[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Proposed Rules]
[Pages 1260-1316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27826]



[[Page 1259]]

Vol. 87

Monday,

No. 6

January 10, 2022

Part II





Consumer Product Safety Commission





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16 CFR Parts 1112 and 1262





Safety Standard for Magnets; Proposed Rule

  Federal Register / Vol. 87 , No. 6 / Monday, January 10, 2022 / 
Proposed Rules  

[[Page 1260]]


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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.

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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: [email protected].
    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: [email protected].

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.
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    \1\ The Commission voted 4-0 to approve this notice and commence 
rulemaking.
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    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.

[[Page 1261]]

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).
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    \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.''
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    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.
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    \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).
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    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\
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    \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).
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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
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    \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.
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    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.
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    \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.
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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

[[Page 1262]]

organizations and other consumer advocacy groups have made numerous 
public outreach efforts to warn consumers about the magnet ingestion 
hazard.\9\
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    \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/).
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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.
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    \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.
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    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.
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    \11\ See https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/page-3.html#h-1109670.
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    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.
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    \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.
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    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\
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    \14\ See https://www.legislation.gov.au/Details/F2008C00607.
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    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\
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    \15\ See https://www.legislation.gov.au/Details/F2012L02171; 
https://www.productsafety.gov.au/bans/small-high-powered-magnets.
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    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\
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    \16\ See https://www.standards.govt.nz/shop/asnzs-iso-8124-12019/.
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    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).
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    \17\ See https://www.beehive.govt.nz/release/ban-sale-high-
powered-magnet-
sets#:~:text=Consumer%20Affairs%20Minister%20Simon%20Bridges,stores%2
0and%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/.
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    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

[[Page 1263]]

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

[[Page 1264]]

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

[[Page 1265]]

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.


[[Page 1266]]

    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
----------------------------------------------------------------------------------------------------------------
                                                  Annual average                     N (not an       Years in
                     Period                          estimate           CV           average)         period
----------------------------------------------------------------------------------------------------------------
2010-2013.......................................           2,300            0.16             395               4
2014-2016.......................................           1,300            0.20             200               3

[[Page 1267]]

 
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
----------------------------------------------------------------------------------------------------------------
                                                                             Age group
                                                                 --------------------------------
                               Sex                                                   8 or more         Total
                                                                   Under 8 years       years
----------------------------------------------------------------------------------------------------------------
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.


[[Page 1268]]

    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:
    [cir] Referred to as a magnet set;
    [cir] identified as a magnet set through product name;
    [cir] included photos identifying the product; or
    [cir] 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

[[Page 1269]]

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
----------------------------------------------------------------------------------------------------------------
                                                  Proportion                                        Proportion
        Magnet category            Incidents          (%)             Scope          Incidents          (%)
----------------------------------------------------------------------------------------------------------------
Magnet Set....................             134            47.2  Amusement/                   214            75.4
                                                                 Jewelry.
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

[[Page 1270]]

[GRAPHIC] [TIFF OMITTED] TP10JA22.000

    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.

[[Page 1271]]

[GRAPHIC] [TIFF OMITTED] TP10JA22.001

BILLING CODE 6355-01-C

[[Page 1272]]

    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
----------------------------------------------------------------------------------------------------------------
                                                                           Disposition
                Magnet category                 ----------------------------------------------------------------
                                                      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.

---------------------------------------------------------------------------

[[Page 1273]]

    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
----------------------------------------------------------------------------------------------------------------
                                                                    Percent of                       Years in
                             Period                                    total             N            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/

[[Page 1274]]

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.

[[Page 1275]]

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_whK
ng2.
---------------------------------------------------------------------------

    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.

---------------------------------------------------------------------------

[[Page 1276]]

    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

[[Page 1277]]

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

[[Page 1278]]

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.\67\ 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.
---------------------------------------------------------------------------

    \67\ 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

[[Page 1279]]

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.\68\
---------------------------------------------------------------------------

    \68\ 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 \69\ 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.\71\
---------------------------------------------------------------------------

    \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
[GRAPHIC] [TIFF OMITTED] TP10JA22.002


[[Page 1280]]


[GRAPHIC] [TIFF OMITTED] TP10JA22.003

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

[[Page 1281]]

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.\72\
---------------------------------------------------------------------------

    \72\ 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.\73\ 
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.
---------------------------------------------------------------------------

    \73\ 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

[[Page 1282]]

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 74
---------------------------------------------------------------------------

    \74\ 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

[[Page 1283]]

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.\75\
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    \75\ 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

[[Page 1284]]

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

[[Page 1285]]

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 
\76\ and specify packaging that is significantly difficult for children 
under 5 years old to open within a reasonable time).
---------------------------------------------------------------------------

    \76\ 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

[[Page 1286]]

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,

[[Page 1287]]

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 have a flux index less than 50 kG\2\ 
mm\2\, or not fit entirely in a small parts cylinder. The flux index is 
determined using the same method as in ASTM F963-17, and the small 
parts cylinder is the same as in ASTM F963-17. EN 71-1: 2014 also 
requires use-and-abuse testing similar to ASTM F963-17, to ensure that 
toys do not liberate a hazardous magnet or hazardous magnetic 
component. The standard includes a similar exemption to ASTM F963-17 
for magnetic/electrical experimental sets intended for children 8 years 
of age and older, which need only bear a warning regarding the magnet 
ingestion hazard.
    Thus, the provisions addressing the magnet ingestion hazard in EN 
71-1: 2014 are largely the same as in ASTM F963-17. As discussed above, 
for ASTM F963-17, CPSC staff does not consider these provisions capable 
of adequately reducing the risk of injury and death associated with 
magnet ingestions because of the limited scope of the standard. Because 
the standard only applies to toys intended for children under 14 years 
old, it does not impose any requirements on products intended for older 
users, or products that would not be considered playthings. As the 
incident data indicate, magnet ingestion incidents include children and 
teens ingesting products intended for older users, and ingesting 
jewelry, neither of which this standard addresses.

F. ISO 8124-1: 2018

    This standard applies to toys, which are products intended for use 
in play by children under 14 years old. The standard requires any loose 
as-received magnet and magnetic component to either have a flux index 
less than 50 kG\2\ mm\2\ or not fit entirely within a small parts 
cylinder. The flux index is determined the same way as in ASTM F963-17, 
and the small parts cylinder is the same as in ASTM F963-17. ISO 8124-1 
also requires similar use-and--abuse testing to ASTM F963-17, to ensure 
that a hazardous magnet or hazardous magnetic component does not 
liberate from a toy. Similar to ASTM F963-17, ISO 8124-1 also provides 
an exemption for magnetic/electrical experimental sets intended for 
children 8 years and older, which need only bear a warning regarding 
the magnet ingestion hazard.
    Thus, the provisions addressing the magnet ingestion hazard in ISO 
8124-1: 2018 are largely the same as in ASTM F963-17. As discussed 
above, for ASTM F963-17, CPSC staff does not consider these provisions 
capable of adequately reducing the risk of injury and death associated 
with magnet ingestions because of the limited scope of the standard. 
Because the standard only applies to toys intended for children under 
14 years old, it does not impose any requirements on products intended 
for older users, or products that would not be considered playthings. 
As the incident data indicate, magnet ingestion incidents include 
children and teens ingesting products intended for older users, and 
ingesting jewelry, neither of which this standard addresses.

G. Compliance With Existing Standards

    CPSC has limited information about the extent to which products 
comply with existing standards. Based on staff's analysis, only a small 
number of magnet ingestion incidents for which a product type could be 
identified involved children's toys subject to ASTM F963, which 
provides some indication that children's toys commonly comply with the 
standard. Of the magnet ingestion incidents that involved children's 
toys, staff identified six incidents that involved internal interaction 
of the magnets through body tissue, again suggesting there may be a 
high level of compliance with the standard. None of the products in 
these six incidents complied with the magnet requirements in ASTM F963.
    CPSC staff does not have detailed information about the extent to 
which products comply with ASTM F2923, F2999, or F3458. Incident 
reports commonly do not provide enough detail for staff to identify the 
specific product (e.g., brand) to obtain it and assess it for 
compliance. In addition, for ASTM F3458, the standard was adopted 
recently (March 2021), making it difficult to determine the level of 
compliance with it. CPSC seeks comments and data about the level of 
compliance with the existing standards that address the magnet 
ingestion hazard.

VI. Description of and Basis for the Proposed Rule

A. Scope and Definitions

1. Proposed Requirements
    The proposed rule applies to ``subject magnet products,'' defined 
as ``a

[[Page 1288]]

consumer product that is 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 contains one or more loose or separable magnets.'' The proposed 
rule exempts from its scope, toys that are subject to 16 CFR part 1250, 
Safety Standard Mandating ASTM F963 for Toys.
    The proposed rule only applies to ``consumer products,'' as defined 
in the CPSA, which are ``article[s], or component part[s] thereof, 
produced or distributed (I) for sale to a consumer for use in or around 
a permanent or temporary household or residence, a school, in 
recreation, or otherwise, or (ii) for the personal use, consumption or 
enjoyment of a consumer in or around a permanent or temporary household 
or residence, a school, in recreation, or otherwise.'' 15 U.S.C. 
2052(a)(1). Consumer products do not include products that are not 
customarily produced or distributed for sale to, or for the use or 
consumption by, or enjoyment of, a consumer. Id.
    The proposed rule also defines ``hazardous magnets'' as ``a magnet 
that fits entirely within the cylinder described in 16 CFR 1501.4 and 
that has a flux index of 50 kG\2\ mm\2\ or more when tested in 
accordance with the method described in this part 1262.''
2. Basis for Proposed Requirements
    To determine the appropriate scope of products to cover in the 
proposed rule to adequately reduce the risk of injury and death 
associated with magnet ingestions, CPSC staff considered magnet 
ingestion incident data, magnet use patterns, magnet ingestion rates 
when other mandatory standards took effect, recalls, child development 
and behavioral patterns, the uses of hazardous magnets in consumer 
products, consumer reviews for products with loose or separable 
hazardous magnets, existing standards, contributions from stakeholders 
in the ASTM Subcommittee F15.77 on Magnets, and relevant research 
literature. The definition of ``subject magnet products'' consists of 
several elements that include and exclude certain products from the 
scope of the proposed rule. This section discusses the reasons for the 
criteria in the definition. The basis for the elements of the proposed 
definition of ``hazardous magnets'' is discussed below, as part of the 
basis for the performance requirements in the proposed rule.
a. Consumer Products
    Subject magnet products are limited to ``consumer products,'' as 
that term is defined in the CPSA. Accordingly, any product that is not 
customarily produced or distributed for sale to or use by a consumer, 
is not within the scope of the proposed rule. This could include 
professional, industrial, or commercial products that would not 
customarily be available to or used by consumers. This element of the 
definition is included because CPSC's authority under the CPSA is 
limited to consumer products, and because products that are not 
customarily available to consumers would not be likely to pose a magnet 
ingestion hazard to children and teens.
b. Loose or Separable Magnets
    Subject magnet products are limited to products that contain 
``loose or separable magnets.'' This is because magnets that are not 
loose or separable, such as non-removable magnets that are integrated 
into or attached to a product, would not pose an ingestion hazard. For 
example, a magnetic clasp attached to a necklace would not pose an 
ingestion hazard because it is connected to a larger object, making it 
unlikely to be swallowed.
    In addition, the definition of ``subject magnet products'' 
specifically refers to magnets. Although not explicit in the 
definition, this refers to permanent magnets, which are magnets that 
maintain their magnetic field after being removed from the magnetizing 
source. Staff does not consider it necessary to specify that the 
standard applies to permanent magnets. For one, products that lose 
their magnetism when separated from their magnetizing source (e.g., 
electromagnets that lose their magnetism when separated from the source 
of electricity) are unlikely to exceed the size criteria in the 
proposed rule when functioning as magnets because, to be magnetized, 
the product would have to be attached to its magnetizing source, which 
would render the product too large to fit entirely within the small 
parts cylinder. When separated from its magnetizing source, thereby 
making the item potentially small enough to fit entirely in the small 
parts cylinder, the item would lose its magnetism, and no longer be a 
``magnet'' subject to the standard. In addition, for the magnet to be 
``loose or separable'' it would need to be a magnet (i.e., magnetized) 
when loose and separated from other components, including a magnetizing 
source. CPSC seeks comments on whether it is necessary for the proposed 
rule to specify that it applies only to permanent magnets, or whether 
the rule should apply to non-permanent magnets as well.
c. One or More Magnets
    The definition also specifies that subject magnet products include 
``one or more'' loose or separable magnets; thus, they include products 
with only a single loose or separable magnet. There are two reasons for 
including this in the definition of ``subject magnet products.'' First, 
an individual magnet can interact internally through body tissue with 
an unrelated magnet or a ferromagnetic object, resulting an internal 
interaction injury. Thus, even a product with a single loose or 
separable magnet poses the same internal interaction hazard as products 
with multiple magnets. Second, subject magnet products may be sold as 
individual magnets or with a choice of how many magnets to include in a 
set. Staff identified magnets sets on the market that are sold with 
extra pieces to serve as replacements for magnets lost from the set. 
Thus, magnets sold individually may be intended as, or may be used as, 
part of a set, posing the risk of children and teens ingesting more 
than one magnet. Limiting the proposed rule to products that include 
two or more loose or separable magnets would not address the hazard 
posed by a single magnet, and would leave a gap in the standard to 
allow firms to sell magnets individually, without having to comply with 
the proposed rule. Moreover, applying the proposed rule to products 
that include a single loose or separable magnet is consistent with the 
toy standard in 16 CFR part 1250 because ASTM F963-17 applies to 
products that contain one or more hazardous magnets.
d. Amusement or Jewelry
    The definition of ``subject magnet products'' is limited to 
products that are designed, marketed, or intended to be used for 
entertainment, jewelry, mental stimulation, stress relief, or a 
combination of these purposes. Essentially, this means that the 
proposed rule applies to products that are designed, marketed, or 
intended for amusement or jewelry. This section discusses the reasons 
CPSC considers it appropriate to focus on magnet products intended for 
amusement and jewelry to reduce the risk of injury and death associated 
with magnet ingestions. The focus on amusement and jewelry products is 
also consistent with

[[Page 1289]]

international standards, which address these products, in 
particular.\77\
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    \77\ As discussed above, Canada's efforts to address the magnet 
ingestion hazard have focused on products intended for amusement, 
and New Zealand's and Australia's efforts have focused on products 
intended for amusement and jewelry.
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    Description of Products. Magnets intended for amusement include a 
variety of products for consumer entertainment, mental stimulation, and 
stress relief. Whether a product is designed, marketed, or intended to 
be used for these purposes depends on multiple considerations, such as 
how the manufacturer describes the product, marketing and advertising 
for the product, product packaging and displays, and how consumers are 
reasonably likely to perceive or use the product. Common examples of 
products that contain loose or separable magnets intended for 
entertainment, mental stimulation, or stress relief (other than 
children's toys) include products commonly referred to as ``executive 
toys,'' ``desk toys,'' ``magnet sets,'' and ``rock magnets.'' Magnet 
sets generally are aggregations of separable magnets commonly used for 
manipulating or constructing sculptures. Rock magnets generally are 
loose magnets shaped like rocks and intended for entertainment or 
fidgeting. These are some examples, and additional products may be 
designed, marketed, or intended to be used for entertainment, mental 
stimulation, stress relief, or a combination of these purposes.
    Subject magnet products that are jewelry also include a variety of 
products, such as jewelry intended for adults or for children, jewelry 
making sets, and magnetic piercings and studs. For example, staff has 
identified necklaces made of numerous small magnets, in multiple 
shapes, that consumers can rearrange in various configurations.
    Incident Data. As the incident data indicate, magnet ingestion 
cases generally involve seven categories of magnet products (see 
section IV.A. Incident Data, above, for a detailed description of the 
categories): Magnet sets, magnet toys, jewelry, home/kitchen magnets, 
ASTM F963 magnet toys, science kits, and unidentified products. 
Products categorized as magnet sets, magnet toys, and ASTM F963 magnet 
toys are generally intended for amusement, however, ASTM F963 magnet 
toys are excluded from the scope of the proposed rule.
    As the incident data show, products categorized as amusement and 
jewelry, by far, are the most common product categories identified in 
magnet ingestion incidents. Table 1 shows that magnet toys, by far, 
were the most common product type category identified \78\ in NEISS 
magnet ingestion incidents (110 of 279, or 39 percent), followed by 
magnet sets (58 of 279, or 21 percent), and jewelry (53 of 279, or 19 
percent). The remaining identified product categories made up fewer of 
the magnet ingestion cases: Home/kitchen magnets (46 of 279, or 16 
percent), ASTM F963 magnet toys (11 of 279, or 4 percent), and science 
kits (1 of 279, or less than 1 percent). Thus, for NEISS magnet 
ingestion incidents in which the product category could be identified, 
79 percent (221 of 279 incidents) involved products in the magnet sets, 
magnet toys, or jewelry categories.
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    \78\ As explained above, for many NEISS incidents, there was 
insufficient information for staff to identify the category of 
magnet products involved. Of the 1,072 NEISS magnet ingestion 
incidents from 2010 through 2020, staff categorized 793 as 
``unidentified'' magnet product types. For this reason, this 
analysis focuses on the remaining 279 incidents for which staff 
could categorize the product type.
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    CPSRMS data similarly show that magnet sets, magnet toys, and 
jewelry are the primary categories of products identified in magnet 
ingestions reports. As Table 9 shows, magnet sets, by far, were the 
most common product type identified \79\ in CPSRMS magnet ingestion 
incidents, making up 56 percent (134 of 241) of the incidents for which 
product type categories could be identified, followed by magnet toys 
(49 of 241, or 20 percent), and jewelry (31 of 241, or 13 percent). The 
remaining identified product categories made up fewer of the magnet 
ingestion cases: ASTM F963 magnet toys (21 of 241, or 9 percent), home/
kitchen magnets (6 of 241, or 2 percent), and 0 science kits. Thus, for 
CPSRMS magnet ingestion incidents in which the product category could 
be identified, 89 percent (214 of 241 incidents) involved products in 
the magnet sets, magnet toys, or jewelry categories.
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    \79\ Like NEISS data, CPSRMS data also includes incidents for 
which there was insufficient information for staff to determine the 
category of magnet products involved. However, the proportion of 
incidents in the unidentified magnet product type category is much 
lower in CPSRMS than in NEISS data. Nevertheless, this analysis 
focuses on the 241 incidents for which staff could categorize the 
product type.
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    The severity of health outcomes associated with magnet ingestions 
provides further support for focusing on amusement and jewelry products 
in the proposed rule. Fatalities are one indication of the severity of 
health outcomes. As discussed above, CPSC identified seven fatalities 
that involved the ingestion of hazardous magnets between November 24, 
2005 and January 5, 2021, 5 of which occurred in the United States. 
CPSC was able to definitively identify one of the products involved in 
these incidents (a 2005 death in the United States), which was a 
children's toy building set, a product intended for amusement. In 
addition, the most recent incident (a 2021 death in the United States) 
involved a magnet set, which is also a product intended for amusement. 
Of the remaining five incidents, three incidents (a 2013 death in the 
United States and two deaths in other countries) involved magnets that 
matched the characteristics of magnets typically found in magnet sets, 
but did not identify the involved product with certainty; one incident 
(a 2018 death in the United States) involved magnets that matched the 
characteristics of magnets typically found in magnet sets, and the 
product was described consistently with magnet sets (i.e., a magnet 
fidget toy building set); and one incident (a 2020 death in the United 
States) did not provide information about the product type. This 
suggests that amusement products, such as magnet sets, are involved in 
the most severe magnet ingestion cases.
    Whether a victim was hospitalized after ingesting magnets provides 
another indication of the severity of injuries or the need for 
significant treatment. As Table 10 shows, using CPSRMS data, the most 
common product types identified \80\ in magnet ingestion cases that 
resulted in hospitalization were magnet sets (88 of 160, or 55 
percent), followed by magnet toys (36 of 160, or 23 percent), and 
jewelry (21 of 160, or 13 percent). Hospitalizations for the remaining 
identified magnet categories were much lower: ASTM F963 magnet toys (10 
of 160, or 6 percent), and home/kitchen magnets (5 of 160, or 3 
percent).\81\ Thus, for CPSRMS magnet ingestion incidents in which the 
product category could be identified, 91 percent (145 of 160 incidents) 
of hospitalizations involved magnet sets, magnet toys, or jewelry. 
Moreover, as Table 10 shows, magnet ingestions from magnet toys, magnet 
sets, and jewelry, all resulted in hospitalization far more often than 
they resulted in other non-hospitalization dispositions.
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    \80\ To determine the type of products involved in magnet 
ingestion hospitalizations, this analysis excludes the 27 incidents 
for which there was insufficient information to categorize the type 
of magnet ingested.
    \81\ There were no incidents in CPSRMS that were identified as 
involving science kits.
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    Use patterns at the time magnets were ingested also show the need 
to address amusement and jewelry products. The most common identified 
use pattern at the time of a magnet ingestion was playing, meaning the 
victim was playing

