65296 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Rules and Regulations 

1To implement requirements in Reese’s Law for 

labeling of button cell or coin battery packaging, on 

September 8, 2023, the Commission voted (4–0) to 

publish this final rule. The Chair, and 

Commissioners Trumpka and Feldman, issued 

statements in connection with their vote, available 

at: https://www.cpsc.gov/s3fs-public/RCA-Reese-sLaw-Implementation-UL-4200A-2023-DFR-forButton-Cell-or-Coin-Batteries-and-Draft-FR-toAmend-Part-1263.pdf?VersionId=V56MNzyWa_

iXqZQlKCyOlRtjl9lcoFit. 

2The Notes of Reese’s Law, 15 U.S.C. 2056e, 

define the phrase ‘‘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.’’ 

3The information in this final rule is based on 

information and analysis provided in the August 

31, 2023, Staff Briefing Package: Draft Final Rule to 

Establish a Safety Standard for Button Cell or Coin 

Batteries and Consumer Products Containing Such 

Batteries (Staff’s Final Rule Briefing Package), 

available at: https://www.cpsc.gov/s3fs-public/ 

Reeses-Law-Implementation-CommissionDetermination-Regarding-UL-4200A-2023-andDraft-DFR-for-Button-Cell-or-Coin-Batteries-and-2- 

Draft-FR-to-Amend-Part-1263--LabelingRequirmnts-for-Button-Cell-or-CoinBatte.pdf?VersionId=PyTbnom1Oem

A3BWl9Z1lONzTlyqbcthW, and on 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: https:// 

www.cpsc.gov/s3fs-public/NoticeofProposed

RulemakingSafetyStandardandNotification

RequirementsforButtonCellorCoin

BatteriesandConsumerProductsContaining

SuchBatteries.pdf?VersionId=kDinNeydktkt

3T8RRtzN4u1GTXPRjpEl. 

§ 1263.3 Requirements for consumer 

products containing button cell or coin 

batteries. 

Each consumer product containing 

button cell or coin batteries shall 

comply with ANSI/UL 4200A, Standard 

for Safety for Products Incorporating 

Button Batteries or Coin Cell Batteries, 

approved on August 30, 2023. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. This material is available 

for inspection at the U.S. Consumer 

Product Safety Commission and at the 

National Archives and Records 

Administration (NARA). Contact the 

U.S. Consumer Product Safety 

Commission at: the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, MD 20814, 

telephone (301) 504–7479, email: cpscos@cpsc.gov. For information on the 

availability of this material at NARA, 

visit https://www.archives.gov/federalregister/cfr/ibr-locations or email 

fr.inspection@nara.gov. A free, readonly copy of the standard is available 

for viewing on UL’s website at https:// 

www.ulstandards.com/IBR/logon.aspx. 

You may also obtain a copy from 

Underwriters Laboratories, Inc (UL), 333 

Pfingsten Road, Northbrook, IL 60062, 

or through UL’s website: www.UL.com. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2023–20333 Filed 9–20–23; 8:45 am] 

BILLING CODE 6355–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1263 

[CPSC Docket No. 2023–0004] 

Safety Standard for Button Cell or Coin 

Batteries and Consumer Products 

Containing Such Batteries 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: In February 2023, as required 

by Reese’s Law, the U.S. Consumer 

Product Safety Commission (CPSC or 

Commission) issued a notice of 

proposed rulemaking (NPR) to establish 

performance and labeling requirements 

for consumer products containing 

button cell or coin batteries, and 

requirements for labeling of button cell 

or coin battery packages, to eliminate or 

adequately reduce the risk of injury 

from ingestion of button cell or coin 

batteries by children six years old and 

younger. Elsewhere in this issue of the 

Federal Register, the Commission is 

publishing a direct final rule to 

incorporate by reference a voluntary 

standard as the mandatory standard for 

consumer products containing button 

cell or coin batteries. The Commission 

issues this final rule to complete Reese’s 

Law requirements for warning labels on 

the packaging of button cell or coin 

batteries. Button cell or coin battery 

packaging subject to this final rule must 

be certified as compliant with these 

warning label requirements. 

DATES: This rule is effective September 

21, 2024. Button cell or coin battery 

packaging manufactured or imported 

after September 21, 2024, must comply 

with this final rule. 

FOR FURTHER INFORMATION CONTACT: 

William Cusey, Small Business 

Ombudsman, U.S. Consumer Product 

Safety Commission, 4330 East-West 

Highway, Bethesda, MD 20814; 

telephone 301–504–7945; email: sbo@

cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory 

Authority 1

On February 9, 2023, pursuant to 

Reese’s Law (Pub. L. 117–171, 15 U.S.C. 

2056e), the Commission published an 

NPR to establish a Safety Standard and 

Notification Requirements for Button 

Cell or Coin Batteries and Consumer 

Products Containing Such Batteries. 88 

FR 8692. Consistent with section 2(a) of 

Reese’s Law, the NPR proposed 

performance and labeling requirements 

for consumer products containing 

button cell or coin batteries 2 and 

labeling requirements for button cell 

and coin battery packaging. 15 U.S.C. 

2056(a). 

