Safety Standard for Toys: Requirements for Toys Containing Button Cell or Coin Cell Batteries

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

In 2008, Congress passed the Consumer Product Safety Improvement Act of 2008 (CPSIA) providing the CPSC with new regulatory and enforcement tools, particularly for the purpose of protecting the safety of children. Among other things, section 106(a) of the CPSIA made ASTM International's voluntary standard for toys, ASTM F963-07, Standard Consumer Safety Specification for Toy Safety (except sections 4.2 and Annex 4) a mandatory standard beginning 180 days after the enactment date of the CPSIA, on February 10, 2009. 15 U.S.C. 2056b(a). Section 106 also directs the Commission to promulgate toy safety standards that are “more stringent than” the applicable voluntary standard if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product, as well as to periodically review and revise the rules set forth under section 106 to ensure that such rules provide the highest level of safety for such products that is feasible. 15 U.S.C. 2056b(c) and (d).

The CPSIA states that ASTM F963 shall be considered a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 2058). Id. Since 2009, CPSC has enforced ASTM F963 as a mandatory standard for toys. In 2017, the Commission codified the mandatory toy standard in 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, and incorporated by reference the newly revised ASTM standard at that time, ASTM F963-16. 82 FR 8989 (Feb. 2, 2017). Most recently, on January 18, 2024, the Commission updated part 1250 to incorporate by reference a 2023 revision, ASTM F963-23. 89 FR 3344.

Some toys within the scope of ASTM F963 and 16 CFR part 1250 contain, or are designed to use, button cell or coin cell batteries. Accordingly, section 4.25 of ASTM F963-23 contains requirements for “battery-operated toys,” including requirements for toys containing button cell or coin cell batteries. The ASTM requirements are intended to address hazards related to battery overheating, leakage, explosion, fire, and children choking on or swallowing batteries. The 2023 updates to ASTM F963 include improvements to safety requirements for toys that contain button cell or coin cell batteries, such as expanding the application of use and abuse testing of toys and labeling requirements that enhance battery accessibility requirements. However, as discussed in section IV of this preamble, ASTM F963-23 does not establish adequate requirements for toys containing button cell or coin cell batteries because the existing requirements do not address all of the identified hazards and are not as stringent as requirements for non-toy consumer products that are found in 16 CFR part 1263, Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries.

Part 1263 implements Reese's Law, Public Law 117-171, a law that protects children 6 years old and younger against hazards associated with the ingestion of button cell or coin batteries. 15 U.S.C. 2056e. Reese's Law, however, excludes children's toys subject to requirements in 16 CFR part 1250 from its scope. 15 U.S.C. 2056e Note. Specifically, the law states, “The standards promulgated under this Act shall not apply with respect to any toy product that is in compliance with the battery accessibility and labeling requirements of part 1250 of title 16, Code of Federal Regulations[.]” Therefore, the current part 1250 standard implementing ASTM F963 does not provide the highest level of safety feasible for such toys.

Accordingly, this notice of proposed rulemaking (NPR) proposes to amend the requirements in part 1250 specific to battery compartments for toys containing button cell or coin cell batteries to align the requirements more closely with the Commission's new rule for consumer products containing button cell or coin batteries, codified at part 1263. Further, this NPR proposes revising the title of part 1250 from “Safety Standard Mandating ASTM F963 for Toys” to “Safety Standard for Toys,” to reflect the inclusion of proposed requirements that do not incorporate by reference existing requirements in ASTM F963.

The Commission is authorized to issue this NPR pursuant to both sections 106(c) and (d) of the CPSIA, 15 U.S.C. 2056b(c) and (d). Section 106(d) of the CPSIA, 15 U.S.C. 2056b(d)(2), requires the Commission to: (1) examine and assess the effectiveness of ASTM F963, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) promulgate consumer product safety standards for such toys. Standards issued under section 106(d) are to be “more stringent than” the applicable voluntary standard if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product. 15 U.S.C. 2056b(d)(2)(B). Since before the CPSIA, CPSC staff has consulted with stakeholders regarding provisions in the toy standard through the ASTM process. Since the passage of Reese's Law in 2022, CPSC staff has been corresponding with the relevant ASTM Subcommittee and task group, discussing the incident data associated with child battery ingestions, staff's testing of toy battery compartments, and staff's recommendations to update the performance and labeling requirements in the toy standard to adequately address the ingestion hazard associated with children accessing button cell or coin cell batteries from toys.

