.S.C. 2056e, are self-implementing, and do not require CPSC to issue a
rule. Section 3(a) of Reese's Law states that not later than 180 days
after the date of enactment of the Act, meaning February 12, 2023,
button cell or coin batteries sold, offered for sale, manufactured for
sale, distributed in commerce, or imported into the United States, or
included separately with a

[[Page 8694]]

consumer product sold, offered for sale, manufactured for sale,
distributed in commerce, or imported into the United States, must be
packaged in accordance with the standards provided in 16 CFR 1700.15,
and tested in accordance with 16 CFR 1700.20 or another test method
specified by rule by the Commission. 15 U.S.C. 2056e Notes. The
requirements in section 3(a) shall be treated as a standard for special
packaging of a household substance under section 3(a) of the Poison
Prevention Packaging Act (PPPA). Id.; 15 U.S.C. 1472(a). At this time
the Commission is not proposing a rule to implement section 3 of
Reese's Law, which is effective by operation of the statute on February
12, 2023.\6\
---------------------------------------------------------------------------

\6\ Section 4 of Reese's Law exempts from the special packaging
requirements in section 3(a) of Reese's Law, button cell or coin
batteries that comply with the marking and packaging provisions in
the ANSI Safety Standard for Portable Lithium Primary Cells and
Batteries (ANSI C18.3M). Packaged button cell or coin batteries that
meet the ANSI standard are exempt from the special packaging
requirements in section 3(a) of Reese's Law, but not from the
labeling requirements in section 2(a) of Reese's Law, as implemented
in this proposed rule. Labeling on such battery packaging can meet
both the ANSI standard and this proposed rule; CPSC's labeling
requirements are additive to ANSI C18.3M labeling requirements.
---------------------------------------------------------------------------

B. Explanation of Section 27(e) of the CPSA

Finally, distinct from implementation of Reese's Law, and as
described in section VI of this preamble, the Commission is also
proposing to use its longstanding authority under section 27(e) of the
CPSA (15 U.S.C. 2076(e)) to require notification of additional
technical and performance data related to the safety of button cell or
coin batteries that is to be provided to the original consumer at the
time of sale, specifically on websites and in-store displays for the
sale of button cell or coin batteries and consumer products that
contain such batteries. Although these draft notification requirements
are codified together with the safety standard requirements proposed
under Reese's Law, this is for the convenience of the public and the
Commission, to ease compliance and enforcement. The two sets of
requirements arise from different statutory authority and are legally
distinct.

II. Products Subject to the Proposed Rule

As required by Reese's Law, the proposed rule establishes
performance requirements for child-resistant button cell or coin
battery compartments on consumer products that contain, or are designed
to contain, such batteries. Reese's Law also requires warning labels
for the: (1) packaging of button cell or coin batteries; (2) packaging
of consumer products containing such button cell or coin batteries; (3)
where practicable, battery compartments on consumer products that use
button cell or coin batteries (regardless of whether they are
replaceable); and (4) any literature, such as a user manual, that
accompanies a consumer product containing button cell or coin
batteries. 15 U.S.C. 2056e(a), (b).

A. Description of Button Cell or Coin Batteries Within the Scope of the
NPR

In general, button cell batteries are small, single-cell batteries
that range from 5 mm to 32 mm (0.2 in. to 1.3 in.) in diameter and 1 mm
to 6 mm (0.04 in. to 0.24 in.) in thickness. Reese's Law defines
``button cell or coin battery'' as: (A) a single cell battery with a
diameter greater than the height of the battery; or (B) any other
battery, regardless of the technology used to produce an electrical
charge, that is determined by the Commission to pose an ingestion
hazard. 15 U.S.C. 2056e Notes. As explained above, this proposed rule
focuses on addressing button cell and coin batteries under part (A),
because other batteries where the diameter is less than the height,
such as AAA cylindrical batteries, do not pose the same type or degree
of ingestion hazard as button cell or coin batteries.
A button cell or coin battery (also referred to 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 battery consists of an anode (negative terminal), a cathode
(positive terminal), and a separator and electrolyte between the anode
and cathode, as shown in Figure 1. When the battery terminals are
connected with a conductive material, such as when the battery is
pressed into moist human tissue, an electric circuit is formed, and
electric current flows through the conductive material and between the
terminals. Button cell or coin batteries come in many shapes and sizes
and are composed of different materials and chemicals. Power (voltage
and capacity) and size requirements are the main driver of battery
shape, chemical composition, and the number of required batteries.
[GRAPHIC] [TIFF OMITTED] TP09FE23.002

Button cell batteries, like those shown in Figure 2, are used to
power small, portable electronic products, such as wrist watches and
calculators. Button cell batteries are usually disposable, single-cell
batteries. Common anode materials are zinc or lithium. Common cathode
materials are manganese dioxide, silver oxide, carbon monofluoride,
cupric oxide, or oxygen from the air. Button cell batteries tend

[[Page 8695]]

to be manganese dioxide (alkaline) (1.5v) or silver oxide (1.55v).
[GRAPHIC] [TIFF OMITTED] TP09FE23.003

Lithium coin batteries, shown in Figure 3, 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, manufacturers have found lithium coin
batteries useful for other applications as well. Lithium coin batteries
are commonly around 20 mm (0.787 inch) in diameter.
[GRAPHIC] [TIFF OMITTED] TP09FE23.004

B. Description of Consumer Products Within the Scope of the NPR

Consumer products containing, or designed to use, one or more
button cell or coin batteries, whether they are replaceable or not, are
subject to the rule. 15 U.S.C. 2056e Note. These products may be sold
with batteries included, or batteries may be sold separately. The term
``consumer product'' has the same meaning as described in section
3(a)(5) of the CPSA, 15 U.S.C. 2052(a)(5): broadly, ``any article, or
component part thereof, produced or distributed (i) for sale to a
consumer for use in or around a permanent or temporary household or
residence, a school, in recreation, or otherwise, or (ii) for the
personal use, consumption or enjoyment of a consumer in or around a
permanent or temporary household or residence, a school, in recreation,
or otherwise.''
Under the CPSA, a ``consumer product'' does not include any article
that is not customarily produced or distributed for sale to, or use or
consumption by, or enjoyment of, a consumer, which may include products
used only in a professional capacity (i.e., expensive heavy machinery
used only by professionally trained operators that is typically sold
only to businesses and not to consumers). Moreover, a ``consumer
product'' does not include products within the jurisdiction of some
other Federal agencies, such as motor vehicles and motor vehicle
equipment (e.g., motor vehicle key fobs), or food, drugs, medical
devices, or cosmetics (e.g., thermometers, hearing aids). 15 U.S.C.
2052(a)(5).
``Toy products'' are also exempt from this proposed rule, pursuant
to section 4 of Reese's Law, if they are in compliance with the battery
accessibility and labeling requirements of 16 CFR part 1250 (the ``toy
standard''). A ``toy product'' is any object designed, manufactured, or
marketed as a plaything for children under 14 years of age. Section 4
of Reese's Law, 15 U.S.C. 2056e Notes. Not all children's products are
toys, however. A ``children's product'' is a consumer product that is
``designed or intended primarily for children 12 years of age or
younger.'' 15 U.S.C. 2052(a)(2). The Commission's regulation at 16 CFR
part 1200 further interprets the term. For example, children's clothing
containing button cell or coin batteries, or child-themed non-toy
products that use button cell or coin batteries, are children's
products subject to the requirements of this proposed rule.
Consumer products within the scope of the proposed rule include
common household portable devices, wearable accessories, and decorative
electronic devices. Some examples of household objects that may use
button cell or coin batteries are remote controls, games and toys,
calculators, keychain flashlights, watches, flashing shoes and
clothing, musical greeting cards, cameras, flameless candles, and
holiday ornaments.

C. Description of Packaging Subject to the NPR

Reese's Law requires warnings on the packaging of button cell and
coin batteries, and on consumer products that contain button cell or
coin batteries. 15 U.S.C. 2056e(a), (b). Accordingly, CPSC staff
reviewed consumer product and button cell and coin battery packaging to
determine what, if any, warnings were already present. Staff found that
some manufacturers of button cell or coin batteries include on the
packaging of those batteries a safety statement, such as: ``Keep away
from small children. If swallowed promptly

[[Page 8696]]

see a doctor,'' or ``CAUTION: Keep batteries away from children. If
swallowed, consult a physician at once.'' See Staff's NPR Briefing
Package, p 7, Figures 5 and 6.
As reflected in ANSI Z535.4 American National Standard Product
Safety Signs and Labels (ANSI Z535.4), use of the word ``CAUTION'' on a
warning label signals less severe injuries than using ``WARNING.'' For
example, the word ``WARNING'' should be used for hazards where serious
injury or death will occur. Staff found that packaging for the more
hazardous lithium coin batteries often includes the icon: ``Keep out of
Reach'' on the front and the signal word ``WARNING,'' followed by a
statement that ``Death or serious injury can occur in as little as 2
hours if swallowed'' on the back side of the packaging, along with
additional safety information related to the ingestion hazard and other
hazards. See, e.g., Staff's NPR Briefing Package, p. 8, Figure 7.
Unlike the packaging for button cell and coin batteries, CPSC
staff's review of packaging for consumer products that contain a button
cell or coin battery found that such packaging does not consistently
warn that the product uses a button cell or coin battery; nor does the
packaging consistently include warnings that button cell or coin
batteries pose an ingestion hazard (see, e.g., Staff's NPR Briefing
Package, p. 8-9, Figures 8 and 9). However, accompanying literature,
when provided with a consumer product, sometimes contains warning
information pertaining to the ingestion hazard, even when the product
packaging does not include such warnings.
As explained in sections V and VI of this preamble, the proposed
rule would require standardized warning statements across packaging for
button cell and coin batteries, and the packaging for consumer products
that contain such batteries.

III. Incident Data and Hazard Patterns

Medical literature, CPSC data, and data from the National Capital
Poison Center (NCPC) describe the deaths and serious injuries
associated with the ingestion or insertion of button cell or coin
batteries, including choking, internal chemical burns, chemical
leakage, pressure necrosis (tissue damage), and the creation of
hazardous chemicals (such as sodium hydroxide and hydrochloric acid)
and related hazards. Tab A of Staff's NPR Briefing Package describes in
more detail the incident data from the National Electronic Injury
Surveillance System (NEISS) and from the Consumer Product Safety Risk
Management System (CPSRMS). Staff also reviewed reports of deaths and
injuries from NCPC data, as described in Tab B of Staff's NPR Briefing
Package.

A. Fatalities

The NCPC, or <a href="http://Poison.org">Poison.org</a>, has tracked button cell or coin battery
ingestions occurring from 1977 to the present. See Tab B of Staff's NPR
Briefing Package. From 1977 to June 2022, the NCPC reported 69 deaths
due to ingestion of button cell or coin batteries.\7\ In the 47 cases
where battery chemistry was known, 44 involved lithium batteries, two
involved manganese dioxide chemistry, and one involved an alkaline
button battery. The sources of these batteries, where known, were a
remote control (8), toy (4), watch (2), camera (2), movie camera,
camera flash, garage door opener, electric candle, remote car alarm,
torch, tea light (spare battery), 3D TV glasses, key fob, and loose
(battery fed to child by older brother). The button cell or coin
battery size, where known, ranged from 10 mm to 25 mm (0.4 in. to 1
in.). The symptoms presented resembled those of a cold or upper
respiratory infection and were often misdiagnosed as an infection or
croup, or missed all together. In some cases, the first symptom was
vomiting blood or blood coming from the nose, followed by death. Two
deaths were caused by sepsis \8\ after removal of the battery. Fifty of
the 69 deaths in the NCPC data set were due to the battery burning
through the esophagus and creating a hole to adjoining tissues, such as
the trachea or arteries.
---------------------------------------------------------------------------

\7\ Fatal Cases (poison.org) Fatal Button Battery Ingestions: 69
Reported Cases (accessed June 2022).
\8\ An infection of the blood stream resulting in a cluster of
symptoms, such as drop in blood pressure, increase in heart rate,
and fever.
\9\ Incidents reported via CPSRMS as of May 2022. CPSC expects
additional reporting of CPSRMS incidents for the most recent years
2020-2021, due to a time lag in reporting to CPSC. The reported
incidents may be included in the NCPC data.
---------------------------------------------------------------------------

The Commission is also aware of 25 fatalities from button cell or
coin battery ingestions reported nationally in the CPSRMS data from
January 1, 2011 to December 31, 2021.\9\ See Tab A of Staff's NPR
Briefing Package. CPSC staff determined the source of the button cell
or coin battery in seven of these fatalities: two from remote controls,
two from a tracking device, one from a toy, one from the battery
packaging, and one loose battery. The mechanisms of death represented
in these fatalities are consistent with those seen in the medical
literature and from the NCPC data.

B. Nonfatal Incidents

From 1982 to June 2022, NCPC reported 267 cases of severe injury
from button cell or coin battery ingestion.\10\ Nine injuries were from
manganese dioxide batteries, two were from mercuric oxide, two were
from alkaline, one was from silver oxide, and 182 were from lithium
batteries. Sources of the batteries, where known, were remote controls
(26), toys (13), cameras (7), watches (7), scales (7), key fobs (7),
calculators (5), battery packages (3), digital ear thermometers (2),
flashlights (2), handheld computer games (2), soles of shoes (2),
portable CD player, hair dryer, ab belt (exerciser), personal digital
organizer, talking book, bicycle computer, computer, singing card,
loose, guitar tuner, night light, baby monitor, lighted tweezers, book
light, video camera, keychain, 3D TV glasses, portable speaker, lighted
ring, and glucometer. Where battery size was known, most of the
batteries were 20 mm in diameter, and the battery size range was from
11.6 mm to 24.6 mm (0.46 in. to 0.97 in.). In many cases, impaction of
the button battery in the esophagus led to damage due to burning of the
esophagus.
---------------------------------------------------------------------------

\10\ Severe Cases (poison.org) Nonfatal Button Battery
Ingestions with Severe Esophageal or Airway Injury: 267 Cases.
(Accessed June 2022).
---------------------------------------------------------------------------

Based on incident information in NEISS, CPSC staff estimates that
from January 1, 2011, through December 31, 2021, 54,300 emergency
department-treated incidents involved button cell or coin battery
ingestion or insertion into the mouth, nose, or ear. This excludes
cases establishing ingestion of a battery in which the type of battery
is not indicated. Staff's estimate generally relied upon the final
diagnosis conclusion as recorded in short summaries from medical
professionals. The lack of detection of a battery as a foreign body
does not necessarily contraindicate battery presence (which may
sometimes be missed by x-ray scans). Consequently, these estimates
likely underestimate the actual number of button cell or coin battery
ingestions or insertions. Table 1 summarizes the number of cases
estimated per year.

[[Page 8697]]

Table 1--Estimated Number of Button Cell or Coin Battery Ingestions, Insertions, or Impactions Treated in
Hospital Emergency Departments, 2011-2021
----------------------------------------------------------------------------------------------------------------
Year Estimate N CV
----------------------------------------------------------------------------------------------------------------
2011............................................................ 4,600 170 0.20
2012............................................................ 4,500 179 0.18
2013............................................................ 5,000 178 0.21
2014............................................................ 5,500 177 0.19
2015............................................................ 3,500 163 0.15
2016............................................................ 6,500 237 0.15
2017............................................................ 5,400 196 0.20
2018............................................................ 4,500 200 0.17
2019............................................................ 4,200 178 0.26
2020............................................................ 5,500 270 0.14
2021............................................................ 5,200 235 0.18
-----------------------------------------------
Total....................................................... 54,300 2,183 0.15
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC.
Summations of estimates may not add to the total estimates provided in the tables, due to rounding. Staff
derived estimates from data in the NEISS sample, with number of observations (N) and coefficient of variation
(CV) provided. Estimates spanning periods of multiple years (such as the 11 years from 2011 to 2021) are total
estimates, not annual averages.