CPSC received 38 comments during a 

30-day comment period ending in 

March 2023; four of the comments were 

duplicates. CPSC received two late-filed 

comments; one is out-of-scope for this 

rulemaking. We also received nine 

comments in response to an April 11, 

2023 Paperwork Reduction Act (PRA) 

notice. 88 FR 21652. Most of the public 

comments concerned performance and 

labeling requirements for consumer 

products, which are addressed in the 

direct final rule, published elsewhere in 

this issue of the Federal Register, 

establishing 16 CFR part 1263. That 

direct final rule incorporates by 

reference ANSI/UL 4200A, Standard for 

Safety for Products Incorporating Button 

Batteries or Coin Cell Batteries, 

approved on August 30, 2023 (UL 

4200A–2023), as the mandatory 

standard for consumer products 

containing button cell or coin batteries. 

UL 4200A–2023 does not contain 

warning label requirements for button 

cell or coin battery packaging. 

Accordingly, in this final rule, pursuant 

to section 2(a)(2)(A) and 2(b) of Reese’s 

Law, we review and respond to the 

public comments related to warning 

labels for packaging of button cell or 

coin batteries and finalize a rule for 

such warning labels. 15 U.S.C. 

2056e(a)(2)(A) and (b). As explained in 

section I.D of this preamble, based on 

the comments, the final rule contains 

several modifications to requirements 

for battery package labeling from the 

NPR.3

A. Reese’s Law 

President Biden signed Reese’s Law 

on August 16, 2022. 15 U.S.C. 2056e. 

The purpose of Reese’s Law is to protect 

children six years old and younger 

against hazards associated with the 

ingestion of button cell or coin batteries 

during reasonably foreseeable use or 

misuse conditions. 15 U.S.C. 

2056e(a)(1). Section 5 of Reese’s Law 

broadly defines a ‘‘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 


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4The definitions in section 5 of Reese’s Law are 

codified in the notes to 15 U.S.C. 2056e. 

5This final 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. 

produce an electrical charge, that is 

determined by the Commission to pose 

an ingestion hazard.’’ 4 5 Notes to 15 

U.S.C. 2056e. 

Section 2(a)(2) of Reese’s Law 

mandates that the Commission 

establish, by rulemaking, warning label 

requirements for consumer products 

containing button cell or coin batteries, 

and for packaging of button cell or coin 

batteries. The warning labels required 

by section 2(a)(2) 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). 

In a companion rulemaking 

document, published elsewhere in this 

issue of the Federal Register, the 

Commission determines that UL 4200A– 

2023 meets the performance and 

labeling requirements of section 2(a) of 

Reese’s Law, and issues a direct final 

rule to incorporate by reference UL 

4200A–2023 as the mandatory standard 

for consumer products containing 

button cell or coin batteries. As the 

scope of UL 4200A–2023 is on 

consumer products, it does not require 

the warnings mandated by Reese’s Law 

for the packaging of button cell or coin 

batteries. 15 U.S.C. 2056e(a)(2)(A). 

Accordingly, we issue this final rule to 

establish warning label requirements for 

packaging of button cell or coin batteries 

to complete implementation of section 2 

of Reese’s Law. 

Section 2(g) of Reese’s Law provides 

that any time after the promulgation of 

a final consumer product safety 

standard under section 2(a), the 

Commission may initiate a rulemaking 

in accordance with 5 U.S.C. 553 to 

modify the requirements of the standard 

or revised standard. 15 U.S.C. 2056e(g). 

Any rule promulgated under section 

2(g) of Reese’s Law will also be treated 

as a consumer product safety rule 

promulgated under section 9 of the 

Consumer Product Safety Act (CPSA) 

(15 U.S.C. 2058). Id. 

Section 3 of Reese’s Law requires 

special packaging, meaning childresistant 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 

of Reese’s Law was effective by 

operation of the statute on February 12, 

2023. 

Section 4 of Reese’s Law, Notes to 15 

U.S.C. 2056e, states that the special 

packaging requirements in section 3(a) 

do not apply with respect to button cell 

or coin batteries that are in compliance 

with the marking and packaging 

provisions of the ANSI Safety Standard 

for Portable Lithium Primary Cells and 

Batteries (ANSI C18.3M). This 

exemption does not apply to the 

requirements for battery package 

labeling in section 2 of Reese’s Law, 

which this final rule implements. 

B. Updated Incident Data 

Based on information in the National 

Electronic Injury Surveillance System 

(NEISS), the NPR reflected staff’s 

estimate that from 2011–2021, 

approximately 54,300 emergency room 

visits were associated with human 

ingestion, impaction, or insertion of 

button cell or coin batteries. The data 

show that these incidents occur most 

often with children aged 4 years or 

younger. Ingestion of a button battery 

has caused severe injuries and deaths: 

based on data in the Consumer Product 

Safety Risk Management System 

(CPSRMS), the NPR identified 25 

fatalities from 2016 through 2021. 88 FR 

8696–98. 

