Home/Federal/Federal Register/2021-27826

Proposed Rule2021-27826

Safety Standard for Magnets

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

January 10, 2022

Issuing agencies

Consumer Product Safety Commission

Abstract

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.

Full Text

<html>
<head>
<title>Federal Register, Volume 87 Issue 6 (Monday, January 10, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27826]

[[Page 1259]]

Vol. 87

Monday,

No. 6

January 10, 2022

Part II

Consumer Product Safety Commission

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

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]]

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

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1262

[Docket No. CPSC-2021-0037]

Safety Standard for Magnets

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The U.S. Consumer Product Safety Commission (Commission or
CPSC) has determined preliminarily that there is an unreasonable risk
of injury and death, particularly to children and teens, associated
with ingestion of one or more high-powered magnets. To address this
risk, the Commission proposes a rule, under the Consumer Product Safety
Act, to apply to consumer products that are designed, marketed, or
intended to be used for entertainment, jewelry (including children's
jewelry), mental stimulation, stress relief, or a combination of these
purposes, and that contain one or more loose or separable magnets. Toys
that are subject to CPSC's mandatory toy standard are exempt from the
proposed rule. Each loose or separable magnet in a product that is
subject to the proposed rule and that fits entirely within CPSC's small
parts cylinder would be required to have a flux index of less than 50
kG\2\ mm\2\. The Commission requests comments about all aspects of this
notice, including the risk of injury, the proposed scope and
requirements, alternatives to the proposed rule, and the economic
impacts of the proposed rule and alternatives.

DATES: Submit comments by March 28, 2022.

ADDRESSES: Submit written comments, identified by Docket No. CPSC-2021-
0037, using the methods described below. CPSC encourages you to submit
comments electronically, rather than in hard copy.
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
instructions for submitting comments. CPSC does not accept comments
submitted by electronic mail (email), except through <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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: <a href="/cdn-cgi/l/email-protection#0467747767296b7744677477672a636b72">[email&#160;protected]</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>, 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: <a href="/cdn-cgi/l/email-protection#8dc0caf8e4eee8cdeefdfeeea3eae2fb">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Overview of the Proposed Rule

The Commission issues this notice of proposed rulemaking (NPR)
under sections 7 and 9 of the Consumer Product Safety Act (CPSA; 15
U.S.C. 2051-2089).\1\ Through this rulemaking, the Commission seeks to
create a safety standard to address the unreasonable risk of injury and
death associated with ingestion of loose or separable high-powered
magnets. Incident data indicate that certain consumer products
containing such magnets are ingested by children and teens. When
ingested, these powerful magnets can interact internally with one
another, or a ferromagnetic object (i.e., material attracted to
magnets), through body tissue, leading to acute and long-term adverse
health consequences or death.
---------------------------------------------------------------------------

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

The proposed rule applies to consumer products that are designed,
marketed, or intended to be used for entertainment, jewelry (including
children's jewelry), mental stimulation, stress relief, or a
combination of these purposes, and that contain one or more loose or
separable magnets. Toys that are subject to CPSC's mandatory toy
standard in 16 CFR part 1250 are exempt from the proposed rule, because
that standard already includes requirements to address the magnet
ingestion hazard in children's toys (i.e., products designed,
manufactured, or marketed as playthings for children under 14 years
old). In this notice, products that are subject to the proposed rule
are referred to as ``subject magnet products.''
The proposed rule seeks to address the risk of injury or death
associated with magnet ingestions, by requiring loose or separable
magnets in subject magnet products to be either too large to swallow,
or weak enough to reduce the risk of internal interaction injuries when
swallowed. Under the proposed rule, each loose or separable magnet in a
subject magnet product that fits entirely within CPSC's small parts
cylinder must have a flux index of less than 50 kG\2\ mm\2\. CPSC's
small parts cylinder is described and illustrated in 16 CFR 1501.4,
which is intended to prevent children from ingesting of small objects.
The proposed rule specifies the method for determining the flux index
of a magnet, and this preamble discusses the basis for the flux index
limit in the proposed rule. The term ``hazardous magnet'' refers to a
magnet that fits entirely within the small parts cylinder and that has
a flux index of 50 kG\2\ mm\2\ or more.
The information discussed in this preamble is derived from CPSC
staff's briefing package for the NPR, which is available on CPSC's
website at: <a href="https://www.cpsc.gov/s3fs-public/Proposed-Rule-Safety-Standard-for-Magnets.pdf?VersionId=2Xizl5izY1OvQRVazWpkqdJHXg5vzRY">https://www.cpsc.gov/s3fs-public/Proposed-Rule-Safety-Standard-for-Magnets.pdf?VersionId=2Xizl5izY1OvQRVazWpkqdJHXg5vzRY</a>.
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).
---------------------------------------------------------------------------