Staff estimates that of the 54,300 cases that were indicated to involve
a button cell or coin battery, approximately 88 percent involved
ingestion through the mouth, while the remainder arose from insertion
into the ear or nose. An estimated 8,800 (16% of 54,300) people were
hospitalized as a result of these incidents, while an estimated 44,500
(82% of 54,300) people were treated and released.
Table 2 provides estimates of victim age at the time of initial
treatment associated with button cell or coin battery incidents. Staff
estimates that 16,100 (30%) of the 54,300 incidents involved young
children under the age of 2 years, and an estimated 26,900 (50%)
involved children between the ages of 2 and 6. In total, an estimated
43,000 (79%) of the incidents were associated with children 6 years of
age or younger--the age group that is the focus of Reese's Law. See 15
U.S.C. 2056e(a)(1). Ingestions by adults and elders can be related to
confusing loose button cell or coin batteries with medication and
ingesting batteries, believing mistakenly that they are pills.

Table 2--Estimated Number of Button Cell or Coin Battery Ingestion or Insertion Incidents by Victim Age (or Age
Range), 2011-2021
----------------------------------------------------------------------------------------------------------------
Estimated
Victim age (or age range) Estimate percent N CV
----------------------------------------------------------------------------------------------------------------
0-11 months..................................... 2,900 5 129 0.27
12-23 months.................................... 13,200 24 513 0.21
2 years......................................... 8,700 16 378 0.19
3 years......................................... 7,100 13 315 0.19
4 years......................................... 5,500 10 220 0.12
5 years......................................... 3,200 6 146 0.17
6 years......................................... 2,400 4 84 0.18
7 years......................................... 1,900 4 71 0.20
8 years......................................... 1,500 3 59 0.24
9 to 14 years................................... 2,900 5 141 0.16
15-24 years..................................... (*) 2 33 (*)
25-34 years..................................... (*) 1 8 (*)
35-44 years..................................... (*) <1 5 (*)
45-54 years..................................... (*) <1 1 (*)
55-64 years..................................... (*) <1 6 (*)
65-74 years..................................... (*) 1 17 (*)
75-84 years..................................... (*) 2 21 (*)
85+ years....................................... 1,500 3 36 0.22
---------------------------------------------------------------
Total....................................... 54,300 100 2,183 0.15
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC.
* This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria,
the coefficient of variation (CV) cannot exceed 0.33, there must be at least 20 sample cases (N), and there
must be at least 1,200 estimated injuries.

Table 3 shows 11,900 (22% of 54,300) incidents where the button
cell or coin battery was known to have come from a product. Staff
estimates that at least 5,300 batteries (45% of 11,900) were obtained
from a ``Non-Toy Consumer Product'' (i.e., in scope of Reese's Law).
Such products included lights (i.e., flashlights, pen lights), remote
controls, watches, calculators, decorations and ornaments, electronic
candles and tea lights, clocks and timers, electronic sound making
books, pens, guitar tuners, and other consumer products. Staff
estimates that 4,400 incidents (37%) classified as ``toys/games''
include children's toys and games that fall within the toy standard and
are

[[Page 8698]]

outside the scope of this proposed rule. An estimated 18 percent of the
11,900 product-related incidents are associated with medical devices,
which are outside the scope of the rulemaking for child-resistant
battery compartments, including hearing aids (13%) and other medical
devices (5%).

Table 3--Estimated Number of Button Cell or Coin Battery Incidents Where Obtained From a Product by Battery
Source and Product Type, 2011-2021
----------------------------------------------------------------------------------------------------------------
Estimated
Battery source product type Estimate percent N CV
----------------------------------------------------------------------------------------------------------------
Consumer Product (excluding Toys/Games and Key 5,300 42 237 0.17
Fobs)..........................................
Toys/games...................................... 4,400 37 176 0.17
Car remotes and key fobs........................ (*) 2 11 (*)
Hearing aid..................................... 1,600 13 52 0.21
Other Medical Device............................ (*) 5 16 (*)
(excluding hearing aids)........................
Unknown Product Type **......................... (*) <1 4 (*)
---------------------------------------------------------------
Total....................................... 11,900 100 496 0.14
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC.
* This estimate does not meet NEISS reporting criteria.
** For a small proportion of cases, although it could be determined that the batteries were neither loose nor
from packaging and came from some product or device, it could not be determined which type of product or
device.

In the CPSRMS data, staff identified 87 nonfatal incidents
involving button cell or coin battery ingestion (i.e., ``Ingestion''
incidents) or unintended access to the button cell or coin battery with
no ingestion (i.e., ``Battery Access'' incidents) from January 1, 2016,
through December 31, 2021. See Staff's NPR Briefing Package, p. 13.
Table 4 provides a summary of the 74 nonfatal incidents that involved a
product, rather than battery packaging, as the source of access to the
battery.

Table 4--Reported Number of Product Classified Nonfatal Incidents by Incident Classification and Battery Source
Product Type, 2016-2021
----------------------------------------------------------------------------------------------------------------
Incident classification Combined nonfatal
Battery source product type ---------------------------------------------------------------
Ingestion Battery access Total Total percent
----------------------------------------------------------------------------------------------------------------
Non-toy Consumer Product........................ 13 16 29 42
Toys/games...................................... 20 23 43 56
Medical Device.................................. 1 1 2 3
---------------------------------------------------------------
Total....................................... 34 40 74 100
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS, CPSC.

A high proportion of button cell and coin battery incidents
reportedly involved toys and games. Based on products in the CPSRMS
database where the exact product is known, many of the toys are subject
to the requirements of the mandatory toy standard, codified in 16 CFR
part 1250, which requires toy products to meet the battery
accessibility requirements in the voluntary standard for toys, ASTM
F963-17.\11\ CPSC staff has raised a concern with ASTM that ASTM F963-
17's requirements for battery compartments do not adequately protect
against the liberation of button cell or coin batteries from toys and
becoming an ingestion hazard.\12\
---------------------------------------------------------------------------

\11\ Products referred to as ``toys'' in the incident data, that
do not fall within the scope of part 1250, would be subject to this
rule; thus, the rule will address some unknown portion of products
indicated in the incident data as toys or games.
\12\ <a href="https://www.cpsc.gov/s3fs-public/8-19-2022-Letter-to-ASTM-Battery-Operated-Toys.pdf?VersionId=PgFoeCeb0BYz0kyg6z87tbwHKv3x9W0y">https://www.cpsc.gov/s3fs-public/8-19-2022-Letter-to-ASTM-Battery-Operated-Toys.pdf?VersionId=PgFoeCeb0BYz0kyg6z87tbwHKv3x9W0y</a>. Staff
Correspondence Relating to Voluntary Standards--Letter to ASTM re:
Battery Operated Toys, August 19, 2022.
---------------------------------------------------------------------------

C. Hazard/Injuries Associated With Button Cell or Coin Batteries

As set forth in detail in Tab B of Staff's NPR Briefing Package,
CPSC staff reviewed medical literature related to battery-ingestion
injuries, CPSC data, and data from <a href="http://Poison.org">Poison.org</a>, and found that ingested
batteries, particularly button cell or coin batteries, can lodge in the
esophagus and cause severe tissue damage after only a few hours. 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 lead to a
burn in the esophagus, perforations, and burning of nearby tissue.
Generation of hydroxide by the current created as a result of the
battery contacting tissue in the digestive tract is the primary pathway
to the chemical burn hazard associated with ingestion of lithium coin
batteries, particularly, because of their higher voltage and capacity.
Other mechanisms of injury associated with button cell or coin
batteries include leakage of alkaline electrolyte from alkaline button
cell batteries or pressure necrosis from extended contact of the
foreign object with the soft tissue.
In addition to ingestion from swallowing, a proportion of nose
insertions ultimately results in ingestion or aspiration, with
batteries getting into the digestive tract or airways. Button cell or
coin batteries impacted in the nose can lead to severe damage to the
endonasal mucous membranes, necrosis (tissue damage) of the nasal
septum cartilage, and nasal septum perforation. Tab B, Appendix G of
Staff's NPR Briefing Package, provides examples of ear and nose
insertion incidents.

[[Page 8699]]

CPSC staff specifically considered the ingestion hazard presented
by zinc-air button cell and coin batteries in consumer products, and
found that the risk is low. Staff estimates that at least 9 percent of
button cell or coin battery ingestion or insertion incidents involve
zinc-air batteries. But zinc-air batteries are primarily used in
hearing aids, which are medical devices under the jurisdiction of the
FDA. Staff did not identify zinc-air batteries being used in any
consumer products. Furthermore, zinc-air batteries are typically much
smaller than other button cell or coin batteries, and therefore, they
do not present the same risk of choking. Staff did not identify any
choking incidents in which zinc-air batteries were the source battery.
Moreover, zinc-air batteries use a technology that needs air for the
current to flow or voltage to be present on the terminals. Accordingly,
if a zinc-air battery is swallowed or inserted into the nose, wet
mucosa stops this flow of air and also the voltage, so there are no
associated chemical or hydroxide burns. Zinc-air batteries are sealed
with a hydrophobic material, so there is also little chance for
electrolyte leakage. See Tab B of Staff's NPR Briefing Package.
Although hearing aids with zinc-air batteries would not be subject
to performance requirements for consumer products (because hearing aids
are medical devices), zinc-air batteries can be consumer products.
Based on staff's assessment of the characteristics of zinc-air
batteries and the lack of ingestion injury associated with these
batteries, however, the Commission proposes that the labeling
requirements of Reese's Law not apply to the packaging for zinc-air
button cell or coin batteries. The Commission seeks comment on whether
any consumer products contain, or are designed to contain, zinc-air
button cell or coin batteries, if so, whether performance standards for
battery compartments should apply to these consumer products, and
whether the Commission should require ingestion warnings on zinc-air
button cell or coin battery packaging.

D. Hazard Patterns

CPSC staff identified the primary ways that children gain access to
button cell or coin batteries before ingesting them:
1. Access to the battery from a product's intact battery
compartment. Seventy-nine out of 112 fatal and nonfatal CPSRMS incident
narratives staff identified in Tab A of Staff's NPR Briefing Package
refer to products with button cell or coin battery compartments that
are potentially easily accessed by children.\13\ Ten of the 79 incident
narratives refer to batteries in compartments that appeared easy to
open or defeat. These batteries did not accidentally come out of a
battery compartment, but appeared easily accessible to children while
in a compartment.
---------------------------------------------------------------------------

\13\ Out of the 79 products included in this hazard pattern
analysis, 77 are consumer products, and two are household medical
devices (body temperature thermometer and toothbrush).
---------------------------------------------------------------------------

2. Obtaining the battery from a battery compartment that broke or
failed to contain the battery as intended. Sixty-nine of the 79 fatal
and nonfatal CPSRMS incidents involving products describe the batteries
unintentionally coming out of the battery compartment or the product,
or the battery compartment opening or breaking, often while a child was
interacting with the product. In some cases, the battery was found to
have come from a product only after a child was diagnosed with having
ingested the battery. Eighteen of these incidents specifically describe
products with ineffective screws, including comments about stripped
threads, continuous spinning, screws that were ``too short,'' and
compartments that popped open, even though there was a screw.
3. Removing the battery from its packaging, or obtaining a loose
battery that was not contained within packaging or a product. Six out
of 112 fatal and nonfatal CPSRMS incident narratives refer to loose
batteries or battery-packaging hazards, and staff estimates that at
least 7 percent of NEISS incidents involve loose batteries or batteries
removed from their packaging.

E. Recalls

Table 5 describes the six CPSC-conducted recalls that occurred
between January 1, 2011, and July 31, 2022, involving consumer products
containing button cell or coin batteries associated with a battery
ingestion hazard. The recalled products were responsible for four
reported battery-ingestion incidents and affected approximately 823,900
products (including toys).

Table 5--Summary of Recalls Involving Products With Button Cell and Coin Batteries
----------------------------------------------------------------------------------------------------------------
Number of
Number of incidents & Press release
Recall date Firm Hazard recalled units injuries No.
reported
----------------------------------------------------------------------------------------------------------------
10/10/2016......... Target.................. The gel clings About 172,000 No Injuries 17-020
can separate units Reported.
and expose the Halloween LED
inner decal Gel Clings.
and LED/button
battery
compartment,
posing choking
and button
battery
ingestion
hazards to
children.
12/16/2016......... Figi's Companies Inc.... The tin's music About 5,000 No Injuries 17-120
sound chip units Reported.
mechanism can ``Christmas
separate and Wishes'' Tins.
expose button
batteries,
posing choking
and button
battery
ingestion
hazards to
children.
5/23/2017.......... Hobby Lobby............. The battery About 43,400 Received one 17-166
cover can units Easter report of a 14-
detach and and July 4th- month-old
expose the themed Light- child who
small coin Up Spinner ingested the
cell Toys. battery.
batteries,
posing choking
and ingestion
hazards to
young children.
12/19/2019......... Toysmith................ The battery About 58,000 One report of a 20-045
cover can units Light-Up child
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.
5/12/2021.......... K & M International..... The coin cell About 463,000 No incidents or 21-134
battery inside units Wild injuries have
the slap Republic Slap been reported.
watches can Watches.
fall out,
posing battery
ingestion and
choking
hazards to
young children.

[[Page 8700]]

12/1/2021.......... Halo Brand Solutions.... A child can About 82,500 Received two 22-024
disassemble units reports of
the 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 case, a child
hazards. required
surgery to
remove a
swallowed
battery.
----------------------------------------------------------------------------------------------------------------

IV. Assessment of Performance Requirements for Battery Compartments in
Relevant Voluntary Standards, and Description of the Proposed Rule's
Battery Compartment Requirements

In this section, the Commission describes staff's assessment of
existing voluntary standards that establish performance requirements
for button cell or coin battery compartments in consumer products, and
the elements of those standards that the Commission proposes to adopt
as the basis for its proposed rule implementing Reese's Law.

A. Preliminary Determination Regarding Performance Requirements in
Existing Voluntary Standards

Section 2(d) of Reese's Law states that the Commission shall not
promulgate a final rule for consumer products that contain button cell
or coin batteries if the Commission determines, with respect to any
consumer product, that a voluntary standard that meets the requirements
of section 2(a) of Reese's Law is either in effect at the time of the
Commission's determination, or will be in effect not later than 180
days after the enactment of Reese's Law (meaning by February 12, 2023).
Accordingly, CPSC staff assessed voluntary standards to determine
whether any existing standards meet the requirements of section 2(a)(1)
of Reese's Law, which mandates that the rule must include performance
requirements for button cell or coin battery compartments on consumer
products to secure them in a manner that eliminates or adequately
reduces the risk of injury from the ingestion of button cell or coin
batteries by children who are 6 years old or younger during reasonably
foreseeable use or misuse of the product. 15 U.S.C. 2056e(a)(1).
Tab D of Staff's NPR Briefing Package contains a detailed review of
six voluntary standards that relate to the accessibility of button cell
or coin batteries. Four of these six standards most directly address
the hazards associated with button cell and coin battery accessibility
in consumer products, as required by Reese's Law. These four voluntary
standards are:
<bullet> UL 4200A, Standard for Safety for Products Incorporating
Button or Coin Cell Batteries of Lithium Technologies (UL 4200A);
<bullet> ASTM F963, Standard Consumer Safety Specification for Toy
Safety;
<bullet> IEC 62368-1, Audio/video, information and communication
technology equipment-Part 1: Safety requirements; and
<bullet> IEC 62115, International Standard for Electric Toys--
Safety.
Table 6 provides CPSC staff's summary of how each of these
standards addresses the battery-ingestion hazard, with requirements
that are intended to minimize the risk of children removing button cell
or coin batteries from a consumer product.

