Safety Standard for Magnets, 1260-1316 [2021-27826]
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Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Proposed Rules
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1262
[Docket No. CPSC–2021–0037]
Safety Standard for Magnets
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
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 kG2
mm2. The Commission requests
comments about all aspects of this
notice, including the risk of injury, the
proposed scope and requirements,
alternatives to the proposed rule, and
the economic impacts of the proposed
rule and alternatives.
DATES: Submit comments by March 28,
2022.
ADDRESSES: Submit written comments,
identified by Docket No. CPSC–2021–
0037, using the methods described
below. CPSC encourages you to submit
comments electronically, rather than in
hard copy.
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
CPSC does not accept comments
submitted by electronic mail (email),
except through https://
www.regulations.gov, and as described
below. CPSC encourages you to submit
electronic comments by using the
Federal eRulemaking Portal, as
described above.
Mail/Hand Delivery/Courier Written
Submissions: Submit comments by
mail/hand delivery/courier to: Division
of the Secretariat, Consumer Product
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SUMMARY:
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Safety Commission 4330 East-West
Highway, Bethesda, MD 20814;
telephone: (301) 504–7479.
Alternatively, as a temporary option
during the COVID–19 pandemic, you
can email such submissions to: cpsc-os@
cpsc.gov.
Instructions: All submissions must
include the agency name and docket
number for this notice. CPSC may post
all comments without change, including
any personal identifiers, contact
information, or other personal
information provided, to: https://
www.regulations.gov. Do not submit
electronically: Confidential business
information, trade secret information, or
other sensitive or protected information
that you do not want to be available to
the public. If you wish to submit such
information, please submit it according
to the instructions for mail/hand
delivery/courier written submissions.
Docket: To read background
documents or comments regarding this
proposed rulemaking, go to: https://
www.regulations.gov, insert docket
number CPSC–2021–0037 in the
‘‘Search’’ box, and follow the prompts.
FOR FURTHER INFORMATION CONTACT:
Michelle Guice, Compliance Officer,
U.S. Consumer Product Safety
Commission, 4330 East-West Highway,
Bethesda, MD 20814; telephone (301)
504–7723; email: MGuice@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Overview of the Proposed Rule
The Commission issues this notice of
proposed rulemaking (NPR) under
sections 7 and 9 of the Consumer
Product Safety Act (CPSA; 15 U.S.C.
2051–2089).1 Through this rulemaking,
the Commission seeks to create a safety
standard to address the unreasonable
risk of injury and death associated with
ingestion of loose or separable highpowered 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.
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
1 The Commission voted 4–0 to approve this
notice and commence rulemaking.
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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 kG2
mm2. 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 kG2 mm2
or more.
The information discussed in this
preamble is derived from CPSC staff’s
briefing package for the NPR, which is
available on CPSC’s website at: https://
www.cpsc.gov/s3fs-public/ProposedRule-Safety-Standard-for-Magnets.pdf?
VersionId=2Xizl5izY1OvQR
VazWpkqdJHXg5vzRY. 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.
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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).
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, asreceived magnets that are small enough
to fit in the small parts cylinder and
have a flux index of 50 kG2 mm2 or
more. Section V. Relevant Existing
Standards, below, further describes the
requirements in ASTM F963–17.
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
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.’’
3 Part 1250 excepts from the mandatory standard,
section 4.2 and Annex 5 (which address
flammability) of ASTM F963–17, as well as ‘‘any
provision of ASTM F963 that restates or
incorporates an existing mandatory standard or ban
promulgated by the Commission or by statute or
any provision that restates or incorporates a
regulation promulgated by the Food and Drug
Administration or any statute administrated by the
Food and Drug Administration.’’ 16 CFR 1250.2(b).
In addition, part 1250 replaces section 8.20.1.5(5)
of ASTM F963 regarding floor and tabletop toys that
move, where a sound is caused as a result of the
movement imparted on the toy. Id. 1250.2(c).
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(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 kG2 mm2 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
2. Voluntary Standards Work
CPSC staff has actively participated in
the development and revision of
voluntary standards intended to address
the magnet ingestion hazard. Since the
development of ASTM F963 in 2007,
CPSC staff has worked with ASTM to
address hazardous magnets in children’s
toys, including working on multiple
revisions to that standard. In addition,
staff has participated actively in the
ASTM Subcommittee F15.77 on
Magnets, which published a voluntary
standard on magnet sets in March
2021—ASTM F3458–21, Standard
Specification for Marketing, Packaging,
and Labeling Adult Magnet Sets
Containing Small, Loose, Powerful
Magnets (with a Flux Index
≥50 kG2 mm2).
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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.
3. Recalls and Compliance Actions 5
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
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
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).
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.
6 The Commission published a Federal Register
notice on October 6, 2017, seeking comments on the
petition. 82 FR 46740.
7 The informational briefing package, ‘‘Staff
Briefing Package In Response to Petition CP 17–1,
Requesting Rulemaking Regarding Magnet Sets,’’ is
available at: https://www.cpsc.gov/s3fs-public/
Informational%20Briefing
%20Package%20Regarding
%20Magnet%20Sets.pdf.
8 Available at: https://www.cpsc.gov/SafetyEducation/Safety-Education-Centers/Magnets.
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Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Proposed Rules
organizations and other consumer
advocacy groups have made numerous
public outreach efforts to warn
consumers about the magnet ingestion
hazard.9
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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 nontoys, to address the magnet ingestion
hazard.
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 kG2
mm2. The standard includes toys with
only one magnet, to account for
attraction to ferromagnetic objects. The
9 Examples include the American Academy of
Pediatrics (https://services.aap.org/en/search/
?k=magnets); the North American Society for
Pediatric Gastroenterology, Hepatology and
Nutrition (https://www.naspghan.org/content/72/
en/Foreign-Body-Ingestion); Consumer Reports
(https://www.consumerreports.org/product-safety/
magnets-marketed-as-toys-could-be-dangerous-tokids/); Consumer Federation of America (https://
consumerfed.org/testimonial/cfa-comments-cpscsnotice-proposed-rulemaking-safety-standardmagnet-sets/); and Kids In Danger (https://
kidsindanger.org/2011/11/cpsc-warns-about-highpowered-magnets/).
10 For example, see: https://
healthycanadians.gc.ca/recall-alert-rappel-avis/hcsc/2013/31619a-eng.php; https://www.canada.ca/
en/health-canada/services/consumer-productsafety/advisories-warnings-recalls/letters-noticesinformation-industry/information-manufacturersimporters-distributors-retailers-productscontaining-small-powerful-magnets.html.
11 See https://laws-lois.justice.gc.ca/eng/
regulations/SOR-2011-17/page-3.html#h-1109670.
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requirements are consistent with ASTM
F963.
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.
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
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 kG2 mm2 (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
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
12 See https://www.canada.ca/en/health-canada/
services/consumer-product-safety/advisorieswarnings-recalls/letters-notices-informationindustry/information-manufacturers-importersdistributors-retailers-products-containing-smallpowerful-magnets.html.
13 See https://laws-lois.justice.gc.ca/eng/acts/c1.68/page-1.html.
14 See https://www.legislation.gov.au/Details/
F2008C00607.
15 See https://www.legislation.gov.au/Details/
F2012L02171; https://www.productsafety.gov.au/
bans/small-high-powered-magnets.
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F963, to address the magnet ingestion
hazard in children’s toys.16
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 kG2 mm2 (using
methods described in AS/NZS ISO
8124.1).
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
16 See https://www.standards.govt.nz/shop/asnzsiso-8124-12019/.
17 See https://www.beehive.govt.nz/release/bansale-high-powered-magnetsets#:∼:text=Consumer%20Affairs
%20Minister%20Simon%20Bridges,
stores%20and%20over%20the%20internet.
18 Unsafe Goods (Small High Powered Magnets)
Indefinite Prohibition Notice 2014, available at:
https://gazette.govt.nz/notice/id/2014-go4501; see
also, https://productsafety.tradingstandards.
govt.nz/for-business/regulated-products/small-highpowered-magnets-unsafe-goods-notice/; https://
productsafety.tradingstandards.govt.nz/forconsumers/safety-with-specific-products/highpowered-magnets/.
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under the CPSA. See 15 U.S.C.
2052(a)(5). Section 7 of the CPSA
authorizes the Commission to issue a
mandatory consumer product safety
standard that consists of performance
requirements or requirements that the
product be marked with, or
accompanied by, warnings or
instructions. Id. 2056(a). Any
requirement in the standard must be
‘‘reasonably necessary to prevent or
reduce an unreasonable risk of injury’’
associated with the product. Id. Section
7 requires the Commission to issue such
a standard in accordance with section 9
of the CPSA. Id.
Section 9 of the CPSA specifies the
procedure the Commission must follow
to issue a consumer product safety
standard under section 7. Id. 2058.
Under section 9, the Commission may
initiate rulemaking by issuing an
advance notice of proposed rulemaking
(ANPR) or NPR. Id. 2058(a). When
issuing an NPR, the Commission must
comply with section 553 of
Administrative Procedure Act (5 U.S.C.
551–559), which requires the
Commission to provide notice of a rule
and the opportunity to submit written
comments on it. 5 U.S.C. 553; 15 U.S.C.
2058(d)(2). In addition, the Commission
must provide interested parties with an
opportunity to make oral presentations
of data, views, or arguments. Id.
2058(d)(2).
Under section 9 of the CPSA, an NPR
must include the text of the proposed
rule, any alternatives the Commission
proposes, and a preliminary regulatory
analysis. Id. 2058(c). The preliminary
regulatory analysis must include:
• A preliminary description of the
potential benefits and costs of the rule,
including benefits and costs that cannot
be quantified, and the analysis must
identify who is likely to receive the
benefits and bear the costs;
• a discussion of the reasons any
standard or portion of a standard
submitted to the Commission in
response to an ANPR was not published
by the Commission as the proposed rule
or part of the proposed rule;
• a discussion of the reasons for the
Commission’s preliminary
determination that efforts submitted to
the Commission in response to an ANPR
to develop or modify a voluntary
standard would not be likely, within a
reasonable period of time, to result in a
voluntary standard that would eliminate
or adequately reduce the risk of injury
addressed by the proposed rule; and
• a description of alternatives to the
proposed rule that the Commission
considered and a brief explanation of
the reasons the alternatives were not
chosen.
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Id.
In addition, to issue a final rule, the
Commission must make certain findings
and include them in the rule. Id.
2058(f)(1), (f)(3). Under section 9(f)(1) of
the CPSA, before promulgating a
consumer product safety rule, the
Commission must consider, and make
appropriate findings to be included in
the rule, concerning the following
issues:
• The degree and nature of the risk of
injury the rule is designed to eliminate
or reduce;
• the approximate number of
consumer products subject to the rule;
• the need of the public for the
products subject to the rule and the
probable effect the rule will have on the
cost, availability, and utility of such
products; and
• the means to achieve the objective
of the rule while minimizing adverse
effects on competition, manufacturing,
and commercial practices.
Id. 2058(f)(1). Under section 9(f)(3) of
the CPSA, the Commission may not
issue a consumer product safety rule
unless it makes the following findings
and includes them in the rule:
• That the rule, including the
effective date, is reasonably necessary to
eliminate or reduce an unreasonable
risk of injury associated with the
product;
• that issuing the rule is in the public
interest;
• if a voluntary standard addressing
the risk of injury has been adopted and
implemented, that either compliance
with the voluntary standard is not likely
to result in the elimination or adequate
reduction of the risk of injury, or there
is unlikely to be substantial compliance
with the voluntary standard;
• that the benefits expected from the
rule bear a reasonable relationship to its
costs; and
• that the rule imposes the least
burdensome requirement that prevents
or adequately reduces the risk of injury.
Id. 2058(f)(3). At the NPR stage, the
Commission is making these findings on
a preliminary basis to allow the public
to comment on them.
III. The Product and Market
A. Description of the Product
The proposed rule applies to ‘‘subject
magnet products,’’ which are consumer
products that are designed, marketed, or
intended to be used for entertainment,
jewelry (including children’s jewelry),
mental stimulation, stress relief, or a
combination of these purposes, and that
contain one or more loose or separable
magnets (subject magnet products). Toys
that are subject to 16 CFR part 1250,
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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 rockshaped magnet toys. The magnetized
cores of subject magnet products are
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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 kG2 mm2, and ferrite rock
magnets measured upwards of 700 kG2
mm2. Staff also identified products
close to the proposed limit of 50 kG2
mm2, ranging from approximately 30
kG2 mm2 to 70 kG2 mm2. Some subject
magnet products advertise having flux
indexes lower than 50 kG2 mm2, 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.
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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
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focuses on magnet sets,19 which are the
largest category of identified products
involved in magnet ingestions.
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.
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
19 Staff’s analysis for the 2014 rule and 2020
informational briefing package focused on magnet
sets.
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.
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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
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.
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
21 For more details about incident data, see Tab
B and Tab C of the NPR briefing package.
22 Data from NEISS are based on a nationally
representative probability sample of about 100
hospitals in the United States and its territories.
NEISS data can be accessed from the CPSC website
under the ‘‘Access NEISS’’ link at: https://
www.cpsc.gov/Research--Statistics/NEISS-InjuryData.
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.
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from January 1, 2010 through December
31, 2020. Staff then excluded from this
data set incidents that staff could not
determine involved magnets (e.g., ‘‘acc
swallowed dog toy vs magnet’’);
incidents that did not involve ingestion,
or where it was uncertain whether
ingestion occurred (e.g., ‘‘possible
ingestion,’’ ‘‘may have ingested’’); and
incidents that provided ambiguous
information about whether the item
ingested was a magnet (e.g., the report
refers to a magnet and ingestion, but it
is not clear that the magnet was the
object ingested). This may have resulted
in underestimating the number of
incidents.
From the remaining data set, staff
categorized incidents by magnet type.
Based on the products identified in
NEISS reports, or the description of the
products, staff organized cases into the
following categories: Magnet sets,
magnet toys, jewelry, science kits,
home/kitchen, ASTM F963 magnet toys,
and unidentified. The criteria staff used
to categorize incidents into these groups
are as follows:
• Magnet Sets: Magnets from sets of
loose, as-received magnets that are
marketed or commonly used as a
manipulative or construction item for
entertainment, such as puzzle working,
sculpture building, mental stimulation,
or stress relief. These items met at least
one of the following criteria: Referred to
as a magnet set or identified as a magnet
set through product name. This category
excludes building sets with plastic and/
or ferromagnetic components, unless
otherwise identified as a magnet set.
This category also excludes products
reasonably identified as belonging to
another product type described below
(e.g., a magnetic clasp from a necklace).
• Magnet Toys: Magnets from
products referred to as toys or games.
This category includes products for
which the manufacturer-intended user
of the toy was 14 years or older, or was
unknown, and it excludes cases that
positively identified toys subject to
ASTM F963 (i.e., excludes products
confirmed to have been designed,
manufactured, or marketed as
playthings for children under 14 years
of age).
• Jewelry: Magnets described as
jewelry (i.e., magnets that are jewelry, or
that were being used as or like jewelry)
and not definitively identified as a
magnet set. Most of these cases involve
magnets described as a bracelet,
necklace, or piercing jewelry.
• Science Kits: Magnets from
products identified as a science kit or
magnetic/electrical experimental set.
• Home/Kitchen: Magnets from
products such as non-toy magnet
decorations, shower curtains, hardware,
and kitchen products. Many of these
incidents refer to the magnets as
‘‘kitchen magnets.’’
• ASTM F963 Magnet Toys: Magnets
from toys subject to ASTM F963 (i.e.,
products designed, manufactured, or
marketed as playthings for children
under 14 years old). Reports for these
incidents included brand names or
other information sufficient for staff to
identify the involved products as toys
subject to ASTM F963. Most of these
cases involved the magnetic tip of a
children’s magnetic stylus toy.
• Unidentified: Unidentified magnet
product type.
As the descriptions above indicate,
‘‘magnet toys’’ and ‘‘ASTM F963 magnet
toys’’ refer to two different types of
products. ‘‘Magnet toys,’’ as used
throughout this preamble, refers to
products described as toys, but that did
not include indications that the product
was marketed for users under 14 years
old. In contrast, ‘‘ASTM F963 magnet
toys’’ refers to products that staff
identified as toys marketed for children
under 14 years old; as such, these
products are subject to ASTM F963, and
they do not fall under the scope of the
proposed rule.
1265
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
N
(original)
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Original magnet category
Magnet Set ...................................................................
Jewelry ..........................................................................
Magnet Toy ...................................................................
Unidentified ...................................................................
Science Kit ....................................................................
F963 magnet toy ..........................................................
Home/Kitchen ...............................................................
58
53
110
793
1
11
46
Total .......................................................................
1,072
Combined magnet category
N
(combined)
Amusement/Jewelry .....................................................
.......................................................................................
.......................................................................................
Unidentified ...................................................................
Exclusions .....................................................................
.......................................................................................
.......................................................................................
221
........................
........................
793
58
........................
........................
1,072
Source: NEISS, CPSC.
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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 .....................................................................................................................
Unidentified ..................................................................................................................................
Exclusions ....................................................................................................................................
4,400
18,100
1,300
0.17
0.14
0.20
221
793
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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
Estimate
CV
N
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
1,900
2,500
2,700
2,000
**
1,200
1,400
2,900
2,400
1,800
2,200
0.18
0.18
0.26
0.21
**
0.24
0.24
0.25
0.18
0.22
0.21
91
101
115
88
62
61
77
112
120
91
96
Total ......................................................................................................................................
22,500
0.14
1,014
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** 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 EDtreated magnet ingestions in 2015 than
in any of the following years: 2010,
2011, 2012, 2017, and 2018. Likewise,
there were significantly fewer EDtreated 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
estimate
Period
2010–2013 .......................................................................................................
2014–2016 .......................................................................................................
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N
(not an
average)
CV
2,300
1,300
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0.16
0.20
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200
Years in
period
4
3
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TABLE 4—ESTIMATED NUMBER OF MAGNET INGESTIONS TREATED IN U.S. HOSPITAL EDS, BY PERIOD—Continued
Annual
average
estimate
Period
N
(not an
average)
CV
Years in
period
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 years .........................................................................................................................................
3–4 years .....................................................................................................................................
5–7 years .....................................................................................................................................
8–10 years ...................................................................................................................................
11–13 years .................................................................................................................................
14 or More years .........................................................................................................................
2,700
2,300
4,700
4,300
3,900
3,400
**
0.19
0.27
0.16
0.14
0.19
0.17
**
120
89
196
207
179
182
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 .........................................................................................................................................
Male .............................................................................................................................................
9,100
13,300
0.15
0.14
421
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
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Under 8 years
8 or more
years
Total
Female .........................................................................................................................................
Male .............................................................................................................................................
5,600
8,400
3,500
4,900
9,100
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.
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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 ..............................................................................................................
Treated and Released .................................................................................................................
Other * ..........................................................................................................................................
4,200
18,000
**
0.19
0.14
**
264
735
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.
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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
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CPSRMS reports typically contained
more product-specific information than
NEISS reports. Based on the products
identified in the CPSRMS reports or the
descriptions of the products, staff
organized cases into the following
categories: Magnet sets, magnet toys,
jewelry, science kits, home/kitchen,
ASTM F963 magnet toys, and
unidentified. The criteria staff used to
categorize incidents into these groups
are as follows:
• Magnet Sets: Magnets from sets of
loose, as-received magnets that are
marketed or commonly used as a
manipulative or construction item for
entertainment, such as puzzle working,
sculpture building, mental stimulation,
or stress relief. These items met at least
one of the following criteria:
Æ Referred to as a magnet set;
Æ identified as a magnet set through
product name;
Æ included photos identifying the
product; or
Æ other available information
provided reasonable certainty that the
product was a magnet set (e.g., products
described identically to known magnet
sets, such as desk toys consisting of 216
loose, magnetic balls).
Brand was indicated for most of these
incidents. Incidents were excluded from
this grouping if a medical professional
identified the product as a magnet set,
but the investigator and victim
indicated that they were unable to
identify the product as a magnet set.
• Magnet Toys: Magnets from
products referred to as toys or games.
This category includes products for
which the manufacturer-intended user
of the toy was 14 years or older, or was
unknown, and excludes cases that
positively identified toys subject to
ASTM F963 (i.e., excludes products
confirmed to have been designed,
manufactured, or marketed as
playthings for children under 14 years
of age).
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Fmt 4701
Sfmt 4702
• Jewelry: Magnets described as
jewelry and not definitively identified
as a magnet set. Most of these cases
involve magnets described as a bracelet,
necklace, or piercing jewelry.
• Science Kits: Magnets from
products identified as a science kit or
magnetic/electrical experimental set.
(No reported incidents fit in this
category.)
• Home/Kitchen: Magnets from
products such as non-toy magnet
decorations, shower curtains, hardware,
and kitchen products.
• ASTM F963 Magnet Toys: Magnets
from toys subject to ASTM F963 (i.e.,
products designed, manufactured, or
marketed as playthings for children
under 14 years old). Reports for these
incidents included brand names or
other information sufficient for staff to
identify the products involved as toys
subject to ASTM F963. Most of these
cases involved magnetic building sets
with magnets encased in plastic.
• Unidentified: Unidentified magnet
product type.
Like NEISS product type categories,
‘‘magnet toys’’ and ‘‘ASTM F963 magnet
toys’’ refer to two different types of
products. Staff categorized as ‘‘magnet
toys’’ products described as toys, which
did not have evidence of having been
marketed for users under 14 years old.
In contrast, ‘‘ASTM F963 magnet toys’’
are toys staff identified as marketed for
children under 14 years old, making
them subject to ASTM F963, and
outside the scope of the proposed rule.
Consistent with the NEISS data
analysis, staff considered the following
categories to be subject magnet
products: Magnet sets, magnet toys, and
jewelry; these are referred to collectively
as ‘‘amusement/jewelry.’’ These
categories include incidents in which
the report identified a subject magnet
product as being ingested, or the
incident report provided information
about the product, such as
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characteristics or use patterns, which
were sufficient for staff to reasonably
conclude that the product fell in a
certain product type category. Staff
considered incidents in the following
categories to be outside the scope of the
proposed rule: Science kits, home/
kitchen, and ASTM F963 magnet toys;
these are referred to collectively as
‘‘exclusions.’’ Incidents in the
unidentified category did not provide
sufficient information to identify the
magnet product category, however, they
did indicate that a magnet was ingested,
and the product had characteristics and
use patterns that could be consistent
with subject magnet products. As with
the NEISS cases, staff concludes that a
substantial proportion of the
unidentified category involved subject
magnet products (see section IV.A.5.
Uncertainties in Incident Data, below).
Table 9 provides the number of
reported magnet ingestions in each
category.
TABLE 9—REPORTED MAGNET INGESTIONS, BY MAGNET CATEGORY, 2010–2020
Magnet category
Proportion
(%)
Incidents
Magnet Set ........................................
Magnet toy ........................................
Jewelry ..............................................
Unidentified .......................................
Science Kit ........................................
F963 Magnet Toy ..............................
Home/Kitchen ....................................
134
49
31
43
0
21
6
47.2
17.3
10.9
15.1
0
7.4
2.1
Total ...........................................
284
100.0%
Scope
Proportion
(%)
Incidents
Amusement/Jewelry .........................
214
75.4
Unidentified ......................................
Exclusions ........................................
43
27
15.1
9.5
Total ..........................................
284
100.0%
Note: CPSRMS reporting for 2019–2020 is ongoing.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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
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20:50 Jan 07, 2022
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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
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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.
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20
;_~,0~201lr201:II~:-.r-·20_1_61201~IL0,912o2o7
j ■ Unidentified·····"t·· i···1----2···l···12·r•«3•··l··1••«i 2
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)"=''"'"·"''~•.e,•,_,,._,,,,""''"'·"""<'"''""''"'""''''''""'''"-·""''''"''"'~'"'"'-'"''''''''"''-·~-"''"''"'"'"'"'"'"-'""''·""''''""'=•,o,-o••a,. ,.. •o••"·.,·,·,..,.,,,c,,•·,c,c"'''''''"'"·"'·"'''"·"''"'''"'~°'''"·''""''""C-"'''""°''"''"=·•" f"'""""""'""""•"••••••
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,,
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Note: CPSRMS reporting for 2019-2020 is ongoing.
Figure 1: Histogram of Reported Magnet Ingestion Incidents, by Incident Year and
Magnet Category, 2010-2020
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2020, and were lowest in 2015 and
2016, consistent with the results seen in
the NEISS data.
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Figure 2 shows reported magnet
ingestions, by victim age and product
type category.
E:\FR\FM\10JAP2.SGM
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EP10JA22.000</GPH>
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Although CPSRMS data cannot be
used to draw statistical conclusions, this
data suggests that magnet ingestion
incidents increased in 2012, 2019, and
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20
15
0
4 sf6 ! 7 I fffl10j]1712!l3i!4l~J!l~I, I
yrslyrntyr~yrs iyrs !yrsryrs Iyrs~yrs lyrsJyrs !yrs lyrs !. ·.J
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'
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!
L,.,..,__,__.....,_,,,"__,",.........,..."""""""''"'
f
._.,,,~,,.,..,.._•,_.,.,,......,,,",...........,"'"''"""'
,.........,,.,,"""""""''""""""'"'.,..,_'"'""°"""""""°""'~ '"""""""' ,_,_,.,••~-~M~"""._"""''"'-"'"""""""'''""""""' ,..,......,,,,,.,,_...,...,_,....,......,,,_.,""""""'••'>'-•"'""''""'"~"""""""'""-""'""-'"'"..,..,._""'""""""'w""i
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s 1· 6
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i
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•
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---=
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-~=-
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--
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!2
-'~"'""'"'""~~•~•"i
_j
Figure 2: Histogram of Reported Magnet Ingestion Incidents, by Victim Age and Magnet
Category, 2010-2020
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Note: CPSRMS reporting for 2019-2020 is ongoing. Incidents for which the victim's age is unknown are indicated
under"?" and are not graphed. For one victim in the "15 yrs" category, the report included conflicting information,
and the victim may have been 16 years old.
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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.
TABLE 10—REPORTED MAGNET INGESTION INCIDENTS, BY DISPOSITION AND MAGNET CATEGORY, 2010–2020
Disposition
Magnet category
Death
Hospitalization
Other
Total
Magnet Sets .....................................................................................................
Magnet Toys ....................................................................................................
Jewelry .............................................................................................................
Unidentified ......................................................................................................
ASTM F963 Magnet Toys ...............................................................................
Home/Kitchen ..................................................................................................
........................
........................
........................
24 3
........................
........................
88
36
21
27
10
5
46
13
10
13
11
1
134
49
31
43
21
6
Total ..........................................................................................................
3
187
94
284
Note: CPSRMS reporting for 2019–2020 is ongoing.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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
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.
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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-monthold child’s death involved multicolored,
5 mm diameter, spherical magnets from
an unidentified product. In 2018, a 2year-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.
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
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.
26 Table 3 provides national estimates of magnet
ingestions per year for incidents categorized as
amusement/jewelry and unidentified product types.
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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
27 Statistically significant differences are not
reported for the year 2014, because the
corresponding estimate does not meet reporting
criteria.
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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 EDtreated 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.
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 CPSRMSreported 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
total
Period
Years in
period
N
2010–2013 ...................................................................................................................................
2014–2016 ...................................................................................................................................
2017–2020 ...................................................................................................................................
47.5
6.6
45.9
122
17
118
4
3
4
2010–2020 ...................................................................................................................................
100
257
11
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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.
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/
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.
29 Flaherty, M.R., Buchmiller, T., Vangel, M., Lee,
L.K. Pediatric Magnet Ingestions After Federal Rule
Changes, 2009–2019. JAMA. Nov. 24, 2020. 324(20):
2102–2104. doi:10.1001/jama.2020.19153, available
at: https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7686864/.
30 For CPSC’s analysis, staff considered 2014 to be
the year the rule was announced because that is the
year the final rule was published. In contrast, this
study considered 2013 to be the year the rule was
announced, likely because that is the first full year
after the rule was initially announced in an NPR in
September 2012.
31 95% confidence interval (CI), 2.20–4.96.
32 95% CI, 1.60–4.06.
33 Slope change, 0.87 (95% CI, 0.71–1.03) ED
visits per 100,000 annually.
34 95% CI, 3.22–7.11.
35 Slope change, ¥0.58 (95% CI, ¥0.68 to ¥0.47)
per 100,000 persons annually.
36 Reeves, P.T., Rudolph, B., Nylund, C.M.
Magnet Ingestions in Children Presenting to
Emergency Departments in the United States 2009–
2019: A Problem in Flux. Journal of Pediatric
Gastroenterology and Nutrition. Dec. 2020.
71(6):699–703, 10.1097/MPG.0000000000002955,
available through: https://
pubmed.ncbi.nlm.nih.gov/32969961/.
37 CI, 15,878–30,635.
38 CI, 2,342–5,076.
39 CI, 3,889–8,311.
40 P = 0.01.
41 P <0.001.
42 P = 0.02.
43 CI, 4,181–8,601.
44 Like the previous study, these researchers
considered 2013 to be part of the period during
which magnet sets were likely to be off the market.
45 CI, 1,045–2,150.
46 CI, 5,472–11,485.
47 CI, 1,824–3,828.
48 P <0.001.
49 P <0.01.
50 P <0.001.
51 CI, 66–263.
52 CI, 200–500.
53 CI, 261–822.
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round and 797 54 multiple magnet
ingestion cases from 2017 through 2019.
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.
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.
54 CI,
442–1152.
L.K., Funk, A.R., Hays, H.L.,
McKenzie, L.B., Rudolph, B., Spiller, H.A. Magnet
Injuries in Children: An Analysis of the National
Poison Data System From 2008–2019. The Journal
of Pediatrics. May 1, 2021. Volume 232, P251–
256.E2, available at: doi: https://doi.org/10.1016/
j.jpeds.2021.01.052.
55 Middelberg,
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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 inscope, 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
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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.
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 EDtreated 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.
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.
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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
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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.
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
Magnets are unique among ingested
foreign bodies because of their intrinsic
57 https://www.cpsc.gov/s3fs-public/pdfs/recall/
lawsuits/abc/163--2017-10-26%20Final%20
Decision%20and%20Order.pdf?Tme8u5fRF2.29_
B.i4Ix7pPwb_whKng2.
58 For more details about injuries and health
outcomes, see Tab A of the NPR briefing package.
In addition, health outcomes associated with
magnet ingestions are discussed in the Final Rule
briefing package for the 2014 rule on magnet sets,
available at: https://www.cpsc.gov/s3fs-public/pdfs/
foia_SafetyStandardforMagnetSets-FinalRule.pdf,
and the 2020 informational briefing package,
available at: https://www.cpsc.gov/s3fs-public/
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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
Informational%20Briefing
%20Package%20Regarding
%20Magnet%20Sets.pdf. Even though the previous
analyses focused on magnet sets, the internal
magnet interaction hazard is the same for the
subject magnet products covered in this proposed
rule.
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
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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
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.
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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-monthold 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.
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Another potential health risk from
ingested magnets is an aspiration threat.
For example, in one reported case, a 3year-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, hypoxicischemic 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
61 These imaging tools present some health risks
themselves. The ionizing radiation associated with
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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.
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
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.
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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 intraabdominal 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
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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
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
63 For additional information about hazard
patterns and incident characteristics, see Tab C of
the NPR briefing package.
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magnet sets, magnet toys, and jewelry
categories, as well as incidents in the
unidentified product type category.64
categories, as well as incidents in the
unidentified product type category.64
TABLE 12—MAGNET INGESTION INCIDENTS, BY AGE
NEISS
(#)
Victim age
NEISS
(%)
CPSRMS
(#)
CPSRMS
(%)
<2 yrs ...............................................................................................................
2 yrs .................................................................................................................
3 yrs thru 4 yrs ................................................................................................
5 yrs thru 7 yrs ................................................................................................
8 yrs thru 10 yrs ..............................................................................................
11 yrs thru 13 yrs ............................................................................................
14 yrs thru 16 yrs ............................................................................................
>16 yrs .............................................................................................................
Unknown ..........................................................................................................
120
89
196
207
179
182
30
11
0
11.8
8.8
19.3
20.4
17.7
18
3
1.1
0
21
32
31
28
66
37
12
1
29
8.2
12.5
12.1
10.9
25.7
14.4
4.7
0.4
11.3
Totals ........................................................................................................
1,014
........................
257
........................
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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
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.
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.
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).
65 16 CFR part 1501.
66 See 16 CFR part 1700, issued under the Poison
Prevention Packaging Act of 1970, 15 U.S.C. 1471–
1477.
67 As discussed above, incidents in the
unidentified product category likely involve subject
magnet products, and not ASTM F963 magnet toys.
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2. Use Patterns
In reviewing incident data, staff
identified the following patterns in how
the magnets were being used at the time
of ingestion:
• Playing—These cases involved
ingestion of magnets while users were
playing, fidgeting, orally exploring the
magnets (e.g., testing the attraction
through teeth or on braces), or
performing a combination of these
actions. If playing involved use of the
product as jewelry, the case was
categorized as jewelry, rather than
playing. This category excludes cases
involving intentional ingestion.
• Jewelry—These cases involved
magnets victims were using as jewelry
at the time of the incident, such as
bracelets, necklaces, and simulated
piercings (e.g., magnets used around the
tongue, lip, and cheek to look like
piercings).
• Intentionally ate—In these cases,
victims reportedly swallowed magnets
on purpose (e.g., curiosity, mistaking
the magnets as edible).
• Other—These cases involved
identified actions that did not fit the
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• Unknown—In these cases, it was
unclear what led to the magnet
ingestion.
Table 13 provides the use patterns
involved in magnet ingestion incidents,
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).
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
TABLE 13—MAGNET INGESTION INCIDENTS, BY USE PATTERN
NEISS
(#)
Use category
NEISS
(%)
CPSRMS
(#)
CPSRMS
(%)
Playing .............................................................................................................
Jewelry .............................................................................................................
Intentionally Ate ...............................................................................................
Other ................................................................................................................
Unknown ..........................................................................................................
143
31
19
10
811
14.1
3.1
1.9
1
80
61
43
21
4
128
23.7
16.7
8.2
1.6
49.8
Totals ........................................................................................................
1,014
........................
257
........................
Source: NEISS, CPSRMS. The percentages are rounded to the nearest tenth.
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.
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
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
BILLING CODE 6355–01–P
Use Patterns by Age in NEISS Incidents
220
200
~
180
QJ
:g 160
C
- 140
1l
t:
120
0
£ 100
~.Unknown
■ Other
-"
~
'o 80
...
.8 60
z§
Intentionally ate
■ Jewelry
it' Playing
40 -
20 ·
0
<2
2
3-4
5-7
8-10
11-13
14-16
>16
Figure 3: Magnet ingestion incidents, by use pattern and victim age, for NEISS incidents.
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-ofscope products (i.e., home/kitchen and ASTM F963
magnet toys).
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69 To see Figure 3 in color, see Figure 2 in Tab
C of the NPR briefing package.
70 To see Figure 4 in color, see Figure 3 in Tab
C of the NPR briefing package.
71 As explained above, several factors indicate
that many of the incidents in the unidentified
product type category likely involved subject
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magnet products, and these incidents indicate the
use patterns and ages involved in magnet ingestion
incidents, generally. The table excludes out-ofscope products (i.e., home/kitchen and ASTM F963
magnet toys).
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Age {years)
1280
Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Proposed Rules
Use Patterns by Age in CPSRMS Incidents
70
60
Unknown
] 40
t
0
■ Other
0..
-
w
ex:: 30
,:':¾
Intentionally ate
0
'-
llllll Jewelry
w
..n 20
E
Playing
::i
z
10
0
<2
2
3-4
5-7
8-10
11-13
>16
14-16
Age (years)
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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.
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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
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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
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Figure 4: Magnet ingestion incidents, by use pattern and age, for CPSRMS incidents.
Federal Register / Vol. 87, No. 6 / Monday, January 10, 2022 / Proposed Rules
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.
1281
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
TABLE 14—MAGNET INGESTION INCIDENTS, BY SOURCE OF ACCESS, FOR CPSRMS DATA
CPSRMS
(#)
Sources of access
CPSRMS
(%)
Description
Family Owned ..................................
59
23%
Friend/Classmate/School/Neighbor
41
16
Purchased for Victim .......................
Purchased by Victim ........................
Found Outside .................................
26
5
4
10.1
1.9
1.6
Unknown ..........................................
122
47.5
Totals ........................................
257
........................
Magnets belonged to the victim’s family. Includes cases of siblings finding magnets and bringing them home.
Magnets belonged to friends, classmates, or neighbors, or the victim
found them at daycare or school.
Magnets purchased for the victim.
Magnets purchased by the victim.
Victim found the magnets outside, such as on a playground. Excludes
cases of siblings finding magnets and bringing them home.
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.
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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.
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
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).
73 In most cases, there was insufficient
information to determine if the involved products
had warnings, age labels, or both.
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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
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
74 For additional information about relevant
existing standards, see Tab C and Tab D of the NPR
briefing package.
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standards are domestic voluntary
standards:
• ASTM F963–17, Standard
Consumer Safety Specification for Toy
Safety;
• ASTM F2923–20, Standard
Specification for Consumer Product
Safety for Children’s Jewelry;
• ASTM F2999–19, Standard
Consumer Safety Specification for Adult
Jewelry; and
• ASTM F3458–21, Standard
Specification for Marketing, Packaging,
and Labeling Adult Magnet Sets
Containing Small, Loose, Powerful
Magnets (with a Flux Index
≥50 kG2 mm2).
In addition, two are international
safety standards:
• EN 71–1: 2014, Safety of Toys; Part
1: Mechanical and Physical Properties;
and
• ISO 8124–1: 2018, Safety of Toys —
Part 1: Safety Aspects Related to
Mechanical and Physical Properties.
This section describes these standards
and provides CPSC staff’s assessment of
their adequacy to address injuries and
deaths associated with magnet
ingestions. Several of the standards
include requirements that do not relate
to magnets, however, this analysis
focuses on those provisions that are
relevant to the magnet ingestion hazard.
A. ASTM F963–17
ASTM F963 was originally approved
in 1986, and has been revised numerous
times since then. In 2007, ASTM
updated the standard to include
requirements to address the magnet
ingestion hazard in children’s toys. In
subsequent revisions, ASTM added
further requirements for toys containing
magnets. As explained above, in 2008,
section 106 of the CPSIA made ASTM
F963 a mandatory consumer product
safety standard; in accordance with that
mandate, the Commission adopted 16
CFR part 1250, which currently
incorporates by reference ASTM F963–
17, which is the most recent version of
the standard. ASTM approved ASTM
F963–17 on May 1, 2017 and published
it in August 2017. CPSC staff
participates in the ASTM F15.22
subcommittee that is responsible for this
standard.
