Rule2023-20334
Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries
Primary source
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Published
September 21, 2023
Effective
September 21, 2024
Issuing agencies
Consumer Product Safety Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 182 (Thursday, September 21, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="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">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</a>.
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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: <a href="https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl">https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl</a>.
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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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