\2\ Section 106 excluded from this mandate the following
provisions in ASTM F963-07: Section 4.2 and Annex 4 (which address
flammability), and ``any provision that restates or incorporates an
existing mandatory standard or ban promulgated by the Commission or
by statute or any provision that restates or incorporates a
regulation promulgated by the Food and Drug Administration or any
statute administrated by the Food and Drug Administration.''
---------------------------------------------------------------------------

Consistent with the mandate in section 106 of the CPSIA, the
Commission adopted 16 CFR part 1250, Safety Standard Mandating ASTM
F963 for Toys (toy standard), which currently incorporates by reference
ASTM F963-17, the most recent revision to the standard.\3\ 82 FR 57119
(Dec. 4, 2017). ASTM F963-17 applies to ``toys,'' which are objects
``designed, manufactured, or marketed as a plaything for children under
14 years of age.'' The standard includes requirements to address the
hazard associated with ingestion of loose, as-received magnets that are
small enough to fit in the small parts cylinder and have a flux index
of 50 kG\2\ mm\2\ or more. Section V. Relevant Existing Standards,
below, further describes the requirements in ASTM F963-17.
---------------------------------------------------------------------------

\3\ Part 1250 excepts from the mandatory standard, section 4.2
and Annex 5 (which address flammability) of ASTM F963-17, as well as
``any provision of ASTM F963 that restates or incorporates an
existing mandatory standard or ban promulgated by the Commission or
by statute or any provision that restates or incorporates a
regulation promulgated by the Food and Drug Administration or any
statute administrated by the Food and Drug Administration.'' 16 CFR
1250.2(b). In addition, part 1250 replaces section 8.20.1.5(5) of
ASTM F963 regarding floor and tabletop toys that move, where a sound
is caused as a result of the movement imparted on the toy. Id.
1250.2(c).
---------------------------------------------------------------------------

In 2012, the Commission initiated rulemaking to address the magnet
ingestion hazard for products that do not fall under 16 CFR part 1250.
The rule focused on magnet sets, which were involved in internal
interaction injuries in children and teens, when ingested. 77 FR 53781
(Sep. 4, 2012) (notice of proposed rulemaking); 79 FR 59962 (Oct. 3,
2014) (final rule). The rule defined ``magnet sets'' as ``any
aggregation of separable magnetic objects that is a consumer product
intended, marketed or commonly used as a manipulative or construction
item for entertainment, such as puzzle working, sculpture building,
mental stimulation, or stress relief.'' The rule required each magnet
in a magnet set, and each individual magnetic object intended or
marketed for use with or as a magnet set, that fit completely within
CPSC's small parts cylinder, to have a flux index of 50 kG\2\ mm\2\ or
less. The final rule was published in October 2014, and it took effect
on April 1, 2015. On November 22, 2016, the U.S. Court of Appeals for
the Tenth Circuit overturned the rule on magnet sets, vacating and
remanding the rule to the Commission. Zen Magnets, LLC v. Consumer
Prod. Safety Comm'n., 841 F.3d 1141 (10th Cir. 2016).\4\
---------------------------------------------------------------------------

\4\ The court decision had legal effect immediately upon its
filing on November 22, 2016. However, in accordance with the court's
decision, the Commission removed the mandatory standard for magnets
sets (16 CFR part 1240) from the Code of Federal Regulations on
March 7, 2017. 82 FR 12716 (Mar. 7, 2017).
---------------------------------------------------------------------------

2. Voluntary Standards Work
CPSC staff has actively participated in the development and
revision of voluntary standards intended to address the magnet
ingestion hazard. Since the development of ASTM F963 in 2007, CPSC
staff has worked with ASTM to address hazardous magnets in children's
toys, including working on multiple revisions to that standard. In
addition, staff has participated actively in the ASTM Subcommittee
F15.77 on Magnets, which published a voluntary standard on magnet sets
in March 2021--ASTM F3458-21, Standard Specification for Marketing,
Packaging, and Labeling Adult Magnet Sets Containing Small, Loose,
Powerful Magnets (with a Flux Index <ls-thn-eq>=50 kG\2\ mm\2\).
3. Recalls and Compliance Actions 5
---------------------------------------------------------------------------

