Safety Standard for Magnets

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1262

[Docket No. CPSC-2021-0037]

Safety Standard for Magnets

AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The U.S. Consumer Product Safety Commission (Commission or CPSC) has determined preliminarily that there is an unreasonable risk of injury and death, particularly to children and teens, associated with ingestion of one or more high-powered magnets. To address this risk, the Commission proposes a rule, under the Consumer Product Safety Act, to apply to consumer products that are designed, marketed, or intended to be used for entertainment, jewelry (including children's jewelry), mental stimulation, stress relief, or a combination of these purposes, and that contain one or more loose or separable magnets. Toys that are subject to CPSC's mandatory toy standard are exempt from the proposed rule. Each loose or separable magnet in a product that is subject to the proposed rule and that fits entirely within CPSC's small parts cylinder would be required to have a flux index of less than 50 kG

2

mm

2

. The Commission requests comments about all aspects of this notice, including the risk of injury, the proposed scope and requirements, alternatives to the proposed rule, and the economic impacts of the proposed rule and alternatives.

DATES:

Submit comments by March 28, 2022.

ADDRESSES:

Submit written comments, identified by Docket No. CPSC-2021-0037, using the methods described below. CPSC encourages you to submit comments electronically, rather than in hard copy.

Electronic Submissions:

Submit electronic comments to the Federal eRulemaking Portal at:

https://www.regulations.gov.

Follow the instructions for submitting comments. CPSC does not accept comments submitted by electronic mail (email), except through

https://www.regulations.gov,

and as described below. CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

Mail/Hand Delivery/Courier Written Submissions:

Submit comments by mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission 4330 East-West Highway, Bethesda, MD 20814; telephone: (301) 504-7479. Alternatively, as a temporary option during the COVID-19 pandemic, you can email such submissions to:

cpsc-os@cpsc.gov.

Instructions:

All submissions must include the agency name and docket number for this notice. 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 electronically: 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 written submissions.

Docket:

To read background documents or comments regarding this proposed rulemaking, go to:

http://www.regulations.gov,

insert docket number CPSC-2021-0037 in the “Search” box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT:

Michelle Guice, Compliance Officer, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone (301) 504-7723; email:

MGuice@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Overview of the Proposed Rule

The Commission issues this notice of proposed rulemaking (NPR) under sections 7 and 9 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 2051-2089).

1

Through this rulemaking, the Commission seeks to create a safety standard to address the unreasonable risk of injury and death associated with ingestion of loose or separable high-powered magnets. Incident data indicate that certain consumer products containing such magnets are ingested by children and teens. When ingested, these powerful magnets can interact internally with one another, or a ferromagnetic object (

i.e.,

material attracted to magnets), through body tissue, leading to acute and long-term adverse health consequences or death.

1

The Commission voted 4-0 to approve this notice and commence rulemaking.

The proposed rule applies to consumer products that are designed, marketed, or intended to be used for entertainment, jewelry (including children's jewelry), mental stimulation, stress relief, or a combination of these purposes, and that contain one or more loose or separable magnets. Toys that are subject to CPSC's mandatory toy standard in 16 CFR part 1250 are exempt from the proposed rule, because that standard already includes requirements to address the magnet ingestion hazard in children's toys (

i.e.,

products designed, manufactured, or marketed as playthings for children under 14 years old). In this notice, products that are subject to the proposed rule are referred to as “subject magnet products.”

The proposed rule seeks to address the risk of injury or death associated with magnet ingestions, by requiring loose or separable magnets in subject magnet products to be either too large to swallow, or weak enough to reduce the risk of internal interaction injuries when swallowed. Under the proposed rule, each loose or separable magnet in a subject magnet product that fits entirely within CPSC's small parts cylinder must have a flux index of less than 50 kG

2

mm

2

. CPSC's small parts cylinder is described and illustrated in 16 CFR 1501.4, which is intended to prevent children from ingesting of small objects. The proposed rule specifies the method for determining the flux index of a magnet, and this preamble discusses the basis for the flux index limit in the proposed rule. The term “hazardous magnet” refers to a magnet that fits entirely within the small parts cylinder and that has a flux index of 50 kG

2

mm

2

or more.

The information discussed in this preamble is derived from CPSC staff's briefing package for the NPR, which is available on CPSC's website at:

https://www.cpsc.gov/s3fs-public/Proposed-Rule-Safety-Standard-for-Magnets.pdf?VersionId=2Xizl5izY1OvQRVazWpkqdJHXg5vzRY.

This preamble provides key information to explain and support the rule; however, for a more comprehensive and detailed discussion, see the NPR briefing package.

B. History of CPSC Work on the Magnet Ingestion Hazard

CPSC has taken several actions to address the magnet ingestion hazard, including issuing mandatory standards, working with voluntary standards organizations, initiating recalls and compliance actions, engaging in staff assessments of the hazard and potential ways to address it, and creating information campaigns.

1. Mandatory Standards

On August 14, 2008, Congress enacted section 106 of the Consumer Product Safety Improvement Act (CPSIA; Pub. L. 110-314, 122 Stat. 3016 (Aug. 14, 2008)), codified at 15 U.S.C. 2056b.

Section 106 of the CPSIA provides that, beginning 180 days after its enactment, ASTM F963-07,

Consumer Safety Specification for Toy Safety,

is considered a consumer product safety standard issued by the Commission under section 9 of the CPSA.

2

15 U.S.C. 2056b(a). Section 106 further provides for updates to the mandatory standard when ASTM F963 is revised or to improve safety.

Id.

2056b(b)(2), (c), (d), (g). Section 106 specifically refers to “internal harm or injury hazards caused by the ingestion or inhalation of magnets in children's products,” among other hazards, in its directive to review and assess ASTM F963.

Id.

2056b(b)(1)(A).

2

Section 106 excluded from this mandate the following provisions in ASTM F963-07: Section 4.2 and Annex 4 (which address flammability), and “any provision that restates or incorporates an existing mandatory standard or ban promulgated by the Commission or by statute or any provision that restates or incorporates a regulation promulgated by the Food and Drug Administration or any statute administrated by the Food and Drug Administration.”

Consistent with the mandate in section 106 of the CPSIA, the Commission adopted 16 CFR part 1250,

Safety Standard Mandating ASTM F963 for Toys

(toy standard), which currently incorporates by reference ASTM F963-17, the most recent revision to the standard.

3

82 FR 57119 (Dec. 4, 2017). ASTM F963-17 applies to “toys,” which are objects “designed, manufactured, or marketed as a plaything for children under 14 years of age.” The standard includes requirements to address the hazard associated with ingestion of loose, as-received magnets that are small enough to fit in the small parts cylinder and have a flux index of 50 kG

2

mm

2

or more. Section V. Relevant Existing Standards, below, further describes the requirements in ASTM F963-17.

3

Part 1250 excepts from the mandatory standard, section 4.2 and Annex 5 (which address flammability) of ASTM F963-17, as well as “any provision of ASTM F963 that restates or incorporates an existing mandatory standard or ban promulgated by the Commission or by statute or any provision that restates or incorporates a regulation promulgated by the Food and Drug Administration or any statute administrated by the Food and Drug Administration.” 16 CFR 1250.2(b). In addition, part 1250 replaces section 8.20.1.5(5) of ASTM F963 regarding floor and tabletop toys that move, where a sound is caused as a result of the movement imparted on the toy.

Id.

1250.2(c).

In 2012, the Commission initiated rulemaking to address the magnet ingestion hazard for products that do not fall under 16 CFR part 1250. The rule focused on magnet sets, which were involved in internal interaction injuries in children and teens, when ingested. 77 FR 53781 (Sep. 4, 2012) (notice of proposed rulemaking); 79 FR 59962 (Oct. 3, 2014) (final rule). The rule defined “magnet sets” as “any aggregation of separable magnetic objects that is a consumer product intended, marketed or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief.” The rule required each magnet in a magnet set, and each individual magnetic object intended or marketed for use with or as a magnet set, that fit completely within CPSC's small parts cylinder, to have a flux index of 50 kG

2

mm

2

or less. The final rule was published in October 2014, and it took effect on April 1, 2015. On November 22, 2016, the U.S. Court of Appeals for the Tenth Circuit overturned the rule on magnet sets, vacating and remanding the rule to the Commission.

Zen Magnets, LLC

v.

Consumer Prod. Safety Comm'n.,

841 F.3d 1141 (10th Cir. 2016).

4

4

The court decision had legal effect immediately upon its filing on November 22, 2016. However, in accordance with the court's decision, the Commission removed the mandatory standard for magnets sets (16 CFR part 1240) from the Code of Federal Regulations on March 7, 2017. 82 FR 12716 (Mar. 7, 2017).

2. Voluntary Standards Work

CPSC staff has actively participated in the development and revision of voluntary standards intended to address the magnet ingestion hazard. Since the development of ASTM F963 in 2007, CPSC staff has worked with ASTM to address hazardous magnets in children's toys, including working on multiple revisions to that standard. In addition, staff has participated actively in the ASTM Subcommittee F15.77 on Magnets, which published a voluntary standard on magnet sets in March 2021—ASTM F3458-21,

Standard Specification for Marketing, Packaging, and Labeling Adult Magnet Sets Containing Small, Loose, Powerful Magnets (with a Flux Index ≥50 kG

2

mm

2

).

3. Recalls and Compliance Actions

5

5

Tab G of the NPR briefing package provides details about the recall dates, hazards, approximate number of units affected, number of reported incidents and injuries, and links to the recall press releases.

CPSC's Office of Compliance has investigated and recalled numerous magnet products involving the magnet ingestion hazard. From January 1, 2010 through August 17, 2021, CPSC conducted 18 such recalls, involving 23 firms/retailers, and totaling approximately 13,832,899 recalled units, including craft kits, desk toys, magnet sets, pencil cases, games, bicycle helmets, and maps, among others. Of these 18 recalls, 5 involved products that would not be subject to the proposed rule; specifically, 4 involved children's toys that are subject to the mandatory toy standard, and 1 involved trivets sold with cookware sets. Although these 5 recalls did not apply to products that would be subject to the rule, they also illustrate the magnet ingestion hazard. In addition to recalls, CPSC has addressed the products that present a magnet ingestion hazard through manufacturers' voluntary cessation of sales.

4. Staff Assessment

In addition to staff's assessments of the magnet ingestion hazard for previous rulemakings and compliance efforts, staff also assessed the hazard and potential ways to address it in response to a petition for rulemaking. On August 17, 2017, CPSC received a petition requesting that the Commission initiate rulemaking to address the hazard associated with magnet sets when “ingested, aspirated, or otherwise inserted into” the body.

6

On April 22, 2020, the petitioner withdrew the petition. Nevertheless, staff provided the Commission with an informational briefing package on June 30, 2020, discussing the hazard and staff's work in response to the petition.

7

In the informational briefing package, staff recommended that CPSC continue to consider performance requirements for magnets, to address the ingestion hazard to children and teens.

6

The Commission published a

Federal Register

notice on October 6, 2017, seeking comments on the petition. 82 FR 46740.

7

The informational briefing package, “Staff Briefing Package In Response to Petition CP 17-1, Requesting Rulemaking Regarding Magnet Sets,” is available at:

https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf.

5. Information Campaigns

In addition to raising awareness of the magnet ingestion hazard through publicized recalls, CPSC has drawn attention to the hazard through safety alerts and public safety bulletins. CPSC maintains a “Magnets Information Center” website,

8

which provides an informational video, a description of the hazard, steps to take when magnets are swallowed, and links to recalls, relevant CPSC materials, applicable regulations, and informational posters. CPSC also issued a safety alert about the magnet ingestion hazard, which describes the hazard and steps to take when magnets are swallowed. In addition to CPSC's information campaigns, health

organizations and other consumer advocacy groups have made numerous public outreach efforts to warn consumers about the magnet ingestion hazard.

9

8

Available at:

https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Magnets.

9

Examples include the American Academy of Pediatrics (

https://services.aap.org/en/search/?k=magnets

); the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (

https://www.naspghan.org/content/72/en/Foreign-Body-Ingestion

); Consumer Reports (

https://www.consumerreports.org/product-safety/magnets-marketed-as-toys-could-be-dangerous-to-kids/

); Consumer Federation of America (

https://consumerfed.org/testimonial/cfa-comments-cpscs-notice-proposed-rulemaking-safety-standard-magnet-sets/

); and Kids In Danger (

https://kidsindanger.org/2011/11/cpsc-warns-about-high-powered-magnets/

).

C. How Other Countries Have Addressed the Magnet Ingestion Hazard

Like CPSC, other countries have recognized the internal interaction hazard associated with magnet ingestions. Several of these countries have issued mandatory requirements to address the hazard. To understand how other countries have addressed magnet ingestions, staff reviewed the mandatory requirements for Canada, Australia, New Zealand, and the European Commission.

Canada's Requirements Regarding Magnet Ingestion.

Since 2006, Health Canada has issued several advisories to warn Canadians of the dangers associated with ingesting magnets.

10

In addition, some manufacturers took steps to keep these products from children (

e.g.,

through package warnings, instructions on safe use, and guidance to retailers on safe sales practices). Despite these efforts, children continued to access and use magnets, and ingestion incidents continued. Consequently, Canada adopted mandatory standards for toys and non-toys, to address the magnet ingestion hazard.

10

For example, see:

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/31619a-eng.php; https://www.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/letters-notices-information-industry/information-manufacturers-importers-distributors-retailers-products-containing-small-powerful-magnets.html.

Canada's regulation for toys, SOR/2018-138, includes requirements for magnetic toys intended for children under 14 years old.

11

The standard requires each magnet toy, and each magnetic component in a toy, that can fit entirely within a small parts cylinder, to have a flux index below a specified limit, which is equivalent to 50 kG

2

mm

2

. The standard includes toys with only one magnet, to account for attraction to ferromagnetic objects. The requirements are consistent with ASTM F963.

11

See

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/page-3.html#h-1109670.

Canada has also specified

12

that its general requirements, under the Canada Consumer Product Safety Act (CCPSA), prohibit the manufacture, import, advertising, and sale of products that contain small, powerful magnets, regardless of the intended user age. The general provision in the CCPSA prohibits the manufacture, import, advertisement, and sale of any consumer product that “is a danger to human health or safety.” Sections 7(a), 8(a).

13

Canada specifically highlighted products intended for entertainment that consist of numerous small, powerful magnets.

12

See

https://www.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/letters-notices-information-industry/information-manufacturers-importers-distributors-retailers-products-containing-small-powerful-magnets.html.

13

See

https://laws-lois.justice.gc.ca/eng/acts/c-1.68/page-1.html.

Australia's Requirements Regarding Magnet Ingestion.

Australia has also issued mandatory requirements for both children's toys, and non-children's products, to address the magnet ingestion hazard. For toys intended for children up to, and including, 36 months, Australia requires compliance with Australia New Zealand Standard AS/NZS ISO 8124.1, which aligns with the magnet requirements in ASTM F963.

14

14

See

https://www.legislation.gov.au/Details/F2008C00607.

In addition, in November 2012, Australia adopted a permanent ban of consumer goods containing 2 or more separable or loose magnetic objects, where at least 2 of the magnetic objects each separately fit entirely within a small parts cylinder (specified in AS/NZS ISO 8124.1) and each have a flux index greater than 50 kG

2

mm

2

(using methods described in AS/NZS ISO 8124.1). The ban applies to magnetic objects marketed or supplied for use as a toy, game, puzzle, construction or modelling kit, or jewelry to be worn in or around the mouth or nose. This includes adult desk toys, educational toys or games, and toys, games, and puzzles for mental stimulation or stress relief.