1. Scope
ASTM F963–17 applies to ‘‘toys,’’
which the standard defines as objects
designed, manufactured, or marketed as
playthings for children under 14 years
old. As such, the standard does not
apply to products that are intended for
users 14 years or older, or products that
would not be considered playthings.
When ASTM adopted the provisions
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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 asreceived ‘‘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 kG2 mm2 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 kG2 mm2
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 crosssectional area (in mm2).
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
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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
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
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.
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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
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1283
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-andabuse 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
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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.
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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.’’
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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
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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
kG2 mm2. 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 kG2 mm2, thereby, addressing
magnets with a flux index of precisely
50 kG2 mm2. 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
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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 kG2 mm2 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.
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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.
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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
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Packaging Act 76 and specify packaging
that is significantly difficult for children
under 5 years old to open within a
reasonable time).
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
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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,
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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
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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,
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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
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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 asreceived magnet and magnetic
component must either have a flux
index less than 50 kG2 mm2, 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 kG2
mm2 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
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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
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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 kG2 mm2 or more
when tested in accordance with the
method described in this part 1262.’’
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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.
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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
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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
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international standards, which address
these products, in particular.77
Description of Products. Magnets
intended for amusement include a
variety of products for consumer
entertainment, mental stimulation, and
stress relief. Whether a product is
designed, marketed, or intended to be
used for these purposes depends on
multiple considerations, such as how
the manufacturer describes the product,
marketing and advertising for the
product, product packaging and
displays, and how consumers are
reasonably likely to perceive or use the
product. Common examples of products
that contain loose or separable magnets
intended for entertainment, mental
stimulation, or stress relief (other than
children’s toys) include products
commonly referred to as ‘‘executive
toys,’’ ‘‘desk toys,’’ ‘‘magnet sets,’’ and
‘‘rock magnets.’’ Magnet sets generally
are aggregations of separable magnets
commonly used for manipulating or
constructing sculptures. Rock magnets
generally are loose magnets shaped like
rocks and intended for entertainment or
fidgeting. These are some examples, and
additional products may be designed,
marketed, or intended to be used for
entertainment, mental stimulation,
stress relief, or a combination of these
purposes.
Subject magnet products that are
jewelry also include a variety of
products, such as jewelry intended for
adults or for children, jewelry making
sets, and magnetic piercings and studs.
For example, staff has identified
necklaces made of numerous small
magnets, in multiple shapes, that
consumers can rearrange in various
configurations.
Incident Data. As the incident data
indicate, magnet ingestion cases
generally involve seven categories of
magnet products (see section IV.A.
Incident Data, above, for a detailed
description of the categories): Magnet
sets, magnet toys, jewelry, home/kitchen
magnets, ASTM F963 magnet toys,
science kits, and unidentified products.
Products categorized as magnet sets,
magnet toys, and ASTM F963 magnet
toys are generally intended for
amusement, however, ASTM F963
magnet toys are excluded from the
scope of the proposed rule.
As the incident data show, products
categorized as amusement and jewelry,
by far, are the most common product
categories identified in magnet ingestion
incidents. Table 1 shows that magnet
77 As discussed above, Canada’s efforts to address
the magnet ingestion hazard have focused on
products intended for amusement, and New
Zealand’s and Australia’s efforts have focused on
products intended for amusement and jewelry.
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toys, by far, were the most common
product type category identified 78 in
NEISS magnet ingestion incidents (110
of 279, or 39 percent), followed by
magnet sets (58 of 279, or 21 percent),
and jewelry (53 of 279, or 19 percent).
The remaining identified product
categories made up fewer of the magnet
ingestion cases: Home/kitchen magnets
(46 of 279, or 16 percent), ASTM F963
magnet toys (11 of 279, or 4 percent),
and science kits (1 of 279, or less than
1 percent). Thus, for NEISS magnet
ingestion incidents in which the
product category could be identified, 79
percent (221 of 279 incidents) involved
products in the magnet sets, magnet
toys, or jewelry categories.
CPSRMS data similarly show that
magnet sets, magnet toys, and jewelry
are the primary categories of products
identified in magnet ingestions reports.
As Table 9 shows, magnet sets, by far,
were the most common product type
identified 79 in CPSRMS magnet
ingestion incidents, making up 56
percent (134 of 241) of the incidents for
which product type categories could be
identified, followed by magnet toys (49
of 241, or 20 percent), and jewelry (31
of 241, or 13 percent). The remaining
identified product categories made up
fewer of the magnet ingestion cases:
ASTM F963 magnet toys (21 of 241, or
9 percent), home/kitchen magnets (6 of
241, or 2 percent), and 0 science kits.
Thus, for CPSRMS magnet ingestion
incidents in which the product category
could be identified, 89 percent (214 of
241 incidents) involved products in the
magnet sets, magnet toys, or jewelry
categories.
The severity of health outcomes
associated with magnet ingestions
provides further support for focusing on
amusement and jewelry products in the
proposed rule. Fatalities are one
indication of the severity of health
outcomes. As discussed above, CPSC
identified seven fatalities that involved
the ingestion of hazardous magnets
between November 24, 2005 and
January 5, 2021, 5 of which occurred in
78 As explained above, for many NEISS incidents,
there was insufficient information for staff to
identify the category of magnet products involved.
Of the 1,072 NEISS magnet ingestion incidents from
2010 through 2020, staff categorized 793 as
‘‘unidentified’’ magnet product types. For this
reason, this analysis focuses on the remaining 279
incidents for which staff could categorize the
product type.
79 Like NEISS data, CPSRMS data also includes
incidents for which there was insufficient
information for staff to determine the category of
magnet products involved. However, the proportion
of incidents in the unidentified magnet product
type category is much lower in CPSRMS than in
NEISS data. Nevertheless, this analysis focuses on
the 241 incidents for which staff could categorize
the product type.
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the United States. CPSC was able to
definitively identify one of the products
involved in these incidents (a 2005
death in the United States), which was
a children’s toy building set, a product
intended for amusement. In addition,
the most recent incident (a 2021 death
in the United States) involved a magnet
set, which is also a product intended for
amusement. Of the remaining five
incidents, three incidents (a 2013 death
in the United States and two deaths in
other countries) involved magnets that
matched the characteristics of magnets
typically found in magnet sets, but did
not identify the involved product with
certainty; one incident (a 2018 death in
the United States) involved magnets that
matched the characteristics of magnets
typically found in magnet sets, and the
product was described consistently with
magnet sets (i.e., a magnet fidget toy
building set); and one incident (a 2020
death in the United States) did not
provide information about the product
type. This suggests that amusement
products, such as magnet sets, are
involved in the most severe magnet
ingestion cases.
Whether a victim was hospitalized
after ingesting magnets provides another
indication of the severity of injuries or
the need for significant treatment. As
Table 10 shows, using CPSRMS data,
the most common product types
identified 80 in magnet ingestion cases
that resulted in hospitalization were
magnet sets (88 of 160, or 55 percent),
followed by magnet toys (36 of 160, or
23 percent), and jewelry (21 of 160, or
13 percent). Hospitalizations for the
remaining identified magnet categories
were much lower: ASTM F963 magnet
toys (10 of 160, or 6 percent), and home/
kitchen magnets (5 of 160, or 3
percent).81 Thus, for CPSRMS magnet
ingestion incidents in which the
product category could be identified, 91
percent (145 of 160 incidents) of
hospitalizations involved magnet sets,
magnet toys, or jewelry. Moreover, as
Table 10 shows, magnet ingestions from
magnet toys, magnet sets, and jewelry,
all resulted in hospitalization far more
often than they resulted in other nonhospitalization dispositions.
Use patterns at the time magnets were
ingested also show the need to address
amusement and jewelry products. The
most common identified use pattern at
the time of a magnet ingestion was
playing, meaning the victim was playing
80 To determine the type of products involved in
magnet ingestion hospitalizations, this analysis
excludes the 27 incidents for which there was
insufficient information to categorize the type of
magnet ingested.
81 There were no incidents in CPSRMS that were
identified as involving science kits.
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with, fidgeting with, or orally exploring
magnets at the time of ingestion. This
use pattern would be expected for
products intended for amusement, since
they are intended for play. As Table 13
shows, in both NEISS and CPSRMS
incidents, by far, playing was the most
common use pattern identified,82
making up 70 percent (143 of 203) of the
NEISS incidents, and 47 percent (61 of
129) of the CPSRMS incidents with
identified use patterns. The next most
common use pattern, after playing, was
jewelry, meaning the magnets were
being used as jewelry at the time of the
incident. These made up 15 percent (31
of 203) of the NEISS incidents, and 33
percent (43 of 129) of the CPSRMS
incidents with identified use patterns.
The remaining identified use patterns
made up fewer of the incidents. As
discussed in section IV.A.5.
Uncertainties in Incident Data, above, it
is reasonable to conclude that magnet
ingestions in the unidentified product
type category follow this same pattern,
with most involving products intended
for amusement or jewelry.
Together, these factors—the
prevalence of magnet ingestion
incidents that involve products
categorized as magnet sets, magnet toys,
or jewelry; the higher rate of
hospitalizations and deaths for these
product categories; and the fact that the
primary uses of magnets at the time of
ingestion were playing and jewelry—
demonstrate that magnet sets, magnet
toys, and jewelry are the primary
products involved in magnet ingestion
incidents and pose an increased risk of
serious health implications when
ingested. For these reasons, CPSC
considers a rule addressing these
specific product categories necessary to
adequately reduce the risk of injury and
death associated with magnet
ingestions. The definition of ‘‘subject
magnets’’ in the proposed rule, which is
limited to amusement and jewelry
products, focuses the proposed rule on
these most problematic products.
Developmental and Behavioral
Factors. Child and teen development
and behavior also support the need to
address magnets intended for
amusement and jewelry in the proposed
rule. Small, powerful magnets, in
general, are likely to appeal to children
and teens. The tactile appeal, shine,
color, snapping/clicking sounds when
manipulated, novelty, unpredictability,
82 For many NEISS and CPSRMS incidents, there
was insufficient information for staff to determine
the use pattern at the time magnets were ingested.
To identify relevant use patterns, this analysis
focuses on the 203 NEISS incidents and 129
CPSRMS incidents for which staff could determine
the use pattern at the time of ingestion.
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and complexity of magnets appeal to
children and teens. For younger
children, it is developmentally normal
to explore and put objects in their
mouths. Incident data demonstrate this,
with younger children more likely to
ingest magnets intentionally (see
Figures 3 and 4). Teens are at a
developmental stage that involves
testing limits, experimentation, bending
rules, and conforming to peer pressures.
Consistent with this, teens commonly
ingested magnets accidentally when
experimenting with them to simulate
jewelry or piercings (see Figures 3 and
4). Magnets offer children and teens a
seemingly safe and reversible way to try
lip, tongue, cheek, and nose piercings.
CPSC staff considers products that are
intended for amusement and jewelry to
be more likely to be accessible to and
appealing to children and teens than
other magnet products. Products that are
intended for amusement and jewelry are
likely to be perceived by children, teens,
and caregivers as appropriate for use by
children and teens; that perception is
likely to make them accessible and
appealing to children and teens. In
contrast, magnets excluded from the
scope of the proposed rule (e.g., home/
kitchen magnets, such as hardware
magnets for fastening items together, or
shower curtain magnets) are likely to be
part of common household products,
making them less conspicuous,
accessible, and appealing to children
and teens, since they are not intended
for amusement or jewelry, and making
caregivers less likely to give them to,
purchase them for, or allow their use by
children and teens.
Incident data and consumer reviews
support this assessment. As the incident
data indicate, for magnet ingestions in
which staff could identify the product
type involved, most products were
magnet sets and magnet toys, neither of
which are products intended for use by
children under 14 years old (see Table
1 and Table 9). Despite this, the vast
majority of magnet ingestion incidents
involved children under 14 years old
(see Table 5 and Table 12), which
demonstrates that children and teens
access these amusement products
intended for older users. Similarly,
incident data show that, where the use
pattern at the time of ingestion is
known, victims were, by far, most often
playing with the magnet (see Table 13),
suggesting that victims may be attracted
to and access products that appear to be
playthings. The second most common
identified use pattern was jewelry (see
Table 13), suggesting that children and
teens are also particularly likely to
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interact with magnets that are part of
jewelry.83
Of the magnet ingestion incidents for
which the source of access could be
identified, 19 percent (26 of 135)
involved magnets that were purchased
for the victim (see Table 14), despite
most incidents involving children under
14 years old and products intended for
users 14 years and older. This suggests
that children, teens, and caregivers
perceive products like magnet sets and
magnet toys to be appealing to and
appropriate for children and teens.
Another reason children and teens are
particularly likely to be attracted by and
access amusement products that include
magnets is that these products often
look the same as products intended as
toys for children. Consumer reviews of
products demonstrate this, with
consumers commonly considering
subject magnet products suitable
playthings for children, and purchasing
them for children, even when warnings
state otherwise. Staff identified
numerous incidents in which children
ingested magnets from products that
were marketed and labeled as not
intended for children, and bore
warnings regarding the magnet ingestion
hazard. For example, staff identified 16
recent incidents in which children
ingested magnets from a magnet set that
included warnings and marketing
indicating that the product was
intended for adults. For older children,
in particular, parents often do not
expect that children would place
magnets in their mouths.
Recalls. Recalls of magnet products
further demonstrate the need to focus on
magnets intended for amusement. Of the
18 recalls that involved the magnet
ingestion hazard between January 1,
2010 and August 17, 2021, the vast
majority involved products intended for
amusement. The recalls primarily
involved magnet sets and desk toys,
rather than children’s toys or other nonamusement products.
83 Incidents categorized as involving jewelry
included cases in which the magnet was from a
jewelry product or was described as jewelry at the
time of ingestion, but the specific product could not
be identified. For some of these incidents, it is
possible that the magnets did not actually come
from jewelry, but rather, came from other magnet
products that children and teens were using as
jewelry. However, staff considers most cases
categorized as jewelry to have involved either
jewelry or amusement products, such as magnet
sets, being used as jewelry. This is because, of the
cases for which staff could determine the product
being used as jewelry, only one case in both the
NEISS and CPSRMS datasets reported that the
magnet being used as jewelry was actually a home/
kitchen magnet, and none indicated the magnet was
from an ASTM F963 magnet toy.
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e. Excluding Children’s Toys
The scope of the proposed rule
specifically excludes products that are
subject to 16 CFR part 1250. Currently,
16 CFR part 1250 incorporates by
reference ASTM F963–17, which
defines a ‘‘toy’’ as ‘‘any object designed,
manufactured, or marketed as a
plaything for children under 14 years of
age.’’ As discussed above, ASTM F963–
17 includes requirements consistent
with the proposed rule, including the
same performance requirements
regarding size and strength.
Recall information suggests that the
toy standard is largely complied with
and has been effective at addressing the
magnet ingestion hazard in children’s
toys. As discussed in section IV.A.5.
Uncertainties in Incident Data, since the
toy standard became mandatory, there
has been an appreciable decline in
recalls of children’s toys related to the
magnet ingestion hazard. Of the 18
recalls between 2010 and 2021 that
involved the magnet ingestion hazard,
only 4 involved children’s toys, and
only 2 of those were confirmed to have
been noncompliant with the magnet
requirements in ASTM F963. Recalls
generally occur when a company
receives information about a product
being hazardous and reports it to CPSC.
As such, the low rate of recalls
involving the magnet ingestion hazard
in children’s toys suggests that these
products largely comply with ASTM
F963, and that the toy standard has been
effective at addressing the magnet
ingestion hazard in children’s toys.
In addition, as Table 10 suggests,
when ASTM F963 magnet toys are
ingested, they appear to result in severe
injuries less commonly than other
products. Magnet ingestions of ASTM
F963 magnet toys resulted in
hospitalization about as often as they
resulted in other non-hospitalization
dispositions; in contrast, magnet toys,
magnet sets, and jewelry all resulted in
hospitalization far more often than they
resulted in other non-hospitalization
dispositions. This suggests that when
ASTM F963 magnet toys are ingested,
they may be less likely to result in
serious health outcomes requiring
hospitalization. Of the 108 CPSRMS
cases that had evidence of internal
interaction through body tissue, only 6
cases involved products identified as
ASTM F963 magnet toys. Of the 124
CPSRMS cases that indicated surgical
procedures were necessary as a result of
magnet ingestion, only 9 cases involved
products identified as ASTM F963
magnet toys. Most, if not all, of the
ingestions of ASTM F963 magnet toys
that resulted in surgical intervention did
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not meet the requirements of ASTM
F963.
For these reasons, CPSC does not
consider it necessary to further address
children’s toys in this proposed rule.
Nevertheless, there are two elements of
the definition of ‘‘toys’’ that are
noteworthy for this proposed rule.
First, ‘‘toys’’ are products that are
intended as ‘‘playthings.’’ Thus, toys do
not include products that are not
playthings, even when they are
intended for children under 14 years
old. For example, children’s jewelry,
when not intended as a plaything,
would not fall under the definition of a
‘‘toy’’ and, therefore, would not be
subject to the toy standard.84 As such,
children’s non-toy jewelry is subject to
the proposed rule. Additional products
may also fall under the scope of the
proposed rule, although intended for
users under 14 years old, if they do not
constitute ‘‘playthings,’’ but otherwise
meet the definition of subject magnet
products.
Second, the definition of ‘‘toys’’ limits
them to products intended for users
under 14 years old. However, as magnet
ingestion incident data show, products
that are intended for users 14 years and
older are commonly ingested by
children and teens, indicating that the
toy standard, on its own, cannot
adequately address the magnet ingestion
hazard. As discussed above, incidents
categorized as involving magnet sets or
magnet toys exclude products that staff
confirmed were intended as playthings
for children under 14 years old. These
two categories were the most common
categories of identified products
involved in magnet ingestion incidents,
despite the fact that most incidents
involved children and teens under 14
years old. As Figure 2 shows, children
as young as 11 months, and many
children between 1 and 13 years old
ingest products in the magnet toys and
magnet sets categories. Staff identified
many incidents in which the product
ingested was clearly marketed and
labeled as intended for adults, with
warnings regarding the magnet ingestion
hazard, but the product was,
84 Section 1.3 of ASTM F963–17 states that the
standard applies to ‘‘toys intended for use by
children under 14 years of age’’ and section 3.1.91
defines a ‘‘toy’’ as ‘‘any object designed,
manufactured, or marketed as a plaything for
children under 14 years of age.’’ Section 1.3.1 of
ASTM F2923–20 specifies that the standard, which
applies to children’s jewelry, does not apply to ‘‘toy
jewelry or any other products that are intended for
use by a child when the child plays (that is, a
necklace worn by a doll or stuffed animal; novelty
jewelry with play value)’’ and further states that
‘‘any product which is predominately used for play
value is a toy’’ and ‘‘toys are subject to the
requirements of Consumer Safety Specification
F963.’’
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nevertheless, ingested by children under
the intended user age. In many cases,
caregivers even provided these products
to children, despite the warnings. This
demonstrates why it is necessary to
adopt a standard for products intended
for users 14 years and older, in addition
to the toy standard, to adequately
address the magnet ingestion hazard.
f. Products Not Covered by the Proposed
Rule
Based on the definition of ‘‘subject
magnet products’’ and the scope of the
proposed rule, certain products that
contain loose or separable magnets are
not subject to the proposed rule. Home
and kitchen magnets are one such
product, if they do not otherwise meet
the definition of subject magnet
products. Common examples of home
and kitchen magnets are refrigerator
magnets, magnetic decorations,
hardware for kitchen cabinets, and
shower curtain accessories. If such
products are not loose or separable or
are not designed, marketed, or intended
to be used for entertainment, jewelry,
mental stimulation, or stress relief, they
would not fall under the scope of the
proposed rule.
CPSC considers it reasonable to
exclude home/kitchen products from
the scope of the proposed rule for
several reasons. For one, incident data
indicate that home/kitchen magnets are
far less commonly involved in magnet
ingestion incidents than amusement and
jewelry products. As Table 1 indicates,
16 percent (46 of 279) of NEISS magnet
ingestion incidents for which the
product category could be determined
involved home/kitchen magnets; as
Table 9 indicates, only 2 percent (6 of
241) of CPSRMS magnet ingestion
incidents for which the product
category could be determined involved
home/kitchen magnets. Home/kitchen
magnets also make up a very small
portion of incidents that resulted in
hospitalization. Table 10 shows that,
only 3 percent (5 of 160) of the CSPRMS
magnet ingestion incidents with
identified product types that resulted in
hospitalization, involved home/kitchen
magnets. Of the 108 CPSRMS cases that
had evidence of internal interaction
through body tissue, only 1 case
involved products identified by staff as
home/kitchen products. Of the 124
CPSRMS cases that indicated surgical
procedures were necessary as a result of
magnet ingestion, only 2 cases involved
products identified by staff as home/
kitchen products.
In addition, as discussed above, CPSC
considers it less likely that children and
teens will interact with, play with, or
experiment with home/kitchen magnets,
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particularly in ways that may lead to
ingestion. Home/kitchen products
excluded from the proposed rule have
intended uses that do not include
amusement or jewelry, and are often
part of common household products,
making them less conspicuous,
accessible, and appealing to children
and teens, since they are not intended
for amusement or jewelry, and making
caregivers less likely to give them to,
purchase them for, or allow their use by
children and teens. In contrast, the
intended uses of amusement and
jewelry products make them appear less
hazardous, and more likely to be
appealing and accessible to children
and teens.
Other products that would fall outside
the scope of the proposed rule include
research and educational products, or
those intended for commercial or
industrial purposes, if they are not also
intended for amusement or jewelry.85
CPSC considers it appropriate to
exclude these products for several
reasons. As incident data indicate,
almost no magnet ingestion incidents
for which product types could be
identified involved products intended
for education, research, commercial, or
industrial use. Among NEISS incidents,
only one incident—involving a science
kit—potentially involved such a
product; no such incidents were
identified in CPSRMS data. For that one
incident, little information was
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85 It is also possible that products intended for
purposes such as education, research, or industrial
applications would not meet the definition of a
‘‘consumer product,’’ if they are not commonly sold
to or used by consumers. If, for example, magnets
for research purposes were sold through outlets
primarily accessible to and used by laboratories or
other research facilities, these may not be
considered consumer products.
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available about the science kit, but staff
considered it possible that the product
was intended for educational purposes.
Staff also considers it less likely that
children or teens would have access to
such products. For example, magnets
used for research or industrial
applications are likely to be in settings
that children do not frequent. Even if
children could access such products, for
the same reasons as home/kitchen
magnets, staff considers it less likely
that these products would appeal to
children, appear to be playthings or
jewelry to children or caregivers, or for
children to interact with them in ways
that would lead to ingestion.
In addition to the likely reduced
hazard these out-of-scope products
present to children and teens, CPSC also
seeks to limit the scope of the proposed
rule to the extent possible to reduce the
impact on products, such as research,
education, and industrial magnet
products, that may have important uses
and require magnets that are small and
strong to serve their function. In
contrast, amusement and jewelry
products likely serve less critical
functions and may still serve their
purpose with slightly larger or slightly
weaker magnets, or non-separable
magnets.
g. Other Factors Not Used in the
Proposed Rule
CPSC considered using additional
criteria, such as magnet composition or
shape, as part of the scope of the
proposed rule. However, CPSC did not
limit the scope of the proposed rule to
specific magnet compositions because
staff has found that various magnet
compositions have been involved in
internal interaction incidents. For
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example, NIB is commonly used for
smaller magnets from magnet sets and
magnetic jewelry sets, and ferrite/
hematite is commonly used for larger
magnets, such as rock-shaped magnet
toys. Staff testing of magnets in
consumer products indicates that
magnets with various compositions
often have very high flux indexes, far in
excess of the proposed limit of less than
50 kG2 mm2, warranting a standard for
various compositions. CPSC did not
include specific shapes or sizes in the
scope of the proposed rule because staff
found that various shapes and sizes of
magnets present the hazard, including
rock-shaped magnets, and most incident
reports lack information about the
specific shapes and sizes of the magnets.
As such, the performance requirements
in the proposed rule address magnets
that could be ingested, regardless of
their shape.
B. Performance Requirements
1. Proposed Requirements
Under the proposed rule, each loose
or separable magnet in a subject magnet
product that fits entirely within the
small parts cylinder described in 16
CFR 1501.4 must have a flux index of
less than 50 kG2 mm2 when tested in
accordance with a prescribed method.
Thus, the first step is to determine
whether each loose or separable magnet
in a subject magnet product fits in the
small parts cylinder and what its flux
index is.
The small parts cylinder is described
and illustrated in 16 CFR part 1501.4.
Figure 5, below, shows the illustration,
including the dimensions, of the
cylinder, provided in the regulation.
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If a magnet fits entirely within this
cylinder, then its flux index must be
less than 50 kG2 mm2.
To determine the flux index of a
magnet, the proposed rule provides that
at least one loose or separable magnet of
each shape and size in the subject
magnet product must have its flux index
determined using the procedure in
sections 8.25.1 through 8.25.3 of ASTM
F963–17, which specify test equipment,
measurements, the test method, and the
calculation for determining flux index.
The test requires a direct current field
gauss meter with a resolution of 5 gauss
(G) capable of determining the field
with an accuracy of 1.5 percent or better
and an axial probe with a specified
active area diameter and a distance
between the active area and probe tip.
Using the meter, the probe tip is placed
in contact with the pole surface of the
magnet, the probe is kept perpendicular
to the surface, and the probe is moved
across the surface to find the maximum
absolute flux density. The flux index, in
kG2 mm2, is determined by multiplying
the area of the pole surface (mm2) of the
magnet by the square of the maximum
flux density (kG2). The flux density
must be less than 50 kG2 mm2 to comply
with the proposed rule.
2. Basis for Proposed Requirements
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a. Size Requirements
The first portion of the performance
requirement in the proposed rule
involves determining whether a magnet
fits entirely within the small parts
cylinder described in 16 CFR 1501.4.
The purpose of this requirement is to
determine whether a magnet is small
enough to be swallowed. If so, then it
is subject to strength requirements to
reduce the risk of internal interaction
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injuries from strong magnets. However,
if the magnet is too large to be
swallowed, as determined by the small
parts cylinder, then it is not subject to
any strength requirements.
The small parts cylinder was
developed to address choking,
aspiration, and ingestion hazards for
children, and was largely based on
research and data regarding the size of
objects children ingest. To address this
hazard, since 1980, the Commission’s
regulations (at 16 CFR part 1501) have
specified that certain toys and other
articles intended for use by children
must not contain choking, aspiration, or
ingestion hazards for children. Whether
these products present such hazards is
determined by whether they fit within
the small parts cylinder described in 16
CFR 1501.4.86 Several ASTM standards
for children’s products reference these
regulations as well, requiring that
products have no small parts as
determined by 16 CFR part 1501,87 and
the small parts cylinder specified in the
ASTM standards that addresses magnet
ingestions is the same as in 16 CFR
1501.4. Similarly, the small parts
cylinders referenced in international
standards that address magnet
ingestions, including EN 71–1: 2014 and
ISO 8124–1: 2018, are also the same as
in 16 CFR 1501.4. These standards are
developed by consensus of various
groups, including consumer groups,
children’s product engineers and
experts, and manufacturers of children’s
products. As such, the small parts
cylinder in 16 CFR 1501.4 is consistent
86 See 43 FR 47684 (Oct. 16, 1978); 44 FR 34892
(June 15, 1979).
87 For example, ASTM F2088–20, Standard
Consumer Safety Specification for Infant and
Cradle Swings.
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with consensus standards developed
with cooperation and input from
various experts, is widely recognized,
and has long been used as a way to
identify products that children can
ingest.
Incident data further support the
effectiveness of the small parts cylinder
in 16 CFR part 1501.4 to address the
magnet ingestion hazard. As discussed
above, magnet ingestion incidents
substantially declined during the years
the magnet sets rule was announced and
in effect, and substantially increased
after the rule was vacated. The magnet
sets rule included the same performance
requirements regarding size and
strength as this proposed rule, including
the small parts cylinder. The marked
decline in magnet ingestions during that
rule suggests that the performance
requirements in that rule were effective
at reducing the risk of children ingesting
magnets.
Similarly, there was a significant
decline in recalls involving the magnet
ingestion hazard after the toy standard
became mandatory. The toy standard
requires compliance with ASTM F963,
which includes the same small parts
cylinder as 16 CFR 1501.4. As such, this
decline in recalled toys that present a
magnet ingestion hazard after the toy
standard became mandatory suggests
that the requirements in that rule were
effective at reducing the risk of children
ingesting magnets. The low number of
magnet ingestion incidents that identify
ASTM F963 magnet toys as the involved
product also indicates that the
requirements in the standard have been
effective at addressing the magnet
ingestion hazard. Moreover, when
magnet ingestions did occur with
children’s toys, they rarely resulted in
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Figure 5: Small parts cylinder in 16 CFR 1501.4
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the internal interaction hazard, and
those that did result in internal
interaction, did not comply with the toy
standard.
For these reasons, the proposed rule
uses 16 CFR 1501.4 as the means of
determining whether a child could
ingest a particular magnet, thereby
subjecting it to performance
requirements regarding strength, to
reduce the risk of injury.
b. Strength Requirements
When a magnet is small enough to fit
entirely within the small parts cylinder,
the proposed rule requires that the
magnet have a flux index less than 50
kG2 mm2. This provision consists of two
elements—a method for determining
flux index, and a flux index limit of less
than 50 kG2 mm2. This requirement is
intended to reduce the risk that a
magnet is strong enough to cause
internal interaction injuries, if ingested.
This section discusses the rationale for
both the flux index methodology and
the flux index limit in the proposed
rule.
Flux Index Methodology. The
proposed rule incorporates by reference
the provisions in ASTM F963 that
specify the method for measuring and
calculating flux index. The ASTM
Subcommittee F15.22 on Toy Safety
developed this methodology and ASTM
first published it in ASTM F963–07.
The magnetic flux index estimates the
magnet attraction force of individual
single-pole magnets.
A magnet’s composition, mass, and
shape determine its magnetic field. This
field is aligned with its north and south
magnetic poles (see Figure 6). Surface
flux density is a measurement of the
magnetic field intensity at a given
perpendicular distance above an area
(dimension ‘‘x’’ in Figure 6). The
maximum flux density is measured
perpendicular to the pole surface of a
magnet.
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BILLING CODE 6355–01–C
The ASTM F963 working group that
developed the flux index methodology
aimed to address injuries involving
children ingesting small, powerful
magnets. As such, it was designed to
address the same hazard at issue in this
proposed rule, and minimize the risk of
internal injuries when magnets are
ingested. As part of an ASTM standard,
this methodology was developed by
consensus, with input from various
stakeholders, such as children’s product
manufacturers, consumer groups, and
children’s product engineers and
experts. In addition, this methodology is
used in multiple ASTM standards that
address the magnet ingestion hazard,
international standards (including EN
71–1: 2014 and ISO 8124–1: 2018), and
the mandatory toy standard in 16 CFR
part 1250. As part of these standards,
the methodology is widely recognized
and accepted, and has been used for
many years.
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CPSC staff considers this
methodology effective for assessing the
strength of subject magnet products.
Incident data also support the
effectiveness of the flux index
methodology in ASTM F963 to address
the magnet ingestion hazard. Magnet
ingestion incidents appreciably
declined during the years the magnet
sets rule was announced and in effect,
and appreciably increased after the rule
was vacated. The magnet sets rule
included the same size and strength
limits as this proposed rule, and
incorporated by reference the flux index
methodology in ASTM F963. The
decline in magnet ingestions during that
rule suggests that the performance
requirements in that rule were effective
at reducing the risk of injury and death
associated with magnet ingestions.
Similarly, there was a significant
decline in recalls involving the magnet
ingestion hazard after the toy standard
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became mandatory. The toy standard
requires compliance with ASTM F963
and, therefore, includes the same flux
index methodology as this proposed
rule. The decline in recalled toys that
present a magnet ingestion hazard after
the toy standard became mandatory
suggests that the requirements in that
rule were effective at reducing the risk
of injury and death associated with
magnet ingestions. The low number of
magnet ingestion incidents that identify
ASTM F963 magnet toys as the involved
product also indicates that the
requirements in the standard have been
effective at reducing the magnet
ingestion hazard. When magnet
ingestions did occur with children’s
toys, they rarely resulted in the internal
interaction hazard, and those that did
result in internal interaction, did not
comply with the toy standard.
For these reasons, the proposed rule
uses the flux index methodology in
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Figure 6: Magnetic field of spherical magnet.
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ASTM F963–17 as the means of
measuring the strength of magnets for
purposes of limiting the risk of internal
interaction injuries when ingested.
There are two issues that the
Commission seeks input on regarding
the flux index methodology. The first
issue involves how many magnets to
test. The proposed rule and ASTM
F963–17 do not explicitly state how
many magnets from a product to test, or
whether to use statistical sampling. The
proposed rule requires at least one loose
or separable magnet of each shape and
size to be tested, and specifies that each
loose or separable magnet in a subject
magnet product that fits entirely within
the small parts cylinder must have a
flux index less than 50 kG2 mm2.
Similarly, section 4.38.1 of ASTM
F963–17 states that ‘‘toys shall not
contain a loose as-received hazardous
magnet or a loose as-received hazardous
magnetic component.’’ These provisions
indicate that each magnet may need to
be tested to ensure that compliance with
the size and strength provisions.
However, subject magnet products
may consist of hundreds or thousands of
individual magnets. As such, it may be
reasonable to require that only a
‘‘representative sample’’ or ‘‘at least one
representative sample of each shape and
size’’ be tested. CPSC staff’s testing of
magnets, described below, suggests that
individual magnets within the same
product may have different flux
indexes, which may suggest that it is
important to test each individual
magnet in a product. CPSC seeks
comments on how firms would test
products to align with the proposed
requirements, whether another
requirement regarding the number of
magnets to test is appropriate, and how
firms would satisfy such alternative
requirements.
The second issue for which the
Commission seeks comments is the
utility of the flux index methodology for
certain magnets—in particular, small
spherical magnets. Staff has found the
flux index methodology straightforward
and consistent when used for large disc
magnets. However, staff encountered
some challenges finding the location of
the poles for magnets smaller than 3 mm
in diameter because of difficulties
handling these particularly small
spherical magnets. This may result in
inaccurate measurements of the highest
flux index values if the value is not
measured above the magnet’s pole. Staff
testing of 2.5 mm spherical magnets,
described below, illustrates this
potential issue.
To examine possible ways to address
this, staff refined the test procedure in
ASTM F963–17 to include additional
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detail to locate the magnet pole and
secure the magnet on a base, rather than
holding it. This test procedure
maintained the flux index methodology
in ASTM F963–17, and merely added
information to it, which staff found
improved the accuracy and consistency
of flux density measurements and
calculations. This refined procedure is
provided in detail in the Appendix to
Tab D of the NPR briefing package. To
summarize, the refined test method
consists of the following steps:
(1) Use a flat magnetic or ferromagnetic
utensil to attract spherical magnets into
alignment with pole orientation towards the
utensil;
(2) Transfer the spherical magnets from the
utensil to a flat surface covered in at least 2
mm depth of putty that is dense/thick
enough to maintain the configuration of the
spherical magnets in the proper pole
orientation (established by magnetic
attraction with the utensil); and
(3) With the spherical magnets aligned in
the flat surface putty with pole orientation
facing away from the test surface, use the
gauss meter probe to determine the
maximum flux value of each individual
magnet.
The additional detail in this refined
procedure is one option for potentially
supplementing the flux index
methodology in ASTM F963–17.
However, there are other potential
alternatives to the method in ASTM
F963–17, such as considering attraction
and repulsion forces. The Commission
requests comments on the variability of
flux index results, issues determining
the flux index of smaller magnets, and
potential refinements or alternatives to
the proposed methodology for assessing
the strength of magnets.
Flux Index Limit. The proposed rule
limits the flux index of magnets small
enough to be swallowed to less than 50
kG2 mm2. ASTM introduced this flux
index limit in 2007, in ASTM F963–
07.88 ASTM set the flux index limit at
50 kG2 mm2 based on measurements of
flux indexes in magnetic toys that were
involved in magnet ingestion incidents
at the time, which generally had flux
index measurements over 70 kG2 mm2.
Based on this information, 70 kG2 mm2
was determined to be an unsafe flux
index measurement, and ASTM set the
limit at 50 kG2 mm2 to provide a factor
of safety.
As part of an ASTM standard, the flux
index limit was developed by consensus
of various groups, including consumer
groups, children’s product engineers
88 ASTM F963–2007 specified that prohibited
hazardous magnets had a flux index greater than 50
kG2 mm2, however, this was revised in later
versions of the standard, and ASTM F963–17 now
prohibits hazardous magnets with a flux index of
50 kG2 mm2 or more.
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and experts, and manufacturers of
children’s products. Additional ASTM
standards, as well as international
standards that address magnet
ingestions, including EN 71–1: 2014 and
ISO 8124–1: 2018, also include a flux
index limit of 50 kG2 mm2 for ingestible
magnets. As such, the flux index limit
of 50 kG2 mm2 is consistent with
consensus standards developed with
cooperation and input from various
experts, is widely recognized, and has
long been used as a way to reduce the
internal interaction hazard when
magnets are ingested.
Incident data support the
effectiveness of this flux index limit to
address the magnet ingestion hazard.
Magnet ingestion incidents substantially
declined during the years the magnet
sets rule was announced and in effect,
and substantially increased after the
rule was vacated. The magnet sets rule
included a flux index limit of 50 kG2
mm2 for ingestible magnets. The marked
decline in magnet ingestions during that
rule suggests that the performance
requirements in that rule were effective
at reducing the risk of injury and death
associated with magnet ingestions.
Similarly, there was a significant
decline in recalls involving the magnet
ingestion hazard after the toy standard
became mandatory. The toy standard
requires compliance with ASTM F963
and, therefore, includes the same 50 kG2
mm2 limit for ingestible magnets as the
proposed rule. This decline in recalled
toys for magnet ingestion hazards
suggests that the requirements in that
rule were effective at reducing the risk
of injury and death associated with
magnet ingestions. The low number of
magnet ingestion incidents that identify
ASTM F963 magnet toys as the involved
product also indicate that the
requirements in that standard have been
effective at addressing the magnet
ingestion hazard. Moreover, when
magnet ingestions did occur with
children’s toys, they rarely resulted in
internal interaction, and those that did
result in internal interaction, did not
comply with the toy standard.