Since the NPR, 2 additional deaths of 

children in the United States associated 

with ingestion of button or coin cell 

batteries have been added to the 

CPSRMS database, for the years 2020– 

2021. Moreover, reporting to CPSC 

through May 1, 2023, indicates another 

5 more recent deaths of children—3 in 

2022 and 2 in the first three months of 

2023. Combining all reported deaths 

since 2011, CPSC staff has identified 32 

reported deaths in the United States 

from button cell or coin battery 

ingestion for the period January 1, 2011 

through March 31, 2023. See Tab B of 

Staff’s Final Rule Briefing Package. 

Additionally, Tab C of Staff’s Final 

Rule Briefing Package updates incident 

data from the National Capital Poison 

Center (NCPC). Since the NPR, from 

June 2022 through May 2023, the NCPC 

reported 2 additional child deaths due 

to ingestion of button cell or coin 

batteries. Both cases were from lithium 

button cell or coin batteries impacted in 

the esophagus; one battery was 

impacted for 25 days, the other for 3 

days. The children died of hematemesis 

and sepsis, respectively. This brings the 

total fatal cases tracked by NCPC to 71 

since 1977. Also, since the NPR, from 

June 2022 through May 2023, NCPC 

reported 13 additional cases of severe 

injury from button cell or coin battery 

ingestion, bringing the total since 1977 

to 280. 

C. Description of Battery Packaging 

Labeling Requirements in the NPR 

The NPR proposed a rule to address 

the battery ingestion hazard for children 

six years of age or younger. Children can 

potentially gain access to button cell or 

coin batteries from battery packaging 

and be exposed to the ingestion hazard. 

Six out of 119 fatal and nonfatal 

incident narratives in the CPSRMS refer 

to loose batteries or battery packaging 

hazards, and staff estimates that at least 

7 percent of NEISS incidents involve 

loose batteries or batteries liberated 

from the packaging. Figure 1 shows 

examples of button cell or coin batteries 

that, when packaged, are subject to this 

final rule. 


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65298 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Rules and Regulations 

The NPR assessed warnings 

requirements in several voluntary 

standards, and preliminarily concluded 

that none of the voluntary standards 

were adequate to meet the requirements 

in Reese’s Law. Tab C of Staff’s NPR 

Briefing Package. 88 FR 8704–05. Table 

11 in the NPR summarizes the 

Commission’s assessment of warnings 

requirements in voluntary standards for 

button cell and coin battery packaging, 

finding that none of the voluntary 

standards adequately address warnings 

on battery packaging in accordance with 

Reese’s Law. 88 FR 8705. 

Because none of the voluntary 

standards were deemed to meet the 

requirements in Reese’s Law, the 

Commission proposed warnings 

requirements for button cell and coin 

battery packaging and packaging of 

batteries included separately with 

consumer products, explaining that 

labeling of button cell or coin battery 

packaging is intended to reduce the 

likelihood of loose batteries being 

liberated from these products and to 

warn caregivers of the battery ingestion 

hazards to children. 88 FR 8706–09. The 

proposed requirements followed the 

format requirements in ANSI Z535.4, 

Product Safety Signs and Labels, and 

were based on warnings found in ANSI 

C18.3M, ASTM F963, UL 4200A–2020, 

and other voluntary standards. Id. 

The NPR also defined two terms 

relevant to placement of warning labels. 

The ‘‘principal display panel’’ is 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. 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. 

The NPR proposed a warning for the 

principal display panel of the battery 

packaging, shown in Figure 2, to meet 

the requirements in section 2 of Reese’s 

Law. 

The NPR proposed that battery 

packaging include the following 

warning statements: 

• ‘‘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. 

• ‘‘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. 

• ‘‘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. 

• ‘‘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 


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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. 

The NPR proposed that the icon 

incorporated with the warning must be 

at least 8 mm (0.31 in.) in diameter for 

visibility, and that text size be 

calculated per Table 1 in the regulation 

text (Table 12 in the NPR preamble at 

88 FR 8706). The NPR also stated that 

if space prohibits the full warning with 

the icon shown in Figure 2 in 

accordance with the formatting 

requirements of Table 1 of the 

regulation text, packaging is required to 

use the ‘‘Keep out of Reach’’ icon 

(Figure 3) on the principal display panel 

and the warning text must be placed on 

the secondary display panel, as shown 

in Figure 4. 88 FR 8707. The icon must 

be at least 20 mm (0.79 in.) in diameter 

for visibility. 

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 NPR proposed that 

the following information implementing 

section 2(b)(2) of Reese’s Law 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 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. 

88 FR 8707. 

D. Changes Adopted in the Final Rule 

Based on the consideration of 

comments received and analysis in 

Staff’s Final Rule Briefing Package, the 

labeling requirements for button cell or 

coin battery packaging are being 

finalized as proposed, with three 

modifications: 

• Warning label colors: The final rule 

clarifies that specific colors on warning 

labels, in accordance with ANSI Z535, 

are required only if the label is present 

in more than one color, to allow 

flexibility in warning label designs and 

align with existing requirements in 

relevant voluntary standards. 

• Warning label letter size: The final 

rule clarifies that the minimum text size 

for warning labels must be based on the 

product display panel size. 