Table 6--Summary of Voluntary Standards Requirements for Button Cell or
Coin Battery Access in a Consumer Product
------------------------------------------------------------------------
Required
action(s) to
Standard Scope open battery Abuse testing
compartment
------------------------------------------------------------------------
UL 4200A........... Household-type (1) A tool, Preconditioning:
products that such as a (1) 7 hours of
incorporate or screwdriver or pre-
may use button coin, is conditioning in
cell or coin required to oven at 70
batteries of open the [deg]C (158
lithium battery [deg]F);
technologies. compartment; (2) Open/close
screw and remove/
fasteners must install battery
be captive; OR 10 times.
(2) The battery Abuse Tests:
compartment (1) Drop test--
door or cover maximum 10
requires the times at 3.3 ft
application of in positions
a minimum of likely to
two produce the
independent maximum force
and on the battery
simultaneous compartment or
movements to enclosure;
open by hand. (2) Impact test--
3 impacts by
steel sphere
imparting 2-J
of energy; and
(3) Crush test--
74 lbf. over 38
square inches
for 10s in
positions
likely to
produce the
most adverse
results.
ASTM F963.......... Toys intended Coin, (1) Drop test--
for use by screwdriver, maximum 10
children under or other times at 4.5 ft
14 years of age. common in random
household tool orientation;
required to minimum of 4
open battery times at 3 ft
compartment. in random
orientation;
(2) Torque test--
2-4 in-lbs. of
torque over 10
seconds;
(3) Tension
test--10-15
lbs. of tension
over 10
seconds;
(4) Tension test
for pliable
materials--10-1
5 lbs. of
tension over 10
seconds; and
(5) Compression
test --20-30
lbf over 1
square inch for
10 seconds.
IEC 62368-1........ Electrical and (1) A tool, Preconditioning:
electronic such as a (1) 7 hours of
equipment screwdriver or pre-
within the coin, is conditioning in
field of audio, required to oven at 70
video, open the [deg]C (158
information and battery [deg]F); and
communication compartment, (2) Open/close
technology, and screw and remove/
business and fasteners must install battery
office machines be captive; OR 10 times.
with a rated (2) The battery Abuse Tests:
voltage not compartment (1) Drop test--
exceeding 600 V. door or cover maximum 10
requires the times at 3.3 ft
application of in positions
a minimum of likely to
two produce the
independent maximum force
and on the battery
simultaneous compartment or
movements to enclosure;
open by hand. (2) Impact test--
3 impacts by
steel sphere
imparting 2-J
of energy; and
(3) Crush test--
apply 74 lbf.
for 10s in
positions
likely to
produce the
most adverse
results.

[[Page 8701]]

IEC 62115.......... Electric toys Batteries that (1) Screw test--
being any fit wholly Remove/replace
product within the screws 10 times
designed or small parts with torque
intended for cylinder shall applied;
use in play by not be (2) Drop test--
children under removable maximum 10
14 years of age. without the times at 93 cm
aid of a tool, <plus-minus> 5
screw fastener cm (36.6 in.)
must be in random
captive. orientation;
minimum 4 times
at 93 cm <plus-
minus> 5 cm
(36.6 in.) in
random
orientation;
(3) Impact test--
3 impacts by
hammer
imparting 0.5-J
of energy;
(4) Tension
test--70 N
<plus-minus> 2
N (15.7 lbs.)
of tension over
10 seconds; and
(5) Tension
test--70 N
<plus-minus> 2
N (15.7 lbs.)
tension force
on a textile
seam over 10
seconds.
------------------------------------------------------------------------

The left-hand column in Table 7 displays the categories staff
evaluated to assess satisfaction of Reese's Law, and staff's evaluation
of whether the standard eliminates or adequately reduces the risk of
injury from button cell or coin battery ingestion by children age 6 or
under. Specifically, Table 7 includes the scope of the voluntary
standard, and whether the scope includes all or only some relevant
battery chemistry types that create an ingestion hazard and associated
consumer products as seen in the incident data; whether the standard's
performance requirements for constructing and securing the battery
compartment would eliminate or adequately reduce the risk of injury
from access to batteries from consumer products and their ingestion, as
seen in the incident data, or inadequately address the risk; and
whether the standard addresses use-and-abuse testing at all, and if so,
the adequacy of the use-and-abuse testing to eliminate or adequately
reduce ingestion incidents as seen in the data.

Table 7--Assessment of Existing Voluntary Standards for Button Cell or Coin Batteries
--------------------------------------------------------------------------------------------------------------------------------------------------------
UL 4200A ASTM F963 IEC 62368-1 IEC 62115
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scope:
Battery Chemistry Type........ Lithium................... Any....................... Any.......................... Any.
Product Type.................. Any....................... Toys...................... Audio/Visual Equipment....... Electronic Toys.
Construction:
Opens with Tool............... A......................... A......................... A............................ A
Captive screws................ I......................... .......................... I............................ A
Threaded attachment A......................... .......................... I............................ .............................
requirements.
Opens with two independent and I......................... .......................... I............................ .............................
simultaneous movements.
Accessibility................. A......................... A......................... A............................ A
Use and Abuse:
Pre-conditioning in oven...... A......................... .......................... A............................ .............................
Open/close and remove/install A......................... .......................... A............................ I
battery/screw(s) 10 times.
Drop test--based on product I......................... I......................... I............................ I
weight/type.
Drop test--based on age .......................... I......................... ............................. .............................
grading.
Impact Test................... A......................... .......................... I............................ I
Crush Test (big surface area). A......................... .......................... I............................ .............................
Torque Test................... .......................... A......................... ............................. .............................
Tension Test.................. .......................... A......................... ............................. A
Tension Test--Seams........... .......................... A......................... ............................. A
Compression Test (little .......................... A......................... ............................. .............................
surface area).
Accessibility Probe Compliance I......................... I......................... I............................ A
Test.
Securement (non-removable A......................... .......................... ............................. .............................
batteries).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blank--Does not address requirements, I-Inadequately addresses requirements, A--Adequately addresses requirements.

Table 7 summarizes staff's assessment in Tab D of Staff's NPR
Briefing Package, displaying an ``I'' where a standard contains a
performance requirement that inadequately addresses the risk of
ingestion, and an ``A'' if CPSC staff assessed the requirement as
adequate to address the risk of ingestion. Table 7 shows that no
existing voluntary standard includes within its scope all battery types
and all consumer products that contain button cell or coin batteries,
as reflected in the incident data. The scope of each voluntary standard
staff reviewed is narrower than the scope of the proposed rule, which
applies to all non-toy consumer products within the Commission's
jurisdiction that contain button cell or coin batteries. For example,
UL 4200A only applies to lithium batteries.
Regarding construction of the battery compartments, UL 4200A is the
only voluntary standard that contains requirements that would address
relevant incidents seen in the data, but in staff's view, not all the
requirements are adequate to address the risk of injury. For example,
although UL 4200A contains a requirement for a double-action locking
mechanism, staff found that the language in UL 4200A could lead to
defective double-action locks, which could allow a child to gain access
to the battery compartment. Staff also found that requirements in UL
4200A are not always clear and could result in different
interpretations by testers,

[[Page 8702]]

leading to inconsistent and unreliable testing and, ultimately, risk to
children.
Regarding ASTM F963, Table 6 reflects that it requires a tool to
open a battery compartment, but does not require captive screws. This
means that consumers could undermine the screw requirement by not using
them, discarding them, or losing the screws. ASTM F963 also does not
have torque requirements for fasteners, nor does it provide
requirements for fastener threading or retention. These omissions are a
deficiency, given the incident data involving lost screws and stripped
screw holes. Staff concluded that the IEC standards contain similar
deficiencies related to battery compartment fasteners, as summarized in
Tables 6 and 7.
As part of its requirements for secure battery compartments,
Reese's Law requires a performance standard for consumer products
addressing reasonably foreseeable use-and-misuse conditions.
Accordingly, staff considered the adequacy of use-and-abuse testing of
consumer products for each voluntary standard, and staff assessed
whether the use-and-abuse testing would eliminate or adequately address
deaths and injuries in the incident data. As shown in Table 7, and as
described in more detail in Tab D of Staff's NPR Briefing Package,
staff advises that none of the voluntary standards, alone, provides for
all the use-and-abuse testing needed to eliminate or adequately reduce
incidents seen in the data.
Based on CPSC staff's review and analysis of voluntary standards
related to child-resistant battery compartments for consumer products
that contain button cell or coin batteries, as set forth in Tables 6
and 7 above, and Tab D of Staff's NPR Briefing Package, the Commission
preliminarily determines that no existing voluntary standard contains
performance requirements that would eliminate or adequately reduce the
risk of button cell or coin battery ingestion associated with consumer
products that contain button cell or coin batteries within the scope of
the proposed rule. However, as set forth below, the Commission draws on
elements of these four voluntary standards to propose a rule that meets
the requirements of Reese's Law. We seek comment from the public
regarding staff's assessment of the relevant voluntary standards, and
on our preliminary conclusion that, for the reasons given by staff,
none of the standards, alone, satisfy the requirements for adoption as
a consumer product safety rule under section 2(d) of Reese's Law, 15
U.S.C. 2056e(d).

B. Elements of the Proposed Standards for Battery Compartment
Accessibility in Products Incorporating Button Cell or Coin Batteries

Tables 8 and 9 summarize the performance requirements in the
proposed rule.

Table 8--Requirements for Consumer Products With Compartments for
Replaceable Batteries
------------------------------------------------------------------------

------------------------------------------------------------------------
Button cell or coin batteries must not become accessible or liberated
when tested to these requirements:
------------------------------------------------------------------------
Construction Requirements
------------------------------------------------------------------------
Battery Compartment Option 1: Coin, screwdriver, or other
Construction Options. household tool.
<bullet> Captive screws
<bullet> Two threads engaged or minimum
torque + spin angle.
Option 2: Two independent & simultaneous
hand movements.
<bullet> Cannot be combinable to a single
movement with a finger or digit.
------------------------------------------------------------------------
Accessibility Test........... Open or remove any part of the
compartment not meeting Option 1 or
Option 2 Apply Tension Test for Seams
from 16 CFR part 1250 on pliable
materials, using a force of 70.0 N (15.7
lbf). Determine whether Test Probe 11
from IEC 61032 can touch the battery.
------------------------------------------------------------------------
Preconditioning Requirements
------------------------------------------------------------------------
Preconditioning in Oven...... Thermoplastics--7 hours at 158 [deg]F or
greater, based on operational
temperature.
------------------------------------------------------------------------
Simulated Battery Replacement Open/Close and remove/install battery 10
times.
------------------------------------------------------------------------
Use and Abuse Tests
------------------------------------------------------------------------
Drop Test.................... 10 drops from 1 m (39.4 in) on hardwood,
in positions likely to produce maximum
force.
Impact Test.................. 3 impacts on battery compartment with
steel sphere, 2 J (1.5 ft-lbf) of
energy.
Crush Test................... 335 N (75.3 lbf) for 10 s, using 100 by
250 mm (3.9 by 9.8 in) flat surface.
Compression Test............. Test from 16 CFR Part 1250, using a force
of 136 N (30.6 lbf).
Torque Test.................. Test from 16 CFR part 1250, using a
torque of 0.50 Nm (4.4 in.-lbf).
Tension Test................. Test from 16 CFR part 1250, using a force
of 72.0 N (16.2 lbf).
Probe for Accessibility...... Apply 50 N (11.2 lbf) with Test Probe 11
from IEC 61032 to confirm compliance.
------------------------------------------------------------------------

Table 9--Requirements for Consumer Products With Compartments for Non-
Replaceable Batteries
------------------------------------------------------------------------

------------------------------------------------------------------------
Option 1--Not Accessible................... Meets the same requirements
as battery compartment for
replaceable batteries.
Option 2--Accessible....................... <bullet> Secured with
soldering, fasteners such
as rivets, or equivalent
means.
<bullet> Applicable
preconditioning
requirements apply.
<bullet> Confirmed with
secureness test: test hook
applies a force of 22 N
(4.9 lbf) directed
outwards for 10 s, at all
possible points. Battery
cannot liberate from the
product.
------------------------------------------------------------------------

[[Page 8703]]

Below we describe the rationale for the proposed requirements.
1. Construction: Actions to Open the Battery Compartment
Each of the four voluntary standards specifies similar requirements
for a locking mechanism to secure the battery compartment that requires
a tool (or coin) to open, to reduce the possibility of children
removing the battery. Generally, requiring a coin or tool to open a
battery compartment addresses child access to the battery compartment,
because younger children may lack the required cognitive ability and
fine motor coordination to perform the necessary actions to access the
battery compartment, as discussed in Tab C of Staff's NPR Briefing
Package. UL 4200A, however, is the only voluntary standard that
includes requirements for this locking mechanism, specifying either a
minimum torque of 0.5 Nm (4.4 in-lbf) and a minimum angle of rotation
of 90 degrees for the battery compartment fastener mechanism, or a
minimum of two full threads engaged. These requirements are important
to secure the battery compartment because staff found incidents
involving battery compartments with stripped screw holes or screws of
insufficient length, defeating the integrity of the screw requirement
and allowing child access. In particular, ASTM F963 does not contain
these torque and rotation requirements for the locking mechanism, and
staff identified incidents of children accessing battery compartments
on toys that purportedly met ASTM F963. Accordingly, the Commission
proposes to include requirements for the locking mechanism, consistent
with the requirements in UL 4200A.
Moreover, all of the assessed voluntary standards, except ASTM
F963-17, include a requirement for captive screws, which are screws
that remain in the compartment or cover when unscrewed. If the screw is
not captive to the compartment door, consumers can more easily lose the
screw or defeat this locking mechanism by removing the screw,
potentially for convenience, without appreciating the safety purpose of
the screw.
The Commission preliminarily concludes that the requirements in UL
4200A related to products that use a tool or coin to open the battery
compartment, when applied to the full scope of products subject to
Reese's Law, and not just to lithium coin batteries, are adequate to
address the battery compartment construction requirements related to
the button cell or coin battery ingestion hazard. Although UL 4200A
includes an exception to the captive screw requirement for large panel
doors, the Commission is not including such an exception in the
proposed rule. Instead, we are requesting comment on this, including
what constitutes a ``large panel door,'' the types of products intended
for this exception, and why these doors would not present the same risk
of injury as any other consumer product that contains button cell or
coin batteries if the screws become lost or discarded by the consumer.
UL 4200A and IEC 62368-1 also specify an option for the battery
compartment door to require a double-action locking mechanism
(requiring at least two independent and simultaneous movements to open
the compartment by hand) that ASTM F963 does not contain. Unlike
screws, a double-action locking mechanism does not rely on the consumer
to keep and reuse a screw. Thus, a double-action lock, if well-designed
and constructed, can be more secure than a screw lock that relies on
consumers to reuse the screw each time the battery compartment is
closed. The Commission preliminarily concludes that double-action
locking mechanisms that meet the requirements of the proposed rule,
which are similar to the double-action lock provisions in UL 4200A,
could be effective in preventing younger children from opening the
battery compartment, while affording additional flexibility to design
effective child-resistant battery enclosures.
2. Use and Abuse Testing
Reese's Law mandates that the rule must include performance
requirements for button cell or coin battery compartments during
reasonably foreseeable use or misuse of the product. Accordingly, staff
evaluated use and abuse testing in each voluntary standard to address
the actual hazard patterns that are apparent in the incident data.
Although all of the voluntary standards reviewed by staff specify abuse
tests, none of the voluntary standards, alone, would eliminate or
adequately reduce the ingestion risks presented by the incident data.
Based on staff's incident review, engineering analysis, and testing of
consumer products as described in Tab D of Staff's NPR Briefing
Package, staff assessed that the drop test and impact test in UL 4200A
adequately simulate use and abuse of consumer products by children.
Staff assessed that the use and abuse testing in ASTM F963-17 is
inadequate, alone, to address the risk of injury, because it does not
precondition the products before abuse testing and does not contain an
impact test, which is the test staff found most likely to simulate
foreseeable use and abuse of consumer products.
Staff, however, also assessed that the compression tests, torque
tests, and tension tests in ASTM F963-17, the toy standard, are
adequate to simulate foreseeable interactions, such as when a child
grasps a part of a product with fingers or teeth, and twists, pulls, or
presses on part of the product, while UL 4200A and IEC 62368-1 do not
contain performance requirements to address these risks. A detailed
assessment of these test methods can be found in Tab D of Staff's NPR
Briefing Package. Staff specifically observed the following regarding
abuse testing:
<bullet> UL 4200A specifies heat pre-conditioning of plastic
component parts of the product. Staff's testing demonstrated that heat
pre-conditioning of the consumer products stresses plastic components
to simulate more realistically, the expected condition of the product
during normal use. ASTM F963 and IEC 62115 do not require heat pre-
conditioning, and therefore, are inadequate to assess consistently and
reliably, the integrity of battery compartments through use-and-abuse
testing.
<bullet> UL 4200A specifies mechanical pre-conditioning of the
product by requiring a battery compartment on a consumer product to be
opened, the battery removed, the battery reinstalled, and then the
compartment closed, a total of 10 times. As with heat pre-conditioning,
staff's testing confirmed that mechanical pre-conditioning assesses
more consistently the durability of a battery compartment to maintain
its integrity over time, by preventing, for example, stripping of
threads, compared to standards that do not require pre-conditioning.
ASTM F963 and IEC 62115 do not require pre-conditioning by opening and
closing the battery compartment, and therefore, inadequate to test
reliably the durability of battery compartments on consumer products
during foreseeable use and misuse.
<bullet> UL 4200A subjects ``portable'' products to three drops
during abuse testing, while ``hand-held'' portable products are
subjected to 10 drops. All drops are from a height of 3.3 feet in
positions likely to produce the maximum force on the battery
compartment. Staff assessed that the 10-cycle drop test for handheld
items in UL 4200A is adequate to address and prevent incidents of
breaking consumer products or battery compartments. The abuse testing
requirements in ASTM F963 and IEC 62115, however, are inadequate to
address the risk of button cell or coin batteries being liberated