Staff’s assessment of the flux index of
subject magnet products, including
those involved in magnet ingestion
incidents, and those known to have
involved internal interaction injuries,
indicates that subject magnet products
have a wide range of flux indexes. The
most common subject magnet products
staff identified are 3 to 6 mm and have
flux indexes of 300 to 400 kG2 mm2.
However, staff’s testing of smaller 2.5
mm magnets, some of which resulted in
internal interaction injuries when
ingested, yielded flux indexes close to
50 kG2 mm2. CPSC expects that, in order
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to comply with the proposed rule, firms
will use magnets with flux indexes
sufficiently lower than 50 kG2 mm2 in
subject magnet products, to account for
manufacturing and testing variances/
tolerances, which may result in subject
magnet products having flux indexes
even lower than required by the rule.
Based on the widespread and
longstanding use of the flux index limit
of 50 kG2 mm2, its development and
acceptance by multiple stakeholders,
the effectiveness of standards that have
used this limit to address magnet
ingestion incidents, and staff testing
showing that magnets involved in
internal interaction incidents had flux
indexes close to 50 kG2 mm2, the
Commission proposes to require that
magnets that are small enough to ingest
have a flux index of less than 50 kG2
mm2.
However, the Commission seeks
comments on this flux index limit,
whether a lower limit may be
appropriate, and seeks testing and safety
data supporting an appropriate flux
index limit. CPSC testing of a small
sample of subject magnet products
suggests that magnets with a flux index
lower than (i.e., weaker than) 50 kG2
mm2 may be capable of causing internal
interaction injuries, indicating that a
flux index limit lower than 50 kG2 mm2
may be appropriate to address the
internal interaction hazard; however,
this testing did not provide conclusive
evidence that magnets weaker than 50
kG2 mm2 present an internal interaction
hazard. This testing is described below.
CPSC Testing. To gather information
about the flux index methodology, flux
index limit, and what flux index can
interact internally though body tissue,
staff conducted testing on a small
number of magnets. Staff tested magnets
with diameters smaller than 5 mm
because they generally had lower flux
indexes than larger magnets, and
because these smaller magnets
presented the testing challenges
described above. Staff used the test
method in ASTM F963–17 with the
additions described in the Appendix to
Tab D of the NPR briefing package. This
testing involved only a small number of
samples, and a limited variety of
products, sizes, and shapes. As such,
while this testing is informative and
raises potential issues, the broader
significance of these results is limited.
In March, April, and June 2021, CPSC
staff tested magnets with diameters
smaller than 5 mm, including 2.5 mm
diameter spherical magnets from nine
exemplar samples of one brand of
magnet set, and two incident samples of
the same brand.89 Additionally, staff
tested 3 mm diameter spherical magnets
from two incident samples from
unknown manufacturers. Staff selected
these samples because of their
involvement in internal interaction
incidents. CPSC is aware of 16 ingestion
incidents and one nasal insertion
incident involving the 2.5 mm diameter
spherical magnets that staff tested.90
These 17 incidents resulted in at least
10 surgeries (such as appendectomy and
bowel resection) and six instances of
internal interaction through body tissue.
The nasal insertion incident involved
two 2.5 mm diameter spherical magnets
attracting through and perforating the
victim’s nasal septum, which is tissue
thicker than the GI walls.
In March 2021, staff conducted interrater reliability testing (i.e., the extent to
which 2 or more observations agree) in
which 3 staff members tested the same
21 exemplar 2.5 mm diameter spherical
magnets. Three magnets were tested
from each of 7 sets/samples of the same
magnet set brand. Staff chose 3 magnets
from each set to analyze intra-set
variability in magnetic flux index. Table
15 shows the results of this testing.
TABLE 15—INTER-RATER RELIABILITY TEST MEASUREMENTS OF 2.5 mm SPHERICAL MAGNETS
[March 2021]
Magnet 1 (kG2 mm2)
Magnet 2 (kG2 mm2)
Magnet 3 (kG2 mm2)
Test set
Tester 1
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1
2
3
4
5
6
7
.................................
.................................
.................................
.................................
.................................
.................................
.................................
Tester 2
53.788
59.477
29.021
33.226
42.940
34.381
55.118
Tester 3
56.294
60.876
29.627
33.932
41.681
34.838
56.522
42.730
53.926
28.191
31.232
46.425
34.217
53.955
Tester 1
Tester 2
48.950
52.055
29.205
51.627
52.600
40.974
56.819
Tester 3
50.797
54.175
30.752
54.623
51.631
40.279
57.577
These results suggest several points of
interest. For one, they indicate that
there was some variation in flux index
results across testers. In addition, these
results suggest that magnets from the
same set tend have more similar flux
index measurements than magnets from
different sets of the same product. The
results also suggest that there is
variation in the flux indexes of magnets
from the same set, and the same
products (across sets). The flux index
measurements of 21 exemplar 2.5 mm
diameter spherical magnets from 7
different magnet sets of the same brand
ranged from 27.507 to 74.308 kG2 mm2.
This variation in flux indexes,
potentially due to manufacturing
variation and testing variation, may
necessitate that firms use magnets with
flux indexes sufficiently lower than 50
kG2 mm2 in subject magnet products, to
account for this potential variation in
flux index results.
This variation also may have
implications for the number of magnets
in a product that should be tested to
assess flux index. Under the proposed
89 Exemplar refers to products that are the same
model and brand as those involved in the incident,
but not the actual product involved in the incident.
Incident samples refer to the actual products
involved in an incident.
90 Many of these cases occurred after the NEISS
and CPSRMS data extraction used for the NPR
briefing package and, therefore, are not captured in
those datasets.
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47.197
40.755
27.507
36.160
48.106
39.920
56.230
Tester 1
50.797
53.372
39.152
53.605
46.501
35.085
40.890
Tester 2
53.246
56.197
41.192
53.705
48.576
36.197
34.274
Tester 3
50.462
74.308
35.507
42.825
44.031
33.905
39.933
rule, one loose or separable magnet with
a flux index of 50 kG2 mm2 or more in
a subject magnet product makes the
whole product violative. However, this
above testing suggests that this
determination may be affected by the
number or sample of magnets tested
from a product because a product that
includes multiple magnets may contain
some magnets that meet and some that
exceed the flux index limit. Thus, this
testing may have implications for how
many magnets from a product should be
tested (e.g., all magnets in the product,
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a representative sample of magnets in
the product).
In addition, because this testing used
exemplars, and not the magnets that
were actually ingested, staff cannot
determine what flux index
measurements resulted in internal
interaction injuries. However, these
results suggest that magnets ranging
from approximately 30 to 70 kG2 mm2
could have resulted in internal
interaction injuries. If the actual
magnets involved in the incident had
flux indexes of 50 kG2 mm2 or more, the
internally through a victim’s body
tissue. The remaining 3 sets had
magnets that were ingested and
removed from the intestines of the
victim who swallowed them (i.e.,
interacted internally through victims’
body tissue). Staff tested 3 magnets from
each of these 3 sets; 2 of the 3 sets were
composed of 3 mm diameter magnets
and 1 set was composed of 2.5 mm
diameter magnets. The results are
provided in Table 16.
proposed rule would address these
injuries; if the actual magnets involved
in the incident had flux indexes closer
to 30 to 40 kG2 mm2, the proposed rule
may not address these injuries.
In March and April 2021, staff
conducted similar testing. Three staff
members tested spherical magnets from
4 separate sample/sets that were
involved in internal interaction
incidents. Set 1 included a single
2.5 mm diameter magnet that had not
been ingested, but was from a set of
ingested magnets that had interacted
TABLE 16—TEST MEASUREMENTS OF 2.5 mm AND 3 mm SPHERICAL MAGNET SETS INVOLVED IN INGESTION INCIDENTS
Magnet 1 (kG2 mm2)
Magnet 2 (kG2 mm2)
Magnet 3 (kG2 mm2)
Set
Tester 1
1
2
3
4
.................................
.................................
.................................
.................................
Tester 2
42.020
76.919
46.239
93.979
Tester 3
45.173
82.469
48.513
96.426
The results in Table 16 show similar
trends as the testing above, with there
being some variation across testers, less
variation within sets than across sets,
and a range of flux indexes across
magnets, and sets. Set 1 in Table 16 was
the same brand as the sets shown in
Table 15, was a 2.5 mm spherical
magnet, and had flux indexes that
ranged from 41.766 to 45.173 kG2 mm2.
Although this magnet was from a set
that was ingested and interacted
internally through body tissue, this
exact magnet was not ingested, so staff
cannot determine the flux index of the
magnets that were ingested, but it is
possible that the magnets that interacted
through body tissue were also in this
range, with flux indexes less than 50
kG2 mm2.
Sets 2 and 4 in Table 16 were 3 mm
diameter spherical magnets from 2 sets
from unknown manufacturers. The
magnets staff tested for these sets were
actually ingested and had interacted
internally through a victim’s body
tissue. As such, the results for these sets
are particularly useful for assessing the
magnet strength that may attract
internally through body tissue. These
41.766
65.959
46.384
89.349
Tester 1
Tester 2
N/A
72.911
47.536
90.240
Tester 3
N/A
70.882
49.427
96.383
N/A
63.795
47.991
88.218
magnets had flux indexes that ranged
from 63.795 to 96.426 kG2 mm2. Thus,
the limit of 50 kG2 mm2 in the proposed
rule would address the magnet
interaction hazard these magnets
presented, with a factor of safety to
account for potential variation in results
across testers, manufacturing variation,
and variation due to the challenges of
testing small spherical magnets.
Set 3 in Table 16 included three 2.5
mm diameter spherical magnets from a
magnet set of the same brand as those
in Table 15. The tested magnets had
been ingested and interacted internally
through the victim’s tissue. Thus, like
sets 2 and 4, these results are
particularly useful for assessing the
magnet strength that may attract
internally through body tissue. The flux
indexes for these magnets ranged from
46.239 to 52.135 kG2 mm2. Using only
Tester 1 or Tester 3’s results, these
magnets would comply with the
proposed rule because these testers
found flux indexes less than 50 kG2
mm2 for all 3 magnets. Using Tester 2’s
results, these magnets would not
comply with the proposed rule because
magnet 3 in the set had a flux index of
Tester 1
Tester 2
N/A
70.206
48.309
89.070
N/A
68.475
52.135
94.970
Tester 3
N/A
63.843
48.749
95.712
more than 50 kG2 mm2. Because,
depending on the tester, this set may
comply with the proposed rule but
interacted internally through body
tissue, these results raise the question
whether a lower flux index limit may be
appropriate. However, even with a flux
index limit of 50 kG2 mm2, it is possible
that the proposed rule would address
the incident involving these magnets
because the flux indexes for this set
were very close to 50 kG2 mm2. To
comply with the proposed rule, firms
may build in a factor of safety to ensure
their magnets are not close to 50 kG2
mm2, to account for variation in test
results and testers and ensure their
products will comply with the standard.
In June 2021, CPSC staff tested
magnets from 2 more exemplar magnet
sets of the same brand shown in Table
15, each of which consisted of spherical
rare-earth magnets that were 2.5 mm in
diameter. Magnet sets of this brand and
type were known to have been involved
in at least 6 internal interaction
incidents. Staff measured the flux index
of 3 magnets from each set and
calculated the flux index values. The
results are in Table 17.
TABLE 17—TEST MEASUREMENTS OF TWO 2.5 mm DIAMETER MAGNET SETS
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[June 2021]
Sample magnet set 1
Magnet
1 ...........
2 ...........
3 ...........
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(kG2)
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2.714
2.798
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(mm)
7.907
7.363
7.826
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2.410
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5.104
4.559
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Max flux
(kG)
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37.585
35.683
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3.450
3.275
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(kG2)
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(mm)
11.174
11.903
10.726
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2.590
2.530
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5.266
5.025
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Again, these results indicate variation
in the flux indexes of magnets within
the same set, and that flux indexes are
more similar within a set than across
sets. For the 6 magnets tested, flux
indexes ranged from 35.683 to 62.677
kG2 mm2.
The following provides a summary of
the consolidated results of all of these
tests. Staff assessed 2.5 mm and 3 mm
diameter spherical magnets associated
with internal interaction incidents. The
exemplar 2.5 mm magnets had flux
index values between 27.507 to 74.308
kG2 mm2. Incident samples with
magnets involved in internal interaction
injuries had flux index values between
46.239 and 52.135 kG2 mm2 for the 2.5
mm magnets, and 63.795 to 96.426 kG2
mm2 for the 3 mm diameter magnets. In
general, these results suggest that the
proposed rule would address the
internal interaction hazard associated
with magnet ingestions because many of
the sets tested would not comply with
the proposed rule because at least one
of the tested magnets had a flux index
of 50 kG2 mm2 or more. For the reasons
described above, staff considers the flux
index methodology and limit in the
proposed rule to be appropriate to
adequately address the magnet ingestion
hazard.
However, these results also suggest
that there is some variability in the flux
index values, which may have
implications for the proposed flux index
test methodology. These results also
indicate that magnets that may have flux
indexes lower than 50 kG2 mm2 may
have caused internal interaction
injuries, suggesting that a lower flux
index limit than 50 kG2 mm2 may be
appropriate; however, the results are
inconclusive because staff could not
identify, with certainty, the flux indexes
of magnets that actually caused internal
interaction injuries. In addition, staff
notes the limited scope of this testing,
including the small sample size, and
limited variety of products tested. The
Commission seeks comments on the
proposed requirements regarding flux
index methodology and limits,
including information about whether
flux indexes below 50 kG2 mm2 present
an internal interaction hazard.
VII. Preliminary Regulatory Analysis 91
The Commission is proposing to issue
a rule under sections 7 and 9 of the
CPSA. The CPSA requires that the
Commission prepare a preliminary
regulatory analysis and publish it with
the text of the proposed rule. 15 U.S.C.
91 Further detail regarding the preliminary
regulatory analysis is available in Tab E of the NPR
briefing package.
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2058(c). The following discussion is
extracted from staff’s memorandum,
‘‘Preliminary Regulatory Analysis of a
Draft Proposed Rule that Would
Establish a Standard for Hazardous
Magnet Products,’’ available in Tab E of
the NPR briefing package.
A. Preliminary Description of Potential
Costs and Benefits of the Proposed Rule
The preliminary regulatory analysis
must include a description of the
potential benefits and costs of the
proposed rule. The benefits of the rule
are measured as the expected reduction
in the societal costs of deaths and
injuries that would result from adopting
the proposed rule and any benefits that
cannot be quantified. The costs of the
rule consist of the added costs
associated with modifying or
discontinuing products that do not
comply with the requirements of the
rule, including any impacts on the
utility of the products for consumers, as
well as any costs that cannot be
quantified.
1. Deaths and Injuries Related to Magnet
Ingestions
As discussed above, based on NEISS
data, which is a nationally
representative probability sample of
about 100 U.S. hospitals, there were an
estimated 4,400 ED-treated magnet
ingestions between 2010 and 2020 that
involved subject magnet products, and
an additional estimated 18,100 EDtreated magnet ingestions that involved
unidentified magnet products, of which
CPSC concludes a large portion
involved subject magnet products.
In addition to injuries initially treated
in hospital EDs, many product-related
injuries are treated in other medical
settings, such as, physicians’ offices,
clinics, and ambulatory surgery centers.
Some injuries also result in direct
hospital admissions, bypassing hospital
EDs entirely. CPSC estimates the
number of subject magnet product
injuries treated outside of hospital EDs
with CPSC’s Injury Cost Model (ICM),
which uses empirical relationships
between the characteristics of injuries
(diagnosis and body part) and victims
(age and sex) initially treated in hospital
EDs and the characteristics of those
initially treated in other settings.92
92 A detailed discussion of the ICM and these
methods is in: Miller, T.R., Lawrence, B.A., Jensen,
A.F., Waehrer, G.M., Spicer, R.S., Lestina, D.C., and
Cohen, M.A., The Consumer Product Safety
Commission’s Revised Injury Cost Model, Calverton,
MD: Public Services Research Institute (2000);
Bhattacharya, S., Lawrence, B., Miller, T.,
Zaloshnja, E., Jones, P., Ratios for Computing
Medical Treated Injury Incidence and Its Standard
Error from NEISS Data (Contract CPSC–D–05–0006,
Task Order 8), Calverton, MD: Pacific Institute for
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The ICM estimate of injuries treated
outside of hospitals or hospital EDs
(e.g., in doctors’ offices, clinics) is based
on data from the Medical Expenditure
Panel Survey (MEPS). The MEPS is a
nationally representative survey of the
civilian, non-institutionalized
population that quantifies individuals’
use of health services and
corresponding medical expenditures. It
combines data from a panel of
participants interviewed quarterly over
a two-year period with data from the
respondents’ medical providers. The
MEPS is administered by the Agency for
Healthcare Research and Quality
(AHRQ). The ICM uses the MEPS data,
in combination with a classification tree
analysis technique, to project the
number and characteristics of injuries
treated outside of hospitals. To project
the number of direct hospital
admissions that bypass hospital EDs, the
ICM uses data from the Nationwide
Inpatient Sample of the Healthcare Cost
and Utilization Project (HCUP–NIS),
which was also analyzed using a
classification tree analysis technique.
HCUP is a family of healthcare
databases and related software tools and
products developed through a federalstate-industry partnership and
sponsored by AHRQ. The HCUP–NIS
provides information annually on
approximately 3 to 4 million in-patient
stays from about 1,000 hospitals.
The classification tree analysis
technique (also called decision tree) is
a statistical tool that divides and sorts
data into smaller and smaller groups for
estimating the ED share of injuries until
no further gains in predictive power can
be obtained. This technique allows for
more precise estimates of injuries
treated in doctor visits or injuries
admitted directly to the hospital than
other regression techniques. For
example, where data permit, the age and
sex of the victim can have an influence
on the estimates of the number of
injuries treated outside the ED.
Combining the national estimates of
NEISS with the non-ED estimates from
the ICM using classification tree
techniques provides total estimated
medically-treated injuries.
Based on the estimate of 2,135 magnet
injuries initially treated in hospital EDs
annually during 2017 through 2020, the
ICM projects that another 856 magnet
injuries were treated annually outside of
hospitals (e.g., in doctors’ offices,
Research and Evaluation (2012); and Lawrence,
B.A., Revised Incidence Estimates for Nonfatal,
Non-Hospitalized Consumer Product Injuries
Treated Outside Emergency Departments (Contract
CPSC–D–89–09–0003, Task Order 2), Calverton,
MD: Pacific Institute for Research and Evaluation
(2013).
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clinics) and that there were about 264
direct hospital admissions annually,
bypassing the ED. Thus, combined with
the ED-treated injuries, staff estimates
that there were a total of 3,255
medically treated injuries annually
involving subject magnets products
from 2017 through 2020.
2. Societal Costs of Deaths and Injuries
The ICM is fully integrated with
NEISS and provides estimates of the
societal costs of injuries reported
through NEISS, as well as the societal
costs of other medically treated injuries
estimated by the ICM. The major
aggregated societal cost components
provided by the ICM include medical
costs, work losses, and the intangible
costs associated with lost quality of life
or pain and suffering.
Medical costs include three categories
of expenditures: (1) Medical and
hospital costs associated with treating
the injury victim during the initial
recovery period and in the long term,
including the costs associated with
corrective surgery, the treatment of
chronic injuries, and rehabilitation
services; (2) ancillary costs, such as
costs for prescriptions, medical
equipment, and ambulance transport;
and (3) costs of health insurance claims
processing. CPSC derived the cost
estimates for these expenditure
categories from a number of national
and state databases, including MEPS,
HCUP–NIS, the Nationwide Emergency
Department Sample (NEDS), the
National Nursing Home Survey (NNHS),
MarketScan® claims data, and a variety
of other federal, state, and private
databases.
Work loss estimates are intended to
include: (1) The forgone earnings of the
victim, including lost wage work and
household work; (2) the forgone
earnings of parents and visitors,
including lost wage work and
household work; (3) imputed long term
work losses of the victim that would be
associated with permanent impairment;
and (4) employer productivity losses,
such as the costs incurred when
employers spend time juggling
schedules or training replacement
workers. Estimates are based on
information from HCUP–NIS, NEDS,
Detailed Claims Information (a workers’
compensation database), the National
Health Interview Survey, U.S. Bureau of
Labor Statistics, and other sources. The
intangible, or non-economic, costs of
injury reflect the physical and
emotional trauma of injury, as well as
the mental anguish of victims and
caregivers. Intangible costs are difficult
to quantify because they do not
represent products or resources traded
in the marketplace. Nevertheless, they
typically represent the largest
component of injury cost and need to be
accounted for in any benefit-cost
analysis involving health outcomes. The
ICM develops a monetary estimate of
these intangible costs from jury awards
for pain and suffering. While these
awards can vary widely on a case-bycase basis, studies have shown them to
be systematically related to a number of
factors, including economic losses, the
type and severity of injury, and the age
of the victim.93 CPSC derived estimates
for the ICM from regression analysis of
jury awards in nonfatal product liability
cases involving consumer products
compiled by Jury Verdicts Research, Inc.
Table 18 provides annual estimates of
the injuries and societal costs associated
with ingestions of magnets categorized
as magnet sets, magnet toys, and
jewelry.
TABLE 18—ESTIMATED AVERAGE ANNUAL MEDICALLY TREATED INJURIES AND ASSOCIATED SOCIETAL COSTS FOR
INGESTIONS OF PRODUCTS CATEGORIZED AS MAGNET SETS, MAGNET TOYS, AND JEWELRY, FOR 2017 THROUGH 2020
Injury disposition
Estimated No.
Estimated
societal costs
($ millions) *
Doctor/Clinic .............................................................................................................................................................
Treated and Released from Hospital ED ................................................................................................................
Admitted to Hospital through ED (NEISS) ..............................................................................................................
Direct Hospital Admissions, Bypassing ...................................................................................................................
164
278
† 159
77
$2.2
6.2
26.4
12.8
Total Medically Attended Injuries .....................................................................................................................
678
47.6
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* In 2018 dollars.
† This estimate may not be reliable because of the small number of cases on which it is based.
The 2017 through 2020 NEISS
estimates suggest an estimated annual
average of about 437 ED-treated injuries,
comprised of 278 injuries that were
treated and released and 159 injuries
that required hospitalization.
Additionally, based on estimates from
the ICM, 164 injuries were treated
outside of hospitals annually and
another 77 injuries resulted in direct
hospital admission.
Based on ICM estimates, these injuries
resulted in annual societal costs of
about $47.6 million (in 2018 dollars)
during 2017 through 2020. The average
estimated societal cost per injury was
about $13,000 for injuries treated in
physician’s offices, clinics, and other
non-hospital settings; about $22,000 for
injuries to victims who were treated and
released from EDs; and about $166,000
for injuries that required admission to
the hospital for treatment. Medical costs
and work losses (including work losses
of caregivers) accounted for about 44
percent of these injury cost estimates,
and the less tangible costs of injury
associated with pain and suffering
accounted for about 56 percent of the
estimated injury costs.
Table 18 reflects magnet ingestion
incidents that involved products
categorized as magnet sets, magnet toys,
and jewelry—it does not include
incidents categorized as involving
unidentified product types. However, as
discussed in section IV.A.5.
Uncertainties in Incident Data, above,
most of the incidents in this
unidentified product type category
likely involved subject magnet products.
Thus, in addition to the magnet
ingestion incidents upon which Table
15 was based, there were 322 NEISS
cases during 2017 through 2020
(representing about 1,873 ED-treated
injuries annually) in the unidentified
product type category. Based on ICM
93 W. Kip Viscusi (1988), The determinants of the
disposition of product liability cases: Systematic
compensation or capricious awards?, International
Review of Law and Economics, 8, 203–220; Gregory
B. Rodgers (1993), Estimating jury compensation for
pain and suffering in product liability cases
involving nonfatal personal injury, Journal of
Forensic Economics 6(3), 251–262; and Mark A.
Cohen and Ted R. Miller (2003), ‘‘Willingness to
award’’ nonmonetary damages and implied value of
life from jury awards, International Journal of Law
and Economics, 23, 165–184.
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estimates for unidentified product types
involved in magnet ingestion injuries,
average annual societal costs for 2017–
2020 totaled $151.8 million.
Consequently, to the extent that the
unidentified magnet products were
products that would be covered by the
proposed rule, Table 18 could
substantially understate the societal
costs associated with the ingestion of
subject magnet products.
injury and death from magnet ingestions
and the resulting value of the societal
costs of the injuries that the rule would
prevent. In addition to the injuries
reflected in the analysis above, staff is
aware of 5 fatalities in the United States
resulting from magnet ingestions. Thus,
the rule would reduce the likelihood of
future fatalities as well as injuries.
The annual expected benefits of the
rule depend on the exposure to risk
associated with subject magnet
products, as well as the estimated
societal costs described in Table 18,
3. Potential Benefits of Proposed Rule
The benefits of the proposed rule
would be the reduction in the risk of
above. Although subject magnet
products may retain their magnetism for
many years, it is likely that some are
discarded well before that time. Thus,
the actual expected product life of
subject magnet products is uncertain;
this analysis presents a range of
potential benefit estimates under an
assumed product life of 1.5, 2, and 3
years. Table 19 presents benefit
estimates under the alternative product
life assumptions (line (b)).
TABLE 19—PRESENT VALUE OF SOCIETAL COSTS PER SUBJECT MAGNET PRODUCT IN USE (OR GROSS BENEFITS OF A
RULE), FOR THREE EXPECTED PRODUCT LIVES FROM 2017 THROUGH 2020.
(a) Aggregate Annual Societal Costs (millions $) .......................................................................
(b) Expected Useful Product Life (years) ....................................................................................
(c) Magnet Products in Use, Average Annual .............................................................................
(d) Annual Societal Costs per Subject Magnet Product [(a) ÷ (c)] .............................................
(e) Present Value of Societal Costs, per Subject Magnet Product (3% Discount Rate) ............
(f) Present Value of Societal Costs, per Subject Magnet Product (7% Discount Rate) .............
subject magnet products through 2020
(including an assumption of 500,000
units per year for 2018–2020), an
assumed expected product life of 1.5, 2,
and 3 years (line b), and the application
of the CPSC’s Product Population
Model, a computer algorithm that
projects the number of products in use
given estimates of annual product sales
and product failure rates. The
In Table 19, line (a) shows the average
annual aggregate societal costs from
Table 18. Line (c) presents the average
annual estimated number of subject
magnet products in use from 2017
through 2020, based on producerreported annual magnet set sales 94
collected by the Directorate for
Compliance through mid-2012 and
assumptions of annual sales of all
$47.6
1.5
444,000
$107
$160
$154
$47.6
2
545,000
$87
$171
$162
$47.6
3
701,000
$68
$190
$178
Commission requests information on
annual sales and expected product life
of subject magnet products.
Figure 7 shows changes in the
estimated number of subject magnet
products in use, from 2009 through
2020.
BILLING CODE 6355–01–P
Estimated Numbers of Subject Magnet Products in Use, 2009 -- 2020
2,500,000
2,000,000
I'
,. '
'
I
1,500,000
3-Year Expected Life
',
l
'
I,
/
'
1,000,000
.
JI"
''
' ..............
Figure 7: Estimated Numbers of Subject Magnet Products in Use, 2009-2020.
94 Although this information is for magnet sets,
and not all subject magnet products, staff primarily
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had information about magnet sets, and magnet sets
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likely make up a large portion of subject magnet
products.
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In Table 19, the annual estimated
societal costs per subject magnet
product in use (line d) are presented as
the quotient of the annual societal costs
(line a), per product in use, and the
estimated average number of products
in use (line c). Based on these estimates,
and an assumed average product life
ranging from 1.5 to 3 years, the present
value of societal costs, per subject
magnet product, ranges from about $160
to about $190 using a 3 percent discount
rate (line e), or from about $154 to $178
using a 7 percent discount rate (line f).
The first order estimate of benefits
would be equal to the present value of
societal costs, presented in lines (e) and
(f) and would range from about $154
(with a 1.5-year product life and a 7
percent discount rate) to $190 (with a 3year product life and a 3 percent
discount rate) per subject magnet
product. The aggregate benefits would
range from $80 million to $95 million
using the 500,000 units assumption
from Table 19 and 3 percent discount
rate.95 If the proposed rule allows some
products to remain on the market that
present the magnet ingestion hazard, the
benefits of the rule would be reduced by
some unknown amount and would be
measured as the net reduction in
injuries and the concomitant reduction
in societal costs that would result.
4. Costs Associated With the Proposed
Rule
This section discusses the costs
associated with the proposed rule,
which include costs to consumers and
to manufacturers/importers of subject
magnet products. Both consumers and
producers benefit from the production
khammond on DSKJM1Z7X2PROD with PROPOSALS2
95 Aggregate benefits are the product of the perunit benefit ($160 and $190 for a 1.5-year and 3year useful life discounted at 3 percent), and
500,000 estimated annual units.
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and sale of consumer products. The
consuming public obtains the use value
or utility associated with the
consumption of products; producers
obtain income and profits from the
production and sale of products.
Consequently, the costs of requiring that
subject magnet products comply with
the proposed rule would consist of: (1)
The lost use value experienced by
consumers who would no longer be able
to purchase magnets that do not meet
the standard (lost consumer surplus);
and (2) the lost income and profits to
firms that could not produce and sell
non-complying products (lost producer
surplus).
Both consumer and producer surplus
depend on product sales, among other
things. However, CPSC does not know
the unit sales of subject magnet
products. Therefore, this analysis
considers possible costs associated with
several estimates of sales, ranging from
about 250,000 to 1 million subject
magnet products per year. For purposes
of discussion, the analysis below
assumes annual sales of 500,000 per
year.
a. Costs to Consumers
The primary cost associated with the
proposed rule is lost utility to
consumers. Subject magnet products
may be used for a variety of purposes,
including amusement and jewelry.
Previous comments CPSC has received
regarding magnet sets, which likely
comprise the majority of subject magnet
products on the market, indicate that
consumers use them as a manipulative
or construction item for entertainment,
such as puzzle working, sculpture
building, mental stimulation, or stress
relief. CPSC is also aware of claims that
the magnets can have beneficial
therapeutic value for children with
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1301
attention-deficit/hyperactivity disorder.
Incident data also suggests that magnet
sets are used as jewelry. The individual
magnets in subject magnet products
might also have additional uses, apart
from those for which they are intended
(e.g., using magnets from a magnet set
on a refrigerator). However, there would
presumably be little lost utility for these
unintended product uses since products
intended for those purposes (e.g.,
refrigerator magnets) would be
unaffected by the proposed rule. If
products that comply with the proposed
rule do not serve the identical utility
(e.g., consumers prefer smaller, stronger
magnets), this represents lost utility to
consumers. CPSC notes that the
proposed rule applies to amusement
and jewelry products and, therefore,
would not affect products intended for
research, education, industrial, or
commercial uses, if they do not
otherwise meet the definition of subject
magnet products.
CPSC cannot estimate the use value
that consumers receive from subject
magnet products, so the following
discussion instead describes use value
conceptually. In general, use value
includes the amount of: (1) Consumer
expenditures for the product, plus (2)
consumer surplus. Assuming annual
sales of about 500,000 subject magnet
products annually, and assuming an
average retail price of about $20 (based
on price data for magnet sets), consumer
expenditures would amount to about
$10 million annually. These
expenditures represent the minimum
value that consumers would expect to
get from these products. It is
represented by the area of the rectangle
OBDE in the standard supply and
demand graph in Figure 8, where B
equals $20, and E equals 500,000 units.
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Quat1t,&·t~r•,;~rioi:t.
Figure 8: Supply and demand graph illustrating the concepts of consumer
and producer surplus.
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In Figure 8, consumer surplus is given
by the area of the triangle BCD under
the graph’s demand function, and
represents the difference between the
market-clearing price and the maximum
amount consumers would have been
willing to pay for the product. This
consumer surplus will vary for
individual consumers, but it represents
a benefit to consumers over and above
what they paid.96 For example, tickets
to a concert might sell for $100 each, but
some consumers who buy them for $100
would have been willing to pay $150
per ticket. Those consumers paid $100
and received benefits that they value at
$150, thereby receiving a consumer
surplus of $50.97
In general, the use value of the subject
magnet products obtained by consumers
is represented by the area of the
trapezoid OCDE in Figure 8. However,
the prospective loss in use value
associated with the proposed rule
would amount to, at most, the area of
the triangle representing the consumer
surplus. This is because consumers
96 The concept of consumer surplus is discussed
in the Office of Management and Budget’s Circular
A–4, Regulatory Analysis, available through 68 FR
58366 (Oct. 9, 2003), and has been applied in a
number of CPSC staff analyses.
97 If the above graph represents the market for
tickets, the demand curve describes the quantity of
tickets demanded at each price (i.e., the quantity of
tickets consumers are willing and able to purchase
at each price). In this example, the $150 that the
consumer would have been willing to pay for the
ticket is represented on the demand curve at a point
to the left of point D. The consumer surplus is given
by the relevant point on the demand curve (i.e.,
where price = $150), minus the market clearing
price of $100.
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would no longer be able to obtain utility
from the products that do not comply
with the proposed rule, but they would
have the $10 million (represented by the
rectangle OBDE) that they would have
spent on non-complying subject magnet
products in the absence of a rule. The
net loss in consumer surplus associated
with the proposed rule would be
reduced by consumers’ ability to
purchase replacement products that
comply with the proposed rule and
provide the same utility, or by their
ability to purchase other products that
provide use-value.
CPSC does not have information
regarding aggregate consumer surplus
or, by extension, the amount of utility
that would be lost as a result of the
proposed rule. However, if, for example,
consumers who purchased subject
magnet products that do not comply
with the proposed rule at an average
price of $20 would have been willing to
spend, on average, $35 to $45 per
product (i.e., an additional $15 to $25
per product), the lost utility might
amount to about $7.5 million (i.e., [$35–
$20] × 500,000 units annually) to $12.5
million (i.e., [$45–$20] × 500,000 units
annually) on an annual basis.
However, the loss in consumer
surplus described above represents the
maximum loss of consumer utility from
the proposed rule because consumers
are likely to gain some amount of
consumer surplus from products that
are purchased as an alternative to
subject magnet products that would no
longer be available because of the rule.
If, for example, there were close
substitutes (e.g., products that are
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similarly satisfying and priced) for the
subject magnet products that do not
meet the standard, the overall loss in
consumer surplus (and, hence, the costs
of the proposed rule) likely would be
small. Staff is aware of subject magnet
products that comply with the proposed
rule. For example, there are magnet sets
with flux indexes less than 50 kG2 mm2,
magnetic desk sculptures that use a
magnetic base and ferromagnetic pieces,
sets of large magnetic balls, and a wide
variety of fidget toys. Manufacturers of
magnetic jewelry with loose or
separable magnets have options for
complying with the rule, including
using magnets that are not hazardous, or
close substitutes that are nonmagnetic.
If jewelry manufacturers wish to offer
separable pieces on necklaces or
bracelets, they might offer nonmagnetic
pieces that attach to a bracelet or
necklace incorporating attached
magnets. Additionally, magnetic stud
earrings and faux piercing jewelry have
clip-on alternatives and pierced jewelry
as substitutes. These products and
alternatives suggest that compliant
products may provide similar utility to
non-compliant subject magnet products.
b. Costs to Manufacturers/Importers
The lost benefits to firms that could
result from the proposed rule are
measured by a loss in producer surplus.
Producer surplus is a profit measure
that is somewhat analogous to consumer
surplus. Whereas consumer surplus is a
measure of benefits received by
individuals who consume products, net
of the cost of purchasing the products,
producer surplus is a measure of the
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benefits accrued to firms that produce
and sell products, net of the costs of
producing them. Producer surplus is
defined as the total revenue (TR) of
firms selling subject magnet products,
less the total variable costs (TVC) of
production. Variable costs are costs that
vary with the level of output and
usually include expenditures for raw
materials, wages, distribution of the
product, and similar costs.
In Figure 8, above, total revenue is
given by the area OBDE, which is the
product of sales and price. The total
variable costs of production are given by
the area under the supply function,
OADE. Consequently, producer surplus
is given by the triangle ABD, which is
the area under the market clearing price
and above the supply function. Note
that this represents the maximum loss to
producers; if there were product
alternatives that were similar to subject
magnet products that suppliers could
produce and sell, the lost producer
surplus could be less.
Following the example above, if sales
of the subject magnet products average
about 500,000 units annually, with an
average retail price of about $20 per
product, then total industry revenues
have averaged about $10 million
annually (i.e., 500,000 units × $20 per
product). Information provided by
magnet set sellers suggests that the
average import cost of magnet sets to
U.S. importers, a major variable cost,
may amount to about $10 per set, or an
average of about $5 million annually
(i.e., 500,000 sets × $10 import cost per
set). Apart from the import costs, the
variable costs of production are
probably relatively small. Because
subject magnet products are often
packaged and shipped from China and
sometimes sent directly to the importers
point of sale, U.S. labor costs may be
low; and because subject magnet
products are small, storage costs are
probably low. If, for example, the
variable costs of production account for
about half of the difference between
total revenues ($10 million) and import
costs ($5 million), producer surplus
would amount to about $2.5 million
(i.e., ($10 million¥$5 million) ÷ 2)
annually. At most, the lost producer
surplus would amount to about $5
million annually, if there were no
variable costs other than the costs of
importing the magnets (i.e., total
revenue of $10 million for 500,000 units
annually less the import costs of about
$5 million). While this information is
specifically related to magnet sets, a
similar relationship could apply to other
subject magnet products.
1303
Like costs to consumers, lost producer
surplus could be offset by products that
comply with the proposed rule. That is,
although firms could not offer subject
magnet products that do not comply
with the proposed rule, they could offer
substitutions that serve the same or
similar purpose but comply with the
proposed rule.
As noted above, CPSC does not know
the actual sales levels of non-complying
subject magnet products, and does not
have information to reliably estimate
either consumer surplus or producer
surplus. Table 20, below, provides
rough estimates of the possible costs of
the rule, for various hypothetical sales
levels ranging from 250,000 to 1 million
products annually. The cost estimates
are based on a number of assumptions
described above, and are made for
illustrative purposes. Nevertheless,
because the range of sales is wide, and
is likely to include actual sales levels on
an annual basis, it is reasonable to
assume that the costs of the proposed
rule could range from about $5 to $8.75
million (if sales amount to about
250,000 products annually), to about
$20 to $35 million (if sales amount to
about 1 million products annually). As
noted above, these costs could be
partially offset by products that comply
with the proposed rule.