[[Page 1290]]

with, fidgeting with, or orally exploring magnets at the time of 
ingestion. This use pattern would be expected for products intended for 
amusement, since they are intended for play. As Table 13 shows, in both 
NEISS and CPSRMS incidents, by far, playing was the most common use 
pattern identified,\82\ making up 70 percent (143 of 203) of the NEISS 
incidents, and 47 percent (61 of 129) of the CPSRMS incidents with 
identified use patterns. The next most common use pattern, after 
playing, was jewelry, meaning the magnets were being used as jewelry at 
the time of the incident. These made up 15 percent (31 of 203) of the 
NEISS incidents, and 33 percent (43 of 129) of the CPSRMS incidents 
with identified use patterns. The remaining identified use patterns 
made up fewer of the incidents. As discussed in section IV.A.5. 
Uncertainties in Incident Data, above, it is reasonable to conclude 
that magnet ingestions in the unidentified product type category follow 
this same pattern, with most involving products intended for amusement 
or jewelry.
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    \82\ For many NEISS and CPSRMS incidents, there was insufficient 
information for staff to determine the use pattern at the time 
magnets were ingested. To identify relevant use patterns, this 
analysis focuses on the 203 NEISS incidents and 129 CPSRMS incidents 
for which staff could determine the use pattern at the time of 
ingestion.
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    Together, these factors--the prevalence of magnet ingestion 
incidents that involve products categorized as magnet sets, magnet 
toys, or jewelry; the higher rate of hospitalizations and deaths for 
these product categories; and the fact that the primary uses of magnets 
at the time of ingestion were playing and jewelry--demonstrate that 
magnet sets, magnet toys, and jewelry are the primary products involved 
in magnet ingestion incidents and pose an increased risk of serious 
health implications when ingested. For these reasons, CPSC considers a 
rule addressing these specific product categories necessary to 
adequately reduce the risk of injury and death associated with magnet 
ingestions. The definition of ``subject magnets'' in the proposed rule, 
which is limited to amusement and jewelry products, focuses the 
proposed rule on these most problematic products.
    Developmental and Behavioral Factors. Child and teen development 
and behavior also support the need to address magnets intended for 
amusement and jewelry in the proposed rule. Small, powerful magnets, in 
general, are likely to appeal to children and teens. The tactile 
appeal, shine, color, snapping/clicking sounds when manipulated, 
novelty, unpredictability, and complexity of magnets appeal to children 
and teens. For younger children, it is developmentally normal to 
explore and put objects in their mouths. Incident data demonstrate 
this, with younger children more likely to ingest magnets intentionally 
(see Figures 3 and 4). Teens are at a developmental stage that involves 
testing limits, experimentation, bending rules, and conforming to peer 
pressures. Consistent with this, teens commonly ingested magnets 
accidentally when experimenting with them to simulate jewelry or 
piercings (see Figures 3 and 4). Magnets offer children and teens a 
seemingly safe and reversible way to try lip, tongue, cheek, and nose 
piercings.
    CPSC staff considers products that are intended for amusement and 
jewelry to be more likely to be accessible to and appealing to children 
and teens than other magnet products. Products that are intended for 
amusement and jewelry are likely to be perceived by children, teens, 
and caregivers as appropriate for use by children and teens; that 
perception is likely to make them accessible and appealing to children 
and teens. In contrast, magnets excluded from the scope of the proposed 
rule (e.g., home/kitchen magnets, such as hardware magnets for 
fastening items together, or shower curtain magnets) are likely to be 
part of common household products, making them less conspicuous, 
accessible, and appealing to children and teens, since they are not 
intended for amusement or jewelry, and making caregivers less likely to 
give them to, purchase them for, or allow their use by children and 
teens.
    Incident data and consumer reviews support this assessment. As the 
incident data indicate, for magnet ingestions in which staff could 
identify the product type involved, most products were magnet sets and 
magnet toys, neither of which are products intended for use by children 
under 14 years old (see Table 1 and Table 9). Despite this, the vast 
majority of magnet ingestion incidents involved children under 14 years 
old (see Table 5 and Table 12), which demonstrates that children and 
teens access these amusement products intended for older users. 
Similarly, incident data show that, where the use pattern at the time 
of ingestion is known, victims were, by far, most often playing with 
the magnet (see Table 13), suggesting that victims may be attracted to 
and access products that appear to be playthings. The second most 
common identified use pattern was jewelry (see Table 13), suggesting 
that children and teens are also particularly likely to interact with 
magnets that are part of jewelry.\83\
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    \83\ Incidents categorized as involving jewelry included cases 
in which the magnet was from a jewelry product or was described as 
jewelry at the time of ingestion, but the specific product could not 
be identified. For some of these incidents, it is possible that the 
magnets did not actually come from jewelry, but rather, came from 
other magnet products that children and teens were using as jewelry. 
However, staff considers most cases categorized as jewelry to have 
involved either jewelry or amusement products, such as magnet sets, 
being used as jewelry. This is because, of the cases for which staff 
could determine the product being used as jewelry, only one case in 
both the NEISS and CPSRMS datasets reported that the magnet being 
used as jewelry was actually a home/kitchen magnet, and none 
indicated the magnet was from an ASTM F963 magnet toy.
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    Of the magnet ingestion incidents for which the source of access 
could be identified, 19 percent (26 of 135) involved magnets that were 
purchased for the victim (see Table 14), despite most incidents 
involving children under 14 years old and products intended for users 
14 years and older. This suggests that children, teens, and caregivers 
perceive products like magnet sets and magnet toys to be appealing to 
and appropriate for children and teens.
    Another reason children and teens are particularly likely to be 
attracted by and access amusement products that include magnets is that 
these products often look the same as products intended as toys for 
children. Consumer reviews of products demonstrate this, with consumers 
commonly considering subject magnet products suitable playthings for 
children, and purchasing them for children, even when warnings state 
otherwise. Staff identified numerous incidents in which children 
ingested magnets from products that were marketed and labeled as not 
intended for children, and bore warnings regarding the magnet ingestion 
hazard. For example, staff identified 16 recent incidents in which 
children ingested magnets from a magnet set that included warnings and 
marketing indicating that the product was intended for adults. For 
older children, in particular, parents often do not expect that 
children would place magnets in their mouths.
    Recalls. Recalls of magnet products further demonstrate the need to 
focus on magnets intended for amusement. Of the 18 recalls that 
involved the magnet ingestion hazard between January 1, 2010 and August 
17, 2021, the vast majority involved products intended for amusement. 
The recalls primarily involved magnet sets and desk toys, rather than 
children's toys or other non-amusement products.

[[Page 1291]]

e. Excluding Children's Toys
    The scope of the proposed rule specifically excludes products that 
are subject to 16 CFR part 1250. Currently, 16 CFR part 1250 
incorporates by reference ASTM F963-17, which defines a ``toy'' as 
``any object designed, manufactured, or marketed as a plaything for 
children under 14 years of age.'' As discussed above, ASTM F963-17 
includes requirements consistent with the proposed rule, including the 
same performance requirements regarding size and strength.
    Recall information suggests that the toy standard is largely 
complied with and has been effective at addressing the magnet ingestion 
hazard in children's toys. As discussed in section IV.A.5. 
Uncertainties in Incident Data, since the toy standard became 
mandatory, there has been an appreciable decline in recalls of 
children's toys related to the magnet ingestion hazard. Of the 18 
recalls between 2010 and 2021 that involved the magnet ingestion 
hazard, only 4 involved children's toys, and only 2 of those were 
confirmed to have been noncompliant with the magnet requirements in 
ASTM F963. Recalls generally occur when a company receives information 
about a product being hazardous and reports it to CPSC. As such, the 
low rate of recalls involving the magnet ingestion hazard in children's 
toys suggests that these products largely comply with ASTM F963, and 
that the toy standard has been effective at addressing the magnet 
ingestion hazard in children's toys.
    In addition, as Table 10 suggests, when ASTM F963 magnet toys are 
ingested, they appear to result in severe injuries less commonly than 
other products. Magnet ingestions of ASTM F963 magnet toys resulted in 
hospitalization about as often as they resulted in other non-
hospitalization dispositions; in contrast, magnet toys, magnet sets, 
and jewelry all resulted in hospitalization far more often than they 
resulted in other non-hospitalization dispositions. This suggests that 
when ASTM F963 magnet toys are ingested, they may be less likely to 
result in serious health outcomes requiring hospitalization. Of the 108 
CPSRMS cases that had evidence of internal interaction through body 
tissue, only 6 cases involved products identified as ASTM F963 magnet 
toys. Of the 124 CPSRMS cases that indicated surgical procedures were 
necessary as a result of magnet ingestion, only 9 cases involved 
products identified as ASTM F963 magnet toys. Most, if not all, of the 
ingestions of ASTM F963 magnet toys that resulted in surgical 
intervention did not meet the requirements of ASTM F963.
    For these reasons, CPSC does not consider it necessary to further 
address children's toys in this proposed rule. Nevertheless, there are 
two elements of the definition of ``toys'' that are noteworthy for this 
proposed rule.
    First, ``toys'' are products that are intended as ``playthings.'' 
Thus, toys do not include products that are not playthings, even when 
they are intended for children under 14 years old. For example, 
children's jewelry, when not intended as a plaything, would not fall 
under the definition of a ``toy'' and, therefore, would not be subject 
to the toy standard.\84\ As such, children's non-toy jewelry is subject 
to the proposed rule. Additional products may also fall under the scope 
of the proposed rule, although intended for users under 14 years old, 
if they do not constitute ``playthings,'' but otherwise meet the 
definition of subject magnet products.
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    \84\ Section 1.3 of ASTM F963-17 states that the standard 
applies to ``toys intended for use by children under 14 years of 
age'' and section 3.1.91 defines a ``toy'' as ``any object designed, 
manufactured, or marketed as a plaything for children under 14 years 
of age.'' Section 1.3.1 of ASTM F2923-20 specifies that the 
standard, which applies to children's jewelry, does not apply to 
``toy jewelry or any other products that are intended for use by a 
child when the child plays (that is, a necklace worn by a doll or 
stuffed animal; novelty jewelry with play value)'' and further 
states that ``any product which is predominately used for play value 
is a toy'' and ``toys are subject to the requirements of Consumer 
Safety Specification F963.''
---------------------------------------------------------------------------

    Second, the definition of ``toys'' limits them to products intended 
for users under 14 years old. However, as magnet ingestion incident 
data show, products that are intended for users 14 years and older are 
commonly ingested by children and teens, indicating that the toy 
standard, on its own, cannot adequately address the magnet ingestion 
hazard. As discussed above, incidents categorized as involving magnet 
sets or magnet toys exclude products that staff confirmed were intended 
as playthings for children under 14 years old. These two categories 
were the most common categories of identified products involved in 
magnet ingestion incidents, despite the fact that most incidents 
involved children and teens under 14 years old. As Figure 2 shows, 
children as young as 11 months, and many children between 1 and 13 
years old ingest products in the magnet toys and magnet sets 
categories. Staff identified many incidents in which the product 
ingested was clearly marketed and labeled as intended for adults, with 
warnings regarding the magnet ingestion hazard, but the product was, 
nevertheless, ingested by children under the intended user age. In many 
cases, caregivers even provided these products to children, despite the 
warnings. This demonstrates why it is necessary to adopt a standard for 
products intended for users 14 years and older, in addition to the toy 
standard, to adequately address the magnet ingestion hazard.
f. Products Not Covered by the Proposed Rule
    Based on the definition of ``subject magnet products'' and the 
scope of the proposed rule, certain products that contain loose or 
separable magnets are not subject to the proposed rule. Home and 
kitchen magnets are one such product, if they do not otherwise meet the 
definition of subject magnet products. Common examples of home and 
kitchen magnets are refrigerator magnets, magnetic decorations, 
hardware for kitchen cabinets, and shower curtain accessories. If such 
products are not loose or separable or are not designed, marketed, or 
intended to be used for entertainment, jewelry, mental stimulation, or 
stress relief, they would not fall under the scope of the proposed 
rule.
    CPSC considers it reasonable to exclude home/kitchen products from 
the scope of the proposed rule for several reasons. For one, incident 
data indicate that home/kitchen magnets are far less commonly involved 
in magnet ingestion incidents than amusement and jewelry products. As 
Table 1 indicates, 16 percent (46 of 279) of NEISS magnet ingestion 
incidents for which the product category could be determined involved 
home/kitchen magnets; as Table 9 indicates, only 2 percent (6 of 241) 
of CPSRMS magnet ingestion incidents for which the product category 
could be determined involved home/kitchen magnets. Home/kitchen magnets 
also make up a very small portion of incidents that resulted in 
hospitalization. Table 10 shows that, only 3 percent (5 of 160) of the 
CSPRMS magnet ingestion incidents with identified product types that 
resulted in hospitalization, involved home/kitchen magnets. Of the 108 
CPSRMS cases that had evidence of internal interaction through body 
tissue, only 1 case involved products identified by staff as home/
kitchen products. Of the 124 CPSRMS cases that indicated surgical 
procedures were necessary as a result of magnet ingestion, only 2 cases 
involved products identified by staff as home/kitchen products.
    In addition, as discussed above, CPSC considers it less likely that 
children and teens will interact with, play with, or experiment with 
home/kitchen magnets,

[[Page 1292]]

particularly in ways that may lead to ingestion. Home/kitchen products 
excluded from the proposed rule have intended uses that do not include 
amusement or jewelry, and are often part of common household products, 
making them less conspicuous, accessible, and appealing to children and 
teens, since they are not intended for amusement or jewelry, and making 
caregivers less likely to give them to, purchase them for, or allow 
their use by children and teens. In contrast, the intended uses of 
amusement and jewelry products make them appear less hazardous, and 
more likely to be appealing and accessible to children and teens.
    Other products that would fall outside the scope of the proposed 
rule include research and educational products, or those intended for 
commercial or industrial purposes, if they are not also intended for 
amusement or jewelry.\85\ CPSC considers it appropriate to exclude 
these products for several reasons. As incident data indicate, almost 
no magnet ingestion incidents for which product types could be 
identified involved products intended for education, research, 
commercial, or industrial use. Among NEISS incidents, only one 
incident--involving a science kit--potentially involved such a product; 
no such incidents were identified in CPSRMS data. For that one 
incident, little information was available about the science kit, but 
staff considered it possible that the product was intended for 
educational purposes.
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    \85\ It is also possible that products intended for purposes 
such as education, research, or industrial applications would not 
meet the definition of a ``consumer product,'' if they are not 
commonly sold to or used by consumers. If, for example, magnets for 
research purposes were sold through outlets primarily accessible to 
and used by laboratories or other research facilities, these may not 
be considered consumer products.
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    Staff also considers it less likely that children or teens would 
have access to such products. For example, magnets used for research or 
industrial applications are likely to be in settings that children do 
not frequent. Even if children could access such products, for the same 
reasons as home/kitchen magnets, staff considers it less likely that 
these products would appeal to children, appear to be playthings or 
jewelry to children or caregivers, or for children to interact with 
them in ways that would lead to ingestion.
    In addition to the likely reduced hazard these out-of-scope 
products present to children and teens, CPSC also seeks to limit the 
scope of the proposed rule to the extent possible to reduce the impact 
on products, such as research, education, and industrial magnet 
products, that may have important uses and require magnets that are 
small and strong to serve their function. In contrast, amusement and 
jewelry products likely serve less critical functions and may still 
serve their purpose with slightly larger or slightly weaker magnets, or 
non-separable magnets.
g. Other Factors Not Used in the Proposed Rule
    CPSC considered using additional criteria, such as magnet 
composition or shape, as part of the scope of the proposed rule. 
However, CPSC did not limit the scope of the proposed rule to specific 
magnet compositions because staff has found that various magnet 
compositions have been involved in internal interaction incidents. For 
example, NIB is commonly used for smaller magnets from magnet sets and 
magnetic jewelry sets, and ferrite/hematite is commonly used for larger 
magnets, such as rock-shaped magnet toys. Staff testing of magnets in 
consumer products indicates that magnets with various compositions 
often have very high flux indexes, far in excess of the proposed limit 
of less than 50 kG\2\ mm\2\, warranting a standard for various 
compositions. CPSC did not include specific shapes or sizes in the 
scope of the proposed rule because staff found that various shapes and 
sizes of magnets present the hazard, including rock-shaped magnets, and 
most incident reports lack information about the specific shapes and 
sizes of the magnets. As such, the performance requirements in the 
proposed rule address magnets that could be ingested, regardless of 
their shape.

B. Performance Requirements

1. Proposed Requirements
    Under the proposed rule, each loose or separable magnet in a 
subject magnet product that fits entirely within the small parts 
cylinder described in 16 CFR 1501.4 must have a flux index of less than 
50 kG\2\ mm\2\ when tested in accordance with a prescribed method. 
Thus, the first step is to determine whether each loose or separable 
magnet in a subject magnet product fits in the small parts cylinder and 
what its flux index is.
    The small parts cylinder is described and illustrated in 16 CFR 
part 1501.4. Figure 5, below, shows the illustration, including the 
dimensions, of the cylinder, provided in the regulation.
BILLING CODE 6355-01-P

[[Page 1293]]

[GRAPHIC] [TIFF OMITTED] TP10JA22.004

    If a magnet fits entirely within this cylinder, then its flux index 
must be less than 50 kG\2\ mm\2\.
    To determine the flux index of a magnet, the proposed rule provides 
that at least one loose or separable magnet of each shape and size in 
the subject magnet product must have its flux index determined using 
the procedure in sections 8.25.1 through 8.25.3 of ASTM F963-17, which 
specify test equipment, measurements, the test method, and the 
calculation for determining flux index. The test requires a direct 
current field gauss meter with a resolution of 5 gauss (G) capable of 
determining the field with an accuracy of 1.5 percent or better and an 
axial probe with a specified active area diameter and a distance 
between the active area and probe tip. Using the meter, the probe tip 
is placed in contact with the pole surface of the magnet, the probe is 
kept perpendicular to the surface, and the probe is moved across the 
surface to find the maximum absolute flux density. The flux index, in 
kG\2\ mm\2\, is determined by multiplying the area of the pole surface 
(mm\2\) of the magnet by the square of the maximum flux density 
(kG\2\). The flux density must be less than 50 kG\2\ mm\2\ to comply 
with the proposed rule.
2. Basis for Proposed Requirements
a. Size Requirements
    The first portion of the performance requirement in the proposed 
rule involves determining whether a magnet fits entirely within the 
small parts cylinder described in 16 CFR 1501.4. The purpose of this 
requirement is to determine whether a magnet is small enough to be 
swallowed. If so, then it is subject to strength requirements to reduce 
the risk of internal interaction injuries from strong magnets. However, 
if the magnet is too large to be swallowed, as determined by the small 
parts cylinder, then it is not subject to any strength requirements.
    The small parts cylinder was developed to address choking, 
aspiration, and ingestion hazards for children, and was largely based 
on research and data regarding the size of objects children ingest. To 
address this hazard, since 1980, the Commission's regulations (at 16 
CFR part 1501) have specified that certain toys and other articles 
intended for use by children must not contain choking, aspiration, or 
ingestion hazards for children. Whether these products present such 
hazards is determined by whether they fit within the small parts 
cylinder described in 16 CFR 1501.4.\86\ Several ASTM standards for 
children's products reference these regulations as well, requiring that 
products have no small parts as determined by 16 CFR part 1501,\87\ and 
the small parts cylinder specified in the ASTM standards that addresses 
magnet ingestions is the same as in 16 CFR 1501.4. Similarly, the small 
parts cylinders referenced in international standards that address 
magnet ingestions, including EN 71-1: 2014 and ISO 8124-1: 2018, are 
also the same as in 16 CFR 1501.4. These standards are developed by 
consensus of various groups, including consumer groups, children's 
product engineers and experts, and manufacturers of children's 
products. As such, the small parts cylinder in 16 CFR 1501.4 is 
consistent with consensus standards developed with cooperation and 
input from various experts, is widely recognized, and has long been 
used as a way to identify products that children can ingest.
---------------------------------------------------------------------------

    \86\ See 43 FR 47684 (Oct. 16, 1978); 44 FR 34892 (June 15, 
1979).
    \87\ For example, ASTM F2088-20, Standard Consumer Safety 
Specification for Infant and Cradle Swings.
---------------------------------------------------------------------------

    Incident data further support the effectiveness of the small parts 
cylinder in 16 CFR part 1501.4 to address the magnet ingestion hazard. 
As discussed above, magnet ingestion incidents substantially declined 
during the years the magnet sets rule was announced and in effect, and 
substantially increased after the rule was vacated. The magnet sets 
rule included the same performance requirements regarding size and 
strength as this proposed rule, including the small parts cylinder. The 
marked decline in magnet ingestions during that rule suggests that the 
performance requirements in that rule were effective at reducing the 
risk of children ingesting magnets.
    Similarly, there was a significant decline in recalls involving the 
magnet ingestion hazard after the toy standard became mandatory. The 
toy standard requires compliance with ASTM F963, which includes the 
same small parts cylinder as 16 CFR 1501.4. As such, this decline in 
recalled toys that present a magnet ingestion hazard after the toy 
standard became mandatory suggests that the requirements in that rule 
were effective at reducing the risk of children ingesting magnets. The 
low number of magnet ingestion incidents that identify ASTM F963 magnet 
toys as the involved product also indicates that the requirements in 
the standard have been effective at addressing the magnet ingestion 
hazard. Moreover, when magnet ingestions did occur with children's 
toys, they rarely resulted in