Section 106(c) of the CPSIA, 15 U.S.C. 2056b(c), requires the Commission to periodically review and revise the rules set forth under section 106, to ensure that such rules provide the highest level of safety for such products that is feasible. The NPR proposes to add performance requirements and revise labeling requirements for toys containing button cell or coin cell batteries that are more stringent than the existing requirements in ASTM F963, which are incorporated by reference into 16 CFR part 1250, and that also provide the highest level of safety feasible, aligning with the requirements in 16 CFR part 1263.

This NPR provides an overview of staff's assessment and analysis, and it discusses the Commission's basis for issuing this NPR. Based on the information and analysis in this NPR, the Commission preliminarily determines that the proposed performance and labeling requirements for toys containing button cell or coin cell batteries are more stringent than the existing requirements in ASTM F963-23, would further reduce the risk of injury associated with products within the scope of the NPR, and would provide the highest level of safety for such products that is feasible.

II. Description of Toys Within the Scope of the Rule

Many toys contain or are designed to use button cell or coin cell batteries like those shown in figure 1. Generally, button cell batteries are small, disposable, single-cell batteries that range from 5 mm to 32 mm (0.2 inches to 1.3 inches) in diameter and are 1 mm to 6 mm (0.04 inches to 0.24 inches) in thickness. Common anode materials are zinc or lithium while common cathode materials are manganese dioxide, silver oxide, carbon monofluoride, cupric oxide, or oxygen from the air. Button cell batteries tend to be manganese dioxide (alkaline) (1.5 volt) or silver oxide (1.55 volt). Lithium coin batteries, also shown in figure 1, 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. Lithium coin batteries are commonly approximately 20 mm (0.787 inch) in diameter.

Section 3.1.9 of ASTM F963-23 defines “battery, button cell” as a “small round non-lithium battery, in which the overall height is less than the diameter” while section 3.1.10 of ASTM F963-23 defines a “battery, coin cell” as a “small, round lithium battery in which the overall height is less than the diameter.” Generally, button cell and coin cell batteries are uniformly defined across safety standards. For example, section 5 of Reese's Law defines “button cell or coin battery” similarly to the ASTM F963-23 definitions, in relevant part, as “. . . a single cell battery with a diameter greater than the height of the battery. . . .” 15 U.S.C. 2056e Notes (Definition 1).

A button cell or coin cell battery (also referred to by industry and consumers 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 cell battery consists of an anode, a cathode, and a separator and electrolyte between the anode and cathode, as shown in figure 2. When connected with a conductive material, such as when the battery is pressed into moist human tissue ( i.e., when swallowed), the connected battery terminals form an electric circuit, and electric current flows through the conductive material and between the terminals. As already described, button cell or coin cell batteries come in many shapes and sizes and are composed of different materials and chemicals. Requirements for power (voltage and capacity) and size are the main driver of battery shape, chemical composition, and the number of batteries required to operate a toy.

Section 3.1.92 of ASTM F963-23 defines a “toy” as “any object designed, manufactured, or marketed as a plaything for children under 14 years of age.” Section 3.1.11 of ASTM F963-23 defines a “battery-operated toy” as a “toy having at least one function dependent on electricity and powered by batteries.” Figure 3 provides examples of toys containing button cell or coin cell batteries that fall within the scope of this NPR. Such toys include, but are not limited to, light up toys, talking dolls, remote controlled vehicles, stuffed animals, science kits, musical toys, do-it-yourself light up craft kits, electronic board games, and learning tablets/games.