• Treatment information: To provide 

specific guidance to consumers on an 

available contact for treatment 

information, the final rule requires that 

button battery packaging display the 

National Battery Ingestion Hotline 

phone number. Additionally, the final 

rule replaces the warning statement 

‘‘Call a local poison control center for 

treatment information’’ with the more 

actionable presentation of the National 

Battery Ingestion Hotline phone 

number. 

E. Scope of Battery Packaging Subject to 

the Final Rule 

This rule finalizes the warning label 

requirements for packaging of button 

cell or coin batteries, including batteries 

packaged separately with consumer 

products. Although section 4 of Reese’s 

Law, Notes to 15 U.S.C. 2056e, states 

that the special packaging requirements 

in section 3(a) do not apply with respect 

to button cell or coin batteries that are 

in compliance with the marking and 

packaging provisions of the ANSI Safety 

Standard for Portable Lithium Primary 

Cells and Batteries (ANSI C18.3M), this 

exemption does not apply to the 

labeling requirements of this rule. 

Therefore, all packages of button cell or 

coin batteries that fall within the 

definition of a ‘‘button cell or coin 

battery,’’ except batteries listed in 

§ 1263.1(d) (currently zinc-air batteries), 

must comply with the warning label 

requirements in this rule. Consistent 

with the NPR, the final rule does not 

require warning labels on zinc-air 

batteries. These requirements are 

consistent with ANSI C18.3M; battery 

packaging can comply with both the 

labeling requirements in ANSI C18.3M 

and this final rule. 

F. Assessment of Labeling Requirements 

for Packaging of Button Cell or Coin 

Batteries in Existing Voluntary 

Standards 

None of the voluntary standards 

addressing warning labels on button cell 

or coin battery packaging have been 

updated since publication of the NPR. 

Accordingly, and for the reasons further 

discussed in Part II below, the 

Commission adopts the NPR’s 

assessment that no existing voluntary 

standard meets the warning label 

requirements that section 2 of Reese’s 

Law establishes for battery packaging. 

II. Comments on the NPR 

Below we summarize and respond to 

the comments received in response to 

the NPR that relate to the proposed 


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65300 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Rules and Regulations 

requirements for battery package 

labeling. 

Comments in Response to Questions on 

Marking and Labeling Requirements 

A. Whether all button cell or coin 

battery packaging should include the 

warning on the principal display panel. 

Comment 1: Several commenters, 

including a coalition of medical and 

consumer organizations, the Battery 

Association of Japan (BAJ), Energizer, 

Duracell, Landsdowne Labs, National 

Electrical Manufacturers Association 

(NEMA), and the Consumer Technology 

Association (CTA), support warning 

labels on the packaging of button cell 

and coin battery packaging. The 

coalition of medical and consumer 

organizations and Duracell support the 

use of a conspicuous warning label on 

the principal display panel, whereas 

others (BAJ, Energizer, CTA, 

Information Technology Industry 

Council (ITI)) request flexibility in the 

warning label location and the 

placement of the ‘‘KEEP OUT OF 

REACH’’ icon, citing limitations of 

battery packaging size. Seven 

commenters support warning label 

placement as allowed by current 

voluntary standards, as such standards 

do not mandate the warning label 

location. BAJ suggests, however, that the 

icon be accompanied by the warning 

‘‘KEEP OUT OF REACH’’ because the 

icon may not be well known. 

Response 1: Reese’s Law requires 

warning labels on the packaging of 

button cell or coin batteries and 

minimum content requirements. 

Existing voluntary standards (IEC 

60086–4 & –5) do not set forth location 

requirements, or specify that warnings 

be on the back of the packaging (ANSI 

C18.3). Existing voluntary standards 

often do not specify the content of the 

warning label. While the use of an icon 

is permissible in voluntary standards, 

icon use is based on the diameter of the 

battery. 

Consistent with Reese’s Law and the 

ANSI standard, the final rule requires 

battery packaging to identify the hazard, 

explain how to avoid the hazard, and 

requires that warnings be conspicuous 

on the front of the packaging where it 

is more likely to be seen. The final rule 

requires a warning label on all button 

cell and coin battery packages within 

the scope of the rule, regardless of 

battery chemistry or battery size. The 

warning’s content also outlines options 

for a condensed warning label in the 

form of an icon on the front with 

additional text to be placed on the back, 

to accommodate limited space on the 

battery packaging. The ‘‘KEEP OUT OF 

REACH’’ text is not required to 

accompany the icon; however, 

manufacturers may choose to include 

the text voluntarily to clarify the icon’s 

meaning. The final rule does not 

include any changes to the warning on 

the front of the battery packaging as a 

result of these comments. 

B. Whether the requirement for the 

‘‘Keep Out of Reach’’ icon to be at least 

20 mm in diameter for visibility 

purposes, when alone on the front of 

battery packaging, provides a sufficient 

warning of the ingestion hazard. 

Comment 2: Renata SA comments that 

the 6 mm minimum icon size 

requirements in the IEC 60086–4 

voluntary standard are adequate. BAJ 

commented that the icon sizes of 

minimum 20 mm and minimum 8 mm 

are not necessary because ‘‘based on the 

market results so far’’ a minimum size 

of 6 mm icon is sufficient. 

