PART 1262—SAFETY STANDARD FOR MAGNETS Authority: 15 U.S.C. 2056, 2058. Source: 87 FR 57789, Sept. 21, 2022, unless otherwise noted. § 1262.1 Scope, purpose, application, and exemptions. (a) Scope and purpose. subject magnet product, hazardous magnets subject magnet product. (b) Application. subject magnet products (c) Exemption. § 1262.2 Definitions. The following definitions apply for purposes of this part: (a) Hazardous magnet 2 2 (b) Subject magnet product § 1262.3 Requirements. Each loose or separable magnet in a subject magnet product 2 2 § 1262.4 Test procedure for determining flux index. (a) Select at least one loose or separable magnet of each shape and size in the subject magnet product. (b) Measure the flux index of each selected magnet in accordance with the procedure in section 8.25.1 through 8.25.3 of ASTM F963-17, Standard Consumer Safety Specification for Toy Safety, www.astm.org. www.astm.org/READINGLIBRARY/. [email protected], [email protected], www.archives.gov/federal-register/cfr/ibr-locations.html. § 1262.5 Findings. (a) General. (b) Degree and nature of the risk of injury. (2) The potential injuries when a child or teen ingests one or more hazardous magnets are serious. Health threats posed by hazardous magnet ingestion include pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia, inflammation, perforation, peritonitis, sepsis, ileus, ulceration, aspiration, and death, among others. These conditions can result from magnets attracting to each other through internal body tissue, or a single magnet attracting to a ferromagnetic object. CPSC is aware of serious injuries and several fatal magnet ingestion incidents that occurred in the United States, resulting from internal interaction of magnets. (c) Number of consumer products subject to the rule. (d) The need of the public for subject magnet products and the effects of the rule on their cost, availability, and utility. (2) Retail prices of subject magnet products generally average under $20. CPSC has identified subject magnet products that comply with the rule, and the prices of compliant and non-compliant products are comparable. (3) If the costs associated with redesigning or modifying subject magnet products to comply with the rule results in manufacturers discontinuing products, there may be some loss in availability to consumers. However, this would be mitigated to the extent that compliant products meet the same consumer needs, and there are compliant products currently available for sale to consumers. (4) Manufacturers may sell complying products to mitigate costs. In addition to products that comply with the performance requirements, there are products that are not subject to the performance requirements. Products sold and/or distributed solely to school educators, researchers, professionals, and/or commercial or industrial users exclusively for educational, research, professional, commercial, and/or industrial purposes are not subject magnet products, and firms may continue to manufacture, sell, and distribute such magnet products. (e) Other means to achieve the objective of the rule while minimizing adverse effects on competition, manufacturing, and commercial practices. (f) Unreasonable risk. (2) The potential injuries when a person ingests one or more magnets are serious. Health threats posed by magnet ingestion include pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia, inflammation, perforation, peritonitis, sepsis, ileus, ulceration, aspiration, and death, among others. These conditions can result from magnets attracting to each other through internal body tissue, or a single magnet attracting to a ferromagnetic object. Magnet ingestion incidents commonly result in hospitalization, particularly when subject magnet products are ingested. The Commission is aware of serious injuries as well as five fatal magnet ingestion incidents that occurred in the United States between November 24, 2005, and January 5, 2021. Four of these incidents involved children 2 years old or younger, and all five victims died from injuries resulting from internal interaction of the magnets. Four of the five incidents identified the products as magnet sets, amusement products, or described them as having characteristics that are consistent with subject magnet products. (3) CPSC's trend analysis of the incident data indicates that magnet ingestions have significantly increased in recent years. In 2014, Commission issued a rule that applied to magnet sets, which are a subset of the subject magnet products addressed in this rule. The 2014 magnet sets rule took effect in April 2015 and remained in effect until it was vacated and remanded by the U.S. Court of Appeals for the Tenth Circuit Court in November 2016. Zen Magnets, LLC Consumer Prod. Safety Comm'n., (4) For these reasons, the Commission finds that the rule is reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with the product. (g) Public interest. (h) Voluntary standards. Standard Consumer Safety Specification for Toy Safety Standard Specification for Consumer Product Safety for Children's Jewelry; Standard Consumer Safety Specification for Adult Jewelry; Standard Specification for Marketing, Packaging, and Labeling Adult Magnet Sets Containing Small, Loose, Powerful Magnets (with a Flux Index ≥ 50 kG 2 2 Safety of Toys; Part 1: Mechanical and Physical Properties www.en-standard.eu