Toys containing or designed to use other types of batteries, where the diameter is less than the height, such as AAA or AA batteries, or non-cylindrical batteries, are out of the scope of this NPR because their size and shape does not pose the same type or degree of ingestion hazard as button cell or coin cell batteries.

III. Incident Data and Hazard Patterns

CPSC staff searched two CPSC-maintained databases to identify incidents and hazard patterns associated with button cell and coin cell batteries in toys using product code 0884 for batteries: the Consumer Product Safety Risk Management System (CPSRMS) and the National Electronic Injury Surveillance System (NEISS). The incidents considered were reported as occurring between January 1, 2016, and December 31, 2022. For this period staff identified incidents associated with battery insertions and ingestion, or the risk of ingestion, involving children who were able to access button cell or coin cell batteries from toy battery compartments. Specifically, staff identified one fatal incident and 46 non-fatal incidents in CPSRMS, and 185 NEISS reported hospital emergency department (ED)-treated incidents, associated with children accessing a toy battery compartment. Of the 47 CPSRMS incidents, all but one incident involved children younger than 9 years old, while 170 of the NEISS incidents involved children aged 6 years old or younger.

A. Overview of Button Cell and Coin Cell Battery Hazards

1. Ingestion

Children may be able to access button cell or coin cell batteries when playing with toys that are operated by such batteries. Children may access such batteries if a toy breaks apart and the batteries become exposed or if a battery compartment remains open while a caregiver is changing the batteries. Once exposed, children may remove and ingest the batteries. For example, in CPSC's In-Depth Investigation (IDI) 171024HCC1059, a 20-month-old male ingested a button battery from an electronic toy; the battery was removed surgically, but the child later died from injury. Medical literature details how death and serious injury are associated with button cell or coin cell battery ingestion. Such injuries including choking, internal chemical burns, chemical leakage, pressure necrosis (tissue damage), the creation of hazardous chemicals (such as sodium hydroxide and hydrochloric acid), and related hazards. Because of the nature of the risk of injury, as described in this section, it is important to identify a battery ingestion in a timely manner and remove the button cell or coin cell battery from the body to prevent serious injury or death.

CPSC staff reviewed medical literature related to battery-ingestion injuries that confirms ingested button cell or coin batteries can lodge in the esophagus and cause severe tissue damage after only a few hours, as discussed in Tab B of the Reese's Law NPR Staff Briefing Package (SBP). 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 cause damage to the esophagus, burning nearby tissue and creating perforations. The battery current generates hydroxide when in contact with tissue in the digestive tract. Hydroxide can create chemical burns. Lithium coin batteries pose a particular threat of chemical burn if ingested because such batteries have a higher voltage and capacity than non-lithium batteries. Other injuries associated with button cell or coin battery ingestion include alkaline electrolyte leakage from alkaline button cell batteries or pressure necrosis from extended contact of the battery with tissue.

While ingested button cell or coin batteries may be able to pass through the digestive tract without complications, ingestion complications can occur, usually when such batteries become stuck (impacted) in the esophagus. The primary injury from impaction is from the transmission of electric current eliciting the production of sodium hydroxide (NaOH) and hydrochloric acid (HCl) in tissues adjacent to the cathode and anode terminals, respectively. After only a few hours of a battery maintaining contact with moist tissue, tissue pH on either side of the battery increases, causing substantial tissue damage. The erosive and perforating effects of esophageal impaction may continue even after removing the battery. Another mechanism of injury involves an electrical burn created by electric current passing between the anode and the cathode.

An imperfectly sealed alkaline button cell battery may leak electrolyte solution when ingested, causing injury or death. The large concentration of potassium hydroxide (KOH) in the electrolyte solution is particularly corrosive to human tissue. Alkalis penetrate deep into the tissue layers, which may cause extensive tissue damage.

Another mechanism of injury common to foreign body impaction is pressure necrosis, which creates ischemic, blackened areas of tissue damage. Impaction of a button cell or coin battery in the esophagus leads to esophagus burns in as little as two hours. A burn in the esophagus may cause a perforation of the esophagus or an esophageal stricture (a narrowing of the esophagus). Perforation or stricture of the esophagus can make eating difficult, requiring use of a feeding tube in the stomach or dilations of the esophagus to expand the stricture to allow normal swallowing.