Response 2: We do not have the 

details of the ‘‘market results so far’’ that 

BAJ references to determine whether the 

6 mm icon is sufficiently attentiongetting for consumers, recognized by 

consumers, and adhered to by industry. 

Based on an evaluation of existing 

battery packaging, staff assesses in Tab 

D of Staff’s Final Rule Briefing Package 

that the recommended sizes of icons in 

the proposed rule are feasible and likely 

to get the attention of the consumer. 

After reviewing a number of battery 

packages, staff advises that the 20 mm 

diameter icon is sufficiently large to be 

visible to most consumers, and 

sufficiently small to fit on existing 

battery packaging. The final rule 

contains no changes in response to these 

comments. 

C. Whether the Commission should 

require ingestion warnings on zinc-air 

button cell or coin battery packaging. 

Comment 3: Three commenters 

(Duracell, Energizer, and NEMA) agree 

that warning labels on zinc-air batteries 

are not needed regarding the ingestion 

hazard, citing low risk of injury. 

Landsdowne Labs Inc., a coalition of 

medical and consumer organizations, 

and Dr. Ian Jacobs (Director at the 

Center for Pediatrics Airway Disorders 

at the Children’s Hospital of 

Philadelphia) support warning labels on 

packaging for zinc-air batteries, because 

they pose an insertion hazard. BAJ 

states that labeling on zinc-air batteries 

should be a recommendation, rather 

than a requirement, and that if zinc-air 

batteries are labeled, then they should 

use the word CAUTION instead of 

WARNING. Dr. Jacobs and Dr. Jatana 

(Director of Pediatric Otolaryngology in 

the Department of Otolaryngology Head 

and Neck Surgery at Nationwide 

Children’s Hospital and Wexner 

Medical Center at Ohio State University) 

state that zinc-air batteries pose a risk of 

injury when inserted into the ear canals 

and nasal cavities, and should be 

labeled accordingly. 

Response 3: Tab C of Staff’s Final 

Rule Briefing Package reviews the 

literature and the incident data 

regarding ingestion of zinc-air batteries. 

Staff advises that labeling of zinc-air 

batteries for an ingestion hazard is 

unnecessary, and may cause consumer 

confusion, because zinc-air batteries are 

not associated with an ingestion hazard. 

D. Comments addressing silver-oxide 

battery chemistries. 

Comment 4: The Permanent European 

Horological Committee (CPHE), 

Federation of the Swiss Watch Industry 

(FH), American Watch Association 

(AWA), and Renata SA state that silveroxide batteries should be excluded from 

a Commission rule implementing 

Reese’s Law because of the lack of data 

on fatal incidents with these batteries 

and children’s inability to access them 

from watches. Duracell states that silveroxide batteries should contain different 

warnings than lithium batteries because 

they are lower voltage. Switzerland asks 

whether silver oxide batteries could be 

excluded from the rule. 

Response 4: Based on the medical 

literature, staff does not recommend that 

silver-oxide batteries be removed from 

the scope of the final rule. As reviewed 

in Tab C of Staff’s Final Rule Briefing 

Package, Jatana et al. (2017) found in 

testing using an animal model that 

silver-oxide button or coin cell batteries 

caused severe esophageal injuries. 

Comments in Response to Questions on 

Other Topics Posed in the NPR 

E. Whether a later or an earlier 

effective date would be appropriate to 

comply with the proposed requirements 

and to provide specific information to 

support such a later or an earlier 

effective date. 

Comment 5: Commenters differed in 

their recommendations for an effective 

date, from the proposed 180 days 

(consumer advocates) to up to 3 years 

(manufacturer associations). Multiple 

manufacturers, trade associations, and 

Switzerland provided comments stating 

that a longer effective date is required to 

provide compliant products to the U.S. 

market. A few commenters provided 

detailed timelines of the necessary 

activities (product redesign, testing, 

certification sourcing, supply chain 

management, etc.), which ranged from 

12 months to 36 months in total. A 

commenter also explained that 

additional time is required to accredit 

third party laboratories for a large 

variety of product types. Energizer and 

NEMA request that battery 


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manufacturers be allowed to sell their 

existing stock of child-resistant 

packaging and labels that were 

purchased to comply with section 3 of 

Reese’s Law. 

Response 5: Arguments made by 

manufacturers for a longer effective date 

relate primarily to performance and 

labeling requirements for consumer 

products, and not to battery package 

labeling. For example, battery packaging 

is not a children’s product that requires 

third party testing; manufacturers can 

self-certify compliance to labeling 

requirements. However, the 

Commission recognizes that warning 

label requirements may compel 

manufacturers to revise or reprint 

existing packaging, and manufacturers 

may want to consult outside laboratories 

regarding compliance. Nevertheless, 

changes to labeling of battery packaging 

does not require extensive product 

redesign. To provide time for battery 

manufacturers to comply with this final 

rule, the Commission is establishing an 

effective date of one year after 

publication in the Federal Register, the 

low end of the time frame sought by 

commenters for the NPR’s proposals, 

generally. 

F. Comments addressing the use of 

color in the requirements for marking 

and labeling. 