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TABLE 20—POSSIBLE COSTS OF THE PROPOSED RULE, FOR VARIOUS LEVELS OF NON-COMPLYING SUBJECT MAGNET
PRODUCT SALES
Magnet product sales
(annually)
Consumer surplus
(millions $)
Producer surplus
(millions $)
250,000 ..........................................
500,000 ..........................................
750,000 ..........................................
1,000,000 .......................................
$3.75 to $6.25 ..............................
$7.5 to $12.5 ................................
$11.25 to $18.75 ..........................
$15 to $25 ....................................
$1.25 to $2.5 ................................
$2.5 to $5 .....................................
$3.75 to $7.5 ................................
$5 to $10 ......................................
In addition to lost producer surplus,
manufacturers/importers of subject
magnet products that comply with the
proposed rule would likely incur some
additional costs associated with
certifying that their products comply
with the rule. Section XII. Testing,
Certification, and Notice of
Requirements, below, describes the
requirements in section 14 of the CPSA
regarding certifications. To summarize,
consumer products that are subject to a
mandatory standard must be certified as
complying with the standard.
Certification must be based on a test of
each product or a reasonable testing
program. For subject magnet products,
the costs of this testing may be minimal,
especially for manufacturers that
currently have product testing done for
products subject to the requirements in
ASTM F963–17, which is mandated in
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16 CFR part 1250. Importers may rely
upon testing completed by other parties,
such as their foreign suppliers, if those
tests provide sufficient information for
the manufacturers or importers to certify
that the magnets in their products
comply with the proposed rule. For
subject magnet products that are
children’s products, such as children’s
jewelry, the certification must be based
on testing by an accredited third-party
conformity assessment body, at
somewhat higher costs.
B. Reasons for Not Relying on a
Voluntary Standard
When the Commission issues an
ANPR, it must invite interested parties
to submit existing standards or provide
a statement of intention to modify or
develop a standard that would address
the hazard at issue. 15 U.S.C. 2058(a).
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Total costs
(millions $)
$5 to $8.75.
$10 to $17.5.
$15 to $26.25.
$20 to $35.
When CPSC receives such standards or
statements in response to an ANPR, the
preliminary regulatory analysis must
provide reasons that the proposed rule
does not include such standards. Id.
2058(c). In the present rulemaking, the
Commission did not issue an ANPR.
Accordingly, CPSC did not receive
submissions of standards or statement of
intention to develop standards regarding
the magnet ingestion hazard.
Nevertheless, staff evaluated existing
standards relevant to magnet ingestions
and determined that these standards
would not adequately reduce the risk of
injury associated with magnet
ingestions because they do not cover the
products most often involved in
incidents or do not include adequate
performance requirements to reduce the
risk of injury. A detailed discussion of
these standards, and why staff considers
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them inadequate, is in section V.
Relevant Existing Standards.
C. Alternatives to the Proposed Rule
Finally, a preliminary regulatory
analysis must describe alternatives to
the proposed rule that CPSC considered,
their potential costs and benefits, and a
brief explanation of the reasons the
alternatives were not chosen. CPSC
considered several alternatives to the
proposed rule. These alternatives, their
potential costs and benefits, and the
reasons the Commission did not select
them, are described in detail in section
VIII. Alternatives to the Proposed Rule,
below, and Tab F of the NPR briefing
package.
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VIII. Alternatives to the Proposed Rule
CPSC considered several alternatives
to reduce the risk of injuries and death
associated with ingestion of subject
magnet products. However, as discussed
below, CPSC does not consider any of
these alternatives capable of adequately
reducing the risk of injury and death.
A. No Mandatory Standard
One alternative to the proposed rule
is to take no regulatory action and,
instead, rely on the ASTM standards to
address the magnet ingestion hazard. As
discussed above, there are four ASTM
standards that address the magnet
ingestion hazard, covering children’s
toys, jewelry, and magnet sets. Relying
on these standards would eliminate the
costs associated with the proposed rule
because it would not mandate
compliance. ASTM F3458, in particular,
has the potential to address the magnet
ingestion hazard because it applies to
magnet sets, which are involved in a
large portion of magnet ingestion
incidents where the product type could
be identified.
However, there are considerable
limitations and unknowns associated
with this alternative. The shortcomings
of the ASTM standards are discussed in
detail in section V. Relevant Existing
Standards. For one, CPSC does not
consider ASTM F3458 capable of
adequately reducing the magnet
ingestion hazard because of its limited
scope and lack of size and strength
requirements for magnets. Although
Subcommittee F15.77 on Magnets
formed a task group to consider revising
ASTM F3458–21 to include
performance requirements for magnet
sets intended for users 14 years and
older, CPSC does not know whether the
standard will be revised or what
requirements may be added to it.
Moreover, ASTM F3458 applies only
to magnets sets, which are not the only
products implicated in magnet ingestion
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incidents. Additional magnet toys
intended for users 14 years and older, as
well as jewelry are also implicated.
Although ASTM has standards
regarding the magnet ingestion hazard
in jewelry, CPSC considers those
standards inadequate because they do
not impose size and strength limits on
all jewelry with loose or separable
magnets. In addition, CPSC does not
know the level of compliance with
ASTM F3458, ASTM F2999, or ASTM
F2923; if the rate of compliance is low,
these would not be an effective way to
address the hazard, even if the
requirements in these standards were
adequate. Finally, waiting for ASTM to
revise its standards to adequately
address the hazard would delay the
safety benefits of the proposed rule. For
these reasons, the Commission did not
select this alternative.
B. Alternative Performance
Requirements
Another alternative to the proposed
rule is to adopt a mandatory standard
with less stringent requirements than
the proposed rule, such as a higher flux
index limit, or different requirements
for certain shapes and sizes of magnets.
This may reduce the costs associated
with the rule by allowing firms to
market and consumers to use a wider
variety of products than under the
proposed rule. The reduction in costs
would depend on the specific
requirements adopted.
However, this option would likely
reduce the safety benefits of the rule. If
the alternative performance
requirements reduced costs by allowing
more products to remain on the market,
it likely would also leave more
hazardous products on the market,
thereby decreasing the safety benefits.
Therefore, the Commission did not
select this alternative. The Commission
seeks comments on what potential
alternative performance requirements
may adequately reduce the risk of injury
associated with magnet ingestions,
while reducing costs to firms and
impacts on consumer utility.
C. Safety Messaging
Instead of performance requirements,
the Commission could require safety
messaging on products to address the
magnet ingestion hazard, such as
through requirements for labeling and
instructional literature. This alternative
would reduce the costs associated with
the proposed rule because it would
allow firms to continue to sell subject
magnet products with loose or separable
hazardous magnets and the costs of
warnings and instructional information
likely would be small.
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However, CPSC does not consider this
alternative effective for adequately
reducing the risk of injury and death
associated with magnet ingestions. For a
detailed discussion of why labeling and
instructional literature requirements are
insufficient to adequately address the
magnet ingestion hazard, see section
V.D. ASTM F3458–21. To summarize,
warnings are the least effective strategy
for addressing a hazard, relative to
designing out the hazard or designing
guards against the hazard. The
effectiveness of warnings depends on
convincing consumers to avoid the
hazard, and there are numerous reasons
consumers may disregard warnings for
these products. Caregivers do not expect
older children and teens to ingest
inedible objects; the magnet ingestion
hazard is not readily apparent;
caregivers and children underappreciate
the likelihood and severity of the
hazard; magnets are often ingested
accidentally; and children and teens
commonly access magnets without their
packaging, such as from friends or at
school.
Warning information on labels and
instructional literature, as well as public
outreach efforts to inform consumers of
the hazard, have been used to try to
address the magnet ingestion hazard for
many years. However, these efforts have
been unsuccessful at reducing the
magnet ingestion hazard, as evidenced
by the increase in magnet ingestion
incidents in recent years, and magnet
ingestion incidents involving products
with clear warnings.
For these reasons, the Commission
did not select this alternative.
D. Packaging Requirements
Another alternative is for the
Commission to require special
packaging for subject magnet products
that contain hazardous magnets to limit
children’s access to the products. Such
packaging could, for example, help
consumers determine if all magnets
have been returned to the packaging and
include child-resistant features.
Although this alternative would create
some costs associated with packaging,
those costs likely would be lower than
the proposed rule because they would
allow subject magnet products to remain
unchanged. Staff estimates that the cost
of safety packaging may amount to
about $1 per magnet product, depending
on the requirements and features of the
packaging.
However, CPSC does not consider this
alternative effective for adequately
reducing the risk of injury and death
associated with magnet ingestions. For a
detailed discussion of why packaging
requirements are insufficient to
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adequately address the magnet ingestion
hazard, see section V.D. ASTM F3458–
21. To summarize, for packaging
requirements to be effective at
preventing the magnet ingestion hazard,
users would have to repackage all
magnets after each use, and the
packaging would have to prevent
children and teens from accessing the
magnets. Neither of these are likely to
occur to a sufficient extent to address
the hazard.
For one, consumers are unlikely to
repackage all magnets after each use.
After assembling structures or jewelry,
or using the magnets for other purposes,
consumers would be unlikely to
disassemble their creations to return
them to the package. In addition,
products often contain hundreds or
thousands of magnets, making it time
consuming and difficult to ensure all of
the magnets are returned to the package.
Moreover, small magnets become loose
in the environment and are hard to
locate to return to the package. In
addition, consumers often do not
perceive subject magnet products as
hazardous, making it less likely that
they would repackage all of the
magnets. Even for products that are
obviously hazardous and commonly use
CR packaging, such as chemicals and
pharmaceuticals, consumers use the
packaging inconsistently. Consumers
may also consider CR packaging a
nuisance, making them unlikely to store
magnets in the packaging after every
use.
Even if consumers return all magnets
to a package after each use, safety
features to prevent easy access to the
contents of the package would only
address a minority of the vulnerable
population. Safety packaging is
generally intended to restrict children
under 5 years old from accessing
package contents. Older children and
teens are likely to have the cognitive
and motor skills necessary to access
products in special packaging. This is
problematic because incident data show
that older children and teens make up
the majority of magnet ingestion
victims. In addition, many incidents
involve children and teens acquiring
magnets without the product packaging,
such as from friends, at school, or loose
in the environment. For these reasons,
the Commission did not select this
alternative.
E. Aversive Agents
Instead of the size and strength
requirements in the proposed rule, the
Commission could require
manufacturers to coat loose or separable
hazardous magnets in subject magnet
products with aversive agents, such foul
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odors or bitterants. Aversive agents may
dissuade some children and teens from
placing hazardous magnets in their
mouths. This alternative would reduce
the costs associated with the proposed
rule because it would allow firms to
continue to sell subject magnet products
with loose or separable hazardous
magnets, would allow consumers to
continue to use them, and the costs of
such coatings likely would be small.
However, real-world investigations
have not demonstrated that bitterants
are effective at preventing ingestions.98
Bitterants do not deter initial ingestion
because the user has not yet tasted the
bitterant; this makes them ineffective at
protecting users from harms that can
result from a single ingestion. Incident
reports indicate that ingesting a single
magnet (and ferromagnetic object), or
multiple magnets at once or in quick
succession, can result in serious
injuries. Thus, the ineffectiveness of
bitterants to prevent an initial ingestion
makes them ineffective for addressing
the magnet ingestion hazard.
Similarly, once a magnet is in a
person’s mouth, they may not be able to
prevent ingestion even if deterred by a
bitterant. The power of the magnetic
forces can cause magnets to move
erratically as pieces repel or attract, and
movement of magnets toward the back
of the throat can trigger the reflex to
swallow the magnets before the person
can remove them. Bitterants would be
particularly ineffective for accidental
ingestions, where victims did not
intentionally place magnets in their
mouths; incident data indicate that
some magnet ingestions involve
unintentional ingestions, particularly
for older victims. Moreover, incidents
involving ingestion of other hazardous
substances demonstrates the
ineffectiveness of aversive agents to
prevent ingestions. Children frequently
ingest unpalatable substances, such as
gasoline, cleaners, and ammonia,
indicating that unpleasant taste or odor,
alone, is not sufficient to deter children
from ingesting items or substances. In
addition, some portion of the
population, possibly as high as 30
percent, may be insensitive to certain
bitterants.
For these reasons, the Commission
did not select this alternative.
F. Longer Effective Date
Another alternative is to provide a
longer effective date for a final rule. In
this proposed rule, the Commission
98 This alternative is discussed in detail in the
Final Rule briefing package for the 2014 rule on
magnet sets, available at: https://www.cpsc.gov/s3fspublic/pdfs/foia_SafetyStandardforMagnetSetsFinalRule.pdf.
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proposes to make a final rule effective
30 days after the final rule is published.
A longer effective date would reduce the
impact of the rule on manufacturers and
importers by extending the time firms
have to develop products that comply
with the rule or modify products to
comply with the rule. However,
delaying the effective date would delay
the safety benefits of the rule as well. As
such, the Commission did not select this
alternative. However, the Commission
requests comments about the proposed
effective date.
IX. Paperwork Reduction Act
This proposed rule does not contain
a collection of information that is
subject to public comment and review
by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521).99
X. Initial Regulatory Flexibility
Analysis 100
When an agency is required to
publish a proposed rule, section 603 of
the Regulatory Flexibility Act (5 U.S.C.
601–612) requires that the agency
prepare an initial regulatory flexibility
analysis (IRFA) that describes the
impact that the rule would have on
small businesses and other entities. An
IRFA is not required if the head of an
agency certifies that the proposed rule
will not have a significant economic
impact on a substantial number of small
entities. 5 U.S.C. 605. The IRFA must
contain:
(1) A description of why action by the
agency is being considered;
(2) a succinct statement of the objectives of,
and legal basis for, the proposed rule;
(3) a description of and, where feasible, an
estimate of the number of small entities to
which the proposed rule will apply;
(4) a description of the projected reporting,
recordkeeping and other compliance
requirements of the proposed rule, including
an estimate of the classes of small entities
that will be subject to the requirement and
the type of professional skills necessary for
preparation of the report or record; and
(5) identification, to the extent practicable,
of relevant Federal rules that may duplicate,
overlap, or conflict with the proposed rule.
An IRFA must also describe any
significant alternatives that would
accomplish the objectives of the
applicable statutes and minimize any
significant economic impact on small
99 There is an Office of Management and Budget
control number, under the Paperwork Reduction
Act, for collection of information regarding thirdparty testing for children’s products, addressed in
16 CFR part 1107.
100 Further details about the initial regulatory
flexibility analysis are available in Tab F of the NPR
briefing package. Additional information about
costs associated with the rule are available in Tab
E of the NPR briefing package.
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entities. Alternatives could include: (1)
Establishing different compliance or
reporting requirements that consider the
resources available to small businesses;
(2) clarification, consolidation, or
simplification of compliance and
reporting requirements for small
entities; (3) use of performance rather
than design standards; and (4) an
exemption from coverage of the rule, or
any part of the rule thereof, for small
entities.
The IRFA for this proposed rule is
available in Tab F of the NPR briefing
package; this section provides an
overview of the impact of the proposed
rule on small businesses.
A. Reason for Agency Action
The intent of this rulemaking is to
reduce deaths and injuries resulting
from magnet ingestions. As incident
data show, magnet ingestion incidents
have increased in recent years, and
commonly involve products categorized
as amusement or jewelry products. Most
incidents involve children and teens,
particularly under 14 years old. If
ingested, some magnets are powerful
enough to interact internally with one
another through body tissue, and resist
natural bodily forces to separate the
magnets. This interaction has led to
serious injuries and several deaths in
the United States. The internal
interaction hazard is a hidden hazard,
which children and caregivers are
unlikely to anticipate, appreciate, and
avoid, as demonstrated by incident data.
Incident data and the health outcomes
of magnet ingestions demonstrate the
need for agency action.
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B. Objectives of and Legal Basis for the
Rule
The objective of the proposed rule is
to reduce the risk of injury and death
associated with ingestion of hazardous
magnets, as discussed above. The
proposed rule would be issued under
the authority of sections 7 and 9 of the
CPSA.
C. Small Entities to Which the Rule Will
Apply
The proposed rule would apply to
small entities that manufacture, import,
or sell subject magnet products, which
are products with one or more magnets,
which are loose or separable, and
designed, marketed, or intended to be
used by consumers for entertainment,
jewelry (including children’s jewelry),
mental stimulation, stress relief, or a
combination of these purposes.
Examples of subject magnet products
include magnet sets, other types of
magnet toys intended for users 14 years
and older, and jewelry with separable
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magnets that can be arranged by the
consumer.
Because CPSC’s previous rulemaking
work regarding magnet ingestions has
focused on magnet sets, CPSC staff has
more detailed information about magnet
sets than other subject magnet products.
For this reason, this analysis provides
detailed information about magnet sets;
however, staff also provides information
about additional subject magnet
products, to the extent information
about these products is available.
All of the importers of magnet sets are
small businesses under U.S. Small
Business Administration (SBA) size
standards, and CPSC expects that this is
also true for manufacturers and
importers of other subject magnet
products. Currently, nearly all marketers
(firms or individuals) of magnet sets sell
through internet sites, rather than
through physical retail stores such as
bookstores, gift shops and other outlets
(which commonly sold magnet sets from
2009 through mid-2012). Some of these
internet sites are operated by the
importers, but the majority of sellers (in
terms of distinct firms or individuals, if
not unit sales) appear to sell through
their stores, operated on the sites of
other internet platforms. These online
retail outlets may also be used
commonly by manufacturers and sellers
of other subject magnet products.
As discussed above, in late 2018, IEc
examined the market for magnet sets. In
its review of internet platforms, IEc
found a total of 69 sellers. IEc also
identified 10 manufacturers and 2
retailers, which also are small
businesses.101 CPSC staff provided IEc
with staff’s prior research, which
identified at least 121 sellers of magnet
sets on two major internet retail
platforms. IEc reviewed these sellers
with the intention of merging CPSC’s
research with newer information but
found that the vast majority of sellers
CPSC identified no longer sold magnet
sets, indicating high turnover rates.
In 2020, CPSC staff reviewed the
status of previously identified sellers of
magnet sets on two major internet
platforms and found further evidence of
high turnover rates: Most of the sellers
identified in late 2018 no longer sold
magnet sets or had abandoned their
stores. Only 9 of 69 sellers were still
selling magnet sets. The remaining
sellers no longer offered magnet sets or
no longer operated on the platforms. In
addition, staff identified 29 sellers that
101 IEc classified manufacturers as firms
producing and selling their own magnet set
products, and retailers as firms that typically sell
magnets from multiple manufacturers.
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IEc had not identified as active in the
market in late 2018.
Based on this information, CPSC staff
expects the dominant business model
for importers of magnet sets will be
direct sales to consumers using their
own internet websites or other internet
shopping sites. However, the proposed
rule could also affect some third-party
retailers of the products, whether selling
them online or in physical stores. Such
retailers sell a wide variety of consumer
products; retailers classified as small
businesses that sell the products would
not be likely to derive significant
proportions of total revenues from sales
of affected magnet sets, and the impacts
on individual firms should be minimal.
D. Compliance, Reporting, and
Recordkeeping Requirements in the
Proposed Rule
The proposed rule would establish a
mandatory standard that all subject
magnet products would have to meet to
be sold in the United States. As stated
above, the proposed rule would require
consumer products that are designed,
marketed, or intended to be used for
entertainment, jewelry, mental
stimulation, stress relief, or a
combination of these purposes, and that
contain one or more loose or separable
magnets to meet performance
requirements. The proposed
performance requirements specify that
each loose or separable magnet in a
subject magnet product that is small
enough to fit entirely in the small parts
cylinder must have a flux index less
than 50 kG2 mm2. The requirements of
the proposed standard are described, in
detail, in this preamble, and the
proposed regulatory text is at the end of
this notice.
In addition, certification
requirements, which are discussed in
section XII. Testing, Certification, and
Notification of Requirements, below,
would apply to subject magnet
products. To summarize, section 14 of
the CPSA requires manufacturers,
importers, or private labelers of a
consumer product that is subject to a
consumer product safety rule to certify,
based on a test of each product or a
reasonable testing program, that the
product complies with all rules, bans or
standards applicable to the product. The
proposed rule specifies the test
procedure to use to determine whether
a subject magnet product complies with
the requirements. For products that
manufacturers certify, manufacturers
would issue a general certificate of
conformity (GCC). In the case of subject
magnet products that could be
considered children’s products, the
certification must be based on testing by
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an accredited third-party conformity
assessment body.
The requirements for the GCC are
stated in section 14 of the CPSA. Among
other requirements, each certificate
must identify the manufacturer or
private labeler issuing the certificate
and any third-party conformity
assessment body on whose testing the
certificate relies; the date and place of
manufacture; the date and place where
the product was tested; each party’s
name, full mailing address, telephone
number; and contact information for the
individual responsible for maintaining
records of test results. The certificates
must be furnished to each distributor or
retailer of the product and to CPSC, if
requested.
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1. Costs of the Proposed Rule That
Would Be Incurred by Small
Manufacturers
Small manufacturers and importers of
subject magnet products would likely
incur some costs to certify that their
products meet the requirements of the
proposed rule, as required by section 14
of the CPSA. The certification must be
based on a test of each product or a
reasonable testing program. The costs of
the testing might be minimal, especially
for small manufacturers that currently
have product testing done for products
subject to the requirements in ASTM
F963–17, which is mandated by 16 CFR
part 1250. Importers may also rely on
testing completed by other parties, such
as their foreign suppliers, if those tests
provide sufficient information for the
manufacturers or importers to certify
that the magnets in their products
comply with the proposed rule. As
noted above, for subject magnet
products that could be considered
children’s products, such as children’s
jewelry, the certification must be based
on testing by an accredited third-party
conformity assessment body, at
somewhat higher costs. The
Commission requests comments
regarding the costs or other impacts of
the certification requirements under
section 14 of the CPSA.
2. Impact on Small Businesses
As discussed in the preliminary
regulatory analysis, the primary impact
of the proposed rule on small businesses
would be the lost income and profits to
firms that could not produce, import,
and sell non-complying products in the
future. The lost benefits to firms
resulting from a proposed rule are
measured by a loss in producer surplus,
which is a measure of the total revenue
of firms selling the magnets, less the
total variable costs of production. As
predominantly imported products, the
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variable costs for small businesses
handling subject magnet products are
mainly the import costs. The producer
surplus for magnet sets could average
about $5 to $10 per unit, based on an
average price of $20. A similar
relationship could apply to other subject
magnet products affected by the
proposed rule.
A few small firms whose businesses
focus on sales of subject magnet
products that would not comply with
the proposed rule, including some of the
firms selling products on their own
websites, would face relatively greater
losses in producer surplus. These and
other small businesses could respond to
the rule by marketing magnets that
comply with or are not subject to the
proposed rule. Such measures could
offset losses in producer surplus.
E. Federal Rules That May Duplicate,
Overlap, or Conflict With the Proposed
Rule
CPSC did not identify any federal
rules that duplicate, overlap, or conflict
with the proposed rule.
F. Alternatives Considered To Reduce
the Burden on Small Entities
As discussed in section VIII.
Alternatives to the Proposed Rule,
above, CPSC examined several
alternatives to the proposed rule, which
could reduce the burden on firms,
including small entities. For the reasons
described in that section, the
Commission concluded that those
alternatives would not adequately
reduce the risk of injury and death
associated with magnet ingestions, and
is not proposing those alternatives. See
Tab F of the NPR briefing package for
further discussion of alternatives to the
proposed rule. The Commission seeks
comments on any alternatives that
would reduce the impact on small
entities, while adequately reducing the
risk of injury and death associated
magnet ingestions.
XI. Incorporation by Reference
The proposed rule incorporates by
reference ASTM F963–17. The Office of
the Federal Register (OFR) has
regulations regarding incorporation by
reference. 1 CFR part 51. Under these
regulations, in the preamble of an NPR,
an agency must summarize the
incorporated material, and discuss the
ways in which the material is
reasonably available to interested
parties or how the agency worked to
make the materials reasonably available.
1 CFR 51.5(a). In accordance with the
OFR requirements, this preamble
summarizes the provisions of ASTM
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1307
F963–17 that the Commission proposes
to incorporate by reference.
The standard is reasonably available
to interested parties and interested
parties can purchase a copy of ASTM
F963–17 from ASTM International, 100
Barr Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959 USA;
telephone: (610) 832–9585;
www.astm.org. Additionally, during the
NPR comment period, a read-only copy
of ASTM F963–17 is available for
viewing on ASTM’s website at: https://
www.astm.org/CPSC.htm. Once a final
rule takes effect, a read-only copy of the
standard will be available for viewing
on the ASTM website at: https://
www.astm.org/READINGLIBRARY/.
Interested parties can also schedule an
appointment to inspect a copy of the
standard at CPSC’s Division of the
Secretariat, U.S. Consumer Product
Safety Commission, 4330 East-West
Highway, Bethesda, MD 20814,
telephone: (301) 504–7479; email: cpscos@cpsc.gov.
XII. Testing, Certification, and Notice of
Requirements
Section 14(a) of the CPSA includes
requirements for certifying that
children’s products and non-children’s
products comply with applicable
mandatory standards. 15 U.S.C. 2063(a).
Section 14(a)(1) addresses required
certifications for non-children’s
products, and sections 14(a)(2) and
(a)(3) address certification requirements
specific to children’s products.
A ‘‘children’s product’’ is a consumer
product that is ‘‘designed or intended
primarily for children 12 years of age or
younger.’’ Id. 2052(a)(2). The following
factors are relevant when determining
whether a product is a children’s
product:
• Manufacturer statements about the
intended use of the product, including
a label on the product if such statement
is reasonable;
• whether the product is represented
in its packaging, display, promotion, or
advertising as appropriate for use by
children 12 years of age or younger;
• whether the product is commonly
recognized by consumers as being
intended for use by a child 12 years of
age or younger; and
• the Age Determination Guidelines
issued by CPSC staff in September 2002,
and any successor to such guidelines.
Id. ‘‘For use’’ by children 12 years and
younger generally means that children
will interact physically with the product
based on reasonably foreseeable use. 16
CFR 1200.2(a)(2). Children’s products
may be decorated or embellished with a
childish theme, be sized for children, or
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be marketed to appeal primarily to
children. Id. 1200.2(d)(1).
As discussed above, some subject
magnet products (e.g., children’s
jewelry) are children’s products and
some are not. Therefore, a final rule
would require subject magnet products
that are not children’s products to meet
the certification requirements under
section 14(a)(1) of the CPSA and would
require subject magnet products that are
children’s products to meet the
certification requirements under
sections 14(a)(2) and (a)(3) of the CPSA.
The Commission’s requirements for
certificates of compliance are codified
in 16 CFR part 1110.
Non-Children’s Products. Section
14(a)(1) of the CPSA requires every
manufacturer (which includes
importers 102) of a non-children’s
product that is subject to a consumer
product safety rule under the CPSA or
a similar rule, ban, standard, or
regulation under any other law enforced
by the Commission to certify that the
product complies with all applicable
CPSC requirements. 15 U.S.C.
2063(a)(1).
Children’s Products. Section 14(a)(2)
of the CPSA requires the manufacturer
or private labeler of a children’s product
that is subject to a children’s product
safety rule to certify that, based on
testing by a third-party conformity
assessment body (i.e., testing
laboratory), the product complies with
the applicable children’s product safety
rule. Id. 2063(a)(2). Section 14(a) also
requires the Commission to publish a
notice of requirements (NOR) for a
testing laboratory to obtain accreditation
to assess conformity with a children’s
product safety rule. Id. 2063(a)(3)(A).
Because some subject magnet products
are children’s products, the proposed
rule is a children’s product safety rule,
as applied to those products.
Accordingly, if the Commission issues a
final rule, it must also issue an NOR.
The Commission published a final
rule, codified at 16 CFR part 1112,
entitled Requirements Pertaining to
Third Party Conformity Assessment
Bodies, which established requirements
and criteria concerning testing
laboratories. 78 FR 15836 (Mar. 12,
2013). Part 1112 includes procedures for
CPSC to accept a testing laboratory’s
accreditation and lists the children’s
product safety rules for which CPSC has
published NORs. When CPSC issues a
new NOR, it must amend part 1112 to
include that NOR. Accordingly, as part
of this NPR, the Commission proposes
102 The CPSA defines a ‘‘manufacturer’’ as ‘‘any
person who manufactures or imports a consumer
product.’’ 15 U.S.C. 2052(a)(11).
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to amend part 1112 to add this proposed
standard for magnets to the list of
children’s product safety rules for
which CPSC has issued an NOR.
Testing laboratories that apply for
CPSC acceptance to test subject magnet
products that are children’s products for
compliance with the new rule would
have to meet the requirements in part
1112. When a laboratory meets the
requirements of a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to CPSC to include
16 CFR part 1262, Safety Standard for
Magnets, in the laboratory’s scope of
accreditation of CPSC safety rules listed
on the CPSC website at: www.cpsc.gov/
labsearch.
XIII. Environmental Considerations
The Commission’s regulations address
whether CPSC is required to prepare an
environmental assessment (EA) or an
environmental impact statement (EIS).
16 CFR 1021.5. Those regulations list
CPSC actions that ‘‘normally have little
or no potential for affecting the human
environment,’’ and, therefore, fall
within a ‘‘categorical exclusion’’ under
the National Environmental Policy Act
(42 U.S.C. 4231–4370h) and the
regulations implementing it (40 CFR
parts 1500–1508) and do not require an
EA or EIS. 16 CFR 1021.5(c). Among
those actions are rules that provide
performance standards for products. Id.
1021.5(c)(1). Because this proposed rule
would create performance requirements
for subject magnet products, the
proposed rule falls within the
categorical exclusion, and thus, no EA
or EIS is required.
XIV. Preemption
Executive Order (E.O.) 12988, Civil
Justice Reform (Feb. 5, 1996), directs
agencies to specify the preemptive effect
of a rule in the regulation. 61 FR 4729
(Feb. 7, 1996), section 3(b)(2)(A). In
accordance with E.O. 12988, CPSC
states the preemptive effect of the
proposed rule, as follows:
The regulation for subject magnet
products is proposed under authority of
the CPSA. 15 U.S.C. 2051–2089. Section
26 of the CPSA provides that ‘‘whenever
a consumer product safety standard
under this Act is in effect and applies
to a risk of injury associated with a
consumer product, no State or political
subdivision of a State shall have any
authority either to establish or to
continue in effect any provision of a
safety standard or regulation which
prescribes any requirements as to the
performance, composition, contents,
design, finish, construction, packaging
or labeling of such product which are
designed to deal with the same risk of
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injury associated with such consumer
product, unless such requirements are
identical to the requirements of the
Federal Standard.’’ 15 U.S.C. 2075(a).
The federal government, or a state or
local government, may establish or
continue in effect a non-identical
requirement for its own use that is
designed to protect against the same risk
of injury as the CPSC standard if the
federal, state, or local requirement
provides a higher degree of protection
than the CPSA requirement. Id. 2075(b).
In addition, states or political
subdivisions of a state may apply for an
exemption from preemption regarding a
consumer product safety standard, and
the Commission may issue a rule
granting the exemption if it finds that
the state or local standard: (1) Provides
a significantly higher degree of
protection from the risk of injury or
illness than the CPSA standard, and (2)
does not unduly burden interstate
commerce. Id. 2075(c).
Thus, the requirements proposed in
today’s Federal Register would, if
finalized, preempt non-identical state or
local requirements for subject magnet
products designed to protect against the
same risk of injury and prescribing
requirements regarding the
performance, composition, contents,
design, finish, construction, packaging
or labeling of subject magnet products.
XV. Effective Date
The CPSA requires that consumer
product safety rules take effect at least
30 days after the date the rule is
promulgated, but not later than 180 days
after the date the rule is promulgated
unless the Commission finds, for good
cause shown, that an earlier or later
effective date is in the public interest
and, in the case of a later effective date,
publishes the reasons for that finding.
15 U.S.C. 2058(g)(1). The Commission
proposes that this rule, and the
amendment to part 1112, become
effective 30 days after publication of the
final rule in the Federal Register. The
rule would apply to all subject magnet
products manufactured or imported on
or after the effective date. The
Commission requests comments on the
proposed effective date.
XVI. Proposed Findings
As discussed in section II. Statutory
Authority, above, the CPSA requires the
Commission to make certain findings
when issuing a consumer product safety
standard. 15 U.S.C. 2058(f)(1), (f)(3).
This section discusses preliminary
support for those findings.
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A. Degree and Nature of the Risk of
Injury
To issue a final rule, the CPSA
requires the Commission to make
findings regarding the degree and nature
of the risk of injury the rule is designed
to eliminate or reduce. NEISS incident
data indicate that there were an
estimated 4,400 magnet ingestions
treated in U.S. hospital EDs between
January 1, 2010 and December 31, 2020
that involved products categorized as
being for amusement or jewelry, which
are the products subject to this rule. An
additional estimated 18,100 ED-treated
magnet ingestions during this period
involved unidentified magnet products.
CPSC concludes that a large portion of
these unidentified magnet product
incidents likely involved subject magnet
products, for the reasons stated below.
In addition to magnet ingestion
injuries treated in U.S. hospital EDs, the
ICM projects that there were an
estimated 3,255 magnet ingestion
injuries per year treated in medical
settings other than EDs from 2017
through 2020. Incident reports available
through CPSRMS indicate that there
were at least 284 magnet ingestions
between January 1, 2010 and December
31, 2020, 75 percent of which involved
products categorized as being for
amusement or jewelry, which are the
products subject to this rule, and an
additional 15 percent involved
unidentified magnet products, which
CPSC concludes are likely to have
involved subject magnet products for
the reasons stated below.
The potential injuries when a person
ingests one or more magnets are serious.
Health threats posed by magnet
ingestion include pressure necrosis,
volvulus, bowel obstruction, bleeding,
fistulae, ischemia, inflammation,
perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among
others. These conditions can result from
magnets attracting to each other through
internal body tissue, or a single magnet
attracting to a ferromagnetic object.
CPSC is aware of several fatal magnet
ingestion incidents resulting from
internal interaction of the magnets.
As indicated above, CPSC concludes
that many of the magnet ingestion
incidents for which information was
insufficient to identify the specific
product type involved subject magnet
products. This conclusion is supported
by incident data, trends in magnet
ingestion rates and recalls surrounding
mandatory standards, and behavioral
and developmental considerations.
Incident data indicate that, of the
magnet ingestion incidents for which
CPSC could identify a product type, the
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primary products involved were magnet
sets, magnet toys, and jewelry; this is
likely to apply to incidents that lacked
product identification information as
well.
Trends in magnet ingestion rates
surrounding a previous Commission
rule on magnet sets indicate that magnet
ingestions significantly declined during
the time the rule was in effect, and
significantly increased after the rule was
vacated. This indicates that a large
portion of magnet ingestions involved
magnet sets, which are subject magnet
products. Similarly, incident data and
recalls surrounding the Commission’s
mandatory standard for magnets in
children’s toys, in 16 CFR part 1250,
indicate that, while amusement
products are involved in most magnet
ingestion incidents with identifiable
product types, those amusement
products are not children’s toys.
Relatively few magnet ingestion
incidents identify children’s toys as the
product involved, suggesting that these
make up few of the unidentified product
type incidents as well. And the number
of recalls of children’s products for
magnet-related hazards has appreciably
declined since 16 CFR part 1250 took
effect, suggesting that these products do
not make up a large portion of magnet
ingestion incidents.
Finally, behavioral and
developmental factors support the
conclusion that many magnet ingestions
with unidentified product types involve
subject magnet products. These include
the attractiveness of magnetic products
and their features to children and teens,
consumers’ perception that amusement
and jewelry products are appropriate
and safe for children, and consumers’
underappreciation of the magnet
ingestion hazard.
B. Number of Consumer Products
Subject to the Proposed Rule
To issue a final rule, the CPSA
requires the Commission to make
findings regarding the approximate
number of consumer products subject to
the rule. Staff estimates that there are
approximately 500,000 subject magnet
products sold annually in the United
States. However, to account for a range
of sales estimates, staff also provided
information for sales ranging from
250,000 to 1 million units annually.
C. The Public Need for Subject Magnet
Products and the Effects of the Proposed
Rule on Their Utility, Cost, and
Availability
To issue a final rule, the CPSA
requires the Commission to make
findings regarding the public’s need for
the products subject to the rule and the
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1309
probable effect of the rule on the cost,
availability, and utility of such
products. Consumers use subject magnet
products for entertainment, mental
stimulation, stress relief, and jewelry.
The proposed rule requires subject
magnet products to meet performance
requirements regarding size or strength,
but does not restrict the design of
products. As such, subject magnet
products that meet the standard would
continue to serve the purpose of
amusement or jewelry for consumers.
Magnets that comply with the proposed
rule, such as non-separable magnets,
larger magnets, weaker magnets, or nonpermanent magnets, would likely still
be useful for amusement or jewelry.
However, it is possible that there may be
some negative effect on the utility of
subject magnet products if compliant
products function differently or do not
include certain desired characteristics.
Retail prices of subject magnet
products generally average under $20.
CPSC has identified subject magnet
products that comply with the proposed
rule, indicating that the costs of
compliant and non-compliant products
are comparable.
If the costs associated with
redesigning or modifying subject magnet
products to comply with the proposed
rule result in manufacturers
discontinuing products, there may be
some loss in availability to consumers.
However, this would be mitigated to the
extent that compliant products meet the
same consumer needs.
D. Other Means To Achieve the
Objective of the Proposed Rule, While
Minimizing Adverse Effects on
Competition and Manufacturing
To issue a final rule, the CPSA
requires the Commission to make
findings regarding ways to achieve the
objective of the rule while minimizing
adverse effects on competition,
manufacturing, and commercial
practices. CPSC considered several
alternatives to achieve the objective of
reducing unreasonable risks of injury
and death associated with magnet
ingestions.
One alternative is to take no
regulatory action and instead rely on
existing ASTM standards to address the
magnet ingestion hazard. This would
eliminate costs associated with the rule
by avoiding a mandatory standard;
however, this alternative is unlikely to
adequately reduce the risk of injury and
death associated with magnet
ingestions. For one, none of the existing
standards address all of the products
most commonly identified in magnet
ingestion incidents, and several of the
standards provide exceptions to
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performance requirements for certain
subject magnet products. In addition,
under the existing standards, certain
subject magnet products would not be
subject to performance requirements
regarding size and strength, instead
relying on alternative requirements,
such as safety messaging, which is
unlikely to adequately reduce the
magnet ingestion hazard.