\5\ Tab G of the NPR briefing package provides details about the
recall dates, hazards, approximate number of units affected, number
of reported incidents and injuries, and links to the recall press
releases.
---------------------------------------------------------------------------

CPSC's Office of Compliance has investigated and recalled numerous
magnet products involving the magnet ingestion hazard. From January 1,
2010 through August 17, 2021, CPSC conducted 18 such recalls, involving
23 firms/retailers, and totaling approximately 13,832,899 recalled
units, including craft kits, desk toys, magnet sets, pencil cases,
games, bicycle helmets, and maps, among others. Of these 18 recalls, 5
involved products that would not be subject to the proposed rule;
specifically, 4 involved children's toys that are subject to the
mandatory toy standard, and 1 involved trivets sold with cookware sets.
Although these 5 recalls did not apply to products that would be
subject to the rule, they also illustrate the magnet ingestion hazard.
In addition to recalls, CPSC has addressed the products that present a
magnet ingestion hazard through manufacturers' voluntary cessation of
sales.
4. Staff Assessment
In addition to staff's assessments of the magnet ingestion hazard
for previous rulemakings and compliance efforts, staff also assessed
the hazard and potential ways to address it in response to a petition
for rulemaking. On August 17, 2017, CPSC received a petition requesting
that the Commission initiate rulemaking to address the hazard
associated with magnet sets when ``ingested, aspirated, or otherwise
inserted into'' the body.\6\ On April 22, 2020, the petitioner withdrew
the petition. Nevertheless, staff provided the Commission with an
informational briefing package on June 30, 2020, discussing the hazard
and staff's work in response to the petition.\7\ In the informational
briefing package, staff recommended that CPSC continue to consider
performance requirements for magnets, to address the ingestion hazard
to children and teens.
---------------------------------------------------------------------------

\6\ The Commission published a Federal Register notice on
October 6, 2017, seeking comments on the petition. 82 FR 46740.
\7\ The informational briefing package, ``Staff Briefing Package
In Response to Petition CP 17-1, Requesting Rulemaking Regarding
Magnet Sets,'' is available at: <a href="https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf">https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf</a>.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

\8\ Available at: <a href="https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Magnets">https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Magnets</a>.
\9\ Examples include the American Academy of Pediatrics (<a href="https://services.aap.org/en/search/?k=magnets">https://services.aap.org/en/search/?k=magnets</a>); the North American Society
for Pediatric Gastroenterology, Hepatology and Nutrition (<a href="https://www.naspghan.org/content/72/en/Foreign-Body-Ingestion">https://www.naspghan.org/content/72/en/Foreign-Body-Ingestion</a>); Consumer
Reports (<a href="https://www.consumerreports.org/product-safety/magnets-marketed-as-toys-could-be-dangerous-to-kids/">https://www.consumerreports.org/product-safety/magnets-marketed-as-toys-could-be-dangerous-to-kids/</a>); Consumer Federation
of America (<a href="https://consumerfed.org/testimonial/cfa-comments-cpscs-notice-proposed-rulemaking-safety-standard-magnet-sets/">https://consumerfed.org/testimonial/cfa-comments-cpscs-notice-proposed-rulemaking-safety-standard-magnet-sets/</a>); and Kids
In Danger (<a href="https://kidsindanger.org/2011/11/cpsc-warns-about-high-powered-magnets/">https://kidsindanger.org/2011/11/cpsc-warns-about-high-powered-magnets/</a>).
---------------------------------------------------------------------------

C. How Other Countries Have Addressed the Magnet Ingestion Hazard

Like CPSC, other countries have recognized the internal interaction
hazard associated with magnet ingestions. Several of these countries
have issued mandatory requirements to address the hazard. To understand
how other countries have addressed magnet ingestions, staff reviewed
the mandatory requirements for Canada, Australia, New Zealand, and the
European Commission.
Canada's Requirements Regarding Magnet Ingestion. Since 2006,
Health Canada has issued several advisories to warn Canadians of the
dangers associated with ingesting magnets.\10\ In addition, some
manufacturers took steps to keep these products from children (e.g.,
through package warnings, instructions on safe use, and guidance to
retailers on safe sales practices). Despite these efforts, children
continued to access and use magnets, and ingestion incidents continued.
Consequently, Canada adopted mandatory standards for toys and non-toys,
to address the magnet ingestion hazard.
---------------------------------------------------------------------------