A button battery that burns through the esophagus can also burn through nearby tissues, creating a fistula, which is an abnormal connection between the esophagus and the other surrounding tissues. When fistulas are created in the esophageal area, they are commonly found with the trachea (tracheoesophageal fistulas or TEF) and with the aorta (aortoesophageal fistulas or AEF). Both of these fistulas are life threatening injuries because they can lead to an open artery and, thus, excessive blood loss. Researchers report that esophageal burns and fistulas sometimes require multiple surgeries to repair. These injuries could require weeks of treatment in a hospital.

Diagnosing an ingested button cell or coin battery requires an x-ray because physical examination after ingestion does not always confirm a battery was ingested. Symptoms of button cell or coin battery ingestion, such as respiratory distress, can be mistaken for other ailments, like an asthma attack. As an example, a child who ingested a button cell or coin cell battery may have a fever but no other evidence of having ingested a button cell or coin battery. Alternatively, the physical examination can be normal, making an ingestion diagnosis difficult.

Lithium button cell or coin battery ingestions have become more common as such batteries are used in more household products, including toys, than they were historically. As noted, lithium batteries pose a significant safety hazard when ingested because lithium batteries generate a relatively high voltage, causing rapid local injury, even when partially discharged (used). Therefore, even partially discharged batteries can cause life-threatening injuries when ingested. Medical literature confirms that caregivers only have approximately two hours to remove a lithium battery from a child's esophagus to prevent injury.

2. Nasal Insertion

Not only do children ingest button cell or coin cell batteries, but children also insert such batteries into the nasal cavity. For example, in NEISS case 170555849, a 2-year-old male put into his nose a button battery that was likely liberated from a toy, as batteries were later found to be missing from a toy. A proportion of nose insertions ultimately become ingestions or aspirations because such batteries travel through the nasal passage and enter the digestive tract or airways. Button cell or coin batteries impacted in the nose can lead to severe damage to the endonasal mucous membranes (tissue inside the nasal passage), necrosis (tissue damage) of the nasal septum cartilage (the tissue that separates the left and right nostril), and nasal septum perforation.

When the battery is not removed immediately, most children experience long-term effects, such as saddle nose; saddle nose is a flattening of the nose after a battery has damaged the nasal septum to the point of disintegration by burning a hole in the tissue. Reconstructive surgery is required to artificially recreate a septum inside the child's nose. The severity of nasal insertion complications depends on the duration of impact (longer duration can lead to more damage), the type of button cell or coin battery (a higher voltage can cause more damage), and in which part of the nasal cavity the battery gets lodged (the septum is most susceptible to damage because it is the thinnest tissue in the nose). Septum perforation complications can result in lifelong consequences, such as facial deformity. A button cell or coin battery that becomes dislodged inside the nose can be ingested, causing damage not only to the nasal structure but to the digestive tract as well.

Tab B, Appendix B of the Reese's Law NPR SBP shows 56 cases from medical literature of nasal insertion with button cell or coin batteries from 1985 to 2015. The most severe injury is septal perforation after a battery burned a hole in the tissue. Sometimes the battery remained lodged in the nose for long periods of time, sometimes for months, leading to extensive damage to the nose. Sometimes an impaction occurred for only a few hours and led to septal perforation of the nose.

3. Ear Insertion

Button cell or coin batteries inserted into the ear canal cause injuries similar to that of nasal insertions when they become impacted. A button cell or coin battery that is inserted into the ear canal may cause ear drum perforation or destruction, marked erosion of the ear canal with exposed bone, hearing impairment, facial nerve paralysis, and destruction of the small bones in the middle ear. Like nose insertions, the severity of ear insertion complications depends on the duration of impact, the voltage of the button cell or coin battery, and in which part of the ear canal the battery gets lodged. Appendix C of the Reese's Law NPR SBP shows 10 cases from medical literature of button cell or coin batteries having been inserted into the ear canal.