Another alternative is a mandatory
standard with less stringent
requirements than the proposed rule,
such as a higher flux index limit, or
different requirements for certain shapes
and sizes of magnets. This could reduce
the costs associated with a rule by
allowing firms to market a wider variety
of products than under the proposed
rule. However, for this alternative to
reduce costs, it would allow more
products to remain on the market,
thereby decreasing the safety benefits.
Safety messaging requirements are
another alternative to the proposed rule.
This would reduce the costs associated
with the rule because it would not
require modifying or discontinuing
subject magnet products, and the costs
of warnings and instructional
information likely would be small.
However, this alternative is not likely to
adequately reduce the risk of injury and
death associated with magnet ingestions
because the effectiveness of safety
messaging depends on consumers
seeing the messaging and being
convinced to avoid the hazard. Incident
data indicate that children commonly
access ingested magnets from sources
that are unlikely to include the product
packaging bearing instructions or
warnings. Moreover, consumers are
unlikely to consistently heed warnings
because of the perception that subject
magnet products are appropriate for
children, and underappreciation of the
magnet ingestion hazard. Safety
messaging is generally considered the
least effective way to address product
hazards, and has been ineffective at
addressing the magnet ingestion hazard,
to date.
Another alternative is to require
special packaging to limit children’s
access to subject magnet products. Such
packaging could help consumers
determine if all magnets have been
returned to the container and include
child-resistant features. Although this
alternative would create some packaging
costs, those likely would be lower than
the costs associated with the proposed
rule because it would allow subject
magnet products to remain unchanged.
However, this alternative is not likely to
adequately reduce the risk of injury and
death associated with magnet
ingestions. For packaging requirements
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to be effective, users would have to
repackage all magnets after each use,
which is unlikely given the size and
number of magnets in a product, the
potential to lose magnets, and
consumers’ demonstrated
underappreciation of the hazard. In
addition, packaging is unlikely to be
effective because it generally only
restricts young children (under 5 years
old) from accessing package contents,
and would not prevent older children or
teens from accessing the package
contents, although the majority of
magnet ingestion incidents involved
children 5 years and older.
Another alternative is to require
subject magnet products to be coated
with aversive agents. This alternative
would reduce the costs associated with
the rule because it would allow firms to
continue to sell subject magnet products
and the costs of such coatings likely
would be small. However, such
requirements are not likely to
adequately reduce the risk of injury and
death associated with magnet ingestions
because they do not address ingestions
that occur when the first magnet is
placed in the victim’s mouth, before the
aversive agent is detected, accidental
ingestions, or children who are
developmentally inclined to place
objects in their mouths.
Another alternative is to provide a
longer effective date for the final rule.
This may reduce the costs associated
with the rule by spreading them over a
longer period, but it would also delay
the safety benefits of the rule.
E. Unreasonable Risk
To issue a final rule, the CPSA
requires the Commission to find that the
rule, including the effective date, is
reasonably necessary to eliminate or
reduce an unreasonable risk of injury
associated with the product. Factors the
Commission considered with respect to
this preliminary finding include the
likelihood and severity of the risk, and
the potential costs and benefits
associated with the proposed rule.
As described above, there were an
estimated 23,700 magnet ingestions
treated in U.S. hospital EDs from
January 1, 2010 to December 31, 2020.
Although this includes ingestions of all
magnet types, and is not limited to
subject magnet products, it provides an
indication of the frequency with which
children and teens ingest magnets, and
the need to address the magnet
ingestion hazard. Of these estimated
23,700 ED-treated magnet ingestions, an
estimated 4,400 involved products
categorized as being used for
amusement or jewelry, which are the
products subject to this rule, and an
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additional estimated 18,100 involved
unidentified magnet product types. As
discussed with respect to the finding
regarding the degree and nature of the
risk of injury, a large portion of the
incidents involving unidentified magnet
products likely involve subject magnet
products. In addition, the ICM projects
that there were an additional estimated
3,255 magnet ingestion injuries per year
treated in medical settings other than
EDs from 2017 through 2020. Trend
analysis indicates that magnet
ingestions have significantly increased
in recent years.
The potential injuries when a person
ingests one or more magnets are serious.
Health threats posed by magnet
ingestion include pressure necrosis,
volvulus, bowel obstruction, bleeding,
fistulae, ischemia, inflammation,
perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among
others. These conditions can result from
magnets attracting to each other through
internal body tissue, or a single magnet
attracting to a ferromagnetic object. One
indication of the potential severity of
magnet ingestions is hospitalization
rates. Considering NEISS data,
approximately 18 percent of estimated
ED-treated magnet ingestions result in
hospitalization. Of the 284 CPSRMS
magnet ingestion cases, approximately
twice as many resulted in
hospitalization as other nonhospitalization treatment (187
hospitalizations, 94 other treatments).
For subject magnet products, in
particular, hospitalization was two to
three times as common as other
treatments. Specifically, for magnet set
ingestions, 88 resulted in
hospitalization and 46 resulted in other
treatment; for magnet toys, 36 resulted
in hospitalization and 13 resulted in
other treatment; and for jewelry, 21
resulted in hospitalization, and 10
resulted in other treatment.
Another clear indication of the
severity of health risks are fatal
incidents. Staff identified five fatal
magnet ingestion incidents that
occurred in the United States between
November 24, 2005 and January 5,
2021.103 All of these incidents involved
victims who died from injuries resulting
from internal interaction of the magnets.
Four of the five incidents involved
children 2 years old or younger (the
additional death involved an adult). At
least one of these fatal incidents
involved a magnet set, one involved an
103 CPSC is also aware of two deaths in other
countries, which involved ingestion of hazardous
magnets. Although staff does not know the specific
products involved in these incidents, the magnets
were similar, if not identical to magnets typically
found in magnet sets.
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amusement product, and two fatal
incidents provided product descriptions
consistent with subject magnet
products.
CPSC staff estimates that the rule
could result in aggregate benefits of
about $80 million to $95 million
annually; this estimate excludes magnet
ingestion incidents involving
unidentified magnet products, which
are likely to commonly involve subject
magnet products, making the benefits of
the rule substantially greater. CPSC staff
estimates that the costs to consumers
and manufacturers associated with the
rule could range from $10 million to
$17.5 million annually, assuming
annual sales of 500,000 units.
For these reasons, the Commission
concludes preliminarily that ingestion
of subject magnet products poses an
unreasonable risk of injury and finds
that the proposed rule is reasonably
necessary to reduce that unreasonable
risk of injury.
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F. Public Interest
To issue a final rule, the CPSA
requires the Commission to find that
issuing the rule is in the public interest.
This proposed rule is intended to
address an unreasonable risk of injury
and death posed by magnet ingestions.
The Commission believes that
compliance with the requirements of the
proposed rule will significantly reduce
magnet ingestion deaths and injuries in
the future; thus, the rule is in the public
interest.
G. Voluntary Standards
To issue a final rule, the CPSA
requires the Commission to find that, if
a voluntary standard addressing the risk
of injury has been adopted and
implemented, that either compliance
with the voluntary standard is not likely
to result in the elimination or adequate
reduction of the risk or injury, or there
is unlikely to be substantial compliance
with the voluntary standard.
The Commission is aware of six
voluntary and international standards
that address the magnet ingestion
hazard: ASTM F963–17, Standard
Consumer Safety Specification for Toy
Safety; ASTM F2923–20, Standard
Specification for Consumer Product
Safety for Children’s Jewelry; ASTM
F2999–19, Standard Consumer Safety
Specification for Adult Jewelry; ASTM
F3458–21, Standard Specification for
Marketing, Packaging, and Labeling
Adult Magnet Sets Containing Small,
Loose, Powerful Magnets (with a Flux
Index ≥ 50 kG2 mm2); EN–71–1: 2014,
Safety of Toys; Part 1: Mechanical and
Physical Properties; and ISO 8124–1:
2018, Safety of Toys—Part 1: Safety
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Aspects Related to Mechanical and
Physical Properties. The Commission
does not consider the standards likely to
result in an adequate reduction of the
risk of injury associated with magnet
ingestions because of the scope of
products each standard covers, and the
types of requirements included in them.
None of these standards apply to all
of the products most commonly
identified in magnet ingestion
incidents—magnet sets intended for
users 14 years and older, magnet toys
intended for users 14 years and older,
and jewelry. Moreover, even for the
products the standards do address,
several standards provide exceptions for
certain amusement and jewelry
products, imposing only warning
requirements for those products.
In addition, several of the standards
do not impose performance
requirements on magnets themselves,
such as size and strength requirements,
instead recommending or requiring
safety messaging or packaging. CPSC
does not consider safety messaging or
packaging requirements sufficient,
without additional performance
requirements, to adequately reduce the
risk of injury and death associated with
magnet ingestions. Incident data
indicate that children commonly access
ingested magnets from sources that do
not include packaging or safety
messaging; children and caregivers have
commonly disregarded safety messaging
to date; safety packaging only limits
young children from accessing its
contents, which does not address the
majority of magnet ingestions, which
involve older children and teens; and
safety packaging requires users to
repackage all magnets after every use to
be effective, which is unlikely given the
large number and small size of magnets
often in subject magnet products.
H. Relationship of Benefits to Costs
On a per unit basis (as shown in Table
19), CPSC estimates the expected
benefits per unit to range from $160
(assuming a 1.5-year product life and a
3 percent discount rate) to $190
(assuming a 3-year product life and a 3
percent discount rate). The estimated
expected cost to manufacturers per unit
is between about $5 and $10, and there
is an unquantifiable cost to consumers
associated with lost utility and
availability.
CPSC estimates the aggregate benefits
of the rule to be $80 million to $95
million annually and estimates the cost
of the rule to be between $10 million to
$17.5 million annually, assuming sales
of 500,000 units annually (estimated
costs range from $5 million to $35
million annually, depending on annual
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sales between 250,000 and 1 million
units). The Commission believes,
preliminarily, that the benefits expected
from the proposed rule bear a
reasonable relationship to its costs.
I. Least Burdensome Requirement That
Would Adequately Reduce the Risk of
Injury
CPSC considered several lessburdensome alternatives to the
proposed rule. One alternative is to take
no regulatory action and, instead, rely
on existing standards to address the
magnet ingestion hazard. This would
reduce the burden associated with the
rule by avoiding a mandatory standard;
however, this alternative is unlikely to
adequately address the magnet ingestion
hazard because none of the existing
standards apply performance
requirements to all of the products most
commonly involved in magnet
ingestions incidents.
Another alternative is a mandatory
standard with less stringent
requirements than the proposed rule,
such as a higher flux index limit, or
different requirements for certain shapes
and sizes of magnets. This could reduce
the burden associated with a rule by
allowing firms to market a wider variety
of products than under the proposed
rule. However, this alternative would
reduce the safety benefits because
allowing certain hazardous magnets in
subject magnet products to remain on
the market does not address the hazard
such products pose.
Safety messaging is another
alternative to the proposed rule. This
alternative would reduce the burdens
associated with the rule because it
would not require modifying or
discontinuing subject magnet products,
and the costs of such warnings and
instructional information likely would
be small. However, this alternative is
not likely to adequately reduce the
magnet ingestion hazard. Safety
messaging is generally the least effective
way to reduce hazards associated with
consumer products; incident data shows
children commonly access ingested
magnets from sources that do not
include product packaging, where
warnings are provided; incident data,
behavioral and developmental factors,
and other information indicate that
children and caregivers commonly
disregard safety messaging regarding the
magnet ingestion hazard; and this
approach has not been effective at
adequately reducing the hazard, to date.
Another alternative is to require
special packaging to limit children’s
access to subject magnet products. Such
packaging could help consumers
determine if all magnets have been
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returned to the container and include
child-resistant features. Although this
alternative would create some packaging
costs, those costs likely would be lower
than the proposed rule because it would
allow subject magnet products to remain
unchanged. However, this alternative is
not likely to adequately reduce the risk
of injury and death associated with
magnet ingestions. Consumers are
unlikely to repackage all magnets after
each use, given the small size and large
number of magnets in products, the
potential to lose magnets, and
consumers’ demonstrated
underappreciation of the hazard. In
addition, packaging requirements are
unlikely to be effective because they
generally only restrict young children
(under 5 years old) from accessing
package contents, and would not
prevent older children or teens from
accessing the package contents,
although the majority of magnet
ingestion incidents involved children 5
years and older.
Another alternative is to require
subject magnet products to be coated
with aversive agents. This alternative
would reduce the burden associated
with the rule because it would allow
firms to continue to sell subject magnet
products and the costs of such coatings
likely would be small. However, such
requirements are not likely to
adequately address the hazard because
they do not address ingestions that
occur when the first magnet is placed in
the victim’s mouth, before the aversive
agent is detected, accidental ingestions,
or children who are developmentally
inclined to place objects in their
mouths.
Another alternative is to provide a
longer effective date for the final rule.
This may reduce the burdens associated
with the rule by spreading them over a
longer period, but it would also delay
the safety benefits of the rule.
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XVII. Request for Comments
The Commission requests comments
on all aspects of the proposed rule.
Comments should be submitted in
accordance with the instructions in the
ADDRESSES section at the beginning of
this notice. The following are specific
comment topics that the Commission
would find helpful:
A. Scope and Definitions
• The scope of products covered by
the proposed rule, and whether
additional products should be included
or excluded from the scope;
• Specifically, whether home/kitchen
magnets or education products should
be addressed in the rule;
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• Data supporting any
recommendations to include or exclude
products from the scope of the rule; and
• Information and data about magnets
involved in ingestion incidents that are
categorized as unidentified product
types in staff’s analysis.
• What safety messaging
requirements should include, and why
they should be included; and
• What packaging requirements
should include, and why they should be
included.
B. Performance Requirements
• Data regarding the level of
compliance with existing standards that
address magnet ingestions, including
ASTM standards.
• Application of the ASTM F963 test
method for measuring flux density,
particularly to test small diameter
spherical magnets in the 2 to 3 mm
diameter range;
• Variances in flux density
measurements of small spherical
magnets, including correct
identification of pole surfaces, accurate
measurement of maximum absolute flux
density, and accurate calculation of
maximum cross section of the magnetic
poles;
• Potential alternative methods of
assessing the strength of magnets or
their ability to cause internal interaction
injuries;
• How many magnets should be
tested, including whether all loose or
separable magnets in subject magnet
products should be tested, or only a
representative sample or at least one
representative sample of each shape and
size should be tested, and how firms
may satisfy such requirements;
• Whether statistical sampling should
be used to determine how many
magnets to test in a subject magnet
product and to reasonably verify the
tested sample is representative,
particularly for products made up of
numerous individual magnets;
• The proposed flux index limit of 50
kG2 mm2, including data on whether
magnets with flux indexes less than 50
kG2 mm2 pose concern for the internal
interaction hazard; and
• Whether the rule should include
requirements similar to ASTM F963 to
ensure that products do not liberate
hazardous magnets after use and abuse
testing.
C. Safety Messaging and Packaging
Requirements
• Whether the rule should include
requirements for safety messaging,
particularly for products with flux
indexes within the permissible range for
which there is uncertainty about the
flux indexes that can cause internal
interaction hazards;
• Whether the rule should include
requirements for packaging, particularly
for products with flux indexes within
the permissible range for which there is
uncertainty about the flux indexes that
can cause internal interaction hazards;
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D. Existing Standards
E. Economic Analysis (Preliminary
Regulatory Analysis and IRFA)
• The estimates and other valuations
used in CPSC’s analysis regarding
benefits and costs associated with the
proposed rule;
• The annual unit sales of subject
magnet products;
• The expected product life of subject
magnet products;
• The number of subject magnet
products subject to the proposed rule;
• The accuracy and reasonableness of
the benefits estimates;
• Information about the costs to
consumers associated with the proposed
rule, including consumer needs for
subject magnet products, and the
potential impact of the proposed rule on
the utility, cost, and availability of
subject magnet products for those needs;
• The accuracy and reasonableness of
the cost estimates for manufacturers and
importers (if available, sales or other
shipment data would be helpful);
• The potential impact of the
proposed rule on small entities;
• Costs associated with testing and
certification requirements, including
requirements in section 14 of the CPSA,
particularly for small businesses;
• Potential modifications to subject
magnet products to comply with the
proposed rule, and the costs associated
with those modifications;
• The types and magnitude of
manufacturing costs that might
disproportionately impact small
businesses or were not considered in the
agency’s analysis;
• The different impacts on small
businesses associated with different
effective dates; and
• Other alternatives that would
minimize the impact on small
businesses while reducing the magnet
ingestion hazard.
F. Effective Date
• The reasonableness of the proposed
30-day effective date and
recommendations for a different
effective date, if justified. Comments
recommending a longer effective date
should describe the problems associated
with meeting the proposed effective
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date and the justification for a longer
one.
the Commission finds that there is good
cause to extend the 60-day period.
G. Anti-Stockpiling
• Whether the Commission should
consider including in the rule antistockpiling provisions to prevent
manufacturing or importing of noncompliant subject magnet products at an
increased rate during the period
between announcing a final rule and the
effective date of the rule; and
• Information relevant to whether an
anti-stockpiling provision is necessary.
XIX. Conclusion
For the reasons stated in this
preamble, the Commission proposes
requirements for subject magnet
products to address an unreasonable
risk of injury associated with ingestion
of such products.
XVIII. Promulgation of a Final Rule
Section 9(d)(1) of the CPSA requires
the Commission to promulgate a final
consumer product safety rule within 60
days of publishing a proposed rule. 15
U.S.C. 2058(d)(1). Otherwise, the
Commission must withdraw the
proposed rule if it determines that the
rule is not reasonably necessary to
eliminate or reduce an unreasonable
risk of injury associated with the
product, or is not in the public interest.
Id. However, the Commission can
extend the 60-day period, for good cause
shown, if it publishes the reasons for
doing so in the Federal Register. Id.
The Commission finds that there is
good cause to extend the 60-day period
for this rulemaking. Under both the
Administrative Procedure Act and the
CPSA, the Commission must provide an
opportunity for interested parties to
submit written comments on a proposed
rule. 5 U.S.C. 553; 15 U.S.C. 2058(d)(2).
The Commission typically provides 75
days for interested parties to submit
written comments. A shorter comment
period may limit the quality and utility
of information CPSC receives in
comments, particularly for areas where
it seeks data and other detailed
information that may take time for
commenters to compile. In addition, the
CPSA requires the Commission to
provide interested parties with an
opportunity to make oral presentations
of data, views, or arguments. 15 U.S.C.
2058. This requires time for the
Commission to arrange a public meeting
for this purpose, and provide notice to
interested parties in advance of that
meeting. After receiving written and
oral comments, CPSC staff must have
time to review and evaluate those
comments.
These factors make it impractical for
the Commission to issue a final rule
within 60 days of this proposed rule.
Moreover, issuing a final rule within 60
days of the NPR may limit commenters’
ability to provide useful input on the
rule, and CPSC’s ability to evaluate and
take that information into consideration
in developing a final rule. Accordingly,
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List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third-party conformity
assessment body.
16 CFR Part 1262
Consumer protection, Imports,
Incorporation by reference, Safety.
For the reasons discussed in the
preamble, the Commission proposes to
amend Title 16 of the Code of Federal
Regulations as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
■
Authority: Pub. L. 110–314, section 3, 122
Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend § 1112.15 by adding
paragraph (b)(52) to read as follows:
■
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
or test method?
*
*
*
*
*
(b) * * *
(52) 16 CFR part 1262, Safety
Standard for Magnets.
*
*
*
*
*
■ 3. Add part 1262 to read as follows:
PART 1262—SAFETY STANDARD FOR
MAGNETS
Sec.
1262.1 Scope, purpose, application, and
exemptions.
1262.2 Definitions.
1262.3 Requirements.
1262.4 Test procedure for determining flux
index.
1262.5 Findings.
Authority: 15 U.S.C. 2056, 2058
§ 1262.1 Scope, purpose, application, and
exemptions.
(a) Scope and purpose. This part
1262, a consumer product safety
standard, prescribes the safety
requirements for a subject magnet
product, as defined in § 1262.2(b). These
requirements are intended to reduce or
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1313
eliminate an unreasonable risk of death
or injury to consumers who ingest one
or more hazardous magnets (as defined
in § 1262.2(a)) from a subject magnet
product.
(b) Application. Except as provided in
paragraph (c) of this section, all subject
magnet products that are manufactured
in the United States, or imported, on or
after [effective date], are subject to the
requirements of this part 1262, if they
are consumer products. Section 3(a)(1)
of the Consumer Product Safety Act (15
U.S.C. 2052(a)(1)) defines the term
consumer product as an ‘‘article, or
component part thereof, produced or
distributed
(i) for sale to a consumer for use in or
around a permanent or temporary
household or residence, a school, in
recreation, or otherwise, or
(ii) for the personal use, consumption
or enjoyment of a consumer in or
around a permanent or temporary
household or residence, a school, in
recreation, or otherwise.’’ The term does
not include products that are not
customarily produced or distributed for
sale to, or for the use or consumption
by, or enjoyment of, a consumer.
(c) Exemptions. Toys that are subject
to 16 CFR part 1250, Safety Standard
Mandating ASTM F963 for Toys, are
exempt from this part 1262.
§ 1262.2
Definitions.
In addition to the definitions given in
section 3 of the Consumer Product
Safety Act (15 U.S.C. 2052), the
following definitions apply for purposes
of this part 1262:
(a) Hazardous magnet means a
magnet that fits entirely within the
cylinder described in 16 CFR 1501.4
and that has a flux index of 50 kG2 mm2
or more when tested in accordance with
the method described in this part 1262.
(b) Subject magnet product means a
consumer product that is designed,
marketed, or intended to be used for
entertainment, jewelry (including
children’s jewelry), mental stimulation,
stress relief, or a combination of these
purposes, and that contains one or more
loose or separable magnets.
§ 1262.3
Requirements.
Each loose or separable magnet in a
subject magnet product that fits entirely
within the cylinder described in 16 CFR
1501.4 must have a flux index of less
than 50 kG2 mm2 when tested in
accordance with the method described
in 1262.4.
§ 1262.4 Test procedure for determining
flux index.
(a) Select at least one loose or
separable magnet of each shape and size
in the subject magnet product.
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(b) Measure the flux index of each
selected magnet in accordance with the
procedure in section 8.25.1 through
8.25.3 of ASTM F963–17, Standard
Consumer Safety Specification for Toy
Safety, approved on May 1, 2017. The
Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959; phone:
(610) 832–9585; www.astm.org. A readonly copy of the standard is available
for viewing on the ASTM website at
https://www.astm.org/
READINGLIBRARY/. You may inspect a
copy at the Division of the Secretariat,
U.S. Consumer Product Safety
Commission, 4330 East-West Highway,
Bethesda, MD 20814, telephone (301)
504–7479, email: cpsc-os@cpsc.gov, or
at the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, email fr.inspection@
nara.gov, or go to: www.archives.gov/
federal-register/cfr/ibr-locations.html.
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§ 1262.5
Findings.
(a) General. Section 9(f) of the
Consumer Product Safety Act (15 U.S.C.
2058(f)) requires the Commission to
make findings concerning the following
topics and to include the findings in the
rule. Because the findings are required
to be published in the rule, they reflect
the information that was available to the
Consumer Product Safety Commission
(Commission, CPSC) when the standard
was issued on [final rule publication
date].
(b) Degree and nature of the risk of
injury. (1) The standard is designed to
reduce the risk of death and injury
associated with magnet ingestions. The
Commission has identified 284 magnet
ingestions that were reported to have
occurred between January 1, 2010 and
December 31, 2020. Seventy-five
percent of these incidents involved
amusement or jewelry products, which
are the products covered by this rule,
and an additional 15 percent involved
unidentified magnet products, a large
portion of which CPSC concludes are
likely to have involved subject magnet
products, based on developmental and
behavioral factors, identified products
involved in magnet ingestion incidents,
products involved in recalls for magnet
ingestion hazards, and trend analyses
indicating a significant decrease in
magnet ingestion incidents when there
was a mandatory standard for certain
subject magnet products. There were an
estimated 4,400 magnet ingestions
treated in U.S. hospital emergency
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departments between January 1, 2010
and December 31, 2020 that involved
products categorized as being for
amusement or jewelry, which are the
products subject to this rule, and an
additional estimated 18,100 emergency
department treated magnet ingestions
involving unidentified magnet products,
a large portion of which CPSC
concludes are likely to have involved
subject magnet products for the reasons
stated above. In addition, the Injury Cost
Model projects that there were an
additional estimated 3,255 magnet
ingestion injuries per year treated in
medical settings other than emergency
departments from 2017 through 2020.
(2) The potential injuries when a
child or teen ingests one or more
magnets are serious. Health threats
posed by magnet ingestion include
pressure necrosis, volvulus, bowel
obstruction, bleeding, fistulae, ischemia,
inflammation, perforation, peritonitis,
sepsis, ileus, ulceration, aspiration, and
death, among others. These conditions
can result from magnets attracting to
each other through internal body tissue,
or a single magnet attracting to a
ferromagnetic object. CPSC is aware of
several fatal magnet ingestion incidents
that occurred in the United States,
resulting from internal interaction of the
magnets (small intestine ischemia and
volvulus).
(c) Number of consumer products
subject to the rule. Approximately
500,000 subject magnet products are
estimated to be sold annually in the
United States.
(d) The need of the public for subject
magnet products and the effects of the
rule on their cost, availability, and
utility. (1) Consumers use subject
magnet products for entertainment,
mental stimulation, stress relief, and
jewelry. The proposed rule requires
subject magnet products to meet
performance requirements regarding
size or strength, but does not restrict the
design of products. As such, subject
magnet products that meet the standard
would continue to serve the purpose of
amusement or jewelry for consumers.
Magnets that comply with the proposed
rule, such as non-separable magnets,
larger magnets, weaker magnets, or nonpermanent magnets, would likely still
be useful for amusement or jewelry.
However, it is possible that there may be
some negative effect on the utility of
subject magnet products if compliant
products function differently or do not
include certain desired characteristics.
(2) Retail prices of subject magnet
products generally average under $20.
CPSC has identified subject magnet
products that comply with the proposed
rule, indicating that the cost of
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compliant and non-compliant products
are comparable.
(3) If the costs associated with
redesigning or modifying subject magnet
products to comply with the proposed
rule results in manufacturers
discontinuing products, there may be
some loss in availability to consumers.
However, this would be mitigated to the
extent that compliant products meet the
same consumer needs.
(e) Other means to achieve the
objective of the rule while minimizing
adverse effects on competition,
manufacturing, and commercial
practices. (1) The Commission
considered several alternatives to
achieve the objective of reducing
unreasonable risks of injury and death
associated with magnet ingestions. One
alternative is to take no regulatory
action and, instead rely on existing
voluntary standards to address the
magnet ingestion hazard. This would
eliminate costs associated with the rule
by avoiding a mandatory standard;
however, this alternative is unlikely to
adequately reduce the risk of injury and
death associated with magnet
ingestions. For one, none of the existing
standards address all of the products
most commonly identified in magnet
ingestion incidents, and several of the
standards provide exceptions to
performance requirements for certain
subject magnet products. In addition,
under the existing standards, certain
subject magnet products would not be
subject to performance requirements
regarding size and strength, instead
relying on alternative requirements,
such as safety messaging, which is
unlikely to adequately reduce the
magnet ingestion hazard.
(2) Another alternative is a mandatory
standard with less stringent
requirements than the proposed rule,
such as a higher flux index limit, or
different requirements for certain shapes
and sizes of magnets. This could reduce
the costs associated with a rule by
allowing firms to market a wider variety
of products than under the proposed
rule. However, for this alternative to
reduce costs, it would allow more
products to remain on the market,
thereby decreasing the safety benefits.
(3) Safety messaging requirements are
another alternative to the proposed rule.
This would reduce the costs associated
with the rule because it would not
require modifying or discontinuing
subject magnet products, and the costs
of warnings and instructional
information likely would be small.
However, this alternative is not likely to
adequately reduce the risk of injury and
death associated with magnet ingestion
because the effectiveness of safety
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messaging depends on consumer seeing
the messaging and convincing them to
avoid the hazard. Incident data indicate
that children commonly access ingested
magnets from sources that are unlikely
to include the product packaging
bearing instructions or warnings.
Moreover, consumers are unlikely to
consistently heed warnings because of
the perception that subject magnet
products are appropriate for children,
and underappreciation of the magnet
ingestion hazard. Safety messaging is
generally considered the least effective
way to address product hazards, and has
been ineffective at addressing the
magnet ingestion hazard, to date.
(4) Another alternative is to require
special packaging to limit children’s
access to subject magnet products. Such
packaging could help consumers
determine if all magnets have been
returned to the container and include
child-resistant features. Although this
alternative would create some packaging
costs, those likely would be lower than
the costs associated with the proposed
rule because it would allow subject
magnet products to remain unchanged.
However, this alternative is not likely to
adequately reduce the risk of injury and
death associated with magnet
ingestions. For packaging requirements
to be effective, users would have to
repackage all magnets after each use,
which is unlikely given the small size
and large number of magnets often in a
product, the potential to lose magnets,
and consumers’ demonstrated
underappreciation of the hazard. In
addition, packaging requirements are
unlikely to be effective because they
generally only restrict young children
(under 5 years old) from accessing
package contents, and would not
prevent older children or teens from
accessing the package contents,
although the majority of magnet
ingestion incidents involved children 5
years and older.
(5) Another alternative is to require
subject magnet products to be coated
with aversive agents. This alternative
would reduce the costs associated with
the rule because it would allow firms to
continue to sell subject magnet products
and the costs of such coatings likely
would be small. However, such
requirements are not likely to
adequately reduce the risk of injury and
death associated with magnet ingestions
because they do not address ingestions
that occur when the first magnet is
placed in the victim’s mouth, before the
aversive agent is detected, accidental
ingestions, or children who are
developmentally inclined to place
objects, including unpalatable
substances, in their mouths.
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(6) Another alternative is to provide a
longer effective date for the final rule.
This may reduce the costs associated
with the rule by spreading them over a
longer period, but it would also delay
the safety benefits of the rule.
(f) Unreasonable risk. (1) Incident
data indicate that there were an
estimated 23,700 magnet ingestions
treated in U.S. hospital emergency
departments from January 1, 2010 to
December 31, 2020. Although this
includes ingestions of all magnet types,
and is not limited to subject magnet
products, it provides an indication of
the frequency with which children and
teens ingest magnets, and the need to
address the magnet ingestion hazard. Of
these estimated 23,700 emergency
department treated magnet ingestions,
an estimated 4,400 involved products
categorized as being for amusement or
jewelry, which are the products subject
to this rule, and an additional estimated
18,100 involved unidentified magnet
product types. The Commission
considers a large portion of the
incidents involving unidentified magnet
products to have been subject magnet
products, based on the factors described
above with respect to the finding
regarding the degree and nature of the
risk of injury. In addition, the Injury
Cost Model projects that there were an
additional estimated 3,255 magnet
ingestion injuries per year treated in
medical settings other than emergency
departments from 2017 through 2020.
Trend analysis indicates that magnet
ingestions have significantly increased
in recent years.
(2) The potential injuries when a
person ingests one or more magnets are
serious. Health threats posed by magnet
ingestion include pressure necrosis,
volvulus, bowel obstruction, bleeding,
fistulae, ischemia, inflammation,
perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among
others. These conditions can result from
magnets attracting to each other through
internal body tissue, or a single magnet
attracting to a ferromagnetic object.
Magnet ingestion incidents commonly
result in hospitalization, particularly
when subject magnet products are
ingested. The Commission is aware of
five fatal magnet ingestion incidents
that occurred in the United States
between November 24, 2005 and
January 5, 2021. Four of these incidents
involved children 2 years old or
younger, and all five victims died from
injuries resulting from internal
interaction of the magnets. Four of the
five incidents identified the products as
magnet sets, amusement products, or
described them as having characteristics
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1315
that are consistent with subject magnet
products.
(3) For these reasons, the Commission
preliminarily concludes that the rule is
reasonably necessary to eliminate or
reduce an unreasonable risk of injury
associated with the product.
(g) Public interest. This rule is
intended to address an unreasonable
risk of injury and death posed by
magnet ingestions. The Commission
believes that compliance with the
requirements of the rule will
significantly reduce magnet ingestion
deaths and injuries in the future; thus,
the rule is in the public interest. For
these reasons, the Commission
preliminarily concludes that issuing the
rule is in the public interest.
(h) Voluntary standards. (1) The
Commission is aware of six voluntary
and international standards that address
the magnet ingestion hazard: ASTM
F963–17, Standard Consumer Safety
Specification for Toy Safety; ASTM
F2923–20, Standard Specification for
Consumer Product Safety for Children’s
Jewelry; ASTM F2999–19, Standard
Consumer Safety Specification for Adult
Jewelry; ASTM F3458–21, Standard
Specification for Marketing, Packaging,
and Labeling Adult Magnet Sets
Containing Small, Loose, Powerful
Magnets (with a Flux Index ≥50 kG2
mm2); EN–71–1: 2014, Safety of Toys;
Part 1: Mechanical and Physical
Properties; and ISO 8124–1: 2018,
Safety of Toys—Part 1: Safety Aspects
Related to Mechanical and Physical
Properties. The Commission does not
consider the standards likely to result in
an adequate reduction of the risk of
injury associated with magnet
ingestions because of the scope of
products each standard covers, and the
types of requirements included in them.
(2) None of these standards apply to
all of the products most commonly
identified in magnet ingestion
incidents—magnet sets intended for
users 14 years and older, magnet toys
intended for users 14 years and older,
and jewelry. Even for the products the
standards do address, several standards
provide exceptions for certain
amusement and jewelry products,
imposing only warning requirements for
those products.
(3) In addition, several of the
standards do not impose performance
requirements on magnet themselves,
such as size and strength requirements,
instead recommending or requiring
safety messaging or packaging. CPSC
does not consider safety messaging or
packaging requirements sufficient,
without additional performance
requirements, to adequately reduce the
risk of injury and death associated with
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magnet ingestions. Incident data
indicate that children commonly access
ingested magnets from sources that do
not include packaging or safety
messaging; children and caregivers have
commonly disregarded safety messaging
to date; safety packaging only limits
young children (typically, children
under 5 years old) from accessing its
contents, which does not address
magnet ingestions by older children and
teens, which make up the majority of
incidents; and safety packaging requires
users to repackage all magnets after
every use to be effective, which is
unlikely given the large number and
small size of magnets often in subject
magnet products.
(4) For these reasons, the Commission
preliminarily concludes that
compliance with existing standards is
not likely to result in the elimination or
adequate reduction of the risk of injury
associated with magnet ingestion.
(i) Relationship of benefits to costs. (1)
CPSC estimates the aggregate benefits of
the rule to be $80 million to $95 million
annually and estimates the cost of the
rule to be between $10 million to $17.5
million annually, assuming sales of
500,000 units annually (estimated costs
range from $5 million to $35 million
annually, depending on annual sales
between 250,000 and 1 million units).
(2) On a per unit basis, CPSC
estimates the expected benefits per unit
to range from $160 (assuming a 1.5-year
product life and a 3 percent discount
rate) to $190 (assuming a 3-year product
life and a 3 percent discount rate). The
estimated expected cost to
manufacturers per unit is between about
$5 and $10, and there is an
unquantifiable cost to consumers
associated with lost utility and
availability.
(3) Based on this analysis, the
Commission preliminarily finds that the
benefits expected from the rule bear a
reasonable relationship to its
anticipated costs.
(j) Least burdensome requirement that
would adequately reduce the risk of
injury. (1) CPSC considered several lessburdensome alternatives to the
proposed rule. One alternative is to take
no regulatory action and, instead, rely
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on existing standards to address the
magnet ingestion hazard. This would
reduce the burden associated with the
rule by avoiding a mandatory standard,
however, this alternative is unlikely to
adequately address the magnet ingestion
hazard because none of the existing
standards apply performance
requirements to all of the products most
commonly involved in magnet
ingestions incidents.
(2) Another alternative is a mandatory
standard with less stringent
requirements than the proposed rule,
such as a higher flux index limit, or
different requirements for certain shapes
and sizes of magnets. This could reduce
the burden associated with a rule by
allowing firms to market a wider variety
of products than under the proposed
rule. However, this alternative would
reduce the safety benefits because
allowing certain hazardous magnets in
subject magnet products to remain on
the market does not address the hazard
such products pose.
(3) Safety messaging is another
alternative to the proposed rule. This
alternative would reduce the burdens
associated with the rule because it
would not require modifying or
discontinuing subject magnet products,
and the costs of such warnings and
instructional information likely would
be small. However, this alternative is
not likely to adequately reduce the
magnet ingestion hazard. Safety
messaging is generally the least effective
way to reduce hazards associated with
consumer products; incident data shows
children commonly access ingested
magnets from sources that do not
include product packaging, where
warnings are provided; incident data,
behavioral and developmental factors,
and other information indicate that
children and caregivers commonly
disregard safety messaging regarding the
magnet ingestion hazard; and this
approach has not been effective at
adequately reducing the hazard, to date.
(4) Another alternative is to require
special packaging to limit children’s
access to subject magnet products. Such
packaging could help consumers
determine if all magnets have been
returned to the container and include
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Sfmt 9990
child-resistant features. Although this
alternative would create some packaging
costs, those costs likely would be lower
than the proposed rule because it would
allow subject magnet products to remain
unchanged. However, this alternative is
not likely to adequately reduce the risk
of injury and death associated with
magnet ingestions. Consumers are
unlikely to repackage all magnets after
each use, given the small size and large
number of magnets in products, the
potential to lose magnets, and
consumers’ demonstrated
underappreciation of the hazard. In
addition, packaging requirements would
only prevent young children (typically,
children under 5 years old) from
accessing the product, not older
children or teens, who are involved in
the majority of magnet ingestion
incidents.
(5) Another alternative is to require
subject magnet products to be coated
with aversive agents. This alternative
would reduce the burden associated
with the rule because it would allow
firms to continue to sell subject magnet
products and the costs of such coatings
likely would be small. However, such
requirements are not likely to
adequately address the hazard because
they do not address ingestions that
occur when the first magnet is placed in
the victim’s mouth, before the aversive
agent is detected, accidental ingestions,
or children who are developmentally
inclined to place objects in their
mouths.