[[Page 8704]]

from broken battery compartments, because they allow for as few as four
drops from a height of 3 feet, in random orientations that may not
exert maximum force on the battery compartment.
<bullet> UL 4200A requires three impact tests that each impart two
joules of energy directly on the battery compartment with a steel ball.
Staff advises that this impact test reasonably indicates the durability
of the battery compartment during foreseeable use and misuse, as
required by Reese's Law. However, ASTM F963 is inadequate to eliminate
or adequately reduce access to batteries caused by foreseeable stress
on the battery compartment, because the standard does not require
impact tests directly on the compartment. IEC 62368-1 varies the
required impact energy based on the type of product, and IEC 62115
requires less energy per impact, which does not adequately reduce
access to the battery compartment for certain products.
<bullet> ASTM F963 specifies torque test and tension test methods
to simulate interactions during reasonably foreseeable use and misuse
conditions, such as a child grasping a part of the product with fingers
or teeth and twisting, pulling, or pressing on the product. Staff
advises that these requirements in the toy standard are adequate to
test the durability and integrity of battery compartments in products
with pliable materials such as shirts and greeting cards that light up
or make sound using batteries. The proposed rule includes torque and
tension tests to eliminate or adequately reduce the risk of ingestion
in pliable products, as required by Reese's Law.
<bullet> UL 4200A specifies a compression test of 74.2 pounds over
a 3.9-inch x 9.8-inch area, which staff assesses adequately addresses a
child pushing on the product with hands or feet. ASTM F963 and IEC
62115 specify a concentrated compression load of 30 pounds over a 1-
square-inch area, which staff assesses adequately addresses a child
unintentionally opening a battery compartment that cannot be impacted
directly during the drop test, but that can be pushed open with hands
or fingers. However, staff advises that the smaller compression test
area in ASTM F963 and IEC 62115 is inadequate to assess a child pushing
on the product with hands or feet. Conversely, the larger compression
area of the UL 4200A is inadequate to address the risk of injury
associated with a child pushing on the product with fingers.
Accordingly, the proposed rule includes both tests to address
adequately the foreseeable possible range of child interactions and
incidents.
<bullet> UL 4200A specifies that if a product has a battery that is
not intended to be removed or replaced by the user, and that is held
fully captive by soldering, fasteners, or any equivalent means, then
the product is not subject to abuse testing, and is subject only to
pre-conditioning tests and secureness testing using a test hook and a
force of 4.5 lb. IEC 62368-1 also excludes from abuse testing any
products with non-removable batteries; but it does not require any
secureness test. The Commission is aware of incidents involving
children gaining access to non-removable batteries in products like
computers. Although the proposed rule requires only the applicable pre-
conditioning tests and the secureness test based on UL 4200A for non-
removable batteries, with no additional abuse testing, the Commission
requests comment on whether the proposed secureness test based on UL
4200A is sufficient to address reasonably foreseeable use and abuse of
consumer products containing non-removable batteries.
3. Accessibility Test
Each of these four voluntary standards relies on a test probe based
on a child's finger to verify whether certain components are accessible
to children. Staff advises that the test probe used in ASTM F963 is
inadequate to test accessibility, because the probe articulates and
therefore cannot be used to apply much force. IEC 62368-1, IEC 62115,
and UL 4200A do require a force to be applied with their respective
probes to verify compliance with the standard. The IEC 62368-1 test
probe head has a 3.5 mm (0.14 in.) radius, and compliance is verified
with a force of 30 N <plus-minus> 1 N (6.7 lbf <plus-minus> 0.2 lbf).
IEC 62115 and UL 4200A use Test Probe 11 of the Standard for Protection
of Persons and Equipment by Enclosures--Probes for Verification, IEC
61032. This test probe has a head with a 4 mm (0.16 in.) radius. Staff
assesses that using test Probe 11 with a force of 50 newtons (11.2
lbf), per IEC 62115, is adequate to assess a child's ability to get
into a battery compartment. The Commission seeks comments on the
adequacy of the probes and accessibility tests in these voluntary
standards.

V. Assessment of Warning Label Requirements in Relevant Voluntary
Standards, and Description of the Proposed Rule's Warning Label
Requirements

Section 2(a)(2) of Reese's Law mandates warning label requirements
for:
<bullet> The packaging of button cell or coin batteries (15 U.S.C.
2056e(a)(2)(A));
<bullet> The packaging of consumer products containing button cell
or coin batteries (15 U.S.C. 2056e(a)(2)(A));
<bullet> Any literature, such as a user manual, that accompanies a
consumer product containing button cell or coin batteries (15 U.S.C.
2056e(a)(2)(B));
<bullet> As practicable, a consumer product that contains button
cell or coin batteries in a manner visible to the consumer upon
installation or replacement of the button cell or coin battery (15
U.S.C. 2056e(a)(2)(C)(i)); and
<bullet> As practicable, a product for which the battery is not
intended to be replaced or installed by the consumer, in a manner that
is visible to the consumer upon access to the battery compartment; if
it is impracticable to label the product, this information shall be
placed on the packaging or instructions (15 U.S.C. 2056e(a)(2)(C)(ii)).
The warning labels required by section 2(a) of Reese's Law must (1)
clearly identify the hazard of ingestion, and (2) instruct consumers,
as practicable, to keep new and used batteries out of the reach of
children, to seek immediate medical attention if a battery is ingested,
and to follow any other consensus medical advice. 15 U.S.C. 2056e(b).
Tab C of Staff's NPR Briefing Package reviews and assesses warning
label requirements in existing voluntary standards, and provides
recommendations for warnings with a detailed rationale for each
recommended requirement. This section discusses and proposes to adopt
staff's recommended implementation of Reese's Law's warning label
requirements.

A. Adequacy of Existing Voluntary Standards

To fulfill the requirement in section 2(d) of Reese's Law, the
Commission first considers whether the labeling requirements in an
existing voluntary standard meet the requirements of section 2(a)(2)
and 2(b) of Reese's Law. Tab C of Staff's NPR Briefing Package and its
Appendix contain a detailed analysis of the warning label requirements
in 10 voluntary standards associated with button cell or coin

[[Page 8705]]

batteries. For each standard, staff considered the scope, placement,
format, and content of the required labels, and whether it adequately
addresses the ingestion hazard warnings required by Reese's Law. Table
10 summarizes staff's assessment of the voluntary standards relevant to
labeling of consumer products that contain button cell or coin
batteries.

Table 10--Summary of Staff's Assessment of Labeling Requirements in Standards for Consumer Products Containing Button Cell or Coin Batteries
--------------------------------------------------------------------------------------------------------------------------------------------------------
ASTM F963 UL 4200A ASTM F2999-19 ASTM F2923-20 IEC 62115
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scope:
Battery Chemistry Type...... All................... Lithium............... All................... All................... All.
Product Type................ Toys.................. All................... Jewelry............... Children's Jewelry.... Toys.
Labeling:
On Consumer Product I..................... ...................... ...................... ...................... I
Packaging.
In instructions or I..................... I..................... ...................... ...................... I
accompanying literature.
On consumer product......... ...................... I..................... ...................... ...................... ......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blank--Does not address requirements, I--Inadequately addresses requirements, A--Adequately addresses requirements.

Table 11 summarizes staff's assessment of the voluntary standards
relevant to labeling of packaging for button cell or coin batteries.

Table 11--Summary of Staff's Assessment of Labeling Requirements in Standards for Batteries
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANSI C18.1M ANSI C18.3M UL 1642 IEC 60086-4 IEC 60086-5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scope:
Battery Chemistry Type...... Aqueous............... Lithium............... Lithium............... Lithium............... Aqueous.
Labeling:
On batteries *.............. I..................... I..................... ...................... I..................... I
On battery packaging........ I..................... I..................... I..................... I..................... I
In instructions or ...................... I..................... ...................... ...................... ......................
accompanying literature.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blank--Does not address requirements, I--Inadequately addresses requirements, A--Adequately addresses requirements.
* Not directly addressed by Reese's Law.

As reflected in Table 10 and explained more fully in Tab C of
Staff's NPR Briefing Package and its Appendix, none of the voluntary
standards relevant to consumer products that contain button cell or
coin batteries have a scope that includes all consumer products. For
example, the warnings required in ASTM F963 are limited to toys, and
they also do not address spare batteries included with a consumer
product. For UL 4200A, the required warnings do not use ANSI formatting
and do not clearly warn of an ingestion hazard; this standard requires
warning of a ``chemical burn'' without informing consumers how this
hazard can occur. IEC 62115 permits a ``Contains coin battery'' symbol
on the product packaging, but it does not instruct consumers to ``Keep
out of reach of children'' on the packaging, instructions, or product.
ASTM F2999-19 and ASTM F2923-20, for jewelry, do not satisfy any of the
labeling requirements of Reese's Law.
Table 11 summarizes staff's assessment that the voluntary
standards' labeling requirements for battery packaging, likewise, do
not satisfy Reese's Law. As reflected in Table 11 and explained more
fully in Tab C of Staff's NPR briefing package and its Appendix, none
of the voluntary standards relevant to button cell or coin batteries
have a scope that includes all button cell or coin batteries for which
the ingestion hazard applies. Warnings in ANSI C18.1M and IEC 60086-5
are limited to aqueous battery chemistries (including alkaline
batteries), while ANSI C18.3M, UL 1642, and IEC 60086-4 are limited to
lithium battery chemistries. Each of the relevant standards addresses
warnings on battery packaging, but do not contain requirements
specifically addressing the contents in Reese's Law. For example, ANSI
C18.3M contains two statements relevant to the ingestion hazard: ``Keep
batteries out of the reach of children, especially those batteries
fitting within the limits of the truncated cylinder,'' in section 8.4;
and ``Immediately seek medical attention if a cell or battery has been
swallowed. Also, contact your local poison control center,'' in section
8.5. However, the section containing these two statements provides
manufacturers with information regarding safe use of lithium batteries,
and does not require the statements to be placed on packaging.
Additional warning statements similar to those in section 8.4 and
section 8.5 can be found in Annex C, but are only required for lithium
coin cells 16 mm in diameter and larger.
Based on CPSC staff's review and analysis of voluntary standards
and for the reasons summarized above, the Commission determines
preliminarily that no existing voluntary standard contains the warnings
required by Reese's Law, for either consumer products containing button
cell or coin batteries, or the packaging of such batteries. Although no
standard, alone, contains labeling requirements that are adequate to
satisfy Reese's Law section 2, the standards collectively contain
elements that can be combined to establish succinct warnings that
address the ingestion hazard associated with button cell or coin
batteries. Accordingly, as discussed below, the labeling requirements
in the proposed rule are based on elements of several voluntary
standards.

[[Page 8706]]

B. Formatting Requirements for Warning Labels

The warning labels in the proposed rule follow requirements found
in ANSI Z535.4, American National Standard Product Safety Signs and
Labels, which is the primary voluntary consensus standard providing
guidelines for the design of safety signs and labels for application to
consumer products. The ANSI Z535.4 standard includes recommendations
for the design, application, use, and placement of warning labels, such
as including the signal word, ``WARNING,'' and the safety alert symbol
of an equilateral triangle surrounding an exclamation mark. The
following format requirements, drawn from this ANSI standard, apply to
all warning labels in the NPR:
1. All warnings must be clearly visible, prominent, legible, and
permanently marked.
2. Warnings must be in contrasting color to the background onto
which they are printed.
3. Warnings must be in English.
4. The safety alert symbol, an exclamation mark in a triangle, when
used with the signal word, must precede the signal word. The base of
the safety alert symbol must be on the same horizontal line as the base
of the letters of the signal word. The height of the safety alert
symbol must equal or exceed the signal word letter height.
5. The signal word ``WARNING'' must be in black letters on an
orange background. The signal word must appear in sans serif letters in
upper case only.
6. Certain text in the message panel must be in bold and in capital
letters, as shown in the example warning labels, to get the attention
of the reader.
7. For labels that are provided on a sticker, hangtag,
instructions, or manual, the safety alert symbol and the signal word
``WARNING'' must be at least 0.2 in. (5 mm) high. The remainder of the
text must be in characters whose upper case must be at least 0.1in.
(2.5 mm), except where otherwise specified.
8. For labels that are required to be on the packaging of button
cell and coin batteries, on the packaging of consumer products
containing such batteries, and directly on consumer products, text size
must be dependent on the area of the principal display panel. Text size
must be determined based on Table 12, which is based on the information
found in 16 CFR 1500.19(d)(7).

Table 12--Letter Size for Warning Labels: Information Based on 16 CFR 1500.19(d)(7)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter size measurements in inches
---------------------------------------------------------------------------------------------------------------------------------------------------------
Display Area: Inches \2\ 0-2 +2-5 +5-10 +10-15 +15-30 +30-100 +100-400 +400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Signal word (WARNING)......................................... 3/64 1/16 3/32 7/64 1/8 5/32 1/4 1/2
Statement of Hazard........................................... 3/64 3/64 1/16 3/32 3/32 7/64 5/32 1/4
Other Text.................................................... 1/32 3/64 1/16 1/16 5/64 3/32 7/64 5/32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter size measurements in cm (for reference only)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Display Area: cm \2\ 0-13 +13-32 +32-65 +65-97 +97-194 +194-645 +645-2,581 +2,581
--------------------------------------------------------------------------------------------------------------------------------------------------------
Signal word (WARNING)......................................... 0.119 0.159 0.238 0.278 0.318 0.397 0.635 1.270
Statement of Hazard........................................... 0.119 0.119 0.159 0.238 0.238 0.278 0.397 0.635
Other Text.................................................... 0.079 0.119 0.159 0.159 0.198 0.238 0.278 0.397
--------------------------------------------------------------------------------------------------------------------------------------------------------

Placement of labels on packaging of button cell or coin batteries,
consumer product packaging, and on consumer products, as set forth in
the proposed rule, rely on the following definitions:
<bullet> The ``principal display panel'' is defined as the display
panel for a retail package of button cell or coin batteries or retail
package of a consumer product containing such batteries that is most
likely to be displayed, shown, presented, or examined under normal or
customary conditions of display for retail sale. The principal display
panel is typically the front of the package.
<bullet> The ``secondary display panel'' means a display panel for
a retail package of a button cell or coin batteries or retail package
of a consumer product containing such batteries that is opposite or
next to the principal display panel. The secondary display panel is
typically the rear or side panels of the package.
<bullet> The ``product display panel'' means the surface area on,
near, or in the battery compartment. For consumer products with
replaceable button cell or coin batteries, the product display panel
must be visible while a consumer installs or replaces the button cell
or coin battery. For consumer products with nonreplaceable button cell
or coin batteries, the product display panel must be visible upon
access to the battery compartment.