\10\ For example, see: <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/31619a-eng.php">https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/31619a-eng.php</a>; <a href="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">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</a>.
---------------------------------------------------------------------------

Canada's regulation for toys, SOR/2018-138, includes requirements
for magnetic toys intended for children under 14 years old.\11\ The
standard requires each magnet toy, and each magnetic component in a
toy, that can fit entirely within a small parts cylinder, to have a
flux index below a specified limit, which is equivalent to 50 kG\2\
mm\2\. The standard includes toys with only one magnet, to account for
attraction to ferromagnetic objects. The requirements are consistent
with ASTM F963.
---------------------------------------------------------------------------

\11\ See <a href="https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/page-3.html#h-1109670">https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/page-3.html#h-1109670</a>.
---------------------------------------------------------------------------

Canada has also specified \12\ that its general requirements, under
the Canada Consumer Product Safety Act (CCPSA), prohibit the
manufacture, import, advertising, and sale of products that contain
small, powerful magnets, regardless of the intended user age. The
general provision in the CCPSA prohibits the manufacture, import,
advertisement, and sale of any consumer product that ``is a danger to
human health or safety.'' Sections 7(a), 8(a).\13\ Canada specifically
highlighted products intended for entertainment that consist of
numerous small, powerful magnets.
---------------------------------------------------------------------------

\12\ See <a href="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">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</a>.
\13\ See <a href="https://laws-lois.justice.gc.ca/eng/acts/c-1.68/page-1.html">https://laws-lois.justice.gc.ca/eng/acts/c-1.68/page-1.html</a>.
---------------------------------------------------------------------------

Australia's Requirements Regarding Magnet Ingestion. Australia has
also issued mandatory requirements for both children's toys, and non-
children's products, to address the magnet ingestion hazard. For toys
intended for children up to, and including, 36 months, Australia
requires compliance with Australia New Zealand Standard AS/NZS ISO
8124.1, which aligns with the magnet requirements in ASTM F963.\14\
---------------------------------------------------------------------------

\14\ See <a href="https://www.legislation.gov.au/Details/F2008C00607">https://www.legislation.gov.au/Details/F2008C00607</a>.
---------------------------------------------------------------------------

In addition, in November 2012, Australia adopted a permanent ban of
consumer goods containing 2 or more separable or loose magnetic
objects, where at least 2 of the magnetic objects each separately fit
entirely within a small parts cylinder (specified in AS/NZS ISO 8124.1)
and each have a flux index greater than 50 kG\2\ mm\2\ (using methods
described in AS/NZS ISO 8124.1). The ban applies to magnetic objects
marketed or supplied for use as a toy, game, puzzle, construction or
modelling kit, or jewelry to be worn in or around the mouth or nose.
This includes adult desk toys, educational toys or games, and toys,
games, and puzzles for mental stimulation or stress relief.\15\
---------------------------------------------------------------------------

\15\ See <a href="https://www.legislation.gov.au/Details/F2012L02171">https://www.legislation.gov.au/Details/F2012L02171</a>;
<a href="https://www.productsafety.gov.au/bans/small-high-powered-magnets">https://www.productsafety.gov.au/bans/small-high-powered-magnets</a>.
---------------------------------------------------------------------------

New Zealand's Requirements Regarding Magnet Ingestion. As indicated
above, New Zealand also uses AS/NZS ISO 8124.1, which aligns with the
magnet requirements in ASTM F963, to address the magnet ingestion
hazard in children's toys.\16\
---------------------------------------------------------------------------

\16\ See <a href="https://www.standards.govt.nz/shop/asnzs-iso-8124-12019/">https://www.standards.govt.nz/shop/asnzs-iso-8124-12019/</a>.
---------------------------------------------------------------------------

In addition, in January 2013, New Zealand issued a temporary ban
\17\ on the sale of certain high-powered magnets, which it extended
indefinitely in July 2014.\18\ The ban applies to magnetic objects for
personal, domestic, or household use that are supplied, offered, or
advertised as a toy, game, puzzle, novelty, construction or modelling
kit, or jewelry that may be warn in or around the mouth or nose. This
includes adult desk toys, educational toys and games, and toys, games,
and puzzles for mental stimulation or stress relief. The ban does not
apply to hardware magnets, magnets used for teaching purposes by
schools and universities, or magnets intended to become part of another
product. The ban applies to the specified products if they contain 2 or
more separable or loose magnetic objects, at least 2 of the magnetic
objects each separately fit entirely within a small parts cylinder
(specified in AS/NZS ISO 8124.1), and at least 2 of those magnets have
a flux index greater than 50 kG\2\ mm\2\ (using methods described in
AS/NZS ISO 8124.1).
---------------------------------------------------------------------------