15

15

See

https://www.legislation.gov.au/Details/F2012L02171; https://www.productsafety.gov.au/bans/small-high-powered-magnets.

New Zealand's Requirements Regarding Magnet Ingestion.

As indicated above, New Zealand also uses AS/NZS ISO 8124.1, which aligns with the magnet requirements in ASTM F963, to address the magnet ingestion hazard in children's toys.

16

16

See

https://www.standards.govt.nz/shop/asnzs-iso-8124-12019/.

In addition, in January 2013, New Zealand issued a temporary ban

17

on the sale of certain high-powered magnets, which it extended indefinitely in July 2014.

18

The ban applies to magnetic objects for personal, domestic, or household use that are supplied, offered, or advertised as a toy, game, puzzle, novelty, construction or modelling kit, or jewelry that may be warn in or around the mouth or nose. This includes adult desk toys, educational toys and games, and toys, games, and puzzles for mental stimulation or stress relief. The ban does not apply to hardware magnets, magnets used for teaching purposes by schools and universities, or magnets intended to become part of another product. The ban applies to the specified products if they contain 2 or more separable or loose magnetic objects, at least 2 of the magnetic objects each separately fit entirely within a small parts cylinder (specified in AS/NZS ISO 8124.1), and at least 2 of those magnets have a flux index greater than 50 kG

2

mm

2

(using methods described in AS/NZS ISO 8124.1).

17

See

https://www.beehive.govt.nz/release/ban-sale-high-powered-magnet-sets#:~:text=Consumer%20Affairs%20Minister%20Simon%20Bridges,stores%20and%20over%20the%20internet.

18

Unsafe Goods (Small High Powered Magnets) Indefinite Prohibition Notice 2014, available at:

https://gazette.govt.nz/notice/id/2014-go4501;

see also,

https://productsafety.tradingstandards.govt.nz/for-business/regulated-products/small-high-powered-magnets-unsafe-goods-notice/; https://productsafety.tradingstandards.govt.nz/for-consumers/safety-with-specific-products/high-powered-magnets/.

The European Commission's Requirements Regarding Magnet Ingestion.

The European Commission requires children's toys to comply with EN 71-1,

Safety of Toys,

discussed further in section V. Relevant Existing Standards, below. The requirements in EN 71-1 relating to magnet ingestion are essentially the same as the requirements in ASTM F963-17. There is no safety standard regarding magnet ingestions for products other than children's toys. However, member states generally apply EN 71-1 when assessing the risk posed by products that are not marketed as children's toys, but are intended for children, including magnet sets intended for adults because they are often bought for and used by children.

II. Statutory Authority

Subject magnet products are “consumer products” that the Commission has authority to regulate

under the CPSA.

See

15 U.S.C. 2052(a)(5). Section 7 of the CPSA authorizes the Commission to issue a mandatory consumer product safety standard that consists of performance requirements or requirements that the product be marked with, or accompanied by, warnings or instructions.

Id.

2056(a). Any requirement in the standard must be “reasonably necessary to prevent or reduce an unreasonable risk of injury” associated with the product.

Id.

Section 7 requires the Commission to issue such a standard in accordance with section 9 of the CPSA.

Id.

Section 9 of the CPSA specifies the procedure the Commission must follow to issue a consumer product safety standard under section 7.

Id.

2058. Under section 9, the Commission may initiate rulemaking by issuing an advance notice of proposed rulemaking (ANPR) or NPR.

Id.

2058(a). When issuing an NPR, the Commission must comply with section 553 of Administrative Procedure Act (5 U.S.C. 551-559), which requires the Commission to provide notice of a rule and the opportunity to submit written comments on it. 5 U.S.C. 553; 15 U.S.C. 2058(d)(2). In addition, the Commission must provide interested parties with an opportunity to make oral presentations of data, views, or arguments.

Id.

2058(d)(2).

Under section 9 of the CPSA, an NPR must include the text of the proposed rule, any alternatives the Commission proposes, and a preliminary regulatory analysis.

Id.

2058(c). The preliminary regulatory analysis must include:

• A preliminary description of the potential benefits and costs of the rule, including benefits and costs that cannot be quantified, and the analysis must identify who is likely to receive the benefits and bear the costs;

• a discussion of the reasons any standard or portion of a standard submitted to the Commission in response to an ANPR was not published by the Commission as the proposed rule or part of the proposed rule;

• a discussion of the reasons for the Commission's preliminary determination that efforts submitted to the Commission in response to an ANPR to develop or modify a voluntary standard would not be likely, within a reasonable period of time, to result in a voluntary standard that would eliminate or adequately reduce the risk of injury addressed by the proposed rule; and

• a description of alternatives to the proposed rule that the Commission considered and a brief explanation of the reasons the alternatives were not chosen.

Id.

In addition, to issue a final rule, the Commission must make certain findings and include them in the rule.

Id.

2058(f)(1), (f)(3). Under section 9(f)(1) of the CPSA, before promulgating a consumer product safety rule, the Commission must consider, and make appropriate findings to be included in the rule, concerning the following issues:

• The degree and nature of the risk of injury the rule is designed to eliminate or reduce;

• the approximate number of consumer products subject to the rule;

• the need of the public for the products subject to the rule and the probable effect the rule will have on the cost, availability, and utility of such products; and

• the means to achieve the objective of the rule while minimizing adverse effects on competition, manufacturing, and commercial practices.

Id.

2058(f)(1). Under section 9(f)(3) of the CPSA, the Commission may not issue a consumer product safety rule unless it makes the following findings and includes them in the rule:

• That the rule, including the effective date, is reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with the product;

• that issuing the rule is in the public interest;

• if a voluntary standard addressing the risk of injury has been adopted and implemented, that either compliance with the voluntary standard is not likely to result in the elimination or adequate reduction of the risk of injury, or there is unlikely to be substantial compliance with the voluntary standard;

• that the benefits expected from the rule bear a reasonable relationship to its costs; and

• that the rule imposes the least burdensome requirement that prevents or adequately reduces the risk of injury.

Id.

2058(f)(3). At the NPR stage, the Commission is making these findings on a preliminary basis to allow the public to comment on them.

III. The Product and Market

A. Description of the Product

The proposed rule applies to “subject magnet products,” which are consumer products that are designed, marketed, or intended to be used for entertainment, jewelry (including children's jewelry), mental stimulation, stress relief, or a combination of these purposes, and that contain one or more loose or separable magnets (subject magnet products). Toys that are subject to 16 CFR part 1250,

Safety Standard Mandating ASTM F963 for Toys,

are exempt from this proposed rule.

Subject magnet products include a wide variety of consumer products. Magnets in subject magnet products typically are small, powerful, magnetic balls, cubes, cylinders, and other shapes that can be used to create jewelry (such as necklaces, bracelets, and simulated piercings), and can be aggregated to make sculptures, for use as desk toys, and as other building sets. One common example of a subject magnet product is magnet sets intended for users 14 years and older. Consistent with the Commission's 2014 rule, magnet sets are aggregations of separable magnetic objects that are marketed or commonly used as a manipulative or construction items for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief. Magnet sets often contain hundreds to thousands of loose, small, high-powered magnets. Another example of a subject magnet product is jewelry with separable magnets, such as jewelry-making sets and faux magnetic piercings/studs. Additional examples include products commonly referred to as “executive toys,” “desk toys,” and “rock magnets” (rock-shaped magnets), intended for amusement of users 14 years and older.

Subject magnet products are available in a variety of shapes (

e.g.,

balls, cubes, cylinders), sizes (

e.g.,

2.5 mm, 3 mm, 5 mm), and number of magnets (

e.g.,

1 to thousands). Subject magnet products often consist of numerous identical magnets, although some products include non-identical magnets, such as two or more different shapes. Subject magnet products commonly include magnets between 3 mm and 6 mm in size, and consist of several hundred magnets. One example of a common subject magnet product that staff identified is magnet sets containing approximately 200 magnetic spheres with 5 mm diameters.

Magnets in subject magnet products have a variety of compositions, such as alloys of neodymium, iron, boron (NIB); ferrite/hematite; aluminum, nickel, cobalt (AlNiCo); and samarium and cobalt (SmCo). NIB and SmCo magnets are often referred to as “rare earth” magnets because neodymium and samarium are “rare earth” elements found on the periodic table. Most subject magnet products that staff identified were made from NIB. NIB is typically used in smaller magnets used for magnet sets and magnetic jewelry sets, and ferrite/hematite is typically used in larger magnets, such as rock-shaped magnet toys. The magnetized cores of subject magnet products are

coated with a variety of metals and other materials to make them more attractive to consumers and to protect the brittle magnetic alloy materials from breaking, chipping, and corroding.

Staff found that 5 mm diameter NIB magnets (the most common size identified in magnet ingestion incidents) typically have strong magnetic properties, ranging between 300 and 400 kG

2

mm

2

, and ferrite rock magnets measured upwards of 700 kG

2

mm

2

. Staff also identified products close to the proposed limit of 50 kG

2

mm

2

, ranging from approximately 30 kG

2

mm

2

to 70 kG

2

mm

2

. Some subject magnet products advertise having flux indexes lower than 50 kG

2

mm

2

, which is more common for smaller magnets (

e.g.,

2.5 mm magnets).

Some subject magnet products are “children's products.” The definition of “children's products,” and the requirements applicable to them, are described in section XII. Testing, Certification, and Notice of Requirements, below. To summarize, 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). Most subject magnet products are not children's products because the proposed rule excepts from the standard products that fall under the mandatory toy standard, which applies to playthings intended for users under 14 years old. However, some subject magnet products are children's products because, although they are intended for users 12 years old and younger, they do not fall under the toy standard because they are not playthings. One example of a subject magnet product that could be a children's product and not a toy is children's jewelry.

B. The Market

Magnet products intended for the purposes covered in the proposed rule largely entered the market in 2008, with significant sales beginning in 2009. Of the various products covered by the proposed rule, magnet sets have been particularly concerning to CPSC, given their popularity, uses for amusement and jewelry, their involvement in ingestion incidents, and the large number of loose, small, high-powered magnets in the sets. For this reason, CPSC's previous efforts to address the magnet ingestion hazard largely have focused on magnet sets. Accordingly, much of the information staff has about the market for subject magnet products focuses on magnet sets,

19

which are the largest category of identified products involved in magnet ingestions.

19

Staff's analysis for the 2014 rule and 2020 informational briefing package focused on magnet sets.

From 2009 through mid-2012, most magnet set sellers were retailers with physical stores, such as bookstores, gift shops, and other outlets. In contrast, nearly all current marketers (firms or individuals) of magnet sets sell through internet sites, rather than physical stores. Some of these internet sites are operated by importers, but most sellers (in terms of distinct firms or individuals, if not unit sales) sell through their stores operated on the sites of other internet retailer platforms.

In 2018, CPSC contracted with Industrial Economics, Incorporated (IEc) to examine the market for magnet sets. IEc found a total of 69 sellers of magnet sets on internet platforms in late 2018. IEc also identified 10 manufacturers and 2 retailers.

20

CPSC staff had previously identified at least 121 sellers of magnet sets on internet retailer platforms. However, IEc found that most sellers CPSC had previously identified were no longer selling relevant magnet set products, indicating a high turnover rate for magnet set products and sellers. In 2020, CPSC staff reviewed the status of previously identified sellers of magnet sets on leading internet marketplaces and found further evidence of the high turnover rates for these platforms. Only 9 of the 69 sellers IEc identified in late 2018 were still selling magnet sets; the remainder either no longer offered magnet sets, or no longer operated on the platforms. In addition, CPSC staff identified 29 new sellers that had not been identified in late 2018.

20

IEc classified manufacturers as firms producing and selling their own magnet set products, and retailers as firms that typically sell magnets from multiple manufacturers.

In both 2018 and 2020, staff found that many magnet-set sellers were located domestically, or in China or Hong Kong. In 2018, approximately 57 percent of magnet set sellers on one internet platform fulfilled orders domestically, whereas, in 2020, this declined to 25 percent. In 2018, approximately 25 percent of magnet set sellers on another internet platform were domestic, whereas, in 2020, this increased to 87 percent. Non-domestic sellers were primarily in China and Hong Kong. In addition to internet retailers based in the United States, consumers can also purchase a wide variety of magnet sets using online retailers based in China. Magnet sets purchased from foreign internet retailers may be shipped to consumers directly from China, or from warehouse facilities located domestically.

Retail prices of subject magnet products are about $20 per unit, on average. Magnet sets comprised of spheres or cubes with smaller dimensions (2.5 mm to 3 mm) typically retail at lower prices.

As indicated above, CPSC staff primarily has information about magnet sets, however, additional products are also subject to the proposed rule. CPSC staff is aware of magnets marketed online as jewelry, jewelry-making sets, and faux studs/piercings, as well as entertainment products, such as “desk toys” and “executive toys.” CPSC requests comments about unit sales and other market information about subject magnet products, particularly for products other than magnet sets.

IV. Risk of Injury

CPSC staff analyzed reported fatalities, reported nonfatal incidents and injuries, and calculated national estimates of injuries treated in U.S. hospital emergency departments (EDs) that were associated with ingestion of subject magnet products. Staff also assessed the health outcomes associated with these incidents, as well as various characteristics of the incidents.

A. Incident Data

21

21

For more details about incident data, see Tab B and Tab C of the NPR briefing package.

To evaluate magnet ingestion incidents, staff reviewed reports in the National Electronic Injury Surveillance System

22

(NEISS), which includes reports of injuries treated in U.S. EDs, and reports in the Consumer Product Safety Risk Management System

23

(CPSRMS). The data presented here represent the minimum number of incidents during the periods described.

22

Data from NEISS are based on a nationally representative probability sample of about 100 hospitals in the United States and its territories. NEISS data can be accessed from the CPSC website under the “Access NEISS” link at:

https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data.

23

CPSRMS is the epidemiological database that houses all anecdotal reports of incidents CPSC receives, “external cause”-based death certificates purchased by CPSC, all in-depth investigations of these anecdotal reports, as well as investigations of select NEISS injuries. Examples of documents in CPSRMS include: Hotline reports, internet reports, news reports, medical examiner reports, death certificates, retailer/manufacturer reports, and documents sent by state/local authorities, among others.

1. National Estimates of ED-Treated Injuries

To evaluate magnet ingestion incidents in NEISS, staff started by identifying magnet ingestion cases in the NEISS database with treatment dates

from January 1, 2010 through December 31, 2020. Staff then excluded from this data set incidents that staff could not determine involved magnets (

e.g.,

“acc swallowed dog toy vs magnet”); incidents that did not involve ingestion, or where it was uncertain whether ingestion occurred (

e.g.,

“possible ingestion,” “may have ingested”); and incidents that provided ambiguous information about whether the item ingested was a magnet (

e.g.,

the report refers to a magnet and ingestion, but it is not clear that the magnet was the object ingested). This may have resulted in underestimating the number of incidents.

From the remaining data set, staff categorized incidents by magnet type. Based on the products identified in NEISS reports, or the description of the products, staff organized cases into the following categories: Magnet sets, magnet toys, jewelry, science kits, home/kitchen, ASTM F963 magnet toys, and unidentified. The criteria staff used to categorize incidents into these groups are as follows:

•

Magnet Sets:

Magnets from sets of loose, as-received magnets that are marketed or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief. These items met at least one of the following criteria: Referred to as a magnet set or identified as a magnet set through product name. This category excludes building sets with plastic and/or ferromagnetic components, unless otherwise identified as a magnet set. This category also excludes products reasonably identified as belonging to another product type described below (

e.g.,

a magnetic clasp from a necklace).

