Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries, 8692-8727 [2023-02356]

Download as PDF 8692 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1263 [CPSC Docket No. 2023–0004] Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking (NPR). AGENCY: As required by Reese’s Law, to eliminate or adequately reduce the risk of injury from ingestion of button cell or coin batteries by children 6 years old and younger, the U.S. Consumer Product Safety Commission (CPSC or Commission) proposes a rule to establish performance requirements for battery compartments on consumer products that contain, or are designed to use, one or more button cell or coin batteries. The proposed rule also requires warning labels on the packaging of button cell or coin batteries, as well as on the packaging, battery compartments, and accompanying instructions and manuals of consumer products containing button cell or coin batteries. In addition to implementing Reese’s Law, the proposed rule requires manufacturers and importers of button cell or coin batteries, and consumer products containing such batteries, to notify consumers of performance and technical data related to the safety of such batteries at the point of sale, both online and in stores. If the rule is finalized, consumer products subject to the rule must be tested and certified as compliant with the rule. DATES: Submit comments by March 13, 2023. ADDRESSES: Comments related to the Paperwork Reduction Act aspects of the testing and certification, and the marking, labeling, and instructional literature requirements of the proposed mandatory standard, should be directed to the Office of Information and Regulatory Affairs, the Office of Management and Budget, Attn: CPSC Desk Officer, FAX: 202–395–6974, or emailed to oira_submission@ omb.eop.gov. You may submit all other comments, identified by Docket No. CPSC–2023– 0004, by any of the following methods: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https:// www.regulations.gov. Follow the khammond on DSKJM1Z7X2PROD with PROPOSALS5 SUMMARY: VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 instructions for submitting comments. CPSC typically does not accept comments submitted by electronic mail (email), except as described below. CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal. Mail/Hand Delivery/Courier/ Confidential Written Submissions: Submit comments by mail, hand delivery, or courier to: Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504–7479. If you wish to submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public, you may submit such comments by mail, hand delivery, or courier, or you may email them to: cpsc-os@cpsc.gov. Instructions: All submissions must include the agency name and docket number. CPSC may post all comments without change, including any personal identifiers, contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit through this website: confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for mail/hand delivery/courier/ confidential written submissions. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov, and insert the docket number, CPSC–2023–0004, into the ‘‘Search’’ box, and follow the prompts. FOR FURTHER INFORMATION CONTACT: Daniel Taxier, Project Manager, Division of Mechanical and Combustion Engineering, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; (301) 987–2211, or by email to: dtaxier@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Background and Statutory Authority 1 A. Explanation of Reese’s Law President Biden signed Reese’s Law, Public Law 117–171, into law on August 1 On January 25, 2023, the Commission voted (4– 0) to publish this notice of proposed rulemaking. Chair Hoehn-Saric and Commissioners Boyle and Trumka issued statements in connection with their vote; statements are available at: https:// www.cpsc.gov/s3fs-public/RCA-NPR-SafetyStandard-and-Notification-Requirements-forButton-Cell-or-Coin-Batteries-and-ConsumerProducts-Containing-Such-Batteries.pdf?VersionId= b9niiZNO11I3MDqWW4JRIkEcBY3Dxp3z. PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 16, 2022. 15 U.S.C. 2056e. The purpose of Reese’s Law is to protect children 6 years old and younger against hazards associated with the ingestion of button cell or coin batteries. Based on a review of the medical literature, CPSC incident data, and data from the National Capital Poison Center (NCPC), an ingestion hazard is associated with swallowing or inserting a button cell or coin battery that becomes lodged (impacted) in the body (typically in the esophagus but potentially in the airways or gastrointestinal tract), which can cause death or serious injury through choking, generation of hazardous chemicals, leaking of hazardous chemicals, electrical burns, pressure necrosis (tissue damage), or other means. See Tab B of Staff’s NPR Briefing Package.2 Although this proposed rule is primarily intended to address hazards associated with oral ingestion of button cell or coin batteries by children 6 years old or younger, the performance and labeling requirements in the proposed rule will likely also reduce insertion of these batteries in the nose. The data on button cell or coin batteries demonstrate that insertions of batteries into the nose can be aspirated into the trachea and become an ingestion that lodges in the esophagus. This scenario presents the same hazard as an oral ingestion of a button cell or coin battery. Accordingly, the proposed labeling requirements include warnings regarding ingestion and insertion. To address ingestion of button cell or coin batteries, section 2(a) of Reese’s Law requires the Commission to publish a final consumer product safety standard for button cell or coin batteries, and consumer products containing button cell or coin batteries, not later than 1 year after the date of enactment, meaning by August 16, 2023. 15 U.S.C. 2056e(a). A ‘‘button cell or coin battery’’ is broadly defined in section 5 of Reese’s Law as ‘‘(A) a single cell battery with a diameter greater than the height of the battery; or (B) any other battery, regardless of the technology used to produce an electrical charge, that is determined by the Commission to pose an ingestion hazard.’’ 3 Thus, the 2 The information in this proposed rule is based on information and analysis provided in the January 11, 2023, Staff Briefing Package: Draft Proposed Rule to Establish a Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries (Staff’s NPR Briefing Package), available at: https://www.cpsc.gov/s3fs-public/Noticeof ProposedRulemakingSafetyStandardand NotificationRequirementsforButtonCellor CoinBatteriesandConsumerProductsContaining SuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRt zN4u1GTXPRjpEl. 3 Definitions in section 5 of Reese’s Law are codified in the Notes to 15 U.S.C. 2056e. E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules definition of an in-scope product does not depend on the battery chemistry, but rather the shape of the battery (which contributes to the ingestionrelated risk) and, as stated in part (B), whether the battery otherwise is associated with an ingestion hazard, which is consistent with the stated purpose in section 2(a)(1) of Reese’s Law. 15 U.S.C. 2056e(a)(1). This proposed rule focuses on addressing button cell and coin batteries under part (A) of the definition because other batteries where the diameter is less than the height, such as AAA cylindrical batteries, do not pose the same type or degree of ingestion hazard as button cell or coin batteries. Cylindrical batteries can pose a choking hazard, and CPSC is aware that consumers have ingested cylindrical batteries. However, the medical literature shows that injury or death due to ingestion of a cylindrical battery is rare. See Staff’s NPR Briefing Package at Tab B, Section II.B. Consequently, the Commission is not including cylindrical batteries in the proposed rule at this time. If CPSC becomes aware of a serious ingestion hazard associated with another battery type, section 2(g) of Reese’s Law allows the Commission to undertake additional rulemaking to address the hazard at any time. 15 U.S.C. 2056e(g). Reese’s Law defines a ‘‘consumer product containing button cell or coin batteries’’ as ‘‘a consumer product containing or designed to use one or more button cell or coin batteries, regardless of whether such batteries are intended to be replaced by the consumer or are included with the product or sold separately.’’ 4 We preliminarily construe this definition to include products that are not sold with a battery, if they are designed to use a button cell or coin battery. Section 2 of Reese’s Law requires the Commission to issue a rule containing performance requirements for consumer products that contain button cell or coin batteries, and labeling requirements. Any rule issued under section 2(a) of Reese’s Law will be considered a consumer product safety rule promulgated under section 9 of the Consumer Product Safety Act (CPSA). 15 U.S.C. 2056e(c); 15 U.S.C. 2058. CPSC’s rule under section 2 of Reese’s Law must be issued in accordance with the notice and comment provisions of the Administrative Procedure Act (APA). 5 U.S.C. 553; 15 U.S.C. 2056e(a). 4 15 U.S.C. 2056e Notes. The term ‘‘consumer product’’ has the same meaning as that in section 3(a) of the Consumer Product Safety Act (CPSA). 15 U.S.C. 2052(a). VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 Insofar as this proposed rule is based on section 2 of Reese’s Law, it sets forth provisions implementing the statute’s required performance and labeling requirements—and ‘‘only’’ those requirements, as specified in section 2(a). The standard promulgated under section 2(a) of Reese’s Law shall apply to consumer products and battery packaging manufactured or imported after the effective date of the standard. See 15 U.S.C. 2056e Notes. Section 2(a)(1) of Reese’s Law mandates that the rule must include performance requirements for button cell or coin battery compartments on consumer products to secure them in a manner that eliminates or adequately reduces the risk of injury from the ingestion of button cell or coin batteries by children who are 6 years old or younger, during reasonably foreseeable use or misuse of the product. 15 U.S.C. 2056e(a)(1). Section 2(a)(2) of Reese’s Law mandates warning label requirements in a rule. Warnings are required: • On the packaging of button cell or coin batteries (15 U.S.C. 2056e(a)(2)(A)); • On the packaging of consumer products containing button cell or coin batteries (15 U.S.C. 2056e(a)(2)(A)); • In any literature, such as a user manual, that accompanies a consumer product containing button cell or coin batteries (15 U.S.C. 2056e(a)(2)(B)); • As practicable, directly on a consumer product that contains button cell or coin batteries in a manner visible to the consumer upon installation or replacement of the button cell or coin battery (15 U.S.C. 2056e(a)(2)(C)(i)); • As practicable, in the case of a product for which the battery is not intended to be replaced or installed by the consumer, to be included directly on the consumer product in a manner that is visible to the consumer upon access to the battery compartment, except that if it is impracticable to label the product, this information shall be placed on the packaging or instructions (15 U.S.C. 2056e(a)(2)(C)(ii)). Warning labels required by section 2(a) of Reese’s Law must: (1) clearly identify the hazard of ingestion; and (2) instruct consumers, as practicable, to keep new and used batteries out of the reach of children, to seek immediate medical attention if a battery is ingested, and to follow any other consensus medical advice. 15 U.S.C. 2056e(b). Section 4 of Reese’s Law specifically exempts from the performance and labeling requirements in section 2 of the law, any toy product 5 that is in 5 Consistent with 16 CFR part 1250, a ‘‘toy product’’ is defined as ‘‘any object designed, PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 8693 compliance with the battery accessibility and labeling requirements in 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys. 15 U.S.C. 2056e Notes. However, children’s products that contain button cell or coin batteries and that are not a ‘‘toy product,’’ would be required to meet the performance and labeling requirements in this proposed rule. An example of such products would be children’s apparel, such as shoes, that light up and use a button cell or coin battery as a power source. Section 2(d) of Reese’s Law (15 U.S.C. 2056e(d)(1)) requires the Commission to rely on the provisions in a voluntary standard if, before promulgating a final rule, the Commission determines that: (A) a voluntary standard exists that meets the requirements for a standard promulgated under section 2(a) of Reese’s Law with respect to any consumer product, and (B) the voluntary standard is in effect at the time of the determination by the Commission, or will be in effect not later than the date that is 180 days after the date of the enactment of Reese’s Law (i.e., February 12, 2023). The Commission must publish in the Federal Register, any determination regarding a voluntary standard under this provision. 15 U.S.C. 2056e(d)(2). As set forth in section IV.A and V.A of this preamble, the Commission preliminarily determines that no existing voluntary standard fully meets the requirements in section 2(a) of Reese’s Law. Accordingly, the Commission is proposing a rule that would meet the requirements of Reese’s Law for all consumer products within the scope of the rule that is based on modifications to several existing voluntary standards. Because the Commission is proposing its own rule under Reese’s Law, the procedural requirements in sections 2(e) and 2(f) of Reese’s Law for relying upon a voluntary standard are not applicable. 15 U.S.C. 2056e(e) and (f). Section 3 of Reese’s Law requires special packaging for button cell or coin batteries. These requirements, codified in the Notes to 15 U.S.C. 2056e, are selfimplementing, and do not require CPSC to issue a rule. Section 3(a) of Reese’s Law states that not later than 180 days after the date of enactment of the Act, meaning February 12, 2023, button cell or coin batteries sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States, or included separately with a manufactured, or marketed as a plaything for children under 14 years of age.’’ Notes to 15 U.S.C. 2056e. E:\FR\FM\09FEP5.SGM 09FEP5 8694 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules consumer product sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States, must be packaged in accordance with the standards provided in 16 CFR 1700.15, and tested in accordance with 16 CFR 1700.20 or another test method specified by rule by the Commission. 15 U.S.C. 2056e Notes. The requirements in section 3(a) shall be treated as a standard for special packaging of a household substance under section 3(a) of the Poison Prevention Packaging Act (PPPA). Id.; 15 U.S.C. 1472(a). At this time the Commission is not proposing a rule to implement section 3 of Reese’s Law, which is effective by operation of the statute on February 12, 2023.6 B. Explanation of Section 27(e) of the CPSA Finally, distinct from implementation of Reese’s Law, and as described in section VI of this preamble, the Commission is also proposing to use its longstanding authority under section 27(e) of the CPSA (15 U.S.C. 2076(e)) to require notification of additional technical and performance data related to the safety of button cell or coin batteries that is to be provided to the original consumer at the time of sale, specifically on websites and in-store displays for the sale of button cell or coin batteries and consumer products that contain such batteries. Although these draft notification requirements are codified together with the safety standard requirements proposed under Reese’s Law, this is for the convenience of the public and the Commission, to ease compliance and enforcement. The two sets of requirements arise from different statutory authority and are legally distinct. II. Products Subject to the Proposed Rule As required by Reese’s Law, the proposed rule establishes performance requirements for child-resistant button cell or coin battery compartments on consumer products that contain, or are designed to contain, such batteries. Reese’s Law also requires warning labels for the: (1) packaging of button cell or coin batteries; (2) packaging of consumer products containing such button cell or coin batteries; (3) where practicable, battery compartments on consumer products that use button cell or coin batteries (regardless of whether they are replaceable); and (4) any literature, such as a user manual, that accompanies a consumer product containing button cell or coin batteries. 15 U.S.C. 2056e(a), (b). A. Description of Button Cell or Coin Batteries Within the Scope of the NPR In general, button cell batteries are small, single-cell batteries that range from 5 mm to 32 mm (0.2 in. to 1.3 in.) in diameter and 1 mm to 6 mm (0.04 in. to 0.24 in.) in thickness. Reese’s Law defines ‘‘button cell or coin battery’’ as: (A) a single cell battery with a diameter greater than the height of the battery; or (B) any other battery, regardless of the technology used to produce an electrical charge, that is determined by the Commission to pose an ingestion hazard. 15 U.S.C. 2056e Notes. As explained above, this proposed rule focuses on addressing button cell and coin batteries under part (A), because other batteries where the diameter is less than the height, such as AAA cylindrical batteries, do not pose the same type or degree of ingestion hazard as button cell or coin batteries. A button cell or coin battery (also referred to as a cell or disc/disk battery) stores chemical energy, which is converted to electrical energy when the battery is connected to a circuit. A button cell or coin battery consists of an anode (negative terminal), a cathode (positive terminal), and a separator and electrolyte between the anode and cathode, as shown in Figure 1. When the battery terminals are connected with a conductive material, such as when the battery is pressed into moist human tissue, an electric circuit is formed, and electric current flows through the conductive material and between the terminals. Button cell or coin batteries come in many shapes and sizes and are composed of different materials and chemicals. Power (voltage and capacity) and size requirements are the main driver of battery shape, chemical composition, and the number of required batteries. Figure 1. Battery Construction Button cell batteries, like those shown in Figure 2, are used to power small, portable electronic products, such as wrist watches and calculators. Button cell batteries are usually disposable, single-cell batteries. Common anode materials are zinc or lithium. Common cathode materials are manganese dioxide, silver oxide, carbon monofluoride, cupric oxide, or oxygen from the air. Button cell batteries tend 6 Section 4 of Reese’s Law exempts from the special packaging requirements in section 3(a) of Reese’s Law, button cell or coin batteries that comply with the marking and packaging provisions in the ANSI Safety Standard for Portable Lithium Primary Cells and Batteries (ANSI C18.3M). Packaged button cell or coin batteries that meet the ANSI standard are exempt from the special packaging requirements in section 3(a) of Reese’s Law, but not from the labeling requirements in section 2(a) of Reese’s Law, as implemented in this proposed rule. Labeling on such battery packaging can meet both the ANSI standard and this proposed rule; CPSC’s labeling requirements are additive to ANSI C18.3M labeling requirements. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.002</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 Insulator Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules 8695 to be manganese dioxide (alkaline) (1.5v) or silver oxide (1.55v). their high-energy density, correspondingly small size, and long shelf life, manufacturers have found lithium coin batteries useful for other CR2032, 20mm 0.787 inch diameter khammond on DSKJM1Z7X2PROD with PROPOSALS5 Consumer products containing, or designed to use, one or more button cell or coin batteries, whether they are replaceable or not, are subject to the rule. 15 U.S.C. 2056e Note. These products may be sold with batteries included, or batteries may be sold separately. The term ‘‘consumer product’’ has the same meaning as described in section 3(a)(5) of the CPSA, 15 U.S.C. 2052(a)(5): broadly, ‘‘any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.’’ Under the CPSA, a ‘‘consumer product’’ does not include any article that is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer, which may include products used only in a professional capacity (i.e., expensive heavy machinery used 17:16 Feb 08, 2023 Jkt 259001 applications as well. Lithium coin batteries are commonly around 20 mm (0.787 inch) in diameter. CR2450, 24mm 0.945 inch diameter CR2025, 20mm 0. 787 inch diameter B. Description of Consumer Products Within the Scope of the NPR VerDate Sep<11>2014 LR626 button cell, 6.8 mm (0.26 inch) diameter, 2.6mm 0.10 inch thick only by professionally trained operators that is typically sold only to businesses and not to consumers). Moreover, a ‘‘consumer product’’ does not include products within the jurisdiction of some other Federal agencies, such as motor vehicles and motor vehicle equipment (e.g., motor vehicle key fobs), or food, drugs, medical devices, or cosmetics (e.g., thermometers, hearing aids). 15 U.S.C. 2052(a)(5). ‘‘Toy products’’ are also exempt from this proposed rule, pursuant to section 4 of Reese’s Law, if they are in compliance with the battery accessibility and labeling requirements of 16 CFR part 1250 (the ‘‘toy standard’’). A ‘‘toy product’’ is any object designed, manufactured, or marketed as a plaything for children under 14 years of age. Section 4 of Reese’s Law, 15 U.S.C. 2056e Notes. Not all children’s products are toys, however. A ‘‘children’s product’’ is a consumer product that is ‘‘designed or intended primarily for children 12 years of age or younger.’’ 15 U.S.C. 2052(a)(2). The Commission’s regulation at 16 CFR part 1200 further interprets the term. For example, children’s clothing containing button cell or coin batteries, or child-themed non-toy products that PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 use button cell or coin batteries, are children’s products subject to the requirements of this proposed rule. Consumer products within the scope of the proposed rule include common household portable devices, wearable accessories, and decorative electronic devices. Some examples of household objects that may use button cell or coin batteries are remote controls, games and toys, calculators, keychain flashlights, watches, flashing shoes and clothing, musical greeting cards, cameras, flameless candles, and holiday ornaments. C. Description of Packaging Subject to the NPR Reese’s Law requires warnings on the packaging of button cell and coin batteries, and on consumer products that contain button cell or coin batteries. 15 U.S.C. 2056e(a), (b). Accordingly, CPSC staff reviewed consumer product and button cell and coin battery packaging to determine what, if any, warnings were already present. Staff found that some manufacturers of button cell or coin batteries include on the packaging of those batteries a safety statement, such as: ‘‘Keep away from small children. If swallowed promptly E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.004</GPH> Lithium coin batteries, shown in Figure 3, were originally developed as a 3-volt power source for low-drain and battery-backup applications; because of LR754 button cell, 7.9 mm (0.31 inch) diameter, 5.4mm 0.21 inch thick EP09FE23.003</GPH> LR44 button cell, 11.6mm (0.45 inch) diameter x 5.4mm 0.21 inch thick 8696 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules see a doctor,’’ or ‘‘CAUTION: Keep batteries away from children. If swallowed, consult a physician at once.’’ See Staff’s NPR Briefing Package, p 7, Figures 5 and 6. As reflected in ANSI Z535.4 American National Standard Product Safety Signs and Labels (ANSI Z535.4), use of the word ‘‘CAUTION’’ on a warning label signals less severe injuries than using ‘‘WARNING.’’ For example, the word ‘‘WARNING’’ should be used for hazards where serious injury or death will occur. Staff found that packaging for the more hazardous lithium coin batteries often includes the icon: ‘‘Keep out of Reach’’ on the front and the signal word ‘‘WARNING,’’ followed by a statement that ‘‘Death or serious injury can occur in as little as 2 hours if swallowed’’ on the back side of the packaging, along with additional safety information related to the ingestion hazard and other hazards. See, e.g., Staff’s NPR Briefing Package, p. 8, Figure 7. Unlike the packaging for button cell and coin batteries, CPSC staff’s review of packaging for consumer products that contain a button cell or coin battery found that such packaging does not consistently warn that the product uses a button cell or coin battery; nor does the packaging consistently include warnings that button cell or coin batteries pose an ingestion hazard (see, e.g., Staff’s NPR Briefing Package, p. 8– 9, Figures 8 and 9). However, accompanying literature, when provided with a consumer product, sometimes contains warning information pertaining to the ingestion hazard, even when the product packaging does not include such warnings. As explained in sections V and VI of this preamble, the proposed rule would require standardized warning statements across packaging for button cell and coin batteries, and the packaging for consumer products that contain such batteries. khammond on DSKJM1Z7X2PROD with PROPOSALS5 III. Incident Data and Hazard Patterns Medical literature, CPSC data, and data from the National Capital Poison Center (NCPC) describe the deaths and serious injuries associated with the ingestion or insertion of button cell or coin batteries, including choking, internal chemical burns, chemical leakage, pressure necrosis (tissue damage), and the creation of hazardous chemicals (such as sodium hydroxide and hydrochloric acid) and related VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 hazards. Tab A of Staff’s NPR Briefing Package describes in more detail the incident data from the National Electronic Injury Surveillance System (NEISS) and from the Consumer Product Safety Risk Management System (CPSRMS). Staff also reviewed reports of deaths and injuries from NCPC data, as described in Tab B of Staff’s NPR Briefing Package. A. Fatalities The NCPC, or Poison.org, has tracked button cell or coin battery ingestions occurring from 1977 to the present. See Tab B of Staff’s NPR Briefing Package. From 1977 to June 2022, the NCPC reported 69 deaths due to ingestion of button cell or coin batteries.7 In the 47 cases where battery chemistry was known, 44 involved lithium batteries, two involved manganese dioxide chemistry, and one involved an alkaline button battery. The sources of these batteries, where known, were a remote control (8), toy (4), watch (2), camera (2), movie camera, camera flash, garage door opener, electric candle, remote car alarm, torch, tea light (spare battery), 3D TV glasses, key fob, and loose (battery fed to child by older brother). The button cell or coin battery size, where known, ranged from 10 mm to 25 mm (0.4 in. to 1 in.). The symptoms presented resembled those of a cold or upper respiratory infection and were often misdiagnosed as an infection or croup, or missed all together. In some cases, the first symptom was vomiting blood or blood coming from the nose, followed by death. Two deaths were caused by sepsis 8 after removal of the battery. Fifty of the 69 deaths in the NCPC data set were due to the battery burning through the esophagus and creating a hole to adjoining tissues, such as the trachea or arteries. The Commission is also aware of 25 fatalities from button cell or coin battery ingestions reported nationally in the CPSRMS data from January 1, 2011 to December 31, 2021.9 See Tab A of Staff’s NPR Briefing Package. CPSC staff determined the source of the button cell or coin battery in seven of these fatalities: two from remote controls, two 7 Fatal Cases (poison.org) Fatal Button Battery Ingestions: 69 Reported Cases (accessed June 2022). 8 An infection of the blood stream resulting in a cluster of symptoms, such as drop in blood pressure, increase in heart rate, and fever. 9 Incidents reported via CPSRMS as of May 2022. CPSC expects additional reporting of CPSRMS incidents for the most recent years 2020–2021, due to a time lag in reporting to CPSC. The reported incidents may be included in the NCPC data. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 from a tracking device, one from a toy, one from the battery packaging, and one loose battery. The mechanisms of death represented in these fatalities are consistent with those seen in the medical literature and from the NCPC data. B. Nonfatal Incidents From 1982 to June 2022, NCPC reported 267 cases of severe injury from button cell or coin battery ingestion.10 Nine injuries were from manganese dioxide batteries, two were from mercuric oxide, two were from alkaline, one was from silver oxide, and 182 were from lithium batteries. Sources of the batteries, where known, were remote controls (26), toys (13), cameras (7), watches (7), scales (7), key fobs (7), calculators (5), battery packages (3), digital ear thermometers (2), flashlights (2), handheld computer games (2), soles of shoes (2), portable CD player, hair dryer, ab belt (exerciser), personal digital organizer, talking book, bicycle computer, computer, singing card, loose, guitar tuner, night light, baby monitor, lighted tweezers, book light, video camera, keychain, 3D TV glasses, portable speaker, lighted ring, and glucometer. Where battery size was known, most of the batteries were 20 mm in diameter, and the battery size range was from 11.6 mm to 24.6 mm (0.46 in. to 0.97 in.). In many cases, impaction of the button battery in the esophagus led to damage due to burning of the esophagus. Based on incident information in NEISS, CPSC staff estimates that from January 1, 2011, through December 31, 2021, 54,300 emergency departmenttreated incidents involved button cell or coin battery ingestion or insertion into the mouth, nose, or ear. This excludes cases establishing ingestion of a battery in which the type of battery is not indicated. Staff’s estimate generally relied upon the final diagnosis conclusion as recorded in short summaries from medical professionals. The lack of detection of a battery as a foreign body does not necessarily contraindicate battery presence (which may sometimes be missed by x-ray scans). Consequently, these estimates likely underestimate the actual number of button cell or coin battery ingestions or insertions. Table 1 summarizes the number of cases estimated per year. 10 Severe Cases (poison.org) Nonfatal Button Battery Ingestions with Severe Esophageal or Airway Injury: 267 Cases. (Accessed June 2022). E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules 8697 TABLE 1—ESTIMATED NUMBER OF BUTTON CELL OR COIN BATTERY INGESTIONS, INSERTIONS, OR IMPACTIONS TREATED IN HOSPITAL EMERGENCY DEPARTMENTS, 2011–2021 Year 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Estimate N CV ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. ............................................................................................................................................. 4,600 4,500 5,000 5,500 3,500 6,500 5,400 4,500 4,200 5,500 5,200 170 179 178 177 163 237 196 200 178 270 235 0.20 0.18 0.21 0.19 0.15 0.15 0.20 0.17 0.26 0.14 0.18 Total ...................................................................................................................................... 54,300 2,183 0.15 Source: NEISS, CPSC. Summations of estimates may not add to the total estimates provided in the tables, due to rounding. Staff derived estimates from data in the NEISS sample, with number of observations (N) and coefficient of variation (CV) provided. Estimates spanning periods of multiple years (such as the 11 years from 2011 to 2021) are total estimates, not annual averages. Staff estimates that of the 54,300 cases that were indicated to involve a button cell or coin battery, approximately 88 percent involved ingestion through the mouth, while the remainder arose from insertion into the ear or nose. An estimated 8,800 (16% of 54,300) people were hospitalized as a result of these incidents, while an estimated 44,500 (82% of 54,300) people were treated and released. Table 2 provides estimates of victim age at the time of initial treatment associated with button cell or coin battery incidents. Staff estimates that 16,100 (30%) of the 54,300 incidents involved young children under the age of 2 years, and an estimated 26,900 (50%) involved children between the ages of 2 and 6. In total, an estimated 43,000 (79%) of the incidents were associated with children 6 years of age or younger—the age group that is the focus of Reese’s Law. See 15 U.S.C. 2056e(a)(1). Ingestions by adults and elders can be related to confusing loose button cell or coin batteries with medication and ingesting batteries, believing mistakenly that they are pills. TABLE 2—ESTIMATED NUMBER OF BUTTON CELL OR COIN BATTERY INGESTION OR INSERTION INCIDENTS BY VICTIM AGE (OR AGE RANGE), 2011–2021 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Victim age (or age range) Estimate Estimated percent N CV 0–11 months .................................................................................................... 12–23 months .................................................................................................. 2 years ............................................................................................................. 3 years ............................................................................................................. 4 years ............................................................................................................. 5 years ............................................................................................................. 6 years ............................................................................................................. 7 years ............................................................................................................. 