B. Incident Data Hazard Scenarios—How Children Accessed Batteries

1. Durability

Fifty reported nonfatal incidents between 2016 and 2022, including 20 CPSRMS and 30 NEISS incidents, involve a toy battery compartment breaking apart or opening unintentionally, allowing children to access and potentially ingest or insert button cell or coin cell batteries. Reports describe battery compartment failures where the toy was dropped (nine incidents), thrown or smashed (two incidents), crushed by foot (one incident), or manipulated by a child's hands or mouth to open the battery compartment in a manner that defeated the locking mechanism (nine incidents). These incident reports demonstrate that some toy battery compartments are not strong enough to withstand reasonably foreseeable use or abuse to prevent children from accessing batteries. For example, incident I17B0493A describes an 8-year-old male who dropped a light-up spinner toy that easily broke apart; the child swallowed the battery, which required surgery to remove and caused tissue damage to his esophagus. Further, incident I1910003A describes a 3-year-old male who was playing with an action figure when the battery compartment unexpectedly broke open; the consumer indicated they were only able to locate two of three batteries.

The NPR proposes to address these incidents by improving the durability of battery compartments through performance tests. The NPR proposes to require sequential use and abuse testing that aligns with use and abuse testing in part 1263, adopting similar use and abuse performance requirements.

2. Fastener Engagement

Twenty reported nonfatal incidents, including 18 CPSRMS and two NEISS incidents, involve a toy battery compartment fastener, such as a screw, that did not adequately secure or close the compartment, potentially allowing children to access and ingest or insert the button cell or coin cell batteries inside. Incident reports describe failing fasteners as not being long enough to engage the threads (four incidents), fasteners continuously spinning, or threads being stripped (four incidents). These incidents demonstrate that some fasteners do not adequately secure toy battery compartments and that the engagement of the fastener can degrade over time. For example, incident I6C0676A describes a 4-year-old male who was found playing with a light up toy in his room with the battery compartment cover off the toy; the batteries were all located, but the screw intended to secure the battery compartment continuously spun when a caregiver attempted to tighten it. Consistent with part 1263 fastener requirements, and to ensure more durable fastener engagement, the NPR proposes minimum requirements for battery compartment thread attachment as well as a test to simulate repeated battery replacement.

3. Sibling Interaction

Twenty-four (24) reported nonfatal incidents, including seven CPSRMS and 17 NEISS incidents, describe a button cell or coin cell battery becoming accessible from a toy when, for example, two or more siblings played with a toy together, or a younger sibling played with an older sibling's toy. Incident reports demonstrate that basing performance requirements for the durability of toy battery compartments on the intended user's age does not adequately address typical use and abuse scenarios leading to the ingestion hazard. For example, incident I1910347A describes a 2-year-old female who played with her 4-year-old male sibling's toys; the 2-year-old dropped the toys on the floor and the toys fell apart; three button batteries fell out of the toys. The NPR proposes to address these incidents by improving the durability of battery compartments through performance tests with limited reliance on age grading. The NPR proposes to require sequential use and abuse testing that aligns with testing in part 1263, incorporating UL 4200A-23 performance requirements.

4. Changing Batteries

Seven reported nonfatal incidents, all from NEISS, describe a child accessing a button cell or coin cell battery while a parent or caregiver was changing batteries in a toy. All children involved in these incidents were taken to a hospital for treatment. For example, NEISS case 190447495 describes an incident where a babysitter was changing a button battery in a toy when an 8-month-old male was able to swallow one battery. The NPR proposes to address these incidents by improving required product warning labels for toy battery compartments to better warn consumers about battery ingestion hazards while the consumer is interacting with the compartment.