[[Page 1294]]

the internal interaction hazard, and those that did result in internal 
interaction, did not comply with the toy standard.
    For these reasons, the proposed rule uses 16 CFR 1501.4 as the 
means of determining whether a child could ingest a particular magnet, 
thereby subjecting it to performance requirements regarding strength, 
to reduce the risk of injury.
b. Strength Requirements
    When a magnet is small enough to fit entirely within the small 
parts cylinder, the proposed rule requires that the magnet have a flux 
index less than 50 kG\2\ mm\2\. This provision consists of two 
elements--a method for determining flux index, and a flux index limit 
of less than 50 kG\2\ mm\2\. This requirement is intended to reduce the 
risk that a magnet is strong enough to cause internal interaction 
injuries, if ingested. This section discusses the rationale for both 
the flux index methodology and the flux index limit in the proposed 
rule.
    Flux Index Methodology. The proposed rule incorporates by reference 
the provisions in ASTM F963 that specify the method for measuring and 
calculating flux index. The ASTM Subcommittee F15.22 on Toy Safety 
developed this methodology and ASTM first published it in ASTM F963-07. 
The magnetic flux index estimates the magnet attraction force of 
individual single-pole magnets.
    A magnet's composition, mass, and shape determine its magnetic 
field. This field is aligned with its north and south magnetic poles 
(see Figure 6). Surface flux density is a measurement of the magnetic 
field intensity at a given perpendicular distance above an area 
(dimension ``x'' in Figure 6). The maximum flux density is measured 
perpendicular to the pole surface of a magnet.
[GRAPHIC] [TIFF OMITTED] TP10JA22.005

BILLING CODE 6355-01-C
    The ASTM F963 working group that developed the flux index 
methodology aimed to address injuries involving children ingesting 
small, powerful magnets. As such, it was designed to address the same 
hazard at issue in this proposed rule, and minimize the risk of 
internal injuries when magnets are ingested. As part of an ASTM 
standard, this methodology was developed by consensus, with input from 
various stakeholders, such as children's product manufacturers, 
consumer groups, and children's product engineers and experts. In 
addition, this methodology is used in multiple ASTM standards that 
address the magnet ingestion hazard, international standards (including 
EN 71-1: 2014 and ISO 8124-1: 2018), and the mandatory toy standard in 
16 CFR part 1250. As part of these standards, the methodology is widely 
recognized and accepted, and has been used for many years.
    CPSC staff considers this methodology effective for assessing the 
strength of subject magnet products. Incident data also support the 
effectiveness of the flux index methodology in ASTM F963 to address the 
magnet ingestion hazard. Magnet ingestion incidents appreciably 
declined during the years the magnet sets rule was announced and in 
effect, and appreciably increased after the rule was vacated. The 
magnet sets rule included the same size and strength limits as this 
proposed rule, and incorporated by reference the flux index methodology 
in ASTM F963. The decline in magnet ingestions during that rule 
suggests that the performance requirements in that rule were effective 
at reducing the risk of injury and death associated with magnet 
ingestions. Similarly, there was a significant decline in recalls 
involving the magnet ingestion hazard after the toy standard became 
mandatory. The toy standard requires compliance with ASTM F963 and, 
therefore, includes the same flux index methodology as this proposed 
rule. The decline in recalled toys that present a magnet ingestion 
hazard after the toy standard became mandatory suggests that the 
requirements in that rule were effective at reducing the risk of injury 
and death associated with magnet ingestions. The low number of magnet 
ingestion incidents that identify ASTM F963 magnet toys as the involved 
product also indicates that the requirements in the standard have been 
effective at reducing the magnet ingestion hazard. When magnet 
ingestions did occur with children's toys, they rarely resulted in the 
internal interaction hazard, and those that did result in internal 
interaction, did not comply with the toy standard.
    For these reasons, the proposed rule uses the flux index 
methodology in

[[Page 1295]]

ASTM F963-17 as the means of measuring the strength of magnets for 
purposes of limiting the risk of internal interaction injuries when 
ingested.
    There are two issues that the Commission seeks input on regarding 
the flux index methodology. The first issue involves how many magnets 
to test. The proposed rule and ASTM F963-17 do not explicitly state how 
many magnets from a product to test, or whether to use statistical 
sampling. The proposed rule requires at least one loose or separable 
magnet of each shape and size to be tested, and specifies that each 
loose or separable magnet in a subject magnet product that fits 
entirely within the small parts cylinder must have a flux index less 
than 50 kG\2\ mm\2\. Similarly, section 4.38.1 of ASTM F963-17 states 
that ``toys shall not contain a loose as-received hazardous magnet or a 
loose as-received hazardous magnetic component.'' These provisions 
indicate that each magnet may need to be tested to ensure that 
compliance with the size and strength provisions.
    However, subject magnet products may consist of hundreds or 
thousands of individual magnets. As such, it may be reasonable to 
require that only a ``representative sample'' or ``at least one 
representative sample of each shape and size'' be tested. CPSC staff's 
testing of magnets, described below, suggests that individual magnets 
within the same product may have different flux indexes, which may 
suggest that it is important to test each individual magnet in a 
product. CPSC seeks comments on how firms would test products to align 
with the proposed requirements, whether another requirement regarding 
the number of magnets to test is appropriate, and how firms would 
satisfy such alternative requirements.
    The second issue for which the Commission seeks comments is the 
utility of the flux index methodology for certain magnets--in 
particular, small spherical magnets. Staff has found the flux index 
methodology straightforward and consistent when used for large disc 
magnets. However, staff encountered some challenges finding the 
location of the poles for magnets smaller than 3 mm in diameter because 
of difficulties handling these particularly small spherical magnets. 
This may result in inaccurate measurements of the highest flux index 
values if the value is not measured above the magnet's pole. Staff 
testing of 2.5 mm spherical magnets, described below, illustrates this 
potential issue.
    To examine possible ways to address this, staff refined the test 
procedure in ASTM F963-17 to include additional detail to locate the 
magnet pole and secure the magnet on a base, rather than holding it. 
This test procedure maintained the flux index methodology in ASTM F963-
17, and merely added information to it, which staff found improved the 
accuracy and consistency of flux density measurements and calculations. 
This refined procedure is provided in detail in the Appendix to Tab D 
of the NPR briefing package. To summarize, the refined test method 
consists of the following steps:

    (1) Use a flat magnetic or ferromagnetic utensil to attract 
spherical magnets into alignment with pole orientation towards the 
utensil;
    (2) Transfer the spherical magnets from the utensil to a flat 
surface covered in at least 2 mm depth of putty that is dense/thick 
enough to maintain the configuration of the spherical magnets in the 
proper pole orientation (established by magnetic attraction with the 
utensil); and
    (3) With the spherical magnets aligned in the flat surface putty 
with pole orientation facing away from the test surface, use the 
gauss meter probe to determine the maximum flux value of each 
individual magnet.

    The additional detail in this refined procedure is one option for 
potentially supplementing the flux index methodology in ASTM F963-17. 
However, there are other potential alternatives to the method in ASTM 
F963-17, such as considering attraction and repulsion forces. The 
Commission requests comments on the variability of flux index results, 
issues determining the flux index of smaller magnets, and potential 
refinements or alternatives to the proposed methodology for assessing 
the strength of magnets.
    Flux Index Limit. The proposed rule limits the flux index of 
magnets small enough to be swallowed to less than 50 kG\2\ mm\2\. ASTM 
introduced this flux index limit in 2007, in ASTM F963-07.\88\ ASTM set 
the flux index limit at 50 kG\2\ mm\2\ based on measurements of flux 
indexes in magnetic toys that were involved in magnet ingestion 
incidents at the time, which generally had flux index measurements over 
70 kG\2\ mm\2\. Based on this information, 70 kG\2\ mm\2\ was 
determined to be an unsafe flux index measurement, and ASTM set the 
limit at 50 kG\2\ mm\2\ to provide a factor of safety.
---------------------------------------------------------------------------

    \88\ ASTM F963-2007 specified that prohibited hazardous magnets 
had a flux index greater than 50 kG\2\ mm\2\, however, this was 
revised in later versions of the standard, and ASTM F963-17 now 
prohibits hazardous magnets with a flux index of 50 kG\2\ mm\2\ or 
more.
---------------------------------------------------------------------------

    As part of an ASTM standard, the flux index limit was developed by 
consensus of various groups, including consumer groups, children's 
product engineers and experts, and manufacturers of children's 
products. Additional ASTM standards, as well as international standards 
that address magnet ingestions, including EN 71-1: 2014 and ISO 8124-1: 
2018, also include a flux index limit of 50 kG\2\ mm\2\ for ingestible 
magnets. As such, the flux index limit of 50 kG\2\ mm\2\ is consistent 
with consensus standards developed with cooperation and input from 
various experts, is widely recognized, and has long been used as a way 
to reduce the internal interaction hazard when magnets are ingested.
    Incident data support the effectiveness of this flux index limit to 
address the magnet ingestion hazard. Magnet ingestion incidents 
substantially declined during the years the magnet sets rule was 
announced and in effect, and substantially increased after the rule was 
vacated. The magnet sets rule included a flux index limit of 50 kG\2\ 
mm\2\ for ingestible magnets. The marked decline in magnet ingestions 
during that rule suggests that the performance requirements in that 
rule were effective at reducing the risk of injury and death associated 
with magnet ingestions. Similarly, there was a significant decline in 
recalls involving the magnet ingestion hazard after the toy standard 
became mandatory. The toy standard requires compliance with ASTM F963 
and, therefore, includes the same 50 kG\2\ mm\2\ limit for ingestible 
magnets as the proposed rule. This decline in recalled toys for magnet 
ingestion hazards suggests that the requirements in that rule were 
effective at reducing the risk of injury and death associated with 
magnet ingestions. The low number of magnet ingestion incidents that 
identify ASTM F963 magnet toys as the involved product also indicate 
that the requirements in that standard have been effective at 
addressing the magnet ingestion hazard. Moreover, when magnet 
ingestions did occur with children's toys, they rarely resulted in 
internal interaction, and those that did result in internal 
interaction, did not comply with the toy standard.
    Staff's assessment of the flux index of subject magnet products, 
including those involved in magnet ingestion incidents, and those known 
to have involved internal interaction injuries, indicates that subject 
magnet products have a wide range of flux indexes. The most common 
subject magnet products staff identified are 3 to 6 mm and have flux 
indexes of 300 to 400 kG\2\ mm\2\. However, staff's testing of smaller 
2.5 mm magnets, some of which resulted in internal interaction injuries 
when ingested, yielded flux indexes close to 50 kG\2\ mm\2\. CPSC 
expects that, in order

[[Page 1296]]

to comply with the proposed rule, firms will use magnets with flux 
indexes sufficiently lower than 50 kG\2\ mm\2\ in subject magnet 
products, to account for manufacturing and testing variances/
tolerances, which may result in subject magnet products having flux 
indexes even lower than required by the rule.
    Based on the widespread and longstanding use of the flux index 
limit of 50 kG\2\ mm\2\, its development and acceptance by multiple 
stakeholders, the effectiveness of standards that have used this limit 
to address magnet ingestion incidents, and staff testing showing that 
magnets involved in internal interaction incidents had flux indexes 
close to 50 kG\2\ mm\2\, the Commission proposes to require that 
magnets that are small enough to ingest have a flux index of less than 
50 kG\2\ mm\2\.
    However, the Commission seeks comments on this flux index limit, 
whether a lower limit may be appropriate, and seeks testing and safety 
data supporting an appropriate flux index limit. CPSC testing of a 
small sample of subject magnet products suggests that magnets with a 
flux index lower than (i.e., weaker than) 50 kG\2\ mm\2\ may be capable 
of causing internal interaction injuries, indicating that a flux index 
limit lower than 50 kG\2\ mm\2\ may be appropriate to address the 
internal interaction hazard; however, this testing did not provide 
conclusive evidence that magnets weaker than 50 kG\2\ mm\2\ present an 
internal interaction hazard. This testing is described below.
    CPSC Testing. To gather information about the flux index 
methodology, flux index limit, and what flux index can interact 
internally though body tissue, staff conducted testing on a small 
number of magnets. Staff tested magnets with diameters smaller than 5 
mm because they generally had lower flux indexes than larger magnets, 
and because these smaller magnets presented the testing challenges 
described above. Staff used the test method in ASTM F963-17 with the 
additions described in the Appendix to Tab D of the NPR briefing 
package. This testing involved only a small number of samples, and a 
limited variety of products, sizes, and shapes. As such, while this 
testing is informative and raises potential issues, the broader 
significance of these results is limited.
    In March, April, and June 2021, CPSC staff tested magnets with 
diameters smaller than 5 mm, including 2.5 mm diameter spherical 
magnets from nine exemplar samples of one brand of magnet set, and two 
incident samples of the same brand.\89\ Additionally, staff tested 3 mm 
diameter spherical magnets from two incident samples from unknown 
manufacturers. Staff selected these samples because of their 
involvement in internal interaction incidents. CPSC is aware of 16 
ingestion incidents and one nasal insertion incident involving the 2.5 
mm diameter spherical magnets that staff tested.\90\ These 17 incidents 
resulted in at least 10 surgeries (such as appendectomy and bowel 
resection) and six instances of internal interaction through body 
tissue. The nasal insertion incident involved two 2.5 mm diameter 
spherical magnets attracting through and perforating the victim's nasal 
septum, which is tissue thicker than the GI walls.
---------------------------------------------------------------------------

    \89\ Exemplar refers to products that are the same model and 
brand as those involved in the incident, but not the actual product 
involved in the incident. Incident samples refer to the actual 
products involved in an incident.
    \90\ Many of these cases occurred after the NEISS and CPSRMS 
data extraction used for the NPR briefing package and, therefore, 
are not captured in those datasets.
---------------------------------------------------------------------------

    In March 2021, staff conducted inter-rater reliability testing 
(i.e., the extent to which 2 or more observations agree) in which 3 
staff members tested the same 21 exemplar 2.5 mm diameter spherical 
magnets. Three magnets were tested from each of 7 sets/samples of the 
same magnet set brand. Staff chose 3 magnets from each set to analyze 
intra-set variability in magnetic flux index. Table 15 shows the 
results of this testing.

                                     Table 15--Inter-Rater Reliability Test Measurements of 2.5 mm Spherical Magnets
                                                                      [March 2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Magnet 1 (kG\2\ mm\2\)              Magnet 2 (kG\2\ mm\2\)              Magnet 3 (kG\2\ mm\2\)
                  Test set                   -----------------------------------------------------------------------------------------------------------
                                               Tester 1    Tester 2    Tester 3    Tester 1    Tester 2    Tester 3    Tester 1    Tester 2    Tester 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...........................................      53.788      56.294      42.730      48.950      50.797      47.197      50.797      53.246      50.462
2...........................................      59.477      60.876      53.926      52.055      54.175      40.755      53.372      56.197      74.308
3...........................................      29.021      29.627      28.191      29.205      30.752      27.507      39.152      41.192      35.507
4...........................................      33.226      33.932      31.232      51.627      54.623      36.160      53.605      53.705      42.825
5...........................................      42.940      41.681      46.425      52.600      51.631      48.106      46.501      48.576      44.031
6...........................................      34.381      34.838      34.217      40.974      40.279      39.920      35.085      36.197      33.905
7...........................................      55.118      56.522      53.955      56.819      57.577      56.230      40.890      34.274      39.933
--------------------------------------------------------------------------------------------------------------------------------------------------------

    These results suggest several points of interest. For one, they 
indicate that there was some variation in flux index results across 
testers. In addition, these results suggest that magnets from the same 
set tend have more similar flux index measurements than magnets from 
different sets of the same product. The results also suggest that there 
is variation in the flux indexes of magnets from the same set, and the 
same products (across sets). The flux index measurements of 21 exemplar 
2.5 mm diameter spherical magnets from 7 different magnet sets of the 
same brand ranged from 27.507 to 74.308 kG\2\ mm\2\. This variation in 
flux indexes, potentially due to manufacturing variation and testing 
variation, may necessitate that firms use magnets with flux indexes 
sufficiently lower than 50 kG\2\ mm\2\ in subject magnet products, to 
account for this potential variation in flux index results.
    This variation also may have implications for the number of magnets 
in a product that should be tested to assess flux index. Under the 
proposed rule, one loose or separable magnet with a flux index of 50 
kG\2\ mm\2\ or more in a subject magnet product makes the whole product 
violative. However, this above testing suggests that this determination 
may be affected by the number or sample of magnets tested from a 
product because a product that includes multiple magnets may contain 
some magnets that meet and some that exceed the flux index limit. Thus, 
this testing may have implications for how many magnets from a product 
should be tested (e.g., all magnets in the product,

[[Page 1297]]

a representative sample of magnets in the product).
    In addition, because this testing used exemplars, and not the 
magnets that were actually ingested, staff cannot determine what flux 
index measurements resulted in internal interaction injuries. However, 
these results suggest that magnets ranging from approximately 30 to 70 
kG\2\ mm\2\ could have resulted in internal interaction injuries. If 
the actual magnets involved in the incident had flux indexes of 50 
kG\2\ mm\2\ or more, the proposed rule would address these injuries; if 
the actual magnets involved in the incident had flux indexes closer to 
30 to 40 kG\2\ mm\2\, the proposed rule may not address these injuries.
    In March and April 2021, staff conducted similar testing. Three 
staff members tested spherical magnets from 4 separate sample/sets that 
were involved in internal interaction incidents. Set 1 included a 
single 2.5 mm diameter magnet that had not been ingested, but was from 
a set of ingested magnets that had interacted internally through a 
victim's body tissue. The remaining 3 sets had magnets that were 
ingested and removed from the intestines of the victim who swallowed 
them (i.e., interacted internally through victims' body tissue). Staff 
tested 3 magnets from each of these 3 sets; 2 of the 3 sets were 
composed of 3 mm diameter magnets and 1 set was composed of 2.5 mm 
diameter magnets. The results are provided in Table 16.

                          Table 16--Test Measurements of 2.5 mm and 3 mm Spherical Magnet Sets Involved in Ingestion Incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Magnet 1 (kG\2\ mm\2\)              Magnet 2 (kG\2\ mm\2\)              Magnet 3 (kG\2\ mm\2\)
                     Set                     -----------------------------------------------------------------------------------------------------------
                                               Tester 1    Tester 2    Tester 3    Tester 1    Tester 2    Tester 3    Tester 1    Tester 2    Tester 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...........................................      42.020      45.173      41.766         N/A         N/A         N/A         N/A         N/A         N/A
2...........................................      76.919      82.469      65.959      72.911      70.882      63.795      70.206      68.475      63.843
3...........................................      46.239      48.513      46.384      47.536      49.427      47.991      48.309      52.135      48.749
4...........................................      93.979      96.426      89.349      90.240      96.383      88.218      89.070      94.970      95.712
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The results in Table 16 show similar trends as the testing above, 
with there being some variation across testers, less variation within 
sets than across sets, and a range of flux indexes across magnets, and 
sets. Set 1 in Table 16 was the same brand as the sets shown in Table 
15, was a 2.5 mm spherical magnet, and had flux indexes that ranged 
from 41.766 to 45.173 kG\2\ mm\2\. Although this magnet was from a set 
that was ingested and interacted internally through body tissue, this 
exact magnet was not ingested, so staff cannot determine the flux index 
of the magnets that were ingested, but it is possible that the magnets 
that interacted through body tissue were also in this range, with flux 
indexes less than 50 kG\2\ mm\2\.
    Sets 2 and 4 in Table 16 were 3 mm diameter spherical magnets from 
2 sets from unknown manufacturers. The magnets staff tested for these 
sets were actually ingested and had interacted internally through a 
victim's body tissue. As such, the results for these sets are 
particularly useful for assessing the magnet strength that may attract 
internally through body tissue. These magnets had flux indexes that 
ranged from 63.795 to 96.426 kG\2\ mm\2\. Thus, the limit of 50 kG\2\ 
mm\2\ in the proposed rule would address the magnet interaction hazard 
these magnets presented, with a factor of safety to account for 
potential variation in results across testers, manufacturing variation, 
and variation due to the challenges of testing small spherical magnets.
    Set 3 in Table 16 included three 2.5 mm diameter spherical magnets 
from a magnet set of the same brand as those in Table 15. The tested 
magnets had been ingested and interacted internally through the 
victim's tissue. Thus, like sets 2 and 4, these results are 
particularly useful for assessing the magnet strength that may attract 
internally through body tissue. The flux indexes for these magnets 
ranged from 46.239 to 52.135 kG\2\ mm\2\. Using only Tester 1 or Tester 
3's results, these magnets would comply with the proposed rule because 
these testers found flux indexes less than 50 kG\2\ mm\2\ for all 3 
magnets. Using Tester 2's results, these magnets would not comply with 
the proposed rule because magnet 3 in the set had a flux index of more 
than 50 kG\2\ mm\2\. Because, depending on the tester, this set may 
comply with the proposed rule but interacted internally through body 
tissue, these results raise the question whether a lower flux index 
limit may be appropriate. However, even with a flux index limit of 50 
kG\2\ mm\2\, it is possible that the proposed rule would address the 
incident involving these magnets because the flux indexes for this set 
were very close to 50 kG\2\ mm\2\. To comply with the proposed rule, 
firms may build in a factor of safety to ensure their magnets are not 
close to 50 kG\2\ mm\2\, to account for variation in test results and 
testers and ensure their products will comply with the standard.
    In June 2021, CPSC staff tested magnets from 2 more exemplar magnet 
sets of the same brand shown in Table 15, each of which consisted of 
spherical rare-earth magnets that were 2.5 mm in diameter. Magnet sets 
of this brand and type were known to have been involved in at least 6 
internal interaction incidents. Staff measured the flux index of 3 
magnets from each set and calculated the flux index values. The results 
are in Table 17.