8 years ............................................................................................................. 9 to 14 years .................................................................................................... 15–24 years ..................................................................................................... 25–34 years ..................................................................................................... 35–44 years ..................................................................................................... 45–54 years ..................................................................................................... 55–64 years ..................................................................................................... 65–74 years ..................................................................................................... 75–84 years ..................................................................................................... 85+ years ......................................................................................................... 2,900 13,200 8,700 7,100 5,500 3,200 2,400 1,900 1,500 2,900 (*) (*) (*) (*) (*) (*) (*) 1,500 5 24 16 13 10 6 4 4 3 5 2 1 <1 <1 <1 1 2 3 129 513 378 315 220 146 84 71 59 141 33 8 5 1 6 17 21 36 0.27 0.21 0.19 0.19 0.12 0.17 0.18 0.20 0.24 0.16 (*) (*) (*) (*) (*) (*) (*) 0.22 Total .......................................................................................................... 54,300 100 2,183 0.15 Source: NEISS, CPSC. * This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria, the coefficient of variation (CV) cannot exceed 0.33, there must be at least 20 sample cases (N), and there must be at least 1,200 estimated injuries. Table 3 shows 11,900 (22% of 54,300) incidents where the button cell or coin battery was known to have come from a product. Staff estimates that at least 5,300 batteries (45% of 11,900) were obtained from a ‘‘Non-Toy Consumer VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 Product’’ (i.e., in scope of Reese’s Law). Such products included lights (i.e., flashlights, pen lights), remote controls, watches, calculators, decorations and ornaments, electronic candles and tea lights, clocks and timers, electronic PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 sound making books, pens, guitar tuners, and other consumer products. Staff estimates that 4,400 incidents (37%) classified as ‘‘toys/games’’ include children’s toys and games that fall within the toy standard and are E:\FR\FM\09FEP5.SGM 09FEP5 8698 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules outside the scope of this proposed rule. An estimated 18 percent of the 11,900 product-related incidents are associated with medical devices, which are outside the scope of the rulemaking for childresistant battery compartments, including hearing aids (13%) and other medical devices (5%). TABLE 3—ESTIMATED NUMBER OF BUTTON CELL OR COIN BATTERY INCIDENTS WHERE OBTAINED FROM A PRODUCT BY BATTERY SOURCE AND PRODUCT TYPE, 2011–2021 Battery source product type Estimated percent Estimate N CV Consumer Product (excluding Toys/Games and Key Fobs) ........................... Toys/games ..................................................................................................... Car remotes and key fobs ............................................................................... Hearing aid ...................................................................................................... Other Medical Device ...................................................................................... (excluding hearing aids) .................................................................................. Unknown Product Type ** ................................................................................ 5,300 4,400 (*) 1,600 42 37 2 13 237 176 11 52 0.17 0.17 (*) 0.21 (*) (*) 5 <1 16 4 (*) (*) Total .......................................................................................................... 11,900 100 496 0.14 Source: NEISS, CPSC. * This estimate does not meet NEISS reporting criteria. ** For a small proportion of cases, although it could be determined that the batteries were neither loose nor from packaging and came from some product or device, it could not be determined which type of product or device. In the CPSRMS data, staff identified 87 nonfatal incidents involving button cell or coin battery ingestion (i.e., ‘‘Ingestion’’ incidents) or unintended access to the button cell or coin battery with no ingestion (i.e., ‘‘Battery Access’’ incidents) from January 1, 2016, through December 31, 2021. See Staff’s NPR Briefing Package, p. 13. Table 4 provides a summary of the 74 nonfatal incidents that involved a product, rather than battery packaging, as the source of access to the battery. TABLE 4—REPORTED NUMBER OF PRODUCT CLASSIFIED NONFATAL INCIDENTS BY INCIDENT CLASSIFICATION AND BATTERY SOURCE PRODUCT TYPE, 2016–2021 Incident classification Combined nonfatal Battery source product type Ingestion Battery access Total Total percent Non-toy Consumer Product ............................................................................. Toys/games ..................................................................................................... Medical Device ................................................................................................ 13 20 1 16 23 1 29 43 2 42 56 3 Total .......................................................................................................... 34 40 74 100 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Source: CPSRMS, CPSC. A high proportion of button cell and coin battery incidents reportedly involved toys and games. Based on products in the CPSRMS database where the exact product is known, many of the toys are subject to the requirements of the mandatory toy standard, codified in 16 CFR part 1250, which requires toy products to meet the battery accessibility requirements in the voluntary standard for toys, ASTM F963–17.11 CPSC staff has raised a concern with ASTM that ASTM F963– 17’s requirements for battery compartments do not adequately protect against the liberation of button cell or coin batteries from toys and becoming an ingestion hazard.12 11 Products referred to as ‘‘toys’’ in the incident data, that do not fall within the scope of part 1250, would be subject to this rule; thus, the rule will address some unknown portion of products indicated in the incident data as toys or games. 12 https://www.cpsc.gov/s3fs-public/8-19-2022Letter-to-ASTM-Battery-Operated-Toys. pdf?VersionId=PgFoeCeb0BYz0kyg6z87tbwHKv VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 C. Hazard/Injuries Associated With Button Cell or Coin Batteries As set forth in detail in Tab B of Staff’s NPR Briefing Package, CPSC staff reviewed medical literature related to battery-ingestion injuries, CPSC data, and data from Poison.org, and found that ingested batteries, particularly button cell or coin batteries, can lodge in the esophagus and cause severe tissue damage after only a few hours. The conductive soft tissue in the digestive tract can form a circuit between the battery terminals, creating an electric current. When lodged in the esophagus, button cell or coin batteries can lead to a burn in the esophagus, perforations, and burning of nearby tissue. Generation of hydroxide by the current created as a result of the battery contacting tissue in the digestive tract is 3x9W0y. Staff Correspondence Relating to Voluntary Standards—Letter to ASTM re: Battery Operated Toys, August 19, 2022. PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 the primary pathway to the chemical burn hazard associated with ingestion of lithium coin batteries, particularly, because of their higher voltage and capacity. Other mechanisms of injury associated with button cell or coin batteries include leakage of alkaline electrolyte from alkaline button cell batteries or pressure necrosis from extended contact of the foreign object with the soft tissue. In addition to ingestion from swallowing, a proportion of nose insertions ultimately results in ingestion or aspiration, with batteries getting into the digestive tract or airways. Button cell or coin batteries impacted in the nose can lead to severe damage to the endonasal mucous membranes, necrosis (tissue damage) of the nasal septum cartilage, and nasal septum perforation. Tab B, Appendix G of Staff’s NPR Briefing Package, provides examples of ear and nose insertion incidents. E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules CPSC staff specifically considered the ingestion hazard presented by zinc-air button cell and coin batteries in consumer products, and found that the risk is low. Staff estimates that at least 9 percent of button cell or coin battery ingestion or insertion incidents involve zinc-air batteries. But zinc-air batteries are primarily used in hearing aids, which are medical devices under the jurisdiction of the FDA. Staff did not identify zinc-air batteries being used in any consumer products. Furthermore, zinc-air batteries are typically much smaller than other button cell or coin batteries, and therefore, they do not present the same risk of choking. Staff did not identify any choking incidents in which zinc-air batteries were the source battery. Moreover, zinc-air batteries use a technology that needs air for the current to flow or voltage to be present on the terminals. Accordingly, if a zinc-air battery is swallowed or inserted into the nose, wet mucosa stops this flow of air and also the voltage, so there are no associated chemical or hydroxide burns. Zinc-air batteries are sealed with a hydrophobic material, so there is also little chance for electrolyte leakage. See Tab B of Staff’s NPR Briefing Package. Although hearing aids with zinc-air batteries would not be subject to performance requirements for consumer products (because hearing aids are medical devices), zinc-air batteries can be consumer products. Based on staff’s assessment of the characteristics of zincair batteries and the lack of ingestion injury associated with these batteries, however, the Commission proposes that the labeling requirements of Reese’s Law not apply to the packaging for zincair button cell or coin batteries. The Commission seeks comment on whether any consumer products contain, or are designed to contain, zinc-air button cell or coin batteries, if so, whether performance standards for battery compartments should apply to these consumer products, and whether the Commission should require ingestion warnings on zinc-air button cell or coin battery packaging. D. Hazard Patterns CPSC staff identified the primary ways that children gain access to button cell or coin batteries before ingesting them: 1. Access to the battery from a product’s intact battery compartment. Seventy-nine out of 112 fatal and nonfatal CPSRMS incident narratives staff identified in Tab A of Staff’s NPR Briefing Package refer to products with button cell or coin battery compartments that are potentially easily accessed by children.13 Ten of the 79 incident narratives refer to batteries in compartments that appeared easy to open or defeat. These batteries did not accidentally come out of a battery compartment, but appeared easily accessible to children while in a compartment. 2. Obtaining the battery from a battery compartment that broke or failed to contain the battery as intended. Sixtynine of the 79 fatal and nonfatal 8699 CPSRMS incidents involving products describe the batteries unintentionally coming out of the battery compartment or the product, or the battery compartment opening or breaking, often while a child was interacting with the product. In some cases, the battery was found to have come from a product only after a child was diagnosed with having ingested the battery. Eighteen of these incidents specifically describe products with ineffective screws, including comments about stripped threads, continuous spinning, screws that were ‘‘too short,’’ and compartments that popped open, even though there was a screw. 3. Removing the battery from its packaging, or obtaining a loose battery that was not contained within packaging or a product. Six out of 112 fatal and nonfatal CPSRMS incident narratives refer to loose batteries or battery-packaging hazards, and staff estimates that at least 7 percent of NEISS incidents involve loose batteries or batteries removed from their packaging. E. Recalls Table 5 describes the six CPSCconducted recalls that occurred between January 1, 2011, and July 31, 2022, involving consumer products containing button cell or coin batteries associated with a battery ingestion hazard. The recalled products were responsible for four reported battery-ingestion incidents and affected approximately 823,900 products (including toys). khammond on DSKJM1Z7X2PROD with PROPOSALS5 TABLE 5—SUMMARY OF RECALLS INVOLVING PRODUCTS WITH BUTTON CELL AND COIN BATTERIES Recall date Firm Hazard Number of recalled units Number of incidents & injuries reported 10/10/2016 ........ Target ......................... About 172,000 units Halloween LED Gel Clings. No Injuries Reported .......................... 17–020 12/16/2016 ........ Figi’s Companies Inc .. About 5,000 units ‘‘Christmas Wishes’’ Tins. No Injuries Reported .......................... 17–120 5/23/2017 .......... Hobby Lobby .............. 17–166 Toysmith ..................... About 43,400 units Easter and July 4ththemed Light-Up Spinner Toys. About 58,000 units Light-Up Magic Wands. Received one report of a 14-monthold child who ingested the battery. 12/19/2019 ........ K & M International .... One report of a child swallowing one of the batteries removed from the toy. Medical attention was required to remove the battery. No incidents or injuries have been reported. 20–045 5/12/2021 .......... The gel clings can separate and expose the inner decal and LED/button battery compartment, posing choking and button battery ingestion hazards to children. The tin’s music sound chip mechanism can separate and expose button batteries, posing choking and button battery ingestion hazards to children. The battery cover can detach and expose the small coin cell batteries, posing choking and ingestion hazards to young children. The battery cover can detach and expose the button-cell batteries, posing choking and ingestion hazards to young children. The coin cell battery inside the slap watches can fall out, posing battery ingestion and choking hazards to young children. 13 Out of the 79 products included in this hazard pattern analysis, 77 are consumer products, and two VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 About 463,000 units Wild Republic Slap Watches. are household medical devices (body temperature thermometer and toothbrush). PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP5.SGM 09FEP5 Press release No. 21–134 8700 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules TABLE 5—SUMMARY OF RECALLS INVOLVING PRODUCTS WITH BUTTON CELL AND COIN BATTERIES—Continued Recall date Firm 12/1/2021 .......... Number of recalled units Hazard Halo Brand Solutions A child can disassemble the projector flashlight and access the button cell batteries, posing ingestion and choking hazards. IV. Assessment of Performance Requirements for Battery Compartments in Relevant Voluntary Standards, and Description of the Proposed Rule’s Battery Compartment Requirements In this section, the Commission describes staff’s assessment of existing voluntary standards that establish performance requirements for button cell or coin battery compartments in consumer products, and the elements of those standards that the Commission proposes to adopt as the basis for its proposed rule implementing Reese’s Law. A. Preliminary Determination Regarding Performance Requirements in Existing Voluntary Standards Section 2(d) of Reese’s Law states that the Commission shall not promulgate a final rule for consumer products that contain button cell or coin batteries if the Commission determines, with respect to any consumer product, that a About 82,500 units Projector Flashlights.. voluntary standard that meets the requirements of section 2(a) of Reese’s Law is either in effect at the time of the Commission’s determination, or will be in effect not later than 180 days after the enactment of Reese’s Law (meaning by February 12, 2023). Accordingly, CPSC staff assessed voluntary standards to determine whether any existing standards meet the requirements of section 2(a)(1) of Reese’s Law, which mandates that the rule must include performance requirements for button cell or coin battery compartments on consumer products to secure them in a manner that eliminates or adequately reduces the risk of injury from the ingestion of button cell or coin batteries by children who are 6 years old or younger during reasonably foreseeable use or misuse of the product. 15 U.S.C. 2056e(a)(1). Tab D of Staff’s NPR Briefing Package contains a detailed review of six voluntary standards that relate to the accessibility of button cell or coin Number of incidents & injuries reported Received two reports of children accessing the button cell batteries from the flashlight, and in one case, a child required surgery to remove a swallowed battery. Press release No. 22–024 batteries. Four of these six standards most directly address the hazards associated with button cell and coin battery accessibility in consumer products, as required by Reese’s Law. These four voluntary standards are: • UL 4200A, Standard for Safety for Products Incorporating Button or Coin Cell Batteries of Lithium Technologies (UL 4200A); • ASTM F963, Standard Consumer Safety Specification for Toy Safety; • IEC 62368–1, Audio/video, information and communication technology equipment-Part 1: Safety requirements; and • IEC 62115, International Standard for Electric Toys—Safety. Table 6 provides CPSC staff’s summary of how each of these standards addresses the battery-ingestion hazard, with requirements that are intended to minimize the risk of children removing button cell or coin batteries from a consumer product. khammond on DSKJM1Z7X2PROD with PROPOSALS5 TABLE 6—SUMMARY OF VOLUNTARY STANDARDS REQUIREMENTS FOR BUTTON CELL OR COIN BATTERY ACCESS IN A CONSUMER PRODUCT Standard Scope Required action(s) to open battery compartment Abuse testing UL 4200A ........... Household-type products that incorporate or may use button cell or coin batteries of lithium technologies. (1) A tool, such as a screwdriver or coin, is required to open the battery compartment; screw fasteners must be captive; OR (2) The battery compartment door or cover requires the application of a minimum of two independent and simultaneous movements to open by hand. ASTM F963 ........ Toys intended for use by children under 14 years of age. Coin, screwdriver, or other common household tool required to open battery compartment. IEC 62368–1 ...... Electrical and electronic equipment within the field of audio, video, information and communication technology, and business and office machines with a rated voltage not exceeding 600 V. (1) A tool, such as a screwdriver or coin, is required to open the battery compartment, screw fasteners must be captive; OR (2) The battery compartment door or cover requires the application of a minimum of two independent and simultaneous movements to open by hand. Preconditioning: (1) 7 hours of pre-conditioning in oven at 70 °C (158 °F); (2) Open/close and remove/install battery 10 times. Abuse Tests: (1) Drop test—maximum 10 times at 3.3 ft in positions likely to produce the maximum force on the battery compartment or enclosure; (2) Impact test—3 impacts by steel sphere imparting 2–J of energy; and (3) Crush test—74 lbf. over 38 square inches for 10s in positions likely to produce the most adverse results. (1) Drop test—maximum 10 times at 4.5 ft in random orientation; minimum of 4 times at 3 ft in random orientation; (2) Torque test—2–4 in-lbs. of torque over 10 seconds; (3) Tension test—10–15 lbs. of tension over 10 seconds; (4) Tension test for pliable materials—10–15 lbs. of tension over 10 seconds; and (5) Compression test —20–30 lbf over 1 square inch for 10 seconds. Preconditioning: (1) 7 hours of pre-conditioning in oven at 70 °C (158 °F); and (2) Open/close and remove/install battery 10 times. Abuse Tests: (1) Drop test—maximum 10 times at 3.3 ft in positions likely to produce the maximum force on the battery compartment or enclosure; (2) Impact test—3 impacts by steel sphere imparting 2–J of energy; and (3) Crush test—apply 74 lbf. for 10s in positions likely to produce the most adverse results. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP5.SGM 09FEP5 8701 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules TABLE 6—SUMMARY OF VOLUNTARY STANDARDS REQUIREMENTS FOR BUTTON CELL OR COIN BATTERY ACCESS IN A CONSUMER PRODUCT—Continued Standard Scope Required action(s) to open battery compartment Abuse testing IEC 62115 .......... Electric toys being any product designed or intended for use in play by children under 14 years of age. Batteries that fit wholly within the small parts cylinder shall not be removable without the aid of a tool, screw fastener must be captive. (1) Screw test—Remove/replace screws 10 times with torque applied; (2) Drop test—maximum 10 times at 93 cm ± 5 cm (36.6 in.) in random orientation; minimum 4 times at 93 cm ± 5 cm (36.6 in.) in random orientation; (3) Impact test—3 impacts by hammer imparting 0.5–J of energy; (4) Tension test—70 N ± 2 N (15.7 lbs.) of tension over 10 seconds; and (5) Tension test—70 N ± 2 N (15.7 lbs.) tension force on a textile seam over 10 seconds. The left-hand column in Table 7 displays the categories staff evaluated to assess satisfaction of Reese’s Law, and staff’s evaluation of whether the standard eliminates or adequately reduces the risk of injury from button cell or coin battery ingestion by children age 6 or under. Specifically, Table 7 includes the scope of the voluntary standard, and whether the scope includes all or only some relevant battery chemistry types that create an ingestion hazard and associated consumer products as seen in the incident data; whether the standard’s performance requirements for constructing and securing the battery compartment would eliminate or adequately reduce the risk of injury from access to batteries from consumer products and their ingestion, as seen in the incident data, or inadequately address the risk; and whether the standard addresses use-and-abuse testing at all, and if so, the adequacy of the use-and-abuse testing to eliminate or adequately reduce ingestion incidents as seen in the data. TABLE 7—ASSESSMENT OF EXISTING VOLUNTARY STANDARDS FOR BUTTON CELL OR COIN BATTERIES Scope: Battery Chemistry Type ..................................................... Product Type ...................................................................... Construction: Opens with Tool ................................................................. Captive screws ................................................................... Threaded attachment requirements ................................... Opens with two independent and simultaneous movements. Accessibility ........................................................................ Use and Abuse: Pre-conditioning in oven .................................................... Open/close and remove/install battery/screw(s) 10 times Drop test—based on product weight/type ......................... Drop test—based on age grading ..................................... Impact Test ........................................................................ Crush Test (big surface area) ............................................ Torque Test ........................................................................ Tension Test ...................................................................... Tension Test—Seams ....................................................... Compression Test (little surface area) .............................. Accessibility Probe Compliance Test ................................ Securement (non-removable batteries) ............................. UL 4200A ASTM F963 IEC 62368–1 IEC 62115 Lithium .............. Any ................... Any ................... Toys .................. Any ......................... Audio/Visual Equipment. Any. Electronic Toys. A ....................... I ........................ A ....................... I ........................ A ....................... ........................... ........................... ........................... A ............................ I .............................. I .............................. I .............................. A A A ....................... A ....................... A ............................ A A ....................... A ....................... I ........................ ........................... A ....................... A ....................... ........................... ........................... ........................... ........................... I ........................ A ....................... ........................... ........................... I ........................ I ........................ ........................... ........................... A ....................... A ....................... A ....................... A ....................... I ........................ ........................... A ............................ A ............................ I .............................. ................................ I .............................. I .............................. ................................ ................................ ................................ ................................ I .............................. ................................ I I I A A A khammond on DSKJM1Z7X2PROD with PROPOSALS5 Blank—Does not address requirements, I–Inadequately addresses requirements, A—Adequately addresses requirements. Table 7 summarizes staff’s assessment in Tab D of Staff’s NPR Briefing Package, displaying an ‘‘I’’ where a standard contains a performance requirement that inadequately addresses the risk of ingestion, and an ‘‘A’’ if CPSC staff assessed the requirement as adequate to address the risk of ingestion. Table 7 shows that no existing voluntary standard includes within its scope all battery types and all consumer products that contain button cell or coin batteries, as reflected in the VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 incident data. The scope of each voluntary standard staff reviewed is narrower than the scope of the proposed rule, which applies to all non-toy consumer products within the Commission’s jurisdiction that contain button cell or coin batteries. For example, UL 4200A only applies to lithium batteries. Regarding construction of the battery compartments, UL 4200A is the only voluntary standard that contains requirements that would address PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 relevant incidents seen in the data, but in staff’s view, not all the requirements are adequate to address the risk of injury. For example, although UL 4200A contains a requirement for a doubleaction locking mechanism, staff found that the language in UL 4200A could lead to defective double-action locks, which could allow a child to gain access to the battery compartment. Staff also found that requirements in UL 4200A are not always clear and could result in different interpretations by testers, E:\FR\FM\09FEP5.SGM 09FEP5 8702 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules leading to inconsistent and unreliable testing and, ultimately, risk to children. Regarding ASTM F963, Table 6 reflects that it requires a tool to open a battery compartment, but does not require captive screws. This means that consumers could undermine the screw requirement by not using them, discarding them, or losing the screws. ASTM F963 also does not have torque requirements for fasteners, nor does it provide requirements for fastener threading or retention. These omissions are a deficiency, given the incident data involving lost screws and stripped screw holes. Staff concluded that the IEC standards contain similar deficiencies related to battery compartment fasteners, as summarized in Tables 6 and 7. As part of its requirements for secure battery compartments, Reese’s Law requires a performance standard for consumer products addressing reasonably foreseeable use-and-misuse conditions. Accordingly, staff considered the adequacy of use-andabuse testing of consumer products for each voluntary standard, and staff assessed whether the use-and-abuse testing would eliminate or adequately address deaths and injuries in the incident data. As shown in Table 7, and as described in more detail in Tab D of Staff’s NPR Briefing Package, staff advises that none of the voluntary standards, alone, provides for all the use-and-abuse testing needed to eliminate or adequately reduce incidents seen in the data. Based on CPSC staff’s review and analysis of voluntary standards related to child-resistant battery compartments for consumer products that contain button cell or coin batteries, as set forth in Tables 6 and 7 above, and Tab D of Staff’s NPR Briefing Package, the Commission preliminarily determines that no existing voluntary standard contains performance requirements that would eliminate or adequately reduce the risk of button cell or coin battery ingestion associated with consumer products that contain button cell or coin batteries within the scope of the proposed rule. However, as set forth below, the Commission draws on elements of these four voluntary standards to propose a rule that meets the requirements of Reese’s Law. We seek comment from the public regarding staff’s assessment of the relevant voluntary standards, and on our preliminary conclusion that, for the reasons given by staff, none of the standards, alone, satisfy the requirements for adoption as a consumer product safety rule under section 2(d) of Reese’s Law, 15 U.S.C. 2056e(d). B. Elements of the Proposed Standards for Battery Compartment Accessibility in Products Incorporating Button Cell or Coin Batteries Tables 8 and 9 summarize the performance requirements in the proposed rule. TABLE 8—REQUIREMENTS FOR CONSUMER PRODUCTS WITH COMPARTMENTS FOR REPLACEABLE BATTERIES Button cell or coin batteries must not become accessible or liberated when tested to these requirements: Construction Requirements Battery Compartment Construction Options. Option 1: Coin, screwdriver, or other household tool. • Captive screws • Two threads engaged or minimum torque + spin angle. Option 2: Two independent & simultaneous hand movements. • Cannot be combinable to a single movement with a finger or digit. Accessibility Test .................. Open or remove any part of the compartment not meeting Option 1 or Option 2 Apply Tension Test for Seams from 16 CFR part 1250 on pliable materials, using a force of 70.0 N (15.7 lbf). Determine whether Test Probe 11 from IEC 61032 can touch the battery. Preconditioning Requirements Preconditioning in Oven ....... Thermoplastics—7 hours at 158 °F or greater, based on operational temperature. Simulated Battery Replacement. Open/Close and remove/install battery 10 times. Use and Abuse Tests khammond on DSKJM1Z7X2PROD with PROPOSALS5 Drop Test ............................. Impact Test .......................... Crush Test ............................ Compression Test ................ Torque Test .......................... Tension Test ........................ Probe for Accessibility .......... 10 drops from 1 m (39.4 in) on hardwood, in positions likely to produce maximum force. 3 impacts on battery compartment with steel sphere, 2 J (1.5 ft-lbf) of energy. 335 N (75.3 lbf) for 10 s, using 100 by 250 mm (3.9 by 9.8 in) flat surface. Test from 16 CFR Part 1250, using a force of 136 N (30.6 lbf). Test from 16 CFR part 1250, using a torque of 0.50 Nm (4.4 in.-lbf). Test from 16 CFR part 1250, using a force of 72.0 N (16.2 lbf). Apply 50 N (11.2 lbf) with Test Probe 11 from IEC 61032 to confirm compliance. TABLE 9—REQUIREMENTS FOR CONSUMER PRODUCTS WITH COMPARTMENTS FOR NON-REPLACEABLE BATTERIES Option 1—Not Accessible ..... Option 2—Accessible ............ VerDate Sep<11>2014 17:16 Feb 08, 2023 Meets the same requirements as battery compartment for replaceable batteries. • Secured with soldering, fasteners such as rivets, or equivalent means. • Applicable preconditioning requirements apply. • Confirmed with secureness test: test hook applies a force of 22 N (4.9 lbf) directed outwards for 10 s, at all possible points. Battery cannot liberate from the product. Jkt 259001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS5 Below we describe the rationale for the proposed requirements. 1. Construction: Actions to Open the Battery Compartment Each of the four voluntary standards specifies similar requirements for a locking mechanism to secure the battery compartment that requires a tool (or coin) to open, to reduce the possibility of children removing the battery. Generally, requiring a coin or tool to open a battery compartment addresses child access to the battery compartment, because younger children may lack the required cognitive ability and fine motor coordination to perform the necessary actions to access the battery compartment, as discussed in Tab C of Staff’s NPR Briefing Package. UL 4200A, however, is the only voluntary standard that includes requirements for this locking mechanism, specifying either a minimum torque of 0.5 Nm (4.4 in-lbf) and a minimum angle of rotation of 90 degrees for the battery compartment fastener mechanism, or a minimum of two full threads engaged. These requirements are important to secure the battery compartment because staff found incidents involving battery compartments with stripped screw holes or screws of insufficient length, defeating the integrity of the screw requirement and allowing child access. In particular, ASTM F963 does not contain these torque and rotation requirements for the locking mechanism, and staff identified incidents of children accessing battery compartments on toys that purportedly met ASTM F963. Accordingly, the Commission proposes to include requirements for the locking mechanism, consistent with the requirements in UL 4200A. Moreover, all of the assessed voluntary standards, except ASTM F963–17, include a requirement for captive screws, which are screws that remain in the compartment or cover when unscrewed. If the screw is not captive to the compartment door, consumers can more easily lose the screw or defeat this locking mechanism by removing the screw, potentially for convenience, without appreciating the safety purpose of the screw. The Commission preliminarily concludes that the requirements in UL 4200A related to products that use a tool or coin to open the battery compartment, when applied to the full scope of products subject to Reese’s Law, and not just to lithium coin batteries, are adequate to address the battery compartment construction requirements related to the button cell or coin battery ingestion hazard. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 Although UL 4200A includes an exception to the captive screw requirement for large panel doors, the Commission is not including such an exception in the proposed rule. Instead, we are requesting comment on this, including what constitutes a ‘‘large panel door,’’ the types of products intended for this exception, and why these doors would not present the same risk of injury as any other consumer product that contains button cell or coin batteries if the screws become lost or discarded by the consumer. UL 4200A and IEC 62368–1 also specify an option for the battery compartment door to require a doubleaction locking mechanism (requiring at least two independent and simultaneous movements to open the compartment by hand) that ASTM F963 does not contain. Unlike screws, a double-action locking mechanism does not rely on the consumer to keep and reuse a screw. Thus, a double-action lock, if welldesigned and constructed, can be more secure than a screw lock that relies on consumers to reuse the screw each time the battery compartment is closed. The Commission preliminarily concludes that double-action locking mechanisms that meet the requirements of the proposed rule, which are similar to the double-action lock provisions in UL 4200A, could be effective in preventing younger children from opening the battery compartment, while affording additional flexibility to design effective child-resistant battery enclosures. 2. Use and Abuse Testing Reese’s Law mandates that the rule must include performance requirements for button cell or coin battery compartments during reasonably foreseeable use or misuse of the product. Accordingly, staff evaluated use and abuse testing in each voluntary standard to address the actual hazard patterns that are apparent in the incident data. Although all of the voluntary standards reviewed by staff specify abuse tests, none of the voluntary standards, alone, would eliminate or adequately reduce the ingestion risks presented by the incident data. Based on staff’s incident review, engineering analysis, and testing of consumer products as described in Tab D of Staff’s NPR Briefing Package, staff assessed that the drop test and impact test in UL 4200A adequately simulate use and abuse of consumer products by children. Staff assessed that the use and abuse testing in ASTM F963–17 is inadequate, alone, to address the risk of injury, because it does not precondition the products before abuse testing and does not contain an impact test, which PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 8703 is the test staff found most likely to simulate foreseeable use and abuse of consumer products. Staff, however, also assessed that the compression tests, torque tests, and tension tests in ASTM F963–17, the toy standard, are adequate to simulate foreseeable interactions, such as when a child grasps a part of a product with fingers or teeth, and twists, pulls, or presses on part of the product, while UL 4200A and IEC 62368–1 do not contain performance requirements to address these risks. A detailed assessment of these test methods can be found in Tab D of Staff’s NPR Briefing Package. Staff specifically observed the following regarding abuse testing: • UL 4200A specifies heat preconditioning of plastic component parts of the product. Staff’s testing demonstrated that heat pre-conditioning of the consumer products stresses plastic components to simulate more realistically, the expected condition of the product during normal use. ASTM F963 and IEC 62115 do not require heat pre-conditioning, and therefore, are inadequate to assess consistently and reliably, the integrity of battery compartments through use-and-abuse testing. • UL 4200A specifies mechanical preconditioning of the product by requiring a battery compartment on a consumer product to be opened, the battery removed, the battery reinstalled, and then the compartment closed, a total of 10 times. As with heat pre-conditioning, staff’s testing confirmed that mechanical pre-conditioning assesses more consistently the durability of a battery compartment to maintain its integrity over time, by preventing, for example, stripping of threads, compared to standards that do not require preconditioning. ASTM F963 and IEC 62115 do not require pre-conditioning by opening and closing the battery compartment, and therefore, inadequate to test reliably the durability of battery compartments on consumer products during foreseeable use and misuse. • UL 4200A subjects ‘‘portable’’ products to three drops during abuse testing, while ‘‘hand-held’’ portable products are subjected to 10 drops. All drops are from a height of 3.3 feet in positions likely to produce the maximum force on the battery compartment. Staff assessed that the 10cycle drop test for handheld items in UL 4200A is adequate to address and prevent incidents of breaking consumer products or battery compartments. The abuse testing requirements in ASTM F963 and IEC 62115, however, are inadequate to address the risk of button cell or coin batteries being liberated E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 8704 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules from broken battery compartments, because they allow for as few as four drops from a height of 3 feet, in random orientations that may not exert maximum force on the battery compartment. • UL 4200A requires three impact tests that each impart two joules of energy directly on the battery compartment with a steel ball. Staff advises that this impact test reasonably indicates the durability of the battery compartment during foreseeable use and misuse, as required by Reese’s Law. However, ASTM F963 is inadequate to eliminate or adequately reduce access to batteries caused by foreseeable stress on the battery compartment, because the standard does not require impact tests directly on the compartment. IEC 62368–1 varies the required impact energy based on the type of product, and IEC 62115 requires less energy per impact, which does not adequately reduce access to the battery compartment for certain products. • ASTM F963 specifies torque test and tension test methods to simulate interactions during reasonably foreseeable use and misuse conditions, such as a child grasping a part of the product with fingers or teeth and twisting, pulling, or pressing on the product. Staff advises that these requirements in the toy standard are adequate to test the durability and integrity of battery compartments in products with pliable materials such as shirts and greeting cards that light up or make sound using batteries. The proposed rule includes torque and tension tests to eliminate or adequately reduce the risk of ingestion in pliable products, as required by Reese’s Law. • UL 4200A specifies a compression test of 74.2 pounds over a 3.9-inch x 9.8inch area, which staff assesses adequately addresses a child pushing on the product with hands or feet. ASTM F963 and IEC 62115 specify a concentrated compression load of 30 pounds over a 1-square-inch area, which staff assesses adequately addresses a child unintentionally opening a battery compartment that cannot be impacted directly during the drop test, but that can be pushed open with hands or fingers. However, staff advises that the smaller compression test area in ASTM F963 and IEC 62115 is inadequate to assess a child pushing on the product with hands or feet. Conversely, the larger compression area of the UL 4200A is inadequate to address the risk of injury associated with a child pushing on the product with fingers. Accordingly, the proposed rule includes both tests to address adequately the VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 foreseeable possible range of child interactions and incidents. • UL 4200A specifies that if a product has a battery that is not intended to be removed or replaced by the user, and that is held fully captive by soldering, fasteners, or any equivalent means, then the product is not subject to abuse testing, and is subject only to preconditioning tests and secureness testing using a test hook and a force of 4.5 lb. IEC 62368–1 also excludes from abuse testing any products with nonremovable batteries; but it does not require any secureness test. The Commission is aware of incidents involving children gaining access to non-removable batteries in products like computers. Although the proposed rule requires only the applicable preconditioning tests and the secureness test based on UL 4200A for nonremovable batteries, with no additional abuse testing, the Commission requests comment on whether the proposed secureness test based on UL 4200A is sufficient to address reasonably foreseeable use and abuse of consumer products containing non-removable batteries. 3. Accessibility Test Each of these four voluntary standards relies on a test probe based on a child’s finger to verify whether certain components are accessible to children. Staff advises that the test probe used in ASTM F963 is inadequate to test accessibility, because the probe articulates and therefore cannot be used to apply much force. IEC 62368–1, IEC 62115, and UL 4200A do require a force to be applied with their respective probes to verify compliance with the standard. The IEC 62368–1 test probe head has a 3.5 mm (0.14 in.) radius, and compliance is verified with a force of 30 N ± 1 N (6.7 lbf ± 0.2 lbf). IEC 62115 and UL 4200A use Test Probe 11 of the Standard for Protection of Persons and Equipment by Enclosures—Probes for Verification, IEC 61032. This test probe has a head with a 4 mm (0.16 in.) radius. Staff assesses that using test Probe 11 with a force of 50 newtons (11.2 lbf), per IEC 62115, is adequate to assess a child’s ability to get into a battery compartment. The Commission seeks comments on the adequacy of the probes and accessibility tests in these voluntary standards. PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 V. Assessment of Warning Label Requirements in Relevant Voluntary Standards, and Description of the Proposed Rule’s Warning Label Requirements Section 2(a)(2) of Reese’s Law mandates warning label requirements for: • The packaging of button cell or coin batteries (15 U.S.C. 2056e(a)(2)(A)); • The packaging of consumer products containing button cell or coin batteries (15 U.S.C. 2056e(a)(2)(A)); • Any literature, such as a user manual, that accompanies a consumer product containing button cell or coin batteries (15 U.S.C. 2056e(a)(2)(B)); • As practicable, a consumer product that contains button cell or coin batteries in a manner visible to the consumer upon installation or replacement of the button cell or coin battery (15 U.S.C. 2056e(a)(2)(C)(i)); and • As practicable, a product for which the battery is not intended to be replaced or installed by the consumer, in a manner that is visible to the consumer upon access to the battery compartment; if it is impracticable to label the product, this information shall be placed on the packaging or instructions (15 U.S.C. 2056e(a)(2)(C)(ii)). The warning labels required by section 2(a) of Reese’s Law must (1) clearly identify the hazard of ingestion, and (2) instruct consumers, as practicable, to keep new and used batteries out of the reach of children, to seek immediate medical attention if a battery is ingested, and to follow any other consensus medical advice. 15 U.S.C. 2056e(b). Tab C of Staff’s NPR Briefing Package reviews and assesses warning label requirements in existing voluntary standards, and provides recommendations for warnings with a detailed rationale for each recommended requirement. This section discusses and proposes to adopt staff’s recommended implementation of Reese’s Law’s warning label requirements. A. Adequacy of Existing Voluntary Standards To fulfill the requirement in section 2(d) of Reese’s Law, the Commission first considers whether the labeling requirements in an existing voluntary standard meet the requirements of section 2(a)(2) and 2(b) of Reese’s Law. Tab C of Staff’s NPR Briefing Package and its Appendix contain a detailed analysis of the warning label requirements in 10 voluntary standards associated with button cell or coin E:\FR\FM\09FEP5.SGM 09FEP5 8705 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules batteries. For each standard, staff considered the scope, placement, format, and content of the required labels, and whether it adequately addresses the ingestion hazard warnings required by Reese’s Law. Table 10 summarizes staff’s assessment of the voluntary standards relevant to labeling of consumer products that contain button cell or coin batteries. TABLE 10—SUMMARY OF STAFF’S ASSESSMENT OF LABELING REQUIREMENTS IN STANDARDS FOR CONSUMER PRODUCTS CONTAINING BUTTON CELL OR COIN BATTERIES ASTM F963 UL 4200A ASTM F2999–19 ASTM F2923–20 IEC 62115 Scope: Battery Chemistry Type ............................................... Product Type ............................................................... All ................... Toys ............... Lithium ........... All ................... All ................... Jewelry ........... All ................... Children’s Jewelry. All. Toys. Labeling: On Consumer Product Packaging .............................. In instructions or accompanying literature .................. On consumer product .................................................. I ...................... I ...................... ........................ ........................ I ...................... I ...................... ........................ ........................ ........................ ........................ ........................ ........................ I I Blank—Does not address requirements, I—Inadequately addresses requirements, A—Adequately addresses requirements. Table 11 summarizes staff’s assessment of the voluntary standards relevant to labeling of packaging for button cell or coin batteries. TABLE 11—SUMMARY OF STAFF’S ASSESSMENT OF LABELING REQUIREMENTS IN STANDARDS FOR BATTERIES Scope: Battery Chemistry Type ............................................... Labeling: On batteries * ............................................................... On battery packaging .................................................. In instructions or accompanying literature .................. ANSI C18.1M ANSI C18.3M UL 1642 IEC 60086–4 IEC 60086–5 Aqueous ......... Lithium ........... Lithium ........... Lithium ........... Aqueous. I ...................... I ...................... ........................ I ...................... I ...................... I ...................... ........................ I ...................... ........................ I ...................... I ...................... ........................ I I khammond on DSKJM1Z7X2PROD with PROPOSALS5 Blank—Does not address requirements, I—Inadequately addresses requirements, A—Adequately addresses requirements. * Not directly addressed by Reese’s Law. As reflected in Table 10 and explained more fully in Tab C of Staff’s NPR Briefing Package and its Appendix, none of the voluntary standards relevant to consumer products that contain button cell or coin batteries have a scope that includes all consumer products. For example, the warnings required in ASTM F963 are limited to toys, and they also do not address spare batteries included with a consumer product. For UL 4200A, the required warnings do not use ANSI formatting and do not clearly warn of an ingestion hazard; this standard requires warning of a ‘‘chemical burn’’ without informing consumers how this hazard can occur. IEC 62115 permits a ‘‘Contains coin battery’’ symbol on the product packaging, but it does not instruct consumers to ‘‘Keep out of reach of children’’ on the packaging, instructions, or product. ASTM F2999– 19 and ASTM F2923–20, for jewelry, do not satisfy any of the labeling requirements of Reese’s Law. Table 11 summarizes staff’s assessment that the voluntary standards’ labeling requirements for battery packaging, likewise, do not satisfy VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 Reese’s Law. As reflected in Table 11 and explained more fully in Tab C of Staff’s NPR briefing package and its Appendix, none of the voluntary standards relevant to button cell or coin batteries have a scope that includes all button cell or coin batteries for which the ingestion hazard applies. Warnings in ANSI C18.1M and IEC 60086–5 are limited to aqueous battery chemistries (including alkaline batteries), while ANSI C18.3M, UL 1642, and IEC 60086– 4 are limited to lithium battery chemistries. Each of the relevant standards addresses warnings on battery packaging, but do not contain requirements specifically addressing the contents in Reese’s Law. For example, ANSI C18.3M contains two statements relevant to the ingestion hazard: ‘‘Keep batteries out of the reach of children, especially those batteries fitting within the limits of the truncated cylinder,’’ in section 8.4; and ‘‘Immediately seek medical attention if a cell or battery has been swallowed. Also, contact your local poison control center,’’ in section 8.5. However, the section containing these two statements provides manufacturers with information PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 regarding safe use of lithium batteries, and does not require the statements to be placed on packaging. Additional warning statements similar to those in section 8.4 and section 8.5 can be found in Annex C, but are only required for lithium coin cells 16 mm in diameter and larger. Based on CPSC staff’s review and analysis of voluntary standards and for the reasons summarized above, the Commission determines preliminarily that no existing voluntary standard contains the warnings required by Reese’s Law, for either consumer products containing button cell or coin batteries, or the packaging of such batteries. Although no standard, alone, contains labeling requirements that are adequate to satisfy Reese’s Law section 2, the standards collectively contain elements that can be combined to establish succinct warnings that address the ingestion hazard associated with button cell or coin batteries. Accordingly, as discussed below, the labeling requirements in the proposed rule are based on elements of several voluntary standards. E:\FR\FM\09FEP5.SGM 09FEP5 8706 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules B. Formatting Requirements for Warning Labels The warning labels in the proposed rule follow requirements found in ANSI Z535.4, American National Standard Product Safety Signs and Labels, which is the primary voluntary consensus standard providing guidelines for the design of safety signs and labels for application to consumer products. The ANSI Z535.4 standard includes recommendations for the design, application, use, and placement of warning labels, such as including the signal word, ‘‘WARNING,’’ and the safety alert symbol of an equilateral triangle surrounding an exclamation mark. The following format requirements, drawn from this ANSI standard, apply to all warning labels in the NPR: 1. All warnings must be clearly visible, prominent, legible, and permanently marked. 2. Warnings must be in contrasting color to the background onto which they are printed. 3. Warnings must be in English. 4. The safety alert symbol, an exclamation mark in a triangle, when used with the signal word, must precede the signal word. The base of the safety alert symbol must be on the same horizontal line as the base of the letters of the signal word. The height of the safety alert symbol must equal or exceed the signal word letter height. 5. The signal word ‘‘WARNING’’ must be in black letters on an orange background. The signal word must appear in sans serif letters in upper case only. 6. Certain text in the message panel must be in bold and in capital letters, as shown in the example warning labels, to get the attention of the reader. 7. For labels that are provided on a sticker, hangtag, instructions, or manual, the safety alert symbol and the signal word ‘‘WARNING’’ must be at least 0.2 in. (5 mm) high. The remainder of the text must be in characters whose upper case must be at least 0.1in. (2.5 mm), except where otherwise specified. 8. For labels that are required to be on the packaging of button cell and coin batteries, on the packaging of consumer products containing such batteries, and directly on consumer products, text size must be dependent on the area of the principal display panel. Text size must be determined based on Table 12, which is based on the information found in 16 CFR 1500.19(d)(7). TABLE 12—LETTER SIZE FOR WARNING LABELS: INFORMATION BASED ON 16 CFR 1500.19(d)(7) Letter size measurements in inches Display Area: Inches 2 0–2 Signal word (WARNING) ............................. Statement of Hazard .................................... Other Text .................................................... I 3/64 3/64 1/32 +2–5 I +5–10 1/16 3/64 3/64 3/32 1/16 1/16 I +10–15 7/64 3/32 1/16 I +15–30 1/8 3/32 5/64 I +30–100 5/32 7/64 3/32 I +100–400 1/4 5/32 7/64 +400 1/2 1/4 5/32 Letter size measurements in cm (for reference only) Display Area: cm 2 0–13 Signal word (WARNING) ............................. Statement of Hazard .................................... Other Text .................................................... I Placement of labels on packaging of button cell or coin batteries, consumer product packaging, and on consumer products, as set forth in the proposed rule, rely on the following definitions: khammond on DSKJM1Z7X2PROD with PROPOSALS5 • The ‘‘principal display panel’’ is defined as the display panel for a retail package of button cell or coin batteries or retail package of a consumer product containing such batteries that is most likely to be displayed, shown, presented, or examined under normal or customary conditions of display for retail sale. The principal display panel is typically the front of the package. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 0.119 0.119 0.079 +13–32 I 0.159 0.119 0.119 +32–65 I 0.238 0.159 0.159 +65–97 I 0.278 0.238 0.159 +97–194 I • 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 ‘‘product display panel’’ means the surface area on, near, or in the battery compartment. For consumer products with replaceable button cell or coin batteries, the product display panel must be visible while a consumer installs or replaces the button cell or PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 0.318 0.238 0.198 +194–645 I 0.397 0.278 0.238 +645–2,581 0.635 0.397 0.278 +2,581 1.270 0.635 0.397 coin battery. For consumer products with nonreplaceable button cell or coin batteries, the product display panel must be visible upon access to the battery compartment. C. Required Warnings for Button Cell or Coin Battery Packaging Using the foregoing formatting requirements, the proposed rule requires a warning for the principal display panel of the battery packaging, shown in Figure 4, that meets the requirements in section 2 of Reese’s Law. BILLING CODE 6355–01–P E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules 8707 Figure 4. Warning oflngestion Hazard for Battery Packaging. • • • • INGESTION HAZARD: DEATH or serious injury can occur if ingested. A swallowed button cell or coin battery can cause Internal Chemical Burns in as little as 2 hours. KEEP new and used batteries OUT OF REACH OF CHILDREN Seek Immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. Accordingly, battery packaging must include the following warnings statements: • ‘‘INGESTION HAZARD: DEATH or serious injury can occur if ingested.’’ This sentence identifies the hazard of ingestion, as required by section 2(b)(1) of Reese’s Law. • ‘‘A swallowed button cell or coin battery can cause Internal Chemical Burns in as little as 2 hours.’’ This sentence provides warning label requirements, as stated in Reese’s Law; an effective warning should have an explanation of how and why ingestion of a button cell or coin battery is hazardous. • ‘‘KEEP new and used batteries OUT OF REACH OF CHILDREN.’’ This sentence implements language in section 2(b)(2) of Reese’s Law. In addition, use of the icon recognized for keeping items out of children’s reach is intended to quickly convey the required message and direct the reader’s attention to the label. The icon incorporated with the warning must be at least 8 mm (0.31 in.) in diameter for visibility. Text size must be calculated per Table 12. • ‘‘Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body.’’ This sentence implements language in section 2(b)(2) of Reese’s Law and informs the consumer what actions should be taken if a button cell or coin battery is ingested or inserted into any part of the body. The warning includes the term ‘‘inserted’’ because insertions into the nose can be aspirated into the trachea and lead to ingestion, with the same risk of injury as oral ingestion. If space prohibits the full warning with the icon shown in Figure 4 in accordance with the formatting requirements of Table 12, packaging is required to use the ‘‘Keep out of Reach’’ icon (Figure 5) on the principal display panel and the warning text must be placed on the secondary display panel, as shown in Figure 6. The icon must be at least 20 mm (0.79 in.) in diameter for visibility. Figure 5. "Keep Out of Reach" Icon Figure 6. Warning Text Without Icon. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 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 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 attention’’ as described in section 2(b)(2) of Reese’s Law, and provides consumers with a resource for obtaining medical advice suitable to their situation. D. Required Warnings for Button Cell or Coin Batteries Included Separately With the Consumer Product Button cell or coin batteries included with a consumer product, but not yet installed in the product, must contain the warning label in Figure 4 on the principal display panel. If space does not allow the full warning consistent with the formatting requirements of E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.006</GPH> To address the hazard of button cell or coin batteries that become loose or separated from packaging, and to provide critical safety-related information should an ingestion incident occur, the following information implementing section 2(b)(2) of Reese’s Law must be placed on the secondary display panel of the packaging: (1) ‘‘Keep in original package until ready to use.’’ This statement instructs consumers to leave the batteries in child-resistant packaging as a specific EP09FE23.005</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 INGESTION HAZARD • DEATH or serious injury can occur • A swallowed button cell or coin battery can cause Internal Chemical Bums in as little as 2 hours• KEEP new and used batteries OUT OF REACH OF CHILDREN • Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. 8708 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules Table 12, then the icon shown in Figure 5 must be placed on the principal display panel with the text shown in Figure 6 on the secondary display panel, and the icon must be at least 20 mm in diameter for visibility. The goal is to ensure consumers have the opportunity to see the appropriate safety-related warning information and take appropriate action to store spare batteries safely away from children until installed in a consumer product. E. Required Warnings for Packaging of Consumer Products That Contain Button Cell or Coin Batteries Reese’s Law requires warning labels on the packaging of consumer products containing button cell or coin batteries. Each warning label must contain the same wording and icon as the battery packaging, except to make the first warning more explicit about the hazard: ‘‘INGESTION HAZARD: This product contains a button cell or coin battery.’’ The warning shown in Figure 7 must be on the principal display panel of the consumer product packaging. Covered consumer products that do not include packaging must affix the warning to the product with a hang tag or sticker label. Figure 7. Warning for consumer product packaging to indicate the presence of button cell or coin battery and the ingestion hazard. • INGESTION HAZARD: This product contains a button cell or coin battery. • DEATH or serious injury can occur if ingested. • A swallowed button cell or coin battery can cause Internal Chemical Bums in as little as 2 hours. • KEEP new and used batteries OUT OF REACH OF CHILDREN • Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. Product packaging that does not have the space to permit the full warning as indicated in Table 12, must include an abbreviated warning on the principal display panel, with the remaining statements (‘‘KEEP new and used batteries OUT OF REACH OF CHILDREN’’ and ‘‘Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body’’) placed on the secondary display panel, as shown in Figure 8. The icon must be at least 8 mm (0.31 in.) in diameter for visibility. Text size must be calculated per Table 12. Figure 8. Abbreviated warning if the consumer product packaging does not have space for the full warning on the front. "" iNGB'flON HAlARD: This µrotfuet oontalm a btlaon t::ei:I or ecin battery, KEEP new and""'" b•Ueries OUT Of REACH OF CHllDREN Seek lmmodillle medl«II attention ii• bottery is suspected to be swallow"d or lns,,rtod insid• •nv par! of the body, '"' DIAJH or ,.,,01jt inj'ury un oi::eu,, lt lnc•11ttd. A ,mtlowl'tl b'Wttol'\ f•ff or tl'.lirt bilittuy (,..,. uu1• ..,._,,.., Ch,,niwl ,..,.. iri •• H:ttli!! as 2 houn. Principal Display Panel F. Required On-Product Warnings for Consumer Products That Contain Button Cell or Coin Batteries Reese’s Law requires, as practicable, warnings directly on the consumer Secondary Display Panel product that contains button cell or coin batteries. A consumer product must be permanently marked with an ingestion warning on the product display panel. The warning in Figure 9 must be used: EP09FE23.008</GPH> battery. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4725 E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.007</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 INGESTION HAZARD: This product contains a button cell Of" coin EP09FE23.009</GPH> Figure 9. On-product warning label Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules If space on the product does not allow the full warning text shown in Figure 9 in accordance with Table 12, then the product must display the internationally recognized: ‘‘Warning: contains coin battery’’ icon, as shown in Figure 10, which is permitted without text. Figure 10. Safety Alert Symbol to Indicate "Warning: Contains coin battery" £ &B. ,.,,,,,,, . ' .. ,,, . 8709 See Staff’s NPR Briefing Package at Tab C. For visibility, the icon must be at least 7 mm (0.28 in.) in width and 9 mm (0.35 in.) in height and must be on the product display panel and must be in yellow with black outlines, as shown in Figure 10. The icon must be defined in accompanying printed materials, such as instructions, manual, insert, or hangtag. Figure 11 illustrates the scaled version of this icon on a product containing a battery, with a 20 mm (0.79 in.) diameter, as well as a scaled version with a 5 mm (0.20 in.) diameter. ' Figure 11. (a) 20mm diameter battery and icon, (b) 5 mm (0.20 in.) battery and icon (a) (b) Product with a 20-mm diameter battery Instructions and manuals for consumer products that contain button cell or coin batteries, if they exist, must contain the full warning label text required for button cell or coin battery packaging, as shown in Figure 7, as well as the three statements implementing section 2(b)(2) of Reese’s Law to address the hazard of button cell or coin batteries that become loose or separated from packaging, which provide critical safety-related information should an ingestion incident occur: VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 will improve safety communication to consumers for the same products subject to the proposed requirements discussed above, and based on the same hazard assessment. Because these proposed notification requirements rest on legal authority independent of Reese’s Law, adopting them is not inconsistent with Reese’s Law’s specification that the safety rule promulgated pursuant to section 2 of that statute ‘‘shall only contain’’ the provisions listed by Congress. 15 U.S.C. 2056e(a). For ease of understanding and administration, however, we propose to integrate the text of the notification requirements established under section 27(e) with the warning requirements established in the safety rule under Reese’s Law. VI. Required Notifications to Purchasers Consumers should be able to view battery-related safety information when purchasing products online. Otherwise, consumers would not be exposed to the warnings until they receive the physical product. Learning of the hazard associated with button cell or coin batteries at the time the consumer is searching for product information and In addition to the required warnings specified in Reese’s Law, and pursuant to the Commission’s independent authority under section 27(e) of the CPSA, the proposed rule requires delivery of technical and performance data to purchasers. These notifications PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 A. Websites or Applications That Enable Consumers To Purchase Products Online E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.011</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 G. Required Warnings for Instructions/ Manuals Accompanying Consumer Products • ‘‘Immediately dispose of used batteries and keep away from children. Do NOT dispose of batteries in household trash.’’ • ‘‘Even used batteries may cause severe injury or death.’’ • ‘‘Call a local poison control center for treatment information.’’ If instructions or manuals are not provided with the consumer product, this information must be present on the principal display panel or the secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label. This ensures that the consumer has the opportunity to see the appropriate safety-related information, even when a consumer product that uses a button cell or coin battery is not sold with a button cell or coin battery. EP09FE23.010</GPH> Based on staff’s assessment, we tentatively find that virtually all consumer products can accommodate either the full warning or one of the scaled icons, and we seek comment on that conclusion. However, if the product is too small to include any of the warnings in Figures 9–11, the product is required to: 1. have packaging containing the warning (see requirements for consumer product packaging), or 2. have a hangtag or sticker label with the full warnings, as shown in Figure 7. Product with a 5-mm diameter 8710 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS5 making purchasing decisions may influence those purchasing decisions or the actions taken to protect children against the hazard. Therefore, pursuant to its authority under section 27(e) of the CPSA, the Commission is proposing point-of-sale warning requirements for websites or other internet presence that manufacturers (including importers, per CPSA section 3(a)(11), 15 U.S.C. 2052(a)(11)) use to allow consumers to purchase these products. Specifically, online sales materials must include the warning in Figure 7 for purchases of button cell or coin batteries, and the warning in Figure 9 for purchases of consumer products containing button cell or coin batteries. The warning must be clearly visible, prominent, and legible next to the product description or near the product image or near the product price. B. Other Battery Safety Information on the Battery Packaging and Consumer Product Packaging In addition to the ingestion hazard warning, the proposed rule requires other safety-related information on the battery packaging and consumer product packaging. To reduce battery leakage, fire, and/or explosion hazards that could lead to personal injury, consumers should be aware of, and have ready access to, technical information about safe handling and use of button cell and coin batteries, as well as the characteristics of the batteries themselves. Therefore, we propose the following additional safety information under the authority in section 27(e) of the CPSA: 1. Battery packaging. (4) Battery type (e.g., LR44, CR2032). (5) Battery chemistry (e.g., silver oxide button or lithium) (6) Nominal voltage. Having battery type, chemistry, and voltage on the packaging constitutes performance and technical data that may help identify the battery if an ingestion is suspected. If a button cell or coin battery is ingested, knowing this information could assist medical providers to assess the severity of the risk of injury, and to treat the patient accordingly. For example, lithium button cell or coin batteries are associated with a higher likelihood of injury or death, in part, because they have a greater voltage than other button cell or coin batteries. The compatible battery type and voltage information on the product packaging will also help consumers avoid hazards associated with using incompatible batteries, such as leakage, fire, and/or explosion hazards. In addition, this statement will assist consumers in selecting the correct VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 type of battery for the product, reducing the likelihood that incorrect battery cells will be taken from their secure packaging and left loose and accessible to children. (7) Year and month or week of manufacture or expiration date. (8) Name or trademark of the manufacturer or supplier. Identification of manufacture date and other manufacturer information is technical data that may facilitate recalls resulting from ingestion of button or coin batteries. • ‘‘Do not mix old and new batteries, different brands or types of batteries, such as alkaline, carbon-zinc, or rechargeable batteries.’’ Mixing batteries can contribute to battery leakage, fire, and/or explosion hazards that could lead to personal injury. In addition, this statement will inform the consumer to use the correct type of battery cell that is called for use in the product, reducing the likelihood that incorrect battery cells will be taken from their secure packaging and left loose and accessible to children. • ‘‘Ensure the batteries are installed correctly according to polarity (+ and ¥).’’ Batteries installed with the wrong polarity can leak or explode. Also, incorrect installation may result in the consumer removing the batteries to install another set of batteries, creating loose batteries. • ‘‘Remove and immediately discard batteries from equipment not used for an extended period of time.’’ This statement is intended to ensure that consumers immediately dispose of batteries in unused products, because if left for an extended period, these batteries can leak, discharge, or explode unexpectedly, creating risks of injury. Furthermore, used button cell or coin batteries may have sufficient energy to cause damage if ingested. • ‘‘Non-rechargeable batteries are not to be recharged.’’ Placing non-rechargeable batteries in a charger can cause battery leakage, fire, and/or exploding hazards. This statement is intended to ensure that consumers do not attempt to recharge non-rechargeable batteries, or leave used batteries accessible to children with the intention of recharging them. • ‘‘Do not force discharge, recharge, disassemble, heat above (manufacturer’s specified temperature rating) or incinerate. Doing so may result in injury due to venting, leakage or explosion resulting in chemical burns.’’ This statement warns against actions that may result in external injuries from chemical burns. Damaged button cell or PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 coin batteries also can leak toxic chemicals that poses a risk if ingested. 2. Consumer product packaging or accompanying hang tag or sticker label. Also pursuant to section 27(e) of the CPSA, the principal display panel or the secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label, must include the following: • Products with non-replaceable batteries must include a statement indicating the product contains nonreplaceable batteries. If a consumer attempts to replace a non-replaceable battery, this action may damage the consumer product or the battery, and contribute to battery leakage, fire and/or explosion hazards. This may also cause the original or the replacement battery to become accessible, contributing to the ingestion hazard. The following additional requirements were previously described for battery packaging, and for the same reasons are also required on either the principal display panel or secondary display panel of the consumer product packaging, or in the absence of consumer product packaging, on the accompanying sticker or hangtag: (9) Battery type (e.g., LR44, CR2032). • Nominal voltage. 3. Instructions and manuals: Likewise, under the authority of CPSA section 27(e), instructions and manuals, when provided with consumer products must include the following additional battery safety-related information that is also required on the battery packaging: • Battery type (e.g., LR44, CR2032). • Nominal voltage. • ‘‘Do not mix old and new batteries, different brands or types of batteries, such as alkaline, carbon-zinc, or rechargeable batteries.’’ • ‘‘Remove and immediately discard batteries from equipment not used for an extended period of time.’’ • ‘‘Non-rechargeable batteries are not to be recharged.’’ • ‘‘Do not force discharge, recharge, disassemble, heat above (manufacturer’s specified temperature rating) or incinerate. Doing so may result in injury due to venting, leakage or explosion resulting in chemical burns.’’ If instructions or manuals are not provided with the consumer product, this information must be present on the principal display panel or the secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label. This ensures that the consumer has the opportunity to see the appropriate safety-related E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules information, even when a consumer product that uses a button cell or coin battery is not sold with a button cell or coin battery. C. Request for Comment on Requiring a Warning Icon on Button Cell or Coin Batteries Reese’s Law does not require marking or labeling regarding the ingestion hazard directly on button cell or coin batteries. However, the voluntary standard ANSI C18.3M advises to durably and indelibly mark coin cells with the ‘‘Keep Out of Reach’’ icon, with a minimum icon size of 6 mm in diameter. In accordance with Reese’s Law, the Commission recommends the ‘‘Keep Out of Reach’’ icon be used in conjunction with warning labels on battery and consumer product packaging to quickly convey the required message and direct the reader’s attention to the warning label. CPSC staff advises that requiring button cell or coin batteries that are visible within the packaging at the point of sale to have the ‘‘Keep Out of Reach’’ icon will further remind the consumer of the ingestion hazard, and direct attention to the icon and warning label on the battery packaging. Additionally, placing the ‘‘Keep Out of Reach’’ icon on button 8711 cell or coin batteries would continue to inform consumers of the ingestion hazard posed by the battery at all stages of its lifecycle, including while it is in battery packaging, when placed in a consumer product, or when loose. The Commission requests comment on whether the rule should require button cell or coin batteries to be durably and indelibly marked with the ‘‘Keep Out of Reach’’ icon where size permits, at a minimum size of 6 mm in diameter, and if so, whether the appropriate legal authority is Reese’s Law, section 27(e) of the CPSA, or another statute. Figure 12. "Keep out of Reach" Icon Etched onto Battery A. Section 1263.1 Scope, Purpose, Effective Date, Units, and Exemption Proposed § 1263.1(a) explains the scope and purpose of the safety standard required by Reese’s Law. 15 U.S.C. 2056e, Public Law 117–171. Reese’s Law requires a rule intended to eliminate or adequately reduce the risk of injury and death to children 6 years old and younger from ingesting button cell or coin batteries. Based on section 2 of Reese’s Law, the scope of the proposed rule includes consumer products that contain, or are designed to use, button cell or coin batteries, the packaging of such consumer products and accompanying literature, and the packaging of button cell or coin batteries. Section 2(a) of Reese’s Law requires performance requirements for childresistant button cell or coin battery compartments during reasonably foreseeable use and misuse of consumer VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 products that use such batteries. Proposed § 1263.1(a) also explains that Reese’s Law provides warning label requirements for packaging containing button cell or coin batteries, packaging of consumer products containing such batteries, consumer products, and instructions and manuals accompanying consumer products. The proposed rule also explains that the Commission will require point-of-sale notification of performance and technical data under the Commission’s authority in section 27(e) of the CPSA, 15 U.S.C. 2076(e). Section 1263.1(b) describes the effective date of the proposed rule. Consistent with section 6 of Reese’s Law (15 U.S.C. 2056e Notes), the rule proposes that all consumer products and packaging containing button cell or coin batteries that are subject to the proposed rule, and that are manufactured or imported after the proposed effective date of 180 days following publication of the final rule in the Federal Register, must comply with the requirements of this part. Section 1263.1(c) provides that values stated without parentheses are the requirement, while values in parentheses are approximate values. This proposal is consistent with UL 4200A. Section 1263.1(d) sets forth the statutory exemption for toys that meet the mandatory toy standard in section 4 of Reese’s Law, proposing that ‘‘any object designed, manufactured, or PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 marketed as a plaything for children under 14 years of age that is in compliance with the battery accessibility and labeling requirements of 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, is exempt from the requirements of this part.’’ See 15 U.S.C. 2056e Notes. Because section 2(a) of Reese’s Law directs the Commission to adopt a rule addressing the risk of injury from ingestion, and because the purpose of the proposed rule is to address the ingestion hazard associated with button cell or coin batteries, proposed § 1263.1(e) states that button cell or coin batteries that the Commission has determined do not present an ingestion risk are not subject to this proposed rule. The proposal applies to zinc-air button cell or coin batteries. B. Section 1263.2 Definitions Proposed § 1263.2 describes the definitions used for this consumer product safety rule and notification requirements. The proposed rule explains that in addition to the definitions given in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) and the definitions in section 5 of Reese’s Law (15 U.S.C. 2056e Notes), the Commission proposes to add eight definitions that specifically apply to this proposed rule. The definitions are listed in the proposed rule in alphabetical order. E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.012</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 VII. Description of the Proposed Rule As noted, we propose for the sake of clarity, convenience, and consistency to integrate the rule text adopted under Reese’s Law with that adopted under the separate authority of CPSA section 27(e), using the same definitions and exceptions for the section 27(e) requirements as for the requirements based on Reese’s Law. Below, we describe the resulting provisions of proposed 16 CFR part 1263. khammond on DSKJM1Z7X2PROD with PROPOSALS5 8712 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules Accessible and Accessibility Probe. As described in section VII.C, the proposed performance requirements for battery compartments require that after useand-abuse testing, a button cell or coin battery must not become accessible to children. The proposed rule measures accessibility using a test probe. Accordingly, proposed § 1263.2 defines the required test probe, stating that an ‘‘accessibility probe’’ means ‘‘Test Probe 11 in IEC 61032 Protection of Persons and Equipment by Enclosures—Probes for Verification.’’ Similarly, proposed § 1263.2 defines ‘‘accessible’’ to mean that the tests probe is ‘‘able to be contacted by the accessibility probe.’’ This means a battery is accessible if the test probe can touch a button cell or coin battery. Specifying the test probe and the definition of ‘‘accessible’’ in the proposed rule is intended to assist those who test consumer products to test consistently and reliability for the accessibility of button cell or coin batteries during testing to the standard. Button Cell or Coin Battery. Proposed § 1263.2 restates the statutory definition of a ‘‘button cell or coin battery’’ in section 5 of Reese’s Law. 15 U.S.C. 2056e Notes. A ‘‘button cell or coin battery’’ means ‘‘(1) a single cell battery with a diameter greater than the height of the battery; or (2) any other battery, regardless of the technology used to produce an electrical charge, that is determined by the Commission to pose an ingestion hazard.’’ Id. For this proposed rule, the Commission is focusing on addressing button cell and coin batteries under part (A) of the definition, because other batteries where the diameter is less than the height, such as AAA cylindrical batteries, do not pose the same type of ingestion hazard as button cell or coin batteries. For example, cylindrical batteries can pose a choking hazard, and CPSC is aware that consumers have ingested cylindrical batteries; however, the medical literature shows that injury or death due to ingestion of a cylindrical battery is rare. Consequently, the Commission is not including cylindrical batteries in the proposed rule at this time, but will expect staff to continue to monitor battery ingestion data. If CPSC becomes aware of a serious ingestion hazard associated with another battery type, section 2(g) of Reese’s Law allows the Commission to undertake additional rulemaking to address the hazard at any time. 15 U.S.C. 2056e(g). Consumer product containing button cell or coin batteries. Proposed § 1263.2 contains the statutory definition of a ‘‘consumer product containing button cell or coin batteries’’ from section 5 of Reese’s Law. 15 U.S.C. 2056e Notes. The VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 Commission preliminarily interprets this definition as providing that these consumer products include consumer products that are sold with a button cell or coin battery, and consumer products that are sold without a battery but are designed to use one or more button cell or coin batteries, regardless of whether such batteries are intended to be replaced by the consumer or are included with the product or sold separately. Ingestion Hazard. Proposed § 1263.2 describes the ‘‘ingestion hazard’’ addressed by the proposed rule. Based on a review of the medical literature, CPSC incident data, and data from the NCPC, an ingestion hazard is caused when a button cell or coin battery becomes lodged in the body, and can potentially cause death or serious injury through choking, generation of hazardous chemicals, leaking of hazardous chemicals, electrical burns, pressure necrosis, or other means. Principal Display Panel and Secondary Display Panel. Proposed § 1263.2 also explains what a ‘‘principal display panel’’ means to aid in understanding the required placement of warning statements on consumer product and button cell or coin battery packaging. The proposed rule explains that a ‘‘principal display panel’’ is typically on the front of the retail package of button cell or coin batteries or consumer products containing such batteries. The principal display panel is the panel most likely to be displayed, shown, presented, or examined under normal or customary conditions of display for retail sale. This definition assists in distinguishing the principal display panel from the proposed definition of a ‘‘secondary display panel,’’ described as a ‘‘display panel for a retail package of button cell or coin batteries or retail package of a consumer product containing such batteries that is opposite or next to the principal display panel. The secondary display panel is typically the rear or side panels of the package.’’ Product Display Panel. Finally, proposed § 1263.2 describes a ‘‘product display panel’’ to differentiate the surface of a consumer product battery compartment, as opposed to the packaging of button cell or coin batteries and the packaging of consumer products that contain such batteries. A product display panel is: the surface area on, near, or in the battery compartment. For consumer products with replaceable button cell or coin batteries, the product display panel must be visible while a consumer installs or replaces the button cell or coin battery. For consumer products with nonreplaceable button cell or coin PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 batteries, the product display panel must be visible upon access to the battery compartment. The intent of this definition is to inform industry that warnings on a product display panel must be located where a consumer will see the warning when interacting with the battery compartment, as required in section 2(a)(2)(C) of Reese’s Law. 15 U.S.C. 2056e(a)(2)(C). C. Section 1263.3 Requirements for Consumer Products Containing Button Cell or Coin Batteries The primary way that children access button cell or coin batteries and then ingest them is by accessing batteries from a consumer product. Accordingly, as required by section 2(a) of Reese’s Law, the proposed rule would establish performance requirements for childresistant button cell or coin battery compartments on consumer products during reasonably foreseeable use and misuse. Performance requirements are based on staff’s incident review, engineering analysis, testing of consumer products, and assessment that none of the relevant voluntary standards meet the risk reduction and warning requirements of Reese’s Law sections 2(a) and (d). The proposed rule is based on the provisions of several existing voluntary standards, including UL 4200A–21, IEC 62368–1, and ASTM F963–17 (as codified in 16 CFR part 1250). Performance requirements in the proposed rule would apply to consumer products containing button cell or coin batteries with replaceable and nonreplaceable batteries. General Requirements. Proposed § 1263.3(a) contains general requirements for consumer products containing button cell or coin batteries. This section explains that, in general, consumer products containing button cell or coin batteries must meet the performance and labeling requirements in the proposed rule to minimize the risk of children accessing and ingesting button cell or coin batteries. Performance requirements for consumer products containing button cell or coin batteries that are removable. Proposed § 1263.3(b) describes the specific performance requirements for consumer products containing button cell or coin batteries that are removable. A removable or replaceable button cell or coin battery in a consumer product cannot be made accessible, meaning able to be contacted with the accessibility probe, when tested to § 1263.3(d); must meet the performance tests in § 1263.3(e); and must require a tool, such as a screwdriver or coin, to open, or be secured using an enclosure E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules that requires a minimum of two independent and simultaneous hand movements to open (a double-action locking mechanism). The proposed rule also requires that battery compartments secured by one or more screws, or a twist-on access cover, meet a test for minimum torque (0.5 Nm (4.4 in-lb)) and minimum angle of rotation (90 degrees), or the fastener(s) must engage a minimum of two full threads. Moreover, screws or fasteners used to secure the battery compartment enclosure must be captive to the compartment door, cover, or closure. Unlike UL 4200A and IEC 62368–1, the proposed rule does not exclude from the requirement for captive screws large panel doors leading to button cell or coin battery compartments. CPSC requests comment on the rationale for such an exception and the types of products to which it should apply, if adopted. Performance requirements for consumer products containing button cell or coin batteries that are nonremovable. Proposed § 1263.3(c) explains that consumer products containing button cell or coin batteries not intended for removal or replacement must be made inaccessible by using a battery compartment enclosure that complies with the performance requirements of § 1263.3(b), meaning secured in a compartment that meets the same requirements as removable button cell or coin batteries, or by securing a button cell or coin battery compartment using soldering, fasteners such as rivets, or equivalent means, that passes the Secureness Test in § 1263.3(f). Accessibility test method. Proposed § 1263.3(d) assesses whether a child can access a button cell or coin battery installed in a consumer product by determining whether the specified accessibility probe can make contact with a button cell or coin battery. If children can touch the battery, then they may be able to remove the battery, leading to a potential ingestion. The test method requires that any part of the battery compartment enclosure that can be opened or removed without a tool, and with fewer than two independent and simultaneous movements (e.g., a zipper or hook and loop), be removed (§ 1263.3(d)(1)). The test method also states that if any part of the battery compartment is protected by pliable materials, such as fabric, paper, foam, or vinyl, or a seam, the tester must first apply the Tension Test for Seams in Stuffed Toys and Beanbag-Type Toys in 16 CFR part 1250, to determine whether the battery compartment enclosure can become exposed or accessible, using the specified force of 70.0 N (15.7 lbf) VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 (§ 1263.3(d)(2)). The test method instructs that if during this assessment a new part of the battery compartment enclosure becomes exposed or accessible, the tester must repeat the test in § 1263.3(d)(1), and the test in paragraph (d)(2), until no new part of the battery compartment enclosure becomes exposed or accessible, and then conduct the test in § 1263.3(d)(3). The test in § 1263.3(d)(3) instructs the tester to insert or apply the accessibility probe to any depth that a battery compartment opening will permit, and rotate or angle the accessibility probe before, during, and after insertion or application through the battery compartment opening to any position that is necessary to determine whether the probe can contact the button cell or coin battery. This test is intended to simulate a child attempting to reach a button cell or coin battery installed in the consumer product; however, this test is not intended to judge the strength of the material comprising the battery compartment. Testers should use the minimum force necessary to determine whether the accessibility probe can contact a button cell or coin battery installed in the consumer product. Performance tests for consumer products containing button cell or coin batteries. Proposed § 1263.3(e) states that testers should first conduct the required pre-conditioning steps in § 1263.3(e)(1) before testing consumer products to the performance requirements in § 1263.3(e)(2) (for products with replaceable battery compartments), and § 1263.3(f) (for products with accessible nonreplaceable batteries). Testers are also instructed to perform pre-conditioning and performance requirements in the order presented in the proposed rule. Performance test: Pre-conditioning: Stress Relief. Proposed § 1263.3(e)(1) requires each test sample of a consumer product to be pre-conditioned prior to conducting the applicable performance tests. The first pre-conditioning step, § 1263.3(e)(1)(i), is ‘‘stress relief’’ and applies to all covered consumer products, i.e., those with replaceable and non-replaceable batteries. Stress relief requires heating each sample consumer product that has a battery compartment enclosure made from molded or formed thermoplastic materials in a circulating air oven for at least 7 hours, at an oven temperature of the higher of at least 70 °C (158 °F) or at least 10 °C (18 °F) higher than the maximum temperature of the thermoplastic battery compartment enclosure during the most stringent normal operation of the consumer product. The rule proposes that testers PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 8713 must allow the product sample to cool to room temperature after removal from the oven before proceeding, to achieve more consistent results across tests and test labs. Performance test: Pre-conditioning: Battery replacement. Mechanical preconditioning breaks-in the component parts associated with securing the battery compartment and is needed to address durability issues associated with battery compartments, such as stripping of threads. Accordingly, proposed § 1263.3(e)(1)(ii), which applies only to consumer products with button cell or coin batteries intended to be removable or replaceable, requires opening the battery compartment enclosure, removing and replacing the button cell or coin battery, and closing the battery compartment enclosure for a total of 10 cycles. When battery compartment enclosures are secured with one or more screws, the screws must be loosened and then tightened using a suitable screwdriver, and applying a continuous linear torque, according to the Torque to Be Applied to Screws table, Table 20, of the Standard for Audio, Video and Similar Electronic Apparatus—Safety Requirements, UL 60065. If the screw(s) do not meet the specified torque requirements during this step, the test method requires removing the screws and repeating the accessibility test in proposed § 1263.3(d). Performance test: Abuse tests. After pre-conditioning consumer product samples, the proposed rule requires that all consumer product samples with removable or replaceable batteries must pass a series of six abuse tests, conducted in the sequence set forth in the proposed rule. After testing, each sample must meet the compliance requirement in proposed § 1263.3(e)(3). Performance test: Abuse tests: Drop test. To address foreseeable risks of breaking consumer products or their battery compartments, proposed § 1263.3(e)(2)(i) requires each sample to be dropped 10 times from a height of 1.0 m (39.4 in) onto a horizontal hardwood surface in positions likely to produce the maximum force on the battery compartment enclosure. The hardwood surface must be at least 13 mm (0.5 in) thick, mounted on two layers of nominal 19 mm (0.75 in) thick plywood, and placed on a concrete or equivalent non-resilient surface. Performance test: Abuse tests: Impact test. Consistent with the UL 4200A standard, proposed § 1263.3(e)(2)(ii) requires that the battery compartment enclosure door or cover on each sample consumer product be subjected to three, at least 2–J (1.5-ft·lbf) impacts, as shown E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 8714 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules in Figures 1 and 2 to proposed paragraph § 1263.3(e)(2)(ii). Performance test: Abuse tests: Crush test. To address the scenario of a child opening a battery compartment that cannot be impacted directly during the drop test proposed § 1263.3(e)(2)(iii) requires each sample consumer product to be subjected to a crush test using requirements similar to UL 4200A and IEC 62368–1. The crush test simulates a child pushing on the product with hands or feet, which cannot be assessed during the drop test on some consumer products. The proposed rule requires that each sample be supported by a fixed, rigid surface, in positions likely to produce the most adverse results, as long as the position of the consumer product is self-supported, and then apply a crushing force of at least 335 N (75.3 lbf) to the exposed surface for a period of 10 seconds. The test method states the force should be applied using a flat surface measuring approximately 100 mm by 250 mm (3.9 in by 9.8 in). Performance test: Abuse tests: Compression test. Proposed § 1263.3(e)(2)(iv) requires the compression test in ASTM F963 as codified in the toy standard. It further subjects consumer products to a crushing load that addresses children unintentionally opening battery compartments that cannot be impacted directly during the drop test, but can be pushed open with hands or fingers. The test method requires that if any surface of the battery compartment enclosure is accessible to a child and inaccessible to flat surface contact during the drop test, then apply the Compression Test from 16 CFR part 1250 (the mandatory toy standard) to that surface, using a force of at least 136 N (30.6 lbf). Performance test: Abuse tests: Torque test. The proposed rule applies to products not specifically contemplated by UL 4200A or IEC 62368–1, such as shirts and shoes that light up and rely on a button cell or coin battery to provide a power source. Accordingly, the proposed rule includes torque and tension tests to address battery accessibility to children in pliable products. If a child can grasp any part of the battery compartment enclosure on a sample consumer product, including the door or cover, with at least the thumb and forefinger, or using teeth, proposed § 1263.3(e)(2)(v) requires the battery compartment enclosure to be tested to the Torque Test for Removal of Components from 16 CFR part 1250 (the toy standard), using a torque of at least 0.50 Nm (4.4 in.-lbf). Performance test: Abuse tests: Tension test. For the same reasons stated for the proposed torque VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 requirement, if a child can grasp any part of the battery compartment enclosure on a sample consumer product, including the door or cover, with at least the thumb and forefinger, or using teeth, proposed § 1263.3(e)(2)(vi) requires application of the Tension Test for Removal of Components from 16 CFR part 1250 (the toy standard) to the battery compartment enclosure, using a force of at least 70.0 N (15.7 lbf). Performance test: Abuse tests: Compliance. Proposed § 1263.3(e)(3) provides that if a button cell or coin battery becomes accessible or is liberated from a consumer product as a result of any of the abuse tests in § 1263.3(e)(2), the consumer product is noncompliant and fails testing. Additionally, after completing all abuse testing, the proposed rule requires that the tester apply a force of at least 50 N (11.2 lbf) for 10 seconds to the battery compartment enclosure door or cover using the accessibility probe at the most unfavorable position on the battery compartment enclosure, and in the most unfavorable direction. The force must be applied in only one direction at a time. If the battery compartment enclosure door or cover opens or does not remain functional, or the button cell or coin battery becomes accessible, the consumer product is noncompliant and fails testing. Performance test: Secureness test. Proposed § 1263.3(f) applies only to button cell or coin batteries not intended for removal or replacement that are installed in a consumer product, and that are accessible based on the test in § 1263.3(b). Such products must be tested by applying a test hook, as shown in Figure 3 to paragraph § 1263.3(f) of the regulation text, using a force of at least 22 N (4.9 lbf), directed outwards, applied for 10 seconds at all points where application of a force is possible. To pass the test, the button cell or coin battery cannot become accessible or liberate from the consumer product during testing. D. Section 1263.4 Requirements for Marking and Labeling As explained in sections V and VI of this preamble, the proposed rule establishes warning label requirements for packaging containing button cell or coin batteries; packaging of consumer products containing such batteries (regardless of whether the batteries are permanent or replaceable); battery compartments of consumer products that contain button cell or coin batteries (where practicable and regardless of whether the batteries are permanent or replaceable); instructions or manuals PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 that accompany such consumer products; as well as time-of-sale (internet and in-store) notification of performance and technical data that provides information about the safety of button cell or coin batteries. Please see sections V and VI of this preamble for a detailed description and rationale for the proposed warning label requirements. E. Section 1263.5 Severability Section 1263.5 proposes a severability clause. The proposed provision states the Commission’s intent that if certain requirements in the rule are stayed or determined to be invalid by a court, the remaining requirements in the rule should continue in effect. This severability clause would apply to all provisions whether adopted as part of the safety standard under Reese’s Law or as a notification requirement under section 27(e) of the CPSA, to reflect the Commission’s intent that part 1263 as whole be given its greatest effect. VIII. Testing, Certification, and Notice of Requirements Section 14(a) of the CPSA includes requirements for certifying that consumer products comply with applicable mandatory standards. 