(6) Another alternative is to provide a
longer effective date for the final rule.
This may reduce the burdens associated
with the rule by spreading them over a
longer period, but it would also delay
the safety benefits of the rule.
(7) For these reasons, the Commission
preliminarily finds that the rule imposes
the least burdensome requirement that
prevents or adequately reduces the risk
of injury associated with magnet
ingestions.
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2021–27826 Filed 1–7–22; 8:45 am]
BILLING CODE 6355–01–P
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[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Proposed Rules]
[Pages 1260-1316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27826]
[[Page 1259]]
Vol. 87
Monday,
No. 6
January 10, 2022
Part II
Consumer Product Safety Commission
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16 CFR Parts 1112 and 1262
Safety Standard for Magnets; Proposed Rule
Federal Register / Vol. 87 , No. 6 / Monday, January 10, 2022 /
Proposed Rules
[[Page 1260]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1262
[Docket No. CPSC-2021-0037]
Safety Standard for Magnets
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The U.S. Consumer Product Safety Commission (Commission or
CPSC) has determined preliminarily that there is an unreasonable risk
of injury and death, particularly to children and teens, associated
with ingestion of one or more high-powered magnets. To address this
risk, the Commission proposes a rule, under the Consumer Product Safety
Act, to apply to consumer products that are designed, marketed, or
intended to be used for entertainment, jewelry (including children's
jewelry), mental stimulation, stress relief, or a combination of these
purposes, and that contain one or more loose or separable magnets. Toys
that are subject to CPSC's mandatory toy standard are exempt from the
proposed rule. Each loose or separable magnet in a product that is
subject to the proposed rule and that fits entirely within CPSC's small
parts cylinder would be required to have a flux index of less than 50
kG\2\ mm\2\. The Commission requests comments about all aspects of this
notice, including the risk of injury, the proposed scope and
requirements, alternatives to the proposed rule, and the economic
impacts of the proposed rule and alternatives.
DATES: Submit comments by March 28, 2022.
ADDRESSES: Submit written comments, identified by Docket No. CPSC-2021-
0037, using the methods described below. CPSC encourages you to submit
comments electronically, rather than in hard copy.
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. CPSC does not accept comments
submitted by electronic mail (email), except through https://www.regulations.gov, and as described below. CPSC encourages you to
submit electronic comments by using the Federal eRulemaking Portal, as
described above.
Mail/Hand Delivery/Courier Written Submissions: Submit comments by
mail/hand delivery/courier to: Division of the Secretariat, Consumer
Product Safety Commission 4330 East-West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479. Alternatively, as a temporary option during
the COVID-19 pandemic, you can email such submissions to: [email protected].
Instructions: All submissions must include the agency name and
docket number for this notice. CPSC may post all comments without
change, including any personal identifiers, contact information, or
other personal information provided, to: https://www.regulations.gov.
Do not submit electronically: Confidential business information, trade
secret information, or other sensitive or protected information that
you do not want to be available to the public. If you wish to submit
such information, please submit it according to the instructions for
mail/hand delivery/courier written submissions.
Docket: To read background documents or comments regarding this
proposed rulemaking, go to: https://www.regulations.gov, insert docket
number CPSC-2021-0037 in the ``Search'' box, and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Michelle Guice, Compliance Officer,
U.S. Consumer Product Safety Commission, 4330 East-West Highway,
Bethesda, MD 20814; telephone (301) 504-7723; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Overview of the Proposed Rule
The Commission issues this notice of proposed rulemaking (NPR)
under sections 7 and 9 of the Consumer Product Safety Act (CPSA; 15
U.S.C. 2051-2089).\1\ Through this rulemaking, the Commission seeks to
create a safety standard to address the unreasonable risk of injury and
death associated with ingestion of loose or separable high-powered
magnets. Incident data indicate that certain consumer products
containing such magnets are ingested by children and teens. When
ingested, these powerful magnets can interact internally with one
another, or a ferromagnetic object (i.e., material attracted to
magnets), through body tissue, leading to acute and long-term adverse
health consequences or death.
---------------------------------------------------------------------------
\1\ The Commission voted 4-0 to approve this notice and commence
rulemaking.
---------------------------------------------------------------------------
The proposed rule applies to consumer products that are designed,
marketed, or intended to be used for entertainment, jewelry (including
children's jewelry), mental stimulation, stress relief, or a
combination of these purposes, and that contain one or more loose or
separable magnets. Toys that are subject to CPSC's mandatory toy
standard in 16 CFR part 1250 are exempt from the proposed rule, because
that standard already includes requirements to address the magnet
ingestion hazard in children's toys (i.e., products designed,
manufactured, or marketed as playthings for children under 14 years
old). In this notice, products that are subject to the proposed rule
are referred to as ``subject magnet products.''
The proposed rule seeks to address the risk of injury or death
associated with magnet ingestions, by requiring loose or separable
magnets in subject magnet products to be either too large to swallow,
or weak enough to reduce the risk of internal interaction injuries when
swallowed. Under the proposed rule, each loose or separable magnet in a
subject magnet product that fits entirely within CPSC's small parts
cylinder must have a flux index of less than 50 kG\2\ mm\2\. CPSC's
small parts cylinder is described and illustrated in 16 CFR 1501.4,
which is intended to prevent children from ingesting of small objects.
The proposed rule specifies the method for determining the flux index
of a magnet, and this preamble discusses the basis for the flux index
limit in the proposed rule. The term ``hazardous magnet'' refers to a
magnet that fits entirely within the small parts cylinder and that has
a flux index of 50 kG\2\ mm\2\ or more.
The information discussed in this preamble is derived from CPSC
staff's briefing package for the NPR, which is available on CPSC's
website at: https://www.cpsc.gov/s3fs-public/Proposed-Rule-Safety-Standard-for-Magnets.pdf?VersionId=2Xizl5izY1OvQRVazWpkqdJHXg5vzRY.
This preamble provides key information to explain and support the rule;
however, for a more comprehensive and detailed discussion, see the NPR
briefing package.
B. History of CPSC Work on the Magnet Ingestion Hazard
CPSC has taken several actions to address the magnet ingestion
hazard, including issuing mandatory standards, working with voluntary
standards organizations, initiating recalls and compliance actions,
engaging in staff assessments of the hazard and potential ways to
address it, and creating information campaigns.
1. Mandatory Standards
On August 14, 2008, Congress enacted section 106 of the Consumer
Product Safety Improvement Act (CPSIA; Pub. L. 110-314, 122 Stat. 3016
(Aug. 14, 2008)), codified at 15 U.S.C. 2056b.
[[Page 1261]]
Section 106 of the CPSIA provides that, beginning 180 days after its
enactment, ASTM F963-07, Consumer Safety Specification for Toy Safety,
is considered a consumer product safety standard issued by the
Commission under section 9 of the CPSA.\2\ 15 U.S.C. 2056b(a). Section
106 further provides for updates to the mandatory standard when ASTM
F963 is revised or to improve safety. Id. 2056b(b)(2), (c), (d), (g).
Section 106 specifically refers to ``internal harm or injury hazards
caused by the ingestion or inhalation of magnets in children's
products,'' among other hazards, in its directive to review and assess
ASTM F963. Id. 2056b(b)(1)(A).
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\2\ Section 106 excluded from this mandate the following
provisions in ASTM F963-07: Section 4.2 and Annex 4 (which address
flammability), and ``any provision that restates or incorporates an
existing mandatory standard or ban promulgated by the Commission or
by statute or any provision that restates or incorporates a
regulation promulgated by the Food and Drug Administration or any
statute administrated by the Food and Drug Administration.''
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Consistent with the mandate in section 106 of the CPSIA, the
Commission adopted 16 CFR part 1250, Safety Standard Mandating ASTM
F963 for Toys (toy standard), which currently incorporates by reference
ASTM F963-17, the most recent revision to the standard.\3\ 82 FR 57119
(Dec. 4, 2017). ASTM F963-17 applies to ``toys,'' which are objects
``designed, manufactured, or marketed as a plaything for children under
14 years of age.'' The standard includes requirements to address the
hazard associated with ingestion of loose, as-received magnets that are
small enough to fit in the small parts cylinder and have a flux index
of 50 kG\2\ mm\2\ or more. Section V. Relevant Existing Standards,
below, further describes the requirements in ASTM F963-17.
---------------------------------------------------------------------------
\3\ Part 1250 excepts from the mandatory standard, section 4.2
and Annex 5 (which address flammability) of ASTM F963-17, as well as
``any provision of ASTM F963 that restates or incorporates an
existing mandatory standard or ban promulgated by the Commission or
by statute or any provision that restates or incorporates a
regulation promulgated by the Food and Drug Administration or any
statute administrated by the Food and Drug Administration.'' 16 CFR
1250.2(b). In addition, part 1250 replaces section 8.20.1.5(5) of
ASTM F963 regarding floor and tabletop toys that move, where a sound
is caused as a result of the movement imparted on the toy. Id.
1250.2(c).
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In 2012, the Commission initiated rulemaking to address the magnet
ingestion hazard for products that do not fall under 16 CFR part 1250.
The rule focused on magnet sets, which were involved in internal
interaction injuries in children and teens, when ingested. 77 FR 53781
(Sep. 4, 2012) (notice of proposed rulemaking); 79 FR 59962 (Oct. 3,
2014) (final rule). The rule defined ``magnet sets'' as ``any
aggregation of separable magnetic objects that is a consumer product
intended, marketed or commonly used as a manipulative or construction
item for entertainment, such as puzzle working, sculpture building,
mental stimulation, or stress relief.'' The rule required each magnet
in a magnet set, and each individual magnetic object intended or
marketed for use with or as a magnet set, that fit completely within
CPSC's small parts cylinder, to have a flux index of 50 kG\2\ mm\2\ or
less. The final rule was published in October 2014, and it took effect
on April 1, 2015. On November 22, 2016, the U.S. Court of Appeals for
the Tenth Circuit overturned the rule on magnet sets, vacating and
remanding the rule to the Commission. Zen Magnets, LLC v. Consumer
Prod. Safety Comm'n., 841 F.3d 1141 (10th Cir. 2016).\4\
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\4\ The court decision had legal effect immediately upon its
filing on November 22, 2016. However, in accordance with the court's
decision, the Commission removed the mandatory standard for magnets
sets (16 CFR part 1240) from the Code of Federal Regulations on
March 7, 2017. 82 FR 12716 (Mar. 7, 2017).
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2. Voluntary Standards Work
CPSC staff has actively participated in the development and
revision of voluntary standards intended to address the magnet
ingestion hazard. Since the development of ASTM F963 in 2007, CPSC
staff has worked with ASTM to address hazardous magnets in children's
toys, including working on multiple revisions to that standard. In
addition, staff has participated actively in the ASTM Subcommittee
F15.77 on Magnets, which published a voluntary standard on magnet sets
in March 2021--ASTM F3458-21, Standard Specification for Marketing,
Packaging, and Labeling Adult Magnet Sets Containing Small, Loose,
Powerful Magnets (with a Flux Index =50 kG\2\ mm\2\).
3. Recalls and Compliance Actions 5
---------------------------------------------------------------------------
\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.
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\6\ The Commission published a Federal Register notice on
October 6, 2017, seeking comments on the petition. 82 FR 46740.
\7\ The informational briefing package, ``Staff Briefing Package
In Response to Petition CP 17-1, Requesting Rulemaking Regarding
Magnet Sets,'' is available at: https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf.
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5. Information Campaigns
In addition to raising awareness of the magnet ingestion hazard
through publicized recalls, CPSC has drawn attention to the hazard
through safety alerts and public safety bulletins. CPSC maintains a
``Magnets Information Center'' website,\8\ which provides an
informational video, a description of the hazard, steps to take when
magnets are swallowed, and links to recalls, relevant CPSC materials,
applicable regulations, and informational posters. CPSC also issued a
safety alert about the magnet ingestion hazard, which describes the
hazard and steps to take when magnets are swallowed. In addition to
CPSC's information campaigns, health
[[Page 1262]]
organizations and other consumer advocacy groups have made numerous
public outreach efforts to warn consumers about the magnet ingestion
hazard.\9\
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\8\ Available at: https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Magnets.
\9\ Examples include the American Academy of Pediatrics (https://services.aap.org/en/search/?k=magnets); the North American Society
for Pediatric Gastroenterology, Hepatology and Nutrition (https://www.naspghan.org/content/72/en/Foreign-Body-Ingestion); Consumer
Reports (https://www.consumerreports.org/product-safety/magnets-marketed-as-toys-could-be-dangerous-to-kids/); Consumer Federation
of America (https://consumerfed.org/testimonial/cfa-comments-cpscs-notice-proposed-rulemaking-safety-standard-magnet-sets/); and Kids
In Danger (https://kidsindanger.org/2011/11/cpsc-warns-about-high-powered-magnets/).
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C. How Other Countries Have Addressed the Magnet Ingestion Hazard
Like CPSC, other countries have recognized the internal interaction
hazard associated with magnet ingestions. Several of these countries
have issued mandatory requirements to address the hazard. To understand
how other countries have addressed magnet ingestions, staff reviewed
the mandatory requirements for Canada, Australia, New Zealand, and the
European Commission.
Canada's Requirements Regarding Magnet Ingestion. Since 2006,
Health Canada has issued several advisories to warn Canadians of the
dangers associated with ingesting magnets.\10\ In addition, some
manufacturers took steps to keep these products from children (e.g.,
through package warnings, instructions on safe use, and guidance to
retailers on safe sales practices). Despite these efforts, children
continued to access and use magnets, and ingestion incidents continued.
Consequently, Canada adopted mandatory standards for toys and non-toys,
to address the magnet ingestion hazard.
---------------------------------------------------------------------------
\10\ For example, see: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/31619a-eng.php; https://www.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/letters-notices-information-industry/information-manufacturers-importers-distributors-retailers-products-containing-small-powerful-magnets.html.
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Canada's regulation for toys, SOR/2018-138, includes requirements
for magnetic toys intended for children under 14 years old.\11\ The
standard requires each magnet toy, and each magnetic component in a
toy, that can fit entirely within a small parts cylinder, to have a
flux index below a specified limit, which is equivalent to 50 kG\2\
mm\2\. The standard includes toys with only one magnet, to account for
attraction to ferromagnetic objects. The requirements are consistent
with ASTM F963.
---------------------------------------------------------------------------
\11\ See https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/page-3.html#h-1109670.
---------------------------------------------------------------------------
Canada has also specified \12\ that its general requirements, under
the Canada Consumer Product Safety Act (CCPSA), prohibit the
manufacture, import, advertising, and sale of products that contain
small, powerful magnets, regardless of the intended user age. The
general provision in the CCPSA prohibits the manufacture, import,
advertisement, and sale of any consumer product that ``is a danger to
human health or safety.'' Sections 7(a), 8(a).\13\ Canada specifically
highlighted products intended for entertainment that consist of
numerous small, powerful magnets.
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\12\ See https://www.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/letters-notices-information-industry/information-manufacturers-importers-distributors-retailers-products-containing-small-powerful-magnets.html.
\13\ See https://laws-lois.justice.gc.ca/eng/acts/c-1.68/page-1.html.
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Australia's Requirements Regarding Magnet Ingestion. Australia has
also issued mandatory requirements for both children's toys, and non-
children's products, to address the magnet ingestion hazard. For toys
intended for children up to, and including, 36 months, Australia
requires compliance with Australia New Zealand Standard AS/NZS ISO
8124.1, which aligns with the magnet requirements in ASTM F963.\14\
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\14\ See https://www.legislation.gov.au/Details/F2008C00607.
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In addition, in November 2012, Australia adopted a permanent ban of
consumer goods containing 2 or more separable or loose magnetic
objects, where at least 2 of the magnetic objects each separately fit
entirely within a small parts cylinder (specified in AS/NZS ISO 8124.1)
and each have a flux index greater than 50 kG\2\ mm\2\ (using methods
described in AS/NZS ISO 8124.1). The ban applies to magnetic objects
marketed or supplied for use as a toy, game, puzzle, construction or
modelling kit, or jewelry to be worn in or around the mouth or nose.
This includes adult desk toys, educational toys or games, and toys,
games, and puzzles for mental stimulation or stress relief.\15\
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\15\ See https://www.legislation.gov.au/Details/F2012L02171;
https://www.productsafety.gov.au/bans/small-high-powered-magnets.
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New Zealand's Requirements Regarding Magnet Ingestion. As indicated
above, New Zealand also uses AS/NZS ISO 8124.1, which aligns with the
magnet requirements in ASTM F963, to address the magnet ingestion
hazard in children's toys.\16\
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\16\ See https://www.standards.govt.nz/shop/asnzs-iso-8124-12019/.
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In addition, in January 2013, New Zealand issued a temporary ban
\17\ on the sale of certain high-powered magnets, which it extended
indefinitely in July 2014.\18\ The ban applies to magnetic objects for
personal, domestic, or household use that are supplied, offered, or
advertised as a toy, game, puzzle, novelty, construction or modelling
kit, or jewelry that may be warn in or around the mouth or nose. This
includes adult desk toys, educational toys and games, and toys, games,
and puzzles for mental stimulation or stress relief. The ban does not
apply to hardware magnets, magnets used for teaching purposes by
schools and universities, or magnets intended to become part of another
product. The ban applies to the specified products if they contain 2 or
more separable or loose magnetic objects, at least 2 of the magnetic
objects each separately fit entirely within a small parts cylinder
(specified in AS/NZS ISO 8124.1), and at least 2 of those magnets have
a flux index greater than 50 kG\2\ mm\2\ (using methods described in
AS/NZS ISO 8124.1).
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\17\ See https://www.beehive.govt.nz/release/ban-sale-high-
powered-magnet-
sets#:~:text=Consumer%20Affairs%20Minister%20Simon%20Bridges,stores%2
0and%20over%20the%20internet.
\18\ Unsafe Goods (Small High Powered Magnets) Indefinite
Prohibition Notice 2014, available at: https://gazette.govt.nz/notice/id/2014-go4501; see also, https://productsafety.tradingstandards.govt.nz/for-business/regulated-products/small-high-powered-magnets-unsafe-goods-notice/; https://productsafety.tradingstandards.govt.nz/for-consumers/safety-with-specific-products/high-powered-magnets/.
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The European Commission's Requirements Regarding Magnet Ingestion.
The European Commission requires children's toys to comply with EN 71-
1, Safety of Toys, discussed further in section V. Relevant Existing
Standards, below. The requirements in EN 71-1 relating to magnet
ingestion are essentially the same as the requirements in ASTM F963-17.
There is no safety standard regarding magnet ingestions for products
other than children's toys. However, member states generally apply EN
71-1 when assessing the risk posed by products that are not marketed as
children's toys, but are intended for children, including magnet sets
intended for adults because they are often bought for and used by
children.
II. Statutory Authority
Subject magnet products are ``consumer products'' that the
Commission has authority to regulate
[[Page 1263]]
under the CPSA. See 15 U.S.C. 2052(a)(5). Section 7 of the CPSA
authorizes the Commission to issue a mandatory consumer product safety
standard that consists of performance requirements or requirements that
the product be marked with, or accompanied by, warnings or
instructions. Id. 2056(a). Any requirement in the standard must be
``reasonably necessary to prevent or reduce an unreasonable risk of
injury'' associated with the product. Id. Section 7 requires the
Commission to issue such a standard in accordance with section 9 of the
CPSA. Id.
Section 9 of the CPSA specifies the procedure the Commission must
follow to issue a consumer product safety standard under section 7. Id.
2058. Under section 9, the Commission may initiate rulemaking by
issuing an advance notice of proposed rulemaking (ANPR) or NPR. Id.
2058(a). When issuing an NPR, the Commission must comply with section
553 of Administrative Procedure Act (5 U.S.C. 551-559), which requires
the Commission to provide notice of a rule and the opportunity to
submit written comments on it. 5 U.S.C. 553; 15 U.S.C. 2058(d)(2). In
addition, the Commission must provide interested parties with an
opportunity to make oral presentations of data, views, or arguments.
Id. 2058(d)(2).
Under section 9 of the CPSA, an NPR must include the text of the
proposed rule, any alternatives the Commission proposes, and a
preliminary regulatory analysis. Id. 2058(c). The preliminary
regulatory analysis must include:
A preliminary description of the potential benefits and
costs of the rule, including benefits and costs that cannot be
quantified, and the analysis must identify who is likely to receive the
benefits and bear the costs;
a discussion of the reasons any standard or portion of a
standard submitted to the Commission in response to an ANPR was not
published by the Commission as the proposed rule or part of the
proposed rule;
a discussion of the reasons for the Commission's
preliminary determination that efforts submitted to the Commission in
response to an ANPR to develop or modify a voluntary standard would not
be likely, within a reasonable period of time, to result in a voluntary
standard that would eliminate or adequately reduce the risk of injury
addressed by the proposed rule; and
a description of alternatives to the proposed rule that
the Commission considered and a brief explanation of the reasons the
alternatives were not chosen.
Id.
In addition, to issue a final rule, the Commission must make
certain findings and include them in the rule. Id. 2058(f)(1), (f)(3).
Under section 9(f)(1) of the CPSA, before promulgating a consumer
product safety rule, the Commission must consider, and make appropriate
findings to be included in the rule, concerning the following issues:
The degree and nature of the risk of injury the rule is
designed to eliminate or reduce;
the approximate number of consumer products subject to the
rule;
the need of the public for the products subject to the
rule and the probable effect the rule will have on the cost,
availability, and utility of such products; and
the means to achieve the objective of the rule while
minimizing adverse effects on competition, manufacturing, and
commercial practices.
Id. 2058(f)(1). Under section 9(f)(3) of the CPSA, the Commission may
not issue a consumer product safety rule unless it makes the following
findings and includes them in the rule:
That the rule, including the effective date, is reasonably
necessary to eliminate or reduce an unreasonable risk of injury
associated with the product;
that issuing the rule is in the public interest;
if a voluntary standard addressing the risk of injury has
been adopted and implemented, that either compliance with the voluntary
standard is not likely to result in the elimination or adequate
reduction of the risk of injury, or there is unlikely to be substantial
compliance with the voluntary standard;
that the benefits expected from the rule bear a reasonable
relationship to its costs; and
that the rule imposes the least burdensome requirement
that prevents or adequately reduces the risk of injury.
Id. 2058(f)(3). At the NPR stage, the Commission is making these
findings on a preliminary basis to allow the public to comment on them.
III. The Product and Market
A. Description of the Product
The proposed rule applies to ``subject magnet products,'' which are
consumer products that are designed, marketed, or intended to be used
for entertainment, jewelry (including children's jewelry), mental
stimulation, stress relief, or a combination of these purposes, and
that contain one or more loose or separable magnets (subject magnet
products). Toys that are subject to 16 CFR part 1250, Safety Standard
Mandating ASTM F963 for Toys, are exempt from this proposed rule.
Subject magnet products include a wide variety of consumer
products. Magnets in subject magnet products typically are small,
powerful, magnetic balls, cubes, cylinders, and other shapes that can
be used to create jewelry (such as necklaces, bracelets, and simulated
piercings), and can be aggregated to make sculptures, for use as desk
toys, and as other building sets. One common example of a subject
magnet product is magnet sets intended for users 14 years and older.
Consistent with the Commission's 2014 rule, magnet sets are
aggregations of separable magnetic objects that are marketed or
commonly used as a manipulative or construction items for
entertainment, such as puzzle working, sculpture building, mental
stimulation, or stress relief. Magnet sets often contain hundreds to
thousands of loose, small, high-powered magnets. Another example of a
subject magnet product is jewelry with separable magnets, such as
jewelry-making sets and faux magnetic piercings/studs. Additional
examples include products commonly referred to as ``executive toys,''
``desk toys,'' and ``rock magnets'' (rock-shaped magnets), intended for
amusement of users 14 years and older.
Subject magnet products are available in a variety of shapes (e.g.,
balls, cubes, cylinders), sizes (e.g., 2.5 mm, 3 mm, 5 mm), and number
of magnets (e.g., 1 to thousands). Subject magnet products often
consist of numerous identical magnets, although some products include
non-identical magnets, such as two or more different shapes. Subject
magnet products commonly include magnets between 3 mm and 6 mm in size,
and consist of several hundred magnets. One example of a common subject
magnet product that staff identified is magnet sets containing
approximately 200 magnetic spheres with 5 mm diameters.
Magnets in subject magnet products have a variety of compositions,
such as alloys of neodymium, iron, boron (NIB); ferrite/hematite;
aluminum, nickel, cobalt (AlNiCo); and samarium and cobalt (SmCo). NIB
and SmCo magnets are often referred to as ``rare earth'' magnets
because neodymium and samarium are ``rare earth'' elements found on the
periodic table. Most subject magnet products that staff identified were
made from NIB. NIB is typically used in smaller magnets used for magnet
sets and magnetic jewelry sets, and ferrite/hematite is typically used
in larger magnets, such as rock-shaped magnet toys. The magnetized
cores of subject magnet products are
[[Page 1264]]
coated with a variety of metals and other materials to make them more
attractive to consumers and to protect the brittle magnetic alloy
materials from breaking, chipping, and corroding.
Staff found that 5 mm diameter NIB magnets (the most common size
identified in magnet ingestion incidents) typically have strong
magnetic properties, ranging between 300 and 400 kG\2\ mm\2\, and
ferrite rock magnets measured upwards of 700 kG\2\ mm\2\. Staff also
identified products close to the proposed limit of 50 kG\2\ mm\2\,
ranging from approximately 30 kG\2\ mm\2\ to 70 kG\2\ mm\2\. Some
subject magnet products advertise having flux indexes lower than 50
kG\2\ mm\2\, which is more common for smaller magnets (e.g., 2.5 mm
magnets).
Some subject magnet products are ``children's products.'' The
definition of ``children's products,'' and the requirements applicable
to them, are described in section XII. Testing, Certification, and
Notice of Requirements, below. To summarize, a ``children's product''
is a consumer product that is ``designed or intended primarily for
children 12 years of age or younger.'' 15 U.S.C. 2052(a)(2). Most
subject magnet products are not children's products because the
proposed rule excepts from the standard products that fall under the
mandatory toy standard, which applies to playthings intended for users
under 14 years old. However, some subject magnet products are
children's products because, although they are intended for users 12
years old and younger, they do not fall under the toy standard because
they are not playthings. One example of a subject magnet product that
could be a children's product and not a toy is children's jewelry.
B. The Market
Magnet products intended for the purposes covered in the proposed
rule largely entered the market in 2008, with significant sales
beginning in 2009. Of the various products covered by the proposed
rule, magnet sets have been particularly concerning to CPSC, given
their popularity, uses for amusement and jewelry, their involvement in
ingestion incidents, and the large number of loose, small, high-powered
magnets in the sets. For this reason, CPSC's previous efforts to
address the magnet ingestion hazard largely have focused on magnet
sets. Accordingly, much of the information staff has about the market
for subject magnet products focuses on magnet sets,\19\ which are the
largest category of identified products involved in magnet ingestions.
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\19\ Staff's analysis for the 2014 rule and 2020 informational
briefing package focused on magnet sets.
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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.
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\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.
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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
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\21\ For more details about incident data, see Tab B and Tab C
of the NPR briefing package.
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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.
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\22\ Data from NEISS are based on a nationally representative
probability sample of about 100 hospitals in the United States and
its territories. NEISS data can be accessed from the CPSC website
under the ``Access NEISS'' link at: https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data.
\23\ CPSRMS is the epidemiological database that houses all
anecdotal reports of incidents CPSC receives, ``external cause''-
based death certificates purchased by CPSC, all in-depth
investigations of these anecdotal reports, as well as investigations
of select NEISS injuries. Examples of documents in CPSRMS include:
Hotline reports, internet reports, news reports, medical examiner
reports, death certificates, retailer/manufacturer reports, and
documents sent by state/local authorities, among others.
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1. National Estimates of ED-Treated Injuries
To evaluate magnet ingestion incidents in NEISS, staff started by
identifying magnet ingestion cases in the NEISS database with treatment
dates
[[Page 1265]]
from January 1, 2010 through December 31, 2020. Staff then excluded
from this data set incidents that staff could not determine involved
magnets (e.g., ``acc swallowed dog toy vs magnet''); incidents that did
not involve ingestion, or where it was uncertain whether ingestion
occurred (e.g., ``possible ingestion,'' ``may have ingested''); and
incidents that provided ambiguous information about whether the item
ingested was a magnet (e.g., the report refers to a magnet and
ingestion, but it is not clear that the magnet was the object
ingested). This may have resulted in underestimating the number of
incidents.
From the remaining data set, staff categorized incidents by magnet
type. Based on the products identified in NEISS reports, or the
description of the products, staff organized cases into the following
categories: Magnet sets, magnet toys, jewelry, science kits, home/
kitchen, ASTM F963 magnet toys, and unidentified. The criteria staff
used to categorize incidents into these groups are as follows:
Magnet Sets: Magnets from sets of loose, as-received
magnets that are marketed or commonly used as a manipulative or
construction item for entertainment, such as puzzle working, sculpture
building, mental stimulation, or stress relief. These items met at
least one of the following criteria: Referred to as a magnet set or
identified as a magnet set through product name. This category excludes
building sets with plastic and/or ferromagnetic components, unless
otherwise identified as a magnet set. This category also excludes
products reasonably identified as belonging to another product type
described below (e.g., a magnetic clasp from a necklace).
Magnet Toys: Magnets from products referred to as toys or
games. This category includes products for which the manufacturer-
intended user of the toy was 14 years or older, or was unknown, and it
excludes cases that positively identified toys subject to ASTM F963
(i.e., excludes products confirmed to have been designed, manufactured,
or marketed as playthings for children under 14 years of age).
Jewelry: Magnets described as jewelry (i.e., magnets that
are jewelry, or that were being used as or like jewelry) and not
definitively identified as a magnet set. Most of these cases involve
magnets described as a bracelet, necklace, or piercing jewelry.
Science Kits: Magnets from products identified as a
science kit or magnetic/electrical experimental set.
Home/Kitchen: Magnets from products such as non-toy magnet
decorations, shower curtains, hardware, and kitchen products. Many of
these incidents refer to the magnets as ``kitchen magnets.''
ASTM F963 Magnet Toys: Magnets from toys subject to ASTM
F963 (i.e., products designed, manufactured, or marketed as playthings
for children under 14 years old). Reports for these incidents included
brand names or other information sufficient for staff to identify the
involved products as toys subject to ASTM F963. Most of these cases
involved the magnetic tip of a children's magnetic stylus toy.
Unidentified: Unidentified magnet product type.
As the descriptions above indicate, ``magnet toys'' and ``ASTM F963
magnet toys'' refer to two different types of products. ``Magnet
toys,'' as used throughout this preamble, refers to products described
as toys, but that did not include indications that the product was
marketed for users under 14 years old. In contrast, ``ASTM F963 magnet
toys'' refers to products that staff identified as toys marketed for
children under 14 years old; as such, these products are subject to
ASTM F963, and they do not fall under the scope of the proposed rule.
With respect to the science kit category, staff identified only one
case that involved a product described as a science kit. There was
insufficient information about the product to determine whether it was
a children's toy subject to ASTM F963, an educational product, or a
subject magnet product. Because of this lack of information, and the
possibility that it was a children's toy or educational product, staff
considered this case outside the scope of the proposed rule.
Staff considered the following categories to be subject magnet
products: Magnet sets, magnet toys, and jewelry; these are referred to
collectively as ``amusement/jewelry.'' These categories include
incidents in which the report identified a subject magnet product as
being ingested, or the incident report provided information about the
product, such as characteristics or use patterns, that were sufficient
for staff to reasonably conclude that the product fell in a certain
product type category. Staff considered cases in the following
categories to be outside the scope of the proposed rule: Science kits,
home/kitchen, and ASTM F963 magnet toys; these are referred to
collectively as ``exclusions.'' Incidents in the unidentified category
did not provide sufficient information to identify the magnet product
category, however, they did indicate that a magnet was ingested, and
the product had characteristics and use patterns that could be
consistent with subject magnet products. Section IV.A.5. Uncertainties
in Incident Data, below, explains several reasons why staff concludes
that a substantial portion of unidentified product type incidents
involved subject magnet products.
Table 1 provides the number of cases in each product type category,
and the combined categories reported by NEISS participating hospitals.
Table 1--Count of Magnet Ingestion Cases Treated in NEISS Hospital EDs, by Magnet Category, 2010-2020
----------------------------------------------------------------------------------------------------------------
Original magnet category N (original) Combined magnet category N (combined)
----------------------------------------------------------------------------------------------------------------
Magnet Set.................................... 58 Amusement/Jewelry............... 221
Jewelry....................................... 53 ................................ ..............
Magnet Toy.................................... 110 ................................ ..............
Unidentified.................................. 793 Unidentified.................... 793
Science Kit................................... 1 Exclusions...................... 58
F963 magnet toy............................... 11 ................................ ..............
Home/Kitchen.................................. 46 ................................ ..............
-----------------------------------------------------------------
Total..................................... 1,072 1,072
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC.
[[Page 1266]]
As Table 1 indicates, of the incidents for which staff could
identify a product type category, most incidents involved magnet toys,
followed by magnet sets, and jewelry. For 74 percent of incidents,
staff could not identify the product type category.
Using the information from the sample of NEISS participating
hospitals, staff derived estimates of the number of magnet ingestions
treated in U.S. hospitals nationally from 2010 through 2020. For staff
to generate national estimates using NEISS data, all of the following
reporting criteria must be met: The coefficient of variation (CV)
cannot exceed 0.33, there must be at least 20 sample cases, and there
must be at least 1,200 estimated injuries. Because of the large portion
of NEISS incidents in the unidentified product type category, to meet
these criteria, it was necessary to combine the amusement/jewelry and
unidentified categories to generate national estimates, and it was not
possible to generate national estimates for individual product
categories. Thus, the national estimates provided in the rest of this
section include incidents in both the amusement/jewelry and
unidentified categories of NEISS data. Although the national estimates
include magnet ingestion cases in the unidentified product type
category, there are several reasons why staff concludes that most
magnet ingestion incidents in the unidentified product type category
involved subject magnet products, including incident data about known
product types, trend data, and recall data. Section IV.A.5.
Uncertainties in Incident Data, below, discusses, in detail, the
reasons staff concludes that most unidentified product type incidents
involved subject magnet products.
Table 2 provides the estimated number of ED-treated magnet
ingestions for the combined categories.
Table 2--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Magnet Category, 2010-2020
----------------------------------------------------------------------------------------------------------------
Magnet category Estimate CV N
----------------------------------------------------------------------------------------------------------------
Amusement/Jewelry............................................... 4,400 0.17 221
Unidentified.................................................... 18,100 0.14 793
Exclusions...................................................... 1,300 0.20 58
-----------------------------------------------
Total....................................................... 23,700 0.21 1,072
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC. Estimates rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
Table 3 provides the national estimates of ED-treated magnet
ingestions, by year.
Table 3--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Year
----------------------------------------------------------------------------------------------------------------
Year Estimate CV N
----------------------------------------------------------------------------------------------------------------
2010............................................................ 1,900 0.18 91
2011............................................................ 2,500 0.18 101
2012............................................................ 2,700 0.26 115
2013............................................................ 2,000 0.21 88
2014............................................................ ** ** 62
2015............................................................ 1,200 0.24 61
2016............................................................ 1,400 0.24 77
2017............................................................ 2,900 0.25 112
2018............................................................ 2,400 0.18 120
2019............................................................ 1,800 0.22 91
2020............................................................ 2,200 0.21 96
-----------------------------------------------
Total....................................................... 22,500 0.14 1,014
----------------------------------------------------------------------------------------------------------------
** This estimate does not meet NEISS reporting criteria.
Source: NEISS, CPSC. Estimates rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
There were significantly fewer ED-treated magnet ingestions in 2015
than in any of the following years: 2010, 2011, 2012, 2017, and 2018.
Likewise, there were significantly fewer ED-treated magnet ingestions
in 2016 than in any of the following years: 2011, 2017, and 2018.
Overall, 2014 through 2016 had the lowest number of estimated ED-
treated magnet ingestions. Table 4 compares these middle 3 years (i.e.,
2014-2016) with the earliest 4 years (i.e., 2010-2013), and the most
recent 4 years (i.e., 2017-2020). Because these periods are not of
equivalent duration, staff estimated annual averages to support fair
comparisons.
Table 4--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Period
----------------------------------------------------------------------------------------------------------------
Annual average N (not an Years in
Period estimate CV average) period
----------------------------------------------------------------------------------------------------------------
2010-2013....................................... 2,300 0.16 395 4
2014-2016....................................... 1,300 0.20 200 3
[[Page 1267]]
2017-2020....................................... 2,300 0.15 419 4
----------------------------------------------------------------------------------------------------------------
2010-2020....................................... 2,000 0.14 1,014 11
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
Table 5 provides estimated ED-treated magnet ingestions, by age
group.
Table 5--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Age Group, 2010-2020
----------------------------------------------------------------------------------------------------------------
Age group Estimate CV N
----------------------------------------------------------------------------------------------------------------
Under 2 years................................................... 2,700 0.19 120
2 years......................................................... 2,300 0.27 89
3-4 years....................................................... 4,700 0.16 196
5-7 years....................................................... 4,300 0.14 207
8-10 years...................................................... 3,900 0.19 179
11-13 years..................................................... 3,400 0.17 182
14 or More years................................................ ** ** 41
-----------------------------------------------
Total....................................................... 22,500 0.14 1,014
----------------------------------------------------------------------------------------------------------------
** This estimate does not meet NEISS reporting criteria.
Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
Table 6 provides the estimated number of ED-treated magnet
ingestions, by sex.
Table 6--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Sex, 2010-2020
----------------------------------------------------------------------------------------------------------------
Sex Estimate CV N
----------------------------------------------------------------------------------------------------------------
Female.......................................................... 9,100 0.15 421
Male............................................................ 13,300 0.14 593
-----------------------------------------------
Total....................................................... 22,500 0.14 1,014
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC. Estimates are rounded to the nearest 100.
Table 7 provides the estimated number of ED-treated magnet
ingestions, by sex and age group. Staff used 8 years old to delineate
older and younger children because, as discussed in section V. Relevant
Existing Standards, several voluntary standards provide less stringent
requirements for magnet products intended for users 8 years and older.