C. Required Warnings for Button Cell or Coin Battery Packaging

Using the foregoing formatting requirements, the proposed rule
requires a warning for the principal display panel of the battery
packaging, shown in Figure 4, that meets the requirements in section 2
of Reese's Law.
BILLING CODE 6355-01-P

[[Page 8707]]

[GRAPHIC] [TIFF OMITTED] TP09FE23.005

Accordingly, battery packaging must include the following warnings
statements:
<bullet> ``INGESTION HAZARD: DEATH or serious injury can occur if
ingested.'' This sentence identifies the hazard of ingestion, as
required by section 2(b)(1) of Reese's Law.
<bullet> ``A swallowed button cell or coin battery can cause
Internal Chemical Burns in as little as 2 hours.'' This sentence
provides warning label requirements, as stated in Reese's Law; an
effective warning should have an explanation of how and why ingestion
of a button cell or coin battery is hazardous.
<bullet> ``KEEP new and used batteries OUT OF REACH OF CHILDREN.''
This sentence implements language in section 2(b)(2) of Reese's Law. In
addition, use of the icon recognized for keeping items out of
children's reach is intended to quickly convey the required message and
direct the reader's attention to the label. The icon incorporated with
the warning must be at least 8 mm (0.31 in.) in diameter for
visibility. Text size must be calculated per Table 12.
<bullet> ``Seek immediate medical attention if a battery is
suspected to be swallowed or inserted inside any part of the body.''
This sentence implements language in section 2(b)(2) of Reese's Law and
informs the consumer what actions should be taken if a button cell or
coin battery is ingested or inserted into any part of the body. The
warning includes the term ``inserted'' because insertions into the nose
can be aspirated into the trachea and lead to ingestion, with the same
risk of injury as oral ingestion.
If space prohibits the full warning with the icon shown in Figure 4
in accordance with the formatting requirements of Table 12, packaging
is required to use the ``Keep out of Reach'' icon (Figure 5) on the
principal display panel and the warning text must be placed on the
secondary display panel, as shown in Figure 6. The icon must be at
least 20 mm (0.79 in.) in diameter for visibility.
[GRAPHIC] [TIFF OMITTED] TP09FE23.006

To address the hazard of button cell or coin batteries that become
loose or separated from packaging, and to provide critical safety-
related information should an ingestion incident occur, the following
information implementing section 2(b)(2) of Reese's Law must be placed
on the secondary display panel of the packaging:
(1) ``Keep in original package until ready to use.'' This statement
instructs consumers to leave the batteries in child-resistant packaging
as a specific means of keeping new batteries out of the reach of
children.
(2) ``Immediately dispose of used batteries and keep away from
children. Do NOT dispose of batteries in household trash.'' This
statement instructs consumers on how to prevent ingestion hazards from
used batteries by keeping used batteries out of the reach of children,
including out of household trash.
(3) ``Call a local poison control center for treatment
information.'' This statement makes more actionable the guidance to
``immediately seek medical attention'' as described in section 2(b)(2)
of Reese's Law, and provides consumers with a resource for obtaining
medical advice suitable to their situation.

D. Required Warnings for Button Cell or Coin Batteries Included
Separately With the Consumer Product

Button cell or coin batteries included with a consumer product, but
not yet installed in the product, must contain the warning label in
Figure 4 on the principal display panel. If space does not allow the
full warning consistent with the formatting requirements of

[[Page 8708]]

Table 12, then the icon shown in Figure 5 must be placed on the
principal display panel with the text shown in Figure 6 on the
secondary display panel, and the icon must be at least 20 mm in
diameter for visibility. The goal is to ensure consumers have the
opportunity to see the appropriate safety-related warning information
and take appropriate action to store spare batteries safely away from
children until installed in a consumer product.

E. Required Warnings for Packaging of Consumer Products That Contain
Button Cell or Coin Batteries

Reese's Law requires warning labels on the packaging of consumer
products containing button cell or coin batteries. Each warning label
must contain the same wording and icon as the battery packaging, except
to make the first warning more explicit about the hazard: ``INGESTION
HAZARD: This product contains a button cell or coin battery.'' The
warning shown in Figure 7 must be on the principal display panel of the
consumer product packaging. Covered consumer products that do not
include packaging must affix the warning to the product with a hang tag
or sticker label.
[GRAPHIC] [TIFF OMITTED] TP09FE23.007

Product packaging that does not have the space to permit the full
warning as indicated in Table 12, must include an abbreviated warning
on the principal display panel, with the remaining statements (``KEEP
new and used batteries OUT OF REACH OF CHILDREN'' and ``Seek immediate
medical attention if a battery is suspected to be swallowed or inserted
inside any part of the body'') placed on the secondary display panel,
as shown in Figure 8. The icon must be at least 8 mm (0.31 in.) in
diameter for visibility. Text size must be calculated per Table 12.
[GRAPHIC] [TIFF OMITTED] TP09FE23.008

F. Required On-Product Warnings for Consumer Products That Contain
Button Cell or Coin Batteries

Reese's Law requires, as practicable, warnings directly on the
consumer product that contains button cell or coin batteries. A
consumer product must be permanently marked with an ingestion warning
on the product display panel. The warning in Figure 9 must be used:
[GRAPHIC] [TIFF OMITTED] TP09FE23.009

[[Page 8709]]

If space on the product does not allow the full warning text shown
in Figure 9 in accordance with Table 12, then the product must display
the internationally recognized: ``Warning: contains coin battery''
icon, as shown in Figure 10, which is permitted without text.
[GRAPHIC] [TIFF OMITTED] TP09FE23.010

See Staff's NPR Briefing Package at Tab C. For visibility, the icon
must be at least 7 mm (0.28 in.) in width and 9 mm (0.35 in.) in height
and must be on the product display panel and must be in yellow with
black outlines, as shown in Figure 10. The icon must be defined in
accompanying printed materials, such as instructions, manual, insert,
or hangtag.
Figure 11 illustrates the scaled version of this icon on a product
containing a battery, with a 20 mm (0.79 in.) diameter, as well as a
scaled version with a 5 mm (0.20 in.) diameter.
[GRAPHIC] [TIFF OMITTED] TP09FE23.011

Based on staff's assessment, we tentatively find that virtually all
consumer products can accommodate either the full warning or one of the
scaled icons, and we seek comment on that conclusion. However, if the
product is too small to include any of the warnings in Figures 9-11,
the product is required to:
1. have packaging containing the warning (see requirements for
consumer product packaging), or
2. have a hangtag or sticker label with the full warnings, as shown
in Figure 7.

G. Required Warnings for Instructions/Manuals Accompanying Consumer
Products

Instructions and manuals for consumer products that contain button
cell or coin batteries, if they exist, must contain the full warning
label text required for button cell or coin battery packaging, as shown
in Figure 7, as well as the three statements implementing section
2(b)(2) of Reese's Law to address the hazard of button cell or coin
batteries that become loose or separated from packaging, which provide
critical safety-related information should an ingestion incident occur:
<bullet> ``Immediately dispose of used batteries and keep away from
children. Do NOT dispose of batteries in household trash.''
<bullet> ``Even used batteries may cause severe injury or death.''
<bullet> ``Call a local poison control center for treatment
information.''
If instructions or manuals are not provided with the consumer
product, this information must be present on the principal display
panel or the secondary display panel of the consumer product packaging,
or if there is no consumer product packaging, the accompanying hang tag
or sticker label. This ensures that the consumer has the opportunity to
see the appropriate safety-related information, even when a consumer
product that uses a button cell or coin battery is not sold with a
button cell or coin battery.

VI. Required Notifications to Purchasers

In addition to the required warnings specified in Reese's Law, and
pursuant to the Commission's independent authority under section 27(e)
of the CPSA, the proposed rule requires delivery of technical and
performance data to purchasers. These notifications will improve safety
communication to consumers for the same products subject to the
proposed requirements discussed above, and based on the same hazard
assessment. Because these proposed notification requirements rest on
legal authority independent of Reese's Law, adopting them is not
inconsistent with Reese's Law's specification that the safety rule
promulgated pursuant to section 2 of that statute ``shall only
contain'' the provisions listed by Congress. 15 U.S.C. 2056e(a). For
ease of understanding and administration, however, we propose to
integrate the text of the notification requirements established under
section 27(e) with the warning requirements established in the safety
rule under Reese's Law.

A. Websites or Applications That Enable Consumers To Purchase Products
Online

Consumers should be able to view battery-related safety information
when purchasing products online. Otherwise, consumers would not be
exposed to the warnings until they receive the physical product.
Learning of the hazard associated with button cell or coin batteries at
the time the consumer is searching for product information and

[[Page 8710]]

making purchasing decisions may influence those purchasing decisions or
the actions taken to protect children against the hazard. Therefore,
pursuant to its authority under section 27(e) of the CPSA, the
Commission is proposing point-of-sale warning requirements for websites
or other internet presence that manufacturers (including importers, per
CPSA section 3(a)(11), 15 U.S.C. 2052(a)(11)) use to allow consumers to
purchase these products.
Specifically, online sales materials must include the warning in
Figure 7 for purchases of button cell or coin batteries, and the
warning in Figure 9 for purchases of consumer products containing
button cell or coin batteries. The warning must be clearly visible,
prominent, and legible next to the product description or near the
product image or near the product price.

B. Other Battery Safety Information on the Battery Packaging and
Consumer Product Packaging

In addition to the ingestion hazard warning, the proposed rule
requires other safety-related information on the battery packaging and
consumer product packaging. To reduce battery leakage, fire, and/or
explosion hazards that could lead to personal injury, consumers should
be aware of, and have ready access to, technical information about safe
handling and use of button cell and coin batteries, as well as the
characteristics of the batteries themselves. Therefore, we propose the
following additional safety information under the authority in section
27(e) of the CPSA:
1. Battery packaging.
(4) Battery type (e.g., LR44, CR2032).
(5) Battery chemistry (e.g., silver oxide button or lithium)
(6) Nominal voltage.
Having battery type, chemistry, and voltage on the packaging
constitutes performance and technical data that may help identify the
battery if an ingestion is suspected. If a button cell or coin battery
is ingested, knowing this information could assist medical providers to
assess the severity of the risk of injury, and to treat the patient
accordingly. For example, lithium button cell or coin batteries are
associated with a higher likelihood of injury or death, in part,
because they have a greater voltage than other button cell or coin
batteries. The compatible battery type and voltage information on the
product packaging will also help consumers avoid hazards associated
with using incompatible batteries, such as leakage, fire, and/or
explosion hazards. In addition, this statement will assist consumers in
selecting the correct type of battery for the product, reducing the
likelihood that incorrect battery cells will be taken from their secure
packaging and left loose and accessible to children.
(7) Year and month or week of manufacture or expiration date.
(8) Name or trademark of the manufacturer or supplier.
Identification of manufacture date and other manufacturer
information is technical data that may facilitate recalls resulting
from ingestion of button or coin batteries.
<bullet> ``Do not mix old and new batteries, different brands or
types of batteries, such as alkaline, carbon-zinc, or rechargeable
batteries.''
Mixing batteries can contribute to battery leakage, fire, and/or
explosion hazards that could lead to personal injury. In addition, this
statement will inform the consumer to use the correct type of battery
cell that is called for use in the product, reducing the likelihood
that incorrect battery cells will be taken from their secure packaging
and left loose and accessible to children.
<bullet> ``Ensure the batteries are installed correctly according
to polarity (+ and -).''
Batteries installed with the wrong polarity can leak or explode.
Also, incorrect installation may result in the consumer removing the
batteries to install another set of batteries, creating loose
batteries.
<bullet> ``Remove and immediately discard batteries from equipment
not used for an extended period of time.''
This statement is intended to ensure that consumers immediately
dispose of batteries in unused products, because if left for an
extended period, these batteries can leak, discharge, or explode
unexpectedly, creating risks of injury. Furthermore, used button cell
or coin batteries may have sufficient energy to cause damage if
ingested.
<bullet> ``Non-rechargeable batteries are not to be recharged.''
Placing non-rechargeable batteries in a charger can cause battery
leakage, fire, and/or exploding hazards. This statement is intended to
ensure that consumers do not attempt to recharge non-rechargeable
batteries, or leave used batteries accessible to children with the
intention of recharging them.
<bullet> ``Do not force discharge, recharge, disassemble, heat
above (manufacturer's specified temperature rating) or incinerate.
Doing so may result in injury due to venting, leakage or explosion
resulting in chemical burns.''
This statement warns against actions that may result in external
injuries from chemical burns. Damaged button cell or coin batteries
also can leak toxic chemicals that poses a risk if ingested.
2. Consumer product packaging or accompanying hang tag or sticker
label.
Also pursuant to section 27(e) of the CPSA, the principal display
panel or the secondary display panel of the consumer product packaging,
or if there is no consumer product packaging, the accompanying hang tag
or sticker label, must include the following:
<bullet> Products with non-replaceable batteries must include a
statement indicating the product contains non-replaceable batteries. If
a consumer attempts to replace a non-replaceable battery, this action
may damage the consumer product or the battery, and contribute to
battery leakage, fire and/or explosion hazards. This may also cause the
original or the replacement battery to become accessible, contributing
to the ingestion hazard.
The following additional requirements were previously described for
battery packaging, and for the same reasons are also required on either
the principal display panel or secondary display panel of the consumer
product packaging, or in the absence of consumer product packaging, on
the accompanying sticker or hangtag:
(9) Battery type (e.g., LR44, CR2032).
<bullet> Nominal voltage.
3. Instructions and manuals:
Likewise, under the authority of CPSA section 27(e), instructions
and manuals, when provided with consumer products must include the
following additional battery safety-related information that is also
required on the battery packaging:
<bullet> Battery type (e.g., LR44, CR2032).
<bullet> Nominal voltage.
<bullet> ``Do not mix old and new batteries, different brands or
types of batteries, such as alkaline, carbon-zinc, or rechargeable
batteries.''
<bullet> ``Remove and immediately discard batteries from equipment
not used for an extended period of time.''
<bullet> ``Non-rechargeable batteries are not to be recharged.''
<bullet> ``Do not force discharge, recharge, disassemble, heat
above (manufacturer's specified temperature rating) or incinerate.
Doing so may result in injury due to venting, leakage or explosion
resulting in chemical burns.''
If instructions or manuals are not provided with the consumer
product, this information must be present on the principal display
panel or the secondary display panel of the consumer product packaging,
or if there is no consumer product packaging, the accompanying hang tag
or sticker label. This ensures that the consumer has the opportunity to
see the appropriate safety-related

[[Page 8711]]

information, even when a consumer product that uses a button cell or
coin battery is not sold with a button cell or coin battery.

C. Request for Comment on Requiring a Warning Icon on Button Cell or
Coin Batteries

Reese's Law does not require marking or labeling regarding the
ingestion hazard directly on button cell or coin batteries. However,
the voluntary standard ANSI C18.3M advises to durably and indelibly
mark coin cells with the ``Keep Out of Reach'' icon, with a minimum
icon size of 6 mm in diameter. In accordance with Reese's Law, the
Commission recommends the ``Keep Out of Reach'' icon be used in
conjunction with warning labels on battery and consumer product
packaging to quickly convey the required message and direct the
reader's attention to the warning label. CPSC staff advises that
requiring button cell or coin batteries that are visible within the
packaging at the point of sale to have the ``Keep Out of Reach'' icon
will further remind the consumer of the ingestion hazard, and direct
attention to the icon and warning label on the battery packaging.
Additionally, placing the ``Keep Out of Reach'' icon on button cell or
coin batteries would continue to inform consumers of the ingestion
hazard posed by the battery at all stages of its lifecycle, including
while it is in battery packaging, when placed in a consumer product, or
when loose.
The Commission requests comment on whether the rule should require
button cell or coin batteries to be durably and indelibly marked with
the ``Keep Out of Reach'' icon where size permits, at a minimum size of
6 mm in diameter, and if so, whether the appropriate legal authority is
Reese's Law, section 27(e) of the CPSA, or another statute.
[GRAPHIC] [TIFF OMITTED] TP09FE23.012

VII. Description of the Proposed Rule

As noted, we propose for the sake of clarity, convenience, and
consistency to integrate the rule text adopted under Reese's Law with
that adopted under the separate authority of CPSA section 27(e), using
the same definitions and exceptions for the section 27(e) requirements
as for the requirements based on Reese's Law. Below, we describe the
resulting provisions of proposed 16 CFR part 1263.