15 U.S.C. 2063(a). Section 14(a)(1) addresses required certifications for non-children’s products, and sections 14(a)(2) and (a)(3) address certification requirements specific to children’s products. Non-Children’s Products. Section 14(a)(1) of the CPSA requires every manufacturer (which includes importers per 15 U.S.C. 2052(a)(11)) of a nonchildren’s product that is subject to a consumer product safety rule under the CPSA or a similar rule, ban, standard, or regulation under any other law enforced by the Commission to certify that the product complies with all applicable CSPSC-enforced requirements. 15 U.S.C. 2063(a)(1). Section 14(g) of the CPSA contains content and availability requirements for certificates. 15 U.S.C. 2063(g). Children’s Products. A ‘‘children’s product’’ is a consumer product that is ‘‘designed or intended primarily for children 12 years of age or younger.’’ 15 U.S.C. 2052(a)(2). Section 4 of Reese’s Law specifically exempts from the performance and labeling requirements in section 2 of the law, any toy product that is in compliance with the battery accessibility and labeling requirements in 16 CFR part 1250, the mandatory toy standard. However, all non-toy children’s products that contain button cell or coin batteries are subject to the proposed rule and must be tested by a E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules CPSC-accepted third party laboratory and certified as compliant. The following factors are relevant when determining whether a product is a children’s product: • manufacturer statements about the intended use of the product, including a label on the product if such statement is reasonable; • whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger; • whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger; and • the Age Determination Guidelines issued by CPSC staff in January 2020, and any successor to such guidelines. Id. ‘‘For use’’ by children 12 years and younger generally means that children will interact physically with the product based on reasonably foreseeable use. 16 CFR 1200.2(a)(2). Children’s products, for example, may be decorated or embellished with a childish theme, be sized for children, or be marketed to appeal primarily to children. Id. § 1200.2(d)(1). Section 14(a)(2) of the CPSA requires the manufacturer or private labeler of a children’s product that is subject to a children’s product safety rule to certify that, based on a third party conformity assessment body’s testing, the product complies with the applicable children’s product safety rule. 15 U.S.C. 2063(a)(2). The Commission’s requirements for children’s product testing and certification are codified in 16 CFR part 1107. Section 14(a) of the CPSA also requires the Commission to publish a notice of requirements (NOR) for a third party conformity assessment body (i.e., testing laboratory) to obtain accreditation to assess conformity with a children’s product safety rule. 15 U.S.C. 2063(a)(3)(A). Because some consumer products that contain button cell or coin batteries are children’s products, the proposed rule is a children’s product safety rule, as applied to those products. Accordingly, if the Commission issues a final rule, it must also issue an NOR. The Commission published a final rule, codified at 16 CFR part 1112, entitled Requirements Pertaining to Third Party Conformity Assessment Bodies, which established requirements and criteria concerning testing laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112 includes procedures for CPSC to accept a testing laboratory’s accreditation and lists the children’s product safety rules for which CPSC has published NORs. When CPSC issues a VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 new NOR, it must amend part 1112 to include that NOR. Accordingly, as part of this NPR for child-resistant battery compartments on consumer products, the Commission proposes to amend part 1112 to add the ‘‘Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries’’ to the list of children’s product safety rules for which CPSC has issued an NOR. Testing laboratories that apply for CPSC acceptance to test consumer products containing button cell or coin batteries, that are children’s products, to comply with the new rule, would have to meet the requirements in part 1112. When a laboratory meets the requirements of a CPSC-accepted third party conformity assessment body, the laboratory can apply to CPSC to include 16 CFR part 1263, Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries, in the laboratory’s scope of accreditation of CPSC safety rules listed on the CPSC website at: www.cpsc.gov/labsearch. IX. Effective Date The APA generally requires that the effective date of a rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). The Commission proposes that a final rule containing (1) performance and warning label requirements for consumer products containing button cell or coin batteries, and (2) warning label requirements for button cell or coin battery packaging, will become effective 180 days after publication of a final rule in the Federal Register. Therefore, in accordance with section 6 of Reese’s Law, products manufactured or imported after 180 days from publication of a final rule would be required to comply with the rule. The Commission is proposing 180 days to comply with the rule because a substantial number of consumer products containing button cell or coin batteries currently do not meet the performance requirements in UL 4200A or ASTM F963, and many affected industries will be unfamiliar with all or part of the proposed requirements. These industries may need to redesign, test, and certify to the requirements in the rule. Children’s products that are not toys will require third party testing to the rule, and 180 days will provide sufficient time for test labs to become ISO-accredited and have this accreditation accepted by CPSC to test children’s products. Additionally, the warning label requirements in the proposed rule include specific language that requires manufacturers to revise or PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 8715 reprint all existing packaging and to revise on-product warnings, where practicable. A 180-day effective date reflects similar language in Reese’s Law, which in section 3(a) sets a 180-day effective date for the child-resistant packaging requirements. The Commission requests comment on whether a later or an earlier effective date would be appropriate to comply with the proposed requirements and asks commenters to provide specific information to support such a later or an earlier effective date. X. Initial Regulatory Flexibility Analysis The Regulatory Flexibility Act (RFA) requires that agencies review a proposed rule for the rule’s potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency publishes an NPR. 5 U.S.C. 603. The IRFA must describe the impact of the proposed rule on small entities and identify significant alternatives that accomplish the statutory objectives and minimize any significant economic impact of the proposed rule on small entities. CPSC staff prepared an IRFA for this rulemaking that appears at Tab E of the Staff’s NPR Briefing Package. We provide a summary of the IRFA below. A. Reasons for Agency Action and Legal Basis for NPR The proposed rule is intended to address ingestion of button cell or coin batteries by children 6 years old and younger, and the associated deaths and injuries, as required by Reese’s Law, 15 U.S.C. 2056e, and authorized by section 27(e) of the CPSA, 15 U.S.C. 2076(e). As detailed in Tab D of Staff’s NPR Briefing Package, the proposed rule would require performance requirements for button cell or coin battery-powered consumer products, and require marking and labeling of consumer products, consumer product packaging, and button cell or coin battery packaging, as provided in Tab C of Staff’s NPR Briefing Package. B. Small Entities to Which the Proposed Rule Would Apply The North American Industry Classification System (NAICS) defines product codes for U.S. firms. Firms that manufacture button cell or coin batterypowered consumer products may list their business under a large variety of NAICS product codes. Most of these E:\FR\FM\09FEP5.SGM 09FEP5 8716 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules firms likely fall under the following NAICS codes: 334118 Computer Terminal and Other Computer Peripheral Equipment Manufacturing; 334310 Audio and Video Equipment Manufacturing; 335999 All Other Miscellaneous Electrical Equipment and Component Manufacturing; and 339920 Sporting and Athletic Goods Manufacturing. Importers of button cell or coin battery-powered consumer products are also as varied as the manufacturers. Staff expects most of the firms to fall under the following NAICS codes as wholesalers: 423620 Household Appliances, Electric Housewares, and Consumer Electronics Merchant Wholesalers; 423430 Computer and Computer Peripheral Equipment and Software Merchant Wholesalers; and 423690 Other Electronic Parts and Equipment Merchant Wholesalers. Retailers of button cell or coin batterypowered consumer products consist of a large variety of retailer types from large, ‘‘big box’’ retailers, to smaller specialized product firms. Nearly every NAICS code listed under retail trade (44, 45) may sell a product within scope of the proposed rule. Staff estimates that most of these products are sold by firms listed in NAICS codes 443140 Electronics and Appliance Retailers; 455219 All Other General Merchandise Retailers; 459420, Gift, Novelty, and Souvenir Retailers; 452000 General Merchandise Stores; and 459110 Sporting Goods Retailers. Under U.S. Small Business Administration guidelines, a manufacturer, importer, and retailer of button cell or coin battery-powered consumer products is categorized as ‘‘small,’’ based on the associated NAICS code. Manufacturers are categorized as small by the number of employees and importers/retailers by annual revenues. Based on 2017 data from U.S. Census Bureau, and a sample of retailers’ estimated revenues, staff estimated the number of firms classified as small for each NAICS code listed above (Census Bureau, 2020). The tables below provide the estimates of the number of small firms by each code. TABLE 13—ESTIMATED NUMBER OF SMALL MANUFACTURERS AND IMPORTERS SBA size standard for manufacturers/ importers (# of employees) NAICS code Description 334118 ......................................... Computer Terminal and Other Computer Peripheral Equipment Manufacturing. Other Communications Equipment Manufacturing ........................... Audio and Video Equipment Manufacturing ..................................... Small Electrical Appliance Manufacturing ......................................... All Other Miscellaneous Electrical Equipment and Component Manufacturing. Sporting and Athletic Goods Manufacturing ..................................... Office Supplies (except Paper) Manufacturing ................................. All Other Miscellaneous Manufacturing ............................................ Office Equipment Merchant Wholesalers ......................................... Computer and Computer Peripheral Equipment and Software Merchant Wholesalers. Household Appliances, Electric Housewares, and Consumer Electronics Merchant Wholesalers. Other Electronic Parts and Equipment Merchant Wholesalers ........ Sporting and Recreational Goods and Supplies Merchant Wholesalers. Other Miscellaneous Durable Goods Merchant Wholesalers ........... 334290 334310 335210 335999 ......................................... ......................................... ......................................... ......................................... 339920 339940 339999 423420 423430 ......................................... ......................................... ......................................... ......................................... ......................................... 423620 ......................................... 423690 ......................................... 423910 ......................................... 423990 ......................................... Number of firms that meet size standard 1,000 509 750 750 1,500 500 305 453 119 734 750 750 500 200 250 1,564 412 5,714 2,197 5,743 225 1,956 250 100 8,826 4,521 100 8,350 TABLE 14—ESTIMATED NUMBER OF SMALL RETAILERS khammond on DSKJM1Z7X2PROD with PROPOSALS5 NAICS code 444110 444130 444240 443140 455110 455211 455219 456110 459110 459410 459420 459999 452000 ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... ......................................... VerDate Sep<11>2014 17:16 Feb 08, 2023 SBA size standard for retailers (annual revenue) $millions Description Home Centers ................................................................................... Hardware Retailers ........................................................................... Nursery, Garden Center, and Farm Supply Retailers ...................... Electronics and Appliance Retailers ................................................. Department Stores ............................................................................ Warehouse Clubs and Supercenters ................................................ All Other General Merchandise Retailers ......................................... Pharmacies and Drug Retailers ........................................................ Sporting Goods Retailers .................................................................. Office Supplies and Stationery Retailers .......................................... Gift, Novelty, and Souvenir Retailers ................................................ All Other Miscellaneous Retailers ..................................................... General Merchandise Stores ............................................................ Jkt 259001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP5.SGM 41.50 14.50 19.00 35.00 35.00 41.50 35.00 33.00 23.50 35.00 12.00 10.00 35.00 09FEP5 Number of firms that meet size standard 1,526 9,623 13,228 18,906 11 3 7,812 18,912 16,123 2,646 15,264 36,225 7,832 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules C. Costs and Impact of the Proposed Rule on Small Entities Button cell or coin battery-powered consumer products may require redesign to meet the rule’s requirement for a battery compartment that requires a coin or tool to secure the enclosure (‘‘tool lock’’), or a double-action lock. Button cell or coin battery-powered consumer product manufacturers would most likely adopt a tool lock secured with a screw for affected products that currently do not conform to the proposed rule requirements. The potential costs of this proposed rule, therefore, are the incremental cost to incorporate a screw lock, and the onetime research, development, and retooling costs associated with any changes to battery compartments. For products that incorporate a doubleaction lock to secure the compartment, the Commission expects the only design-related cost incurred would be the redesign of the compartment to accommodate the change. Staff’s estimate of the incremental costs to modify a battery compartment for a tool lock ranges from $0.02 to $0.04 per product. The estimate of possible research, development, and retooling costs is a maximum of $15,400 per firm. We expect firms that choose to meet the requirement of the proposed rule using a double-action lock would only incur research and development costs. Manufacturers would likely incur additional costs to certify that their button cell or coin battery-powered consumer products meet the proposed rule, as required by section 14 of the CPSA, 15 U.S.C. 2063. For general use products, the certification must be based on a test of each product or a reasonable testing program. Manufacturers may complete the testing themselves or use a testing laboratory. Certification of children’s products, however, must be completed by a CPSC-accepted, third party conformity assessment body (i.e., third party laboratory). The cost of laboratory certification testing is expected to range from $150 to $350 per product sample. These third party testing costs should be considered as a possible maximum testing cost of the proposed rule, because less costly alternatives may be available.14 To comply with the proposed rule, small manufacturers would incur a one14 Certificate content requirements are set forth in section 14(g) of the CPSA and codified in 16 CFR part 1110. A reasonable testing program performed by the manufacturer would meet the requirements for general use (non-children’s) products, but children’s products are required to be tested and certified based on the third party testing requirements in 16 CFR part 1107. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 time redesign cost and continuous incremental component costs, described above, for some product lines that currently do not meet the requirements. We do not expect most small manufacturers to suffer a disproportionate cost effect from the proposed rule. Firms that rely heavily on the production of small, unique or novel electronic products, or highvolume, low-price products, could be affected adversely, however. Retail prices for button cell or coin batterypowered consumer products vary widely, with the least expensive product, on a per-unit basis, being mini flashlights at $1.00.15 A small manufacturer could incur costs that exceed 1 percent of annual revenue if the firm only produced these highvolume, low-price, or novel electronic products. Also, smaller manufacturers with less than $770,000 to $1,540,000 in annual revenue could incur one-time costs that exceed 1 percent of annual revenue, based on CPSC staff’s estimate of the potential research and development costs, which range from $7,700 to $15,400 per firm. Generally, CPSC staff considers an impact to be potentially significant if it exceeds 1 percent of a firm’s revenue. CPSC staff anticipates a potentially significant impact on some small firms that manufacture button cell or coin battery-powered consumer products. Staff assesses, however, that most small firms would not incur costs that exceed 1 percent of annual revenues, and therefore, would not be significantly impacted by the proposed rule. D. Alternatives Under section 603(c) of the Regulatory Flexibility Act, an IRFA analysis should ‘‘contain a description of any significant alternatives to the proposed rule which accomplish the stated objectives of the applicable statutes and which minimize any significant impact of the proposed rule on small entities.’’ 5 U.S.C. 603(c). CPSC staff assessed that the broad scope of Reese’s Law does not allow for a significant alternative that would reduce impacts to small businesses, such as limiting scope, providing exemptions, and educating consumers in lieu of regulatory action. To reduce the impact of the proposed rule on small firms, CPSC proposes not to require labeling of zinc-air batteries, which do not pose the same type of ingestion hazard as other button cell or coin batteries. This proposal will decrease burden, but not consequentially, because incremental labeling costs are not significant. CPSC 15 Based on staff’s review of product offerings on retailer websites and in-store locations. PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 8717 also could refrain from proposing the additional labeling requirements under section 27(e) of the CPSA, which are not required by Reese’s Law. However, removing section 27(e) performance and technical data requirements would reduce burden by an inconsequential amount, because firms would still have to conform to the other labeling provisions mandated by Reese’s Law. The incremental increase in burden from staff’s additional labeling requirements is insignificant. XI. Environmental Considerations The Commission’s regulations address whether the agency is required to prepare an environmental assessment or an environmental impact statement. Under these regulations, certain categories of CPSC actions normally have ‘‘little or no potential for affecting the human environment,’’ and therefore, do not require an environmental assessment or an environmental impact statement. 16 CFR 1021.5(c)(1). Safety standards providing performance and labeling requirements for consumer products that contain button cell or coin batteries fall within this categorical exclusion. XII. Paperwork Reduction Act This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501–3521). Under the PRA, an agency must publish the following information: D A title for the collection of information; D A summary of the collection of information; D A brief description of the need for the information and the proposed use of the information; D A description of the likely respondents and proposed frequency of response to the collection of information; D An estimate of the burden that will result from the collection of information; and D Notice that comments may be submitted to OMB. 44 U.S.C. 3507(a)(1)(D). In accordance with this requirement, the Commission provides the following information: Title: Amendment to Third Party Testing of Children’s Products, approved previously under OMB Control No. 3041–0159. Summary, Need, and Use of Information: Based on the requirements in Reese’s Law, 15 U.S.C. 2056e(a) and (b), and section 27(e) of the Consumer Product Safety Act, 15 U.S.C. 2076(e), E:\FR\FM\09FEP5.SGM 09FEP5 8718 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules the proposed consumer product safety standard prescribes performance requirements for child-resistant battery compartments on consumer products that contain button cell or coin batteries, and warning requirements for button cell and coin-battery packaging, consumer product packaging, consumer products, and instructions and manuals. These performance and labeling requirements are intended to reduce or eliminate injuries and deaths associated with children 6 years old and younger ingesting button cell or coin batteries. Section 4 of Reese’s Law specifically exempts from the performance and labeling requirements in section 2 of the law, any toy product 16 that is in compliance with the battery accessibility and labeling requirements in 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys. However, some consumer products that are not toys subject to the toy standard are considered children’s products. A ‘‘children’s product’’ is a consumer product that is ‘‘designed or intended primarily for children 12 years of age or younger.’’ 15 U.S.C. 2052(a)(2). The Commission’s regulation at 16 CFR part 1200 further interprets the term. Section 14 of the CPSA requires that children’s products be tested by a third party conformity assessment body, and that the manufacturer of the product, including an importer, must issue a compartments on children’s products (that are not toys) that contain button cell or coin batteries, as well as warnings on the packaging of these children’s products, the battery compartment of these children’s products, and any accompanying instructions and manuals, as set forth in the proposed rule. Respondents and Frequency: Respondents include manufacturers and importers of non-toy children’s products that contain button cell or coin batteries. Manufacturers and importers must comply with the information collection requirements when children’s products that contain button cell or coin batteries are manufactured or imported after the effective date of the rule. Estimated Burden: CPSC has estimated the respondent burden in hours, and the estimated labor costs to the respondent. Estimate of Respondent Burden: The hourly reporting burden imposed on firms that manufacture or import nontoy children’s products that contain button cell or coin batteries include the time and cost to maintain records related to third party testing, the time to issue a CPC, and the time to include required warning labels on children’s product battery compartments, children’s product packaging, and to update instructions or manuals with required warnings. children’s product certificate (CPC). Based on such third party testing, a manufacturer or importer must attest to compliance with the applicable consumer product safety rule by issuing the CPC. The requirement to test and certify children’s products falls within the definition of ‘‘collection of information,’’ as defined in 44 U.S.C. 3502(3). The requirements for the CPCs are stated in section 14 of the CPSA, and in the Commission’s regulation at 16 CFR parts 1107 and 1110. Among other requirements, each certificate must identify the manufacturer or private labeler issuing the certificate and any third party conformity assessment body, on whose testing the certificate depends, the date and place of manufacture, the date and place where the product was tested, each party’s name, full mailing address, telephone number, and contact information for the individual responsible for maintaining records of test results. The certificates must be in English. The certificates must be furnished to each distributor or retailer of the product and to the CPSC, if requested. The Commission has an OMB control number, 3041–0159, for children’s product testing and certification. This proposed rule would amend this collection of information to add testing and certification to the performance requirements for child-resistant battery TABLE 15—ESTIMATED ANNUAL REPORTING BURDEN Total annual reponses khammond on DSKJM1Z7X2PROD with PROPOSALS5 Burden type Length of response (hours) Annual burden (hours) Third-party testing, recordkeeping and record maintenance ...................................................... Certification and labeling ............................................................................................................. 6,046 1,209 5.0 1.0 30,230 1,209 Total Burden ......................................................................................................................... ........................ ........................ 31,439 Three types of third party testing of children’s products are required: certification testing, material change testing, and periodic testing. Requirements state that manufacturers must conduct sufficient testing to ensure that they have a high degree of assurance that their children’s products comply with all applicable children’s product safety rules before such products are introduced into commerce. If a manufacturer conducts periodic testing, they are required to keep records that describe how the samples of periodic testing are selected. CPSC estimates that 0.4 percent of all children’s products sold annually, or 6,046 children’s products, are children’s products that contain button cell or coin batteries and would be subject to thirdparty testing, for each of which 5.0 hours of recordkeeping and record maintenance will be required. Thus, the total hourly burden of the recordkeeping associated with certification is 30,230 hours (5.0 × 6,046). Additionally, battery compartments, product packaging, and instructions and manuals must be updated to include the required warnings statements. We estimate that the time required to make these modifications is about 1 hour per product. Based on an evaluation of a sample of supplier product lines, there 16 For purposes of Reese’s Law, a ‘‘toy product’’ is ‘‘any object designed, manufactured, or marketed as a plaything for children under 14 years of age.’’ 15 U.S.C. 2056e Notes. VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 are a total of 1,209 affected products; therefore, the estimated burden associated with warnings and labeling is 1 hour per product × number of product lines = 1,209 hours. We estimate the hourly compensation for the time required to create and update labels is $36.80 (U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ Sept. 2022, total compensation for all sales and office workers in goods-producing private industries: https://www.bls.gov/ news.release/archives/ecec_ 12152022.pdf). Therefore, the estimated annual cost to industry associated with the labeling requirements is $1,156,955 E:\FR\FM\09FEP5.SGM 09FEP5 khammond on DSKJM1Z7X2PROD with PROPOSALS5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules ($36.80 per hour × 31,439 hours = $1,156,955.2). No operating, maintenance, or capital costs are associated with the collection. This burden estimate is the largest reasonably possible, assuming that every manufacturer had to modify three product labels (battery compartment, packaging, and instructions/manual). However, based on staff’s review of nontoy children’s products that contain button cell or coin batteries, many of these products already contain some type of warning on the product or product packaging. Accordingly, staff believes it possible that product modification for warnings and any associated burden could be very low. Under the OMB’s regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the ‘‘normal course of their activities’’ are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are ‘‘usual and customary.’’ If warning statements on one or more battery compartments, product packaging, and instructions/manuals is usual and customary for non-toy children’s products that contain button cell or coin batteries, CPSC could estimate that no burden hours are associated with the labeling requirements in the proposed rule, because any burden associated with warning labels would be ‘‘usual and customary’’ and not within the definition of ‘‘burden’’ under the OMB’s regulations. We request comments on this potential estimate of no burden for warning labels, or any aspect of labeling. We also request comment on the preliminary analysis demonstrating that the largest possible burden estimate for the proposed standard to require warning labels is 1,209 hours at a cost of $44,491 annually. The total estimated burden associated with the proposed rule on non-toy children’s products that contain a button cell or coin battery for third party testing, recordkeeping, issuing a certificate (CPC), and placing the required warning statements on the battery compartment of the children’s product, on the packaging of the children’s product, and on any associated instructions or manuals is 31,439 labor hours annually. Labor Cost of Respondent Burden. According to the U.S. Bureau of Labor Statistics (BLS), Employer Costs for Employee Compensation, the total compensation cost per hour worked for all private industry workers was $39.61 (September 2022, https://www.bls.gov/ ncs/ect/). Based on this analysis, CPSC VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 staff estimates that labor cost of respondent burden would impose a cost to industry of approximately $1,245,299 annually (31,439 hours × $39.61 per hour = $1,245,298.79). Cost to the Federal Government. The estimated annual cost of the information collection requirements to the Federal Government is approximately $4,448, which includes 60 staff hours to examine and evaluate the information, as needed, for Compliance activities. This is based on a GS–12, step 5 level salaried employee. The average hourly wage rate for a mid-level salaried GS– 12 employee in the Washington, DC metropolitan area (effective as of January 2023 is $51.15 (GS–12, step 5). This represents 69.0 percent of total compensation (U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ September 2022, Table 2., percentage of wages and salaries for all civilian management, professional, and related employees: https://www.bls.gov/news.release/ archives/ecec_12152022.pdf). Adding an additional 31.0 percent for benefits brings average annual compensation for a mid-level salaried GS–12 employee to $74.13 per hour. Assuming that approximately 60 hours will be required annually, this results in an annual cost of $4,448 ($74.13 per hour × 60 hours = $ 4,447.8). Comments. CPSC has submitted the information collection requirements of this proposed rule to OMB for review in accordance with PRA requirements. 44 U.S.C. 3507(d). CPSC requests that interested parties submit comments regarding information collection to the Office of Information and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of this NPR). Pursuant to 44 U.S.C. 3506(c)(2)(A), the Commission invites comments on: • Whether the proposed collection of information is necessary for the proper performance of CPSC’s functions, including whether the information will have practical utility; D The accuracy of CPSC’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; D Ways to enhance the quality, utility, and clarity of the information the Commission proposes to collect; D Ways to reduce the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology; D The estimated burden hours associated with labels and hang tags, including any alternative Estimates; and PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 8719 D The estimated respondent cost other than burden hour cost. XIII. 