Safety of Toys—Part 1: Safety Aspects Related to Mechanical and Physical Properties www.iso.org (2) The Commission finds that compliance with existing standards is not likely to result in the elimination or adequate reduction of the risk of injury associated with ingestion of subject magnet products. (i) Relationship of benefits to costs. (2) If unidentified magnet products involved in ingestion injuries, which are also likely to be subject magnet products, are considered as well, average annual societal costs for 2017 through 2021 would increase by $167.9 million. A sensitivity analysis shows that adding even a relatively small portion of NEISS cases involving unidentified magnet products to the base case substantially increases the estimated gross benefits of the rule. Although CPSC's analysis of the data, the trends in NEISS, CPSRMS, and poison center-reported, magnet-related incidents support the conclusion that the unidentified magnet products generally involved magnets considered within the scope of the rule, because CPSC does not know precisely how many of these products would fall within the scope of this rule, CPSC has not included them in the primary benefit analysis. Instead, CPSC includes the benefits from unidentified magnet products in this final rule's sensitivity analysis to illustrate the theoretical upper bounds of benefits from this rule. Theoretically, including 100 percent of these societal costs with those estimated for identified subject magnet products ($51.8 million) could yield average annual societal costs of magnet ingestion injuries of $219.7 million for the period 2017 through 2021. (j) Least burdensome requirement that would adequately reduce the risk of injury. (1) One alternative is to take no regulatory action and, instead, rely on existing standards to address the magnet ingestion hazard. This alternative would reduce the burden associated with the rule by avoiding a mandatory standard, but it is unlikely to adequately address the magnet ingestion hazard due to the limited scope and requirements of existing standards and uncertainty regarding compliance with them. (2) Another alternative is a mandatory standard with less stringent requirements than the proposed rule, such as a higher flux index limit, or different requirements for certain shapes and sizes of magnets. This could reduce the burden associated with a rule by allowing firms to market a wider variety of products than under the rule. However, this alternative would reduce the safety benefits because allowing certain hazardous magnets in subject magnet products to remain on the market does not address the hazard such products pose. (3) Safety messaging is another alternative to the rule. This alternative would reduce the burdens associated with the rule because it would not require modifying or discontinuing subject magnet products, and the costs of such warnings and instructional information likely would be small. However, this alternative is not likely to adequately reduce the magnet ingestion hazard. Incident data shows children commonly access ingested magnets from sources that do not include the product packaging where warnings are provided. Incident data, behavioral and developmental factors, and other information indicate that children and caregivers commonly disregard safety messaging regarding the magnet ingestion hazard. Finally, this approach has not been effective at adequately reducing the hazard, to date. (4) Another alternative is to require special packaging to limit children's access to subject magnet products. Although this alternative would create some packaging costs, those costs likely would be lower than the costs of the rule because this alternative would allow subject magnet products to remain unchanged. However, this alternative is not likely to adequately reduce the risk of injury and death associated with magnet ingestions. Consumers are unlikely to repackage all magnets after each use, given the small size and large number of magnets in products, the potential to lose magnets, and consumers' underappreciation of the hazard. In addition, commercially reasonable packaging requirements would only prevent young children (typically, children under 5 years old) from accessing the product, not older children, or teens, who are involved in the majority of magnet ingestion incidents. (5) Another alternative is to require subject magnet products to be coated with aversive agents. This alternative would reduce the burden associated with the rule because it would allow firms to continue to sell subject magnet products and the costs of such coatings likely would be small. However, such requirements are not likely to adequately address the hazard because they do not address ingestions that occur when the first magnet is placed in the victim's mouth, before the aversive agent is detected, accidental ingestions, or children who are developmentally inclined to place objects in their mouths. (6) Another alternative is to provide a later effective date for the final rule. This may reduce the burdens associated with the rule by spreading them over a longer period, but it would also delay the safety benefits of the rule. (7) For these reasons, the Commission finds that the rule imposes the least burdensome requirement that prevents or adequately reduces the risk of injury associated with magnet ingestions.