•

Magnet Toys:

Magnets from products referred to as toys or games. This category includes products for which the manufacturer-intended user of the toy was 14 years or older, or was unknown, and it excludes cases that positively identified toys subject to ASTM F963 (

i.e.,

excludes products confirmed to have been designed, manufactured, or marketed as playthings for children under 14 years of age).

•

Jewelry:

Magnets described as jewelry (

i.e.,

magnets that are jewelry, or that were being used as or like jewelry) and not definitively identified as a magnet set. Most of these cases involve magnets described as a bracelet, necklace, or piercing jewelry.

•

Science Kits:

Magnets from products identified as a science kit or magnetic/electrical experimental set.

•

Home/Kitchen:

Magnets from products such as non-toy magnet decorations, shower curtains, hardware, and kitchen products. Many of these incidents refer to the magnets as “kitchen magnets.”

•

ASTM F963 Magnet Toys:

Magnets from toys subject to ASTM F963 (

i.e.,

products designed, manufactured, or marketed as playthings for children under 14 years old). Reports for these incidents included brand names or other information sufficient for staff to identify the involved products as toys subject to ASTM F963. Most of these cases involved the magnetic tip of a children's magnetic stylus toy.

•

Unidentified:

Unidentified magnet product type.

As the descriptions above indicate, “magnet toys” and “ASTM F963 magnet toys” refer to two different types of products. “Magnet toys,” as used throughout this preamble, refers to products described as toys, but that did not include indications that the product was marketed for users under 14 years old. In contrast, “ASTM F963 magnet toys” refers to products that staff identified as toys marketed for children under 14 years old; as such, these products are subject to ASTM F963, and they do not fall under the scope of the proposed rule.

With respect to the science kit category, staff identified only one case that involved a product described as a science kit. There was insufficient information about the product to determine whether it was a children's toy subject to ASTM F963, an educational product, or a subject magnet product. Because of this lack of information, and the possibility that it was a children's toy or educational product, staff considered this case outside the scope of the proposed rule.

Staff considered the following categories to be subject magnet products: Magnet sets, magnet toys, and jewelry; these are referred to collectively as “amusement/jewelry.” These categories include incidents in which the report identified a subject magnet product as being ingested, or the incident report provided information about the product, such as characteristics or use patterns, that were sufficient for staff to reasonably conclude that the product fell in a certain product type category. Staff considered cases in the following categories to be outside the scope of the proposed rule: Science kits, home/kitchen, and ASTM F963 magnet toys; these are referred to collectively as “exclusions.” Incidents in the unidentified category did not provide sufficient information to identify the magnet product category, however, they did indicate that a magnet was ingested, and the product had characteristics and use patterns that could be consistent with subject magnet products. Section

IV.A.5. Uncertainties in Incident Data,

below, explains several reasons why staff concludes that a substantial portion of unidentified product type incidents involved subject magnet products.

Table 1 provides the number of cases in each product type category, and the combined categories reported by NEISS participating hospitals.

Table 1—Count of Magnet Ingestion Cases Treated in NEISS Hospital EDs, by Magnet Category, 2010-2020

Original magnet category

N

(original)

Combined magnet category

N

(combined)

Magnet Set

58

Amusement/Jewelry

221

Jewelry

53

Magnet Toy

110

Unidentified

793

Unidentified

793

Science Kit

1

Exclusions

58

F963 magnet toy

11

Home/Kitchen

46

Total

1,072

1,072

Source: NEISS, CPSC.

As Table 1 indicates, of the incidents for which staff could identify a product type category, most incidents involved magnet toys, followed by magnet sets, and jewelry. For 74 percent of incidents, staff could not identify the product type category.

Using the information from the sample of NEISS participating hospitals, staff derived estimates of the number of magnet ingestions treated in U.S. hospitals nationally from 2010 through 2020. For staff to generate national estimates using NEISS data, all of the following reporting criteria must be met: The coefficient of variation (CV) cannot exceed 0.33, there must be at least 20 sample cases, and there must be at least 1,200 estimated injuries. Because of the large portion of NEISS incidents in the unidentified product type category, to meet these criteria, it was necessary to combine the amusement/jewelry and unidentified categories to generate national estimates, and it was not possible to generate national estimates for individual product categories. Thus, the national estimates provided in the rest of this section include incidents in both the amusement/jewelry and unidentified categories of NEISS data. Although the national estimates include magnet ingestion cases in the unidentified product type category, there are several reasons why staff concludes that most magnet ingestion incidents in the unidentified product type category involved subject magnet products, including incident data about known product types, trend data, and recall data. Section

IV.A.5. Uncertainties in Incident Data,

below, discusses, in detail, the reasons staff concludes that most unidentified product type incidents involved subject magnet products.

Table 2 provides the estimated number of ED-treated magnet ingestions for the combined categories.

Table 2—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Magnet Category, 2010-2020

Magnet category

Estimate

CV

N

Amusement/Jewelry

4,400

0.17

221

Unidentified

18,100

0.14

793

Exclusions

1,300

0.20

58

Total

23,700

0.21

1,072

Source: NEISS, CPSC. Estimates rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

Table 3 provides the national estimates of ED-treated magnet ingestions, by year.

Table 3—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Year

Year

Estimate

CV

N

2010

1,900

0.18

91

2011

2,500

0.18

101

2012

2,700

0.26

115

2013

2,000

0.21

88

2014

**

**

62

2015

1,200

0.24

61

2016

1,400

0.24

77

2017

2,900

0.25

112

2018

2,400

0.18

120

2019

1,800

0.22

91

2020

2,200

0.21

96

Total

22,500

0.14

1,014

** This estimate does not meet NEISS reporting criteria.

Source: NEISS, CPSC. Estimates rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

There were significantly fewer ED-treated magnet ingestions in 2015 than in any of the following years: 2010, 2011, 2012, 2017, and 2018. Likewise, there were significantly fewer ED-treated magnet ingestions in 2016 than in any of the following years: 2011, 2017, and 2018. Overall, 2014 through 2016 had the lowest number of estimated ED-treated magnet ingestions. Table 4 compares these middle 3 years (

i.e.,

2014-2016) with the earliest 4 years (

i.e.,

2010-2013), and the most recent 4 years (

i.e.,

2017-2020). Because these periods are not of equivalent duration, staff estimated annual averages to support fair comparisons.

Table 4—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Period

Period

Annual

average

estimate

CV

N

(not an

average)

Years in

period

2010-2013

2,300

0.16

395

4

2014-2016

1,300

0.20

200

3

2017-2020

2,300

0.15

419

4

2010-2020

2,000

0.14

1,014

11

Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

Table 5 provides estimated ED-treated magnet ingestions, by age group.

Table 5—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Age Group, 2010-2020

Age group

Estimate

CV

N

Under 2 years

2,700

0.19

120

2 years

2,300

0.27

89

3-4 years

4,700

0.16

196

5-7 years

4,300

0.14

207

8-10 years

3,900

0.19

179

11-13 years

3,400

0.17

182

14 or More years

**

**

41

Total

22,500

0.14

1,014

** This estimate does not meet NEISS reporting criteria.

Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

Table 6 provides the estimated number of ED-treated magnet ingestions, by sex.

Table 6—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Sex, 2010-2020

Sex

Estimate

CV

N

Female

9,100

0.15

421

Male

13,300

0.14

593

Total

22,500

0.14

1,014

Source: NEISS, CPSC. Estimates are rounded to the nearest 100.

Table 7 provides the estimated number of ED-treated magnet ingestions, by sex and age group. Staff used 8 years old to delineate older and younger children because, as discussed in section V. Relevant Existing Standards, several voluntary standards provide less stringent requirements for magnet products intended for users 8 years and older.

Table 7—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Sex and Age Group, 2010-2020

Sex

Age group

Under 8 years

8 or more years

Total

Female

5,600

3,500

9,100

Male

8,400

4,900

13,300

Total

14,000

8,500

22,500

Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

Table 8 provides the estimated number of ED-treated magnet ingestions, by disposition.

Table 8—Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Disposition, 2010-2020

Disposition

Estimate

CV

N

Hospitalized/Transferred

4,200

0.19

264

Treated and Released

18,000

0.14

735

Other *

**

**

15

Total

22,500

0.14

1,014

* Dispositions in the “other” category include cases in which the victim was “held for observation (includes admitted for observation)” and “left without being seen/left against medical advice.”

** This estimate does not meet reporting criteria.

Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total estimates, due to rounding.

As Table 8 indicates, approximately 80 percent of estimated ED-treated magnet ingestions are treated and released, and approximately 19 percent are hospitalized or treated and transferred to another hospital. Some portion of cases that report the victim being treated and released may have resulted in later hospitalization because magnet ingestion patients are often sent home initially to monitor for natural passage, and the NEISS data typically capture only one part of the treatment process—the ED visit—and do not typically provide information about treatment after the initial ED visit.

2. Reported Incidents

CPSC staff also reviewed CPSRMS data for magnet ingestion incidents. CPSRMS reports commonly contain more information about the incident, product, and victims than NEISS reports because CPSRMS reports may provide photos and websites with detailed narratives and medical documents, whereas, NEISS reports contain only brief narratives from the ED visit. However, CPSRMS data do not provide a complete count of all incidents that occurred during a period, and unlike NEISS data, CPSRMS cannot be used for statistical estimates or to draw conclusions about trends. Rather, CPSRMS data provide a minimum number of incidents that occurred during a period and provide details about incidents.

CPSC staff identified 284 magnet ingestion incidents in CPSRMS that were reported to have occurred between January 1, 2010 and December 31, 2020. Data collection is ongoing for CPSRMS, and is considered incomplete for 2019 and after, so CPSC may receive additional reports for those years in the future. Staff categorized these cases similarly to the NEISS incidents, however, there are some minor differences in the criteria because CPSRMS reports typically contained more product-specific information than NEISS reports. Based on the products identified in the CPSRMS reports or the descriptions of the products, staff organized cases into the following categories: Magnet sets, magnet toys, jewelry, science kits, home/kitchen, ASTM F963 magnet toys, and unidentified. The criteria staff used to categorize incidents into these groups are as follows:

• Magnet Sets: Magnets from sets of loose, as-received magnets that are marketed or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief. These items met at least one of the following criteria:

○ Referred to as a magnet set;

○ identified as a magnet set through product name;

○ included photos identifying the product; or

○ other available information provided reasonable certainty that the product was a magnet set (

e.g.,

products described identically to known magnet sets, such as desk toys consisting of 216 loose, magnetic balls).

Brand was indicated for most of these incidents. Incidents were excluded from this grouping if a medical professional identified the product as a magnet set, but the investigator and victim indicated that they were unable to identify the product as a magnet set.

• Magnet Toys: Magnets from products referred to as toys or games. This category includes products for which the manufacturer-intended user of the toy was 14 years or older, or was unknown, and excludes cases that positively identified toys subject to ASTM F963 (

i.e.,

excludes products confirmed to have been designed, manufactured, or marketed as playthings for children under 14 years of age).

• Jewelry: Magnets described as jewelry and not definitively identified as a magnet set. Most of these cases involve magnets described as a bracelet, necklace, or piercing jewelry.

• Science Kits: Magnets from products identified as a science kit or magnetic/electrical experimental set. (No reported incidents fit in this category.)

• Home/Kitchen: Magnets from products such as non-toy magnet decorations, shower curtains, hardware, and kitchen products.

• ASTM F963 Magnet Toys: Magnets from toys subject to ASTM F963 (

i.e.,

products designed, manufactured, or marketed as playthings for children under 14 years old). Reports for these incidents included brand names or other information sufficient for staff to identify the products involved as toys subject to ASTM F963. Most of these cases involved magnetic building sets with magnets encased in plastic.

• Unidentified: Unidentified magnet product type.

Like NEISS product type categories, “magnet toys” and “ASTM F963 magnet toys” refer to two different types of products. Staff categorized as “magnet toys” products described as toys, which did not have evidence of having been marketed for users under 14 years old. In contrast, “ASTM F963 magnet toys” are toys staff identified as marketed for children under 14 years old, making them subject to ASTM F963, and outside the scope of the proposed rule.

Consistent with the NEISS data analysis, staff considered the following categories to be subject magnet products: Magnet sets, magnet toys, and jewelry; these are referred to collectively as “amusement/jewelry.” These categories include incidents in which the report identified a subject magnet product as being ingested, or the incident report provided information about the product, such as

characteristics or use patterns, which were sufficient for staff to reasonably conclude that the product fell in a certain product type category. Staff considered incidents in the following categories to be outside the scope of the proposed rule: Science kits, home/kitchen, and ASTM F963 magnet toys; these are referred to collectively as “exclusions.” Incidents in the unidentified category did not provide sufficient information to identify the magnet product category, however, they did indicate that a magnet was ingested, and the product had characteristics and use patterns that could be consistent with subject magnet products. As with the NEISS cases, staff concludes that a substantial proportion of the unidentified category involved subject magnet products (see section

IV.A.5. Uncertainties in Incident Data,

below).

Table 9 provides the number of reported magnet ingestions in each category.

Table 9—Reported Magnet Ingestions, by Magnet Category, 2010-2020

Magnet category

Incidents

Proportion

(%)

Scope

Incidents

Proportion

(%)

Magnet Set

134

47.2

Amusement/Jewelry

214

75.4

Magnet toy

49

17.3

Jewelry

31

10.9

Unidentified

43

15.1

Unidentified

43

15.1

Science Kit

0

0

Exclusions

27

9.5

F963 Magnet Toy

21

7.4

Home/Kitchen

6

2.1

Total

284

100.0%

Total

284

100.0%

Note:

CPSRMS reporting for 2019-2020 is ongoing.

As Table 9 shows, of the incidents for which staff could identify a product type category, most involved magnet sets, followed by magnet toys, and jewelry. Fewer cases involved products that are not subject magnet products (

i.e.,

science kits, ASTM F963 magnet toys, and home/kitchen). Compared to NEISS data, far fewer incidents involved unidentified product types.

To further analyze CPSRMS data, staff combined the following categories—magnet sets, magnet toys, jewelry, and unidentified. Staff included the unidentified product type category in this analysis because, as noted for NEISS data, there are several reasons that staff concludes that most magnet ingestion incidents in the unidentified product type category involved subject magnet products, including incident data about known product types, trend data, and recall data. Section

IV.A.5. Uncertainties in Incident Data,

below, discusses, in detail, the reasons staff concludes that most unidentified product type incidents involved subject magnet products. Thus, the data provided in the rest of this section includes incidents in both the amusement/jewelry and unidentified categories of CPSRMS data.

Figure 1 shows the reported CPSRMS magnet ingestion incidents, by year of incident and product type category.

BILLING CODE 6355-01-P

EP10JA22.000

Although CPSRMS data cannot be used to draw statistical conclusions, this data suggests that magnet ingestion incidents increased in 2012, 2019, and 2020, and were lowest in 2015 and 2016, consistent with the results seen in the NEISS data.

Figure 2 shows reported magnet ingestions, by victim age and product type category.

EP10JA22.001

BILLING CODE 6355-01-C

Again, although CPSRMS data cannot be used to draw statistical conclusions, the data suggest that children and teens of all ages ingest magnets, and similar to the NEISS data, most magnet ingestions involve children 5 years or older, with almost half of the ingestions involving children 8 years or older.

Table 10 provides the disposition of reported magnet ingestion cases, by product type category.

24

As discussed below, staff identified a total of 7 deaths resulting from magnet ingestions between November 24, 2005 and January 5, 2021. The 3 deaths reflected here include only the fatalities that occurred in the United States between January 1, 2010 and December 31, 2020.