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 would apply to a final rule issued under section 2 of Reese’s Law. 15 U.S.C. 2056e. A notification requirement under section 27(e) of the CPSA is not a consumer product safety rule and would not be subject to the preemption provision in section 26(c) of the CPSA. XIV. Request for Comments The Commission requests comment on all aspects of the proposed rule, including specifically the following items: A. Performance Requirements • Whether any consumer products (as opposed to medical devices, such as hearing aids) contain zinc-air button cell or coin batteries, and whether such products should be required to meet the performance requirements for battery compartments on consumer products; • Whether any voluntary standard meets the performance and labeling requirements of Reese’s Law; • Whether the requirements for accessibility of battery compartments should incorporate test methods commonly used on toy products, such as the torque and tensile tests for parts of the product that can be gripped by a child’s fingers or teeth, or a tensile test for pliable materials; E:\FR\FM\09FEP5.SGM 09FEP5 8720 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS5 • For consumer products that use button cell or coin batteries and have large panel doors, what consumer products have such doors, and should the Commission exclude large panel doors from the requirement for captive screws; why or why not (i.e., why does a large panel door represent a different risk of injury from battery access without using captive screws than a smaller battery compartment door does?); • Whether a double-action locking mechanism used to secure battery compartment enclosures, meaning those mechanism that rely on two independent and simultaneous hand movements to open (versus a screw, for example), should be allowed to secure button cell or coin battery compartments; • Whether the proposed secureness test based on UL 4200A is sufficient to address reasonably foreseeable use and abuse of consumer products containing non-removable batteries; • Whether Test Probe 11 of the Standard for Protection of Persons and Equipment by Enclosures—Probes for Verification, IEC 61032, is adequate to verify accessibility of a button cell or coin battery in a battery compartment; • Whether there are any additional performance requirements that should be considered, either for specific types of products, or in general; • Whether one or more performance requirements should be based on IEC 62368–1, in addition to, or instead of, performance requirements based on UL 4200A; and • Whether the proposed performance requirements are needed and are likely to eliminate or adequately reduce the ingestion hazard associated with access to button cell or coin batteries from consumer products. B. Marking and Labeling Requirements • Whether the Commission should require ingestion warnings on zinc-air button cell or coin battery packaging; • Whether all button cell or coin battery packaging should include the warning on the principal display panel; • Whether the requirement for the ‘‘Keep Out of Reach’’ icon to be 20 mm in diameter for visibility purposes, when alone on the front of battery packaging, provides a sufficient warning of the ingestion hazard; • 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; • For technical and performance data related to the safety of button cell or VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 coin batteries required at the time of purchase, whether the proposed warnings’ content and location requirements are adequate to advise consumers who purchase a product online or in-store about the hazards associated with these batteries; • Whether staff’s assessment in V.F of this preamble that virtually all consumer products can accommodate either the full warning or one of the scaled icons is accurate; • Whether the rule should require button cell or coin batteries to be durably and indelibly marked with the ‘‘Keep Out of Reach’’ icon where size permits, at a minimum size of 6 mm in diameter, and if so, whether the appropriate legal authority is Reese’s Law, section 27(e) of the CPSA, or another statute; and • Whether the internationally recognized safety alert symbol, as shown in yellow color, indicating the presence of a button cell or coin battery, should be required on all consumer products containing such batteries. C. Other Comments • 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. • In the IRFA, the number of small firms impacted and expected cost impact on small firms (as a percentage of annual revenue) of the proposed rule. Submit all comments in accordance with the instructions in the ADDRESSES section at the beginning of this document. List of Subjects 16 CFR Part 1112 Administrative practice and procedure, Audit, Consumer protection, Reporting and recordkeeping requirements, Third party conformity assessment body. 16 CFR Part 1263 Batteries, Consumer protection, Imports, Infants and children, Labeling, Law enforcement. For the reasons discussed in the preamble, the Commission proposes to amend Title 16 of the Code of Federal Regulations as follows: PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 1. The authority citation for part 1112 is revised to read as follows: ■ Authority: 15 U.S.C. 2063; 15 U.S.C. 2051 Notes. PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 2. Amend § 1112.15 by adding paragraph (b)(55) to read as follows: ■ § 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule or test method? * * * * * (b) * * * (55) 16 CFR part 1263, Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries. * * * * * ■ 3. Add part 1263 to read as follows: PART 1263—SAFETY STANDARD AND NOTIFICATION REQUIREMENTS FOR BUTTON CELL OR COIN BATTERIES AND CONSUMER PRODUCTS CONTAINING SUCH BATTERIES Sec. 1263.1 Scope, purpose, effective date, units, exemption. 1263.2 Definitions. 1263.3 Requirements for consumer products containing button cell or coin batteries. 1263.4 Requirements for marking and labeling. 1263.5 Severability. Authority: 15 U.S.C. 2052, 2056e, 2058, 2076(e). § 1263.1 Scope, purpose, effective date, units, and exemption. (a) Scope and purpose. As required by Reese’s Law (15 U.S.C. 2056e, Pub. L. 117–171), this part establishes performance requirements for childresistant button cell or coin battery compartments on all consumer products that contain, or are designed to contain, such batteries to prevent child access to batteries during reasonably foreseeable use and misuse of the consumer product. The rule is intended to eliminate or adequately reduce the risk of injury and death to children 6 years old and younger from ingesting these batteries. This part also establishes warning label requirements for packaging containing button cell or coin batteries, packaging of consumer products containing such batteries, consumer products, instructions and manuals accompanying consumer products, as well as point-of-sale performance and technical data pursuant to section 27(e) of the Consumer Product Safety Act (15 U.S.C. 2076(e). (b) Effective date. Except as provided in paragraph (d) of this section, all consumer products containing button cell or coin batteries and all packaging containing button cell or coin batteries subject to the rule that are manufactured or imported after [180 DAYS AFTER E:\FR\FM\09FEP5.SGM 09FEP5 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules PUBLICATION IN THE FEDERAL REGISTER] must comply with the requirements of this part. (c) Units. In this part, values stated without parentheses are the requirement. Values in parentheses are approximate information. (d) Exemption for toy products. Any object designed, manufactured, or marketed as a plaything for children under 14 years of age that is in compliance with the battery accessibility and labeling requirements of 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, is exempt from the requirements of this part. (e) Batteries that do not present an ingestion risk. Button cell or coin batteries that the Commission has determined do not present an ingestion risk are not subject to this rule. These are: zinc-air button cell or coin batteries. khammond on DSKJM1Z7X2PROD with PROPOSALS5 § 1263.2 Definitions. In addition to the definitions given in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) and section 5 of Reese’s Law (15 U.S.C. 2056e Notes), the following definitions apply for purposes of this part: Accessibility probe means Test Probe 11 in IEC 61032 Protection of Persons and Equipment by Enclosures—Probes for Verification. Accessible means able to be contacted by the accessibility probe. Button cell or coin battery means: (1) A single cell battery with a diameter greater than the height of the battery; or (2) Any other battery, regardless of the technology used to produce an electrical charge, that is determined by the Commission to pose an ingestion hazard. Consumer product containing button cell or coin batteries means 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. Ingestion hazard means a hazard caused by a person swallowing or inserting a button cell or coin battery into their body whereby: (1) The button cell or coin battery can become lodged in the digestive tract or airways; and (2) Can potentially cause death or serious injury through choking, generation of hazardous chemicals, leaking of hazardous chemicals, electrical burns, pressure necrosis, or other means. Principal display panel means the display panel, for a retail package of one VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 or more button cell or coin batteries or retail package of a consumer product containing 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. Product display panel means the surface area on, near, or in the battery compartment of a consumer product containing button cell or coin batteries. For consumer products containing button cell or coin batteries where such batteries are replaceable, the product display panel must be visible while a consumer installs or replaces any button cell or coin battery. For consumer products with one or more nonreplaceable button cell or coin batteries, the product display panel must be visible upon access to the battery compartment. Secondary display panel means a display panel for a retail package of one or more button cell or coin batteries or retail package of a consumer product containing 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. § 1263.3 Requirements for consumer products containing button cell or coin batteries. (a) General. Consumer products containing button cell or coin batteries must meet the performance and labeling requirements in this part to minimize the risk of children accessing and ingesting button cell or coin batteries. Consumer products with battery compartments that allow consumers to remove or replace a button cell or coin battery must comply with the performance requirements in paragraph (b) of this section. Consumer products with battery compartments that do not allow for the removal or replacement of any button cell or coin batteries must comply with the performance requirements in paragraph (c) of this section. (b) Performance requirements for consumer products containing button cell or coin batteries that are removable. (1) A removable or replaceable button cell or coin battery in a consumer product must not be made accessible when tested pursuant to paragraph (d) of this section. (2) Battery compartments for removable or replaceable button cell or coin batteries must meet the requirements in paragraph (e) of this section and be secured using at least one of the following methods: PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 8721 (i) Secure the battery compartment enclosure so that it requires a tool, such as a screwdriver or coin, to open the battery compartment. Opening a battery compartment secured by one or more screws, or a twist-on access cover, must require a minimum torque of 0.5 Nm (4.4 in-lb) and a minimum angle of 90 degrees of rotation, or the fastener(s) must engage a minimum of two full threads. Screws or fasteners used to secure the battery compartment enclosure must be captive to the compartment door, cover, or closure. (ii) Secure the battery compartment enclosure so that it requires a minimum of two independent and simultaneous hand movements to open. The movements to open cannot be combinable to a single movement with a single finger or digit. (c) Performance requirements for consumer products containing button cell or coin batteries that are nonremovable. Consumer products containing button cell or coin batteries not intended for removal or replacement must be made inaccessible by: (1) Using a battery compartment enclosure that complies with the performance requirements of paragraph (b) of this section; or (2) Securing the button cell or coin battery using soldering, fasteners such as rivets, or equivalent means, that passes the Secureness Test in paragraph (f) of this section. (d) Accessibility test method. This test assesses whether a child can access a button cell or coin battery installed in a consumer product by determining whether the accessibility probe can contact a button cell or coin battery. The test method is as follows: (1) To determine whether a button cell or coin battery is accessible, first open and remove any part of the battery compartment enclosure that can be opened or removed without a tool or that can be opened or removed with anything less than two independent and simultaneous movements (for example, a zipper or hook and loop). (2) If a part of the battery compartment enclosure is protected by pliable material such as fabric, paper, foam, or vinyl, or a pliable material with a seam, apply the Tension Test for Seams in Stuffed Toys and BeanbagType Toys test in 16 CFR part 1250 to determine whether the battery compartment enclosure can become exposed or accessible, using a force of at least 70.0 N (15.7 lbf). If a new part of the battery compartment enclosure becomes exposed or accessible, repeat the test in paragraph (d)(1) of this section and the test in this paragraph (d)(2) until no new part of the battery E:\FR\FM\09FEP5.SGM 09FEP5 8722 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules compartment enclosure becomes exposed or accessible, and then conduct the test in paragraph (d)(3) of this section. (3) Insert or apply the accessibility probe to any depth that a battery compartment opening will permit, and rotate or angle the accessibility probe before, during, and after insertion or application through the battery compartment opening to any position that is necessary to determine whether the probe can contact the button cell or coin battery. This test is not intended to judge the strength of the material comprising the battery compartment. Use the minimum force necessary in determining whether the probe can contact a button cell or coin battery. (e) Performance tests for consumer products containing button cell or coin batteries. After pre-conditioning in accordance with paragraph (e)(1) of this section, consumer products containing a button cell or coin battery must pass the performance requirements in paragraph (e)(2) or (f) of this section in the order presented, as applicable. (1) Pre-conditioning. Subject each test sample consumer product to applicable pre-conditioning: (i) Stress relief. Subject each sample consumer product with a battery compartment enclosure, door/cover, or door/cover opening mechanism that is made from molded or formed thermoplastic materials to a stress relief test. Place each test sample consumer product in a circulating air oven for at least 7 hours, using an oven temperature of the higher of at least 70°C (158 °F) or at least 10°C (18 °F) higher than the maximum temperature of thermoplastic battery compartment enclosures, doors/ covers, or door/cover opening mechanisms during the most stringent normal operation of the consumer product. Allow the sample consumer product to cool to room temperature after removal from the oven. (ii) Battery replacement. This step applies only to consumer products with button cell or coin batteries intended to be removable or replaceable. Open the battery compartment enclosure, remove and replace the button cell or coin battery, and close the battery compartment enclosure for a total of 10 cycles. For battery compartment enclosures that are secured with a screw(s), the screw(s) must be loosened and then tightened each time using a suitable screwdriver, applying a continuous linear torque according to the Torque to be Applied to Screws table, Table 20, of the Standard for Audio, Video and Similar Electronic Apparatus—Safety Requirements, UL 60065. If the screw(s) do not meet the specified torque requirements during this step, remove the screw(s) and repeat the test in paragraph (d) of this section. (2) Abuse tests. Subject each test sample consumer product to the following abuse tests, performed sequentially, as applicable. Check compliance of the sample using paragraph (e)(3) of this section. If the consumer product contains button cell or coin batteries that are not intended for removal or replacement, and that are accessible based on paragraph (c) of this section, then the consumer product must be tested under paragraph (f) of this section and this paragraph (e)(2) does not apply. (i) Drop test. Drop each sample consumer product ten times from a height of 1.0 m (39.4 in) onto a horizontal hardwood surface in positions likely to produce the maximum force on the battery compartment enclosure. The hardwood surface must be at least 13 mm (0.5 in) thick, mounted on two layers of nominal 19 mm (0.75 in) thick plywood, and placed on a concrete or equivalent non-resilient surface. (ii) Impact test. Subject the battery compartment enclosure door or cover on each sample consumer product to three, at least 2–J (1.5-ft·lbf) impacts. Produce the impact by dropping a steel sphere, 50.8 mm (2 in) in diameter, and weighing approximately 0.5 kg (1.1 lb) from the height required to produce the specified impact, as shown in figure 1 to this paragraph (e)(2)(ii), or suspend the steel sphere by a cord and swing as a pendulum, dropping through the vertical distance required to cause the steel sphere to strike the battery compartment enclosure door or cover with the specified impact, as shown in figure 2 to this paragraph (e)(2)(ii). The steel sphere must strike the battery compartment enclosure door or cover perpendicular to the surface of the battery compartment enclosure. Figure 1 to Paragraph (e)(2)(ii). Example Impact Test With a Dropped Steel Sphere. ~ I I I I I Height I I Impact Position I I I I l .........\ '-...i--x.- VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4725 E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.013</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 Sample Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules 8723 Figure 2 to Paragraph (e)(2)(ii). Impact Test With a Swinging Steel Sphere. Start 'I I I I I I I I I I I I (~~~ khammond on DSKJM1Z7X2PROD with PROPOSALS5 (iii) Crush test. Support each sample consumer product by a fixed rigid supporting surface, in positions likely to produce the most adverse results as long as the position of the consumer product is self-supported. Apply a crushing force of at least 335 N (75.3 lbf) to the exposed surface for a period of 10 seconds. Apply the force using a flat surface measuring approximately 100 by 250 mm (3.9 by 9.8 in). (iv) Compression test. If any surface of the battery compartment enclosure is accessible to a child and inaccessible to a flat surface contact during the drop test, apply the Compression Test from 16 CFR part 1250 to that surface, using a force of at least 136 N (30.6 lbf). (v) Torque test. If a child can grasp any part of the battery compartment enclosure on a sample consumer product, including the door or cover, with at least the thumb and forefinger, or using teeth, apply the Torque Test for Removal of Components from 16 CFR VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 part 1250 to the battery compartment enclosure, using a torque of at least 0.50 Nm (4.4 in.-lbf). (vi) Tension test. If a child can grasp any part of the battery compartment enclosure on a sample consumer product, including the door or cover, with at least the thumb and forefinger, or using teeth, apply the Tension Test for Removal of Components from 16 CFR part 1250 to the battery compartment enclosure, using a force of at least 72.0 N (16.2 lbf). (3) Compliance. If a button cell or coin battery becomes accessible or liberates from a consumer product as a result of any of the abuse tests in paragraph (e)(2) of this section, the consumer product is non-compliant and fails testing. Additionally, after completing all abuse testing, apply a force of at least 50 N (11.2 lbf) for 10 seconds to the battery compartment enclosure door or cover using the accessibility probe. Apply the PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 accessibility probe at the most unfavorable position on the battery compartment enclosure, and in the most unfavorable direction. Apply a force in only one direction at a time. If the battery compartment enclosure door or cover opens or does not remain functional, or the button cell or coin battery becomes accessible, the consumer product is non-compliant and fails testing. (f) Secureness test. Button cell or coin batteries installed in a consumer product that are not intended for removal or replacement, and that are accessible based on paragraph (d) of this section, must be tested by applying a steel test hook, as shown in figure 3 to this paragraph (f), using a force of at least 22 N (4.9 lbf), directed outwards, applied for 10 seconds at all points where application of a force is possible. To pass the test, the button cell or coin battery cannot liberate from the consumer product during testing. E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.014</GPH> Sample 8724 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules Figure 3 to Paragraph (f). Secureness Test Hook for Consumer Products With Accessible Button Cell or Coin Batteries not Intended for Removal or Replacement. I § 1263.4 Requirements for marking and labeling. (a) General Requirements. (1) All warning statements or icons must be clearly visible, prominent, legible, and permanently marked. (2) Warning statements or icons must be in contrasting color to the background onto which the warning statement or icon 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 I Material: Steel manual, the safety alert symbol and the signal word ‘‘WARNING’’ must be at least 0.2 in. (5 mm) high. The remainder of the text must be in characters whose upper case must be at least 0.1 in. (2.5 mm), except where otherwise specified. (8) For labels that are required to be on the packaging of button cell and coin batteries, the packaging of consumer products containing such batteries, and directly on consumer products, text size must be dependent on the area of the principal display panel. Text size must be determined based on table 1 to this paragraph (a)(8). alert symbol must be on the same horizontal line as the base of the letters of the signal word. The height of the safety alert symbol must equal or exceed the signal word letter height. (5) The signal word ‘‘WARNING’’ must be in black letters on an orange background. The signal word must appear in sans serif letters in upper case only. (6) Certain text in the message panel must be in bold and in capital letters as shown in the example warning labels to get the attention of the reader. (7) For labels that are provided on a sticker, hang tag, instructions or TABLE 1 TO PARAGRAPH (a)(8)—LETTER SIZE FOR RECOMMENDED WARNING LABELS [Information based on 16 CFR 1500.19(d)(7)] Letter Size Measurements in Inches Signal word (WARNING) Statement of Hazard ........ Other Text ........................ 0–2 +2–5 3/64 3/64 1/32 +5–10 1/16 3/64 3/64 3/32 1/16 1/16 +10–15 +15–30 7/64 3/32 1/16 1/8 3/32 5/64 +30–100 5/32 7/64 3/32 +100–400 1/4 5/32 7/64 +400 1/2 1/4 5/32 Letter Size Measurements in cm (For Reference Only) Display Area: cm2 ............ Signal word (WARNING) Statement of Hazard ........ VerDate Sep<11>2014 17:16 Feb 08, 2023 0–13 0.119 0.119 Jkt 259001 +13–32 +32–65 0.159 0.119 PO 00000 Frm 00034 0.238 0.159 Fmt 4701 +65–97 +97–194 0.278 0.238 Sfmt 4702 0.318 0.238 E:\FR\FM\09FEP5.SGM +194–645 0.397 0.278 09FEP5 +645–2,581 0.635 0.397 +2,581 1.270 0.635 EP09FE23.015</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 Display Area: Inches 2 8725 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules TABLE 1 TO PARAGRAPH (a)(8)—LETTER SIZE FOR RECOMMENDED WARNING LABELS—Continued [Information based on 16 CFR 1500.19(d)(7)] Other Text ........................ 0.079 0.119 (b) Warning label requirements for button cell or coin battery packaging. (1) The principal display panel of the packaging must include the warning • • • • 0.159 0.159 0.198 label in figure 4 to this paragraph (b)(1). The icon must be at least 8 mm (0.3 inches) in diameter. The text must state 0.238 0.278 0.397 the following warnings as shown on figure 4 to this paragraph (b)(1). Figure 4 to Paragraph (b)(1) INGESTION HAZARD: DEATH or serious injury can occur if ingested. A swallowed button cell or coin battery can cause Internal Chemical Burns in as little as 2 hours. KEEP new and used batteries OUT OF REACH OF CHILDREN Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. (2) If space prohibits the full warning label shown in Figure 4 to paragraph (b)(1), place the icon shown in figure 5 to this paragraph (b)(2) on the principal display panel with the text shown in figure 6 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 6 to this paragraph (b)(2): Figure 6 to Paragraph (b)(2) Figure 5 to Paragraph (b)(2) VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 (xii) The statement: ‘‘Nonrechargeable batteries are not to be recharged.’’; and (xiii) The statement: ‘‘Do not force discharge, recharge, disassemble, heat above (manufacturer’s specified temperature rating) or incinerate. Doing so may result in injury due to venting, leakage or explosion resulting in chemical burns.’’. (xiv) For button cell or coin batteries that are packaged and included separately with a consumer product, only paragraphs (b)(1) and (2) of this section apply. (c) Warning label requirements for packaging of consumer products E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.018</GPH> (vii) Year and month or week of manufacture or expiration date; (viii) Name or trademark of the manufacturer or supplier; (ix) The statement: ‘‘Do not mix old and new batteries, different brands or types of batteries, such as alkaline, carbon-zinc, or rechargeable batteries.’’; (x) The statement: ‘‘Ensure the batteries are installed correctly according to polarity (+ and -).’’; (xi) The statement: ‘‘Remove and immediately discard batteries from equipment not used for an extended period of time.’’; EP09FE23.017</GPH> (3) The following safety-related statements must be included on the principal display panel or secondary display panel: (i) The statement: Keep in original package until ready to use. (ii) The statement: Immediately dispose of used batteries and keep away from children. Do NOT dispose of batteries in household trash. (iii) The statement: Call a local poison control center for treatment information.’’; (iv) Battery type (e.g., LR44, CR2032); (v) Battery chemistry (e.g., silver oxide or lithium); (vi) Nominal voltage; EP09FE23.016</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 INGESTION HAZARD • DEATH or serious injury can occur • A swallowed button cell or coin battery can cause Internal Chemical Bums in as little as 2 houn • KEEP new and used batteries OUT OF REACH OF CHILDREN • Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. 8726 Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules containing button cell or coin batteries. (1) The principal display panel must contain the warning label in figure 7 to this paragraph (c)(1). The icon must be at least 8 mm in diameter. The text must state the following as shown in figure 7 to this paragraph (c)(1): Figure 7 to Paragraph (c)(1) • • • INGESTION HAZARD: This product contains a button cell or coin battery. DEATH or serious injury can occur if ingested. A swallowed button cell or coin battery can cause Internal Chemical Burns in as little as 2 hours. • KEEP new and used batteries OUT OF REACH OF CHILDREN • Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. (2) Consumer products that are not contained in packaging must have the warning label in Figure 7 to paragraph (c)(1) affixed to the consumer product with a hang tag or a sticker label. (3) If space on the principal display panel of the consumer product packaging does not permit the warning label in Figure 7 to paragraph (c)(1), the principal display panel must include the warning in figure 8 to this paragraph (c)(3) in a conspicuous location. The icon must be at least 8 mm in diameter. The remaining warning statements must be on a secondary display panel, as shown in figure 9 to this paragraph (c)(3). The text must state the following on the principal display panel as shown in figure 8 to this paragraph (c)(3): Figure 8 to Paragraph (c)(3) • INGESTION HAZARD: This product contains a button cell or coin battery. • DEATH or serious injury can occur if ingested. • A swallowed button cell or coin battery can cause Internal Chemical Burns in as little as 2 hours. Figure 9 to Paragraph (c)(3) (1) Consumer products must be durably and indelibly marked with a warning label on the product display panel that alerts the consumer of the presence of a button cell or coin battery. The warning text must include the safety alert symbol, signal word, and text, as shown in figure 10 to this paragraph (d)(1). Figure 10 to Paragraph (d)(1) INGESTION HAZARD: This product contains a button cell or coin battery. (2) If space on the product is limited, use the ‘‘Warning: contains coin VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 battery’’ icon shown in figure 11 to this paragraph (d)(2), without text. The icon PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 must be at least 7 mm in width and 9 mm in height and must be on the E:\FR\FM\09FEP5.SGM 09FEP5 EP09FE23.021</GPH> (i) For products with non-replaceable batteries, include a statement indicating the product contains non-replaceable batteries; (ii) Battery type (e.g., LR44, CR2032); and (iii) Nominal voltage. (d) Warning label requirements for consumer products containing button cell or coin batteries. EP09FE23.020</GPH> khammond on DSKJM1Z7X2PROD with PROPOSALS5 (4) The text must state the following on the secondary display panel as shown in Figure 9 to paragraph (c)(3). (5) The principal display panel or secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label, must include the following text: EP09FE23.022</GPH> KEEP new and used batteries OUT OF REACH OF CHILDREN Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body. EP09FE23.019</GPH> • • Figure 11 to Paragraph (d)(2) product display panel and must be in yellow with black outlines as shown in figure 11 to this paragraph (d)(2). The icon must be defined in accompanying printed materials such as instructions, manual, insert, or hangtag. ' \):\.11'1 VerDate Sep<11>2014 17:16 Feb 08, 2023 Jkt 259001 PO 00000 (3) If the product itself is too small to include the warning with text in Figure 10 to paragraph (d)(1) or the icon in Figure 11 to paragraph (d)(2), the product must: (i) Have packaging containing the warning label following the requirements in paragraph (c) of this section; or (ii) Contain a hangtag or sticker label with the full warning label using requirements for the packaging of consumer products containing batteries in paragraph (c) of this section. (e) Instructions/Manuals accompanying consumer products containing button cell and coin batteries. (1) Instructions and manuals, if provided, must include the warning label shown in Figure 7 to paragraph (c)(1) and the following warning statements: Frm 00037 Fmt 4701 Sfmt 9990 8727 09FEP5 BILLING CODE 6355–01–P [FR Doc. 2023–02356 Filed 2–8–23; 8:45 am] Alberta E. Mills, Secretary, Consumer Product Safety Commission. The provisions of this part are separate and severable from one another. If any provision is stayed or determined to be invalid, it is the Commission’s intention that the remaining provisions shall continue in effect. § 1263.5 Severability. (2) If instructions and manuals are not provided, the warning statements in paragraph (e)(1) of this section must be present on the principal display panel or secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label. (f) Online information. Manufacturers shall include, in a manner that is clearly visible, prominent, and legible (either next to the product description, the product image, or the product price): (1) in their online materials that enable consumers to purchase button cell or coin batteries, the warning in Figure 4 to paragraph (b)(1); and (2) in their online materials that enable consumers to purchase products containing button cell or coin batteries, the warning in Figure 7 to paragraph (c)(1). E:\FR\FM\09FEP5.SGM (i) The statement: ‘‘Immediately dispose of used batteries and keep away from children. Do NOT dispose of batteries in household trash.’’; (ii) The statement: ‘‘Even used batteries may cause severe injury or death.’’; (iii) The statement: ‘‘Call a local poison control center for treatment information.’’; (iv) Compatible battery type (e.g., LR44, CR2032); (v) Nominal voltage; (vi) For products with nonreplaceable batteries, include a statement indicating the product contains non-replaceable batteries; (vii) The statement: ‘‘Do not mix old and new batteries, different brands or types of batteries, such as alkaline, carbon-zinc, or rechargeable batteries.’’; (viii) The statement: ‘‘Ensure the batteries are installed correctly according to polarity (+ and -).’’; (ix) The statement: ‘‘Remove and immediately discard batteries from equipment not used for an extended period of time.’’; (x) The statement: ‘‘Non-rechargeable batteries are not to be recharged.’’; and (xi) The statement: ‘‘Do not force discharge, recharge, disassemble, heat above (manufacturer’s specified temperature rating) or incinerate. Doing so may result in injury due to venting, leakage or explosion resulting in chemical burns.’’. Federal Register / Vol. 88, No. 27 / Thursday, February 9, 2023 / Proposed Rules ' khammond on DSKJM1Z7X2PROD with PROPOSALS5 ◄'>' EP09FE23.023</GPH>