Table 7--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Sex and Age Group, 2010-2020
----------------------------------------------------------------------------------------------------------------
Age group
--------------------------------
Sex 8 or more Total
Under 8 years years
----------------------------------------------------------------------------------------------------------------
Female.......................................................... 5,600 3,500 9,100
Male............................................................ 8,400 4,900 13,300
-----------------------------------------------
Total....................................................... 14,000 8,500 22,500
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
[[Page 1268]]
Table 8 provides the estimated number of ED-treated magnet
ingestions, by disposition.
Table 8--Estimated Number of Magnet Ingestions Treated in U.S. Hospital EDs, by Disposition, 2010-2020
----------------------------------------------------------------------------------------------------------------
Disposition Estimate CV N
----------------------------------------------------------------------------------------------------------------
Hospitalized/Transferred........................................ 4,200 0.19 264
Treated and Released............................................ 18,000 0.14 735
Other *......................................................... ** ** 15
-----------------------------------------------
Total....................................................... 22,500 0.14 1,014
----------------------------------------------------------------------------------------------------------------
* Dispositions in the ``other'' category include cases in which the victim was ``held for observation (includes
admitted for observation)'' and ``left without being seen/left against medical advice.''
** This estimate does not meet reporting criteria.
Source: NEISS, CPSC. Estimates are rounded to the nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
As Table 8 indicates, approximately 80 percent of estimated ED-
treated magnet ingestions are treated and released, and approximately
19 percent are hospitalized or treated and transferred to another
hospital. Some portion of cases that report the victim being treated
and released may have resulted in later hospitalization because magnet
ingestion patients are often sent home initially to monitor for natural
passage, and the NEISS data typically capture only one part of the
treatment process--the ED visit--and do not typically provide
information about treatment after the initial ED visit.
2. Reported Incidents
CPSC staff also reviewed CPSRMS data for magnet ingestion
incidents. CPSRMS reports commonly contain more information about the
incident, product, and victims than NEISS reports because CPSRMS
reports may provide photos and websites with detailed narratives and
medical documents, whereas, NEISS reports contain only brief narratives
from the ED visit. However, CPSRMS data do not provide a complete count
of all incidents that occurred during a period, and unlike NEISS data,
CPSRMS cannot be used for statistical estimates or to draw conclusions
about trends. Rather, CPSRMS data provide a minimum number of incidents
that occurred during a period and provide details about incidents.
CPSC staff identified 284 magnet ingestion incidents in CPSRMS that
were reported to have occurred between January 1, 2010 and December 31,
2020. Data collection is ongoing for CPSRMS, and is considered
incomplete for 2019 and after, so CPSC may receive additional reports
for those years in the future. Staff categorized these cases similarly
to the NEISS incidents, however, there are some minor differences in
the criteria because CPSRMS reports typically contained more product-
specific information than NEISS reports. Based on the products
identified in the CPSRMS reports or the descriptions of the products,
staff organized cases into the following categories: Magnet sets,
magnet toys, jewelry, science kits, home/kitchen, ASTM F963 magnet
toys, and unidentified. The criteria staff used to categorize incidents
into these groups are as follows:
Magnet Sets: Magnets from sets of loose, as-received
magnets that are marketed or commonly used as a manipulative or
construction item for entertainment, such as puzzle working, sculpture
building, mental stimulation, or stress relief. These items met at
least one of the following criteria:
[cir] Referred to as a magnet set;
[cir] identified as a magnet set through product name;
[cir] included photos identifying the product; or
[cir] other available information provided reasonable certainty
that the product was a magnet set (e.g., products described identically
to known magnet sets, such as desk toys consisting of 216 loose,
magnetic balls).
Brand was indicated for most of these incidents. Incidents were
excluded from this grouping if a medical professional identified the
product as a magnet set, but the investigator and victim indicated that
they were unable to identify the product as a magnet set.
Magnet Toys: Magnets from products referred to as toys or
games. This category includes products for which the manufacturer-
intended user of the toy was 14 years or older, or was unknown, and
excludes cases that positively identified toys subject to ASTM F963
(i.e., excludes products confirmed to have been designed, manufactured,
or marketed as playthings for children under 14 years of age).
Jewelry: Magnets described as jewelry and not definitively
identified as a magnet set. Most of these cases involve magnets
described as a bracelet, necklace, or piercing jewelry.
Science Kits: Magnets from products identified as a
science kit or magnetic/electrical experimental set. (No reported
incidents fit in this category.)
Home/Kitchen: Magnets from products such as non-toy magnet
decorations, shower curtains, hardware, and kitchen products.
ASTM F963 Magnet Toys: Magnets from toys subject to ASTM
F963 (i.e., products designed, manufactured, or marketed as playthings
for children under 14 years old). Reports for these incidents included
brand names or other information sufficient for staff to identify the
products involved as toys subject to ASTM F963. Most of these cases
involved magnetic building sets with magnets encased in plastic.
Unidentified: Unidentified magnet product type.
Like NEISS product type categories, ``magnet toys'' and ``ASTM F963
magnet toys'' refer to two different types of products. Staff
categorized as ``magnet toys'' products described as toys, which did
not have evidence of having been marketed for users under 14 years old.
In contrast, ``ASTM F963 magnet toys'' are toys staff identified as
marketed for children under 14 years old, making them subject to ASTM
F963, and outside the scope of the proposed rule.
Consistent with the NEISS data analysis, staff considered the
following categories to be subject magnet products: Magnet sets, magnet
toys, and jewelry; these are referred to collectively as ``amusement/
jewelry.'' These categories include incidents in which the report
identified a subject magnet product as being ingested, or the incident
report provided information about the product, such as
[[Page 1269]]
characteristics or use patterns, which were sufficient for staff to
reasonably conclude that the product fell in a certain product type
category. Staff considered incidents in the following categories to be
outside the scope of the proposed rule: Science kits, home/kitchen, and
ASTM F963 magnet toys; these are referred to collectively as
``exclusions.'' Incidents in the unidentified category did not provide
sufficient information to identify the magnet product category,
however, they did indicate that a magnet was ingested, and the product
had characteristics and use patterns that could be consistent with
subject magnet products. As with the NEISS cases, staff concludes that
a substantial proportion of the unidentified category involved subject
magnet products (see section IV.A.5. Uncertainties in Incident Data,
below).
Table 9 provides the number of reported magnet ingestions in each
category.
Table 9--Reported Magnet Ingestions, by Magnet Category, 2010-2020
----------------------------------------------------------------------------------------------------------------
Proportion Proportion
Magnet category Incidents (%) Scope Incidents (%)
----------------------------------------------------------------------------------------------------------------
Magnet Set.................... 134 47.2 Amusement/ 214 75.4
Jewelry.
Magnet toy.................... 49 17.3
Jewelry....................... 31 10.9
Unidentified.................. 43 15.1 Unidentified.... 43 15.1
Science Kit................... 0 0 Exclusions...... 27 9.5
F963 Magnet Toy............... 21 7.4
Home/Kitchen.................. 6 2.1
----------------------------------------------------------------------------------------------------------------
Total..................... 284 100.0% Total........ 284 100.0%
----------------------------------------------------------------------------------------------------------------
Note: CPSRMS reporting for 2019-2020 is ongoing.
As Table 9 shows, of the incidents for which staff could identify a
product type category, most involved magnet sets, followed by magnet
toys, and jewelry. Fewer cases involved products that are not subject
magnet products (i.e., science kits, ASTM F963 magnet toys, and home/
kitchen). Compared to NEISS data, far fewer incidents involved
unidentified product types.
To further analyze CPSRMS data, staff combined the following
categories--magnet sets, magnet toys, jewelry, and unidentified. Staff
included the unidentified product type category in this analysis
because, as noted for NEISS data, there are several reasons that staff
concludes that most magnet ingestion incidents in the unidentified
product type category involved subject magnet products, including
incident data about known product types, trend data, and recall data.
Section IV.A.5. Uncertainties in Incident Data, below, discusses, in
detail, the reasons staff concludes that most unidentified product type
incidents involved subject magnet products. Thus, the data provided in
the rest of this section includes incidents in both the amusement/
jewelry and unidentified categories of CPSRMS data.
Figure 1 shows the reported CPSRMS magnet ingestion incidents, by
year of incident and product type category.
BILLING CODE 6355-01-P
[[Page 1270]]
[GRAPHIC] [TIFF OMITTED] TP10JA22.000
Although CPSRMS data cannot be used to draw statistical
conclusions, this data suggests that magnet ingestion incidents
increased in 2012, 2019, and 2020, and were lowest in 2015 and 2016,
consistent with the results seen in the NEISS data.
Figure 2 shows reported magnet ingestions, by victim age and
product type category.
[[Page 1271]]
[GRAPHIC] [TIFF OMITTED] TP10JA22.001
BILLING CODE 6355-01-C
[[Page 1272]]
Again, although CPSRMS data cannot be used to draw statistical
conclusions, the data suggest that children and teens of all ages
ingest magnets, and similar to the NEISS data, most magnet ingestions
involve children 5 years or older, with almost half of the ingestions
involving children 8 years or older.
Table 10 provides the disposition of reported magnet ingestion
cases, by product type category.
---------------------------------------------------------------------------
\24\ As discussed below, staff identified a total of 7 deaths
resulting from magnet ingestions between November 24, 2005 and
January 5, 2021. The 3 deaths reflected here include only the
fatalities that occurred in the United States between January 1,
2010 and December 31, 2020.
Table 10--Reported Magnet Ingestion Incidents, by Disposition and Magnet Category, 2010-2020
----------------------------------------------------------------------------------------------------------------
Disposition
Magnet category ----------------------------------------------------------------
Death Hospitalization Other Total
----------------------------------------------------------------------------------------------------------------
Magnet Sets.................................... .............. 88 46 134
Magnet Toys.................................... .............. 36 13 49
Jewelry........................................ .............. 21 10 31
Unidentified................................... \24\ 3 27 13 43
ASTM F963 Magnet Toys.......................... .............. 10 11 21
Home/Kitchen................................... .............. 5 1 6
----------------------------------------------------------------
Total...................................... 3 187 94 284
----------------------------------------------------------------------------------------------------------------
Note: CPSRMS reporting for 2019-2020 is ongoing.
As Table 10 indicates, of the 284 ingestions reported to have
occurred between January 1, 2010 and December 31, 2020, the vast
majority resulted in hospitalization, and three resulted in death. The
remaining ``other'' dispositions include all remaining reported
incidents that did not report either hospitalization or death.
In analyzing CPSRMS magnet ingestion incidents, CPSC staff
identified at least 124 cases that resulted in some form of surgery,
including laparoscopy, laparotomy, appendectomy, cecostomy, enterotomy,
colostomy, cecectomy, gastrotomy, jejunostomy, resection, and
transplant. Numerous additional cases resulted in less-invasive
procedures than surgery, such as endoscopies and colonoscopies, and
could have resulted in surgery if the magnets had not been retrieved
soon after ingestion. In 108 cases, the reports specifically described
the magnets internally attracting through bodily tissue, and for other
cases, there was insufficient information to determine if the surgeries
were a result of the magnetic properties.
3. Fatalities
The CPSRMS data above indicate that staff identified three fatal
magnet ingestion incidents that were reported to have occurred during
the period staff used for incident data analysis--January 1, 2010 and
December 31, 2020. However, in total, CPSC is aware of seven deaths
involving the ingestion of hazardous magnets between November 24, 2005
and January 5, 2021.\25\ Five of these deaths occurred in the United
States. In 2005, a 20-month-old child's death involved ingestion of
magnets from a children's toy building set with plastic-encased
magnets; the product was later recalled. In 2013, a 19-month-old
child's death involved multicolored, 5 mm diameter, spherical magnets
from an unidentified product. In 2018, a 2-year-old child's death
involved multicolored, 3-5 mm diameter, spherical magnets, with
indications that the product likely was a magnet set. In 2020, a 43-
year-old man's death involved magnets from an unknown product. In 2021,
a 15-month-old-child's death involved a magnet set of an unknown brand.
In addition, CPSC is aware of two deaths in other countries that
involved ingestion of hazardous 5 mm diameter, spherical NIB magnets.
In Australia in 2011, an 18-month-old child's death involved a product
that included indications that it may have been a magnet set; and in
Poland in 2014, an 8-year-old child's death involved a product that
appeared likely to be a magnet set. One of these seven incidents
involved a children's amusement product; one explicitly identified the
product as a magnet set; and another four incidents described the
products as having characteristics consistent with magnet sets.
---------------------------------------------------------------------------
\25\ The additional deaths are not included in Table 10 because
they occurred outside the timeframe of staff's data analysis or
outside the United States.
---------------------------------------------------------------------------
4. Incident Data Surrounding the Vacated Magnet Sets Rule
In looking at annual magnet ingestion incidents, staff noted a
considerable change in magnet ingestion rates before, during, and after
the Commission's vacated rule on magnet sets. As discussed above, the
Commission issued a final rule in October 2014 that applied to magnet
sets, which are a subset of the subject magnet products addressed in
this proposed rule. The magnet sets rule aimed to address the magnet
ingestion hazard and consisted of size and strength limits consistent
with the requirements in this proposed rule. The magnet sets rule took
effect in April 2015 and remained in effect until it was vacated by the
U.S. Court of Appeals for the Tenth Circuit Court in November 2016.
CPSC's assessment of incident data, as well as other researchers'
assessments of NEISS data, and national poison center data, indicate
that magnet ingestion cases significantly declined during the years in
which the magnet sets rule was announced and in effect, compared to the
periods before and after the rule.
As Table 3,\26\ above, shows, the number of estimated ED-treated
magnet ingestion incidents was significantly lower in 2015--when the
magnet sets rule was in effect--than in the years before the rule was
announced (specifically, 2010, 2011, 2012) and the years after the rule
was vacated (specifically, 2017 and 2018). Similarly, the number of
estimated ED-treated magnet ingestion incidents was significantly lower
in 2016--when the rule was in effect--than before the rule was
announced (specifically, 2011) and the years after the rule was vacated
(specifically, 2017 and 2018).\27\
---------------------------------------------------------------------------
\26\ Table 3 provides national estimates of magnet ingestions
per year for incidents categorized as amusement/jewelry and
unidentified product types.
\27\ Statistically significant differences are not reported for
the year 2014, because the corresponding estimate does not meet
reporting criteria.
---------------------------------------------------------------------------
[[Page 1273]]
To assess these trends further, staff grouped years in relation to
the vacated magnet sets rule, using the following periods: 2010 through
2013 (prior to the announcement of the rule), 2014 through 2016 (when
the final rule was announced and in effect \28\), and 2017 through 2020
(after the rule was vacated). Table 4, above, shows the estimated
number of magnet ingestions treated in U.S. hospital EDs during these
periods, using annual estimates for each period to account for the
periods including different numbers of years (i.e., 2014-2016 covers 3
years, whereas, 2010-2013 and 2017-2020 cover 4-year periods). For
2010-2013 and 2017-2020, there were an estimated 2,300 ED-treated
magnet ingestion incidents per year; for 2014-2016, there were an
estimated 1,300 ED-treated magnet ingestion incidents per year. Thus,
during the period when the rule was announced and in effect (2014-
2016), there were appreciably fewer magnet ingestions compared with the
earlier and more recent periods, and there were nearly equivalent rates
during the periods both before and after the rule.
---------------------------------------------------------------------------
\28\ Staff grouped 2014, 2015, and 2016 together for this
analysis because these are the years firms were likely to comply
with the size and strength limits in the magnet sets rule. Because
the standard took effect in April 2015 and remained in effect until
November 2016, firms were required to comply with the standard for
nearly all of 2015 and 2016. Although the rule was not in effect in
2014, the proposed rule was published in 2012, and the final rule
was published, with essentially the same requirements, in October
2014. Once an NPR is published, firms have notice to prepare for the
requirements that may be finalized, and once a final rule is
published, firms often take steps to comply with the rule even
before it takes effect. Accordingly, it is reasonable to conclude
that firms took steps to comply with the magnet sets standard in
2014.
---------------------------------------------------------------------------
Although CPSRMS data cannot be used to draw statistical
conclusions, the data also suggest a similar decline in incidents for
the period when the magnet sets rule was announced and in effect. Table
11 shows CPSRMS-reported magnet ingestions, by period, using incidents
categorized as amusement/jewelry and unidentified product types,
consistent with the NEISS analysis, above.
Table 11--Number of CPSRMS-Reported Magnet Ingestions, by Period
----------------------------------------------------------------------------------------------------------------
Percent of Years in
Period total N period
----------------------------------------------------------------------------------------------------------------
2010-2013....................................................... 47.5 122 4
2014-2016....................................................... 6.6 17 3
2017-2020....................................................... 45.9 118 4
-----------------------------------------------
2010-2020....................................................... 100 257 11
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS. Percentages are rounded to the nearest tenth. CPSRMS reporting for the years 2019-2020 is
ongoing and counts for those years may increase as reporting continues.
Consistent with NEISS trends shown in Table 3, Table 11 shows that
CPSRMS data also reflect an appreciable decline in magnet ingestion
incidents during the period when the magnet sets rule was announced and
in effect (2014-2016), compared with earlier and more recent periods,
and nearly equivalent incident rates during the periods both before and
after the rule.
Other researchers analyzing NEISS data made similar findings. One
study \29\ reviewed magnet ingestions for children under 18 years old
using NEISS data from 2009 through 2019, focusing on three periods:
2009 through 2012 (before the Commission rule on magnet sets); 2013
\30\ through 2016 (magnet sets rule announced and in effect); and 2017
through 2019 (after the rule was vacated). In 2009-2012, there was an
aggregate mean ED-visit rate of 3.58 \31\ per 100,000 people; in 2013-
2016, this decreased to 2.83 \32\ per 100,000 people; \33\ and in 2017-
2019, this increased to 5.16 \34\ per 100,000 people.\35\ Like CPSC's
analysis, this illustrates an appreciable decline in magnet ingestions
during the period the magnet sets rule was announced and in effect,
with an even greater increase in incidents after the rule than before
it.
---------------------------------------------------------------------------
\29\ Flaherty, M.R., Buchmiller, T., Vangel, M., Lee, L.K.
Pediatric Magnet Ingestions After Federal Rule Changes, 2009-2019.
JAMA. Nov. 24, 2020. 324(20): 2102-2104. doi:10.1001/
jama.2020.19153, available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686864/.
\30\ For CPSC's analysis, staff considered 2014 to be the year
the rule was announced because that is the year the final rule was
published. In contrast, this study considered 2013 to be the year
the rule was announced, likely because that is the first full year
after the rule was initially announced in an NPR in September 2012.
\31\ 95% confidence interval (CI), 2.20-4.96.
\32\ 95% CI, 1.60-4.06.
\33\ Slope change, 0.87 (95% CI, 0.71-1.03) ED visits per
100,000 annually.
\34\ 95% CI, 3.22-7.11.
\35\ Slope change, -0.58 (95% CI, -0.68 to -0.47) per 100,000
persons annually.
---------------------------------------------------------------------------
Another study \36\ found similar results when looking at suspected
magnet ingestion (SMI) cases involving children under 18 years old
using NEISS data. That study found that there were an estimated 23,756
\37\ total SMI cases between 2009 and 2019, of which an estimated 3,709
\38\ cases involved small/round magnets and 6,100 \39\ involved
multiple magnets. The average annual increase in total cases was 6.1
percent for 2009 to 2019,\40\ and there was a statistically significant
increase in small/round magnet ingestions \41\ and multiple magnet
ingestions \42\ between 2009 and 2019. When stratified by period, there
were 6,391 \43\ estimated total magnet ingestion cases during 2013-
2016,\44\ or 1,598 \45\ estimated cases per year. In contrast, there
were an estimated 8,478 \46\ cases from 2017-2019, or 2,826 \47\ per
year. This represents a 32 percent increase \48\ in total magnet
ingestions after 2016. There was also a statistically significant
increase in the number of estimated small/round \49\ and multiple
magnet \50\ ingestions across these two periods, with 164 \51\ small/
round and 350 \52\ multiple magnet ingestions from 2013 through 2016,
compared to 541 \53\ small/
[[Page 1274]]
round and 797 \54\ multiple magnet ingestion cases from 2017 through
2019.
---------------------------------------------------------------------------
\36\ Reeves, P.T., Rudolph, B., Nylund, C.M. Magnet Ingestions
in Children Presenting to Emergency Departments in the United States
2009-2019: A Problem in Flux. Journal of Pediatric Gastroenterology
and Nutrition. Dec. 2020. 71(6):699-703, 10.1097/
MPG.0000000000002955, available through: https://pubmed.ncbi.nlm.nih.gov/32969961/.
\37\ CI, 15,878-30,635.
\38\ CI, 2,342-5,076.
\39\ CI, 3,889-8,311.
\40\ P = 0.01.
\41\ P <0.001.
\42\ P = 0.02.
\43\ CI, 4,181-8,601.
\44\ Like the previous study, these researchers considered 2013
to be part of the period during which magnet sets were likely to be
off the market.
\45\ CI, 1,045-2,150.
\46\ CI, 5,472-11,485.
\47\ CI, 1,824-3,828.
\48\ P <0.001.
\49\ P <0.01.
\50\ P <0.001.
\51\ CI, 66-263.
\52\ CI, 200-500.
\53\ CI, 261-822.
\54\ CI, 442-1152.
---------------------------------------------------------------------------
Researchers \55\ analyzing national poison center data also found
an increase in magnet ingestions in recent years, particularly since
the magnet sets rule was vacated. This study looked at magnet foreign
body injuries in pediatric patients in the National Poison Data System
(NPDS). For 2012-2017, there were 281 magnet exposure calls per year,
compared to 1,249 calls per year for 2018-2019, representing a 444
percent increase. Considering cases dating back to 2008 (5,738 total),
the cases from 2018 and 2019, alone, account for 39 percent of the
magnet cases. Although these periods do not directly align with the
magnet sets rule, they further illustrate the general increase in
magnet ingestion incidents in recent years, particularly after the
magnet sets rule was vacated.
---------------------------------------------------------------------------
\55\ Middelberg, L.K., Funk, A.R., Hays, H.L., McKenzie, L.B.,
Rudolph, B., Spiller, H.A. Magnet Injuries in Children: An Analysis
of the National Poison Data System From 2008-2019. The Journal of
Pediatrics. May 1, 2021. Volume 232, P251-256.E2, available at: doi:
https://doi.org/10.1016/j.jpeds.2021.01.052.
---------------------------------------------------------------------------
These analyses raise relevant considerations for this proposed
rule. For one, the marked decline in incidents during the period when
the magnet sets rule was announced and in effect suggests that a large
portion of magnet ingestion incidents involve magnet sets. Because that
rule applied only to magnet sets, the fact that incidents significantly
declined during the pendency of that rule indicates that magnet sets
were involved in most of the incidents. This is useful information,
given the lack of details regarding product types involved in many
magnet ingestion incidents. In addition, these analyses indicate the
current need to address the magnet ingestion hazard. Magnet ingestion
incidents have significantly increased in recent years, showing a
heightened need to address the hazard. Finally, these analyses suggest
that a mandatory standard is necessary to effectively reduce the risk
of injuries and death associated with magnet ingestions. Before,
during, and after the magnet sets rule, CPSC and other groups have
worked to raise awareness of the magnet ingestion hazard, and CPSC has
taken steps to address the hazard though information campaigns,
recalls, and voluntary standards work. However, the only appreciable
decline in magnet ingestion incidents occurred during the period when
the mandatory standard for magnet sets was announced and in effect.
5. Uncertainties in Incident Data
As explained above, magnet ingestion incident reports often include
limited information for staff to identify the type of product involved
in the magnet ingestion. Caregivers and medical providers may know that
a magnet was ingested, but may not know from what type of product the
magnet came. This differs from many consumer products that are readily
identifiable when involved in an incident and report. NEISS data, in
particular, tend to provide limited information with which to identify
the product involved in magnet ingestions. This may be because NEISS
data are collected through hospital EDs. At hospital EDs, medical
professionals may not know what product was the source of the magnet
ingestion, and are focused on information needed to treat the victim
(e.g., that a magnet was ingested), rather than the specific product
involved in the incident (e.g., that the magnet came from a magnet
set). Because CPSRMS data usually come from manufacturers and
consumers, these data often contain more information to identify the
product.
As Table 1, above, shows, of the 1,072 magnet ingestion incidents
identified in NEISS, 74 percent (793 incidents) did not provide
sufficient information for staff to identify the type of product
involved. As Table 9, above, shows, of the 284 magnet ingestion
incidents identified in CPSRMS, 15 percent (43 incidents) did not
provide sufficient information for staff to identify the type of
product involved. However, staff does have some information about the
incidents in the unidentified product type category--specifically,
these incidents involved ingestion of one or more magnets, and included
product characteristics and use patterns that could be consistent with
subject magnet products.
To account for the lack of product identification in many magnet
ingestion incidents, staff analyzed magnet ingestion incident data in
several ways. For one, staff provided information about all magnet
ingestion cases. Aggregated information for all of the in-scope, out-
of-scope, and unidentified product categories indicates that magnet
ingestions, in general, are an issue, and have increased in recent
years. This indicates the propensity for children and teens to ingest
magnets, and it demonstrates the increasing risk of injury and death as
magnet ingestion cases increase.
Staff also categorized incidents into specific product groups,
based on information that was available in incident reports. For
incidents that provided information to help identify the product type,
the data revealed that six categories of products were involved in
magnet ingestions--magnet sets, jewelry, magnet toys, science kits,
ASTM F963 magnet toys, and home/kitchen magnets. For some of the
incidents in these categories, there was specific information about the
product--such as brand names--that allowed staff to determine the
product involved in the incident. For other incidents in these
categories, the product was referred to as a specific type (e.g.,
magnet sets, desk toy, science kit, kitchen magnet, bracelet).\56\
These categories provide information about the products involved in
magnet ingestions, and the relative frequency of their involvement, to
help determine which products the proposed rule should address.
---------------------------------------------------------------------------
\56\ Staff categorized incidents based on all of the information
available in the reports, including descriptions, names, and uses of
the product. However, for some of the incidents in which the report
provided a product type, but not a specific product brand/name, it
is possible that the product was actually from another category. For
example, the jewelry category includes cases in which the report
indicates that the magnets were described as jewelry at the time of
the incident, such as magnetic earrings. It is possible that the
magnets in such cases were actually from a non-jewelry product.
Similarly, products categorized as magnet toys could actually be
another product type; for example, a product described as an
``executive desk toy,'' which did not meet the parameters for the
magnet set category, and did not indicate marketing to children
under 14 years old, was included in the magnet toy group, although
it is possible that the product actually was a magnet set or other
product type, and the report lacked information to indicate this.
However, even if incidents in these categories were miscategorized,
they likely would still fall within the scope of the proposed rule
because they meet the description of an in-scope product.
---------------------------------------------------------------------------
Staff also aggregated these categories into in-scope and out-of-
scope groupings. Staff combined incidents from the magnets sets, magnet
toys, and jewelry categories as ``amusement/jewelry'' and combined
incidents from the home/kitchen, ASTM F963 magnet toys, and science kit
categories as ``exclusions.'' Grouping several product type categories
together allowed staff to generate national estimates of ED-treated
magnet ingestions, to provide an idea of the number of ingestions
nationally, and the relative involvement of in-scope and out-of-scope
products, which helps identify the magnitude of the risk and the
potential benefits of the rule to reduce that risk.
In addition, staff combined the amusement/jewelry and unidentified
categories to conduct more detailed analyses. Because the proposed rule
applies to amusement and jewelry products, the amusement/jewelry
category of incidents is informative.
[[Page 1275]]
Staff also included in these analyses, incidents in the unidentified
product type category because there are several factors that indicate
that many of the incidents in the unidentified product type category
likely fall within the scope of the proposed rule. The following is a
discussion of these factors.
First, the incident data discussed in this preamble supports the
conclusion that many of the magnet ingestion incidents in the
unidentified product type category actually involved subject magnet
products. Of the NEISS magnet ingestion incidents for which staff could
identify a product category, the primary products involved were magnet
sets, magnet toys, and jewelry; far fewer incidents involved ASTM F963
magnet toys, home/kitchen magnets, or science kits (see Table 1,
above). The same was true for CPSRMS incidents (see Table 9, above),
for which far fewer incidents were in the ``unidentified'' category.
Given this consistency across data sets, it is reasonable to conclude
that the relative involvement of magnet product types in magnet
ingestions applied to the incidents that lacked product identification
as well.
Second, magnet ingestion rates before, during, and after the
vacated rule on magnet sets suggest that a significant portion of
magnet ingestion cases involve magnet sets. As discussed above, CPSC's
assessment of incident data, as well as other researchers' assessments
of NEISS data, and national poison center data, indicate that magnet
ingestion cases significantly declined during the years the magnet sets
rule was announced and in effect, compared to the periods before and
after the rule. Magnet sets were the only products subject to that
rule. As such, the significant decline in incidents during that rule,
and the significant increase in incidents after that rule was vacated,
strongly suggest that many magnet ingestion incidents involve magnet
sets. Thus, it is reasonable to assume that many of the incidents in
the unidentified product category involved magnet sets. Moreover, the
definition of ``magnet sets'' in the vacated rule was largely
equivalent to the description of amusement products in the present
proposed rule (i.e., magnet sets and magnet toys), suggesting that many
magnet ingestion incidents, including those with unidentified product
types, involve amusement products.
Third, incident data and recalls regarding magnets in children's
toys further support the conclusion that magnet ingestions categorized
as ``unidentified'' products are largely subject magnet products. As
discussed above, ASTM F963 magnet toys make up only a small portion of
magnet ingestion incidents where the product can be identified. It is
reasonable to assume that this holds true for unidentified products in
magnet ingestions, as well. Recall information further supports this
conclusion. Recalls of children's toys involving the magnet ingestion
hazard have declined substantially since the toy standard took effect.
As explained above, ASTM F963 was announced as the mandatory standard
for toys in 2008, and it took effect in 2009. From 2006 through 2009,
CPSC issued more than a dozen recalls of children's toys, due to the
ingestion hazard associated with loose or separable, small, powerful
magnets.\57\ In contrast, from January 2010 through August 2021--a
period approximately three times as long--there were a total of 18
recalls related to the magnet ingestion hazard, only four of which
involved children's toys. Of those four recalls, only two involved
confirmed violations of the magnet provisions in the toy standard.
Recalls provide some indication of the products involved in magnet
ingestions because products are recalled when they present a hazard.
Thus, this marked decline in recalls of children's toys for magnet
ingestion hazards suggests that children's toys largely comply with the
toy standard and are not involved in hazardous incidents.
---------------------------------------------------------------------------
\57\ https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/
163_2017-10-
26%20Final%20Decision%20and%20Order.pdf?Tme8u5fRF2.29_B.i4Ix7pPwb_whK
ng2.
---------------------------------------------------------------------------
Taken together, these factors support the conclusion that most
magnet ingestion incidents, including those in the unidentified product
type category, involved products that fall within the magnet sets,
magnet toys, and jewelry categories, and not the science kit, home/
kitchen, or ASTM F963 magnet toys categories. For these reasons, staff
included magnet ingestion incidents in the unidentified product type
category in many of its analyses; to exclude such incidents likely
would vastly underrepresent ingestions of subject magnet products.
B. Details Concerning Health Outcomes 58
---------------------------------------------------------------------------
\58\ For more details about injuries and health outcomes, see
Tab A of the NPR briefing package. In addition, health outcomes
associated with magnet ingestions are discussed in the Final Rule
briefing package for the 2014 rule on magnet sets, available at:
https://www.cpsc.gov/s3fs-public/pdfs/foia_SafetyStandardforMagnetSets-FinalRule.pdf, and the 2020
informational briefing package, available at: https://www.cpsc.gov/s3fs-public/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf.
Even though the previous analyses focused on magnet sets, the
internal magnet interaction hazard is the same for the subject
magnet products covered in this proposed rule.
---------------------------------------------------------------------------
Magnets are unique among ingested foreign bodies because of their
intrinsic ability to attract to one another or to ferromagnetic
objects. Assuming the same elemental composition, a magnet with large
physical dimensions and mass can exhibit stronger attractive forces
than a magnet with small physical dimensions and mass. Similarly,
magnets coupled together can exhibit greater attractive strengths than
individual magnets. One mechanism of injury following magnet ingestion
involves separate magnets in adjacent tissue walls (e.g., from distinct
loops of bowel) attracting to each other and trapping tissue between
the magnets. The mechanism of injury is the same for a single hazardous
magnet and a ferromagnetic object that might interact internally. As
such, individual magnets pose the same health risk.
Health threats posed by magnet ingestion include pressure necrosis,
volvulus, bowel obstruction, bleeding, fistulae, ischemia,
inflammation, perforation, peritonitis, sepsis, ileus, ulceration,
aspiration, and death, among others. The normal functions of the
gastrointestinal (GI) tract, including peristalsis, are not likely to
dislodge magnets that are attracted to each other through component
tissues.
The time between magnet ingestion and injury varies and depends on
several factors, such as the number of ingested magnets; awareness of
the magnet ingestion by caregivers; awareness that magnet ingestion is
hazardous; whether multiple ingested magnets interact with each other
inside of the body through tissue structures; and the configuration of
coupled magnets, relative to involved tissue structures. Incident
reports describe injuries from internal magnet interaction through
tissue taking anywhere from days to months to progress to a stage at
which caregivers seek medical attention. There have been several
efforts to develop medical devices using magnets to deliberately
compress and necrose \59\ target tissue and create healthy anastomoses
(openings/passages) that connect or reconnect distinct channels in the
body. In these controlled cases, tissue necrosis typically took
multiple days to weeks.\60\
---------------------------------------------------------------------------
\59\ Necrosis is a process of cell death.
\60\ These efforts are still in early stages, but may ultimately
provide some examples of the time it takes for tissue necrosis to
occur from magnetic compression. Although not pathological examples,
the length of time required for successful anastomoses in
preclinical medical device development settings ranged from multiple
days to weeks, as evaluated by necropsy and passage of the magnet
after anastomosis formation. In a human trial, magnets passed
naturally multiple weeks after placement to create healthy
anastomoses.
---------------------------------------------------------------------------
[[Page 1276]]
Ambiguous symptomatology following magnet ingestion that results in
an internal interaction injury may complicate the timely delivery of
medical care. Symptoms related to magnet ingestion may appear flu-like
and include vomiting, fever, and abdominal pain, among others. Symptoms
following magnet ingestion have been mistaken for a virus, ear
infection, and bronchitis, among others. Medical professionals who know
of the magnet ingestion may be able to minimize or avoid injury by
promptly removing the magnets.
Internal Magnet Interaction Injuries. As indicated above, one of
the health threats presented by magnet ingestion is internal magnet
interaction leading to pressure necrosis injuries that occur in the
alimentary canal. Necrosis is a process of cell death, secondary to
injury, which undermines cell membrane integrity and involves intricate
cell signaling responses. In the case of internal magnet interactions,
the injury leading to necrosis is the pressure on the involved
biological tissues that exceeds local capillary pressure and leads to
ischemia.
Volvulus is another internal interaction hazard associated with
magnet ingestion. Volvulus is an obstructive twisting of the GI tract.
Volvulus is often accompanied by abdominal pain, distended abdomen,
vomiting, constipation, and bloody stools. If left untreated, volvulus
may lead to bowel ischemia, perforation, peritonitis, and death.
Volvulus following magnet ingestion has been linked to fatal outcomes.
In the United States, CPSC is aware of one death of a 20-month-old
child who ingested magnets from a toy construction set, which caused
volvulus, and one death of a 2-year-old child who ingested multiple
magnets, resulting in small intestine ischemia secondary to volvulus.
In addition, CPSC is aware of one death of an 8-year-old child in
Poland, due to small intestine ischemia secondary to volvulus, after
the victim ingested magnets that resulted in necrosis, toxemia (blood
poisoning), hypovolemic shock, and eventually cardiopulmonary failure.
Like outcomes related to volvulus, small bowel ischemia can lead to
local tissue necrosis, perforation, and subsequent peritonitis. Small
intestine ischemia was implicated in the death of a 19-month-old child
following ingestion of multiple magnets. Bowel obstruction, often a
consequence of volvulus, is associated with abdominal cramps, vomiting,
constipation, and distention. With respect to the relationships among
local capillary and intraluminal pressures and magnet ingestions,
subsequent outcomes include possible blockage of local blood and
nutrient supply; progressive pressure necrosis of the involved tissues;
and local inflammation, ulceration, and tissue death, with putative
outcomes such as perforation (hole) or fistula in the GI tract. If left
untreated, or otherwise unnoticed, such events can progress into
infection, sepsis, and death. The obstruction from the trapped tissue
can elicit vomiting, and the local mucosa irritation may stimulate
diarrhea. Advancing pressure necrosis of the involved tissues can lead
to necrosis and subsequent leakage of the bowel contents into the
peritoneal cavity.
Another example of the potential health outcomes associated with
magnet ingestion is a case in which an asymptomatic 4-year-old child
sustained several fistulae in the intestines that required surgical
repair after ingesting magnets. Fistulae are abnormal passages between
channels in the body that are associated with increased mortality.
Fistulae may enable the leakage of gut contents into adjacent tissue
structures or abdominal cavities, which can lead to infection,
inflammation, perforation, sepsis, and possibly death. Fistulae may
also bypass portions of the GI tract, thus undermining normal GI
function.
Another potential health outcome of magnet ingestions is
ulcerations. For example, one case involved a 28-month-old child who
experienced stomach ulcerations after ingesting 10 magnets and
receiving treatment with medication after the endoscopic removal and
natural passage of the magnets. Untreated ulcers may require surgical
intervention if they progress to perforation, and a perforated bowel
may lead to leakage from the GI tract. Several magnet ingestion
incident reports highlight the threat of perforation with possible
outcomes such as peritonitis. Peritonitis is an inflammation of the
peritoneum, a membrane lining of the abdominal cavity, which may be
associated with leakage from the GI tract that can lead to sepsis.
Sepsis is the body's response to severe infection, and it is associated
with elevated rates of morbidity and mortality that can be mitigated
with prompt treatment. Treatment of abdominal sepsis may require repair
of a leaky GI tract.
Another potential health risk from ingested magnets is an
aspiration threat. For example, in one reported case, a 3-year-old
child ingested multiple magnets, two of which were found attracting to
each other on opposing surfaces of the pharyngoepiglottic fold in the
throat, presenting an immediate aspiration threat given the proximity
to the airway. Aspiration of magnets has also been reported elsewhere
in medical literature. Foreign body aspiration presents a risk of
airway obstruction, ventilatory difficulty, choking, hypoxic-ischemic
brain injury, pulmonary hemorrhage, and death, among other health
outcomes.