Table 10—Reported Magnet Ingestion Incidents, by Disposition and Magnet Category, 2010-2020

Magnet category

Disposition

Death

Hospitalization

Other

Total

Magnet Sets

88

46

134

Magnet Toys

36

13

49

Jewelry

21

10

31

Unidentified

24

3

27

13

43

ASTM F963 Magnet Toys

10

11

21

Home/Kitchen

5

1

6

Total

3

187

94

284

Note:

CPSRMS reporting for 2019-2020 is ongoing.

As Table 10 indicates, of the 284 ingestions reported to have occurred between January 1, 2010 and December 31, 2020, the vast majority resulted in hospitalization, and three resulted in death. The remaining “other” dispositions include all remaining reported incidents that did not report either hospitalization or death.

In analyzing CPSRMS magnet ingestion incidents, CPSC staff identified at least 124 cases that resulted in some form of surgery, including laparoscopy, laparotomy, appendectomy, cecostomy, enterotomy, colostomy, cecectomy, gastrotomy, jejunostomy, resection, and transplant. Numerous additional cases resulted in less-invasive procedures than surgery, such as endoscopies and colonoscopies, and could have resulted in surgery if the magnets had not been retrieved soon after ingestion. In 108 cases, the reports specifically described the magnets internally attracting through bodily tissue, and for other cases, there was insufficient information to determine if the surgeries were a result of the magnetic properties.

3. Fatalities

The CPSRMS data above indicate that staff identified three fatal magnet ingestion incidents that were reported to have occurred during the period staff used for incident data analysis—January 1, 2010 and December 31, 2020. However, in total, CPSC is aware of seven deaths involving the ingestion of hazardous magnets between November 24, 2005 and January 5, 2021.

25

Five of these deaths occurred in the United States. In 2005, a 20-month-old child's death involved ingestion of magnets from a children's toy building set with plastic-encased magnets; the product was later recalled. In 2013, a 19-month-old child's death involved multicolored, 5 mm diameter, spherical magnets from an unidentified product. In 2018, a 2-year-old child's death involved multicolored, 3-5 mm diameter, spherical magnets, with indications that the product likely was a magnet set. In 2020, a 43-year-old man's death involved magnets from an unknown product. In 2021, a 15-month-old-child's death involved a magnet set of an unknown brand. In addition, CPSC is aware of two deaths in other countries that involved ingestion of hazardous 5 mm diameter, spherical NIB magnets. In Australia in 2011, an 18-month-old child's death involved a product that included indications that it may have been a magnet set; and in Poland in 2014, an 8-year-old child's death involved a product that appeared likely to be a magnet set. One of these seven incidents involved a children's amusement product; one explicitly identified the product as a magnet set; and another four incidents described the products as having characteristics consistent with magnet sets.

25

The additional deaths are not included in Table 10 because they occurred outside the timeframe of staff's data analysis or outside the United States.

4. Incident Data Surrounding the Vacated Magnet Sets Rule

In looking at annual magnet ingestion incidents, staff noted a considerable change in magnet ingestion rates before, during, and after the Commission's vacated rule on magnet sets. As discussed above, the Commission issued a final rule in October 2014 that applied to magnet sets, which are a subset of the subject magnet products addressed in this proposed rule. The magnet sets rule aimed to address the magnet ingestion hazard and consisted of size and strength limits consistent with the requirements in this proposed rule. The magnet sets rule took effect in April 2015 and remained in effect until it was vacated by the U.S. Court of Appeals for the Tenth Circuit Court in November 2016. CPSC's assessment of incident data, as well as other researchers' assessments of NEISS data, and national poison center data, indicate that magnet ingestion cases significantly declined during the years in which the magnet sets rule was announced and in effect, compared to the periods before and after the rule.

As Table 3,

26

above, shows, the number of estimated ED-treated magnet ingestion incidents was significantly lower in 2015—when the magnet sets rule was in effect—than in the years before the rule was announced (specifically, 2010, 2011, 2012) and the years after the rule was vacated (specifically, 2017 and 2018). Similarly, the number of estimated ED-treated magnet ingestion incidents was significantly lower in 2016—when the rule was in effect—than before the rule was announced (specifically, 2011) and the years after the rule was vacated (specifically, 2017 and 2018).

27

26

Table 3 provides national estimates of magnet ingestions per year for incidents categorized as amusement/jewelry and unidentified product types.

27

Statistically significant differences are not reported for the year 2014, because the corresponding estimate does not meet reporting criteria.

To assess these trends further, staff grouped years in relation to the vacated magnet sets rule, using the following periods: 2010 through 2013 (prior to the announcement of the rule), 2014 through 2016 (when the final rule was announced and in effect

28

), and 2017 through 2020 (after the rule was vacated). Table 4, above, shows the estimated number of magnet ingestions treated in U.S. hospital EDs during these periods, using annual estimates for each period to account for the periods including different numbers of years (

i.e.,

2014-2016 covers 3 years, whereas, 2010-2013 and 2017-2020 cover 4-year periods). For 2010-2013 and 2017-2020, there were an estimated 2,300 ED-treated magnet ingestion incidents per year; for 2014-2016, there were an estimated 1,300 ED-treated magnet ingestion incidents per year. Thus, during the period when the rule was announced and in effect (2014-2016), there were appreciably fewer magnet ingestions compared with the earlier and more recent periods, and there were nearly equivalent rates during the periods both before and after the rule.

28

Staff grouped 2014, 2015, and 2016 together for this analysis because these are the years firms were likely to comply with the size and strength limits in the magnet sets rule. Because the standard took effect in April 2015 and remained in effect until November 2016, firms were required to comply with the standard for nearly all of 2015 and 2016. Although the rule was not in effect in 2014, the proposed rule was published in 2012, and the final rule was published, with essentially the same requirements, in October 2014. Once an NPR is published, firms have notice to prepare for the requirements that may be finalized, and once a final rule is published, firms often take steps to comply with the rule even before it takes effect. Accordingly, it is reasonable to conclude that firms took steps to comply with the magnet sets standard in 2014.

Although CPSRMS data cannot be used to draw statistical conclusions, the data also suggest a similar decline in incidents for the period when the magnet sets rule was announced and in effect. Table 11 shows CPSRMS-reported magnet ingestions, by period, using incidents categorized as amusement/jewelry and unidentified product types, consistent with the NEISS analysis, above.

Table 11—Number of CPSRMS-Reported Magnet Ingestions, by Period

Period

Percent of

total

N

Years in

period

2010-2013

47.5

122

4

2014-2016

6.6

17

3

2017-2020

45.9

118

4

2010-2020

100

257

11

Source: CPSRMS. Percentages are rounded to the nearest tenth. CPSRMS reporting for the years 2019-2020 is ongoing and counts for those years may increase as reporting continues.

Consistent with NEISS trends shown in Table 3, Table 11 shows that CPSRMS data also reflect an appreciable decline in magnet ingestion incidents during the period when the magnet sets rule was announced and in effect (2014-2016), compared with earlier and more recent periods, and nearly equivalent incident rates during the periods both before and after the rule.

Other researchers analyzing NEISS data made similar findings. One study

29

reviewed magnet ingestions for children under 18 years old using NEISS data from 2009 through 2019, focusing on three periods: 2009 through 2012 (before the Commission rule on magnet sets); 2013

30

through 2016 (magnet sets rule announced and in effect); and 2017 through 2019 (after the rule was vacated). In 2009-2012, there was an aggregate mean ED-visit rate of 3.58

31

per 100,000 people; in 2013-2016, this decreased to 2.83

32

per 100,000 people;

33

and in 2017-2019, this increased to 5.16

34

per 100,000 people.

35

Like CPSC's analysis, this illustrates an appreciable decline in magnet ingestions during the period the magnet sets rule was announced and in effect, with an even greater increase in incidents after the rule than before it.

29

Flaherty, M.R., Buchmiller, T., Vangel, M., Lee, L.K. Pediatric Magnet Ingestions After Federal Rule Changes, 2009-2019.

JAMA.

Nov. 24, 2020. 324(20): 2102-2104. doi:10.1001/jama.2020.19153, available at:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686864/.

30

For CPSC's analysis, staff considered 2014 to be the year the rule was announced because that is the year the final rule was published. In contrast, this study considered 2013 to be the year the rule was announced, likely because that is the first full year after the rule was initially announced in an NPR in September 2012.

31

95% confidence interval (CI), 2.20-4.96.

32

95% CI, 1.60-4.06.

33

Slope change, 0.87 (95% CI, 0.71-1.03) ED visits per 100,000 annually.

34

95% CI, 3.22-7.11.

35

Slope change, −0.58 (95% CI, −0.68 to −0.47) per 100,000 persons annually.

Another study

36

found similar results when looking at suspected magnet ingestion (SMI) cases involving children under 18 years old using NEISS data. That study found that there were an estimated 23,756

37

total SMI cases between 2009 and 2019, of which an estimated 3,709

38

cases involved small/round magnets and 6,100

39

involved multiple magnets. The average annual increase in total cases was 6.1 percent for 2009 to 2019,

40

and there was a statistically significant increase in small/round magnet ingestions

41

and multiple magnet ingestions

42

between 2009 and 2019. When stratified by period, there were 6,391

43

estimated total magnet ingestion cases during 2013-2016,

44

or 1,598

45

estimated cases per year. In contrast, there were an estimated 8,478

46

cases from 2017-2019, or 2,826

47

per year. This represents a 32 percent increase

48

in total magnet ingestions after 2016. There was also a statistically significant increase in the number of estimated small/round

49

and multiple magnet

50

ingestions across these two periods, with 164

51

small/round and 350

52

multiple magnet ingestions from 2013 through 2016, compared to 541

53

small/

round and 797

54

multiple magnet ingestion cases from 2017 through 2019.

36

Reeves, P.T., Rudolph, B., Nylund, C.M. Magnet Ingestions in Children Presenting to Emergency Departments in the United States 2009-2019: A Problem in Flux.

Journal of Pediatric Gastroenterology and Nutrition.

Dec. 2020. 71(6):699-703, 10.1097/MPG.0000000000002955, available through:

https://pubmed.ncbi.nlm.nih.gov/32969961/.

37

CI, 15,878-30,635.

38

CI, 2,342-5,076.

39

CI, 3,889-8,311.

40

P = 0.01.

41

P <0.001.

42

P = 0.02.

43

CI, 4,181-8,601.

44

Like the previous study, these researchers considered 2013 to be part of the period during which magnet sets were likely to be off the market.

45

CI, 1,045-2,150.

46

CI, 5,472-11,485.

47

CI, 1,824-3,828.

48

P <0.001.

49

P <0.01.

50

P <0.001.

51

CI, 66-263.

52

CI, 200-500.

53

CI, 261-822.

54

CI, 442-1152.

Researchers

55

analyzing national poison center data also found an increase in magnet ingestions in recent years, particularly since the magnet sets rule was vacated. This study looked at magnet foreign body injuries in pediatric patients in the National Poison Data System (NPDS). For 2012-2017, there were 281 magnet exposure calls per year, compared to 1,249 calls per year for 2018-2019, representing a 444 percent increase. Considering cases dating back to 2008 (5,738 total), the cases from 2018 and 2019, alone, account for 39 percent of the magnet cases. Although these periods do not directly align with the magnet sets rule, they further illustrate the general increase in magnet ingestion incidents in recent years, particularly after the magnet sets rule was vacated.

55

Middelberg, L.K., Funk, A.R., Hays, H.L., McKenzie, L.B., Rudolph, B., Spiller, H.A. Magnet Injuries in Children: An Analysis of the National Poison Data System From 2008-2019.

The Journal of Pediatrics.

May 1, 2021. Volume 232, P251-256.E2, available at: doi:

https://doi.org/10.1016/j.jpeds.2021.01.052.

These analyses raise relevant considerations for this proposed rule. For one, the marked decline in incidents during the period when the magnet sets rule was announced and in effect suggests that a large portion of magnet ingestion incidents involve magnet sets. Because that rule applied only to magnet sets, the fact that incidents significantly declined during the pendency of that rule indicates that magnet sets were involved in most of the incidents. This is useful information, given the lack of details regarding product types involved in many magnet ingestion incidents. In addition, these analyses indicate the current need to address the magnet ingestion hazard. Magnet ingestion incidents have significantly increased in recent years, showing a heightened need to address the hazard. Finally, these analyses suggest that a mandatory standard is necessary to effectively reduce the risk of injuries and death associated with magnet ingestions. Before, during, and after the magnet sets rule, CPSC and other groups have worked to raise awareness of the magnet ingestion hazard, and CPSC has taken steps to address the hazard though information campaigns, recalls, and voluntary standards work. However, the only appreciable decline in magnet ingestion incidents occurred during the period when the mandatory standard for magnet sets was announced and in effect.

5. Uncertainties in Incident Data

As explained above, magnet ingestion incident reports often include limited information for staff to identify the type of product involved in the magnet ingestion. Caregivers and medical providers may know that a magnet was ingested, but may not know from what type of product the magnet came. This differs from many consumer products that are readily identifiable when involved in an incident and report. NEISS data, in particular, tend to provide limited information with which to identify the product involved in magnet ingestions. This may be because NEISS data are collected through hospital EDs. At hospital EDs, medical professionals may not know what product was the source of the magnet ingestion, and are focused on information needed to treat the victim (

e.g.,

that a magnet was ingested), rather than the specific product involved in the incident (

e.g.,

that the magnet came from a magnet set). Because CPSRMS data usually come from manufacturers and consumers, these data often contain more information to identify the product.

As Table 1, above, shows, of the 1,072 magnet ingestion incidents identified in NEISS, 74 percent (793 incidents) did not provide sufficient information for staff to identify the type of product involved. As Table 9, above, shows, of the 284 magnet ingestion incidents identified in CPSRMS, 15 percent (43 incidents) did not provide sufficient information for staff to identify the type of product involved. However, staff does have some information about the incidents in the unidentified product type category—specifically, these incidents involved ingestion of one or more magnets, and included product characteristics and use patterns that could be consistent with subject magnet products.

To account for the lack of product identification in many magnet ingestion incidents, staff analyzed magnet ingestion incident data in several ways. For one, staff provided information about all magnet ingestion cases. Aggregated information for all of the in-scope, out-of-scope, and unidentified product categories indicates that magnet ingestions, in general, are an issue, and have increased in recent years. This indicates the propensity for children and teens to ingest magnets, and it demonstrates the increasing risk of injury and death as magnet ingestion cases increase.

Staff also categorized incidents into specific product groups, based on information that was available in incident reports. For incidents that provided information to help identify the product type, the data revealed that six categories of products were involved in magnet ingestions—magnet sets, jewelry, magnet toys, science kits, ASTM F963 magnet toys, and home/kitchen magnets. For some of the incidents in these categories, there was specific information about the product—such as brand names—that allowed staff to determine the product involved in the incident. For other incidents in these categories, the product was referred to as a specific type (

e.g.,

magnet sets, desk toy, science kit, kitchen magnet, bracelet).

56

These categories provide information about the products involved in magnet ingestions, and the relative frequency of their involvement, to help determine which products the proposed rule should address.

56

Staff categorized incidents based on all of the information available in the reports, including descriptions, names, and uses of the product. However, for some of the incidents in which the report provided a product type, but not a specific product brand/name, it is possible that the product was actually from another category. For example, the jewelry category includes cases in which the report indicates that the magnets were described as jewelry at the time of the incident, such as magnetic earrings. It is possible that the magnets in such cases were actually from a non-jewelry product. Similarly, products categorized as magnet toys could actually be another product type; for example, a product described as an “executive desk toy,” which did not meet the parameters for the magnet set category, and did not indicate marketing to children under 14 years old, was included in the magnet toy group, although it is possible that the product actually was a magnet set or other product type, and the report lacked information to indicate this. However, even if incidents in these categories were miscategorized, they likely would still fall within the scope of the proposed rule because they meet the description of an in-scope product.