Agencies

Consumer Product Safety Commission

[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Proposed Rules]
[Pages 8692-8727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02356]



[[Page 8691]]

Vol. 88

Thursday,

No. 27

February 9, 2023

Part V





Consumer Product Safety Commission





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16 CFR Parts 1112 and 1263





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

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

[[Page 8692]]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1263

[CPSC Docket No. 2023-0004]


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

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking (NPR).

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

DATES: Submit comments by March 13, 2023.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the testing and certification, and the marking, labeling, and 
instructional literature requirements of the proposed mandatory 
standard, should be directed to the Office of Information and 
Regulatory Affairs, the Office of Management and Budget, Attn: CPSC 
Desk Officer, FAX: 202-395-6974, or emailed to 
[email protected].
    You may submit all other comments, identified by Docket No. CPSC-
2023-0004, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. CPSC typically does not accept 
comments submitted by electronic mail (email), except as described 
below. CPSC encourages you to submit electronic comments by using the 
Federal eRulemaking Portal.
    Mail/Hand Delivery/Courier/Confidential Written Submissions: Submit 
comments by mail, hand delivery, or courier to: Office of the 
Secretary, Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone: (301) 504-7479. If you wish to submit 
confidential business information, trade secret information, or other 
sensitive or protected information that you do not want to be available 
to the public, you may submit such comments by mail, hand delivery, or 
courier, or you may email them to: [email protected].
    Instructions: All submissions must include the agency name and 
docket number. CPSC may post all comments without change, including any 
personal identifiers, contact information, or other personal 
information provided, to: https://www.regulations.gov. Do not submit 
through this website: confidential business information, trade secret 
information, or other sensitive or protected information that you do 
not want to be available to the public. If you wish to submit such 
information, please submit it according to the instructions for mail/
hand delivery/courier/confidential written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2023-0004, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Daniel Taxier, Project Manager, 
Division of Mechanical and Combustion Engineering, Consumer Product 
Safety Commission, 5 Research Place, Rockville, MD 20850; (301) 987-
2211, or by email to: [email protected].

SUPPLEMENTARY INFORMATION: 

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

    President Biden signed Reese's Law, Public Law 117-171, into law on 
August 16, 2022. 15 U.S.C. 2056e. The purpose of Reese's Law is to 
protect children 6 years old and younger against hazards associated 
with the ingestion of button cell or coin batteries. Based on a review 
of the medical literature, CPSC incident data, and data from the 
National Capital Poison Center (NCPC), an ingestion hazard is 
associated with swallowing or inserting a button cell or coin battery 
that becomes lodged (impacted) in the body (typically in the esophagus 
but potentially in the airways or gastrointestinal tract), which can 
cause death or serious injury through choking, generation of hazardous 
chemicals, leaking of hazardous chemicals, electrical burns, pressure 
necrosis (tissue damage), or other means. See Tab B of Staff's NPR 
Briefing Package.\2\
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    \2\ The information in this proposed rule is based on 
information and analysis provided in the January 11, 2023, Staff 
Briefing Package: Draft Proposed Rule to Establish a Safety Standard 
and Notification Requirements for Button Cell or Coin Batteries and 
Consumer Products Containing Such Batteries (Staff's NPR Briefing 
Package), available at: https://www.cpsc.gov/s3fs-public/NoticeofProposedRulemakingSafetyStandardandNotificationRequirementsforButtonCellorCoinBatteriesandConsumerProductsContainingSuchBatteries.pdf?VersionId=kDinNeydktkt3T8RRtzN4u1GTXPRjpEl.
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    Although this proposed rule is primarily intended to address 
hazards associated with oral ingestion of button cell or coin batteries 
by children 6 years old or younger, the performance and labeling 
requirements in the proposed rule will likely also reduce insertion of 
these batteries in the nose. The data on button cell or coin batteries 
demonstrate that insertions of batteries into the nose can be aspirated 
into the trachea and become an ingestion that lodges in the esophagus. 
This scenario presents the same hazard as an oral ingestion of a button 
cell or coin battery. Accordingly, the proposed labeling requirements 
include warnings regarding ingestion and insertion.
    To address ingestion of button cell or coin batteries, section 2(a) 
of Reese's Law requires the Commission to publish a final consumer 
product safety standard for button cell or coin batteries, and consumer 
products containing button cell or coin batteries, not later than 1 
year after the date of enactment, meaning by August 16, 2023. 15 U.S.C. 
2056e(a). A ``button cell or coin battery'' is broadly defined in 
section 5 of Reese's Law as ``(A) a single cell battery with a diameter 
greater than the height of the battery; or (B) any other battery, 
regardless of the technology used to produce an electrical charge, that 
is determined by the Commission to pose an ingestion hazard.'' \3\ 
Thus, the

[[Page 8693]]

definition of an in-scope product does not depend on the battery 
chemistry, but rather the shape of the battery (which contributes to 
the ingestion-related risk) and, as stated in part (B), whether the 
battery otherwise is associated with an ingestion hazard, which is 
consistent with the stated purpose in section 2(a)(1) of Reese's Law. 
15 U.S.C. 2056e(a)(1).
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    \3\ Definitions in section 5 of Reese's Law are codified in the 
Notes to 15 U.S.C. 2056e.
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    This proposed rule focuses on addressing button cell and coin 
batteries under part (A) of the definition because other batteries 
where the diameter is less than the height, such as AAA cylindrical 
batteries, do not pose the same type or degree of ingestion hazard as 
button cell or coin batteries. Cylindrical batteries can pose a choking 
hazard, and CPSC is aware that consumers have ingested cylindrical 
batteries. However, the medical literature shows that injury or death 
due to ingestion of a cylindrical battery is rare. See Staff's NPR 
Briefing Package at Tab B, Section II.B. Consequently, the Commission 
is not including cylindrical batteries in the proposed rule at this 
time. If CPSC becomes aware of a serious ingestion hazard associated 
with another battery type, section 2(g) of Reese's Law allows the 
Commission to undertake additional rulemaking to address the hazard at 
any time. 15 U.S.C. 2056e(g).
    Reese's Law defines a ``consumer product containing button cell or 
coin batteries'' as ``a consumer product containing or designed to use 
one or more button cell or coin batteries, regardless of whether such 
batteries are intended to be replaced by the consumer or are included 
with the product or sold separately.'' \4\ We preliminarily construe 
this definition to include products that are not sold with a battery, 
if they are designed to use a button cell or coin battery.
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    \4\ 15 U.S.C. 2056e Notes. The term ``consumer product'' has the 
same meaning as that in section 3(a) of the Consumer Product Safety 
Act (CPSA). 15 U.S.C. 2052(a).
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    Section 2 of Reese's Law requires the Commission to issue a rule 
containing performance requirements for consumer products that contain 
button cell or coin batteries, and labeling requirements. Any rule 
issued under section 2(a) of Reese's Law will be considered a consumer 
product safety rule promulgated under section 9 of the Consumer Product 
Safety Act (CPSA). 15 U.S.C. 2056e(c); 15 U.S.C. 2058. CPSC's rule 
under section 2 of Reese's Law must be issued in accordance with the 
notice and comment provisions of the Administrative Procedure Act 
(APA). 5 U.S.C. 553; 15 U.S.C. 2056e(a). Insofar as this proposed rule 
is based on section 2 of Reese's Law, it sets forth provisions 
implementing the statute's required performance and labeling 
requirements--and ``only'' those requirements, as specified in section 
2(a). The standard promulgated under section 2(a) of Reese's Law shall 
apply to consumer products and battery packaging manufactured or 
imported after the effective date of the standard. See 15 U.S.C. 2056e 
Notes.
    Section 2(a)(1) of Reese's Law mandates that the rule must include 
performance requirements for button cell or coin battery compartments 
on consumer products to secure them in a manner that eliminates or 
adequately reduces the risk of injury from the ingestion of button cell 
or coin batteries by children who are 6 years old or younger, during 
reasonably foreseeable use or misuse of the product. 15 U.S.C. 
2056e(a)(1).
    Section 2(a)(2) of Reese's Law mandates warning label requirements 
in a rule. Warnings are required:
     On the packaging of button cell or coin batteries (15 
U.S.C. 2056e(a)(2)(A));
     On the packaging of consumer products containing button 
cell or coin batteries (15 U.S.C. 2056e(a)(2)(A));
     In any literature, such as a user manual, that accompanies 
a consumer product containing button cell or coin batteries (15 U.S.C. 
2056e(a)(2)(B));
     As practicable, directly on a consumer product that 
contains button cell or coin batteries in a manner visible to the 
consumer upon installation or replacement of the button cell or coin 
battery (15 U.S.C. 2056e(a)(2)(C)(i));
     As practicable, in the case of a product for which the 
battery is not intended to be replaced or installed by the consumer, to 
be included directly on the consumer product in a manner that is 
visible to the consumer upon access to the battery compartment, except 
that if it is impracticable to label the product, this information 
shall be placed on the packaging or instructions (15 U.S.C. 
2056e(a)(2)(C)(ii)).
    Warning labels required by section 2(a) of Reese's Law must: (1) 
clearly identify the hazard of ingestion; and (2) instruct consumers, 
as practicable, to keep new and used batteries out of the reach of 
children, to seek immediate medical attention if a battery is ingested, 
and to follow any other consensus medical advice. 15 U.S.C. 2056e(b).
    Section 4 of Reese's Law specifically exempts from the performance 
and labeling requirements in section 2 of the law, any toy product \5\ 
that is in compliance with the battery accessibility and labeling 
requirements in 16 CFR part 1250, Safety Standard Mandating ASTM F963 
for Toys. 15 U.S.C. 2056e Notes. However, children's products that 
contain button cell or coin batteries and that are not a ``toy 
product,'' would be required to meet the performance and labeling 
requirements in this proposed rule. An example of such products would 
be children's apparel, such as shoes, that light up and use a button 
cell or coin battery as a power source.
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    \5\ Consistent with 16 CFR part 1250, a ``toy product'' is 
defined as ``any object designed, manufactured, or marketed as a 
plaything for children under 14 years of age.'' Notes to 15 U.S.C. 
2056e.
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    Section 2(d) of Reese's Law (15 U.S.C. 2056e(d)(1)) requires the 
Commission to rely on the provisions in a voluntary standard if, before 
promulgating a final rule, the Commission determines that: (A) a 
voluntary standard exists that meets the requirements for a standard 
promulgated under section 2(a) of Reese's Law with respect to any 
consumer product, and (B) the voluntary standard is in effect at the 
time of the determination by the Commission, or will be in effect not 
later than the date that is 180 days after the date of the enactment of 
Reese's Law (i.e., February 12, 2023). The Commission must publish in 
the Federal Register, any determination regarding a voluntary standard 
under this provision. 15 U.S.C. 2056e(d)(2).
    As set forth in section IV.A and V.A of this preamble, the 
Commission preliminarily determines that no existing voluntary standard 
fully meets the requirements in section 2(a) of Reese's Law. 
Accordingly, the Commission is proposing a rule that would meet the 
requirements of Reese's Law for all consumer products within the scope 
of the rule that is based on modifications to several existing 
voluntary standards. Because the Commission is proposing its own rule 
under Reese's Law, the procedural requirements in sections 2(e) and 
2(f) of Reese's Law for relying upon a voluntary standard are not 
applicable. 15 U.S.C. 2056e(e) and (f).
    Section 3 of Reese's Law requires special packaging for button cell 
or coin batteries. These requirements, codified in the Notes to 15 
U.S.C. 2056e, are self-implementing, and do not require CPSC to issue a 
rule. Section 3(a) of Reese's Law states that not later than 180 days 
after the date of enactment of the Act, meaning February 12, 2023, 
button cell or coin batteries sold, offered for sale, manufactured for 
sale, distributed in commerce, or imported into the United States, or 
included separately with a

[[Page 8694]]

consumer product sold, offered for sale, manufactured for sale, 
distributed in commerce, or imported into the United States, must be 
packaged in accordance with the standards provided in 16 CFR 1700.15, 
and tested in accordance with 16 CFR 1700.20 or another test method 
specified by rule by the Commission. 15 U.S.C. 2056e Notes. The 
requirements in section 3(a) shall be treated as a standard for special 
packaging of a household substance under section 3(a) of the Poison 
Prevention Packaging Act (PPPA). Id.; 15 U.S.C. 1472(a). At this time 
the Commission is not proposing a rule to implement section 3 of 
Reese's Law, which is effective by operation of the statute on February 
12, 2023.\6\
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    \6\ Section 4 of Reese's Law exempts from the special packaging 
requirements in section 3(a) of Reese's Law, button cell or coin 
batteries that comply with the marking and packaging provisions in 
the ANSI Safety Standard for Portable Lithium Primary Cells and 
Batteries (ANSI C18.3M). Packaged button cell or coin batteries that 
meet the ANSI standard are exempt from the special packaging 
requirements in section 3(a) of Reese's Law, but not from the 
labeling requirements in section 2(a) of Reese's Law, as implemented 
in this proposed rule. Labeling on such battery packaging can meet 
both the ANSI standard and this proposed rule; CPSC's labeling 
requirements are additive to ANSI C18.3M labeling requirements.
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B. Explanation of Section 27(e) of the CPSA

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

II. Products Subject to the Proposed Rule

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

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

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

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

[[Page 8695]]

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

    Lithium coin batteries, shown in Figure 3, were originally 
developed as a 3-volt power source for low-drain and battery-backup 
applications; because of their high-energy density, correspondingly 
small size, and long shelf life, manufacturers have found lithium coin 
batteries useful for other applications as well. Lithium coin batteries 
are commonly around 20 mm (0.787 inch) in diameter.
[GRAPHIC] [TIFF OMITTED] TP09FE23.004

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

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

C. Description of Packaging Subject to the NPR

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

[[Page 8696]]

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

III. Incident Data and Hazard Patterns

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

A. Fatalities

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

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

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

B. Nonfatal Incidents

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

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

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

[[Page 8697]]



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

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

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

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

[[Page 8698]]

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

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

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

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

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

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

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

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

[[Page 8699]]

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

D. Hazard Patterns

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

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

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

E. Recalls

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

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

[[Page 8700]]

 
12/1/2021..........  Halo Brand Solutions....  A child can      About 82,500     Received two             22-024
                                                disassemble      units            reports of
                                                the projector    Projector        children
                                                flashlight and   Flashlights..    accessing the
                                                access the                        button cell
                                                button cell                       batteries from
                                                batteries,                        the
                                                posing                            flashlight,
                                                ingestion and                     and in one
                                                choking                           case, a child
                                                hazards.                          required
                                                                                  surgery to
                                                                                  remove a
                                                                                  swallowed
                                                                                  battery.
----------------------------------------------------------------------------------------------------------------

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

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

A. Preliminary Determination Regarding Performance Requirements in 
Existing Voluntary Standards

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

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

[[Page 8701]]

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

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

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

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

[[Page 8702]]

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

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

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

    Table 8--Requirements for Consumer Products With Compartments for
                          Replaceable Batteries
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Button cell or coin batteries must not become accessible or liberated
 when tested to these requirements:
------------------------------------------------------------------------
                        Construction Requirements
------------------------------------------------------------------------
Battery Compartment            Option 1: Coin, screwdriver, or other
 Construction Options.          household tool.
                                Captive screws
                                Two threads engaged or minimum
                                torque + spin angle.
                               Option 2: Two independent & simultaneous
                                hand movements.
                                Cannot be combinable to a single
                                movement with a finger or digit.
------------------------------------------------------------------------
Accessibility Test...........  Open or remove any part of the
                                compartment not meeting Option 1 or
                                Option 2 Apply Tension Test for Seams
                                from 16 CFR part 1250 on pliable
                                materials, using a force of 70.0 N (15.7
                                lbf). Determine whether Test Probe 11
                                from IEC 61032 can touch the battery.
------------------------------------------------------------------------
                      Preconditioning Requirements
------------------------------------------------------------------------
Preconditioning in Oven......  Thermoplastics--7 hours at 158 [deg]F or
                                greater, based on operational
                                temperature.
------------------------------------------------------------------------
Simulated Battery Replacement  Open/Close and remove/install battery 10
                                times.
------------------------------------------------------------------------
                           Use and Abuse Tests
------------------------------------------------------------------------
Drop Test....................  10 drops from 1 m (39.4 in) on hardwood,
                                in positions likely to produce maximum
                                force.
Impact Test..................  3 impacts on battery compartment with
                                steel sphere, 2 J (1.5 ft-lbf) of
                                energy.
Crush Test...................  335 N (75.3 lbf) for 10 s, using 100 by
                                250 mm (3.9 by 9.8 in) flat surface.
Compression Test.............  Test from 16 CFR Part 1250, using a force
                                of 136 N (30.6 lbf).
Torque Test..................  Test from 16 CFR part 1250, using a
                                torque of 0.50 Nm (4.4 in.-lbf).
Tension Test.................  Test from 16 CFR part 1250, using a force
                                of 72.0 N (16.2 lbf).
Probe for Accessibility......  Apply 50 N (11.2 lbf) with Test Probe 11
                                from IEC 61032 to confirm compliance.
------------------------------------------------------------------------


 Table 9--Requirements for Consumer Products With Compartments for Non-
                          Replaceable Batteries
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Option 1--Not Accessible...................  Meets the same requirements
                                              as battery compartment for
                                              replaceable batteries.
Option 2--Accessible.......................   Secured with
                                              soldering, fasteners such
                                              as rivets, or equivalent
                                              means.
                                              Applicable
                                              preconditioning
                                              requirements apply.
                                              Confirmed with
                                              secureness test: test hook
                                              applies a force of 22 N
                                              (4.9 lbf) directed
                                              outwards for 10 s, at all
                                              possible points. Battery
                                              cannot liberate from the
                                              product.
------------------------------------------------------------------------


[[Page 8703]]

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

[[Page 8704]]

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

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

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

A. Adequacy of Existing Voluntary Standards

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

[[Page 8705]]

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

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

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

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

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

[[Page 8706]]

B. Formatting Requirements for Warning Labels

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

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

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

C. Required Warnings for Button Cell or Coin Battery Packaging

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

[[Page 8707]]

[GRAPHIC] [TIFF OMITTED] TP09FE23.005

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

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

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

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

[[Page 8708]]

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

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

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

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

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

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


[[Page 8709]]


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

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

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

G. Required Warnings for Instructions/Manuals Accompanying Consumer 
Products

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

VI. Required Notifications to Purchasers

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

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

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

[[Page 8710]]

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

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

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

[[Page 8711]]

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

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

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

VII. Description of the Proposed Rule

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

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

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

B. Section 1263.2 Definitions

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

[[Page 8712]]

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

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

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

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

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

[[Page 8713]]

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

[[Page 8714]]

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

D. Section 1263.4 Requirements for Marking and Labeling

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

E. Section 1263.5 Severability

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

VIII. Testing, Certification, and Notice of Requirements

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

[[Page 8715]]

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

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

IX. Effective Date

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

X. Initial Regulatory Flexibility Analysis

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

A. Reasons for Agency Action and Legal Basis for NPR

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

B. Small Entities to Which the Proposed Rule Would Apply

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

[[Page 8716]]

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

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


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


[[Page 8717]]

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

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

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

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

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

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

D. Alternatives

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

XI. Environmental Considerations

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

XII. Paperwork Reduction Act

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

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

[[Page 8718]]

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

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

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

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

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

[[Page 8719]]

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

XIII. 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 would apply to a final rule issued under section 2 of 
Reese's Law. 15 U.S.C. 2056e. A notification requirement under section 
27(e) of the CPSA is not a consumer product safety rule and would not 
be subject to the preemption provision in section 26(c) of the CPSA.