A. Section 1263.1 Scope, Purpose, Effective Date, Units, and Exemption

Proposed Sec. 1263.1(a) explains the scope and purpose of the
safety standard required by Reese's Law. 15 U.S.C. 2056e, Public Law
117-171. Reese's Law requires a rule intended to eliminate or
adequately reduce the risk of injury and death to children 6 years old
and younger from ingesting button cell or coin batteries. Based on
section 2 of Reese's Law, the scope of the proposed rule includes
consumer products that contain, or are designed to use, button cell or
coin batteries, the packaging of such consumer products and
accompanying literature, and the packaging of button cell or coin
batteries.
Section 2(a) of Reese's Law requires performance requirements for
child-resistant button cell or coin battery compartments during
reasonably foreseeable use and misuse of consumer products that use
such batteries. Proposed Sec. 1263.1(a) also explains that Reese's Law
provides warning label requirements for packaging containing button
cell or coin batteries, packaging of consumer products containing such
batteries, consumer products, and instructions and manuals accompanying
consumer products. The proposed rule also explains that the Commission
will require point-of-sale notification of performance and technical
data under the Commission's authority in section 27(e) of the CPSA, 15
U.S.C. 2076(e).
Section 1263.1(b) describes the effective date of the proposed
rule. Consistent with section 6 of Reese's Law (15 U.S.C. 2056e Notes),
the rule proposes that all consumer products and packaging containing
button cell or coin batteries that are subject to the proposed rule,
and that are manufactured or imported after the proposed effective date
of 180 days following publication of the final rule in the Federal
Register, must comply with the requirements of this part.
Section 1263.1(c) provides that values stated without parentheses
are the requirement, while values in parentheses are approximate
values. This proposal is consistent with UL 4200A. Section 1263.1(d)
sets forth the statutory exemption for toys that meet the mandatory toy
standard in section 4 of Reese's Law, proposing that ``any object
designed, manufactured, or marketed as a plaything for children under
14 years of age that is in compliance with the battery accessibility
and labeling requirements of 16 CFR part 1250, Safety Standard
Mandating ASTM F963 for Toys, is exempt from the requirements of this
part.'' See 15 U.S.C. 2056e Notes.
Because section 2(a) of Reese's Law directs the Commission to adopt
a rule addressing the risk of injury from ingestion, and because the
purpose of the proposed rule is to address the ingestion hazard
associated with button cell or coin batteries, proposed Sec. 1263.1(e)
states that button cell or coin batteries that the Commission has
determined do not present an ingestion risk are not subject to this
proposed rule. The proposal applies to zinc-air button cell or coin
batteries.

B. Section 1263.2 Definitions

Proposed Sec. 1263.2 describes the definitions used for this
consumer product safety rule and notification requirements. The
proposed rule explains that in addition to the definitions given in
section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) and the
definitions in section 5 of Reese's Law (15 U.S.C. 2056e Notes), the
Commission proposes to add eight definitions that specifically apply to
this proposed rule. The definitions are listed in the proposed rule in
alphabetical order.

[[Page 8712]]

Accessible and Accessibility Probe. As described in section VII.C,
the proposed performance requirements for battery compartments require
that after use-and-abuse testing, a button cell or coin battery must
not become accessible to children. The proposed rule measures
accessibility using a test probe. Accordingly, proposed Sec. 1263.2
defines the required test probe, stating that an ``accessibility
probe'' means ``Test Probe 11 in IEC 61032 Protection of Persons and
Equipment by Enclosures--Probes for Verification.'' Similarly, proposed
Sec. 1263.2 defines ``accessible'' to mean that the tests probe is
``able to be contacted by the accessibility probe.'' This means a
battery is accessible if the test probe can touch a button cell or coin
battery. Specifying the test probe and the definition of ``accessible''
in the proposed rule is intended to assist those who test consumer
products to test consistently and reliability for the accessibility of
button cell or coin batteries during testing to the standard.
Button Cell or Coin Battery. Proposed Sec. 1263.2 restates the
statutory definition of a ``button cell or coin battery'' in section 5
of Reese's Law. 15 U.S.C. 2056e Notes. A ``button cell or coin
battery'' means ``(1) a single cell battery with a diameter greater
than the height of the battery; or (2) any other battery, regardless of
the technology used to produce an electrical charge, that is determined
by the Commission to pose an ingestion hazard.'' Id. For this proposed
rule, the Commission is focusing on addressing button cell and coin
batteries under part (A) of the definition, because other batteries
where the diameter is less than the height, such as AAA cylindrical
batteries, do not pose the same type of ingestion hazard as button cell
or coin batteries. For example, cylindrical batteries can pose a
choking hazard, and CPSC is aware that consumers have ingested
cylindrical batteries; however, the medical literature shows that
injury or death due to ingestion of a cylindrical battery is rare.
Consequently, the Commission is not including cylindrical batteries in
the proposed rule at this time, but will expect staff to continue to
monitor battery ingestion data. If CPSC becomes aware of a serious
ingestion hazard associated with another battery type, section 2(g) of
Reese's Law allows the Commission to undertake additional rulemaking to
address the hazard at any time. 15 U.S.C. 2056e(g).
Consumer product containing button cell or coin batteries. Proposed
Sec. 1263.2 contains the statutory definition of a ``consumer product
containing button cell or coin batteries'' from section 5 of Reese's
Law. 15 U.S.C. 2056e Notes. The Commission preliminarily interprets
this definition as providing that these consumer products include
consumer products that are sold with a button cell or coin battery, and
consumer products that are sold without a battery but are 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.
Ingestion Hazard. Proposed Sec. 1263.2 describes the ``ingestion
hazard'' addressed by the proposed rule. Based on a review of the
medical literature, CPSC incident data, and data from the NCPC, an
ingestion hazard is caused when a button cell or coin battery becomes
lodged in the body, and can potentially cause death or serious injury
through choking, generation of hazardous chemicals, leaking of
hazardous chemicals, electrical burns, pressure necrosis, or other
means.
Principal Display Panel and Secondary Display Panel. Proposed Sec.
1263.2 also explains what a ``principal display panel'' means to aid in
understanding the required placement of warning statements on consumer
product and button cell or coin battery packaging. The proposed rule
explains that a ``principal display panel'' is typically on the front
of the retail package of button cell or coin batteries or consumer
products containing such batteries. The principal display panel is the
panel most likely to be displayed, shown, presented, or examined under
normal or customary conditions of display for retail sale. This
definition assists in distinguishing the principal display panel from
the proposed definition of a ``secondary display panel,'' described as
a ``display panel for a retail package of button cell or coin batteries
or retail package of a consumer product containing such batteries that
is opposite or next to the principal display panel. The secondary
display panel is typically the rear or side panels of the package.''
Product Display Panel. Finally, proposed Sec. 1263.2 describes a
``product display panel'' to differentiate the surface of a consumer
product battery compartment, as opposed to the packaging of button cell
or coin batteries and the packaging of consumer products that contain
such batteries. A product display panel is:

the surface area on, near, or in the battery compartment. For
consumer products with replaceable button cell or coin batteries,
the product display panel must be visible while a consumer installs
or replaces the button cell or coin battery. For consumer products
with nonreplaceable button cell or coin batteries, the product
display panel must be visible upon access to the battery
compartment.

The intent of this definition is to inform industry that warnings
on a product display panel must be located where a consumer will see
the warning when interacting with the battery compartment, as required
in section 2(a)(2)(C) of Reese's Law. 15 U.S.C. 2056e(a)(2)(C).

C. Section 1263.3 Requirements for Consumer Products Containing Button
Cell or Coin Batteries

The primary way that children access button cell or coin batteries
and then ingest them is by accessing batteries from a consumer product.
Accordingly, as required by section 2(a) of Reese's Law, the proposed
rule would establish performance requirements for child-resistant
button cell or coin battery compartments on consumer products during
reasonably foreseeable use and misuse. Performance requirements are
based on staff's incident review, engineering analysis, testing of
consumer products, and assessment that none of the relevant voluntary
standards meet the risk reduction and warning requirements of Reese's
Law sections 2(a) and (d). The proposed rule is based on the provisions
of several existing voluntary standards, including UL 4200A-21, IEC
62368-1, and ASTM F963-17 (as codified in 16 CFR part 1250).
Performance requirements in the proposed rule would apply to consumer
products containing button cell or coin batteries with replaceable and
non-replaceable batteries.
General Requirements. Proposed Sec. 1263.3(a) contains general
requirements for consumer products containing button cell or coin
batteries. This section explains that, in general, consumer products
containing button cell or coin batteries must meet the performance and
labeling requirements in the proposed rule to minimize the risk of
children accessing and ingesting button cell or coin batteries.
Performance requirements for consumer products containing button
cell or coin batteries that are removable. Proposed Sec. 1263.3(b)
describes the specific performance requirements for consumer products
containing button cell or coin batteries that are removable. A
removable or replaceable button cell or coin battery in a consumer
product cannot be made accessible, meaning able to be contacted with
the accessibility probe, when tested to Sec. 1263.3(d); must meet the
performance tests in Sec. 1263.3(e); and must require a tool, such as
a screwdriver or coin, to open, or be secured using an enclosure

[[Page 8713]]

that requires a minimum of two independent and simultaneous hand
movements to open (a double-action locking mechanism).
The proposed rule also requires that battery compartments secured
by one or more screws, or a twist-on access cover, meet a test for
minimum torque (0.5 Nm (4.4 in-lb)) and minimum angle of rotation (90
degrees), or the fastener(s) must engage a minimum of two full threads.
Moreover, screws or fasteners used to secure the battery compartment
enclosure must be captive to the compartment door, cover, or closure.
Unlike UL 4200A and IEC 62368-1, the proposed rule does not exclude
from the requirement for captive screws large panel doors leading to
button cell or coin battery compartments. CPSC requests comment on the
rationale for such an exception and the types of products to which it
should apply, if adopted.
Performance requirements for consumer products containing button
cell or coin batteries that are non-removable. Proposed Sec. 1263.3(c)
explains that consumer products containing button cell or coin
batteries not intended for removal or replacement must be made
inaccessible by using a battery compartment enclosure that complies
with the performance requirements of Sec. 1263.3(b), meaning secured
in a compartment that meets the same requirements as removable button
cell or coin batteries, or by securing a button cell or coin battery
compartment using soldering, fasteners such as rivets, or equivalent
means, that passes the Secureness Test in Sec. 1263.3(f).
Accessibility test method. Proposed Sec. 1263.3(d) assesses
whether a child can access a button cell or coin battery installed in a
consumer product by determining whether the specified accessibility
probe can make contact with a button cell or coin battery. If children
can touch the battery, then they may be able to remove the battery,
leading to a potential ingestion. The test method requires that any
part of the battery compartment enclosure that can be opened or removed
without a tool, and with fewer than two independent and simultaneous
movements (e.g., a zipper or hook and loop), be removed (Sec.
1263.3(d)(1)). The test method also states that if any part of the
battery compartment is protected by pliable materials, such as fabric,
paper, foam, or vinyl, or a seam, the tester must first apply the
Tension Test for Seams in Stuffed Toys and Beanbag-Type Toys in 16 CFR
part 1250, to determine whether the battery compartment enclosure can
become exposed or accessible, using the specified force of 70.0 N (15.7
lbf) (Sec. 1263.3(d)(2)). The test method instructs that if during
this assessment a new part of the battery compartment enclosure becomes
exposed or accessible, the tester must repeat the test in Sec.
1263.3(d)(1), and the test in paragraph (d)(2), until no new part of
the battery compartment enclosure becomes exposed or accessible, and
then conduct the test in Sec. 1263.3(d)(3).
The test in Sec. 1263.3(d)(3) instructs the tester to insert or
apply the accessibility probe to any depth that a battery compartment
opening will permit, and rotate or angle the accessibility probe
before, during, and after insertion or application through the battery
compartment opening to any position that is necessary to determine
whether the probe can contact the button cell or coin battery. This
test is intended to simulate a child attempting to reach a button cell
or coin battery installed in the consumer product; however, this test
is not intended to judge the strength of the material comprising the
battery compartment. Testers should use the minimum force necessary to
determine whether the accessibility probe can contact a button cell or
coin battery installed in the consumer product.
Performance tests for consumer products containing button cell or
coin batteries. Proposed Sec. 1263.3(e) states that testers should
first conduct the required pre-conditioning steps in Sec. 1263.3(e)(1)
before testing consumer products to the performance requirements in
Sec. 1263.3(e)(2) (for products with replaceable battery
compartments), and Sec. 1263.3(f) (for products with accessible non-
replaceable batteries). Testers are also instructed to perform pre-
conditioning and performance requirements in the order presented in the
proposed rule.
Performance test: Pre-conditioning: Stress Relief. Proposed Sec.
1263.3(e)(1) requires each test sample of a consumer product to be pre-
conditioned prior to conducting the applicable performance tests. The
first pre-conditioning step, Sec. 1263.3(e)(1)(i), is ``stress
relief'' and applies to all covered consumer products, i.e., those with
replaceable and non-replaceable batteries. Stress relief requires
heating each sample consumer product that has a battery compartment
enclosure made from molded or formed thermoplastic materials in a
circulating air oven for at least 7 hours, at an oven temperature of
the higher of at least 70 [deg]C (158 [deg]F) or at least 10 [deg]C (18
[deg]F) higher than the maximum temperature of the thermoplastic
battery compartment enclosure during the most stringent normal
operation of the consumer product. The rule proposes that testers must
allow the product sample to cool to room temperature after removal from
the oven before proceeding, to achieve more consistent results across
tests and test labs.
Performance test: Pre-conditioning: Battery replacement. Mechanical
pre-conditioning breaks-in the component parts associated with securing
the battery compartment and is needed to address durability issues
associated with battery compartments, such as stripping of threads.
Accordingly, proposed Sec. 1263.3(e)(1)(ii), which applies only to
consumer products with button cell or coin batteries intended to be
removable or replaceable, requires opening the battery compartment
enclosure, removing and replacing the button cell or coin battery, and
closing the battery compartment enclosure for a total of 10 cycles.
When battery compartment enclosures are secured with one or more
screws, the screws must be loosened and then tightened using a suitable
screwdriver, and applying a continuous linear torque, according to the
Torque to Be Applied to Screws table, Table 20, of the Standard for
Audio, Video and Similar Electronic Apparatus--Safety Requirements, UL
60065. If the screw(s) do not meet the specified torque requirements
during this step, the test method requires removing the screws and
repeating the accessibility test in proposed Sec. 1263.3(d).
Performance test: Abuse tests. After pre-conditioning consumer
product samples, the proposed rule requires that all consumer product
samples with removable or replaceable batteries must pass a series of
six abuse tests, conducted in the sequence set forth in the proposed
rule. After testing, each sample must meet the compliance requirement
in proposed Sec. 1263.3(e)(3).
Performance test: Abuse tests: Drop test. To address foreseeable
risks of breaking consumer products or their battery compartments,
proposed Sec. 1263.3(e)(2)(i) requires each sample to be dropped 10
times from a height of 1.0 m (39.4 in) onto a horizontal hardwood
surface in positions likely to produce the maximum force on the battery
compartment enclosure. The hardwood surface must be at least 13 mm (0.5
in) thick, mounted on two layers of nominal 19 mm (0.75 in) thick
plywood, and placed on a concrete or equivalent non-resilient surface.
Performance test: Abuse tests: Impact test. Consistent with the UL
4200A standard, proposed Sec. 1263.3(e)(2)(ii) requires that the
battery compartment enclosure door or cover on each sample consumer
product be subjected to three, at least 2-J (1.5-ft[middot]lbf)
impacts, as shown