                                             Table 17--Test Measurements of Two 2.5 mm Diameter Magnet Sets
                                                                       [June 2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Sample magnet set 1                                         Sample magnet set 2
                                 -----------------------------------------------------------------------------------------------------------------------
             Magnet                               Max                                                         Max
                                   Max flux     flux\2\    Diameter      Area     Flux index   Max flux     flux\2\    Diameter      Area     Flux index
                                     (kG)       (kG\2\)      (mm)       (mm\2\)                  (kG)       (kG\2\)      (mm)       (mm\2\)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................       2.812       7.907       2.520       4.985      39.417       3.343      11.174       2.520       4.985      55.705
2...............................       2.714       7.363       2.550       5.104      37.585       3.450      11.903       2.590       5.266      62.677
3...............................       2.798       7.826       2.410       4.559      35.683       3.275      10.726       2.530       5.025      53.896
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 1298]]

    Again, these results indicate variation in the flux indexes of 
magnets within the same set, and that flux indexes are more similar 
within a set than across sets. For the 6 magnets tested, flux indexes 
ranged from 35.683 to 62.677 kG\2\ mm\2\.
    The following provides a summary of the consolidated results of all 
of these tests. Staff assessed 2.5 mm and 3 mm diameter spherical 
magnets associated with internal interaction incidents. The exemplar 
2.5 mm magnets had flux index values between 27.507 to 74.308 kG\2\ 
mm\2\. Incident samples with magnets involved in internal interaction 
injuries had flux index values between 46.239 and 52.135 kG\2\ mm\2\ 
for the 2.5 mm magnets, and 63.795 to 96.426 kG\2\ mm\2\ for the 3 mm 
diameter magnets. In general, these results suggest that the proposed 
rule would address the internal interaction hazard associated with 
magnet ingestions because many of the sets tested would not comply with 
the proposed rule because at least one of the tested magnets had a flux 
index of 50 kG\2\ mm\2\ or more. For the reasons described above, staff 
considers the flux index methodology and limit in the proposed rule to 
be appropriate to adequately address the magnet ingestion hazard.
    However, these results also suggest that there is some variability 
in the flux index values, which may have implications for the proposed 
flux index test methodology. These results also indicate that magnets 
that may have flux indexes lower than 50 kG\2\ mm\2\ may have caused 
internal interaction injuries, suggesting that a lower flux index limit 
than 50 kG\2\ mm\2\ may be appropriate; however, the results are 
inconclusive because staff could not identify, with certainty, the flux 
indexes of magnets that actually caused internal interaction injuries. 
In addition, staff notes the limited scope of this testing, including 
the small sample size, and limited variety of products tested. The 
Commission seeks comments on the proposed requirements regarding flux 
index methodology and limits, including information about whether flux 
indexes below 50 kG\2\ mm\2\ present an internal interaction hazard.

VII. Preliminary Regulatory Analysis 91
---------------------------------------------------------------------------

    \91\ Further detail regarding the preliminary regulatory 
analysis is available in Tab E of the NPR briefing package.
---------------------------------------------------------------------------

    The Commission is proposing to issue a rule under sections 7 and 9 
of the CPSA. The CPSA requires that the Commission prepare a 
preliminary regulatory analysis and publish it with the text of the 
proposed rule. 15 U.S.C. 2058(c). The following discussion is extracted 
from staff's memorandum, ``Preliminary Regulatory Analysis of a Draft 
Proposed Rule that Would Establish a Standard for Hazardous Magnet 
Products,'' available in Tab E of the NPR briefing package.

A. Preliminary Description of Potential Costs and Benefits of the 
Proposed Rule

    The preliminary regulatory analysis must include a description of 
the potential benefits and costs of the proposed rule. The benefits of 
the rule are measured as the expected reduction in the societal costs 
of deaths and injuries that would result from adopting the proposed 
rule and any benefits that cannot be quantified. The costs of the rule 
consist of the added costs associated with modifying or discontinuing 
products that do not comply with the requirements of the rule, 
including any impacts on the utility of the products for consumers, as 
well as any costs that cannot be quantified.
1. Deaths and Injuries Related to Magnet Ingestions
    As discussed above, based on NEISS data, which is a nationally 
representative probability sample of about 100 U.S. hospitals, there 
were an estimated 4,400 ED-treated magnet ingestions between 2010 and 
2020 that involved subject magnet products, and an additional estimated 
18,100 ED-treated magnet ingestions that involved unidentified magnet 
products, of which CPSC concludes a large portion involved subject 
magnet products.
    In addition to injuries initially treated in hospital EDs, many 
product-related injuries are treated in other medical settings, such 
as, physicians' offices, clinics, and ambulatory surgery centers. Some 
injuries also result in direct hospital admissions, bypassing hospital 
EDs entirely. CPSC estimates the number of subject magnet product 
injuries treated outside of hospital EDs with CPSC's Injury Cost Model 
(ICM), which uses empirical relationships between the characteristics 
of injuries (diagnosis and body part) and victims (age and sex) 
initially treated in hospital EDs and the characteristics of those 
initially treated in other settings.\92\
---------------------------------------------------------------------------

    \92\ A detailed discussion of the ICM and these methods is in: 
Miller, T.R., Lawrence, B.A., Jensen, A.F., Waehrer, G.M., Spicer, 
R.S., Lestina, D.C., and Cohen, M.A., The Consumer Product Safety 
Commission's Revised Injury Cost Model, Calverton, MD: Public 
Services Research Institute (2000); Bhattacharya, S., Lawrence, B., 
Miller, T., Zaloshnja, E., Jones, P., Ratios for Computing Medical 
Treated Injury Incidence and Its Standard Error from NEISS Data 
(Contract CPSC-D-05-0006, Task Order 8), Calverton, MD: Pacific 
Institute for Research and Evaluation (2012); and Lawrence, B.A., 
Revised Incidence Estimates for Nonfatal, Non-Hospitalized Consumer 
Product Injuries Treated Outside Emergency Departments (Contract 
CPSC-D-89-09-0003, Task Order 2), Calverton, MD: Pacific Institute 
for Research and Evaluation (2013).
---------------------------------------------------------------------------

    The ICM estimate of injuries treated outside of hospitals or 
hospital EDs (e.g., in doctors' offices, clinics) is based on data from 
the Medical Expenditure Panel Survey (MEPS). The MEPS is a nationally 
representative survey of the civilian, non-institutionalized population 
that quantifies individuals' use of health services and corresponding 
medical expenditures. It combines data from a panel of participants 
interviewed quarterly over a two-year period with data from the 
respondents' medical providers. The MEPS is administered by the Agency 
for Healthcare Research and Quality (AHRQ). The ICM uses the MEPS data, 
in combination with a classification tree analysis technique, to 
project the number and characteristics of injuries treated outside of 
hospitals. To project the number of direct hospital admissions that 
bypass hospital EDs, the ICM uses data from the Nationwide Inpatient 
Sample of the Healthcare Cost and Utilization Project (HCUP-NIS), which 
was also analyzed using a classification tree analysis technique. HCUP 
is a family of healthcare databases and related software tools and 
products developed through a federal-state-industry partnership and 
sponsored by AHRQ. The HCUP-NIS provides information annually on 
approximately 3 to 4 million in-patient stays from about 1,000 
hospitals.
    The classification tree analysis technique (also called decision 
tree) is a statistical tool that divides and sorts data into smaller 
and smaller groups for estimating the ED share of injuries until no 
further gains in predictive power can be obtained. This technique 
allows for more precise estimates of injuries treated in doctor visits 
or injuries admitted directly to the hospital than other regression 
techniques. For example, where data permit, the age and sex of the 
victim can have an influence on the estimates of the number of injuries 
treated outside the ED. Combining the national estimates of NEISS with 
the non-ED estimates from the ICM using classification tree techniques 
provides total estimated medically-treated injuries.
    Based on the estimate of 2,135 magnet injuries initially treated in 
hospital EDs annually during 2017 through 2020, the ICM projects that 
another 856 magnet injuries were treated annually outside of hospitals 
(e.g., in doctors' offices,

[[Page 1299]]

clinics) and that there were about 264 direct hospital admissions 
annually, bypassing the ED. Thus, combined with the ED-treated 
injuries, staff estimates that there were a total of 3,255 medically 
treated injuries annually involving subject magnets products from 2017 
through 2020.
2. Societal Costs of Deaths and Injuries
    The ICM is fully integrated with NEISS and provides estimates of 
the societal costs of injuries reported through NEISS, as well as the 
societal costs of other medically treated injuries estimated by the 
ICM. The major aggregated societal cost components provided by the ICM 
include medical costs, work losses, and the intangible costs associated 
with lost quality of life or pain and suffering.
    Medical costs include three categories of expenditures: (1) Medical 
and hospital costs associated with treating the injury victim during 
the initial recovery period and in the long term, including the costs 
associated with corrective surgery, the treatment of chronic injuries, 
and rehabilitation services; (2) ancillary costs, such as costs for 
prescriptions, medical equipment, and ambulance transport; and (3) 
costs of health insurance claims processing. CPSC derived the cost 
estimates for these expenditure categories from a number of national 
and state databases, including MEPS, HCUP-NIS, the Nationwide Emergency 
Department Sample (NEDS), the National Nursing Home Survey (NNHS), 
MarketScan[supreg] claims data, and a variety of other federal, state, 
and private databases.
    Work loss estimates are intended to include: (1) The forgone 
earnings of the victim, including lost wage work and household work; 
(2) the forgone earnings of parents and visitors, including lost wage 
work and household work; (3) imputed long term work losses of the 
victim that would be associated with permanent impairment; and (4) 
employer productivity losses, such as the costs incurred when employers 
spend time juggling schedules or training replacement workers. 
Estimates are based on information from HCUP-NIS, NEDS, Detailed Claims 
Information (a workers' compensation database), the National Health 
Interview Survey, U.S. Bureau of Labor Statistics, and other sources. 
The intangible, or non-economic, costs of injury reflect the physical 
and emotional trauma of injury, as well as the mental anguish of 
victims and caregivers. Intangible costs are difficult to quantify 
because they do not represent products or resources traded in the 
marketplace. Nevertheless, they typically represent the largest 
component of injury cost and need to be accounted for in any benefit-
cost analysis involving health outcomes. The ICM develops a monetary 
estimate of these intangible costs from jury awards for pain and 
suffering. While these awards can vary widely on a case-by-case basis, 
studies have shown them to be systematically related to a number of 
factors, including economic losses, the type and severity of injury, 
and the age of the victim.\93\ CPSC derived estimates for the ICM from 
regression analysis of jury awards in nonfatal product liability cases 
involving consumer products compiled by Jury Verdicts Research, Inc.
---------------------------------------------------------------------------

    \93\ W. Kip Viscusi (1988), The determinants of the disposition 
of product liability cases: Systematic compensation or capricious 
awards?, International Review of Law and Economics, 8, 203-220; 
Gregory B. Rodgers (1993), Estimating jury compensation for pain and 
suffering in product liability cases involving nonfatal personal 
injury, Journal of Forensic Economics 6(3), 251-262; and Mark A. 
Cohen and Ted R. Miller (2003), ``Willingness to award'' nonmonetary 
damages and implied value of life from jury awards, International 
Journal of Law and Economics, 23, 165-184.
---------------------------------------------------------------------------

    Table 18 provides annual estimates of the injuries and societal 
costs associated with ingestions of magnets categorized as magnet sets, 
magnet toys, and jewelry.

    Table 18--Estimated Average Annual Medically Treated Injuries and
   Associated Societal Costs for Ingestions of Products Categorized as
      Magnet Sets, Magnet Toys, and Jewelry, for 2017 Through 2020
------------------------------------------------------------------------
                                                             Estimated
           Injury disposition              Estimated No.  societal costs
                                                          ($ millions) *
------------------------------------------------------------------------
Doctor/Clinic...........................             164            $2.2
Treated and Released from Hospital ED...             278             6.2
Admitted to Hospital through ED (NEISS).    [dagger] 159            26.4
Direct Hospital Admissions, Bypassing...              77            12.8
                                         -------------------------------
    Total Medically Attended Injuries...             678            47.6
------------------------------------------------------------------------
* In 2018 dollars.
[dagger] This estimate may not be reliable because of the small number
  of cases on which it is based.

    The 2017 through 2020 NEISS estimates suggest an estimated annual 
average of about 437 ED-treated injuries, comprised of 278 injuries 
that were treated and released and 159 injuries that required 
hospitalization. Additionally, based on estimates from the ICM, 164 
injuries were treated outside of hospitals annually and another 77 
injuries resulted in direct hospital admission.
    Based on ICM estimates, these injuries resulted in annual societal 
costs of about $47.6 million (in 2018 dollars) during 2017 through 
2020. The average estimated societal cost per injury was about $13,000 
for injuries treated in physician's offices, clinics, and other non-
hospital settings; about $22,000 for injuries to victims who were 
treated and released from EDs; and about $166,000 for injuries that 
required admission to the hospital for treatment. Medical costs and 
work losses (including work losses of caregivers) accounted for about 
44 percent of these injury cost estimates, and the less tangible costs 
of injury associated with pain and suffering accounted for about 56 
percent of the estimated injury costs.
    Table 18 reflects magnet ingestion incidents that involved products 
categorized as magnet sets, magnet toys, and jewelry--it does not 
include incidents categorized as involving unidentified product types. 
However, as discussed in section IV.A.5. Uncertainties in Incident 
Data, above, most of the incidents in this unidentified product type 
category likely involved subject magnet products. Thus, in addition to 
the magnet ingestion incidents upon which Table 15 was based, there 
were 322 NEISS cases during 2017 through 2020 (representing about 1,873 
ED-treated injuries annually) in the unidentified product type 
category. Based on ICM

[[Page 1300]]

estimates for unidentified product types involved in magnet ingestion 
injuries, average annual societal costs for 2017-2020 totaled $151.8 
million. Consequently, to the extent that the unidentified magnet 
products were products that would be covered by the proposed rule, 
Table 18 could substantially understate the societal costs associated 
with the ingestion of subject magnet products.
3. Potential Benefits of Proposed Rule
    The benefits of the proposed rule would be the reduction in the 
risk of injury and death from magnet ingestions and the resulting value 
of the societal costs of the injuries that the rule would prevent. In 
addition to the injuries reflected in the analysis above, staff is 
aware of 5 fatalities in the United States resulting from magnet 
ingestions. Thus, the rule would reduce the likelihood of future 
fatalities as well as injuries.
    The annual expected benefits of the rule depend on the exposure to 
risk associated with subject magnet products, as well as the estimated 
societal costs described in Table 18, above. Although subject magnet 
products may retain their magnetism for many years, it is likely that 
some are discarded well before that time. Thus, the actual expected 
product life of subject magnet products is uncertain; this analysis 
presents a range of potential benefit estimates under an assumed 
product life of 1.5, 2, and 3 years. Table 19 presents benefit 
estimates under the alternative product life assumptions (line (b)).

 Table 19--Present Value of Societal Costs Per Subject Magnet Product in Use (or Gross Benefits of a Rule), for
                              Three Expected Product Lives From 2017 Through 2020.
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
(a) Aggregate Annual Societal Costs (millions $)................           $47.6           $47.6           $47.6
(b) Expected Useful Product Life (years)........................             1.5               2               3
(c) Magnet Products in Use, Average Annual......................         444,000         545,000         701,000
(d) Annual Societal Costs per Subject Magnet Product [(a) / (c)]            $107             $87             $68
(e) Present Value of Societal Costs, per Subject Magnet Product             $160            $171            $190
 (3% Discount Rate).............................................
(f) Present Value of Societal Costs, per Subject Magnet Product             $154            $162            $178
 (7% Discount Rate).............................................
----------------------------------------------------------------------------------------------------------------

    In Table 19, line (a) shows the average annual aggregate societal 
costs from Table 18. Line (c) presents the average annual estimated 
number of subject magnet products in use from 2017 through 2020, based 
on producer-reported annual magnet set sales \94\ collected by the 
Directorate for Compliance through mid-2012 and assumptions of annual 
sales of all subject magnet products through 2020 (including an 
assumption of 500,000 units per year for 2018-2020), an assumed 
expected product life of 1.5, 2, and 3 years (line b), and the 
application of the CPSC's Product Population Model, a computer 
algorithm that projects the number of products in use given estimates 
of annual product sales and product failure rates. The Commission 
requests information on annual sales and expected product life of 
subject magnet products.
---------------------------------------------------------------------------

    \94\ Although this information is for magnet sets, and not all 
subject magnet products, staff primarily had information about 
magnet sets, and magnet sets likely make up a large portion of 
subject magnet products.
---------------------------------------------------------------------------

    Figure 7 shows changes in the estimated number of subject magnet 
products in use, from 2009 through 2020.
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TP10JA22.006


[[Page 1301]]


    In Table 19, the annual estimated societal costs per subject magnet 
product in use (line d) are presented as the quotient of the annual 
societal costs (line a), per product in use, and the estimated average 
number of products in use (line c). Based on these estimates, and an 
assumed average product life ranging from 1.5 to 3 years, the present 
value of societal costs, per subject magnet product, ranges from about 
$160 to about $190 using a 3 percent discount rate (line e), or from 
about $154 to $178 using a 7 percent discount rate (line f).
    The first order estimate of benefits would be equal to the present 
value of societal costs, presented in lines (e) and (f) and would range 
from about $154 (with a 1.5-year product life and a 7 percent discount 
rate) to $190 (with a 3-year product life and a 3 percent discount 
rate) per subject magnet product. The aggregate benefits would range 
from $80 million to $95 million using the 500,000 units assumption from 
Table 19 and 3 percent discount rate.\95\ If the proposed rule allows 
some products to remain on the market that present the magnet ingestion 
hazard, the benefits of the rule would be reduced by some unknown 
amount and would be measured as the net reduction in injuries and the 
concomitant reduction in societal costs that would result.
---------------------------------------------------------------------------

    \95\ Aggregate benefits are the product of the per-unit benefit 
($160 and $190 for a 1.5-year and 3-year useful life discounted at 3 
percent), and 500,000 estimated annual units.
---------------------------------------------------------------------------

4. Costs Associated With the Proposed Rule
    This section discusses the costs associated with the proposed rule, 
which include costs to consumers and to manufacturers/importers of 
subject magnet products. Both consumers and producers benefit from the 
production and sale of consumer products. The consuming public obtains 
the use value or utility associated with the consumption of products; 
producers obtain income and profits from the production and sale of 
products. Consequently, the costs of requiring that subject magnet 
products comply with the proposed rule would consist of: (1) The lost 
use value experienced by consumers who would no longer be able to 
purchase magnets that do not meet the standard (lost consumer surplus); 
and (2) the lost income and profits to firms that could not produce and 
sell non-complying products (lost producer surplus).
    Both consumer and producer surplus depend on product sales, among 
other things. However, CPSC does not know the unit sales of subject 
magnet products. Therefore, this analysis considers possible costs 
associated with several estimates of sales, ranging from about 250,000 
to 1 million subject magnet products per year. For purposes of 
discussion, the analysis below assumes annual sales of 500,000 per 
year.
a. Costs to Consumers
    The primary cost associated with the proposed rule is lost utility 
to consumers. Subject magnet products may be used for a variety of 
purposes, including amusement and jewelry. Previous comments CPSC has 
received regarding magnet sets, which likely comprise the majority of 
subject magnet products on the market, indicate that consumers use them 
as a manipulative or construction item for entertainment, such as 
puzzle working, sculpture building, mental stimulation, or stress 
relief. CPSC is also aware of claims that the magnets can have 
beneficial therapeutic value for children with attention-deficit/
hyperactivity disorder. Incident data also suggests that magnet sets 
are used as jewelry. The individual magnets in subject magnet products 
might also have additional uses, apart from those for which they are 
intended (e.g., using magnets from a magnet set on a refrigerator). 
However, there would presumably be little lost utility for these 
unintended product uses since products intended for those purposes 
(e.g., refrigerator magnets) would be unaffected by the proposed rule. 
If products that comply with the proposed rule do not serve the 
identical utility (e.g., consumers prefer smaller, stronger magnets), 
this represents lost utility to consumers. CPSC notes that the proposed 
rule applies to amusement and jewelry products and, therefore, would 
not affect products intended for research, education, industrial, or 
commercial uses, if they do not otherwise meet the definition of 
subject magnet products.
    CPSC cannot estimate the use value that consumers receive from 
subject magnet products, so the following discussion instead describes 
use value conceptually. In general, use value includes the amount of: 
(1) Consumer expenditures for the product, plus (2) consumer surplus. 
Assuming annual sales of about 500,000 subject magnet products 
annually, and assuming an average retail price of about $20 (based on 
price data for magnet sets), consumer expenditures would amount to 
about $10 million annually. These expenditures represent the minimum 
value that consumers would expect to get from these products. It is 
represented by the area of the rectangle OBDE in the standard supply 
and demand graph in Figure 8, where B equals $20, and E equals 500,000 
units.