XIV. Request for Comments

    The Commission requests comment on all aspects of the proposed 
rule, including specifically the following items:

A. Performance Requirements

     Whether any consumer products (as opposed to medical 
devices, such as hearing aids) contain zinc-air button cell or coin 
batteries, and whether such products should be required to meet the 
performance requirements for battery compartments on consumer products;
     Whether any voluntary standard meets the performance and 
labeling requirements of Reese's Law;
     Whether the requirements for accessibility of battery 
compartments should incorporate test methods commonly used on toy 
products, such as the torque and tensile tests for parts of the product 
that can be gripped by a child's fingers or teeth, or a tensile test 
for pliable materials;

[[Page 8720]]

     For consumer products that use button cell or coin 
batteries and have large panel doors, what consumer products have such 
doors, and should the Commission exclude large panel doors from the 
requirement for captive screws; why or why not (i.e., why does a large 
panel door represent a different risk of injury from battery access 
without using captive screws than a smaller battery compartment door 
does?);
     Whether a double-action locking mechanism used to secure 
battery compartment enclosures, meaning those mechanism that rely on 
two independent and simultaneous hand movements to open (versus a 
screw, for example), should be allowed to secure button cell or coin 
battery compartments;
     Whether the proposed secureness test based on UL 4200A is 
sufficient to address reasonably foreseeable use and abuse of consumer 
products containing non-removable batteries;
     Whether Test Probe 11 of the Standard for Protection of 
Persons and Equipment by Enclosures--Probes for Verification, IEC 
61032, is adequate to verify accessibility of a button cell or coin 
battery in a battery compartment;
     Whether there are any additional performance requirements 
that should be considered, either for specific types of products, or in 
general;
     Whether one or more performance requirements should be 
based on IEC 62368-1, in addition to, or instead of, performance 
requirements based on UL 4200A; and
     Whether the proposed performance requirements are needed 
and are likely to eliminate or adequately reduce the ingestion hazard 
associated with access to button cell or coin batteries from consumer 
products.

B. Marking and Labeling Requirements

     Whether the Commission should require ingestion warnings 
on zinc-air button cell or coin battery packaging;
     Whether all button cell or coin battery packaging should 
include the warning on the principal display panel;
     Whether the requirement for the ``Keep Out of Reach'' icon 
to be 20 mm in diameter for visibility purposes, when alone on the 
front of battery packaging, provides a sufficient warning of the 
ingestion hazard;
     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;
     For technical and performance data related to the safety 
of button cell or coin batteries required at the time of purchase, 
whether the proposed warnings' content and location requirements are 
adequate to advise consumers who purchase a product online or in-store 
about the hazards associated with these batteries;
     Whether staff's assessment in V.F of this preamble that 
virtually all consumer products can accommodate either the full warning 
or one of the scaled icons is accurate;
     Whether the rule should require button cell or coin 
batteries to be durably and indelibly marked with the ``Keep Out of 
Reach'' icon where size permits, at a minimum size of 6 mm in diameter, 
and if so, whether the appropriate legal authority is Reese's Law, 
section 27(e) of the CPSA, or another statute; and
     Whether the internationally recognized safety alert 
symbol, as shown in yellow color, indicating the presence of a button 
cell or coin battery, should be required on all consumer products 
containing such batteries.

C. Other Comments

     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.
     In the IRFA, the number of small firms impacted and 
expected cost impact on small firms (as a percentage of annual revenue) 
of the proposed rule.
    Submit all comments in accordance with the instructions in the 
ADDRESSES section at the beginning of this document.

List of Subjects

16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Reporting and recordkeeping requirements, Third party conformity 
assessment body.

16 CFR Part 1263

    Batteries, Consumer protection, Imports, Infants and children, 
Labeling, Law enforcement.

    For the reasons discussed in the preamble, the Commission proposes 
to amend Title 16 of the Code of Federal Regulations as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
1. The authority citation for part 1112 is revised to read as follows:

    Authority:  15 U.S.C. 2063; 15 U.S.C. 2051 Notes.

0
2. Amend Sec.  1112.15 by adding paragraph (b)(55) to read as follows:


Sec.  1112.15   When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (55) 16 CFR part 1263, Safety Standard and Notification 
Requirements for Button Cell or Coin Batteries and Consumer Products 
Containing Such Batteries.
* * * * *
0
3. Add part 1263 to read as follows:

PART 1263--SAFETY STANDARD AND NOTIFICATION REQUIREMENTS FOR BUTTON 
CELL OR COIN BATTERIES AND CONSUMER PRODUCTS CONTAINING SUCH 
BATTERIES

Sec.
1263.1 Scope, purpose, effective date, units, exemption.
1263.2 Definitions.
1263.3 Requirements for consumer products containing button cell or 
coin batteries.
1263.4 Requirements for marking and labeling.
1263.5 Severability.

    Authority: 15 U.S.C. 2052, 2056e, 2058, 2076(e).


Sec.  1263.1  Scope, purpose, effective date, units, and exemption.

    (a) Scope and purpose. As required by Reese's Law (15 U.S.C. 2056e, 
Pub. L. 117-171), this part establishes performance requirements for 
child-resistant button cell or coin battery compartments on all 
consumer products that contain, or are designed to contain, such 
batteries to prevent child access to batteries during reasonably 
foreseeable use and misuse of the consumer product. The rule is 
intended to eliminate or adequately reduce the risk of injury and death 
to children 6 years old and younger from ingesting these batteries. 
This part also establishes warning label requirements for packaging 
containing button cell or coin batteries, packaging of consumer 
products containing such batteries, consumer products, instructions and 
manuals accompanying consumer products, as well as point-of-sale 
performance and technical data pursuant to section 27(e) of the 
Consumer Product Safety Act (15 U.S.C. 2076(e).
    (b) Effective date. Except as provided in paragraph (d) of this 
section, all consumer products containing button cell or coin batteries 
and all packaging containing button cell or coin batteries subject to 
the rule that are manufactured or imported after [180 DAYS AFTER

[[Page 8721]]

PUBLICATION IN THE FEDERAL REGISTER] must comply with the requirements 
of this part.
    (c) Units. In this part, values stated without parentheses are the 
requirement. Values in parentheses are approximate information.
    (d) Exemption for toy products. Any object designed, manufactured, 
or marketed as a plaything for children under 14 years of age that is 
in compliance with the battery accessibility and labeling requirements 
of 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, is 
exempt from the requirements of this part.
    (e) Batteries that do not present an ingestion risk. Button cell or 
coin batteries that the Commission has determined do not present an 
ingestion risk are not subject to this rule. These are: zinc-air button 
cell or coin batteries.


Sec.  1263.2  Definitions.

    In addition to the definitions given in section 3 of the Consumer 
Product Safety Act (15 U.S.C. 2052) and section 5 of Reese's Law (15 
U.S.C. 2056e Notes), the following definitions apply for purposes of 
this part:
    Accessibility probe means Test Probe 11 in IEC 61032 Protection of 
Persons and Equipment by Enclosures--Probes for Verification.
    Accessible means able to be contacted by the accessibility probe.
    Button cell or coin battery means:
    (1) A single cell battery with a diameter greater than the height 
of the battery; or
    (2) Any other battery, regardless of the technology used to produce 
an electrical charge, that is determined by the Commission to pose an 
ingestion hazard.
    Consumer product containing button cell or coin batteries means 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.
    Ingestion hazard means a hazard caused by a person swallowing or 
inserting a button cell or coin battery into their body whereby:
    (1) The button cell or coin battery can become lodged in the 
digestive tract or airways; and
    (2) Can potentially cause death or serious injury through choking, 
generation of hazardous chemicals, leaking of hazardous chemicals, 
electrical burns, pressure necrosis, or other means.
    Principal display panel means the display panel, for a retail 
package of one or more button cell or coin batteries or retail package 
of a consumer product containing 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.
    Product display panel means the surface area on, near, or in the 
battery compartment of a consumer product containing button cell or 
coin batteries. For consumer products containing button cell or coin 
batteries where such batteries are replaceable, the product display 
panel must be visible while a consumer installs or replaces any button 
cell or coin battery. For consumer products with one or more 
nonreplaceable button cell or coin batteries, the product display panel 
must be visible upon access to the battery compartment.
    Secondary display panel means a display panel for a retail package 
of one or more button cell or coin batteries or retail package of a 
consumer product containing 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.


Sec.  1263.3  Requirements for consumer products containing button cell 
or coin batteries.

    (a) General. Consumer products containing button cell or coin 
batteries must meet the performance and labeling requirements in this 
part to minimize the risk of children accessing and ingesting button 
cell or coin batteries. Consumer products with battery compartments 
that allow consumers to remove or replace a button cell or coin battery 
must comply with the performance requirements in paragraph (b) of this 
section. Consumer products with battery compartments that do not allow 
for the removal or replacement of any button cell or coin batteries 
must comply with the performance requirements in paragraph (c) of this 
section.
    (b) Performance requirements for consumer products containing 
button cell or coin batteries that are removable. (1) A removable or 
replaceable button cell or coin battery in a consumer product must not 
be made accessible when tested pursuant to paragraph (d) of this 
section.
    (2) Battery compartments for removable or replaceable button cell 
or coin batteries must meet the requirements in paragraph (e) of this 
section and be secured using at least one of the following methods:
    (i) Secure the battery compartment enclosure so that it requires a 
tool, such as a screwdriver or coin, to open the battery compartment. 
Opening a battery compartment secured by one or more screws, or a 
twist-on access cover, must require a minimum torque of 0.5 Nm (4.4 in-
lb) and a minimum angle of 90 degrees of rotation, or the fastener(s) 
must engage a minimum of two full threads. Screws or fasteners used to 
secure the battery compartment enclosure must be captive to the 
compartment door, cover, or closure.
    (ii) Secure the battery compartment enclosure so that it requires a 
minimum of two independent and simultaneous hand movements to open. The 
movements to open cannot be combinable to a single movement with a 
single finger or digit.
    (c) Performance requirements for consumer products containing 
button cell or coin batteries that are non-removable. Consumer products 
containing button cell or coin batteries not intended for removal or 
replacement must be made inaccessible by:
    (1) Using a battery compartment enclosure that complies with the 
performance requirements of paragraph (b) of this section; or
    (2) Securing the button cell or coin battery using soldering, 
fasteners such as rivets, or equivalent means, that passes the 
Secureness Test in paragraph (f) of this section.
    (d) Accessibility test method. This test assesses whether a child 
can access a button cell or coin battery installed in a consumer 
product by determining whether the accessibility probe can contact a 
button cell or coin battery. The test method is as follows:
    (1) To determine whether a button cell or coin battery is 
accessible, first open and remove any part of the battery compartment 
enclosure that can be opened or removed without a tool or that can be 
opened or removed with anything less than two independent and 
simultaneous movements (for example, a zipper or hook and loop).
    (2) If a part of the battery compartment enclosure is protected by 
pliable material such as fabric, paper, foam, or vinyl, or a pliable 
material with a seam, apply the Tension Test for Seams in Stuffed Toys 
and Beanbag-Type Toys test in 16 CFR part 1250 to determine whether the 
battery compartment enclosure can become exposed or accessible, using a 
force of at least 70.0 N (15.7 lbf). If a new part of the battery 
compartment enclosure becomes exposed or accessible, repeat the test in 
paragraph (d)(1) of this section and the test in this paragraph (d)(2) 
until no new part of the battery

[[Page 8722]]

compartment enclosure becomes exposed or accessible, and then conduct 
the test in paragraph (d)(3) of this section.
    (3) Insert or apply the accessibility probe to any depth that a 
battery compartment opening will permit, and rotate or angle the 
accessibility probe before, during, and after insertion or application 
through the battery compartment opening to any position that is 
necessary to determine whether the probe can contact the button cell or 
coin battery. This test is not intended to judge the strength of the 
material comprising the battery compartment. Use the minimum force 
necessary in determining whether the probe can contact a button cell or 
coin battery.
    (e) Performance tests for consumer products containing button cell 
or coin batteries. After pre-conditioning in accordance with paragraph 
(e)(1) of this section, consumer products containing a button cell or 
coin battery must pass the performance requirements in paragraph (e)(2) 
or (f) of this section in the order presented, as applicable.
    (1) Pre-conditioning. Subject each test sample consumer product to 
applicable pre-conditioning:
    (i) Stress relief. Subject each sample consumer product with a 
battery compartment enclosure, door/cover, or door/cover opening 
mechanism that is made from molded or formed thermoplastic materials to 
a stress relief test. Place each test sample consumer product in a 
circulating air oven for at least 7 hours, using an oven temperature of 
the higher of at least 70[deg]C (158 [deg]F) or at least 10[deg]C (18 
[deg]F) higher than the maximum temperature of thermoplastic battery 
compartment enclosures, doors/covers, or door/cover opening mechanisms 
during the most stringent normal operation of the consumer product. 
Allow the sample consumer product to cool to room temperature after 
removal from the oven.
    (ii) Battery replacement. This step applies only to consumer 
products with button cell or coin batteries intended to be removable or 
replaceable. Open the battery compartment enclosure, remove and replace 
the button cell or coin battery, and close the battery compartment 
enclosure for a total of 10 cycles. For battery compartment enclosures 
that are secured with a screw(s), the screw(s) must be loosened and 
then tightened each time using a suitable screwdriver, applying a 
continuous linear torque according to the Torque to be Applied to 
Screws table, Table 20, of the Standard for Audio, Video and Similar 
Electronic Apparatus--Safety Requirements, UL 60065. If the screw(s) do 
not meet the specified torque requirements during this step, remove the 
screw(s) and repeat the test in paragraph (d) of this section.
    (2) Abuse tests. Subject each test sample consumer product to the 
following abuse tests, performed sequentially, as applicable. Check 
compliance of the sample using paragraph (e)(3) of this section. If the 
consumer product contains button cell or coin batteries that are not 
intended for removal or replacement, and that are accessible based on 
paragraph (c) of this section, then the consumer product must be tested 
under paragraph (f) of this section and this paragraph (e)(2) does not 
apply.
    (i) Drop test. Drop each sample consumer product ten times from a 
height of 1.0 m (39.4 in) onto a horizontal hardwood surface in 
positions likely to produce the maximum force on the battery 
compartment enclosure. The hardwood surface must be at least 13 mm (0.5 
in) thick, mounted on two layers of nominal 19 mm (0.75 in) thick 
plywood, and placed on a concrete or equivalent non-resilient surface.
    (ii) Impact test. Subject the battery compartment enclosure door or 
cover on each sample consumer product to three, at least 2-J (1.5-
ft[middot]lbf) impacts. Produce the impact by dropping a steel sphere, 
50.8 mm (2 in) in diameter, and weighing approximately 0.5 kg (1.1 lb) 
from the height required to produce the specified impact, as shown in 
figure 1 to this paragraph (e)(2)(ii), or suspend the steel sphere by a 
cord and swing as a pendulum, dropping through the vertical distance 
required to cause the steel sphere to strike the battery compartment 
enclosure door or cover with the specified impact, as shown in figure 2 
to this paragraph (e)(2)(ii). The steel sphere must strike the battery 
compartment enclosure door or cover perpendicular to the surface of the 
battery compartment enclosure.

Figure 1 to Paragraph (e)(2)(ii). Example Impact Test With a Dropped 
Steel Sphere.
[GRAPHIC] [TIFF OMITTED] TP09FE23.013


[[Page 8723]]



Figure 2 to Paragraph (e)(2)(ii). Impact Test With a Swinging Steel 
Sphere.
[GRAPHIC] [TIFF OMITTED] TP09FE23.014

    (iii) Crush test. Support each sample consumer product by a fixed 
rigid supporting surface, in positions likely to produce the most 
adverse results as long as the position of the consumer product is 
self-supported. Apply a crushing force of at least 335 N (75.3 lbf) to 
the exposed surface for a period of 10 seconds. Apply the force using a 
flat surface measuring approximately 100 by 250 mm (3.9 by 9.8 in).
    (iv) Compression test. If any surface of the battery compartment 
enclosure is accessible to a child and inaccessible to a flat surface 
contact during the drop test, apply the Compression Test from 16 CFR 
part 1250 to that surface, using a force of at least 136 N (30.6 lbf).
    (v) Torque test. If a child can grasp any part of the battery 
compartment enclosure on a sample consumer product, including the door 
or cover, with at least the thumb and forefinger, or using teeth, apply 
the Torque Test for Removal of Components from 16 CFR part 1250 to the 
battery compartment enclosure, using a torque of at least 0.50 Nm (4.4 
in.-lbf).
    (vi) Tension test. If a child can grasp any part of the battery 
compartment enclosure on a sample consumer product, including the door 
or cover, with at least the thumb and forefinger, or using teeth, apply 
the Tension Test for Removal of Components from 16 CFR part 1250 to the 
battery compartment enclosure, using a force of at least 72.0 N (16.2 
lbf).
    (3) Compliance. If a button cell or coin battery becomes accessible 
or liberates from a consumer product as a result of any of the abuse 
tests in paragraph (e)(2) of this section, the consumer product is non-
compliant and fails testing. Additionally, after completing all abuse 
testing, apply a force of at least 50 N (11.2 lbf) for 10 seconds to 
the battery compartment enclosure door or cover using the accessibility 
probe. Apply the accessibility probe at the most unfavorable position 
on the battery compartment enclosure, and in the most unfavorable 
direction. Apply a force in only one direction at a time. If the 
battery compartment enclosure door or cover opens or does not remain 
functional, or the button cell or coin battery becomes accessible, the 
consumer product is non-compliant and fails testing.
    (f) Secureness test. Button cell or coin batteries installed in a 
consumer product that are not intended for removal or replacement, and 
that are accessible based on paragraph (d) of this section, must be 
tested by applying a steel test hook, as shown in figure 3 to this 
paragraph (f), using a force of at least 22 N (4.9 lbf), directed 
outwards, applied for 10 seconds at all points where application of a 
force is possible. To pass the test, the button cell or coin battery 
cannot liberate from the consumer product during testing.

[[Page 8724]]

Figure 3 to Paragraph (f). Secureness Test Hook for Consumer Products 
With Accessible Button Cell or Coin Batteries not Intended for Removal 
or Replacement.
[GRAPHIC] [TIFF OMITTED] TP09FE23.015

Sec.  1263.4  Requirements for marking and labeling.

    (a) General Requirements. (1) All warning statements or icons must 
be clearly visible, prominent, legible, and permanently marked.
    (2) Warning statements or icons must be in contrasting color to the 
background onto which the warning statement or icon 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'' must be in black letters on an 
orange background. The signal word must appear in sans serif letters in 
upper case only.
    (6) Certain text in the message panel must be in bold and in 
capital letters as shown in the example warning labels to get the 
attention of the reader.
    (7) For labels that are provided on a sticker, hang tag, 
instructions or manual, the safety alert symbol and the signal word 
``WARNING'' must be at least 0.2 in. (5 mm) high. The remainder of the 
text must be in characters whose upper case must be at least 0.1 in. 
(2.5 mm), except where otherwise specified.
    (8) For labels that are required to be on the packaging of button 
cell and coin batteries, the packaging of consumer products containing 
such batteries, and directly on consumer products, text size must be 
dependent on the area of the principal display panel. Text size must be 
determined based on table 1 to this paragraph (a)(8).

                                         Table 1 to Paragraph (a)(8)--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

[[Page 8725]]

 
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 4 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 on figure 4 to this paragraph 
(b)(1).

Figure 4 to Paragraph (b)(1)
[GRAPHIC] [TIFF OMITTED] TP09FE23.016

    (2) If space prohibits the full warning label shown in Figure 4 to 
paragraph (b)(1), place the icon shown in figure 5 to this paragraph 
(b)(2) on the principal display panel with the text shown in figure 6 
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 6 to this paragraph (b)(2):

Figure 5 to Paragraph (b)(2)
[GRAPHIC] [TIFF OMITTED] TP09FE23.017

Figure 6 to Paragraph (b)(2)
[GRAPHIC] [TIFF OMITTED] TP09FE23.018

    (3) The following safety-related statements must be included on the 
principal display panel or secondary display panel:
    (i) The statement: Keep in original package until ready to use.
    (ii) The statement: Immediately dispose of used batteries and keep 
away from children. Do NOT dispose of batteries in household trash.
    (iii) The statement: Call a local poison control center for 
treatment information.'';
    (iv) Battery type (e.g., LR44, CR2032);
    (v) Battery chemistry (e.g., silver oxide or lithium);
    (vi) Nominal voltage;
    (vii) Year and month or week of manufacture or expiration date;
    (viii) Name or trademark of the manufacturer or supplier;
    (ix) The statement: ``Do not mix old and new batteries, different 
brands or types of batteries, such as alkaline, carbon-zinc, or 
rechargeable batteries.'';
    (x) The statement: ``Ensure the batteries are installed correctly 
according to polarity (+ and -).'';
    (xi) The statement: ``Remove and immediately discard batteries from 
equipment not used for an extended period of time.'';
    (xii) The statement: ``Non-rechargeable batteries are not to be 
recharged.''; and
    (xiii) The statement: ``Do not force discharge, recharge, 
disassemble, heat above (manufacturer's specified temperature rating) 
or incinerate. Doing so may result in injury due to venting, leakage or 
explosion resulting in chemical burns.''.
    (xiv) For button cell or coin batteries that are packaged and 
included separately with a consumer product, only paragraphs (b)(1) and 
(2) of this section apply.
    (c) Warning label requirements for packaging of consumer products

[[Page 8726]]

containing button cell or coin batteries. (1) The principal display 
panel must contain the warning label in figure 7 to this paragraph 
(c)(1). The icon must be at least 8 mm in diameter. The text must state 
the following as shown in figure 7 to this paragraph (c)(1):

Figure 7 to Paragraph (c)(1)
[GRAPHIC] [TIFF OMITTED] TP09FE23.019

    (2) Consumer products that are not contained in packaging must have 
the warning label in Figure 7 to paragraph (c)(1) affixed to the 
consumer product with a hang tag or a sticker label.
    (3) If space on the principal display panel of the consumer product 
packaging does not permit the warning label in Figure 7 to paragraph 
(c)(1), the principal display panel must include the warning in figure 
8 to this paragraph (c)(3) in a conspicuous location. The icon must be 
at least 8 mm in diameter. The remaining warning statements must be on 
a secondary display panel, as shown in figure 9 to this paragraph 
(c)(3). The text must state the following on the principal display 
panel as shown in figure 8 to this paragraph (c)(3):

Figure 8 to Paragraph (c)(3)
[GRAPHIC] [TIFF OMITTED] TP09FE23.020

Figure 9 to Paragraph (c)(3)
[GRAPHIC] [TIFF OMITTED] TP09FE23.021

    (4) The text must state the following on the secondary display 
panel as shown in Figure 9 to paragraph (c)(3).
    (5) The principal display panel or secondary display panel of the 
consumer product packaging, or if there is no consumer product 
packaging, the accompanying hang tag or sticker label, must include the 
following text:
    (i) For products with non-replaceable batteries, include a 
statement indicating the product contains non-replaceable batteries;
    (ii) Battery type (e.g., LR44, CR2032); and
    (iii) Nominal voltage.
    (d) Warning label requirements for consumer products containing 
button cell or coin batteries.
    (1) Consumer products must be durably and indelibly marked with a 
warning label on the product display panel that alerts the consumer of 
the presence of a button cell or coin battery. The warning text must 
include the safety alert symbol, signal word, and text, as shown in 
figure 10 to this paragraph (d)(1).

Figure 10 to Paragraph (d)(1)
[GRAPHIC] [TIFF OMITTED] TP09FE23.022

    (2) If space on the product is limited, use the ``Warning: contains 
coin battery'' icon shown in figure 11 to this paragraph (d)(2), 
without text. The icon must be at least 7 mm in width and 9 mm in 
height and must be on the

[[Page 8727]]

product display panel and must be in yellow with black outlines as 
shown in figure 11 to this paragraph (d)(2). The icon must be defined 
in accompanying printed materials such as instructions, manual, insert, 
or hangtag.

Figure 11 to Paragraph (d)(2)
[GRAPHIC] [TIFF OMITTED] TP09FE23.023

    (3) If the product itself is too small to include the warning with 
text in Figure 10 to paragraph (d)(1) or the icon in Figure 11 to 
paragraph (d)(2), the product must:
    (i) Have packaging containing the warning label following the 
requirements in paragraph (c) of this section; or
    (ii) Contain a hangtag or sticker label with the full warning label 
using requirements for the packaging of consumer products containing 
batteries in paragraph (c) of this section.
    (e) Instructions/Manuals accompanying consumer products containing 
button cell and coin batteries. (1) Instructions and manuals, if 
provided, must include the warning label shown in Figure 7 to paragraph 
(c)(1) and the following warning statements:
    (i) The statement: ``Immediately dispose of used batteries and keep 
away from children. Do NOT dispose of batteries in household trash.'';
    (ii) The statement: ``Even used batteries may cause severe injury 
or death.'';
    (iii) The statement: ``Call a local poison control center for 
treatment information.'';
    (iv) Compatible battery type (e.g., LR44, CR2032);
    (v) Nominal voltage;
    (vi) For products with non-replaceable batteries, include a 
statement indicating the product contains non-replaceable batteries;
    (vii) The statement: ``Do not mix old and new batteries, different 
brands or types of batteries, such as alkaline, carbon-zinc, or 
rechargeable batteries.'';
    (viii) The statement: ``Ensure the batteries are installed 
correctly according to polarity (+ and -).'';
    (ix) The statement: ``Remove and immediately discard batteries from 
equipment not used for an extended period of time.'';
    (x) The statement: ``Non-rechargeable batteries are not to be 
recharged.''; and
    (xi) The statement: ``Do not force discharge, recharge, 
disassemble, heat above (manufacturer's specified temperature rating) 
or incinerate. Doing so may result in injury due to venting, leakage or 
explosion resulting in chemical burns.''.
    (2) If instructions and manuals are not provided, the warning 
statements in paragraph (e)(1) of this section must be present on the 
principal display panel or secondary display panel of the consumer 
product packaging, or if there is no consumer product packaging, the 
accompanying hang tag or sticker label.
    (f) Online information. Manufacturers shall include, in a manner 
that is clearly visible, prominent, and legible (either next to the 
product description, the product image, or the product price):
    (1) in their online materials that enable consumers to purchase 
button cell or coin batteries, the warning in Figure 4 to paragraph 
(b)(1); and
    (2) in their online materials that enable consumers to purchase 
products containing button cell or coin batteries, the warning in 
Figure 7 to paragraph (c)(1).


Sec.  1263.5  Severability.

    The provisions of this part are separate and severable from one 
another. If any provision is stayed or determined to be invalid, it is 
the Commission's intention that the remaining provisions shall continue 
in effect.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2023-02356 Filed 2-8-23; 8:45 am]
BILLING CODE 6355-01-P

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