Staff also aggregated these categories into in-scope and out-of-scope groupings. Staff combined incidents from the magnets sets, magnet toys, and jewelry categories as “amusement/jewelry” and combined incidents from the home/kitchen, ASTM F963 magnet toys, and science kit categories as “exclusions.” Grouping several product type categories together allowed staff to generate national estimates of ED-treated magnet ingestions, to provide an idea of the number of ingestions nationally, and the relative involvement of in-scope and out-of-scope products, which helps identify the magnitude of the risk and the potential benefits of the rule to reduce that risk.

In addition, staff combined the amusement/jewelry and unidentified categories to conduct more detailed analyses. Because the proposed rule applies to amusement and jewelry products, the amusement/jewelry category of incidents is informative.

Staff also included in these analyses, incidents in the unidentified product type category because there are several factors that indicate that many of the incidents in the unidentified product type category likely fall within the scope of the proposed rule. The following is a discussion of these factors.

First, the incident data discussed in this preamble supports the conclusion that many of the magnet ingestion incidents in the unidentified product type category actually involved subject magnet products. Of the NEISS magnet ingestion incidents for which staff could identify a product category, the primary products involved were magnet sets, magnet toys, and jewelry; far fewer incidents involved ASTM F963 magnet toys, home/kitchen magnets, or science kits (see Table 1, above). The same was true for CPSRMS incidents (see Table 9, above), for which far fewer incidents were in the “unidentified” category. Given this consistency across data sets, it is reasonable to conclude that the relative involvement of magnet product types in magnet ingestions applied to the incidents that lacked product identification as well.

Second, magnet ingestion rates before, during, and after the vacated rule on magnet sets suggest that a significant portion of magnet ingestion cases involve magnet sets. As discussed above, CPSC's assessment of incident data, as well as other researchers' assessments of NEISS data, and national poison center data, indicate that magnet ingestion cases significantly declined during the years the magnet sets rule was announced and in effect, compared to the periods before and after the rule. Magnet sets were the only products subject to that rule. As such, the significant decline in incidents during that rule, and the significant increase in incidents after that rule was vacated, strongly suggest that many magnet ingestion incidents involve magnet sets. Thus, it is reasonable to assume that many of the incidents in the unidentified product category involved magnet sets. Moreover, the definition of “magnet sets” in the vacated rule was largely equivalent to the description of amusement products in the present proposed rule (

i.e.,

magnet sets and magnet toys), suggesting that many magnet ingestion incidents, including those with unidentified product types, involve amusement products.

Third, incident data and recalls regarding magnets in children's toys further support the conclusion that magnet ingestions categorized as “unidentified” products are largely subject magnet products. As discussed above, ASTM F963 magnet toys make up only a small portion of magnet ingestion incidents where the product can be identified. It is reasonable to assume that this holds true for unidentified products in magnet ingestions, as well. Recall information further supports this conclusion. Recalls of children's toys involving the magnet ingestion hazard have declined substantially since the toy standard took effect. As explained above, ASTM F963 was announced as the mandatory standard for toys in 2008, and it took effect in 2009. From 2006 through 2009, CPSC issued more than a dozen recalls of children's toys, due to the ingestion hazard associated with loose or separable, small, powerful magnets.

57

In contrast, from January 2010 through August 2021—a period approximately three times as long—there were a total of 18 recalls related to the magnet ingestion hazard, only four of which involved children's toys. Of those four recalls, only two involved confirmed violations of the magnet provisions in the toy standard. Recalls provide some indication of the products involved in magnet ingestions because products are recalled when they present a hazard. Thus, this marked decline in recalls of children's toys for magnet ingestion hazards suggests that children's toys largely comply with the toy standard and are not involved in hazardous incidents.

57

https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/163--2017-10-26%20Final%20Decision%20and%20Order.pdf?Tme8u5fRF2.29_B.i4Ix7pPwb_whKng2.

Taken together, these factors support the conclusion that most magnet ingestion incidents, including those in the unidentified product type category, involved products that fall within the magnet sets, magnet toys, and jewelry categories, and not the science kit, home/kitchen, or ASTM F963 magnet toys categories. For these reasons, staff included magnet ingestion incidents in the unidentified product type category in many of its analyses; to exclude such incidents likely would vastly underrepresent ingestions of subject magnet products.

B. Details Concerning Health Outcomes

58

58

For more details about injuries and health outcomes, see Tab A of the NPR briefing package. In addition, health outcomes associated with magnet ingestions are discussed in the Final Rule briefing package for the 2014 rule on magnet sets, available at:

https://www.cpsc.gov/s3fs-public/pdfs/foia_SafetyStandardforMagnetSets-FinalRule.pdf,

and the 2020 informational briefing package, available at:

https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf.

Even though the previous analyses focused on magnet sets, the internal magnet interaction hazard is the same for the subject magnet products covered in this proposed rule.

Magnets are unique among ingested foreign bodies because of their intrinsic ability to attract to one another or to ferromagnetic objects. Assuming the same elemental composition, a magnet with large physical dimensions and mass can exhibit stronger attractive forces than a magnet with small physical dimensions and mass. Similarly, magnets coupled together can exhibit greater attractive strengths than individual magnets. One mechanism of injury following magnet ingestion involves separate magnets in adjacent tissue walls (

e.g.,

from distinct loops of bowel) attracting to each other and trapping tissue between the magnets. The mechanism of injury is the same for a single hazardous magnet and a ferromagnetic object that might interact internally. As such, individual magnets pose the same health risk.

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. The normal functions of the gastrointestinal (GI) tract, including peristalsis, are not likely to dislodge magnets that are attracted to each other through component tissues.

The time between magnet ingestion and injury varies and depends on several factors, such as the number of ingested magnets; awareness of the magnet ingestion by caregivers; awareness that magnet ingestion is hazardous; whether multiple ingested magnets interact with each other inside of the body through tissue structures; and the configuration of coupled magnets, relative to involved tissue structures. Incident reports describe injuries from internal magnet interaction through tissue taking anywhere from days to months to progress to a stage at which caregivers seek medical attention. There have been several efforts to develop medical devices using magnets to deliberately compress and necrose

59

target tissue and create healthy anastomoses (openings/passages) that connect or reconnect distinct channels in the body. In these controlled cases, tissue necrosis typically took multiple days to weeks.

60

59

Necrosis is a process of cell death.

60

These efforts are still in early stages, but may ultimately provide some examples of the time it takes for tissue necrosis to occur from magnetic compression. Although not pathological examples, the length of time required for successful

anastomoses in preclinical medical device development settings ranged from multiple days to weeks, as evaluated by necropsy and passage of the magnet after anastomosis formation. In a human trial, magnets passed naturally multiple weeks after placement to create healthy anastomoses.

Ambiguous symptomatology following magnet ingestion that results in an internal interaction injury may complicate the timely delivery of medical care. Symptoms related to magnet ingestion may appear flu-like and include vomiting, fever, and abdominal pain, among others. Symptoms following magnet ingestion have been mistaken for a virus, ear infection, and bronchitis, among others. Medical professionals who know of the magnet ingestion may be able to minimize or avoid injury by promptly removing the magnets.

Internal Magnet Interaction Injuries.

As indicated above, one of the health threats presented by magnet ingestion is internal magnet interaction leading to pressure necrosis injuries that occur in the alimentary canal. Necrosis is a process of cell death, secondary to injury, which undermines cell membrane integrity and involves intricate cell signaling responses. In the case of internal magnet interactions, the injury leading to necrosis is the pressure on the involved biological tissues that exceeds local capillary pressure and leads to ischemia.

Volvulus is another internal interaction hazard associated with magnet ingestion. Volvulus is an obstructive twisting of the GI tract. Volvulus is often accompanied by abdominal pain, distended abdomen, vomiting, constipation, and bloody stools. If left untreated, volvulus may lead to bowel ischemia, perforation, peritonitis, and death. Volvulus following magnet ingestion has been linked to fatal outcomes. In the United States, CPSC is aware of one death of a 20-month-old child who ingested magnets from a toy construction set, which caused volvulus, and one death of a 2-year-old child who ingested multiple magnets, resulting in small intestine ischemia secondary to volvulus. In addition, CPSC is aware of one death of an 8-year-old child in Poland, due to small intestine ischemia secondary to volvulus, after the victim ingested magnets that resulted in necrosis, toxemia (blood poisoning), hypovolemic shock, and eventually cardiopulmonary failure.

Like outcomes related to volvulus, small bowel ischemia can lead to local tissue necrosis, perforation, and subsequent peritonitis. Small intestine ischemia was implicated in the death of a 19-month-old child following ingestion of multiple magnets. Bowel obstruction, often a consequence of volvulus, is associated with abdominal cramps, vomiting, constipation, and distention. With respect to the relationships among local capillary and intraluminal pressures and magnet ingestions, subsequent outcomes include possible blockage of local blood and nutrient supply; progressive pressure necrosis of the involved tissues; and local inflammation, ulceration, and tissue death, with putative outcomes such as perforation (hole) or fistula in the GI tract. If left untreated, or otherwise unnoticed, such events can progress into infection, sepsis, and death. The obstruction from the trapped tissue can elicit vomiting, and the local mucosa irritation may stimulate diarrhea. Advancing pressure necrosis of the involved tissues can lead to necrosis and subsequent leakage of the bowel contents into the peritoneal cavity.

Another example of the potential health outcomes associated with magnet ingestion is a case in which an asymptomatic 4-year-old child sustained several fistulae in the intestines that required surgical repair after ingesting magnets. Fistulae are abnormal passages between channels in the body that are associated with increased mortality. Fistulae may enable the leakage of gut contents into adjacent tissue structures or abdominal cavities, which can lead to infection, inflammation, perforation, sepsis, and possibly death. Fistulae may also bypass portions of the GI tract, thus undermining normal GI function.

Another potential health outcome of magnet ingestions is ulcerations. For example, one case involved a 28-month-old child who experienced stomach ulcerations after ingesting 10 magnets and receiving treatment with medication after the endoscopic removal and natural passage of the magnets. Untreated ulcers may require surgical intervention if they progress to perforation, and a perforated bowel may lead to leakage from the GI tract. Several magnet ingestion incident reports highlight the threat of perforation with possible outcomes such as peritonitis. Peritonitis is an inflammation of the peritoneum, a membrane lining of the abdominal cavity, which may be associated with leakage from the GI tract that can lead to sepsis. Sepsis is the body's response to severe infection, and it is associated with elevated rates of morbidity and mortality that can be mitigated with prompt treatment. Treatment of abdominal sepsis may require repair of a leaky GI tract.

Another potential health risk from ingested magnets is an aspiration threat. For example, in one reported case, a 3-year-old child ingested multiple magnets, two of which were found attracting to each other on opposing surfaces of the pharyngoepiglottic fold in the throat, presenting an immediate aspiration threat given the proximity to the airway. Aspiration of magnets has also been reported elsewhere in medical literature. Foreign body aspiration presents a risk of airway obstruction, ventilatory difficulty, choking, hypoxic-ischemic brain injury, pulmonary hemorrhage, and death, among other health outcomes.

Other Health Outcomes and Injuries.

In addition to internal interaction hazards, ingested magnets present additional health risks. Ingested magnets that are not attracting to each other through tissue walls may cause harm, such as irritation of the GI mucosa in the form of erythematous, mucosal inflammation, and minor tears. Ingested magnets embedded in the bowel may be associated with multiple days of hospitalization. A foreign body lodged in the GI tract can also cause mucosal wall deterioration, migration, and perforation. Comorbidities, such as eosinophilic esophagitis, gastroesophageal reflux disease, GI anomalies, and neuromuscular disorders can exacerbate the potential outcomes. The wall of the esophagus is susceptible to edema and weakening that increase the risk of bleeding and perforation in the presence of foreign bodies. Foreign body irritation of the GI tract may also prompt local mucosal irritation that can stimulate diarrhea.

Medical Care for Magnet Ingestions.

Several approaches to medical care are available when assessing and treating magnet ingestions, however, many of these approaches pose health risks, themselves. Medical providers routinely use medical imaging during treatment of magnet ingestions. Current imaging diagnostic capabilities may be able to identify ingested foreign bodies, but they do not allow for the definitive identification of magnets in the body. The usefulness of metal detectors to locate ingested metallic objects, including magnets, has decreased as the size of ingested magnets decreases. This presents challenges when a caregiver and medical professional do not know the victim ingested a magnet.

When ingested magnets are identified, x-ray radiography, fluoroscopy, computed tomography (CT) scans, or ultrasound

61

can be used to monitor the

ingested magnets. If the magnets' passage through the GI tract is arrested or symptoms manifest, then endoscopic or surgical intervention may be necessary. Bowel cleanout or bowel preparation procedures that use laxatives,

62

such as polyethylene glycol, may be used to try to flush ingested magnets out of the GI tract, or to prepare patients for endoscopy or other medical procedures.

61

These imaging tools present some health risks themselves. The ionizing radiation associated with

x-ray radiography has the potential to damage DNA and may contribute to the development of cancer later in life. The risks from CT scans are similar. Prolonged fluoroscopy, which is often used during surgery or medical procedures such as endoscopy, may contribute to the development of cataracts, skin reddening, or hair loss. Ultrasound is relatively safe, but it may heat tissue or produce pockets of gas in body fluids or tissues.

62

Bowel cleanout is not often associated with risk in the pediatric population; dehydration is the most common adverse event that occurs. However, in certain instances, bowel cleanout laxatives may be delivered via nasogastric tube; there are rare reports of life-threatening aspiration of laxative solutions delivered via nasogastric tubes, especially in older populations with certain comorbidities.

Endoscopy may be used to retrieve ingested magnets from the stomach, duodenum, esophagus, pylorus and cecum (via colonoscopy), or other areas. Endoscopy may also be used to treat bowel obstruction secondary to magnet ingestion. Endoscopy is associated with a risk of bleeding from mucosal shearing or tearing that is elevated in the presence of anemia. There is also risk of adverse cardiopulmonary events (

e.g.,

oxygen desaturation, aspiration, respiratory arrest, shock, myocardial infarction) as a result of sedation and anesthesia; perforation from procedure instruments; infection from contaminated equipment, or from a perturbed endogenous source; and procedural risks largely associated with comorbidities (

e.g.,

cardiac disease, diabetes).

Colonoscopy is a common endoscopic procedure performed via the anus and shares many of the same risks as endoscopy. Laryngoscopy—a medical procedure to evaluate the upper aerodigestive tract—is used to investigate suspected magnets lodged in the throat. Associated risks of laryngoscopy include esophageal perforation, airway compromise, bleeding, dysphagia, and fever, among others. Nasal endoscopy may be useful to treat magnets embedded in the nose. Nasal endoscopy is associated with risks of mucosal irritation, minor hemorrhage, and overt hemorrhage.