[[Page 1302]]

[GRAPHIC] [TIFF OMITTED] TP10JA22.007

BILLING CODE 6355-01-C
    In Figure 8, consumer surplus is given by the area of the triangle 
BCD under the graph's demand function, and represents the difference 
between the market-clearing price and the maximum amount consumers 
would have been willing to pay for the product. This consumer surplus 
will vary for individual consumers, but it represents a benefit to 
consumers over and above what they paid.\96\ For example, tickets to a 
concert might sell for $100 each, but some consumers who buy them for 
$100 would have been willing to pay $150 per ticket. Those consumers 
paid $100 and received benefits that they value at $150, thereby 
receiving a consumer surplus of $50.\97\
---------------------------------------------------------------------------

    \96\ The concept of consumer surplus is discussed in the Office 
of Management and Budget's Circular A-4, Regulatory Analysis, 
available through 68 FR 58366 (Oct. 9, 2003), and has been applied 
in a number of CPSC staff analyses.
    \97\ If the above graph represents the market for tickets, the 
demand curve describes the quantity of tickets demanded at each 
price (i.e., the quantity of tickets consumers are willing and able 
to purchase at each price). In this example, the $150 that the 
consumer would have been willing to pay for the ticket is 
represented on the demand curve at a point to the left of point D. 
The consumer surplus is given by the relevant point on the demand 
curve (i.e., where price = $150), minus the market clearing price of 
$100.
---------------------------------------------------------------------------

    In general, the use value of the subject magnet products obtained 
by consumers is represented by the area of the trapezoid OCDE in Figure 
8. However, the prospective loss in use value associated with the 
proposed rule would amount to, at most, the area of the triangle 
representing the consumer surplus. This is because consumers would no 
longer be able to obtain utility from the products that do not comply 
with the proposed rule, but they would have the $10 million 
(represented by the rectangle OBDE) that they would have spent on non-
complying subject magnet products in the absence of a rule. The net 
loss in consumer surplus associated with the proposed rule would be 
reduced by consumers' ability to purchase replacement products that 
comply with the proposed rule and provide the same utility, or by their 
ability to purchase other products that provide use-value.
    CPSC does not have information regarding aggregate consumer surplus 
or, by extension, the amount of utility that would be lost as a result 
of the proposed rule. However, if, for example, consumers who purchased 
subject magnet products that do not comply with the proposed rule at an 
average price of $20 would have been willing to spend, on average, $35 
to $45 per product (i.e., an additional $15 to $25 per product), the 
lost utility might amount to about $7.5 million (i.e., [$35-$20] x 
500,000 units annually) to $12.5 million (i.e., [$45-$20] x 500,000 
units annually) on an annual basis.
    However, the loss in consumer surplus described above represents 
the maximum loss of consumer utility from the proposed rule because 
consumers are likely to gain some amount of consumer surplus from 
products that are purchased as an alternative to subject magnet 
products that would no longer be available because of the rule. If, for 
example, there were close substitutes (e.g., products that are 
similarly satisfying and priced) for the subject magnet products that 
do not meet the standard, the overall loss in consumer surplus (and, 
hence, the costs of the proposed rule) likely would be small. Staff is 
aware of subject magnet products that comply with the proposed rule. 
For example, there are magnet sets with flux indexes less than 50 kG\2\ 
mm\2\, magnetic desk sculptures that use a magnetic base and 
ferromagnetic pieces, sets of large magnetic balls, and a wide variety 
of fidget toys. Manufacturers of magnetic jewelry with loose or 
separable magnets have options for complying with the rule, including 
using magnets that are not hazardous, or close substitutes that are 
nonmagnetic. If jewelry manufacturers wish to offer separable pieces on 
necklaces or bracelets, they might offer nonmagnetic pieces that attach 
to a bracelet or necklace incorporating attached magnets. Additionally, 
magnetic stud earrings and faux piercing jewelry have clip-on 
alternatives and pierced jewelry as substitutes. These products and 
alternatives suggest that compliant products may provide similar 
utility to non-compliant subject magnet products.
b. Costs to Manufacturers/Importers
    The lost benefits to firms that could result from the proposed rule 
are measured by a loss in producer surplus. Producer surplus is a 
profit measure that is somewhat analogous to consumer surplus. Whereas 
consumer surplus is a measure of benefits received by individuals who 
consume products, net of the cost of purchasing the products, producer 
surplus is a measure of the

[[Page 1303]]

benefits accrued to firms that produce and sell products, net of the 
costs of producing them. Producer surplus is defined as the total 
revenue (TR) of firms selling subject magnet products, less the total 
variable costs (TVC) of production. Variable costs are costs that vary 
with the level of output and usually include expenditures for raw 
materials, wages, distribution of the product, and similar costs.
    In Figure 8, above, total revenue is given by the area OBDE, which 
is the product of sales and price. The total variable costs of 
production are given by the area under the supply function, OADE. 
Consequently, producer surplus is given by the triangle ABD, which is 
the area under the market clearing price and above the supply function. 
Note that this represents the maximum loss to producers; if there were 
product alternatives that were similar to subject magnet products that 
suppliers could produce and sell, the lost producer surplus could be 
less.
    Following the example above, if sales of the subject magnet 
products average about 500,000 units annually, with an average retail 
price of about $20 per product, then total industry revenues have 
averaged about $10 million annually (i.e., 500,000 units x $20 per 
product). Information provided by magnet set sellers suggests that the 
average import cost of magnet sets to U.S. importers, a major variable 
cost, may amount to about $10 per set, or an average of about $5 
million annually (i.e., 500,000 sets x $10 import cost per set). Apart 
from the import costs, the variable costs of production are probably 
relatively small. Because subject magnet products are often packaged 
and shipped from China and sometimes sent directly to the importers 
point of sale, U.S. labor costs may be low; and because subject magnet 
products are small, storage costs are probably low. If, for example, 
the variable costs of production account for about half of the 
difference between total revenues ($10 million) and import costs ($5 
million), producer surplus would amount to about $2.5 million (i.e., 
($10 million-$5 million) / 2) annually. At most, the lost producer 
surplus would amount to about $5 million annually, if there were no 
variable costs other than the costs of importing the magnets (i.e., 
total revenue of $10 million for 500,000 units annually less the import 
costs of about $5 million). While this information is specifically 
related to magnet sets, a similar relationship could apply to other 
subject magnet products.
    Like costs to consumers, lost producer surplus could be offset by 
products that comply with the proposed rule. That is, although firms 
could not offer subject magnet products that do not comply with the 
proposed rule, they could offer substitutions that serve the same or 
similar purpose but comply with the proposed rule.
    As noted above, CPSC does not know the actual sales levels of non-
complying subject magnet products, and does not have information to 
reliably estimate either consumer surplus or producer surplus. Table 
20, below, provides rough estimates of the possible costs of the rule, 
for various hypothetical sales levels ranging from 250,000 to 1 million 
products annually. The cost estimates are based on a number of 
assumptions described above, and are made for illustrative purposes. 
Nevertheless, because the range of sales is wide, and is likely to 
include actual sales levels on an annual basis, it is reasonable to 
assume that the costs of the proposed rule could range from about $5 to 
$8.75 million (if sales amount to about 250,000 products annually), to 
about $20 to $35 million (if sales amount to about 1 million products 
annually). As noted above, these costs could be partially offset by 
products that comply with the proposed rule.

 Table 20--Possible Costs of the Proposed Rule, for Various Levels of Non-Complying Subject Magnet Product Sales
----------------------------------------------------------------------------------------------------------------
                                           Consumer surplus         Producer surplus      Total costs (millions
   Magnet product sales (annually)           (millions $)             (millions $)                  $)
----------------------------------------------------------------------------------------------------------------
250,000..............................  $3.75 to $6.25.........  $1.25 to $2.5..........  $5 to $8.75.
500,000..............................  $7.5 to $12.5..........  $2.5 to $5.............  $10 to $17.5.
750,000..............................  $11.25 to $18.75.......  $3.75 to $7.5..........  $15 to $26.25.
1,000,000............................  $15 to $25.............  $5 to $10..............  $20 to $35.
----------------------------------------------------------------------------------------------------------------

    In addition to lost producer surplus, manufacturers/importers of 
subject magnet products that comply with the proposed rule would likely 
incur some additional costs associated with certifying that their 
products comply with the rule. Section XII. Testing, Certification, and 
Notice of Requirements, below, describes the requirements in section 14 
of the CPSA regarding certifications. To summarize, consumer products 
that are subject to a mandatory standard must be certified as complying 
with the standard. Certification must be based on a test of each 
product or a reasonable testing program. For subject magnet products, 
the costs of this testing may be minimal, especially for manufacturers 
that currently have product testing done for products subject to the 
requirements in ASTM F963-17, which is mandated in 16 CFR part 1250. 
Importers may rely upon testing completed by other parties, such as 
their foreign suppliers, if those tests provide sufficient information 
for the manufacturers or importers to certify that the magnets in their 
products comply with the proposed rule. For subject magnet products 
that are children's products, such as children's jewelry, the 
certification must be based on testing by an accredited third-party 
conformity assessment body, at somewhat higher costs.

B. Reasons for Not Relying on a Voluntary Standard

    When the Commission issues an ANPR, it must invite interested 
parties to submit existing standards or provide a statement of 
intention to modify or develop a standard that would address the hazard 
at issue. 15 U.S.C. 2058(a). When CPSC receives such standards or 
statements in response to an ANPR, the preliminary regulatory analysis 
must provide reasons that the proposed rule does not include such 
standards. Id. 2058(c). In the present rulemaking, the Commission did 
not issue an ANPR. Accordingly, CPSC did not receive submissions of 
standards or statement of intention to develop standards regarding the 
magnet ingestion hazard.
    Nevertheless, staff evaluated existing standards relevant to magnet 
ingestions and determined that these standards would not adequately 
reduce the risk of injury associated with magnet ingestions because 
they do not cover the products most often involved in incidents or do 
not include adequate performance requirements to reduce the risk of 
injury. A detailed discussion of these standards, and why staff 
considers

[[Page 1304]]

them inadequate, is in section V. Relevant Existing Standards.

C. Alternatives to the Proposed Rule

    Finally, a preliminary regulatory analysis must describe 
alternatives to the proposed rule that CPSC considered, their potential 
costs and benefits, and a brief explanation of the reasons the 
alternatives were not chosen. CPSC considered several alternatives to 
the proposed rule. These alternatives, their potential costs and 
benefits, and the reasons the Commission did not select them, are 
described in detail in section VIII. Alternatives to the Proposed Rule, 
below, and Tab F of the NPR briefing package.

VIII. Alternatives to the Proposed Rule

    CPSC considered several alternatives to reduce the risk of injuries 
and death associated with ingestion of subject magnet products. 
However, as discussed below, CPSC does not consider any of these 
alternatives capable of adequately reducing the risk of injury and 
death.

A. No Mandatory Standard

    One alternative to the proposed rule is to take no regulatory 
action and, instead, rely on the ASTM standards to address the magnet 
ingestion hazard. As discussed above, there are four ASTM standards 
that address the magnet ingestion hazard, covering children's toys, 
jewelry, and magnet sets. Relying on these standards would eliminate 
the costs associated with the proposed rule because it would not 
mandate compliance. ASTM F3458, in particular, has the potential to 
address the magnet ingestion hazard because it applies to magnet sets, 
which are involved in a large portion of magnet ingestion incidents 
where the product type could be identified.
    However, there are considerable limitations and unknowns associated 
with this alternative. The shortcomings of the ASTM standards are 
discussed in detail in section V. Relevant Existing Standards. For one, 
CPSC does not consider ASTM F3458 capable of adequately reducing the 
magnet ingestion hazard because of its limited scope and lack of size 
and strength requirements for magnets. Although Subcommittee F15.77 on 
Magnets formed a task group to consider revising ASTM F3458-21 to 
include performance requirements for magnet sets intended for users 14 
years and older, CPSC does not know whether the standard will be 
revised or what requirements may be added to it.
    Moreover, ASTM F3458 applies only to magnets sets, which are not 
the only products implicated in magnet ingestion incidents. Additional 
magnet toys intended for users 14 years and older, as well as jewelry 
are also implicated. Although ASTM has standards regarding the magnet 
ingestion hazard in jewelry, CPSC considers those standards inadequate 
because they do not impose size and strength limits on all jewelry with 
loose or separable magnets. In addition, CPSC does not know the level 
of compliance with ASTM F3458, ASTM F2999, or ASTM F2923; if the rate 
of compliance is low, these would not be an effective way to address 
the hazard, even if the requirements in these standards were adequate. 
Finally, waiting for ASTM to revise its standards to adequately address 
the hazard would delay the safety benefits of the proposed rule. For 
these reasons, the Commission did not select this alternative.

B. Alternative Performance Requirements

    Another alternative to the proposed rule is to adopt a mandatory 
standard with less stringent requirements than the proposed rule, such 
as a higher flux index limit, or different requirements for certain 
shapes and sizes of magnets. This may reduce the costs associated with 
the rule by allowing firms to market and consumers to use a wider 
variety of products than under the proposed rule. The reduction in 
costs would depend on the specific requirements adopted.
    However, this option would likely reduce the safety benefits of the 
rule. If the alternative performance requirements reduced costs by 
allowing more products to remain on the market, it likely would also 
leave more hazardous products on the market, thereby decreasing the 
safety benefits. Therefore, the Commission did not select this 
alternative. The Commission seeks comments on what potential 
alternative performance requirements may adequately reduce the risk of 
injury associated with magnet ingestions, while reducing costs to firms 
and impacts on consumer utility.

C. Safety Messaging

    Instead of performance requirements, the Commission could require 
safety messaging on products to address the magnet ingestion hazard, 
such as through requirements for labeling and instructional literature. 
This alternative would reduce the costs associated with the proposed 
rule because it would allow firms to continue to sell subject magnet 
products with loose or separable hazardous magnets and the costs of 
warnings and instructional information likely would be small.
    However, CPSC does not consider this alternative effective for 
adequately reducing the risk of injury and death associated with magnet 
ingestions. For a detailed discussion of why labeling and instructional 
literature requirements are insufficient to adequately address the 
magnet ingestion hazard, see section V.D. ASTM F3458-21. To summarize, 
warnings are the least effective strategy for addressing a hazard, 
relative to designing out the hazard or designing guards against the 
hazard. The effectiveness of warnings depends on convincing consumers 
to avoid the hazard, and there are numerous reasons consumers may 
disregard warnings for these products. Caregivers do not expect older 
children and teens to ingest inedible objects; the magnet ingestion 
hazard is not readily apparent; caregivers and children underappreciate 
the likelihood and severity of the hazard; magnets are often ingested 
accidentally; and children and teens commonly access magnets without 
their packaging, such as from friends or at school.
    Warning information on labels and instructional literature, as well 
as public outreach efforts to inform consumers of the hazard, have been 
used to try to address the magnet ingestion hazard for many years. 
However, these efforts have been unsuccessful at reducing the magnet 
ingestion hazard, as evidenced by the increase in magnet ingestion 
incidents in recent years, and magnet ingestion incidents involving 
products with clear warnings.
    For these reasons, the Commission did not select this alternative.

D. Packaging Requirements

    Another alternative is for the Commission to require special 
packaging for subject magnet products that contain hazardous magnets to 
limit children's access to the products. Such packaging could, for 
example, help consumers determine if all magnets have been returned to 
the packaging and include child-resistant features. Although this 
alternative would create some costs associated with packaging, those 
costs likely would be lower than the proposed rule because they would 
allow subject magnet products to remain unchanged. Staff estimates that 
the cost of safety packaging may amount to about $1 per magnet product, 
depending on the requirements and features of the packaging.
    However, CPSC does not consider this alternative effective for 
adequately reducing the risk of injury and death associated with magnet 
ingestions. For a detailed discussion of why packaging requirements are 
insufficient to

[[Page 1305]]

adequately address the magnet ingestion hazard, see section V.D. ASTM 
F3458-21. To summarize, for packaging requirements to be effective at 
preventing the magnet ingestion hazard, users would have to repackage 
all magnets after each use, and the packaging would have to prevent 
children and teens from accessing the magnets. Neither of these are 
likely to occur to a sufficient extent to address the hazard.
    For one, consumers are unlikely to repackage all magnets after each 
use. After assembling structures or jewelry, or using the magnets for 
other purposes, consumers would be unlikely to disassemble their 
creations to return them to the package. In addition, products often 
contain hundreds or thousands of magnets, making it time consuming and 
difficult to ensure all of the magnets are returned to the package. 
Moreover, small magnets become loose in the environment and are hard to 
locate to return to the package. In addition, consumers often do not 
perceive subject magnet products as hazardous, making it less likely 
that they would repackage all of the magnets. Even for products that 
are obviously hazardous and commonly use CR packaging, such as 
chemicals and pharmaceuticals, consumers use the packaging 
inconsistently. Consumers may also consider CR packaging a nuisance, 
making them unlikely to store magnets in the packaging after every use.
    Even if consumers return all magnets to a package after each use, 
safety features to prevent easy access to the contents of the package 
would only address a minority of the vulnerable population. Safety 
packaging is generally intended to restrict children under 5 years old 
from accessing package contents. Older children and teens are likely to 
have the cognitive and motor skills necessary to access products in 
special packaging. This is problematic because incident data show that 
older children and teens make up the majority of magnet ingestion 
victims. In addition, many incidents involve children and teens 
acquiring magnets without the product packaging, such as from friends, 
at school, or loose in the environment. For these reasons, the 
Commission did not select this alternative.

E. Aversive Agents

    Instead of the size and strength requirements in the proposed rule, 
the Commission could require manufacturers to coat loose or separable 
hazardous magnets in subject magnet products with aversive agents, such 
foul odors or bitterants. Aversive agents may dissuade some children 
and teens from placing hazardous magnets in their mouths. This 
alternative would reduce the costs associated with the proposed rule 
because it would allow firms to continue to sell subject magnet 
products with loose or separable hazardous magnets, would allow 
consumers to continue to use them, and the costs of such coatings 
likely would be small.
    However, real-world investigations have not demonstrated that 
bitterants are effective at preventing ingestions.\98\ Bitterants do 
not deter initial ingestion because the user has not yet tasted the 
bitterant; this makes them ineffective at protecting users from harms 
that can result from a single ingestion. Incident reports indicate that 
ingesting a single magnet (and ferromagnetic object), or multiple 
magnets at once or in quick succession, can result in serious injuries. 
Thus, the ineffectiveness of bitterants to prevent an initial ingestion 
makes them ineffective for addressing the magnet ingestion hazard.
---------------------------------------------------------------------------

    \98\ This alternative is discussed in detail 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.
---------------------------------------------------------------------------

    Similarly, once a magnet is in a person's mouth, they may not be 
able to prevent ingestion even if deterred by a bitterant. The power of 
the magnetic forces can cause magnets to move erratically as pieces 
repel or attract, and movement of magnets toward the back of the throat 
can trigger the reflex to swallow the magnets before the person can 
remove them. Bitterants would be particularly ineffective for 
accidental ingestions, where victims did not intentionally place 
magnets in their mouths; incident data indicate that some magnet 
ingestions involve unintentional ingestions, particularly for older 
victims. Moreover, incidents involving ingestion of other hazardous 
substances demonstrates the ineffectiveness of aversive agents to 
prevent ingestions. Children frequently ingest unpalatable substances, 
such as gasoline, cleaners, and ammonia, indicating that unpleasant 
taste or odor, alone, is not sufficient to deter children from 
ingesting items or substances. In addition, some portion of the 
population, possibly as high as 30 percent, may be insensitive to 
certain bitterants.
    For these reasons, the Commission did not select this alternative.

F. Longer Effective Date

    Another alternative is to provide a longer effective date for a 
final rule. In this proposed rule, the Commission proposes to make a 
final rule effective 30 days after the final rule is published. A 
longer effective date would reduce the impact of the rule on 
manufacturers and importers by extending the time firms have to develop 
products that comply with the rule or modify products to comply with 
the rule. However, delaying the effective date would delay the safety 
benefits of the rule as well. As such, the Commission did not select 
this alternative. However, the Commission requests comments about the 
proposed effective date.