Comment 6: Several commenters 

(JEITA, Duracell, Gramin, HCPS and 

CTA) state that the use of color on 

packing, instructions, or manuals, and 

on some consumer products would be 

challenging and, in most cases, add 

costs to the manufacturing and printing 

process, particularly to those materials 

that do not already incorporate color. 

Duracell and Technet also stress that 

other product safety standards (e.g., 

ASTM F963, ANSI C18.3, or ANSI Z535 

series) do not mandate the use of colors 

and accept black and white printing or 

contrasting colors to the background it 

is printed on. Commenters state, 

however, that if color is used for the 

signal panel, colors should conform to 

ANSI Z535.1 safety colors that 

correspond to the safety message. The 

Toy Association and RILA state that the 

use of color may not be reasonable for 

printing on certain product materials, 

for example, colored or textured 

plastics. 

Response 6: Applying color to some 

materials (e.g., consumer product 

packaging, manuals, or other collateral 

material) that do not already contain 

color may present a burden to some 

manufacturers. ANSI Z535.4 provides 

flexibility for special circumstances that 

limit the use of colors while preserving 

the visibility and noticeability of the 

label by requiring contrast. To address 

commenter concerns, the final rule 

requires the use of color when the 

subject materials already use printed 

color processing; otherwise, the use of 

either black and white or contrasting 

colors is acceptable. The use of color is 

not specified in Reese’s Law, and with 

this modification the label or icon will 

visually align with other information on 

the display while still being noticeable 

due to its contrast or color. 

G. Comments addressing text size, 

icons, and alternative symbols for 

marking and labeling. 

Comment 7: Renata Batteries, ITI, The 

Toy Association, RILA, BAJ, and 

Duracell express cost concerns with 

increased packaging dimensions 

required to accommodate larger warning 

labels and font sizes, especially for 

small products. Another commenter 

states that the minimum letter size 

requirements for packaging warnings 

may reduce the prominence of other 

warnings on product packaging. 

Response 7: The NPR proposed that 

font size requirements for both onproduct and on-packaging warning 

labels be determined based on the size 

of the principal display panel (e.g., the 

front face) of the package or the product 

display panel (e.g., surface area on, near, 

or in the battery compartment). Reese’s 

Law requires that warning labels clearly 

identify the hazard of ingestion, and this 

requirement is met when warning labels 

are displayed prominently on the 

principal display panel. For very large 

products or packages with principal 

display panels exceeding 400 inch2, the 

required letter size could be larger than 

standard font sizes usually referenced in 

other standards. The required letter size 

in the final rule is proportional to the 

display panel size and allows easy 

visibility and noticeability of the label. 

The minimum letter size is otherwise 

comparable to font sizes in other 

standards, and therefore of similar 

prominence when displayed on the 

same panel. The largest packaging will 

have ample room for additional 

warnings that are of comparable size to 

the requirements in the final rule. This 

level of prominence is appropriate to 

inform consumers which products 

contain button cell or coin batteries and 

to adequately reduce the risk of injury 

from ingestion. 

H. Whether the requirement to 

provide other information related to the 

safety of button cell or coin batteries is 

sufficient to address the risk of ingestion 

and other hazards associated with 

button cell or coin batteries. 

Comment 8: One commenter (Billie Jo 

Burr) states that labeling should provide 

consumers with the nationwide poison 

control center phone number to ease the 

process of obtaining assistance quickly. 

Response 8: We agree with the 

commenter that providing consumers 

with an appropriate contact phone 

number will provide an actionable step 

that will ease the process of obtaining 

assistance quickly if a caregiver suspects 

a button cell or coin battery ingestion. 

The National Battery Ingestion Hotline 

(NBIH) is dedicated solely to addressing 

battery ingestions, and is therefore an 

immediate and practical resource 

available to consumers who suspect a 

battery ingestion. The final rule adds the 

contact number for the NBIH, currently 

1–(800) 498–8666, on the required 

warning labels for battery packaging. 

Comments Addressing the Paperwork 

Reduction Act 

Tab A of Staff’s Final Rule Briefing 

Package and the companion direct final 

rule to establish in 16 CFR part 1263 a 

Safety Standard for Button Cell or Coin 

Batteries and Consumer Products 

Containing Such Batteries, published 

elsewhere in this issue of the Federal 

Register, provide CPSC’s final rule PRA 

burden estimate for battery package 

labeling, and summarize and respond to 

comments related to CPSC’s PRA 

burden estimate in the NPR. 

III. Description of the Final Rule 

This final rule adds to 16 CFR part 

1263 warning label requirements for 

packaging of button cell or coin 

batteries, including such batteries 

packaged separately with a consumer 

product. Primarily, the final rule adds 

§ 1263.4, requirements for labeling of 

button cell or coin battery packaging. 

We also add several provisions in the 

scope and definitions to fully 

implement and explain the required 

warnings. 

The final rule amends the last 

sentence in the NPR’s proposed 

§ 1263.1(a) to state that part 1263 

establishes warning label requirements 

for ‘‘packaging of button cell or coin 

batteries, including button cell or coin 

batteries packaged separately with a 

consumer product,’’ to ensure that the 

scope of the rule reflects requirements 

for battery package labeling. The final 

rule also amends § 1263.1(b) to add a 

one-year effective date for battery 

packaging labeling, as explained in 

section V of this preamble. 

