[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Rules and Regulations]
[Pages 65296-65304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20334]


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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.

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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: 
<a href="/cdn-cgi/l/email-protection#6112030e21021112024f060e17"><span class="__cf_email__" data-cfemail="b8cbdad7f8dbc8cbdb96dfd7ce">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority \1\
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    \1\ To 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-s-Law-Implementation-UL-4200A-2023-DFR-for-Button-Cell-or-Coin-Batteries-and-Draft-FR-to-Amend-Part-1263.pdf?VersionId=V56MNzyWa_iXqZQlKCyOlRtjl9lcoFit.
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    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).
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    \2\ The 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.''
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    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\
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    \3\ The 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-
Commission-Determination-Regarding-UL-4200A-2023-and-Draft-DFR-for-
Button-Cell-or-Coin-Batteries-and-2-Draft-FR-to-Amend-Part-1263_
Labeling-Requirmnts-for-Button-Cell-or-Coin-
Batte.pdf?VersionId=PyTbnom1OemA3BWl9Z1lONzTlyqbcthW, 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/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl.
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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

[[Page 65297]]

produce an electrical charge, that is determined by the Commission to 
pose an ingestion hazard.'' <SUP>4 5</SUP> Notes to 15 U.S.C. 2056e.
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    \4\ The definitions in section 5 of Reese's Law are codified in 
the notes to 15 U.S.C. 2056e.
    \5\ This 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.
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    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 child-
resistant 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.

[[Page 65298]]

[GRAPHIC] [TIFF OMITTED] TR21SE23.002

    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.
[GRAPHIC] [TIFF OMITTED] TR21SE23.003

    The NPR proposed that battery packaging include the following 
warning 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.
    <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

[[Page 65299]]

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.
[GRAPHIC] [TIFF OMITTED] TR21SE23.004

    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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 Sec.  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

[[Page 65300]]

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 attention-getting 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 silver-oxide 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 silver-
oxide 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

[[Page 65301]]

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 
on-product 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 inch\2\, 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 Sec.  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 Sec.  
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 
Sec.  1263.1(b) to add a one-year effective date for battery packaging 
labeling, as explained in section V of this preamble.
    Final rule Sec.  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.

[[Page 65302]]

    Final rule Sec.  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

[[Page 65303]]

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

0
1. The authority citation for part 1263 continues to read as follows:

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

0
2. Amend Sec.  1263.1 by adding sentences at the end of pargraphs (a) 
and (b) to read as follows:


Sec.  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 Sec.  1263.4.
* * * * *

0
3. Amend Sec.  1263.2 by adding the definitions of ``Principal display 
panel'' and ``Secondary display panel'' in alaphabetical order to read 
as follows:


Sec.  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.

0
4. Add Sec.  1263.4 to read as follows:


Sec.  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: 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (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).

[[Page 65304]]

Figure 1 to Paragraph (b)(1)
[GRAPHIC] [TIFF OMITTED] TR21SE23.005

    (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)
[GRAPHIC] [TIFF OMITTED] TR21SE23.006

    (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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