\17\ See https://www.beehive.govt.nz/release/ban-sale-high-
powered-magnet-
sets#:~:text=Consumer%20Affairs%20Minister%20Simon%20Bridges,stores%2
0and%20over%20the%20internet.
\18\ Unsafe Goods (Small High Powered Magnets) Indefinite
Prohibition Notice 2014, available at: <a href="https://gazette.govt.nz/notice/id/2014-go4501">https://gazette.govt.nz/notice/id/2014-go4501</a>; see also, <a href="https://productsafety.tradingstandards.govt.nz/for-business/regulated-products/small-high-powered-magnets-unsafe-goods-notice/">https://productsafety.tradingstandards.govt.nz/for-business/regulated-products/small-high-powered-magnets-unsafe-goods-notice/</a>; <a href="https://productsafety.tradingstandards.govt.nz/for-consumers/safety-with-specific-products/high-powered-magnets/">https://productsafety.tradingstandards.govt.nz/for-consumers/safety-with-specific-products/high-powered-magnets/</a>.
---------------------------------------------------------------------------

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:
<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> 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:
<bullet> The degree and nature of the risk of injury the rule is
designed to eliminate or reduce;
<bullet> the approximate number of consumer products subject to the
rule;
<bullet> 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
<bullet> 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:
<bullet> That the rule, including the effective date, is reasonably
necessary to eliminate or reduce an unreasonable risk of injury
associated with the product;
<bullet> that issuing the rule is in the public interest;
<bullet> 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;
<bullet> that the benefits expected from the rule bear a reasonable
relationship to its costs; and
<bullet> 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: <a href="https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data">https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data</a>.
\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:
<bullet> 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).
<bullet> 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).
<bullet> 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.
<bullet> Science Kits: Magnets from products identified as a
science kit or magnetic/electrical experimental set.
<bullet> 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.''
<bullet> 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.
<bullet> 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:
<bullet> 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.
<bullet> 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).
<bullet> 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.
<bullet> Science Kits: Magnets from products identified as a
science kit or magnetic/electrical experimental set. (No reported
incidents fit in this category.)
<bullet> Home/Kitchen: Magnets from products such as non-toy magnet
decorations, shower curtains, hardware, and kitchen products.
<bullet> 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.
<bullet> 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: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686864/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686864/</a>.
\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: <a href="https://pubmed.ncbi.nlm.nih.gov/32969961/">https://pubmed.ncbi.nlm.nih.gov/32969961/</a>.
\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:
<a href="https://doi.org/10.1016/j.jpeds.2021.01.052">https://doi.org/10.1016/j.jpeds.2021.01.052</a>.
---------------------------------------------------------------------------

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:
<a href="https://www.cpsc.gov/s3fs-public/pdfs/foia_SafetyStandardforMagnetSets-FinalRule.pdf">https://www.cpsc.gov/s3fs-public/pdfs/foia_SafetyStandardforMagnetSets-FinalRule.pdf</a>, and the 2020
informational briefing package, available at: <a href="https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf">https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf</a>.
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:
<bullet> 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.
<bullet> 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).
<bullet> Intentionally ate--In these cases, victims reportedly
swallowed magnets on purpose (e.g., curiosity, mistaking the magnets as
edible).
<bullet> 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).
<bullet> 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:
<bullet> ASTM F963-17, Standard Consumer Safety Specification for
Toy Safety;
<bullet> ASTM F2923-20, Standard Specification for Consumer Product
Safety for Children's Jewelry;
<bullet> ASTM F2999-19, Standard Consumer Safety Specification for
Adult Jewelry; and
<bullet> ASTM F3458-21, Standard Specification for Marketing,
Packaging, and Labeling Adult Magnet Sets Containing Small, Loose,
Powerful Magnets (with a Flux Index <ls-thn-eq>=50 kG2 mm2).
In addition, two are international safety standards:
<bullet> EN 71-1: 2014, Safety of Toys; Part 1: Mechanical and
Physical Properties; and
<bullet> 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\
---------------------------------------------------------------------------

\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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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 exa

[…truncated; see source link]

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on January 10, 2022.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.