Final rule § 1263.2 adds two 

definitions for the ‘‘principal display 

panel’’ and the ‘‘secondary display 

panel.’’ Section 1263.4 uses these 

definitions to explain requirements for 

the placement of battery package 

labeling. 


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Final rule § 1263.4 adds requirements 

for warning labels for button cell or coin 

battery packaging, including for such 

batteries packaged separately with a 

consumer product. The NPR’s warning 

label requirements are explained in 

section I.C of this preamble. They are 

being finalized with the three 

modifications explained in section I.D 

of this preamble. 

IV. 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. Packages of button cell and 

coin batteries are unlikely to ever be 

children’s products and therefore do not 

require third party testing. 

Manufacturers can self-certify 

compliance with the labeling 

requirements in this final rule. 

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 to a similar rule, ban, 

standard, or regulation under any other 

law enforced by the Commission, to 

certify that the product complies with 

all applicable CPSC-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). 

V. Effective Date 

The Administrative Procedure Act 

(APA) generally requires that the 

effective date of a rule must be at least 

30 days after publication of a final rule. 

5 U.S.C. 553(d). In the NPR, the 

Commission proposed 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, would become 

effective 180 days after publication of a 

final rule in the Federal Register. 

Section II.E of this preamble describes 

comments from multiple manufacturers 

and trade associations stating that a 

longer effective date is required to 

supply compliant products to the U.S. 

market. Commenters provided detailed 

timelines of the necessary activities to 

become compliant, including time for 

product redesign, testing, certification 

sourcing, supply chain management, 

and other issues, with the timeline 

ranging from 12 months to 36 months in 

total. A commenter also explained that 

additional time is required to accredit 

third party laboratories for a large 

variety of product types. 

The Commission recognizes that the 

rule’s warning label requirements may 

require manufacturers to revise or 

reprint existing packaging. However, 

battery packaging is not a children’s 

product that requires third party testing. 

Manufacturers can self-certify 

compliance to labeling requirements. 

Also, changes to labeling of battery 

packaging do not require extensive 

product redesign; revising labeling on 

battery packaging will not require a 

lengthy timeframe. To provide time for 

battery manufacturers to comply with 

this final rule, the Commission 

establishes an effective date of one year 

after publication in the Federal 

Register, the low end of the time frame 

suggested by commenters with respect 

to the full set of requirements proposed 

in the NPR. 

VI. 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 labeling 

requirements for packaging of button 

cell or coin batteries fall within this 

categorical exclusion. 

VII. Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (RFA; 

5 U.S.C. 601–612) generally requires 

agencies to review proposed and final 

rules for their potential economic 

impact on small entities, including 

small businesses, and prepare regulatory 

flexibility analyses. 5 U.S.C. 603, 604. 

The RFA applies to any rule that is 

subject to notice and comment 

procedures under section 553 of the 

APA. Id. However, a regulatory 

flexibility analysis is not required if an 

agency certifies that a rule will not have 

a significant impact on a substantial 

number of small businesses. Tab H of 

Staff’s Final Rule Briefing Package 

contains an economic analysis for this 

final rule establishing labeling 

requirements for packaging of button 

cell or coin batteries. Based on the 

information in that analysis, the 

Commission certifies that this final rule 

will not have a significant impact on a 

substantial number of small businesses. 

VIII. Paperwork Reduction Act 

This final 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 (44 U.S.C. 3501–3521). For 

convenience and clarity to stakeholders, 

section XII of the preamble for the direct 

final rule ‘‘Safety Standard for Button 

Cell or Coin Batteries and Consumer 

Products Containing Such Batteries,’’ 

published elsewhere in this issue of the 

Federal Register, contains the PRA 

analysis for both rules implementing 

Reese’s Law, including this rule 

addressing the labeling of packaging of 

button cell or coin batteries. 

CPSC has submitted the information 

collection requirements of this final rule 

for button cell or coin battery package 

labeling to OMB for review in 

accordance with PRA requirements. See 

44 U.S.C. 3507(d). 

IX. Preemption 

Section 26(a) of the CPSA, 15 U.S.C. 

2075(a), provides that when a consumer 

product safety standard is in effect and 

applies to a product, no state or political 

subdivision of a state may either 

establish or continue in effect a standard 

or regulation that prescribes 

requirements for the performance, 

composition, contents, design, finish, 

construction, packaging, or labeling of 

such product dealing with the same risk 

of injury unless the state requirement is 

identical to the Federal standard. 

Section 26(c) of the CPSA also provides 

that states or political subdivisions of 

states may apply to the Commission for 

an exemption from this preemption 

under certain circumstances. 

Section 2(a) of Reese’s Law requires 

the Commission to issue a ‘‘consumer 

product safety standard for button cell 

or coin batteries and consumer products 

containing button cell or coin batteries,’’ 

and section 2(c) of Reese’s Law states 

that a consumer product safety standard 

promulgated under subsection (a) shall 

be treated as a consumer product safety 

rule promulgated under section 9 of the 

CPSA (15 U.S.C. 2058). Therefore, the 

preemption provision of section 26(a) of 

the CPSA applies to all consumer 

products that fall within the scope of 

this final rule issued under section 2 of 

Reese’s Law. 15 U.S.C. 2056e. 