5. Easily Accessed Battery Compartments

Four reported nonfatal incidents, all from CPSRMS, involve a child who was able to open a toy battery compartment without the use of a tool. For example, IDI 170623CFE0001 describes a 9-year-old boy who opened a battery compartment by pulling a battery compartment access tab with his teeth. The remaining three incidents describe toys that lacked battery compartment securing mechanisms or that opened easily without a tool. The NPR proposes to better address the hazard of easily accessed battery compartment incidents by mandating minimum performance requirements for battery compartment threaded attachments.

C. National Estimates From NEISS

Based on NEISS data, CPSC staff estimates that over the seven-year period from 2016 through 2022 there were 4,500 U.S. hospital emergency department visits (sample size = 185, coefficient of variation = 0.1705) associated with a person (generally a child) accessing a button cell or coin cell battery from a toy. An estimated 81 percent of victims ingested or swallowed a button cell or coin cell battery or put a button cell or coin cell battery in their mouth. An estimated 92 percent of the victims were children between the ages of 6 months and 5 years old. An estimated 58 percent of the victims were male, while an estimated 42 percent were female. An estimated 81 percent were treated at the hospital emergency department and released, 16 percent were admitted for hospitalization, and 3 percent were held for observation. Of the 185 sample cases supporting these estimates, none were fatal. To ensure that only button cell and coin cell battery incidents involving toys are captured, CPSC staff's estimates do not include cases that failed to identify battery source or battery type. Accordingly, the injury estimates based on NEISS data are conservative and represent a lower bound for actual ED-treated injuries associated with button cell and coin cell batteries in children's toys.

D. Availability of Incident Data

Upon publication of this NPR in the Federal Register , CPSC will make available for review and comment, to the extent allowed by applicable law, the CPSRMS and NEISS incident reports relied upon and discussed, along with the associated IDIs. The data can be obtained by submitting a request to: https://forms.office.com/g/kSefsxqT3X. You will receive a website link to access the data at the email address you provided. If you do not receive a link within two business days, please contact bmordecai@cpsc.gov.

E. Child Supervision and Behavior

Battery compartment security is important for toys containing button cell or coin cell batteries because children often play with these types of toys while unsupervised, and infants or toddlers often mouth objects, leading to incidents of battery ingestion or insertion.

Research by Morrongiello and colleagues (2006) indicates that older toddlers and preschool children (ages 2 through 5 years old) typically are out of view of a supervising parent for about 20 percent of their awake time at home and are not within visual range or hearing distance for about 4 percent of awake time in the home because caregivers reasonably allow young children to be unsupervised for a few minutes in a presumably safe room. Most caregivers recognize hazards such as a hot stove and actively guard against them; however, items such as toys reasonably do not present a high level of concern. Therefore, consumers may not be aware that certain toys contain button or coin cell batteries and that such products pose a hazard. Often, caregivers notice that a toy is missing a battery only after a child has already accessed it.

Mouthing and ingestion of non-food items is a normal part of children's exploratory behavior that contributes to incidents of choking and poisoning. Because of this, CPSC has banned small parts for toys intended for children younger than 3 years of age and mandates small-parts warnings for toys and games intended for children ages 3 to 6 years old. Still, toys containing button or coin cell batteries pose a similar danger. Unintentional foreign body ingestion is one of the top five leading causes for nonfatal emergency department visits in children under the ages of 9 years old. Medical literature indicates that children most commonly ingest or insert foreign objects found in the home environment that are small, round, shiny, and relatively smooth, as are button cell and coin batteries.

Children develop rapidly, both physically and cognitively, in the first few years of life, learning to grasp object, bring object to their mouth, stand, and often walk all during the first year. Between the ages of 12 to 18 months of age, children progress from walking, to running and climbing. Increased mobility, physical strength, and coordination, combined with an inherent predisposition towards curiosity and exploration can lead to dangerous situations for young children who may discover hazardous items.

F. Recalls

From January 1, 2011, through March 19, 2024, CPSC's Office of Compliance and Field Operations conducted six recalls of toys containing button cell or coin cell batteries. Table 1 below summarizes the recalls, including the press release date, firm, hazard, approximate number of recalled units, number of incidents and injuries reported, and press release number.