Surgical interventions may be necessary to treat magnet ingestions when less invasive procedures, such as endoscopy or bowel cleanout, are clinically inappropriate or unsuccessful. In one example, in which a 5-year-old child ingested magnets, endoscopy failed to retrieve all of the magnets, and the remaining magnets were recovered via laparotomy with appendectomy. Abdominal surgeries, such as laparotomy (abdominal incision) and laparoscopy (fiber-optic visualization of the viscera via abdominal incision), that involve abdominal incisions and manipulation of abdominal organs are associated with the risk of adhesions that can cause pain, bowel obstructions that may require additional surgical intervention, female infertility, and bowel injury. For example, 6 months after a 2-year-old child underwent enterotomy and gastrostomy to remove 26 magnets from her jejunum and stomach, the child developed bowel adhesions that caused obstructions and required treatment with surgical adhesiolysis to cut the adhesions. Possible complications associated with laparotomy include pneumonia, cardiac complications, surgical site infection, wound dehiscence (rupture), urinary tract infection, respiratory tract infection, venous thromboembolism, kidney failure, heart and GI tract complications, septicemia, and death. Emergency laparotomies may be more prone to complications than elective laparotomies. For example, a 6-year-old child who ingested 20 magnets underwent a 20-day hospital stay to treat surgical wound infections following exploratory laparotomy with small bowel resection and appendectomy to retrieve the magnets.

Appendectomy may also result from magnet ingestions, and is commonly achieved via laparotomy or laparoscopy. Pain, wound infections, and intra-abdominal abscesses are possible following both laparoscopic and open appendectomies. Laparotomy may be accompanied by incisions of the stomach (gastrotomy) or intestines (enterotomy) to retrieve ingested magnets. Complications from surgical enterotomies, or incisions into the intestine, may be similar to those of inadvertent enterotomies, which can occur during anastomosis procedures and include leakage, intra-abdominal abscesses, and death.

Surgical resection of the bowel may be performed to remove necrotic portions of the bowel, secondary to magnet ingestion. Small bowel resection is associated with risks of infection, fistulae, peritonitis, abscess, sepsis, and wound dehiscence secondary to leaky anastomoses. There is also the possibility of impairment to the intrinsic nutrient absorption functions of the bowel, depending on the resection location. End-to-end surgical anastomoses used to restore bowel continuity following resection are associated with the risk of leakage, intra-abdominal abscess, and death.

Complications associated with surgery to treat magnet ingestion have also included pancreatitis and additional hospitalization, additional surgery to treat incisional hernia, and the need for a lifelong feeding tube, among others. Endotracheal general anesthesia may be required for surgical treatments of magnet ingestion. Possible complications associated with general anesthesia include nausea, vomiting, sore throat, dental damage, myocardial ischemia or infarction, heart failure, cardiac arrest, arrhythmia, atelectasis (lung collapse), aspiration, bronchospasm, neurological effects, and renal effects, among others.

In addition to the medical procedures necessary to treat magnet ingestions, and the risks associated with those procedures, ingested magnets present unique challenges for medical professionals. For example, technical precision is reduced, and technical difficulty increases when ingested magnets attract to the metallic instruments used to retrieve them. In one example case, ingested magnets in the throat of a 3-year-old child suddenly attracted to the optic graspers inserted to retrieve the foreign bodies.

C. Incident Characteristics

63

63

For additional information about hazard patterns and incident characteristics, see Tab C of the NPR briefing package.

Staff conducted a detailed analysis of incident data to identify hazard patterns and characteristics associated with magnet ingestion incidents, and staff also considered developmental and behavioral factors relevant to the hazard. These considerations helped inform the scope of products that need to be addressed in the proposed rule and the types of requirements that would be effective at reducing the magnet ingestion hazard.

1. Victim Age

Table 12 provides the ages of victims involved in magnet ingestion incidents, from both the NEISS and CPSRMS data sets. The table includes incidents in the

magnet sets, magnet toys, and jewelry categories, as well as incidents in the unidentified product type category.

64

64

As explained above, several factors indicate that many of the incidents in the unidentified product type category likely involved subject magnet products, and these incidents indicate the age of children and teens involved in magnet ingestion incidents, generally. The table excludes out-of-scope products (

i.e.,

home/kitchen and ASTM F963 magnet toys).

Table 12—Magnet Ingestion Incidents, by Age

Victim age

NEISS

(#)

NEISS

(%)

CPSRMS

(#)

CPSRMS

(%)

<2 yrs

120

11.8

21

8.2

2 yrs

89

8.8

32

12.5

3 yrs thru 4 yrs

196

19.3

31

12.1

5 yrs thru 7 yrs

207

20.4

28

10.9

8 yrs thru 10 yrs

179

17.7

66

25.7

11 yrs thru 13 yrs

182

18

37

14.4

14 yrs thru 16 yrs

30

3

12

4.7

>16 yrs

11

1.1

1

0.4

Unknown

0

0

29

11.3

Totals

1,014

257

Source: NEISS, CPSRMS. Percentages are rounded to the nearest tenth.

The youngest victim for which an age was reported was 6 months old; the oldest age reported was 54 years old. Approximately 20 percent of the NEISS incidents and CPSRMS incidents involved victims under 3 years old. This is consistent with developmental and behavioral factors—typically, foreign body ingestions peak for children between 6 months and 3 years old, and 2-year-old children generally are mobile and unlikely to be supervised directly at all times. Children of these ages are commonly cited in reports involving ingestion of inedible objects, given their likelihood of orally exploring their environment and their limited ability to comprehend hazards. For these and other reasons, toys with small parts must have a choking hazard warning for children under 3 years old.

65

65

16 CFR part 1501.

As Table 12 indicates, approximately 60 percent of NEISS incidents and 56 percent of CPSRMS incidents involved victims 5 years old and older. This age group is important because one option CPSC and voluntary standards groups have considered to address the magnet ingestion hazard is child-resistant (CR) packaging, which is packaging that is designed or constructed to be significantly difficult for children under 5 years old to open.

66

Because the majority of incidents involve victims who would not be protected by CR packaging, these data suggest that CR packaging would be unlikely to adequately reduce the magnet ingestion hazard.

66

See 16 CFR part 1700, issued under the Poison Prevention Packaging Act of 1970, 15 U.S.C. 1471-1477.

Table 12 also shows that approximately 40 percent of NEISS incidents and 45 percent of CPSRMS incidents involved victims 8 years old and older. This is noteworthy because several voluntary standards exempt magnet products intended for users 8 years and older from size and strength requirements, instead requiring only warnings on such products. These standards seemingly assume that users 8 years old and older are less likely to ingest magnets or are able to understand and heed warnings about the magnet ingestion hazard better than younger children. However, the frequency of incidents involving users 8 years and older suggests that this is not the case.

As indicated above, Table 12 includes incidents in the magnet sets, magnet toys, jewelry, and unidentified product categories, indicating that these incidents did not involve products that are intended for children under 14 years old.

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Despite this, most magnet ingestion incidents involved children under 14 years old, indicating that subject magnet products appeal to and are accessible to children and teens. This demonstrates that a standard for children's toys, alone, is not sufficient to address the magnet ingestion hazard. Subject magnet products appeal to children and teens for various reasons. Magnets, particularly smooth magnets, have tactile appeal for fidgeting, stress relief, and other amusement. Some magnets capture attention because they are shiny, colorful, or both. They make soft snapping/clicking sounds when manipulated, which children and teens may find appealing. The magnets have properties of novelty, which arouse curiosity; incongruity, which tends to surprise and amuse; and complexity, which tends to challenge and maintain interest. Their strong magnetic properties cause them to behave in unexpected ways, with pieces suddenly snapping together, and moving apart. Such behavior is likely to seem magical to younger children, and evoke a degree of awe and amusement among older children and teens.

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As discussed above, incidents in the unidentified product category likely involve subject magnet products, and not ASTM F963 magnet toys.

2. Use Patterns

In reviewing incident data, staff identified the following patterns in how the magnets were being used at the time of ingestion:

• Playing—These cases involved ingestion of magnets while users were playing, fidgeting, orally exploring the magnets (

e.g.,

testing the attraction through teeth or on braces), or performing a combination of these actions. If playing involved use of the product as jewelry, the case was categorized as jewelry, rather than playing. This category excludes cases involving intentional ingestion.

• Jewelry—These cases involved magnets victims were using as jewelry at the time of the incident, such as bracelets, necklaces, and simulated piercings (

e.g.,

magnets used around the tongue, lip, and cheek to look like piercings).

• Intentionally ate—In these cases, victims reportedly swallowed magnets on purpose (

e.g.,

curiosity, mistaking the magnets as edible).

• Other—These cases involved identified actions that did not fit the

categories above (

e.g.,

transporting magnets orally, magnets thrown into a victim's mouth when not playing, and magnets placed in a victim's drink).

• Unknown—In these cases, it was unclear what led to the magnet ingestion.

Table 13 provides the use patterns involved in magnet ingestion incidents, from both the NEISS and CPSRMS data sets. The table includes incidents in the magnet sets, magnet toys, and jewelry categories, as well as incidents in the unidentified product type category.

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As explained above, several factors indicate that many of the incidents in the unidentified product type category likely involved subject magnet products, and these incidents indicate the use patterns involved in magnet ingestion incidents, generally. The table excludes out-of-scope products (

i.e.,

home/kitchen and ASTM F963 magnet toys).

Table 13—Magnet Ingestion Incidents, by Use Pattern

Use category

NEISS

(#)

NEISS

(%)

CPSRMS

(#)

CPSRMS

(%)

Playing

143

14.1

61

23.7

Jewelry

31

3.1

43

16.7

Intentionally Ate

19

1.9

21

8.2

Other

10

1

4

1.6

Unknown

811

80

128

49.8

Totals

1,014

257

Source: NEISS, CPSRMS. The percentages are rounded to the nearest tenth.

As Table 13 shows, in both data sets, for incidents in which the use pattern could be identified, magnets were commonly used as playthings at the time of ingestion, followed by magnets used as jewelry. This supports the need to address amusement and jewelry products in the proposed rule. In addition, these data indicate that the use pattern is unknown for many magnet ingestions, suggesting that victims are too young to report the use pattern and ingest magnets while outside caregiver supervision.

Figure 3

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shows the use patterns during magnet ingestion incidents, by victim age, for the NEISS data set. Figure 4

70

shows the use patterns during magnet ingestion incidents, by victim age, for the CPSRMS data set. Both figures include incidents in the magnet sets, magnet toys, and jewelry categories, as well as incidents in the unidentified product type category.

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69

To see Figure 3 in color, see Figure 2 in Tab C of the NPR briefing package.

70

To see Figure 4 in color, see Figure 3 in Tab C of the NPR briefing package.

71

As explained above, several factors indicate that many of the incidents in the unidentified product type category likely involved subject magnet products, and these incidents indicate the use patterns and ages involved in magnet ingestion incidents, generally. The table excludes out-of-scope products (

i.e.,

home/kitchen and ASTM F963 magnet toys).

BILLING CODE 6355-01-P

EP10JA22.002

EP10JA22.003

BILLING CODE 6355-01-C

As Figures 3 and 4 show, for incidents in which the use pattern was identified, the majority of victims accidentally ingested the magnets. A common example of these accidental ingestions is children using the magnets in or around their mouths when the magnets unexpectedly rolled to the back of their throats and were ingested, in some cases by swallow reflex. This is consistent with normal child development, including exploration and the likelihood that children will be drawn to magnets aesthetically, and to their invisible attraction and repulsion properties. Consistent with developmental factors, younger children, particularly those under 8 years old, were more likely than older children to be involved in reports of intentional magnet ingestion (only 4 reports of intentional ingestion involved children 8 years old and older). The frequency of accidental ingestions suggests that safety messaging may have limited effectiveness in addressing magnet ingestions, because children and caregivers are unlikely to anticipate and appreciate the likelihood of accidental ingestion of magnets.

Victims 8 years old and older were more likely than younger ages to swallow magnets while simulating piercings. It is foreseeable for this age group to use magnets as jewelry in or around their mouths, because experimentation and peer influence are common determinants of behavior for this age group. Older children and teens often value acceptance by peers more than obeying parental guidelines, and social influences and peer pressure can drive adolescent behavior more strongly than their own independent thought processes. The subject magnet products offer a seemingly safe and reversible way to try out lip, tongue, cheek, and nose piercings. If these children see their peers performing this activity, they may feel compelled to act similarly, even if they are aware of the risks. Furthermore, older children and early adolescents are at a developmental stage in which they test limits and bend rules.

3. Post-Ingestion Response

Staff also assessed incident data for information about how victims and caregivers behaved after a magnet ingestion event, including whether caregivers became aware of the ingestion, and the time between ingestion and treatment. Staff found that the invasiveness of medical interventions was often associated with the length of delay between the ingestion event and correct medical treatment. At least 56 of the 257 CPSRMS incidents (22 percent) involved a delay of several days between ingestion and correct treatment, with some delays spanning months. At least 16 additional incidents (6 percent) involved a delay of 1 day.

One common cause of delays was caregivers being unaware of the ingestion, resulting in delayed hospital visits and subsequent misdiagnoses. In many cases, particularly those involving children under 8 years old, caregivers were not aware that magnets were ingested. These cases often involved ingestions that were not witnessed by caregivers, and where the children were unable or unwilling to communicate what happened.

Another common cause of delays was caregivers misunderstanding the hazard, such as expecting the magnets to pass naturally. Whether ingested magnets

will pass naturally depends on several factors, including the number of magnets ingested, whether the magnets interact through tissue, and whether the interaction is strong enough to resist natural bodily forces. Similarly, delays in care often result when caregivers and children fail to make the connection between the magnet ingestion and symptoms, because there is frequently a time delay between magnet ingestion and symptoms, and because preliminary symptoms typically are similar to common illnesses. Many cases detail victims receiving treatment only after experiencing significant discomfort, at which point substantial internal damage had occurred. For example, one report indicates that in 2017, a 3-year-old child was found playing with an older sibling's magnet set, but stated that she had not swallowed any magnets. Days after the incident, the child became ill and was misdiagnosed with a stomach virus. Eventually, x-rays were taken, revealing three magnets in her small intestine. The victim lost a portion of her digestive tract and was hospitalized for approximately 2 weeks to recover after the surgery.

4. Sources of Access

Staff also examined incident data to determine how and from whom victims acquired magnets they ingested. Because most NEISS reports (97 percent) did not include sufficient information to determine the source of access, staff focused on CPSRMS incidents.

Table 14 shows the source of access for the 257 CPSRMS magnet ingestion incidents. The table includes incidents in the magnet sets, magnet toys, and jewelry categories, as well as incidents in the unidentified product type category.

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As explained above, several factors indicate that many of the incidents in the unidentified product type category likely involved subject magnet products, and these incidents indicate sources of access in magnet ingestion incidents, generally. The table excludes out-of-scope products (

i.e.,

home/kitchen and ASTM F963 magnet toys).

Table 14—Magnet Ingestion Incidents, by Source of Access, for CPSRMS Data

Sources of access

CPSRMS

(#)

CPSRMS

(%)

Description

Family Owned

59

23%

Magnets belonged to the victim's family. Includes cases of siblings finding magnets and bringing them home.

Friend/Classmate/School/Neighbor

41

16

Magnets belonged to friends, classmates, or neighbors, or the victim found them at daycare or school.

Purchased for Victim

26

10.1

Magnets purchased for the victim.

Purchased by Victim

5

1.9

Magnets purchased by the victim.

Found Outside

4

1.6

Victim found the magnets outside, such as on a playground. Excludes cases of siblings finding magnets and bringing them home.

Unknown

122

47.5

Unclear where the magnet was acquired, by whom, or for whom. Includes cases of magnets found in the home but where the product owner was unknown.

Totals

257

Percentages are rounded to the nearest tenth.

As Table 14 shows, of the 135 cases with a known source of access, most cases involved magnets that belonged to family members of the victim (44 percent), followed by magnets that victims acquired from friends, classmates, daycares, or schools (30 percent), and magnets purchased for the victim (19 percent). A small number of incidents involved magnets purchased by the victim (4 percent), or that the victim found outside (3 percent).