X. Congressional Review Act 

The Congressional Review Act (CRA; 

5 U.S.C. 801–808) states that, before a 

rule may take effect, the agency issuing 

the rule must submit the rule, and 


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certain related information, to each 

House of Congress and the Comptroller 

General. 5 U.S.C. 801(a)(1). The 

submission must indicate whether the 

rule is a ‘‘major rule.’’ The CRA states 

that the Office of Information and 

Regulatory Affairs (OIRA) determines 

whether a rule qualifies as a ‘‘major 

rule.’’ Pursuant to the CRA, OIRA 

designated this rule as not a ‘‘major 

rule,’’ as defined in 5 U.S.C. 804(2). To 

comply with the CRA, CPSC will submit 

the required information to each House 

of Congress and the Comptroller 

General. 

List of Subjects in 16 CFR Part 1263 

Administrative practice and 

procedure, Batteries, Consumer 

protection, Imports, Infants and 

children, Labeling, Law enforcement. 

For the reasons discussed in the 

preamble, the Commission amends 16 

CFR chapter II as follows: 

PART 1263—SAFETY STANDARD FOR 

BUTTON CELL OR COIN BATTERIES 

AND CONSUMER PRODUCTS 

CONTAINING SUCH BATTERIES 

■ 1. The authority citation for part 1263 

continues to read as follows: 

Authority: 15 U.S.C. 2052, 2056e. 

■ 2. Amend § 1263.1 by adding 

sentences at the end of pargraphs (a) 

and (b) to read as follows: 

§ 1263.1 Scope, purpose, effective date, 

and exemption. 

(a) * * * Additionally, this part 

establishes warning label requirements 

for packaging of button cell or coin 

batteries, including button cell or coin 

batteries packaged separately with a 

consumer product. 

(b) * * * Packages of button cell or 

coin batteries manufactured or imported 

after September 21, 2024, must meet the 

labeling requirements for battery 

packaging in § 1263.4. 

* * * * * 

■ 3. Amend § 1263.2 by adding the 

definitions of ‘‘Principal display panel’’ 

and ‘‘Secondary display panel’’ in 

alaphabetical order to read as follows: 

§ 1263.2 Definitions. 

* * * * * 

Principal display panel means the 

display panel for a retail package of 

button cell or coin 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. 

Secondary display panel means a 

display panel for a retail package of 

button cell or coin 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. 

■ 4. Add § 1263.4 to read as follows: 

§ 1263.4 Requirements for labeling of 

button cell or coin battery packaging. 

(a) General requirements for labeling 

of button cell or coin battery packaging. 

(1) All warning statements must be 

clearly visible, prominent, legible, and 

permanently marked. 

(2) Warning statements must be in 

contrasting color to the background onto 

which the warning statement is printed. 

(3) Warning statements 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’’ and 

safety alert symbol must be in black 

letters on an orange background unless 

this would conflict with paragraphs 

(a)(1) and (2) of this section or only one 

color is present, in which case, the 

signal word and safety alert symbol 

must contrast to the background on 

which they are printed. 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 

(figure 1 to paragraph (b)(1) and figure 

3 to paragraph (b)(2)) to get the attention 

of the reader. 

(7) For labels that are required to be 

on the packaging of button cell and coin 

batteries, text size must be dependent 

on the area of the principal display 

panel. Text size must be determined 

based on table 1 to this paragraph (a)(7). 

TABLE 1 TO PARAGRAPH (a)(7)—LETTER SIZE FOR RECOMMENDED WARNING LABELS

[Information based on 16 CFR 1500.19(d)(7)] 

Letter size measurements in inches 

Display area: inches2 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: cm2 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 

(b) Warning label requirements for 

button cell or coin battery packaging. (1) 

The principal display panel of the 

packaging must include the warning 

label in figure 1 to this paragraph (b)(1). 

The icon must be at least 8 mm (0.3 

inches) in diameter. The text must state 

the following warnings as shown in 

figure 1 to this paragraph (b)(1). 


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65304 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Rules and Regulations 

Figure 1 to Paragraph (b)(1) 

(2) If space prohibits the full warning 

label shown in figure 1 to paragraph 

(b)(1), place the icon shown in figure 2 

to this paragraph (b)(2) on the principal 

display panel with the text shown in 

figure 3 to this paragraph (b)(2) on the 

secondary display panel. The icon must 

be at least 20 mm in diameter. The text 

must state the following warnings as 

shown on figure 3 to this paragraph 

(b)(2). 

Figure 2 to Paragraph (b)(2) 

(3) The following safety-related 

statements must be addressed on the 

principal display panel or secondary 

display panel: 

(i) Keep in original package until 

ready to use. 

(ii) Immediately dispose of used 

batteries and keep away from children. 

Do NOT dispose of batteries in 

household trash. 

(4) For button cell or coin battery 

packaging included separately with a 

consumer product, only paragraphs 

(b)(1) and (2) of this section apply. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2023–20334 Filed 9–20–23; 8:45 am] 

BILLING CODE 6355–01–P 


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