[[Page 8714]]

in Figures 1 and 2 to proposed paragraph Sec. 1263.3(e)(2)(ii).
Performance test: Abuse tests: Crush test. To address the scenario
of a child opening a battery compartment that cannot be impacted
directly during the drop test proposed Sec. 1263.3(e)(2)(iii) requires
each sample consumer product to be subjected to a crush test using
requirements similar to UL 4200A and IEC 62368-1. The crush test
simulates a child pushing on the product with hands or feet, which
cannot be assessed during the drop test on some consumer products. The
proposed rule requires that each sample be supported by a fixed, rigid
surface, in positions likely to produce the most adverse results, as
long as the position of the consumer product is self-supported, and
then apply a crushing force of at least 335 N (75.3 lbf) to the exposed
surface for a period of 10 seconds. The test method states the force
should be applied using a flat surface measuring approximately 100 mm
by 250 mm (3.9 in by 9.8 in).
Performance test: Abuse tests: Compression test. Proposed Sec.
1263.3(e)(2)(iv) requires the compression test in ASTM F963 as codified
in the toy standard. It further subjects consumer products to a
crushing load that addresses children unintentionally opening battery
compartments that cannot be impacted directly during the drop test, but
can be pushed open with hands or fingers. The test method requires that
if any surface of the battery compartment enclosure is accessible to a
child and inaccessible to flat surface contact during the drop test,
then apply the Compression Test from 16 CFR part 1250 (the mandatory
toy standard) to that surface, using a force of at least 136 N (30.6
lbf).
Performance test: Abuse tests: Torque test. The proposed rule
applies to products not specifically contemplated by UL 4200A or IEC
62368-1, such as shirts and shoes that light up and rely on a button
cell or coin battery to provide a power source. Accordingly, the
proposed rule includes torque and tension tests to address battery
accessibility to children in pliable products. If a child can grasp any
part of the battery compartment enclosure on a sample consumer product,
including the door or cover, with at least the thumb and forefinger, or
using teeth, proposed Sec. 1263.3(e)(2)(v) requires the battery
compartment enclosure to be tested to the Torque Test for Removal of
Components from 16 CFR part 1250 (the toy standard), using a torque of
at least 0.50 Nm (4.4 in.-lbf).
Performance test: Abuse tests: Tension test. For the same reasons
stated for the proposed torque requirement, if a child can grasp any
part of the battery compartment enclosure on a sample consumer product,
including the door or cover, with at least the thumb and forefinger, or
using teeth, proposed Sec. 1263.3(e)(2)(vi) requires application of
the Tension Test for Removal of Components from 16 CFR part 1250 (the
toy standard) to the battery compartment enclosure, using a force of at
least 70.0 N (15.7 lbf).
Performance test: Abuse tests: Compliance. Proposed Sec.
1263.3(e)(3) provides that if a button cell or coin battery becomes
accessible or is liberated from a consumer product as a result of any
of the abuse tests in Sec. 1263.3(e)(2), the consumer product is
noncompliant and fails testing. Additionally, after completing all
abuse testing, the proposed rule requires that the tester apply a force
of at least 50 N (11.2 lbf) for 10 seconds to the battery compartment
enclosure door or cover using the accessibility probe at the most
unfavorable position on the battery compartment enclosure, and in the
most unfavorable direction. The force must be applied in only one
direction at a time. If the battery compartment enclosure door or cover
opens or does not remain functional, or the button cell or coin battery
becomes accessible, the consumer product is noncompliant and fails
testing.
Performance test: Secureness test. Proposed Sec. 1263.3(f) applies
only to button cell or coin batteries not intended for removal or
replacement that are installed in a consumer product, and that are
accessible based on the test in Sec. 1263.3(b). Such products must be
tested by applying a test hook, as shown in Figure 3 to paragraph Sec.
1263.3(f) of the regulation text, using a force of at least 22 N (4.9
lbf), directed outwards, applied for 10 seconds at all points where
application of a force is possible. To pass the test, the button cell
or coin battery cannot become accessible or liberate from the consumer
product during testing.

D. Section 1263.4 Requirements for Marking and Labeling

As explained in sections V and VI of this preamble, the proposed
rule establishes warning label requirements for packaging containing
button cell or coin batteries; packaging of consumer products
containing such batteries (regardless of whether the batteries are
permanent or replaceable); battery compartments of consumer products
that contain button cell or coin batteries (where practicable and
regardless of whether the batteries are permanent or replaceable);
instructions or manuals that accompany such consumer products; as well
as time-of-sale (internet and in-store) notification of performance and
technical data that provides information about the safety of button
cell or coin batteries. Please see sections V and VI of this preamble
for a detailed description and rationale for the proposed warning label
requirements.

E. Section 1263.5 Severability

Section 1263.5 proposes a severability clause. The proposed
provision states the Commission's intent that if certain requirements
in the rule are stayed or determined to be invalid by a court, the
remaining requirements in the rule should continue in effect. This
severability clause would apply to all provisions whether adopted as
part of the safety standard under Reese's Law or as a notification
requirement under section 27(e) of the CPSA, to reflect the
Commission's intent that part 1263 as whole be given its greatest
effect.

VIII. Testing, Certification, and Notice of Requirements

Section 14(a) of the CPSA includes requirements for certifying that
consumer products comply with applicable mandatory standards. 15 U.S.C.
2063(a). Section 14(a)(1) addresses required certifications for non-
children's products, and sections 14(a)(2) and (a)(3) address
certification requirements specific to children's products.
Non-Children's Products. Section 14(a)(1) of the CPSA requires
every manufacturer (which includes importers per 15 U.S.C. 2052(a)(11))
of a non-children's product that is subject to a consumer product
safety rule under the CPSA or a similar rule, ban, standard, or
regulation under any other law enforced by the Commission to certify
that the product complies with all applicable CSPSC-enforced
requirements. 15 U.S.C. 2063(a)(1). Section 14(g) of the CPSA contains
content and availability requirements for certificates. 15 U.S.C.
2063(g).
Children's Products. A ``children's product'' is a consumer product
that is ``designed or intended primarily for children 12 years of age
or younger.'' 15 U.S.C. 2052(a)(2). Section 4 of Reese's Law
specifically exempts from the performance and labeling requirements in
section 2 of the law, any toy product that is in compliance with the
battery accessibility and labeling requirements in 16 CFR part 1250,
the mandatory toy standard. However, all non-toy children's products
that contain button cell or coin batteries are subject to the proposed
rule and must be tested by a

[[Page 8715]]

CPSC-accepted third party laboratory and certified as compliant.
The following factors are relevant when determining whether a
product is a children's product:
<bullet> manufacturer statements about the intended use of the
product, including a label on the product if such statement is
reasonable;
<bullet> whether the product is represented in its packaging,
display, promotion, or advertising as appropriate for use by children
12 years of age or younger;
<bullet> whether the product is commonly recognized by consumers as
being intended for use by a child 12 years of age or younger; and
<bullet> the Age Determination Guidelines issued by CPSC staff in
January 2020, and any successor to such guidelines.

Id. ``For use'' by children 12 years and younger generally means
that children will interact physically with the product based on
reasonably foreseeable use. 16 CFR 1200.2(a)(2). Children's products,
for example, may be decorated or embellished with a childish theme, be
sized for children, or be marketed to appeal primarily to children. Id.
Sec. 1200.2(d)(1).
Section 14(a)(2) of the CPSA requires the manufacturer or private
labeler of a children's product that is subject to a children's product
safety rule to certify that, based on a third party conformity
assessment body's testing, the product complies with the applicable
children's product safety rule. 15 U.S.C. 2063(a)(2). The Commission's
requirements for children's product testing and certification are
codified in 16 CFR part 1107. Section 14(a) of the CPSA also requires
the Commission to publish a notice of requirements (NOR) for a third
party conformity assessment body (i.e., testing laboratory) to obtain
accreditation to assess conformity with a children's product safety
rule. 15 U.S.C. 2063(a)(3)(A). Because some consumer products that
contain button cell or coin batteries are children's products, the
proposed rule is a children's product safety rule, as applied to those
products. Accordingly, if the Commission issues a final rule, it must
also issue an NOR.
The Commission published a final rule, codified at 16 CFR part
1112, entitled Requirements Pertaining to Third Party Conformity
Assessment Bodies, which established requirements and criteria
concerning testing laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112
includes procedures for CPSC to accept a testing laboratory's
accreditation and lists the children's product safety rules for which
CPSC has published NORs. When CPSC issues a new NOR, it must amend part
1112 to include that NOR. Accordingly, as part of this NPR for child-
resistant battery compartments on consumer products, the Commission
proposes to amend part 1112 to add the ``Safety Standard and
Notification Requirements for Button Cell or Coin Batteries and
Consumer Products Containing Such Batteries'' to the list of children's
product safety rules for which CPSC has issued an NOR.
Testing laboratories that apply for CPSC acceptance to test
consumer products containing button cell or coin batteries, that are
children's products, to comply with the new rule, would have to meet
the requirements in part 1112. When a laboratory meets the requirements
of a CPSC-accepted third party conformity assessment body, the
laboratory can apply to CPSC to include 16 CFR part 1263, Safety
Standard and Notification Requirements for Button Cell or Coin
Batteries and Consumer Products Containing Such Batteries, in the
laboratory's scope of accreditation of CPSC safety rules listed on the
CPSC website at: <a href="http://www.cpsc.gov/labsearch">www.cpsc.gov/labsearch</a>.

IX. Effective Date

The APA generally requires that the effective date of a rule be at
least 30 days after publication of the final rule. 5 U.S.C. 553(d). The
Commission proposes that a final rule containing (1) performance and
warning label requirements for consumer products containing button cell
or coin batteries, and (2) warning label requirements for button cell
or coin battery packaging, will become effective 180 days after
publication of a final rule in the Federal Register. Therefore, in
accordance with section 6 of Reese's Law, products manufactured or
imported after 180 days from publication of a final rule would be
required to comply with the rule.
The Commission is proposing 180 days to comply with the rule
because a substantial number of consumer products containing button
cell or coin batteries currently do not meet the performance
requirements in UL 4200A or ASTM F963, and many affected industries
will be unfamiliar with all or part of the proposed requirements. These
industries may need to redesign, test, and certify to the requirements
in the rule. Children's products that are not toys will require third
party testing to the rule, and 180 days will provide sufficient time
for test labs to become ISO-accredited and have this accreditation
accepted by CPSC to test children's products. Additionally, the warning
label requirements in the proposed rule include specific language that
requires manufacturers to revise or reprint all existing packaging and
to revise on-product warnings, where practicable.
A 180-day effective date reflects similar language in Reese's Law,
which in section 3(a) sets a 180-day effective date for the child-
resistant packaging requirements. The Commission requests comment on
whether a later or an earlier effective date would be appropriate to
comply with the proposed requirements and asks commenters to provide
specific information to support such a later or an earlier effective
date.

X. Initial Regulatory Flexibility Analysis

The Regulatory Flexibility Act (RFA) requires that agencies review
a proposed rule for the rule's potential economic impact on small
entities, including small businesses. Section 603 of the RFA generally
requires that agencies prepare an initial regulatory flexibility
analysis (IRFA) and make the analysis available to the public for
comment when the agency publishes an NPR. 5 U.S.C. 603. The IRFA must
describe the impact of the proposed rule on small entities and identify
significant alternatives that accomplish the statutory objectives and
minimize any significant economic impact of the proposed rule on small
entities. CPSC staff prepared an IRFA for this rulemaking that appears
at Tab E of the Staff's NPR Briefing Package. We provide a summary of
the IRFA below.

A. Reasons for Agency Action and Legal Basis for NPR

The proposed rule is intended to address ingestion of button cell
or coin batteries by children 6 years old and younger, and the
associated deaths and injuries, as required by Reese's Law, 15 U.S.C.
2056e, and authorized by section 27(e) of the CPSA, 15 U.S.C. 2076(e).
As detailed in Tab D of Staff's NPR Briefing Package, the proposed rule
would require performance requirements for button cell or coin battery-
powered consumer products, and require marking and labeling of consumer
products, consumer product packaging, and button cell or coin battery
packaging, as provided in Tab C of Staff's NPR Briefing Package.

B. Small Entities to Which the Proposed Rule Would Apply

The North American Industry Classification System (NAICS) defines
product codes for U.S. firms. Firms that manufacture button cell or
coin battery-powered consumer products may list their business under a
large variety of NAICS product codes. Most of these

[[Page 8716]]

firms likely fall under the following NAICS codes: 334118 Computer
Terminal and Other Computer Peripheral Equipment Manufacturing; 334310
Audio and Video Equipment Manufacturing; 335999 All Other Miscellaneous
Electrical Equipment and Component Manufacturing; and 339920 Sporting
and Athletic Goods Manufacturing. Importers of button cell or coin
battery-powered consumer products are also as varied as the
manufacturers. Staff expects most of the firms to fall under the
following NAICS codes as wholesalers: 423620 Household Appliances,
Electric Housewares, and Consumer Electronics Merchant Wholesalers;
423430 Computer and Computer Peripheral Equipment and Software Merchant
Wholesalers; and 423690 Other Electronic Parts and Equipment Merchant
Wholesalers.
Retailers of button cell or coin battery-powered consumer products
consist of a large variety of retailer types from large, ``big box''
retailers, to smaller specialized product firms. Nearly every NAICS
code listed under retail trade (44, 45) may sell a product within scope
of the proposed rule. Staff estimates that most of these products are
sold by firms listed in NAICS codes 443140 Electronics and Appliance
Retailers; 455219 All Other General Merchandise Retailers; 459420,
Gift, Novelty, and Souvenir Retailers; 452000 General Merchandise
Stores; and 459110 Sporting Goods Retailers.
Under U.S. Small Business Administration guidelines, a
manufacturer, importer, and retailer of button cell or coin battery-
powered consumer products is categorized as ``small,'' based on the
associated NAICS code. Manufacturers are categorized as small by the
number of employees and importers/retailers by annual revenues. Based
on 2017 data from U.S. Census Bureau, and a sample of retailers'
estimated revenues, staff estimated the number of firms classified as
small for each NAICS code listed above (Census Bureau, 2020). The
tables below provide the estimates of the number of small firms by each
code.