Victims under 8 years old typically gained access to magnets that belonged to family members, such as siblings, parents, and relatives. Magnets from family members were usually found on floors, in or on furniture, in bags, and affixed to surfaces (

e.g.,

refrigerators, wallboards); and in some cases, family members intentionally shared the magnets with victims. In contrast, victims 8 years old and older typically obtained magnets from friends, classmates, or at school, or the magnets were purchased for them. Most cases involved children and teens acquiring loose magnets, as opposed to accessing the full set or product at the time of ingestion.

Staff also reviewed incident reports for information about product warnings and age labels on the ingested products, to determine if such warnings were present and considered by the victims and caregivers.

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Of the 57 cases that reported whether there were product warnings, at least 45 (79 percent) involved products with a magnet ingestion warning. Similarly, of the 60 cases that reported whether there were age labels on the product, at least 49 (82 percent) involved products with a warning to keep the product away from children. At least 44 cases involved products with both magnet ingestion warnings and warnings to keep the product away from children. Recent magnet ingestion incidents, in 2021, which are not included in the above analysis, also indicate that there are numerous incidents in which involved magnet sets had clear and repeated warnings about the magnet ingestion hazard and warnings to keep the product away from children.

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In most cases, there was insufficient information to determine if the involved products had warnings, age labels, or both.

Staff further assessed incident data to determine the age of victims in incidents where the ingested magnets were purchased for or by the victims. Of the 133 cases with a known source of access and known victim age, about 23 percent involved magnets purchased for or by victims under 14 years old, including 9 cases in which the magnets were purchased for victims under 8 years old. Despite the ages of these victims, these cases involved products that were not marketed for children under 14 years old, and were not subject to the toy standard. For example, in one case, a parent purchased a magnet set for a 9-year-old child, despite there being clear and repeated warnings about the magnet ingestion hazard and warnings to keep the product away from children. In another case, a caregiver gave the same product to a 5-year-old child, believing the product to be harmless, and believing that swallowed magnets would pass naturally. The

child swallowed the magnets, and required surgery, including an appendectomy, because the magnets attracted internally through tissue.

Based on technical analysis and examination of incident reports, online and on-package marketing, and consumer reviews for subject magnet products, staff identified the following factors that likely contribute to children accessing magnet products that are intended for older users: Caregivers and victims underestimate the potential severity of the hazard; social pressures from children, other family members, and friends; consumers see subject magnet products or similar products marketed to children; consumers see other children handling subject magnet products or similar products without incident; consumers read product reviews about other children handling subject magnet products or similar products without incident; and caregivers underestimate the likelihood that children or teens would ingest a magnet.

This information has implications for the types of requirements that are likely to effectively reduce the magnet ingestion hazard. For one, it indicates that requirements that rely on caregiver intervention, such as safety messaging and packaging requirements, are unlikely to adequately address the hazard. As the data suggest, caregivers cannot easily manage children's and teen's access to magnet products, since children and teens often access them outside the home. There are additional reasons why these requirements are unlikely to adequately address the hazard. As these data suggest, many incidents involve children and teens accessing ingested magnets without their packaging, making safety messaging and packaging ineffective. In addition, many incidents involve products that included safety messaging and age recommendations that consumers did not follow. Similarly, these data suggest that the toy standard, alone, cannot adequately address the magnet ingestion hazard because children and teens purchase, receive, and access magnets from products that are not intended for their ages.

V. Relevant Existing Standards

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For additional information about relevant existing standards, see Tab C and Tab D of the NPR briefing package.

CPSC identified six existing safety standards that address the magnet ingestion hazard. Each of these standards applies to certain products, and none of the standards apply to all subject magnet products. Four of the standards are domestic voluntary standards:

• ASTM F963-17,

Standard Consumer Safety Specification for Toy Safety;

• ASTM F2923-20,

Standard Specification for Consumer Product Safety for Children's Jewelry;

• ASTM F2999-19,

Standard Consumer Safety Specification for Adult Jewelry;

and

• ASTM F3458-21,

Standard Specification for Marketing, Packaging, and Labeling Adult Magnet Sets Containing Small, Loose, Powerful Magnets (with a Flux Index ≥50 kG2 mm2).

In addition, two are international safety standards:

• EN 71-1: 2014,

Safety of Toys; Part 1: Mechanical and Physical Properties;

and

• ISO 8124-1: 2018,

Safety of Toys — Part 1: Safety Aspects Related to Mechanical and Physical Properties.

This section describes these standards and provides CPSC staff's assessment of their adequacy to address injuries and deaths associated with magnet ingestions. Several of the standards include requirements that do not relate to magnets, however, this analysis focuses on those provisions that are relevant to the magnet ingestion hazard.

A. ASTM F963-17

ASTM F963 was originally approved in 1986, and has been revised numerous times since then. In 2007, ASTM updated the standard to include requirements to address the magnet ingestion hazard in children's toys. In subsequent revisions, ASTM added further requirements for toys containing magnets. As explained above, in 2008, section 106 of the CPSIA made ASTM F963 a mandatory consumer product safety standard; in accordance with that mandate, the Commission adopted 16 CFR part 1250, which currently incorporates by reference ASTM F963-17, which is the most recent version of the standard. ASTM approved ASTM F963-17 on May 1, 2017 and published it in August 2017. CPSC staff participates in the ASTM F15.22 subcommittee that is responsible for this standard.

1. Scope

ASTM F963-17 applies to “toys,” which the standard defines as objects designed, manufactured, or marketed as playthings for children under 14 years old. As such, the standard does not apply to products that are intended for users 14 years or older, or products that would not be considered playthings. When ASTM adopted the provisions regarding magnets, it explained that the purpose of the requirements was to address magnet ingestion incidents resulting in serious injury or death by identifying magnets and magnetic components that can be readily swallowed (section A9.4).

2. Performance Requirements for Magnets

The standard specifies that toys may not contain a loose as-received “hazardous magnet” or a loose as-received “hazardous magnetic component.” In addition, toys may not liberate a “hazardous magnet” or “hazardous magnetic component” after specified use-and-abuse testing, which consists of soaking under water, cycling attachment and detachment, drop testing, torque testing, tension testing, impact testing, and compression testing. The standard excepts from the requirements “magnetic/electrical experimental sets” intended for children 8 years and older—such products need only comply with warning requirements, discussed below.

The standard defines a “hazardous magnet” as a magnet that is a small object (

i.e.,

fits entirely within a small parts cylinder specified in the standard) and has a flux index of 50 kG

2

mm

2

or more (as measured in accordance with the method specified in the standard). Thus, a magnet must be both small and strong, according to the criteria in the standard, to be “hazardous.” A “hazardous magnetic component” is any part of a toy that is a small object and contains an attached or imbedded magnet with a flux index of 50 kG

2

mm

2

or more.

ASTM F963-17 describes the small parts cylinder in section 4.6 and illustrates it in Figure 3; to be a small object, the magnet must fit entirely within the cylinder. The small parts cylinder depicted in ASTM F963-17 is the same as the small parts cylinder in CPSC's regulations, at 16 CFR 1501.4. Sections 8.25.1 through 8.25.3 describe the test methodology to measure the maximum absolute flux of a magnet and to calculate the flux index. A flux index is a calculated value of magnetic density and size. The flux index of a magnet is calculated by multiplying the square of the magnet's maximum surface flux density (in KGauss (kG)) by its cross-sectional area (in mm

2

).

3. Warning Requirements

ASTM F963-17 does not include specific labeling requirements for toys containing loose as-received hazardous magnets or hazardous magnetic components, except for “magnetic/electrical experimental sets” intended

for children 8 years and older, which are exempt from the performance requirements and need only meet labeling requirements. The standard defines a “magnetic/electrical experimental set” as a “toy containing one or more magnets intended for carrying out educational experiments that involve both magnetism and electricity.” Section A12.4 in the standard explains that this definition is intended to cover only products that combine magnetism and electricity. The packaging and instructions for magnetic/electrical experimental sets intended for children 8 years and older must be labeled with a warning that addresses the magnet ingestion hazard.

4. Assessment of Adequacy

CPSC staff does not consider ASTM F963-17 capable of adequately reducing the risk of injury and death associated with magnet ingestions because of the scope of products it covers.

The size and strength requirements in ASTM F963-17 are consistent with the requirements proposed in this rule for subject magnet products. Section VI. Description of and Basis for the Proposed Rule, below, discusses these size and strength requirements and their ability to address the hazard. Staff considers the size and strength requirements adequate to address the hazard. However, ASTM F963-17 only applies to products designed, manufactured, or marketed as playthings for children under 14 years old; it does not apply to products intended for older users or products that would not be considered playthings. Accordingly, staff does not believe that compliance with the standard is likely to adequately reduce the magnet ingestion hazard.

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Based on incident data, staff believes that the exception in ASTM F963-17 for magnetic/electrical experimental sets intended for children 8 years and older is likely not problematic for adequately addressing the magnet ingestion hazard. Staff identified only one magnet ingestion incident that involved a “science kit,” which potentially could be a magnetic/electrical experimental set.

As the incident data indicate, children and teens commonly access and ingest magnets from products intended for older users. Both NEISS and CPSRMS data indicate that the most common products identified in magnet ingestions were magnet sets and magnet toys, which are products that are intended for users 14 years or older, or where the intended user age was unknown, but there were no indications that the product was intended for users under 14 years. Despite the involvement of products intended for users 14 years and older, the vast majority of magnet ingestion incidents involved children under 14 years old. For example, among CPSRMS incidents for which the victim's age was known, the most common ages that ingested magnet sets were 2, 8, 9, and 10 years old.

The sources from which children access ingested magnets further illustrates the need to address magnets in products intended for older users. For example, according to CPSRMS data, children and teens commonly access ingested magnets that belong to other family members, in the home, from friends, or loose in the environment, suggesting their access is not limited to toys intended for them.

In addition, ASTM F963-17 does not apply to products that are not intended to be playthings. Both NEISS and CPSRMS data indicate that many products involved in magnet ingestion incidents are described as jewelry, and that children of various ages ingest magnet jewelry (

e.g.,

accidentally ingesting magnets while simulating lip, tongue, and cheek piercings). Because ASTM F963-17 only applies to playthings, it does not apply to jewelry, regardless of the intended user age.

As such, ASTM F963-17, alone, is not sufficient to address the magnet ingestion hazard, because it does not impose any requirements on products intended for users 14 years or older or jewelry, which are known to be involved in many magnet ingestion incidents.

B. ASTM F2923-20

ASTM first issued ASTM F2923 in 2011. The current version of the standard is ASTM F2923-20, which was approved on February 1, 2020, and published in March 2020.

1. Scope

ASTM F2923-20 applies to “children's jewelry,” which is jewelry designed or intended primarily for use by children 12 years old or younger. The standard defines “jewelry” as a product that is primarily designed and intended as an ornament worn by a person. The standard does not apply to toy jewelry or products intended for a child when playing. The standard includes requirements that are intended to address ingestion, inhalation, and attachment hazards associated with children's jewelry that contains a hazardous magnet or hazardous magnetic component. The standard defines a “hazardous magnet” and “hazardous magnetic component” be referencing the definition in ASTM F963, except that the standard exempts chains that are longer than 6 inches from the definition of “hazardous magnetic component.”

2. Performance Requirements for Magnets

ASTM F2923-20 prohibits children's jewelry from having an as-received hazardous magnet or hazardous magnetic component. The standard excepts from this requirement children's jewelry intended for children 8 years and older consisting of earrings, brooches, necklaces, or bracelets—such products need only comply with warning requirements, discussed below. In addition, the standard prohibits children's jewelry from liberating a hazardous magnet or hazardous magnetic component after the use-and-abuse testing specified in ASTM F963.

3. Warning Requirements

ASTM F2923-20 does not include specific labeling requirements for children's jewelry containing hazardous magnets or hazardous magnetic components, except for children's jewelry intended for children 8 years and older that consists of earrings, brooches, necklaces, or bracelets. These products are exempt from the performance requirements and need to include a warning that addresses the magnet ingestion hazard. Instructions that accompany the product must also include these warnings.

4. Assessment of Adequacy

CPSC staff does not consider ASTM F2923-20 capable of adequately reducing the risk of injury and death associated with magnet ingestions. Although staff considers the size and strength requirements in the standard adequate to address the magnet ingestion hazard, the standard excepts certain children's jewelry from these performance requirements, and the scope of products covered by the rule makes the standard insufficient to address the magnet ingestions, generally.

The first issue with the standard is that it excludes from the size and strength requirements for magnets children's jewelry that is intended for children 8 years and older that consists of earrings, brooches, necklaces, and bracelets. Applying only warning requirements to these products is not adequate to reduce the magnet ingestion hazard. As the incident data indicate, almost half of magnet ingestion incidents involve children 8 years and older, and children and teens, particularly in this age group, commonly used magnets as jewelry at the time of ingestion. Warning requirements, alone, are not adequate to

address these incidents. As the discussion of ASTM F3458-21, below, covers in detail, caregivers and children commonly do not heed warnings, and children and teens commonly access magnets that are separated from their packaging, where warnings are provided.

The second issue with the standard is that it applies only to jewelry that is designed or intended primarily for use by children 12 years old or younger. As such, it does not impose requirements on magnet sets or magnet toys intended for users 14 years and older, which are the most common product types identified in magnet ingestion incidents. The standard also does not apply to jewelry intended for users over 12 years old. Although incident data do not indicate the intended user age of jewelry products involved in ingestions, the data indicate that children and teens of various ages ingested magnets intended for users 14 years and older when using the magnets as jewelry, making it is reasonable to conclude that jewelry intended for users over 12 years old poses an ingestion hazard for children and teens.

For these reasons, ASTM F2923-20, on its own, is not sufficient to address the magnet ingestion hazard because it does not impose requirements on magnet sets, magnet toys, or certain jewelry, which are shown to be involved in many magnet ingestion incidents.

C. ASTM F2999-19

ASTM first issued ASTM F2999 in 2013; the current version of the standard is ASTM F2999-19, which ASTM approved on November 1, 2019, and published in November 2019.

1. Scope

ASTM F2999-19 establishes requirements and test methods for certain hazards associated with adult jewelry, including magnets. The standard defines “adult jewelry” as jewelry designed or intended primarily for use by consumers over 12 years old. It defines “jewelry” as a product primarily designed and intended as an ornament worn by a person, and provides several examples, such as bracelets, necklaces, earrings, and jewelry craft kits where the final assembled product meets the definition of “jewelry.” The standard defines a “hazardous magnet” as “a magnet with a flux index >50 as measured by the method described in Consumer Safety Specification F963 and which is swallowable or a small object.”

2. Performance Requirements for Magnets

ASTM F2999-19 does not include any performance requirements for adult jewelry that contains magnets; it specifies only labeling requirements, discussed below.

3. Labeling Requirements

ASTM F2999-19 states that “adult jewelry that contains hazardous magnets as received should include a warnings statement which contains the following text or substantial equivalent text which clearly conveys the same warning.” Thus, rather than the mandatory language ASTM standards typically use (

i.e.,

shall), the standard merely recommends (

i.e.,

should) that warnings regarding hazardous magnets be provided with adult jewelry. The warning statement provided in the standard warns of the internal interaction hazard if magnets are swallowed or inhaled, and recommends seeking immediate medical attention.

4. Assessment of Adequacy

CPSC staff does not consider ASTM F2999-19 capable of adequately reducing the risk of injury and death associated with magnet ingestions. For one, the standard does not include any requirements for adult jewelry containing magnets—rather, it suggests complying with the magnet provisions. As incident data indicate, many magnet ingestion incidents involve products used as jewelry, and children and teens accessing products intended for older users. This demonstrates the need for a mandatory requirement for adult jewelry.