IX. Paperwork Reduction Act

    This proposed rule does not contain a collection of information 
that is subject to public comment and review by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521).\99\
---------------------------------------------------------------------------

    \99\ There is an Office of Management and Budget control number, 
under the Paperwork Reduction Act, for collection of information 
regarding third-party testing for children's products, addressed in 
16 CFR part 1107.
---------------------------------------------------------------------------

X. Initial Regulatory Flexibility Analysis 100
---------------------------------------------------------------------------

    \100\ Further details about the initial regulatory flexibility 
analysis are available in Tab F of the NPR briefing package. 
Additional information about costs associated with the rule are 
available in Tab E of the NPR briefing package.
---------------------------------------------------------------------------

    When an agency is required to publish a proposed rule, section 603 
of the Regulatory Flexibility Act (5 U.S.C. 601-612) requires that the 
agency prepare an initial regulatory flexibility analysis (IRFA) that 
describes the impact that the rule would have on small businesses and 
other entities. An IRFA is not required if the head of an agency 
certifies that the proposed rule will not have a significant economic 
impact on a substantial number of small entities. 5 U.S.C. 605. The 
IRFA must contain:

    (1) A description of why action by the agency is being 
considered;
    (2) a succinct statement of the objectives of, and legal basis 
for, the proposed rule;
    (3) a description of and, where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
    (4) a description of the projected reporting, recordkeeping and 
other compliance requirements of the proposed rule, including an 
estimate of the classes of small entities that will be subject to 
the requirement and the type of professional skills necessary for 
preparation of the report or record; and
    (5) identification, to the extent practicable, of relevant 
Federal rules that may duplicate, overlap, or conflict with the 
proposed rule.

    An IRFA must also describe any significant alternatives that would 
accomplish the objectives of the applicable statutes and minimize any 
significant economic impact on small

[[Page 1306]]

entities. Alternatives could include: (1) Establishing different 
compliance or reporting requirements that consider the resources 
available to small businesses; (2) clarification, consolidation, or 
simplification of compliance and reporting requirements for small 
entities; (3) use of performance rather than design standards; and (4) 
an exemption from coverage of the rule, or any part of the rule 
thereof, for small entities.
    The IRFA for this proposed rule is available in Tab F of the NPR 
briefing package; this section provides an overview of the impact of 
the proposed rule on small businesses.

A. Reason for Agency Action

    The intent of this rulemaking is to reduce deaths and injuries 
resulting from magnet ingestions. As incident data show, magnet 
ingestion incidents have increased in recent years, and commonly 
involve products categorized as amusement or jewelry products. Most 
incidents involve children and teens, particularly under 14 years old. 
If ingested, some magnets are powerful enough to interact internally 
with one another through body tissue, and resist natural bodily forces 
to separate the magnets. This interaction has led to serious injuries 
and several deaths in the United States. The internal interaction 
hazard is a hidden hazard, which children and caregivers are unlikely 
to anticipate, appreciate, and avoid, as demonstrated by incident data. 
Incident data and the health outcomes of magnet ingestions demonstrate 
the need for agency action.

B. Objectives of and Legal Basis for the Rule

    The objective of the proposed rule is to reduce the risk of injury 
and death associated with ingestion of hazardous magnets, as discussed 
above. The proposed rule would be issued under the authority of 
sections 7 and 9 of the CPSA.

C. Small Entities to Which the Rule Will Apply

    The proposed rule would apply to small entities that manufacture, 
import, or sell subject magnet products, which are products with one or 
more magnets, which are loose or separable, and designed, marketed, or 
intended to be used by consumers for entertainment, jewelry (including 
children's jewelry), mental stimulation, stress relief, or a 
combination of these purposes. Examples of subject magnet products 
include magnet sets, other types of magnet toys intended for users 14 
years and older, and jewelry with separable magnets that can be 
arranged by the consumer.
    Because CPSC's previous rulemaking work regarding magnet ingestions 
has focused on magnet sets, CPSC staff has more detailed information 
about magnet sets than other subject magnet products. For this reason, 
this analysis provides detailed information about magnet sets; however, 
staff also provides information about additional subject magnet 
products, to the extent information about these products is available.
    All of the importers of magnet sets are small businesses under U.S. 
Small Business Administration (SBA) size standards, and CPSC expects 
that this is also true for manufacturers and importers of other subject 
magnet products. Currently, nearly all marketers (firms or individuals) 
of magnet sets sell through internet sites, rather than through 
physical retail stores such as bookstores, gift shops and other outlets 
(which commonly sold magnet sets from 2009 through mid-2012). Some of 
these internet sites are operated by the importers, but the majority of 
sellers (in terms of distinct firms or individuals, if not unit sales) 
appear to sell through their stores, operated on the sites of other 
internet platforms. These online retail outlets may also be used 
commonly by manufacturers and sellers of other subject magnet products.
    As discussed above, in late 2018, IEc examined the market for 
magnet sets. In its review of internet platforms, IEc found a total of 
69 sellers. IEc also identified 10 manufacturers and 2 retailers, which 
also are small businesses.\101\ CPSC staff provided IEc with staff's 
prior research, which identified at least 121 sellers of magnet sets on 
two major internet retail platforms. IEc reviewed these sellers with 
the intention of merging CPSC's research with newer information but 
found that the vast majority of sellers CPSC identified no longer sold 
magnet sets, indicating high turnover rates.
---------------------------------------------------------------------------

    \101\ 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 2020, CPSC staff reviewed the status of previously identified 
sellers of magnet sets on two major internet platforms and found 
further evidence of high turnover rates: Most of the sellers identified 
in late 2018 no longer sold magnet sets or had abandoned their stores. 
Only 9 of 69 sellers were still selling magnet sets. The remaining 
sellers no longer offered magnet sets or no longer operated on the 
platforms. In addition, staff identified 29 sellers that IEc had not 
identified as active in the market in late 2018.
    Based on this information, CPSC staff expects the dominant business 
model for importers of magnet sets will be direct sales to consumers 
using their own internet websites or other internet shopping sites. 
However, the proposed rule could also affect some third-party retailers 
of the products, whether selling them online or in physical stores. 
Such retailers sell a wide variety of consumer products; retailers 
classified as small businesses that sell the products would not be 
likely to derive significant proportions of total revenues from sales 
of affected magnet sets, and the impacts on individual firms should be 
minimal.

D. Compliance, Reporting, and Recordkeeping Requirements in the 
Proposed Rule

    The proposed rule would establish a mandatory standard that all 
subject magnet products would have to meet to be sold in the United 
States. As stated above, the proposed rule would require consumer 
products that are designed, marketed, or intended to be used for 
entertainment, jewelry, mental stimulation, stress relief, or a 
combination of these purposes, and that contain one or more loose or 
separable magnets to meet performance requirements. The proposed 
performance requirements specify that each loose or separable magnet in 
a subject magnet product that is small enough to fit entirely in the 
small parts cylinder must have a flux index less than 50 kG\2\ mm\2\. 
The requirements of the proposed standard are described, in detail, in 
this preamble, and the proposed regulatory text is at the end of this 
notice.
    In addition, certification requirements, which are discussed in 
section XII. Testing, Certification, and Notification of Requirements, 
below, would apply to subject magnet products. To summarize, section 14 
of the CPSA requires manufacturers, importers, or private labelers of a 
consumer product that is subject to a consumer product safety rule to 
certify, based on a test of each product or a reasonable testing 
program, that the product complies with all rules, bans or standards 
applicable to the product. The proposed rule specifies the test 
procedure to use to determine whether a subject magnet product complies 
with the requirements. For products that manufacturers certify, 
manufacturers would issue a general certificate of conformity (GCC). In 
the case of subject magnet products that could be considered children's 
products, the certification must be based on testing by

[[Page 1307]]

an accredited third-party conformity assessment body.
    The requirements for the GCC are stated in section 14 of the CPSA. 
Among other requirements, each certificate must identify the 
manufacturer or private labeler issuing the certificate and any third-
party conformity assessment body on whose testing the certificate 
relies; the date and place of manufacture; the date and place where the 
product was tested; each party's name, full mailing address, telephone 
number; and contact information for the individual responsible for 
maintaining records of test results. The certificates must be furnished 
to each distributor or retailer of the product and to CPSC, if 
requested.
1. Costs of the Proposed Rule That Would Be Incurred by Small 
Manufacturers
    Small manufacturers and importers of subject magnet products would 
likely incur some costs to certify that their products meet the 
requirements of the proposed rule, as required by section 14 of the 
CPSA. The certification must be based on a test of each product or a 
reasonable testing program. The costs of the testing might be minimal, 
especially for small manufacturers that currently have product testing 
done for products subject to the requirements in ASTM F963-17, which is 
mandated by 16 CFR part 1250. Importers may also rely on testing 
completed by other parties, such as their foreign suppliers, if those 
tests provide sufficient information for the manufacturers or importers 
to certify that the magnets in their products comply with the proposed 
rule. As noted above, for subject magnet products that could be 
considered children's products, such as children's jewelry, the 
certification must be based on testing by an accredited third-party 
conformity assessment body, at somewhat higher costs. The Commission 
requests comments regarding the costs or other impacts of the 
certification requirements under section 14 of the CPSA.
2. Impact on Small Businesses
    As discussed in the preliminary regulatory analysis, the primary 
impact of the proposed rule on small businesses would be the lost 
income and profits to firms that could not produce, import, and sell 
non-complying products in the future. The lost benefits to firms 
resulting from a proposed rule are measured by a loss in producer 
surplus, which is a measure of the total revenue of firms selling the 
magnets, less the total variable costs of production. As predominantly 
imported products, the variable costs for small businesses handling 
subject magnet products are mainly the import costs. The producer 
surplus for magnet sets could average about $5 to $10 per unit, based 
on an average price of $20. A similar relationship could apply to other 
subject magnet products affected by the proposed rule.
    A few small firms whose businesses focus on sales of subject magnet 
products that would not comply with the proposed rule, including some 
of the firms selling products on their own websites, would face 
relatively greater losses in producer surplus. These and other small 
businesses could respond to the rule by marketing magnets that comply 
with or are not subject to the proposed rule. Such measures could 
offset losses in producer surplus.

E. Federal Rules That May Duplicate, Overlap, or Conflict With the 
Proposed Rule

    CPSC did not identify any federal rules that duplicate, overlap, or 
conflict with the proposed rule.

F. Alternatives Considered To Reduce the Burden on Small Entities

    As discussed in section VIII. Alternatives to the Proposed Rule, 
above, CPSC examined several alternatives to the proposed rule, which 
could reduce the burden on firms, including small entities. For the 
reasons described in that section, the Commission concluded that those 
alternatives would not adequately reduce the risk of injury and death 
associated with magnet ingestions, and is not proposing those 
alternatives. See Tab F of the NPR briefing package for further 
discussion of alternatives to the proposed rule. The Commission seeks 
comments on any alternatives that would reduce the impact on small 
entities, while adequately reducing the risk of injury and death 
associated magnet ingestions.

XI. Incorporation by Reference

    The proposed rule incorporates by reference ASTM F963-17. The 
Office of the Federal Register (OFR) has regulations regarding 
incorporation by reference. 1 CFR part 51. Under these regulations, in 
the preamble of an NPR, an agency must summarize the incorporated 
material, and discuss the ways in which the material is reasonably 
available to interested parties or how the agency worked to make the 
materials reasonably available. 1 CFR 51.5(a). In accordance with the 
OFR requirements, this preamble summarizes the provisions of ASTM F963-
17 that the Commission proposes to incorporate by reference.
    The standard is reasonably available to interested parties and 
interested parties can purchase a copy of ASTM F963-17 from ASTM 
International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, 
PA 19428-2959 USA; telephone: (610) 832-9585; www.astm.org. 
Additionally, during the NPR comment period, a read-only copy of ASTM 
F963-17 is available for viewing on ASTM's website at: https://www.astm.org/CPSC.htm. Once a final rule takes effect, a read-only copy 
of the standard will be available for viewing on the ASTM website at: 
https://www.astm.org/READINGLIBRARY/. Interested parties can also 
schedule an appointment to inspect a copy of the standard at CPSC's 
Division of the Secretariat, U.S. Consumer Product Safety Commission, 
4330 East-West Highway, Bethesda, MD 20814, telephone: (301) 504-7479; 
email: [email protected].

XII. Testing, Certification, and Notice of Requirements

    Section 14(a) of the CPSA includes requirements for certifying that 
children's products and non-children's products comply with applicable 
mandatory standards. 15 U.S.C. 2063(a). Section 14(a)(1) addresses 
required certifications for non-children's products, and sections 
14(a)(2) and (a)(3) address certification requirements specific to 
children's products.
    A ``children's product'' is a consumer product that is ``designed 
or intended primarily for children 12 years of age or younger.'' Id. 
2052(a)(2). The following factors are relevant when determining whether 
a product is a children's product:
     Manufacturer statements about the intended use of the 
product, including a label on the product if such statement is 
reasonable;
     whether the product is represented in its packaging, 
display, promotion, or advertising as appropriate for use by children 
12 years of age or younger;
     whether the product is commonly recognized by consumers as 
being intended for use by a child 12 years of age or younger; and
     the Age Determination Guidelines issued by CPSC staff in 
September 2002, and any successor to such guidelines.

Id. ``For use'' by children 12 years and younger generally means that 
children will interact physically with the product based on reasonably 
foreseeable use. 16 CFR 1200.2(a)(2). Children's products may be 
decorated or embellished with a childish theme, be sized for children, 
or

[[Page 1308]]

be marketed to appeal primarily to children. Id. 1200.2(d)(1).
    As discussed above, some subject magnet products (e.g., children's 
jewelry) are children's products and some are not. Therefore, a final 
rule would require subject magnet products that are not children's 
products to meet the certification requirements under section 14(a)(1) 
of the CPSA and would require subject magnet products that are 
children's products to meet the certification requirements under 
sections 14(a)(2) and (a)(3) of the CPSA. The Commission's requirements 
for certificates of compliance are codified in 16 CFR part 1110.
    Non-Children's Products. Section 14(a)(1) of the CPSA requires 
every manufacturer (which includes importers \102\) of a non-children's 
product that is subject to a consumer product safety rule under the 
CPSA or a similar rule, ban, standard, or regulation under any other 
law enforced by the Commission to certify that the product complies 
with all applicable CPSC requirements. 15 U.S.C. 2063(a)(1).
---------------------------------------------------------------------------

    \102\ The CPSA defines a ``manufacturer'' as ``any person who 
manufactures or imports a consumer product.'' 15 U.S.C. 2052(a)(11).
---------------------------------------------------------------------------

    Children's Products. Section 14(a)(2) of the CPSA requires the 
manufacturer or private labeler of a children's product that is subject 
to a children's product safety rule to certify that, based on testing 
by a third-party conformity assessment body (i.e., testing laboratory), 
the product complies with the applicable children's product safety 
rule. Id. 2063(a)(2). Section 14(a) also requires the Commission to 
publish a notice of requirements (NOR) for a testing laboratory to 
obtain accreditation to assess conformity with a children's product 
safety rule. Id. 2063(a)(3)(A). Because some subject magnet products 
are children's products, the proposed rule is a children's product 
safety rule, as applied to those products. Accordingly, if the 
Commission issues a final rule, it must also issue an NOR.
    The Commission published a final rule, codified at 16 CFR part 
1112, entitled Requirements Pertaining to Third Party Conformity 
Assessment Bodies, which established requirements and criteria 
concerning testing laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112 
includes procedures for CPSC to accept a testing laboratory's 
accreditation and lists the children's product safety rules for which 
CPSC has published NORs. When CPSC issues a new NOR, it must amend part 
1112 to include that NOR. Accordingly, as part of this NPR, the 
Commission proposes to amend part 1112 to add this proposed standard 
for magnets to the list of children's product safety rules for which 
CPSC has issued an NOR.
    Testing laboratories that apply for CPSC acceptance to test subject 
magnet products that are children's products for compliance with the 
new rule would have to meet the requirements in part 1112. When a 
laboratory meets the requirements of a CPSC-accepted third party 
conformity assessment body, the laboratory can apply to CPSC to include 
16 CFR part 1262, Safety Standard for Magnets, in the laboratory's 
scope of accreditation of CPSC safety rules listed on the CPSC website 
at: www.cpsc.gov/labsearch.

XIII. Environmental Considerations

    The Commission's regulations address whether CPSC is required to 
prepare an environmental assessment (EA) or an environmental impact 
statement (EIS). 16 CFR 1021.5. Those regulations list CPSC actions 
that ``normally have little or no potential for affecting the human 
environment,'' and, therefore, fall within a ``categorical exclusion'' 
under the National Environmental Policy Act (42 U.S.C. 4231-4370h) and 
the regulations implementing it (40 CFR parts 1500-1508) and do not 
require an EA or EIS. 16 CFR 1021.5(c). Among those actions are rules 
that provide performance standards for products. Id. 1021.5(c)(1). 
Because this proposed rule would create performance requirements for 
subject magnet products, the proposed rule falls within the categorical 
exclusion, and thus, no EA or EIS is required.

XIV. Preemption

    Executive Order (E.O.) 12988, Civil Justice Reform (Feb. 5, 1996), 
directs agencies to specify the preemptive effect of a rule in the 
regulation. 61 FR 4729 (Feb. 7, 1996), section 3(b)(2)(A). In 
accordance with E.O. 12988, CPSC states the preemptive effect of the 
proposed rule, as follows:
    The regulation for subject magnet products is proposed under 
authority of the CPSA. 15 U.S.C. 2051-2089. Section 26 of the CPSA 
provides that ``whenever a consumer product safety standard under this 
Act is in effect and applies to a risk of injury associated with a 
consumer product, no State or political subdivision of a State shall 
have any authority either to establish or to continue in effect any 
provision of a safety standard or regulation which prescribes any 
requirements as to the performance, composition, contents, design, 
finish, construction, packaging or labeling of such product which are 
designed to deal with the same risk of injury associated with such 
consumer product, unless such requirements are identical to the 
requirements of the Federal Standard.'' 15 U.S.C. 2075(a). The federal 
government, or a state or local government, may establish or continue 
in effect a non-identical requirement for its own use that is designed 
to protect against the same risk of injury as the CPSC standard if the 
federal, state, or local requirement provides a higher degree of 
protection than the CPSA requirement. Id. 2075(b). In addition, states 
or political subdivisions of a state may apply for an exemption from 
preemption regarding a consumer product safety standard, and the 
Commission may issue a rule granting the exemption if it finds that the 
state or local standard: (1) Provides a significantly higher degree of 
protection from the risk of injury or illness than the CPSA standard, 
and (2) does not unduly burden interstate commerce. Id. 2075(c).
    Thus, the requirements proposed in today's Federal Register would, 
if finalized, preempt non-identical state or local requirements for 
subject magnet products designed to protect against the same risk of 
injury and prescribing requirements regarding the performance, 
composition, contents, design, finish, construction, packaging or 
labeling of subject magnet products.

XV. Effective Date

    The CPSA requires that consumer product safety rules take effect at 
least 30 days after the date the rule is promulgated, but not later 
than 180 days after the date the rule is promulgated unless the 
Commission finds, for good cause shown, that an earlier or later 
effective date is in the public interest and, in the case of a later 
effective date, publishes the reasons for that finding. 15 U.S.C. 
2058(g)(1). The Commission proposes that this rule, and the amendment 
to part 1112, become effective 30 days after publication of the final 
rule in the Federal Register. The rule would apply to all subject 
magnet products manufactured or imported on or after the effective 
date. The Commission requests comments on the proposed effective date.

XVI. Proposed Findings

    As discussed in section II. Statutory Authority, above, the CPSA 
requires the Commission to make certain findings when issuing a 
consumer product safety standard. 15 U.S.C. 2058(f)(1), (f)(3). This 
section discusses preliminary support for those findings.