Table 13--Estimated Number of Small Manufacturers and Importers
----------------------------------------------------------------------------------------------------------------
SBA size
standard for Number of firms
NAICS code Description manufacturers/ that meet size
importers (# of standard
employees)
----------------------------------------------------------------------------------------------------------------
334118.................................. Computer Terminal and Other 1,000 509
Computer Peripheral Equipment
Manufacturing.
334290.................................. Other Communications Equipment 750 305
Manufacturing.
334310.................................. Audio and Video Equipment 750 453
Manufacturing.
335210.................................. Small Electrical Appliance 1,500 119
Manufacturing.
335999.................................. All Other Miscellaneous 500 734
Electrical Equipment and
Component Manufacturing.
339920.................................. Sporting and Athletic Goods 750 1,564
Manufacturing.
339940.................................. Office Supplies (except Paper) 750 412
Manufacturing.
339999.................................. All Other Miscellaneous 500 5,714
Manufacturing.
423420.................................. Office Equipment Merchant 200 2,197
Wholesalers.
423430.................................. Computer and Computer Peripheral 250 5,743
Equipment and Software Merchant
Wholesalers.
423620.................................. Household Appliances, Electric 225 1,956
Housewares, and Consumer
Electronics Merchant
Wholesalers.
423690.................................. Other Electronic Parts and 250 8,826
Equipment Merchant Wholesalers.
423910.................................. Sporting and Recreational Goods 100 4,521
and Supplies Merchant
Wholesalers.
423990.................................. Other Miscellaneous Durable 100 8,350
Goods Merchant Wholesalers.
----------------------------------------------------------------------------------------------------------------

Table 14--Estimated Number of Small Retailers
----------------------------------------------------------------------------------------------------------------
SBA size standard
for retailers Number of firms
NAICS code Description (annual revenue) that meet size
$millions standard
----------------------------------------------------------------------------------------------------------------
444110.................................. Home Centers.................... 41.50 1,526
444130.................................. Hardware Retailers.............. 14.50 9,623
444240.................................. Nursery, Garden Center, and Farm 19.00 13,228
Supply Retailers.
443140.................................. Electronics and Appliance 35.00 18,906
Retailers.
455110.................................. Department Stores............... 35.00 11
455211.................................. Warehouse Clubs and Supercenters 41.50 3
455219.................................. All Other General Merchandise 35.00 7,812
Retailers.
456110.................................. Pharmacies and Drug Retailers... 33.00 18,912
459110.................................. Sporting Goods Retailers........ 23.50 16,123
459410.................................. Office Supplies and Stationery 35.00 2,646
Retailers.
459420.................................. Gift, Novelty, and Souvenir 12.00 15,264
Retailers.
459999.................................. All Other Miscellaneous 10.00 36,225
Retailers.
452000.................................. General Merchandise Stores...... 35.00 7,832
----------------------------------------------------------------------------------------------------------------

[[Page 8717]]

C. Costs and Impact of the Proposed Rule on Small Entities

Button cell or coin battery-powered consumer products may require
redesign to meet the rule's requirement for a battery compartment that
requires a coin or tool to secure the enclosure (``tool lock''), or a
double-action lock. Button cell or coin battery-powered consumer
product manufacturers would most likely adopt a tool lock secured with
a screw for affected products that currently do not conform to the
proposed rule requirements. The potential costs of this proposed rule,
therefore, are the incremental cost to incorporate a screw lock, and
the one-time research, development, and retooling costs associated with
any changes to battery compartments. For products that incorporate a
double-action lock to secure the compartment, the Commission expects
the only design-related cost incurred would be the redesign of the
compartment to accommodate the change.
Staff's estimate of the incremental costs to modify a battery
compartment for a tool lock ranges from $0.02 to $0.04 per product. The
estimate of possible research, development, and retooling costs is a
maximum of $15,400 per firm. We expect firms that choose to meet the
requirement of the proposed rule using a double-action lock would only
incur research and development costs.
Manufacturers would likely incur additional costs to certify that
their button cell or coin battery-powered consumer products meet the
proposed rule, as required by section 14 of the CPSA, 15 U.S.C. 2063.
For general use products, the certification must be based on a test of
each product or a reasonable testing program. Manufacturers may
complete the testing themselves or use a testing laboratory.
Certification of children's products, however, must be completed by a
CPSC-accepted, third party conformity assessment body (i.e., third
party laboratory). The cost of laboratory certification testing is
expected to range from $150 to $350 per product sample. These third
party testing costs should be considered as a possible maximum testing
cost of the proposed rule, because less costly alternatives may be
available.\14\
---------------------------------------------------------------------------

\14\ Certificate content requirements are set forth in section
14(g) of the CPSA and codified in 16 CFR part 1110. A reasonable
testing program performed by the manufacturer would meet the
requirements for general use (non-children's) products, but
children's products are required to be tested and certified based on
the third party testing requirements in 16 CFR part 1107.
---------------------------------------------------------------------------

To comply with the proposed rule, small manufacturers would incur a
one-time redesign cost and continuous incremental component costs,
described above, for some product lines that currently do not meet the
requirements. We do not expect most small manufacturers to suffer a
disproportionate cost effect from the proposed rule. Firms that rely
heavily on the production of small, unique or novel electronic
products, or high-volume, low-price products, could be affected
adversely, however. Retail prices for button cell or coin battery-
powered consumer products vary widely, with the least expensive
product, on a per-unit basis, being mini flashlights at $1.00.\15\ A
small manufacturer could incur costs that exceed 1 percent of annual
revenue if the firm only produced these high-volume, low-price, or
novel electronic products. Also, smaller manufacturers with less than
$770,000 to $1,540,000 in annual revenue could incur one-time costs
that exceed 1 percent of annual revenue, based on CPSC staff's estimate
of the potential research and development costs, which range from
$7,700 to $15,400 per firm.
---------------------------------------------------------------------------

\15\ Based on staff's review of product offerings on retailer
websites and in-store locations.
---------------------------------------------------------------------------

Generally, CPSC staff considers an impact to be potentially
significant if it exceeds 1 percent of a firm's revenue. CPSC staff
anticipates a potentially significant impact on some small firms that
manufacture button cell or coin battery-powered consumer products.
Staff assesses, however, that most small firms would not incur costs
that exceed 1 percent of annual revenues, and therefore, would not be
significantly impacted by the proposed rule.

D. Alternatives

Under section 603(c) of the Regulatory Flexibility Act, an IRFA
analysis should ``contain a description of any significant alternatives
to the proposed rule which accomplish the stated objectives of the
applicable statutes and which minimize any significant impact of the
proposed rule on small entities.'' 5 U.S.C. 603(c). CPSC staff assessed
that the broad scope of Reese's Law does not allow for a significant
alternative that would reduce impacts to small businesses, such as
limiting scope, providing exemptions, and educating consumers in lieu
of regulatory action. To reduce the impact of the proposed rule on
small firms, CPSC proposes not to require labeling of zinc-air
batteries, which do not pose the same type of ingestion hazard as other
button cell or coin batteries. This proposal will decrease burden, but
not consequentially, because incremental labeling costs are not
significant. CPSC also could refrain from proposing the additional
labeling requirements under section 27(e) of the CPSA, which are not
required by Reese's Law. However, removing section 27(e) performance
and technical data requirements would reduce burden by an
inconsequential amount, because firms would still have to conform to
the other labeling provisions mandated by Reese's Law. The incremental
increase in burden from staff's additional labeling requirements is
insignificant.

XI. Environmental Considerations

The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, certain categories of CPSC actions
normally have ``little or no potential for affecting the human
environment,'' and therefore, do not require an environmental
assessment or an environmental impact statement. 16 CFR 1021.5(c)(1).
Safety standards providing performance and labeling requirements for
consumer products that contain button cell or coin batteries fall
within this categorical exclusion.

XII. Paperwork Reduction Act

This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA; 44 U.S.C. 3501-3521). Under the PRA, an agency must publish the
following information:
[ssquf] A title for the collection of information;
[ssquf] A summary of the collection of information;
[ssquf] A brief description of the need for the information and the
proposed use of the information;
[ssquf] A description of the likely respondents and proposed
frequency of response to the collection of information;
[ssquf] An estimate of the burden that will result from the
collection of information; and
[ssquf] Notice that comments may be submitted to OMB.

44 U.S.C. 3507(a)(1)(D). In accordance with this requirement, the
Commission provides the following information:
Title: Amendment to Third Party Testing of Children's Products,
approved previously under OMB Control No. 3041-0159.
Summary, Need, and Use of Information: Based on the requirements in
Reese's Law, 15 U.S.C. 2056e(a) and (b), and section 27(e) of the
Consumer Product Safety Act, 15 U.S.C. 2076(e),

[[Page 8718]]

the proposed consumer product safety standard prescribes performance
requirements for child-resistant battery compartments on consumer
products that contain button cell or coin batteries, and warning
requirements for button cell and coin-battery packaging, consumer
product packaging, consumer products, and instructions and manuals.
These performance and labeling requirements are intended to reduce or
eliminate injuries and deaths associated with children 6 years old and
younger ingesting button cell or coin batteries.
Section 4 of Reese's Law specifically exempts from the performance
and labeling requirements in section 2 of the law, any toy product \16\
that is in compliance with the battery accessibility and labeling
requirements in 16 CFR part 1250, Safety Standard Mandating ASTM F963
for Toys. However, some consumer products that are not toys subject to
the toy standard are considered children's products. A ``children's
product'' is a consumer product that is ``designed or intended
primarily for children 12 years of age or younger.'' 15 U.S.C.
2052(a)(2). The Commission's regulation at 16 CFR part 1200 further
interprets the term. Section 14 of the CPSA requires that children's
products be tested by a third party conformity assessment body, and
that the manufacturer of the product, including an importer, must issue
a children's product certificate (CPC). Based on such third party
testing, a manufacturer or importer must attest to compliance with the
applicable consumer product safety rule by issuing the CPC. The
requirement to test and certify children's products falls within the
definition of ``collection of information,'' as defined in 44 U.S.C.
3502(3).
---------------------------------------------------------------------------

\16\ For purposes of Reese's Law, a ``toy product'' is ``any
object designed, manufactured, or marketed as a plaything for
children under 14 years of age.'' 15 U.S.C. 2056e Notes.
---------------------------------------------------------------------------

The requirements for the CPCs are stated in section 14 of the CPSA,
and in the Commission's regulation at 16 CFR parts 1107 and 1110. Among
other requirements, each certificate must identify the manufacturer or
private labeler issuing the certificate and any third party conformity
assessment body, on whose testing the certificate depends, the date and
place of manufacture, the date and place where the product was tested,
each party's name, full mailing address, telephone number, and contact
information for the individual responsible for maintaining records of
test results. The certificates must be in English. The certificates
must be furnished to each distributor or retailer of the product and to
the CPSC, if requested.
The Commission has an OMB control number, 3041-0159, for children's
product testing and certification. This proposed rule would amend this
collection of information to add testing and certification to the
performance requirements for child-resistant battery compartments on
children's products (that are not toys) that contain button cell or
coin batteries, as well as warnings on the packaging of these
children's products, the battery compartment of these children's
products, and any accompanying instructions and manuals, as set forth
in the proposed rule.
Respondents and Frequency: Respondents include manufacturers and
importers of non-toy children's products that contain button cell or
coin batteries. Manufacturers and importers must comply with the
information collection requirements when children's products that
contain button cell or coin batteries are manufactured or imported
after the effective date of the rule.
Estimated Burden: CPSC has estimated the respondent burden in
hours, and the estimated labor costs to the respondent.
Estimate of Respondent Burden: The hourly reporting burden imposed
on firms that manufacture or import non-toy children's products that
contain button cell or coin batteries include the time and cost to
maintain records related to third party testing, the time to issue a
CPC, and the time to include required warning labels on children's
product battery compartments, children's product packaging, and to
update instructions or manuals with required warnings.

Table 15--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Length of
Burden type Total annual response Annual burden
reponses (hours) (hours)
----------------------------------------------------------------------------------------------------------------
Third-party testing, recordkeeping and record maintenance....... 6,046 5.0 30,230
Certification and labeling...................................... 1,209 1.0 1,209
-----------------------------------------------
Total Burden................................................ .............. .............. 31,439
----------------------------------------------------------------------------------------------------------------

Three types of third party testing of children's products are
required: certification testing, material change testing, and periodic
testing. Requirements state that manufacturers must conduct sufficient
testing to ensure that they have a high degree of assurance that their
children's products comply with all applicable children's product
safety rules before such products are introduced into commerce. If a
manufacturer conducts periodic testing, they are required to keep
records that describe how the samples of periodic testing are selected.
CPSC estimates that 0.4 percent of all children's products sold
annually, or 6,046 children's products, are children's products that
contain button cell or coin batteries and would be subject to third-
party testing, for each of which 5.0 hours of recordkeeping and record
maintenance will be required. Thus, the total hourly burden of the
recordkeeping associated with certification is 30,230 hours (5.0 x
6,046).
Additionally, battery compartments, product packaging, and
instructions and manuals must be updated to include the required
warnings statements. We estimate that the time required to make these
modifications is about 1 hour per product. Based on an evaluation of a
sample of supplier product lines, there are a total of 1,209 affected
products; therefore, the estimated burden associated with warnings and
labeling is 1 hour per product x number of product lines = 1,209 hours.
We estimate the hourly compensation for the time required to create and
update labels is $36.80 (U.S. Bureau of Labor Statistics, ``Employer
Costs for Employee Compensation,'' Sept. 2022, total compensation for
all sales and office workers in goods-producing private industries:
<a href="https://www.bls.gov/news.release/archives/ecec_12152022.pdf">https://www.bls.gov/news.release/archives/ecec_12152022.pdf</a>).
Therefore, the estimated annual cost to industry associated with the
labeling requirements is $1,156,955

[[Page 8719]]

($36.80 per hour x 31,439 hours = $1,156,955.2). No operating,
maintenance, or capital costs are associated with the collection.
This burden estimate is the largest reasonably possible, assuming
that every manufacturer had to modify three product labels (battery
compartment, packaging, and instructions/manual). However, based on
staff's review of non-toy children's products that contain button cell
or coin batteries, many of these products already contain some type of
warning on the product or product packaging. Accordingly, staff
believes it possible that product modification for warnings and any
associated burden could be very low.
Under the OMB's regulations (5 CFR 1320.3(b)(2)), the time, effort,
and financial resources necessary to comply with a collection of
information that would be incurred by persons in the ``normal course of
their activities'' are excluded from a burden estimate, where an agency
demonstrates that the disclosure activities required to comply are
``usual and customary.'' If warning statements on one or more battery
compartments, product packaging, and instructions/manuals is usual and
customary for non-toy children's products that contain button cell or
coin batteries, CPSC could estimate that no burden hours are associated
with the labeling requirements in the proposed rule, because any burden
associated with warning labels would be ``usual and customary'' and not
within the definition of ``burden'' under the OMB's regulations. We
request comments on this potential estimate of no burden for warning
labels, or any aspect of labeling. We also request comment on the
preliminary analysis demonstrating that the largest possible burden
estimate for the proposed standard to require warning labels is 1,209
hours at a cost of $44,491 annually.
The total estimated burden associated with the proposed rule on
non-toy children's products that contain a button cell or coin battery
for third party testing, recordkeeping, issuing a certificate (CPC),
and placing the required warning statements on the battery compartment
of the children's product, on the packaging of the children's product,
and on any associated instructions or manuals is 31,439 labor hours
annually.
Labor Cost of Respondent Burden. According to the U.S. Bureau of
Labor Statistics (BLS), Employer Costs for Employee Compensation, the
total compensation cost per hour worked for all private industry
workers was $39.61 (September 2022, <a href="https://www.bls.gov/ncs/ect/">https://www.bls.gov/ncs/ect/</a>).
Based on this analysis, CPSC staff estimates that labor cost of
respondent burden would impose a cost to industry of approximately
$1,245,299 annually (31,439 hours x $39.61 per hour = $1,245,298.79).
Cost to the Federal Government. The estimated annual cost of the
information collection requirements to the Federal Government is
approximately $4,448, which includes 60 staff hours to examine and
evaluate the information, as needed, for Compliance activities. This is
based on a GS-12, step 5 level salaried employee. The average hourly
wage rate for a mid-level salaried GS-12 employee in the Washington, DC
metropolitan area (effective as of January 2023 is $51.15 (GS-12, step
5). This represents 69.0 percent of total compensation (U.S. Bureau of
Labor Statistics, ``Employer Costs for Employee Compensation,''
September 2022, Table 2., percentage of wages and salaries for all
civilian management, professional, and related employees: <a href="https://www.bls.gov/news.release/archives/ecec_12152022.pdf">https://www.bls.gov/news.release/archives/ecec_12152022.pdf</a>). Adding an
additional 31.0 percent for benefits brings average annual compensation
for a mid-level salaried GS-12 employee to $74.13 per hour. Assuming
that approximately 60 hours will be required annually, this results in
an annual cost of $4,448 ($74.13 per hour x 60 hours = $ 4,447.8).
Comments. CPSC has submitted the information collection
requirements of this proposed rule to OMB for review in accordance with
PRA requirements. 44 U.S.C. 3507(d). CPSC requests that interested
parties submit comments regarding information collection to the Office
of Information and Regulatory Affairs, OMB (see the ADDRESSES section
at the beginning of this NPR).
Pursuant to 44 U.S.C. 3506(c)(2)(A), the Commission invites
comments on:
<bullet> Whether the proposed collection of information is
necessary for the proper performance of CPSC's functions, including
whether the information will have practical utility;
[ssquf] The accuracy of CPSC's estimate of the burden of the
proposed collection of

[…truncated; see source link]

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on February 9, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.