In addition, the only provisions in the standard that address magnet ingestions are warnings. As the discussion of ASTM F3458-21, below, covers in detail, warning requirements, alone, are not adequate to address the magnet ingestion hazard because caregivers and children commonly do not heed warnings, and children and teens commonly access magnets that are separated from their packaging, where warnings are provided.

The scope of the standard also makes it insufficient to adequately address the magnet ingestion hazard. Because it applies only to jewelry designed or intended primarily for use by consumers over 12 years old, the standard does not impose requirements on magnet sets or magnet toys intended for users 14 years and older, which are the most common products identified in magnet ingestion incidents. It also does not impose requirements on jewelry intended for users 12 years old and younger. Although the incident data do not indicate the intended user age of jewelry involved in magnet ingestions, because many incidents involve children 12 years old and younger, it is reasonable to conclude that jewelry intended for such users pose the magnet ingestion hazard for children and teens.

Another potential issue with ASTM F2999-19 is that it defines a hazardous magnet, for purposes of determining whether the warning provisions apply, as having a flux index greater than 50 kG

2

mm

2

. In contrast, ASTM F963-17, ASTM F2923-20, and this proposed rule, define a hazardous magnet as having a flux index greater than or equal to 50 kG

2

mm

2

, thereby, addressing magnets with a flux index of precisely 50 kG

2

mm

2

. This makes ASTM F2999-19 inconsistent with the toy standard, which has been in effect for many years and has been effective at addressing the magnet ingestion hazard for toys.

For these reasons, ASTM F2999-19, alone, is not sufficient to address the magnet ingestion hazard because it does not impose performance requirements on magnet sets, magnet toys, or certain jewelry, which are involved in many magnet ingestion incidents.

D. ASTM F3458-21

In 2019, ASTM Subcommittee F15.77 on Magnets began work to develop a standard for magnet sets intended for users 14 years and older. On February 15, 2021, ASTM approved ASTM F3458-21, and published the standard in March 2021. ASTM F3458-21 consists of marketing, packaging, labeling, and instructional requirements for magnet sets intended for users 14 years and older.

Since March 2019, CPSC staff has participated actively in Subcommittee F15.77 on Magnets. During the development of ASTM F3458-21, CPSC staff raised several concerns to the subcommittee about the developing standard, including the reliance on marketing, packaging, labeling, and warnings requirements, rather than performance requirements to limit the size and strength of magnets. The assessment of the standard, below, and Tab C of the NPR briefing package, detail these concerns; Tab C also includes a letter CPSC staff sent the subcommittee, expressing these concerns. Based on these issues, CPSC considered the standard inadequate to address the magnet ingestion hazard and voted against the final version of the standard that was ultimately adopted.

In May 2021, after ASTM F3458-21 was adopted, Subcommittee F15.77 on Magnets voted to form a task group to

consider revising the standard to include performance requirements for magnet sets intended for users 14 years and older. CPSC staff will continue to work with the subcommittee, however, whether the standard will be revised, and what requirements may be added to it, are, as yet, undetermined.

1. Scope

ASTM F3458-21 aims to minimize the hazards to children and teens associated with ingesting small, powerful magnets in magnet sets that are intended for users 14 years and older. The standard defines a “magnet set” as “an aggregation of separable magnetic objects that are marketed or commonly used as a manipulative or construction item for puzzle working, sculpture building, mental stimulation, education, or stress relief.” It also defines a “small, powerful magnet” as an “individual magnet of a magnet set that is a small object” and has a flux index of 50 kG

2

mm

2

or more. The criteria for identifying a small object and the flux index are the same as in ASTM F963-17.

2. Performance Requirements for Magnets

The standard does not include size and strength limits for magnet sets themselves. The standard includes performance criteria in the form of test methods to determine if a product is a “small, powerful magnet,” and test methods for assessing label permanence; however, the standard does not include performance requirements preventing small, powerful magnets from being used in magnet sets. Instead, ASTM F3458-21 includes requirements for instructional literature, sales/marketing, labeling, and packaging, discussed below. These requirements seek to inform and encourage consumers to keep magnets away from children.

3. Instructional Literature Requirements

ASTM F3458-21 requires magnet sets intended for users 14 years and older to come with instructions that address assembly, maintenance, cleaning, storage, and use. The instructions must include warnings (as specified below), the manufacturer's suggested strategy for counting and storing magnets, a description of typical hazard patterns (

e.g.,

young children finding loose magnets), an illustration of the hazard, a description of typical symptoms associated with magnet ingestion, and statements regarding medical attention when magnets are ingested.

4. Sales/Marketing Requirements

The standard prohibits manufacturers from knowingly marketing or selling magnet sets intended for users 14 years and older to children under 14 years old, and requires them to “undertake reasonable efforts” (with examples) to ensure the product is not marketed or displayed as a children's toy. For online sales, manufacturers must “undertake reasonable efforts” (with examples) to ensure that online sellers do not sell magnet sets intended for users 14 years and older to children under 14 years. When selling directly to consumers online, manufacturers must include warnings (as specified below) and instructional literature about the hazard pattern.

5. Labeling Requirements

ASTM F3458-21 requires magnet sets intended for users 14 years and older to bear warnings on the retail packaging and “permanent storage container,” which the standard defines as a container designed to hold the magnet set when it is not in use. At a minimum, the warnings must address the hazard associated with magnet ingestions, direct users to keep the product away from children, and provide information about medical attention. The standard includes an example warning label, and specifies design and style requirements for the warning label. In addition, the standard requires the label to be permanent and provides a test method for assessing label permanence.

6. Packaging Requirements

The standard requires magnet sets intended for users 14 years and older to be sold with or in a permanent storage container. The permanent storage container must include a way to verify that all the magnets have been returned to the container. In addition, the standard requires the permanent storage container to be re-closeable and include one of the following means of restricting the ability to the open the container: (1) The container requires two consecutive actions, the first of which must be maintained while the second is carried out, or requires two separate and independent simultaneous actions to fully release, withstanding specified testing; (2) the container requires one action that requires at least 15 lbf to open or requires at least 4 inches lbf of torque to open, withstanding specified testing; or (3) the container meets the performance requirements in 16 CFR 1700.15 and the testing requirements of 16 CFR 1700.20 (which are poison preventing packaging standards, adopted under the Poison Prevention Packaging Act

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and specify packaging that is significantly difficult for children under 5 years old to open within a reasonable time).

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15 U.S.C. 1471-1477.

7. Assessment of Adequacy

CPSC staff does not consider ASTM F3458-21 capable of adequately reducing the risk of injury and death associated with magnet ingestions. For one, the limited scope of products subject to the standard is inadequate to address the hazard. The standard only applies to magnet sets intended for users 14 years and older. As such, it imposes no requirements on other products intended for users 14 years and older, or on jewelry (both children's and adult), which are shown to be involved in magnet ingestion incidents.

In addition, the types of requirements in the standard make it inadequate to address the magnet ingestion hazard. For a detailed discussion of the weaknesses of warnings, instructional, sales/marketing, and packaging requirements to address the magnet ingestion hazard, see Tab C of the NPR briefing package. The following is an overview of these weaknesses.

Throughout the standard development process, CPSC staff emphasized that performance requirements for magnets are necessary to adequately address the magnet ingestion hazard. Such requirements typically include size and strength requirements for the magnets themselves, as in the toy standard and this proposed rule. However, ASTM F3458-21 does not include performance requirements to prevent magnet sets intended for users 14 years and older from containing small, powerful magnets, and instead, relies on requirements to inform and encourage consumers to keep magnets away from children. As incident data indicate, children and teens access magnet products, including magnet sets, that are intended for older users, making it important to address the magnet ingestion hazard for magnet sets intended for users 14 years and older. However, safety messaging (

e.g.,

warnings and instructions) and packaging requirements, without performance requirements for the magnets themselves, are not likely to adequately address the hazard.

Safety Messaging.

Safety literature has shown that warnings are the least effective strategy for addressing a hazard, relative to designing out the hazard or designing guards against the hazard. This is because safety messaging relies on persuading consumers to avoid

hazards, but numerous factors can reduce the likelihood that consumers will read and follow safety messaging.

One factor that weighs against consumers heeding safety warnings is their perception that magnet products present a low safety risk. Magnets in products intended for amusement or jewelry are likely to appear simple, familiar, and non-threatening to children, teens, and caregivers. Incident data and consumer reviews demonstrate that consumers commonly recognize these types of magnetic products as suitable playthings for children, which undermines the perceived credibility of warnings that state the magnets are hazardous for children. The availability of children's toys that are similar to subject magnet products intended for users 14 years and older may also affect consumers' perception of the hazard because the products appear similar, and some are marketed for children. Once familiar with a product, consumers tend to generalize across similar products, and the more familiar consumers are with a product, the less likely they are to look for, or read, warnings and instructions. If caregivers observe their child, or their child's peers using a product or a similar product without incident, caregivers may conclude that their child can use the product safely, regardless of what the warnings state. This is also true for recommendations from others, including online reviews of products, which can influence the likelihood of consumers disregarding warnings. Staff reviewed numerous consumer reviews of subject magnet products, and found that many indicated that consumers purchased the product for a child, or that their children started playing with it, despite the product not being intended for users under 14 years old. Similarly, when a child or teen repeatedly uses the product in or around their mouth without ingesting a magnet or experiencing consequences from ingestion, they and their caregivers are likely to conclude that the hazard is not likely to occur, or is not relevant to them.

Another reason that safety messaging has limited effectiveness is that consumers misunderstand the hazard. For small, powerful magnets, the internal interaction hazard is a hidden hazard, so consumers are unlikely to anticipate and appreciate the risk to children, especially older children and teens who do not have a history of mouthing or ingesting inedible objects. However, of the magnet ingestion cases that identify whether the ingestions were intentional or accidental, the majority describe accidental ingestions, which is much more difficult for consumers to appreciate and prevent.

Similarly, there are developmental factors that predispose older children and teens to disregard warnings and use the small, powerful magnet products in and around their mouths and noses. As discussed above, older children and teens are at a developmental stage in which they test limits and bend rules. Experimentation and peer influence are common determinants of behavior for this age group. Small, powerful magnets offer a seemingly safe and reversible way to try out lip, tongue, cheek, and nose piercings; and if children and teens see their peers doing this, they may act similarly, despite being aware of the risks.

In addition, consumers misunderstand the progression of symptoms associated with magnet ingestions, which may lead them to disregard warnings. As incident reports show, many children, teens, and caregivers wrongly assume that, when ingested, magnets will pass through the body without causing harm. This contributes to delays between ingestion and correct treatment, increasing the risks associated with magnet ingestion.

Another factor that limits the potential effectiveness of safety messaging is how children and teens obtain magnets they ingest. As incident data show, children and teens commonly obtain ingested magnets loose in their environments, from friends, or at school, where the product is separated from any packaging or instructions that bear warnings. Because small, powerful magnets themselves are too small to bear warnings, these children and teens, and their caregivers, may not be made aware of the hazard.

Finally, safety messaging has been ineffective at reducing the magnet ingestion hazard, to date. As discussed above, and in Tab C of the NPR briefing package, staff has examined dozens of incident reports that indicate children and teens obtained and ingested small, powerful magnets even when the product was marketed and prominently labeled with warnings about the hazard and stated that the product was not appropriate for children. For example, of the CPSRMS incidents reported to have occurred between January 1, 2010 and December 31, 2020, staff examined at least 44 incidents in which a child ingested a magnet product that included warnings about the hazard and cautioned to keep the product away from children. Similarly, of 41 magnet sets for which staff assessed consumer reviews, 35 percent of the reviews mentioned use by children, despite 68 percent including a warning about the magnet ingestion hazard.

Another indication of the ineffectiveness of safety messaging to address the magnet ingestion hazard, to date, is the upward trend in magnet ingestion cases in recent years, despite many years of consumer awareness campaigns. As discussed above, for many years, CPSC has drawn attention to the magnet ingestion hazard through recalls, safety alerts, public safety bulletins, and rulemaking activity. In addition, there have been numerous public outreach efforts by health organizations and other consumer advocacy groups to warn consumers about the internal interaction hazard posed by small, powerful magnets. Despite these efforts, magnet ingestion incidents have increased in recent years.

Packaging.

Similar to safety messaging, there are several reasons staff considers packaging requirements inadequate to address the magnet ingestion hazard. For one, incident data show that children and teens commonly access ingested magnets loose in their environment and from friends, in which case the product is likely to be separated from its packaging, rendering CR packaging or visual cues that all magnets are in the package ineffective.

In addition, the features provided for in ASTM F3458-21 to make the packaging difficult for children to open would not be effective at preventing older children and teens from accessing the magnets in the packaging. For example, the third packaging option provided in the standard allows the packaging to meet the requirements in 16 CFR 1700.15 and 1700.20. Those provisions are intended to make packaging significantly difficult for children under 5 years old to open within a reasonable time. Thus, such packaging does not prevent all children under 5 years old from opening it, particularly given ample time, and it is not intended to prevent any children 5 years and older from opening the packaging. As the incident data indicate, the majority of magnet ingestion incidents involved victims 5 years and older, making this packaging ineffective at restricting their access. Similarly, for the alternative packaging options in the standard, children and teens are likely to have cognitive and motor skills sufficient to access the products.

Even if CR packaging features did prevent children and teens from opening the packaging, the effectiveness of packaging to address the hazard would rely on consumers correctly repackaging all the magnets after every use, which is likely unrealistic. For one,

the products often are intended for purposes that make repackaging after each use unlikely. For example, products such as magnet sets are intended to assemble and display complex sculptures, and some jewelry may involve creating designs, making consumers unlikely to disassemble their designs to repackage all the magnets after every use. In addition, consumers are not likely to perceive the products as hazardous because they are intended for amusement or jewelry and are not hazardous in appearance, and therefore, would not consider it necessary to repackage all the magnets after every use. Even for products that are obviously hazardous and commonly use CR packaging, such as chemicals and pharmaceuticals, consumers have inconsistently used the packaging. Consumers may also consider CR packaging a nuisance, making them unlikely to store magnets in the packaging after every use.

In addition, the small size of the magnets and large number of magnets (particularly in some magnet sets and magnetic jewelry sets), make it unlikely that consumers would return all the magnets to the packaging after every use. The small size and often large quantity of magnets in a set make locating and counting the magnets after every use, to ensure they are all returned to the package, not feasible or realistic. For example, staff has identified products that were involved in magnet ingestion incidents that consisted of thousands of 2.5 mm diameter magnets. Staff has found that it is common for magnets to be flicked away from one another when they are being handled, such as when separating magnets, resulting in magnets being dropped. These actions are foreseeable, particularly for magnets intended for fidgeting and building. In examining magnet sets, staff found that many sets are sold with extra pieces, in part, because losing magnets is expected. In addition, many incident reports and consumer reviews of magnet sets mention lost magnets. Given the large number of magnets often included in a set, their small size, and their tendency to be separated and lost, it is unlikely that consumers will use CR packaging effectively. The time and effort necessary to locate, assemble, and repackage such small and numerous magnets is likely to be beyond what consumers are willing to spend.

For these reasons, ASTM F3458-21, alone, is not sufficient to address the magnet ingestion hazard because it does not impose performance requirements on magnets themselves, and it does not apply to several products that are involved in magnet ingestion incidents.

E. EN 71-1: 2014

The European standard applies to children's toys, which are products intended for use in play by children younger than 14 years old. The requirements regarding magnets in EN 71-1: 2014 are essentially the same as in ASTM F963-17—any loose as-received magnet and magnetic component must either

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