[[Page 1309]]

A. Degree and Nature of the Risk of Injury

    To issue a final rule, the CPSA requires the Commission to make 
findings regarding the degree and nature of the risk of injury the rule 
is designed to eliminate or reduce. NEISS incident data indicate that 
there were an estimated 4,400 magnet ingestions treated in U.S. 
hospital EDs between January 1, 2010 and December 31, 2020 that 
involved products categorized as being for amusement or jewelry, which 
are the products subject to this rule. An additional estimated 18,100 
ED-treated magnet ingestions during this period involved unidentified 
magnet products. CPSC concludes that a large portion of these 
unidentified magnet product incidents likely involved subject magnet 
products, for the reasons stated below.
    In addition to magnet ingestion injuries treated in U.S. hospital 
EDs, the ICM projects that there were an estimated 3,255 magnet 
ingestion injuries per year treated in medical settings other than EDs 
from 2017 through 2020. Incident reports available through CPSRMS 
indicate that there were at least 284 magnet ingestions between January 
1, 2010 and December 31, 2020, 75 percent of which involved products 
categorized as being for amusement or jewelry, which are the products 
subject to this rule, and an additional 15 percent involved 
unidentified magnet products, which CPSC concludes are likely to have 
involved subject magnet products for the reasons stated below.
    The potential injuries when a person ingests one or more magnets 
are serious. Health threats posed by magnet ingestion include pressure 
necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia, 
inflammation, perforation, peritonitis, sepsis, ileus, ulceration, 
aspiration, and death, among others. These conditions can result from 
magnets attracting to each other through internal body tissue, or a 
single magnet attracting to a ferromagnetic object. CPSC is aware of 
several fatal magnet ingestion incidents resulting from internal 
interaction of the magnets.
    As indicated above, CPSC concludes that many of the magnet 
ingestion incidents for which information was insufficient to identify 
the specific product type involved subject magnet products. This 
conclusion is supported by incident data, trends in magnet ingestion 
rates and recalls surrounding mandatory standards, and behavioral and 
developmental considerations. Incident data indicate that, of the 
magnet ingestion incidents for which CPSC could identify a product 
type, the primary products involved were magnet sets, magnet toys, and 
jewelry; this is likely to apply to incidents that lacked product 
identification information as well.
    Trends in magnet ingestion rates surrounding a previous Commission 
rule on magnet sets indicate that magnet ingestions significantly 
declined during the time the rule was in effect, and significantly 
increased after the rule was vacated. This indicates that a large 
portion of magnet ingestions involved magnet sets, which are subject 
magnet products. Similarly, incident data and recalls surrounding the 
Commission's mandatory standard for magnets in children's toys, in 16 
CFR part 1250, indicate that, while amusement products are involved in 
most magnet ingestion incidents with identifiable product types, those 
amusement products are not children's toys. Relatively few magnet 
ingestion incidents identify children's toys as the product involved, 
suggesting that these make up few of the unidentified product type 
incidents as well. And the number of recalls of children's products for 
magnet-related hazards has appreciably declined since 16 CFR part 1250 
took effect, suggesting that these products do not make up a large 
portion of magnet ingestion incidents.
    Finally, behavioral and developmental factors support the 
conclusion that many magnet ingestions with unidentified product types 
involve subject magnet products. These include the attractiveness of 
magnetic products and their features to children and teens, consumers' 
perception that amusement and jewelry products are appropriate and safe 
for children, and consumers' underappreciation of the magnet ingestion 
hazard.

B. Number of Consumer Products Subject to the Proposed Rule

    To issue a final rule, the CPSA requires the Commission to make 
findings regarding the approximate number of consumer products subject 
to the rule. Staff estimates that there are approximately 500,000 
subject magnet products sold annually in the United States. However, to 
account for a range of sales estimates, staff also provided information 
for sales ranging from 250,000 to 1 million units annually.

C. The Public Need for Subject Magnet Products and the Effects of the 
Proposed Rule on Their Utility, Cost, and Availability

    To issue a final rule, the CPSA requires the Commission to make 
findings regarding the public's need for the products subject to the 
rule and the probable effect of the rule on the cost, availability, and 
utility of such products. Consumers use subject magnet products for 
entertainment, mental stimulation, stress relief, and jewelry. The 
proposed rule requires subject magnet products to meet performance 
requirements regarding size or strength, but does not restrict the 
design of products. As such, subject magnet products that meet the 
standard would continue to serve the purpose of amusement or jewelry 
for consumers. Magnets that comply with the proposed rule, such as non-
separable magnets, larger magnets, weaker magnets, or non-permanent 
magnets, would likely still be useful for amusement or jewelry. 
However, it is possible that there may be some negative effect on the 
utility of subject magnet products if compliant products function 
differently or do not include certain desired characteristics.
    Retail prices of subject magnet products generally average under 
$20. CPSC has identified subject magnet products that comply with the 
proposed rule, indicating that the costs of compliant and non-compliant 
products are comparable.
    If the costs associated with redesigning or modifying subject 
magnet products to comply with the proposed rule result in 
manufacturers discontinuing products, there may be some loss in 
availability to consumers. However, this would be mitigated to the 
extent that compliant products meet the same consumer needs.

D. Other Means To Achieve the Objective of the Proposed Rule, While 
Minimizing Adverse Effects on Competition and Manufacturing

    To issue a final rule, the CPSA requires the Commission to make 
findings regarding ways to achieve the objective of the rule while 
minimizing adverse effects on competition, manufacturing, and 
commercial practices. CPSC considered several alternatives to achieve 
the objective of reducing unreasonable risks of injury and death 
associated with magnet ingestions.
    One alternative is to take no regulatory action and instead rely on 
existing ASTM standards to address the magnet ingestion hazard. This 
would eliminate costs associated with the rule by avoiding a mandatory 
standard; however, this alternative is unlikely to adequately reduce 
the risk of injury and death associated with magnet ingestions. For 
one, none of the existing standards address all of the products most 
commonly identified in magnet ingestion incidents, and several of the 
standards provide exceptions to

[[Page 1310]]

performance requirements for certain subject magnet products. In 
addition, under the existing standards, certain subject magnet products 
would not be subject to performance requirements regarding size and 
strength, instead relying on alternative requirements, such as safety 
messaging, which is unlikely to adequately reduce the magnet ingestion 
hazard.
    Another alternative is a mandatory standard with less stringent 
requirements than the proposed rule, such as a higher flux index limit, 
or different requirements for certain shapes and sizes of magnets. This 
could reduce the costs associated with a rule by allowing firms to 
market a wider variety of products than under the proposed rule. 
However, for this alternative to reduce costs, it would allow more 
products to remain on the market, thereby decreasing the safety 
benefits.
    Safety messaging requirements are another alternative to the 
proposed rule. This would reduce the costs associated with the rule 
because it would not require modifying or discontinuing subject magnet 
products, and the costs of warnings and instructional information 
likely would be small. However, this alternative is not likely to 
adequately reduce the risk of injury and death associated with magnet 
ingestions because the effectiveness of safety messaging depends on 
consumers seeing the messaging and being convinced to avoid the hazard. 
Incident data indicate that children commonly access ingested magnets 
from sources that are unlikely to include the product packaging bearing 
instructions or warnings. Moreover, consumers are unlikely to 
consistently heed warnings because of the perception that subject 
magnet products are appropriate for children, and underappreciation of 
the magnet ingestion hazard. Safety messaging is generally considered 
the least effective way to address product hazards, and has been 
ineffective at addressing the magnet ingestion hazard, to date.
    Another alternative is to require special packaging to limit 
children's access to subject magnet products. Such packaging could help 
consumers determine if all magnets have been returned to the container 
and include child-resistant features. Although this alternative would 
create some packaging costs, those likely would be lower than the costs 
associated with the proposed rule because it would allow subject magnet 
products to remain unchanged. However, this alternative is not likely 
to adequately reduce the risk of injury and death associated with 
magnet ingestions. For packaging requirements to be effective, users 
would have to repackage all magnets after each use, which is unlikely 
given the size and number of magnets in a product, the potential to 
lose magnets, and consumers' demonstrated underappreciation of the 
hazard. In addition, packaging is unlikely to be effective because it 
generally only restricts young children (under 5 years old) from 
accessing package contents, and would not prevent older children or 
teens from accessing the package contents, although the majority of 
magnet ingestion incidents involved children 5 years and older.
    Another alternative is to require subject magnet products to be 
coated with aversive agents. This alternative would reduce the costs 
associated with the rule because it would allow firms to continue to 
sell subject magnet products and the costs of such coatings likely 
would be small. However, such requirements are not likely to adequately 
reduce the risk of injury and death associated with magnet ingestions 
because they do not address ingestions that occur when the first magnet 
is placed in the victim's mouth, before the aversive agent is detected, 
accidental ingestions, or children who are developmentally inclined to 
place objects in their mouths.
    Another alternative is to provide a longer effective date for the 
final rule. This may reduce the costs associated with the rule by 
spreading them over a longer period, but it would also delay the safety 
benefits of the rule.

E. Unreasonable Risk

    To issue a final rule, the CPSA requires the Commission to find 
that the rule, including the effective date, is reasonably necessary to 
eliminate or reduce an unreasonable risk of injury associated with the 
product. Factors the Commission considered with respect to this 
preliminary finding include the likelihood and severity of the risk, 
and the potential costs and benefits associated with the proposed rule.
    As described above, there were an estimated 23,700 magnet 
ingestions treated in U.S. hospital EDs from January 1, 2010 to 
December 31, 2020. Although this includes ingestions of all magnet 
types, and is not limited to subject magnet products, it provides an 
indication of the frequency with which children and teens ingest 
magnets, and the need to address the magnet ingestion hazard. Of these 
estimated 23,700 ED-treated magnet ingestions, an estimated 4,400 
involved products categorized as being used for amusement or jewelry, 
which are the products subject to this rule, and an additional 
estimated 18,100 involved unidentified magnet product types. As 
discussed with respect to the finding regarding the degree and nature 
of the risk of injury, a large portion of the incidents involving 
unidentified magnet products likely involve subject magnet products. In 
addition, the ICM projects that there were an additional estimated 
3,255 magnet ingestion injuries per year treated in medical settings 
other than EDs from 2017 through 2020. Trend analysis indicates that 
magnet ingestions have significantly increased in recent years.
    The potential injuries when a person ingests one or more magnets 
are serious. Health threats posed by magnet ingestion include pressure 
necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia, 
inflammation, perforation, peritonitis, sepsis, ileus, ulceration, 
aspiration, and death, among others. These conditions can result from 
magnets attracting to each other through internal body tissue, or a 
single magnet attracting to a ferromagnetic object. One indication of 
the potential severity of magnet ingestions is hospitalization rates. 
Considering NEISS data, approximately 18 percent of estimated ED-
treated magnet ingestions result in hospitalization. Of the 284 CPSRMS 
magnet ingestion cases, approximately twice as many resulted in 
hospitalization as other non-hospitalization treatment (187 
hospitalizations, 94 other treatments). For subject magnet products, in 
particular, hospitalization was two to three times as common as other 
treatments. Specifically, for magnet set ingestions, 88 resulted in 
hospitalization and 46 resulted in other treatment; for magnet toys, 36 
resulted in hospitalization and 13 resulted in other treatment; and for 
jewelry, 21 resulted in hospitalization, and 10 resulted in other 
treatment.
    Another clear indication of the severity of health risks are fatal 
incidents. Staff identified five fatal magnet ingestion incidents that 
occurred in the United States between November 24, 2005 and January 5, 
2021.\103\ All of these incidents involved victims who died from 
injuries resulting from internal interaction of the magnets. Four of 
the five incidents involved children 2 years old or younger (the 
additional death involved an adult). At least one of these fatal 
incidents involved a magnet set, one involved an

[[Page 1311]]

amusement product, and two fatal incidents provided product 
descriptions consistent with subject magnet products.
---------------------------------------------------------------------------

    \103\ CPSC is also aware of two deaths in other countries, which 
involved ingestion of hazardous magnets. Although staff does not 
know the specific products involved in these incidents, the magnets 
were similar, if not identical to magnets typically found in magnet 
sets.
---------------------------------------------------------------------------

    CPSC staff estimates that the rule could result in aggregate 
benefits of about $80 million to $95 million annually; this estimate 
excludes magnet ingestion incidents involving unidentified magnet 
products, which are likely to commonly involve subject magnet products, 
making the benefits of the rule substantially greater. CPSC staff 
estimates that the costs to consumers and manufacturers associated with 
the rule could range from $10 million to $17.5 million annually, 
assuming annual sales of 500,000 units.
    For these reasons, the Commission concludes preliminarily that 
ingestion of subject magnet products poses an unreasonable risk of 
injury and finds that the proposed rule is reasonably necessary to 
reduce that unreasonable risk of injury.

F. Public Interest

    To issue a final rule, the CPSA requires the Commission to find 
that issuing the rule is in the public interest. This proposed rule is 
intended to address an unreasonable risk of injury and death posed by 
magnet ingestions. The Commission believes that compliance with the 
requirements of the proposed rule will significantly reduce magnet 
ingestion deaths and injuries in the future; thus, the rule is in the 
public interest.

G. Voluntary Standards

    To issue a final rule, the CPSA requires the Commission to find 
that, 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 or injury, or there is unlikely to be substantial 
compliance with the voluntary standard.
    The Commission is aware of six voluntary and international 
standards that address the magnet ingestion hazard: 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; 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\); 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. The Commission does not consider 
the standards likely to result in an adequate reduction of the risk of 
injury associated with magnet ingestions because of the scope of 
products each standard covers, and the types of requirements included 
in them.
    None of these standards apply to all of the products most commonly 
identified in magnet ingestion incidents--magnet sets intended for 
users 14 years and older, magnet toys intended for users 14 years and 
older, and jewelry. Moreover, even for the products the standards do 
address, several standards provide exceptions for certain amusement and 
jewelry products, imposing only warning requirements for those 
products.
    In addition, several of the standards do not impose performance 
requirements on magnets themselves, such as size and strength 
requirements, instead recommending or requiring safety messaging or 
packaging. CPSC does not consider safety messaging or packaging 
requirements sufficient, without additional performance requirements, 
to adequately reduce the risk of injury and death associated with 
magnet ingestions. Incident data indicate that children commonly access 
ingested magnets from sources that do not include packaging or safety 
messaging; children and caregivers have commonly disregarded safety 
messaging to date; safety packaging only limits young children from 
accessing its contents, which does not address the majority of magnet 
ingestions, which involve older children and teens; and safety 
packaging requires users to repackage all magnets after every use to be 
effective, which is unlikely given the large number and small size of 
magnets often in subject magnet products.

H. Relationship of Benefits to Costs

    On a per unit basis (as shown in Table 19), CPSC estimates the 
expected benefits per unit to range from $160 (assuming a 1.5-year 
product life and a 3 percent discount rate) to $190 (assuming a 3-year 
product life and a 3 percent discount rate). The estimated expected 
cost to manufacturers per unit is between about $5 and $10, and there 
is an unquantifiable cost to consumers associated with lost utility and 
availability.
    CPSC estimates the aggregate benefits of the rule to be $80 million 
to $95 million annually and estimates the cost of the rule to be 
between $10 million to $17.5 million annually, assuming sales of 
500,000 units annually (estimated costs range from $5 million to $35 
million annually, depending on annual sales between 250,000 and 1 
million units). The Commission believes, preliminarily, that the 
benefits expected from the proposed rule bear a reasonable relationship 
to its costs.

I. Least Burdensome Requirement That Would Adequately Reduce the Risk 
of Injury

    CPSC considered several less-burdensome alternatives to the 
proposed rule. One alternative is to take no regulatory action and, 
instead, rely on existing standards to address the magnet ingestion 
hazard. This would reduce the burden associated with the rule by 
avoiding a mandatory standard; however, this alternative is unlikely to 
adequately address the magnet ingestion hazard because none of the 
existing standards apply performance requirements to all of the 
products most commonly involved in magnet ingestions incidents.
    Another alternative is a mandatory standard with less stringent 
requirements than the proposed rule, such as a higher flux index limit, 
or different requirements for certain shapes and sizes of magnets. This 
could reduce the burden associated with a rule by allowing firms to 
market a wider variety of products than under the proposed rule. 
However, this alternative would reduce the safety benefits because 
allowing certain hazardous magnets in subject magnet products to remain 
on the market does not address the hazard such products pose.
    Safety messaging is another alternative to the proposed rule. This 
alternative would reduce the burdens associated with the rule because 
it would not require modifying or discontinuing subject magnet 
products, and the costs of such warnings and instructional information 
likely would be small. However, this alternative is not likely to 
adequately reduce the magnet ingestion hazard. Safety messaging is 
generally the least effective way to reduce hazards associated with 
consumer products; incident data shows children commonly access 
ingested magnets from sources that do not include product packaging, 
where warnings are provided; incident data, behavioral and 
developmental factors, and other information indicate that children and 
caregivers commonly disregard safety messaging regarding the magnet 
ingestion hazard; and this approach has not been effective at 
adequately reducing the hazard, to date.
    Another alternative is to require special packaging to limit 
children's access to subject magnet products. Such packaging could help 
consumers determine if all magnets have been

[[Page 1312]]

returned to the container and include child-resistant features. 
Although this alternative would create some packaging costs, those 
costs likely would be lower than the proposed rule because it would 
allow subject magnet products to remain unchanged. However, this 
alternative is not likely to adequately reduce the risk of injury and 
death associated with magnet ingestions. Consumers are unlikely to 
repackage all magnets after each use, given the small size and large 
number of magnets in products, the potential to lose magnets, and 
consumers' demonstrated underappreciation of the hazard. In addition, 
packaging requirements are unlikely to be effective because they 
generally only restrict young children (under 5 years old) from 
accessing package contents, and would not prevent older children or 
teens from accessing the package contents, although the majority of 
magnet ingestion incidents involved children 5 years and older.
    Another alternative is to require subject magnet products to be 
coated with aversive agents. This alternative would reduce the burden 
associated with the rule because it would allow firms to continue to 
sell subject magnet products and the costs of such coatings likely 
would be small. However, such requirements are not likely to adequately 
address the hazard because they do not address ingestions that occur 
when the first magnet is placed in the victim's mouth, before the 
aversive agent is detected, accidental ingestions, or children who are 
developmentally inclined to place objects in their mouths.
    Another alternative is to provide a longer effective date for the 
final rule. This may reduce the burdens associated with the rule by 
spreading them over a longer period, but it would also delay the safety 
benefits of the rule.

XVII. Request for Comments

    The Commission requests comments on all aspects of the proposed 
rule. Comments should be submitted in accordance with the instructions 
in the ADDRESSES section at the beginning of this notice. The following 
are specific comment topics that the Commission would find helpful:

A. Scope and Definitions

     The scope of products covered by the proposed rule, and 
whether additional products should be included or excluded from the 
scope;
     Specifically, whether home/kitchen magnets or education 
products should be addressed in the rule;
     Data supporting any recommendations to include or exclude 
products from the scope of the rule; and
     Information and data about magnets involved in ingestion 
incidents that are categorized as unidentified product types in staff's 
analysis.

B. Performance Requirements

     Application of the ASTM F963 test method for measuring 
flux density, particularly to test small diameter spherical magnets in 
the 2 to 3 mm diameter range;
     Variances in flux density measurements of small spherical 
magnets, including correct identification of pole surfaces, accurate 
measurement of maximum absolute flux density, and accurate calculation 
of maximum cross section of the magnetic poles;
     Potential alternative methods of assessing the strength of 
magnets or their ability to cause internal interaction injuries;
     How many magnets should be tested, including whether all 
loose or separable magnets in subject magnet products should be tested, 
or only a representative sample or at least one representative sample 
of each shape and size should be tested, and how firms may satisfy such 
requirements;
     Whether statistical sampling should be used to determine 
how many magnets to test in a subject magnet product and to reasonably 
verify the tested sample is representative, particularly for products 
made up of numerous individual magnets;
     The proposed flux index limit of 50 kG\2\ mm\2\, including 
data on whether magnets with flux indexes less than 50 kG\2\ mm\2\ pose 
concern for the internal interaction hazard; and
     Whether the rule should include requirements similar to 
ASTM F963 to ensure that products do not liberate hazardous magnets 
after use and abuse testing.

C. Safety Messaging and Packaging Requirements

     Whether the rule should include requirements for safety 
messaging, particularly for products with flux indexes within the 
permissible range for which there is uncertainty about the flux indexes 
that can cause internal interaction hazards;
     Whether the rule should include requirements for 
packaging, particularly for products with flux indexes within the 
permissible range for which there is uncertainty about the flux indexes 
that can cause internal interaction hazards;
     What safety messaging requirements should include, and why 
they should be included; and
     What packaging requirements should include, and why they 
should be included.

D. Existing Standards

     Data regarding the level of compliance with existing 
standards that address magnet ingestions, including ASTM standards.

E. Economic Analysis (Preliminary Regulatory Analysis and IRFA)

     The estimates and other valuations used in CPSC's analysis 
regarding benefits and costs associated with the proposed rule;
     The annual unit sales of subject magnet products;
     The expected product life of subject magnet products;
     The number of subject magnet products subject to the 
proposed rule;
     The accuracy and reasonableness of the benefits estimates;
     Information about the costs to consumers associated with 
the proposed rule, including consumer needs for subject magnet 
products, and the potential impact of the proposed rule on the utility, 
cost, and availability of subject magnet products for those needs;
     The accuracy and reasonableness of the cost estimates for 
manufacturers and importers (if available, sales or other shipment data 
would be helpful);
     The potential impact of the proposed rule on small 
entities;
     Costs associated with testing and certification 
requirements, including requirements in section 14 of the CPSA, 
particularly for small businesses;
     Potential modifications to subject magnet products to 
comply with the proposed rule, and the costs associated with those 
modifications;
     The types and magnitude of manufacturing costs that might 
disproportionately impact small businesses or were not considered in 
the agency's analysis;
     The different impacts on small businesses associated with 
different effective dates; and
     Other alternatives that would minimize the impact on small 
businesses while reducing the magnet ingestion hazard.

F. Effective Date

     The reasonableness of the proposed 30-day effective date 
and recommendations for a different effective date, if justified. 
Comments recommending a longer effective date should describe the 
problems associated with meeting the proposed effective

[[Page 1313]]

date and the justification for a longer one.

G. Anti-Stockpiling

     Whether the Commission should consider including in the 
rule anti-stockpiling provisions to prevent manufacturing or importing 
of non-compliant subject magnet products at an increased rate during 
the period between announcing a final rule and the effective date of 
the rule; and
     Information relevant to whether an anti-stockpiling 
provision is necessary.

XVIII. Promulgation of a Final Rule

    Section 9(d)(1) of the CPSA requires the Commission to promulgate a 
final consumer product safety rule within 60 days of publishing a 
proposed rule. 15 U.S.C. 2058(d)(1). Otherwise, the Commission must 
withdraw the proposed rule if it determines that the rule is not 
reasonably necessary to eliminate or reduce an unreasonable risk of 
injury associated with the product, or is not in the public interest. 
Id. However, the Commission can extend the 60-day period, for good 
cause shown, if it publishes the reasons for doing so in the Federal 
Register. Id.
    The Commission finds that there is good cause to extend the 60-day 
period for this rulemaking. Under both the Administrative Procedure Act 
and the CPSA, the Commission must provide an opportunity for interested 
parties to submit written comments on a proposed rule. 5 U.S.C. 553; 15 
U.S.C. 2058(d)(2). The Commission typically provides 75 days for 
interested parties to submit written comments. A shorter comment period 
may limit the quality and utility of information CPSC receives in 
comments, particularly for areas where it seeks data and other detailed 
information that may take time for commenters to compile. In addition, 
the CPSA requires the Commission to provide interested parties with an 
opportunity to make oral presentations of data, views, or arguments. 15 
U.S.C. 2058. This requires time for the Commission to arrange a public 
meeting for this purpose, and provide notice to interested parties in 
advance of that meeting. After receiving written and oral comments, 
CPSC staff must have time to review and evaluate those comments.
    These factors make it impractical for the Commission to issue a 
final rule within 60 days of this proposed rule. Moreover, issuing a 
final rule within 60 days of the NPR may limit commenters' ability to 
provide useful input on the rule, and CPSC's ability to evaluate and 
take that information into consideration in developing a final rule. 
Accordingly, the Commission finds that there is good cause to extend 
the 60-day period.

XIX. Conclusion

    For the reasons stated in this preamble, the Commission proposes 
requirements for subject magnet products to address an unreasonable 
risk of injury associated with ingestion of such products.

List of Subjects

16 CFR Part 1112

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

16 CFR Part 1262

    Consumer protection, Imports, Incorporation by reference, Safety.

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

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

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

    Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.

0
2. Amend Sec.  1112.15 by adding paragraph (b)(52) to read as follows:


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

* * * * *
    (b) * * *
    (52) 16 CFR part 1262, Safety Standard for Magnets.
* * * * *
0
3. Add part 1262 to read as follows:

PART 1262--SAFETY STANDARD FOR MAGNETS

Sec.
1262.1 Scope, purpose, application, and exemptions.
1262.2 Definitions.
1262.3 Requirements.
1262.4 Test procedure for determining flux index.
1262.5 Findings.

    Authority: 15 U.S.C. 2056, 2058


Sec.  1262.1  Scope, purpose, application, and exemptions.

    (a) Scope and purpose. This part 1262, a consumer product safety 
standard, prescribes the safety requirements for a subject magnet 
product, as defined in Sec.  1262.2(b). These requirements are intended 
to reduce or eliminate an unreasonable risk of death or injury to 
consumers who ingest one or more hazardous magnets (as defined in Sec.  
1262.2(a)) from a subject magnet product.
    (b) Application. Except as provided in paragraph (c) of this 
section, all subject magnet products that are manufactured in the 
United States, or imported, on or after [effective date], are subject 
to the requirements of this part 1262, if they are consumer products. 
Section 3(a)(1) of the Consumer Product Safety Act (15 U.S.C. 
2052(a)(1)) defines the term consumer product as an ``article, or 
component part thereof, produced or distributed
    (i) for sale to a consumer for use in or around a permanent or 
temporary household or residence, a school, in recreation, or 
otherwise, or
    (ii) for the personal use, consumption or enjoyment of a consumer 
in or around a permanent or temporary household or residence, a school, 
in recreation, or otherwise.'' The term does not include products that 
are not customarily produced or distributed for sale to, or for the use 
or consumption by, or enjoyment of, a consumer.
    (c) Exemptions. Toys that are subject to 16 CFR part 1250, Safety 
Standard Mandating ASTM F963 for Toys, are exempt from this part 1262.


Sec.  1262.2  Definitions.

    In addition to the definitions given in section 3 of the Consumer 
Product Safety Act (15 U.S.C. 2052), the following definitions apply 
for purposes of this part 1262:
    (a) Hazardous magnet means a magnet that fits entirely within the 
cylinder described in 16 CFR 1501.4 and that has a flux index of 50 
kG\2\ mm\2\ or more when tested in accordance with the method described 
in this part 1262.
    (b) Subject magnet product means a consumer product that is 
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 contains one or more loose or 
separable magnets.


Sec.  1262.3  Requirements.

    Each loose or separable magnet in a subject magnet product that 
fits entirely within the cylinder described in 16 CFR 1501.4 must have 
a flux index of less than 50 kG\2\ mm\2\ when tested in accordance with 
the method described in 1262.4.


Sec.  1262.4  Test procedure for determining flux index.

    (a) Select at least one loose or separable magnet of each shape and 
size in the subject magnet product.

[[Page 1314]]

    (b) Measure the flux index of each selected magnet in accordance 
with the procedure in section 8.25.1 through 8.25.3 of ASTM F963-17, 
Standard Consumer Safety Specification for Toy Safety, approved on May 
1, 2017. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain a copy from ASTM International, 100 Barr Harbor 
Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; phone: (610) 
832-9585; www.astm.org. A read-only copy of the standard is available 
for viewing on the ASTM website at https://www.astm.org/READINGLIBRARY/. You may inspect a copy at the Division of the 
Secretariat, U.S. Consumer Product Safety Commission, 4330 East-West 
Highway, Bethesda, MD 20814, telephone (301) 504-7479, email: [email protected], or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.


Sec.  1262.5  Findings.

    (a) General. Section 9(f) of the Consumer Product Safety Act (15 
U.S.C. 2058(f)) requires the Commission to make findings concerning the 
following topics and to include the findings in the rule. Because the 
findings are required to be published in the rule, they reflect the 
information that was available to the Consumer Product Safety 
Commission (Commission, CPSC) when the standard was issued on [final 
rule publication date].
    (b) Degree and nature of the risk of injury. (1) The standard is 
designed to reduce the risk of death and injury associated with magnet 
ingestions. The Commission has identified 284 magnet ingestions that 
were reported to have occurred between January 1, 2010 and December 31, 
2020. Seventy-five percent of these incidents involved amusement or 
jewelry products, which are the products covered by this rule, and an 
additional 15 percent involved unidentified magnet products, a large 
portion of which CPSC concludes are likely to have involved subject 
magnet products, based on developmental and behavioral factors, 
identified products involved in magnet ingestion incidents, products 
involved in recalls for magnet ingestion hazards, and trend analyses 
indicating a significant decrease in magnet ingestion incidents when 
there was a mandatory standard for certain subject magnet products. 
There were an estimated 4,400 magnet ingestions treated in U.S. 
hospital emergency departments between January 1, 2010 and December 31, 
2020 that involved products categorized as being for amusement or 
jewelry, which are the products subject to this rule, and an additional 
estimated 18,100 emergency department treated magnet ingestions 
involving unidentified magnet products, a large portion of which CPSC 
concludes are likely to have involved subject magnet products for the 
reasons stated above. In addition, the Injury Cost Model projects that 
there were an additional estimated 3,255 magnet ingestion injuries per 
year treated in medical settings other than emergency departments from 
2017 through 2020.
    (2) The potential injuries when a child or teen ingests one or more 
magnets are serious. Health threats posed by magnet ingestion include 
pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae, 
ischemia, inflammation, perforation, peritonitis, sepsis, ileus, 
ulceration, aspiration, and death, among others. These conditions can 
result from magnets attracting to each other through internal body 
tissue, or a single magnet attracting to a ferromagnetic object. CPSC 
is aware of several fatal magnet ingestion incidents that occurred in 
the United States, resulting from internal interaction of the magnets 
(small intestine ischemia and volvulus).
    (c) Number of consumer products subject to the rule. Approximately 
500,000 subject magnet products are estimated to be sold annually in 
the United States.
    (d) The need of the public for subject magnet products and the 
effects of the rule on their cost, availability, and utility. (1) 
Consumers use subject magnet products for entertainment, mental 
stimulation, stress relief, and jewelry. The proposed rule requires 
subject magnet products to meet performance requirements regarding size 
or strength, but does not restrict the design of products. As such, 
subject magnet products that meet the standard would continue to serve 
the purpose of amusement or jewelry for consumers. Magnets that comply 
with the proposed rule, such as non-separable magnets, larger magnets, 
weaker magnets, or non-permanent magnets, would likely still be useful 
for amusement or jewelry. However, it is possible that there may be 
some negative effect on the utility of subject magnet products if 
compliant products function differently or do not include certain 
desired characteristics.
    (2) Retail prices of subject magnet products generally average 
under $20. CPSC has identified subject magnet products that comply with 
the proposed rule, indicating that the cost of compliant and non-
compliant products are comparable.
    (3) If the costs associated with redesigning or modifying subject 
magnet products to comply with the proposed rule results in 
manufacturers discontinuing products, there may be some loss in 
availability to consumers. However, this would be mitigated to the 
extent that compliant products meet the same consumer needs.
    (e) Other means to achieve the objective of the rule while 
minimizing adverse effects on competition, manufacturing, and 
commercial practices. (1) The Commission considered several 
alternatives to achieve the objective of reducing unreasonable risks of 
injury and death associated with magnet ingestions. One alternative is 
to take no regulatory action and, instead rely on existing voluntary 
standards to address the magnet ingestion hazard. This would eliminate 
costs associated with the rule by avoiding a mandatory standard; 
however, this alternative is unlikely to adequately reduce the risk of 
injury and death associated with magnet ingestions. For one, none of 
the existing standards address all of the products most commonly 
identified in magnet ingestion incidents, and several of the standards 
provide exceptions to performance requirements for certain subject 
magnet products. In addition, under the existing standards, certain 
subject magnet products would not be subject to performance 
requirements regarding size and strength, instead relying on 
alternative requirements, such as safety messaging, which is unlikely 
to adequately reduce the magnet ingestion hazard.
    (2) Another alternative is a mandatory standard with less stringent 
requirements than the proposed rule, such as a higher flux index limit, 
or different requirements for certain shapes and sizes of magnets. This 
could reduce the costs associated with a rule by allowing firms to 
market a wider variety of products than under the proposed rule. 
However, for this alternative to reduce costs, it would allow more 
products to remain on the market, thereby decreasing the safety 
benefits.
    (3) Safety messaging requirements are another alternative to the 
proposed rule. This would reduce the costs associated with the rule 
because it would not require modifying or discontinuing subject magnet 
products, and the costs of warnings and instructional information 
likely would be small. However, this alternative is not likely to 
adequately reduce the risk of injury and death associated with magnet 
ingestion because the effectiveness of safety

[[Page 1315]]

messaging depends on consumer seeing the messaging and convincing them 
to avoid the hazard. Incident data indicate that children commonly 
access ingested magnets from sources that are unlikely to include the 
product packaging bearing instructions or warnings. Moreover, consumers 
are unlikely to consistently heed warnings because of the perception 
that subject magnet products are appropriate for children, and 
underappreciation of the magnet ingestion hazard. Safety messaging is 
generally considered the least effective way to address product 
hazards, and has been ineffective at addressing the magnet ingestion 
hazard, to date.
    (4) Another alternative is to require special packaging to limit 
children's access to subject magnet products. Such packaging could help 
consumers determine if all magnets have been returned to the container 
and include child-resistant features. Although this alternative would 
create some packaging costs, those likely would be lower than the costs 
associated with the proposed rule because it would allow subject magnet 
products to remain unchanged. However, this alternative is not likely 
to adequately reduce the risk of injury and death associated with 
magnet ingestions. For packaging requirements to be effective, users 
would have to repackage all magnets after each use, which is unlikely 
given the small size and large number of magnets often in a product, 
the potential to lose magnets, and consumers' demonstrated 
underappreciation of the hazard. In addition, packaging requirements 
are unlikely to be effective because they generally only restrict young 
children (under 5 years old) from accessing package contents, and would 
not prevent older children or teens from accessing the package 
contents, although the majority of magnet ingestion incidents involved 
children 5 years and older.
    (5) Another alternative is to require subject magnet products to be 
coated with aversive agents. This alternative would reduce the costs 
associated with the rule because it would allow firms to continue to 
sell subject magnet products and the costs of such coatings likely 
would be small. However, such requirements are not likely to adequately 
reduce the risk of injury and death associated with magnet ingestions 
because they do not address ingestions that occur when the first magnet 
is placed in the victim's mouth, before the aversive agent is detected, 
accidental ingestions, or children who are developmentally inclined to 
place objects, including unpalatable substances, in their mouths.
    (6) Another alternative is to provide a longer effective date for 
the final rule. This may reduce the costs associated with the rule by 
spreading them over a longer period, but it would also delay the safety 
benefits of the rule.
    (f) Unreasonable risk. (1) Incident data indicate that there were 
an estimated 23,700 magnet ingestions treated in U.S. hospital 
emergency departments from January 1, 2010 to December 31, 2020. 
Although this includes ingestions of all magnet types, and is not 
limited to subject magnet products, it provides an indication of the 
frequency with which children and teens ingest magnets, and the need to 
address the magnet ingestion hazard. Of these estimated 23,700 
emergency department treated magnet ingestions, an estimated 4,400 
involved products categorized as being for amusement or jewelry, which 
are the products subject to this rule, and an additional estimated 
18,100 involved unidentified magnet product types. The Commission 
considers a large portion of the incidents involving unidentified 
magnet products to have been subject magnet products, based on the 
factors described above with respect to the finding regarding the 
degree and nature of the risk of injury. In addition, the Injury Cost 
Model projects that there were an additional estimated 3,255 magnet 
ingestion injuries per year treated in medical settings other than 
emergency departments from 2017 through 2020. Trend analysis indicates 
that magnet ingestions have significantly increased in recent years.
    (2) The potential injuries when a person ingests one or more 
magnets are serious. Health threats posed by magnet ingestion include 
pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae, 
ischemia, inflammation, perforation, peritonitis, sepsis, ileus, 
ulceration, aspiration, and death, among others. These conditions can 
result from magnets attracting to each other through internal body 
tissue, or a single magnet attracting to a ferromagnetic object. Magnet 
ingestion incidents commonly result in hospitalization, particularly 
when subject magnet products are ingested. The Commission is aware of 
five fatal magnet ingestion incidents that occurred in the United 
States between November 24, 2005 and January 5, 2021. Four of these 
incidents involved children 2 years old or younger, and all five 
victims died from injuries resulting from internal interaction of the 
magnets. Four of the five incidents identified the products as magnet 
sets, amusement products, or described them as having characteristics 
that are consistent with subject magnet products.
    (3) For these reasons, the Commission preliminarily concludes that 
the rule is reasonably necessary to eliminate or reduce an unreasonable 
risk of injury associated with the product.
    (g) Public interest. This rule is intended to address an 
unreasonable risk of injury and death posed by magnet ingestions. The 
Commission believes that compliance with the requirements of the rule 
will significantly reduce magnet ingestion deaths and injuries in the 
future; thus, the rule is in the public interest. For these reasons, 
the Commission preliminarily concludes that issuing the rule is in the 
public interest.
    (h) Voluntary standards. (1) The Commission is aware of six 
voluntary and international standards that address the magnet ingestion 
hazard: 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; 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\); 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. The Commission 
does not consider the standards likely to result in an adequate 
reduction of the risk of injury associated with magnet ingestions 
because of the scope of products each standard covers, and the types of 
requirements included in them.
    (2) None of these standards apply to all of the products most 
commonly identified in magnet ingestion incidents--magnet sets intended 
for users 14 years and older, magnet toys intended for users 14 years 
and older, and jewelry. Even for the products the standards do address, 
several standards provide exceptions for certain amusement and jewelry 
products, imposing only warning requirements for those products.
    (3) In addition, several of the standards do not impose performance 
requirements on magnet themselves, such as size and strength 
requirements, instead recommending or requiring safety messaging or 
packaging. CPSC does not consider safety messaging or packaging 
requirements sufficient, without additional performance requirements, 
to adequately reduce the risk of injury and death associated with

[[Page 1316]]

magnet ingestions. Incident data indicate that children commonly access 
ingested magnets from sources that do not include packaging or safety 
messaging; children and caregivers have commonly disregarded safety 
messaging to date; safety packaging only limits young children 
(typically, children under 5 years old) from accessing its contents, 
which does not address magnet ingestions by older children and teens, 
which make up the majority of incidents; and safety packaging requires 
users to repackage all magnets after every use to be effective, which 
is unlikely given the large number and small size of magnets often in 
subject magnet products.
    (4) For these reasons, the Commission preliminarily concludes that 
compliance with existing standards is not likely to result in the 
elimination or adequate reduction of the risk of injury associated with 
magnet ingestion.
    (i) Relationship of benefits to costs. (1) CPSC estimates the 
aggregate benefits of the rule to be $80 million to $95 million 
annually and estimates the cost of the rule to be between $10 million 
to $17.5 million annually, assuming sales of 500,000 units annually 
(estimated costs range from $5 million to $35 million annually, 
depending on annual sales between 250,000 and 1 million units).
    (2) On a per unit basis, CPSC estimates the expected benefits per 
unit to range from $160 (assuming a 1.5-year product life and a 3 
percent discount rate) to $190 (assuming a 3-year product life and a 3 
percent discount rate). The estimated expected cost to manufacturers 
per unit is between about $5 and $10, and there is an unquantifiable 
cost to consumers associated with lost utility and availability.
    (3) Based on this analysis, the Commission preliminarily finds that 
the benefits expected from the rule bear a reasonable relationship to 
its anticipated costs.
    (j) Least burdensome requirement that would adequately reduce the 
risk of injury. (1) CPSC considered several less-burdensome 
alternatives to the proposed rule. One alternative is to take no 
regulatory action and, instead, rely on existing standards to address 
the magnet ingestion hazard. This would reduce the burden associated 
with the rule by avoiding a mandatory standard, however, this 
alternative is unlikely to adequately address the magnet ingestion 
hazard because none of the existing standards apply performance 
requirements to all of the products most commonly involved in magnet 
ingestions incidents.
    (2) Another alternative is a mandatory standard with less stringent 
requirements than the proposed rule, such as a higher flux index limit, 
or different requirements for certain shapes and sizes of magnets. This 
could reduce the burden associated with a rule by allowing firms to 
market a wider variety of products than under the proposed rule. 
However, this alternative would reduce the safety benefits because 
allowing certain hazardous magnets in subject magnet products to remain 
on the market does not address the hazard such products pose.
    (3) Safety messaging is another alternative to the proposed rule. 
This alternative would reduce the burdens associated with the rule 
because it would not require modifying or discontinuing subject magnet 
products, and the costs of such warnings and instructional information 
likely would be small. However, this alternative is not likely to 
adequately reduce the magnet ingestion hazard. Safety messaging is 
generally the least effective way to reduce hazards associated with 
consumer products; incident data shows children commonly access 
ingested magnets from sources that do not include product packaging, 
where warnings are provided; incident data, behavioral and 
developmental factors, and other information indicate that children and 
caregivers commonly disregard safety messaging regarding the magnet 
ingestion hazard; and this approach has not been effective at 
adequately reducing the hazard, to date.
    (4) Another alternative is to require special packaging to limit 
children's access to subject magnet products. Such packaging could help 
consumers determine if all magnets have been returned to the container 
and include child-resistant features. Although this alternative would 
create some packaging costs, those costs likely would be lower than the 
proposed rule because it would allow subject magnet products to remain 
unchanged. However, this alternative is not likely to adequately reduce 
the risk of injury and death associated with magnet ingestions. 
Consumers are unlikely to repackage all magnets after each use, given 
the small size and large number of magnets in products, the potential 
to lose magnets, and consumers' demonstrated underappreciation of the 
hazard. In addition, packaging requirements would only prevent young 
children (typically, children under 5 years old) from accessing the 
product, not older children or teens, who are involved in the majority 
of magnet ingestion incidents.
    (5) Another alternative is to require subject magnet products to be 
coated with aversive agents. This alternative would reduce the burden 
associated with the rule because it would allow firms to continue to 
sell subject magnet products and the costs of such coatings likely 
would be small. However, such requirements are not likely to adequately 
address the hazard because they do not address ingestions that occur 
when the first magnet is placed in the victim's mouth, before the 
aversive agent is detected, accidental ingestions, or children who are 
developmentally inclined to place objects in their mouths.
    (6) Another alternative is to provide a longer effective date for 
the final rule. This may reduce the burdens associated with the rule by 
spreading them over a longer period, but it would also delay the safety 
benefits of the rule.
    (7) For these reasons, the Commission preliminarily finds that the 
rule imposes the least burdensome requirement that prevents or 
adequately reduces the risk of injury associated with magnet 
ingestions.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2021-27826 Filed 1-7-22; 8:45 am]
BILLING CODE 6355-01-P