Other Health Outcomes and Injuries. In addition to internal
interaction hazards, ingested magnets present additional health risks.
Ingested magnets that are not attracting to each other through tissue
walls may cause harm, such as irritation of the GI mucosa in the form
of erythematous, mucosal inflammation, and minor tears. Ingested
magnets embedded in the bowel may be associated with multiple days of
hospitalization. A foreign body lodged in the GI tract can also cause
mucosal wall deterioration, migration, and perforation. Comorbidities,
such as eosinophilic esophagitis, gastroesophageal reflux disease, GI
anomalies, and neuromuscular disorders can exacerbate the potential
outcomes. The wall of the esophagus is susceptible to edema and
weakening that increase the risk of bleeding and perforation in the
presence of foreign bodies. Foreign body irritation of the GI tract may
also prompt local mucosal irritation that can stimulate diarrhea.
Medical Care for Magnet Ingestions. Several approaches to medical
care are available when assessing and treating magnet ingestions,
however, many of these approaches pose health risks, themselves.
Medical providers routinely use medical imaging during treatment of
magnet ingestions. Current imaging diagnostic capabilities may be able
to identify ingested foreign bodies, but they do not allow for the
definitive identification of magnets in the body. The usefulness of
metal detectors to locate ingested metallic objects, including magnets,
has decreased as the size of ingested magnets decreases. This presents
challenges when a caregiver and medical professional do not know the
victim ingested a magnet.
When ingested magnets are identified, x-ray radiography,
fluoroscopy, computed tomography (CT) scans, or ultrasound \61\ can be
used to monitor the
[[Page 1277]]
ingested magnets. If the magnets' passage through the GI tract is
arrested or symptoms manifest, then endoscopic or surgical intervention
may be necessary. Bowel cleanout or bowel preparation procedures that
use laxatives,\62\ such as polyethylene glycol, may be used to try to
flush ingested magnets out of the GI tract, or to prepare patients for
endoscopy or other medical procedures.
---------------------------------------------------------------------------
\61\ These imaging tools present some health risks themselves.
The ionizing radiation associated with x-ray radiography has the
potential to damage DNA and may contribute to the development of
cancer later in life. The risks from CT scans are similar. Prolonged
fluoroscopy, which is often used during surgery or medical
procedures such as endoscopy, may contribute to the development of
cataracts, skin reddening, or hair loss. Ultrasound is relatively
safe, but it may heat tissue or produce pockets of gas in body
fluids or tissues.
\62\ Bowel cleanout is not often associated with risk in the
pediatric population; dehydration is the most common adverse event
that occurs. However, in certain instances, bowel cleanout laxatives
may be delivered via nasogastric tube; there are rare reports of
life-threatening aspiration of laxative solutions delivered via
nasogastric tubes, especially in older populations with certain
comorbidities.
---------------------------------------------------------------------------
Endoscopy may be used to retrieve ingested magnets from the
stomach, duodenum, esophagus, pylorus and cecum (via colonoscopy), or
other areas. Endoscopy may also be used to treat bowel obstruction
secondary to magnet ingestion. Endoscopy is associated with a risk of
bleeding from mucosal shearing or tearing that is elevated in the
presence of anemia. There is also risk of adverse cardiopulmonary
events (e.g., oxygen desaturation, aspiration, respiratory arrest,
shock, myocardial infarction) as a result of sedation and anesthesia;
perforation from procedure instruments; infection from contaminated
equipment, or from a perturbed endogenous source; and procedural risks
largely associated with comorbidities (e.g., cardiac disease,
diabetes).
Colonoscopy is a common endoscopic procedure performed via the anus
and shares many of the same risks as endoscopy. Laryngoscopy--a medical
procedure to evaluate the upper aerodigestive tract--is used to
investigate suspected magnets lodged in the throat. Associated risks of
laryngoscopy include esophageal perforation, airway compromise,
bleeding, dysphagia, and fever, among others. Nasal endoscopy may be
useful to treat magnets embedded in the nose. Nasal endoscopy is
associated with risks of mucosal irritation, minor hemorrhage, and
overt hemorrhage.
Surgical interventions may be necessary to treat magnet ingestions
when less invasive procedures, such as endoscopy or bowel cleanout, are
clinically inappropriate or unsuccessful. In one example, in which a 5-
year-old child ingested magnets, endoscopy failed to retrieve all of
the magnets, and the remaining magnets were recovered via laparotomy
with appendectomy. Abdominal surgeries, such as laparotomy (abdominal
incision) and laparoscopy (fiber-optic visualization of the viscera via
abdominal incision), that involve abdominal incisions and manipulation
of abdominal organs are associated with the risk of adhesions that can
cause pain, bowel obstructions that may require additional surgical
intervention, female infertility, and bowel injury. For example, 6
months after a 2-year-old child underwent enterotomy and gastrostomy to
remove 26 magnets from her jejunum and stomach, the child developed
bowel adhesions that caused obstructions and required treatment with
surgical adhesiolysis to cut the adhesions. Possible complications
associated with laparotomy include pneumonia, cardiac complications,
surgical site infection, wound dehiscence (rupture), urinary tract
infection, respiratory tract infection, venous thromboembolism, kidney
failure, heart and GI tract complications, septicemia, and death.
Emergency laparotomies may be more prone to complications than elective
laparotomies. For example, a 6-year-old child who ingested 20 magnets
underwent a 20-day hospital stay to treat surgical wound infections
following exploratory laparotomy with small bowel resection and
appendectomy to retrieve the magnets.
Appendectomy may also result from magnet ingestions, and is
commonly achieved via laparotomy or laparoscopy. Pain, wound
infections, and intra-abdominal abscesses are possible following both
laparoscopic and open appendectomies. Laparotomy may be accompanied by
incisions of the stomach (gastrotomy) or intestines (enterotomy) to
retrieve ingested magnets. Complications from surgical enterotomies, or
incisions into the intestine, may be similar to those of inadvertent
enterotomies, which can occur during anastomosis procedures and include
leakage, intra-abdominal abscesses, and death.
Surgical resection of the bowel may be performed to remove necrotic
portions of the bowel, secondary to magnet ingestion. Small bowel
resection is associated with risks of infection, fistulae, peritonitis,
abscess, sepsis, and wound dehiscence secondary to leaky anastomoses.
There is also the possibility of impairment to the intrinsic nutrient
absorption functions of the bowel, depending on the resection location.
End-to-end surgical anastomoses used to restore bowel continuity
following resection are associated with the risk of leakage, intra-
abdominal abscess, and death.
Complications associated with surgery to treat magnet ingestion
have also included pancreatitis and additional hospitalization,
additional surgery to treat incisional hernia, and the need for a
lifelong feeding tube, among others. Endotracheal general anesthesia
may be required for surgical treatments of magnet ingestion. Possible
complications associated with general anesthesia include nausea,
vomiting, sore throat, dental damage, myocardial ischemia or
infarction, heart failure, cardiac arrest, arrhythmia, atelectasis
(lung collapse), aspiration, bronchospasm, neurological effects, and
renal effects, among others.
In addition to the medical procedures necessary to treat magnet
ingestions, and the risks associated with those procedures, ingested
magnets present unique challenges for medical professionals. For
example, technical precision is reduced, and technical difficulty
increases when ingested magnets attract to the metallic instruments
used to retrieve them. In one example case, ingested magnets in the
throat of a 3-year-old child suddenly attracted to the optic graspers
inserted to retrieve the foreign bodies.
C. Incident Characteristics 63
---------------------------------------------------------------------------
\63\ For additional information about hazard patterns and
incident characteristics, see Tab C of the NPR briefing package.
---------------------------------------------------------------------------
Staff conducted a detailed analysis of incident data to identify
hazard patterns and characteristics associated with magnet ingestion
incidents, and staff also considered developmental and behavioral
factors relevant to the hazard. These considerations helped inform the
scope of products that need to be addressed in the proposed rule and
the types of requirements that would be effective at reducing the
magnet ingestion hazard.
1. Victim Age
Table 12 provides the ages of victims involved in magnet ingestion
incidents, from both the NEISS and CPSRMS data sets. The table includes
incidents in the
[[Page 1278]]
magnet sets, magnet toys, and jewelry categories, as well as incidents
in the unidentified product type category.\64\
---------------------------------------------------------------------------
\64\ As explained above, several factors indicate that many of
the incidents in the unidentified product type category likely
involved subject magnet products, and these incidents indicate the
age of children and teens involved in magnet ingestion incidents,
generally. The table excludes out-of-scope products (i.e., home/
kitchen and ASTM F963 magnet toys).
Table 12--Magnet Ingestion Incidents, by Age
----------------------------------------------------------------------------------------------------------------
Victim age NEISS (#) NEISS (%) CPSRMS (#) CPSRMS (%)
----------------------------------------------------------------------------------------------------------------
<2 yrs.......................................... 120 11.8 21 8.2
2 yrs........................................... 89 8.8 32 12.5
3 yrs thru 4 yrs................................ 196 19.3 31 12.1
5 yrs thru 7 yrs................................ 207 20.4 28 10.9
8 yrs thru 10 yrs............................... 179 17.7 66 25.7
11 yrs thru 13 yrs.............................. 182 18 37 14.4
14 yrs thru 16 yrs.............................. 30 3 12 4.7
>16 yrs......................................... 11 1.1 1 0.4
Unknown......................................... 0 0 29 11.3
---------------------------------------------------------------
Totals...................................... 1,014 .............. 257 ..............
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSRMS. Percentages are rounded to the nearest tenth.
The youngest victim for which an age was reported was 6 months old;
the oldest age reported was 54 years old. Approximately 20 percent of
the NEISS incidents and CPSRMS incidents involved victims under 3 years
old. This is consistent with developmental and behavioral factors--
typically, foreign body ingestions peak for children between 6 months
and 3 years old, and 2-year-old children generally are mobile and
unlikely to be supervised directly at all times. Children of these ages
are commonly cited in reports involving ingestion of inedible objects,
given their likelihood of orally exploring their environment and their
limited ability to comprehend hazards. For these and other reasons,
toys with small parts must have a choking hazard warning for children
under 3 years old.\65\
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\65\ 16 CFR part 1501.
---------------------------------------------------------------------------
As Table 12 indicates, approximately 60 percent of NEISS incidents
and 56 percent of CPSRMS incidents involved victims 5 years old and
older. This age group is important because one option CPSC and
voluntary standards groups have considered to address the magnet
ingestion hazard is child-resistant (CR) packaging, which is packaging
that is designed or constructed to be significantly difficult for
children under 5 years old to open.\66\ Because the majority of
incidents involve victims who would not be protected by CR packaging,
these data suggest that CR packaging would be unlikely to adequately
reduce the magnet ingestion hazard.
---------------------------------------------------------------------------
\66\ See 16 CFR part 1700, issued under the Poison Prevention
Packaging Act of 1970, 15 U.S.C. 1471-1477.
---------------------------------------------------------------------------
Table 12 also shows that approximately 40 percent of NEISS
incidents and 45 percent of CPSRMS incidents involved victims 8 years
old and older. This is noteworthy because several voluntary standards
exempt magnet products intended for users 8 years and older from size
and strength requirements, instead requiring only warnings on such
products. These standards seemingly assume that users 8 years old and
older are less likely to ingest magnets or are able to understand and
heed warnings about the magnet ingestion hazard better than younger
children. However, the frequency of incidents involving users 8 years
and older suggests that this is not the case.
As indicated above, Table 12 includes incidents in the magnet sets,
magnet toys, jewelry, and unidentified product categories, indicating
that these incidents did not involve products that are intended for
children under 14 years old.\67\ Despite this, most magnet ingestion
incidents involved children under 14 years old, indicating that subject
magnet products appeal to and are accessible to children and teens.
This demonstrates that a standard for children's toys, alone, is not
sufficient to address the magnet ingestion hazard. Subject magnet
products appeal to children and teens for various reasons. Magnets,
particularly smooth magnets, have tactile appeal for fidgeting, stress
relief, and other amusement. Some magnets capture attention because
they are shiny, colorful, or both. They make soft snapping/clicking
sounds when manipulated, which children and teens may find appealing.
The magnets have properties of novelty, which arouse curiosity;
incongruity, which tends to surprise and amuse; and complexity, which
tends to challenge and maintain interest. Their strong magnetic
properties cause them to behave in unexpected ways, with pieces
suddenly snapping together, and moving apart. Such behavior is likely
to seem magical to younger children, and evoke a degree of awe and
amusement among older children and teens.
---------------------------------------------------------------------------
\67\ As discussed above, incidents in the unidentified product
category likely involve subject magnet products, and not ASTM F963
magnet toys.
---------------------------------------------------------------------------
2. Use Patterns
In reviewing incident data, staff identified the following patterns
in how the magnets were being used at the time of ingestion:
Playing--These cases involved ingestion of magnets while
users were playing, fidgeting, orally exploring the magnets (e.g.,
testing the attraction through teeth or on braces), or performing a
combination of these actions. If playing involved use of the product as
jewelry, the case was categorized as jewelry, rather than playing. This
category excludes cases involving intentional ingestion.
Jewelry--These cases involved magnets victims were using
as jewelry at the time of the incident, such as bracelets, necklaces,
and simulated piercings (e.g., magnets used around the tongue, lip, and
cheek to look like piercings).
Intentionally ate--In these cases, victims reportedly
swallowed magnets on purpose (e.g., curiosity, mistaking the magnets as
edible).
Other--These cases involved identified actions that did
not fit the
[[Page 1279]]
categories above (e.g., transporting magnets orally, magnets thrown
into a victim's mouth when not playing, and magnets placed in a
victim's drink).
Unknown--In these cases, it was unclear what led to the
magnet ingestion.
Table 13 provides the use patterns involved in magnet ingestion
incidents, from both the NEISS and CPSRMS data sets. The table includes
incidents in the magnet sets, magnet toys, and jewelry categories, as
well as incidents in the unidentified product type category.\68\
---------------------------------------------------------------------------
\68\ As explained above, several factors indicate that many of
the incidents in the unidentified product type category likely
involved subject magnet products, and these incidents indicate the
use patterns involved in magnet ingestion incidents, generally. The
table excludes out-of-scope products (i.e., home/kitchen and ASTM
F963 magnet toys).
Table 13--Magnet Ingestion Incidents, by Use Pattern
----------------------------------------------------------------------------------------------------------------
Use category NEISS (#) NEISS (%) CPSRMS (#) CPSRMS (%)
----------------------------------------------------------------------------------------------------------------
Playing......................................... 143 14.1 61 23.7
Jewelry......................................... 31 3.1 43 16.7
Intentionally Ate............................... 19 1.9 21 8.2
Other........................................... 10 1 4 1.6
Unknown......................................... 811 80 128 49.8
---------------------------------------------------------------
Totals...................................... 1,014 .............. 257 ..............
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSRMS. The percentages are rounded to the nearest tenth.
As Table 13 shows, in both data sets, for incidents in which the
use pattern could be identified, magnets were commonly used as
playthings at the time of ingestion, followed by magnets used as
jewelry. This supports the need to address amusement and jewelry
products in the proposed rule. In addition, these data indicate that
the use pattern is unknown for many magnet ingestions, suggesting that
victims are too young to report the use pattern and ingest magnets
while outside caregiver supervision.
Figure 3 \69\ shows the use patterns during magnet ingestion
incidents, by victim age, for the NEISS data set. Figure 4 \70\ shows
the use patterns during magnet ingestion incidents, by victim age, for
the CPSRMS data set. Both figures include incidents in the magnet sets,
magnet toys, and jewelry categories, as well as incidents in the
unidentified product type category.\71\
---------------------------------------------------------------------------
\69\ To see Figure 3 in color, see Figure 2 in Tab C of the NPR
briefing package.
\70\ To see Figure 4 in color, see Figure 3 in Tab C of the NPR
briefing package.
\71\ As explained above, several factors indicate that many of
the incidents in the unidentified product type category likely
involved subject magnet products, and these incidents indicate the
use patterns and ages involved in magnet ingestion incidents,
generally. The table excludes out-of-scope products (i.e., home/
kitchen and ASTM F963 magnet toys).
---------------------------------------------------------------------------
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TP10JA22.002
[[Page 1280]]
[GRAPHIC] [TIFF OMITTED] TP10JA22.003
BILLING CODE 6355-01-C
As Figures 3 and 4 show, for incidents in which the use pattern was
identified, the majority of victims accidentally ingested the magnets.
A common example of these accidental ingestions is children using the
magnets in or around their mouths when the magnets unexpectedly rolled
to the back of their throats and were ingested, in some cases by
swallow reflex. This is consistent with normal child development,
including exploration and the likelihood that children will be drawn to
magnets aesthetically, and to their invisible attraction and repulsion
properties. Consistent with developmental factors, younger children,
particularly those under 8 years old, were more likely than older
children to be involved in reports of intentional magnet ingestion
(only 4 reports of intentional ingestion involved children 8 years old
and older). The frequency of accidental ingestions suggests that safety
messaging may have limited effectiveness in addressing magnet
ingestions, because children and caregivers are unlikely to anticipate
and appreciate the likelihood of accidental ingestion of magnets.
Victims 8 years old and older were more likely than younger ages to
swallow magnets while simulating piercings. It is foreseeable for this
age group to use magnets as jewelry in or around their mouths, because
experimentation and peer influence are common determinants of behavior
for this age group. Older children and teens often value acceptance by
peers more than obeying parental guidelines, and social influences and
peer pressure can drive adolescent behavior more strongly than their
own independent thought processes. The subject magnet products offer a
seemingly safe and reversible way to try out lip, tongue, cheek, and
nose piercings. If these children see their peers performing this
activity, they may feel compelled to act similarly, even if they are
aware of the risks. Furthermore, older children and early adolescents
are at a developmental stage in which they test limits and bend rules.
3. Post-Ingestion Response
Staff also assessed incident data for information about how victims
and caregivers behaved after a magnet ingestion event, including
whether caregivers became aware of the ingestion, and the time between
ingestion and treatment. Staff found that the invasiveness of medical
interventions was often associated with the length of delay between the
ingestion event and correct medical treatment. At least 56 of the 257
CPSRMS incidents (22 percent) involved a delay of several days between
ingestion and correct treatment, with some delays spanning months. At
least 16 additional incidents (6 percent) involved a delay of 1 day.
One common cause of delays was caregivers being unaware of the
ingestion, resulting in delayed hospital visits and subsequent
misdiagnoses. In many cases, particularly those involving children
under 8 years old, caregivers were not aware that magnets were
ingested. These cases often involved ingestions that were not witnessed
by caregivers, and where the children were unable or unwilling to
communicate what happened.
Another common cause of delays was caregivers misunderstanding the
hazard, such as expecting the magnets to pass naturally. Whether
ingested magnets
[[Page 1281]]
will pass naturally depends on several factors, including the number of
magnets ingested, whether the magnets interact through tissue, and
whether the interaction is strong enough to resist natural bodily
forces. Similarly, delays in care often result when caregivers and
children fail to make the connection between the magnet ingestion and
symptoms, because there is frequently a time delay between magnet
ingestion and symptoms, and because preliminary symptoms typically are
similar to common illnesses. Many cases detail victims receiving
treatment only after experiencing significant discomfort, at which
point substantial internal damage had occurred. For example, one report
indicates that in 2017, a 3-year-old child was found playing with an
older sibling's magnet set, but stated that she had not swallowed any
magnets. Days after the incident, the child became ill and was
misdiagnosed with a stomach virus. Eventually, x-rays were taken,
revealing three magnets in her small intestine. The victim lost a
portion of her digestive tract and was hospitalized for approximately 2
weeks to recover after the surgery.
4. Sources of Access
Staff also examined incident data to determine how and from whom
victims acquired magnets they ingested. Because most NEISS reports (97
percent) did not include sufficient information to determine the source
of access, staff focused on CPSRMS incidents.
Table 14 shows the source of access for the 257 CPSRMS magnet
ingestion incidents. The table includes incidents in the magnet sets,
magnet toys, and jewelry categories, as well as incidents in the
unidentified product type category.\72\
---------------------------------------------------------------------------
\72\ As explained above, several factors indicate that many of
the incidents in the unidentified product type category likely
involved subject magnet products, and these incidents indicate
sources of access in magnet ingestion incidents, generally. The
table excludes out-of-scope products (i.e., home/kitchen and ASTM
F963 magnet toys).
Table 14--Magnet Ingestion Incidents, by Source of Access, for CPSRMS Data
----------------------------------------------------------------------------------------------------------------
Sources of access CPSRMS (#) CPSRMS (%) Description
----------------------------------------------------------------------------------------------------------------
Family Owned............................... 59 23% Magnets belonged to the victim's
family. Includes cases of siblings
finding magnets and bringing them
home.
Friend/Classmate/School/Neighbor........... 41 16 Magnets belonged to friends,
classmates, or neighbors, or the
victim found them at daycare or
school.
Purchased for Victim....................... 26 10.1 Magnets purchased for the victim.
Purchased by Victim........................ 5 1.9 Magnets purchased by the victim.
Found Outside.............................. 4 1.6 Victim found the magnets outside,
such as on a playground. Excludes
cases of siblings finding magnets
and bringing them home.
Unknown.................................... 122 47.5 Unclear where the magnet was
acquired, by whom, or for whom.
Includes cases of magnets found in
the home but where the product
owner was unknown.
--------------------------------
Totals................................. 257 .............. ...................................
----------------------------------------------------------------------------------------------------------------
Percentages are rounded to the nearest tenth.
As Table 14 shows, of the 135 cases with a known source of access,
most cases involved magnets that belonged to family members of the
victim (44 percent), followed by magnets that victims acquired from
friends, classmates, daycares, or schools (30 percent), and magnets
purchased for the victim (19 percent). A small number of incidents
involved magnets purchased by the victim (4 percent), or that the
victim found outside (3 percent).
Victims under 8 years old typically gained access to magnets that
belonged to family members, such as siblings, parents, and relatives.
Magnets from family members were usually found on floors, in or on
furniture, in bags, and affixed to surfaces (e.g., refrigerators,
wallboards); and in some cases, family members intentionally shared the
magnets with victims. In contrast, victims 8 years old and older
typically obtained magnets from friends, classmates, or at school, or
the magnets were purchased for them. Most cases involved children and
teens acquiring loose magnets, as opposed to accessing the full set or
product at the time of ingestion.
Staff also reviewed incident reports for information about product
warnings and age labels on the ingested products, to determine if such
warnings were present and considered by the victims and caregivers.\73\
Of the 57 cases that reported whether there were product warnings, at
least 45 (79 percent) involved products with a magnet ingestion
warning. Similarly, of the 60 cases that reported whether there were
age labels on the product, at least 49 (82 percent) involved products
with a warning to keep the product away from children. At least 44
cases involved products with both magnet ingestion warnings and
warnings to keep the product away from children. Recent magnet
ingestion incidents, in 2021, which are not included in the above
analysis, also indicate that there are numerous incidents in which
involved magnet sets had clear and repeated warnings about the magnet
ingestion hazard and warnings to keep the product away from children.
---------------------------------------------------------------------------
\73\ In most cases, there was insufficient information to
determine if the involved products had warnings, age labels, or
both.
---------------------------------------------------------------------------
Staff further assessed incident data to determine the age of
victims in incidents where the ingested magnets were purchased for or
by the victims. Of the 133 cases with a known source of access and
known victim age, about 23 percent involved magnets purchased for or by
victims under 14 years old, including 9 cases in which the magnets were
purchased for victims under 8 years old. Despite the ages of these
victims, these cases involved products that were not marketed for
children under 14 years old, and were not subject to the toy standard.
For example, in one case, a parent purchased a magnet set for a 9-year-
old child, despite there being clear and repeated warnings about the
magnet ingestion hazard and warnings to keep the product away from
children. In another case, a caregiver gave the same product to a 5-
year-old child, believing the product to be harmless, and believing
that swallowed magnets would pass naturally. The
[[Page 1282]]
child swallowed the magnets, and required surgery, including an
appendectomy, because the magnets attracted internally through tissue.
Based on technical analysis and examination of incident reports,
online and on-package marketing, and consumer reviews for subject
magnet products, staff identified the following factors that likely
contribute to children accessing magnet products that are intended for
older users: Caregivers and victims underestimate the potential
severity of the hazard; social pressures from children, other family
members, and friends; consumers see subject magnet products or similar
products marketed to children; consumers see other children handling
subject magnet products or similar products without incident; consumers
read product reviews about other children handling subject magnet
products or similar products without incident; and caregivers
underestimate the likelihood that children or teens would ingest a
magnet.
This information has implications for the types of requirements
that are likely to effectively reduce the magnet ingestion hazard. For
one, it indicates that requirements that rely on caregiver
intervention, such as safety messaging and packaging requirements, are
unlikely to adequately address the hazard. As the data suggest,
caregivers cannot easily manage children's and teen's access to magnet
products, since children and teens often access them outside the home.
There are additional reasons why these requirements are unlikely to
adequately address the hazard. As these data suggest, many incidents
involve children and teens accessing ingested magnets without their
packaging, making safety messaging and packaging ineffective. In
addition, many incidents involve products that included safety
messaging and age recommendations that consumers did not follow.
Similarly, these data suggest that the toy standard, alone, cannot
adequately address the magnet ingestion hazard because children and
teens purchase, receive, and access magnets from products that are not
intended for their ages.
V. Relevant Existing Standards 74
---------------------------------------------------------------------------
\74\ For additional information about relevant existing
standards, see Tab C and Tab D of the NPR briefing package.
---------------------------------------------------------------------------
CPSC identified six existing safety standards that address the
magnet ingestion hazard. Each of these standards applies to certain
products, and none of the standards apply to all subject magnet
products. Four of the standards are domestic voluntary standards:
ASTM F963-17, Standard Consumer Safety Specification for
Toy Safety;
ASTM F2923-20, Standard Specification for Consumer Product
Safety for Children's Jewelry;
ASTM F2999-19, Standard Consumer Safety Specification for
Adult Jewelry; and
ASTM F3458-21, Standard Specification for Marketing,
Packaging, and Labeling Adult Magnet Sets Containing Small, Loose,
Powerful Magnets (with a Flux Index =50 kG2 mm2).
In addition, two are international safety standards:
EN 71-1: 2014, Safety of Toys; Part 1: Mechanical and
Physical Properties; and
ISO 8124-1: 2018, Safety of Toys -- Part 1: Safety Aspects
Related to Mechanical and Physical Properties.
This section describes these standards and provides CPSC staff's
assessment of their adequacy to address injuries and deaths associated
with magnet ingestions. Several of the standards include requirements
that do not relate to magnets, however, this analysis focuses on those
provisions that are relevant to the magnet ingestion hazard.
A. ASTM F963-17
ASTM F963 was originally approved in 1986, and has been revised
numerous times since then. In 2007, ASTM updated the standard to
include requirements to address the magnet ingestion hazard in
children's toys. In subsequent revisions, ASTM added further
requirements for toys containing magnets. As explained above, in 2008,
section 106 of the CPSIA made ASTM F963 a mandatory consumer product
safety standard; in accordance with that mandate, the Commission
adopted 16 CFR part 1250, which currently incorporates by reference
ASTM F963-17, which is the most recent version of the standard. ASTM
approved ASTM F963-17 on May 1, 2017 and published it in August 2017.
CPSC staff participates in the ASTM F15.22 subcommittee that is
responsible for this standard.
1. Scope
ASTM F963-17 applies to ``toys,'' which the standard defines as
objects designed, manufactured, or marketed as playthings for children
under 14 years old. As such, the standard does not apply to products
that are intended for users 14 years or older, or products that would
not be considered playthings. When ASTM adopted the provisions
regarding magnets, it explained that the purpose of the requirements
was to address magnet ingestion incidents resulting in serious injury
or death by identifying magnets and magnetic components that can be
readily swallowed (section A9.4).
2. Performance Requirements for Magnets
The standard specifies that toys may not contain a loose as-
received ``hazardous magnet'' or a loose as-received ``hazardous
magnetic component.'' In addition, toys may not liberate a ``hazardous
magnet'' or ``hazardous magnetic component'' after specified use-and-
abuse testing, which consists of soaking under water, cycling
attachment and detachment, drop testing, torque testing, tension
testing, impact testing, and compression testing. The standard excepts
from the requirements ``magnetic/electrical experimental sets''
intended for children 8 years and older--such products need only comply
with warning requirements, discussed below.
The standard defines a ``hazardous magnet'' as a magnet that is a
small object (i.e., fits entirely within a small parts cylinder
specified in the standard) and has a flux index of 50 kG\2\ mm\2\ or
more (as measured in accordance with the method specified in the
standard). Thus, a magnet must be both small and strong, according to
the criteria in the standard, to be ``hazardous.'' A ``hazardous
magnetic component'' is any part of a toy that is a small object and
contains an attached or imbedded magnet with a flux index of 50 kG\2\
mm\2\ or more.
ASTM F963-17 describes the small parts cylinder in section 4.6 and
illustrates it in Figure 3; to be a small object, the magnet must fit
entirely within the cylinder. The small parts cylinder depicted in ASTM
F963-17 is the same as the small parts cylinder in CPSC's regulations,
at 16 CFR 1501.4. Sections 8.25.1 through 8.25.3 describe the test
methodology to measure the maximum absolute flux of a magnet and to
calculate the flux index. A flux index is a calculated value of
magnetic density and size. The flux index of a magnet is calculated by
multiplying the square of the magnet's maximum surface flux density (in
KGauss (kG)) by its cross-sectional area (in mm\2\).
3. Warning Requirements
ASTM F963-17 does not include specific labeling requirements for
toys containing loose as-received hazardous magnets or hazardous
magnetic components, except for ``magnetic/electrical experimental
sets'' intended
[[Page 1283]]
for children 8 years and older, which are exempt from the performance
requirements and need only meet labeling requirements. The standard
defines a ``magnetic/electrical experimental set'' as a ``toy
containing one or more magnets intended for carrying out educational
experiments that involve both magnetism and electricity.'' Section
A12.4 in the standard explains that this definition is intended to
cover only products that combine magnetism and electricity. The
packaging and instructions for magnetic/electrical experimental sets
intended for children 8 years and older must be labeled with a warning
that addresses the magnet ingestion hazard.
4. Assessment of Adequacy
CPSC staff does not consider ASTM F963-17 capable of adequately
reducing the risk of injury and death associated with magnet ingestions
because of the scope of products it covers.
The size and strength requirements in ASTM F963-17 are consistent
with the requirements proposed in this rule for subject magnet
products. Section VI. Description of and Basis for the Proposed Rule,
below, discusses these size and strength requirements and their ability
to address the hazard. Staff considers the size and strength
requirements adequate to address the hazard. However, ASTM F963-17 only
applies to products designed, manufactured, or marketed as playthings
for children under 14 years old; it does not apply to products intended
for older users or products that would not be considered playthings.
Accordingly, staff does not believe that compliance with the standard
is likely to adequately reduce the magnet ingestion hazard.\75\
---------------------------------------------------------------------------
\75\ Based on incident data, staff believes that the exception
in ASTM F963-17 for magnetic/electrical experimental sets intended
for children 8 years and older is likely not problematic for
adequately addressing the magnet ingestion hazard. Staff identified
only one magnet ingestion incident that involved a ``science kit,''
which potentially could be a magnetic/electrical experimental set.
---------------------------------------------------------------------------
As the incident data indicate, children and teens commonly access
and ingest magnets from products intended for older users. Both NEISS
and CPSRMS data indicate that the most common products identified in
magnet ingestions were magnet sets and magnet toys, which are products
that are intended for users 14 years or older, or where the intended
user age was unknown, but there were no indications that the product
was intended for users under 14 years. Despite the involvement of
products intended for users 14 years and older, the vast majority of
magnet ingestion incidents involved children under 14 years old. For
example, among CPSRMS incidents for which the victim's age was known,
the most common ages that ingested magnet sets were 2, 8, 9, and 10
years old.
The sources from which children access ingested magnets further
illustrates the need to address magnets in products intended for older
users. For example, according to CPSRMS data, children and teens
commonly access ingested magnets that belong to other family members,
in the home, from friends, or loose in the environment, suggesting
their access is not limited to toys intended for them.
In addition, ASTM F963-17 does not apply to products that are not
intended to be playthings. Both NEISS and CPSRMS data indicate that
many products involved in magnet ingestion incidents are described as
jewelry, and that children of various ages ingest magnet jewelry (e.g.,
accidentally ingesting magnets while simulating lip, tongue, and cheek
piercings). Because ASTM F963-17 only applies to playthings, it does
not apply to jewelry, regardless of the intended user age.
As such, ASTM F963-17, alone, is not sufficient to address the
magnet ingestion hazard, because it does not impose any requirements on
products intended for users 14 years or older or jewelry, which are
known to be involved in many magnet ingestion incidents.
B. ASTM F2923-20
ASTM first issued ASTM F2923 in 2011. The current version of the
standard is ASTM F2923-20, which was approved on February 1, 2020, and
published in March 2020.
1. Scope
ASTM F2923-20 applies to ``children's jewelry,'' which is jewelry
designed or intended primarily for use by children 12 years old or
younger. The standard defines ``jewelry'' as a product that is
primarily designed and intended as an ornament worn by a person. The
standard does not apply to toy jewelry or products intended for a child
when playing. The standard includes requirements that are intended to
address ingestion, inhalation, and attachment hazards associated with
children's jewelry that contains a hazardous magnet or hazardous
magnetic component. The standard defines a ``hazardous magnet'' and
``hazardous magnetic component'' be referencing the definition in ASTM
F963, except that the standard exempts chains that are longer than 6
inches from the definition of ``hazardous magnetic component.''
2. Performance Requirements for Magnets
ASTM F2923-20 prohibits children's jewelry from having an as-
received hazardous magnet or hazardous magnetic component. The standard
excepts from this requirement children's jewelry intended for children
8 years and older consisting of earrings, brooches, necklaces, or
bracelets--such products need only comply with warning requirements,
discussed below. In addition, the standard prohibits children's jewelry
from liberating a hazardous magnet or hazardous magnetic component
after the use-and-abuse testing specified in ASTM F963.
3. Warning Requirements
ASTM F2923-20 does not include specific labeling requirements for
children's jewelry containing hazardous magnets or hazardous magnetic
components, except for children's jewelry intended for children 8 years
and older that consists of earrings, brooches, necklaces, or bracelets.
These products are exempt from the performance requirements and need to
include a warning that addresses the magnet ingestion hazard.
Instructions that accompany the product must also include these
warnings.
4. Assessment of Adequacy
CPSC staff does not consider ASTM F2923-20 capable of adequately
reducing the risk of injury and death associated with magnet
ingestions. Although staff considers the size and strength requirements
in the standard adequate to address the magnet ingestion hazard, the
standard excepts certain children's jewelry from these performance
requirements, and the scope of products covered by the rule makes the
standard insufficient to address the magnet ingestions, generally.
The first issue with the standard is that it excludes from the size
and strength requirements for magnets children's jewelry that is
intended for children 8 years and older that consists of earrings,
brooches, necklaces, and bracelets. Applying only warning requirements
to these products is not adequate to reduce the magnet ingestion
hazard. As the incident data indicate, almost half of magnet ingestion
incidents involve children 8 years and older, and children and teens,
particularly in this age group, commonly used magnets as jewelry at the
time of ingestion. Warning requirements, alone, are not adequate to
[[Page 1284]]
address these incidents. As the discussion of ASTM F3458-21, below,
covers in detail, caregivers and children commonly do not heed
warnings, and children and teens commonly access magnets that are
separated from their packaging, where warnings are provided.
The second issue with the standard is that it applies only to
jewelry that is designed or intended primarily for use by children 12
years old or younger. As such, it does not impose requirements on
magnet sets or magnet toys intended for users 14 years and older, which
are the most common product types identified in magnet ingestion
incidents. The standard also does not apply to jewelry intended for
users over 12 years old. Although incident data do not indicate the
intended user age of jewelry products involved in ingestions, the data
indicate that children and teens of various ages ingested magnets
intended for users 14 years and older when using the magnets as
jewelry, making it is reasonable to conclude that jewelry intended for
users over 12 years old poses an ingestion hazard for children and
teens.
For these reasons, ASTM F2923-20, on its own, is not sufficient to
address the magnet ingestion hazard because it does not impose
requirements on magnet sets, magnet toys, or certain jewelry, which are
shown to be involved in many magnet ingestion incidents.
C. ASTM F2999-19
ASTM first issued ASTM F2999 in 2013; the current version of the
standard is ASTM F2999-19, which ASTM approved on November 1, 2019, and
published in November 2019.
1. Scope
ASTM F2999-19 establishes requirements and test methods for certain
hazards associated with adult jewelry, including magnets. The standard
defines ``adult jewelry'' as jewelry designed or intended primarily for
use by consumers over 12 years old. It defines ``jewelry'' as a product
primarily designed and intended as an ornament worn by a person, and
provides several examples, such as bracelets, necklaces, earrings, and
jewelry craft kits where the final assembled product meets the
definition of ``jewelry.'' The standard defines a ``hazardous magnet''
as ``a magnet with a flux index >50 as measured by the method described
in Consumer Safety Specification F963 and which is swallowable or a
small object.''
2. Performance Requirements for Magnets
ASTM F2999-19 does not include any performance requirements for
adult jewelry that contains magnets; it specifies only labeling
requirements, discussed below.
3. Labeling Requirements
ASTM F2999-19 states that ``adult jewelry that contains hazardous
magnets as received should include a warnings statement which contains
the following text or substantial equivalent text which clearly conveys
the same warning.'' Thus, rather than the mandatory language ASTM
standards typically use (i.e., shall), the standard merely recommends
(i.e., should) that warnings regarding hazardous magnets be provided
with adult jewelry. The warning statement provided in the standard
warns of the internal interaction hazard if magnets are swallowed or
inhaled, and recommends seeking immediate medical attention.
4. Assessment of Adequacy
CPSC staff does not consider ASTM F2999-19 capable of adequately
reducing the risk of injury and death associated with magnet
ingestions. For one, the standard does not include any requirements for
adult jewelry containing magnets--rather, it suggests complying with
the magnet provisions. As incident data indicate, many magnet ingestion
incidents involve products used as jewelry, and children and teens
accessing products intended for older users. This demonstrates the need
for a mandatory requirement for adult jewelry.
In addition, the only provisions in the standard that address
magnet ingestions are warnings. As the discussion of ASTM F3458-21,
below, covers in detail, warning requirements, alone, are not adequate
to address the magnet ingestion hazard because caregivers and children
commonly do not heed warnings, and children and teens commonly access
magnets that are separated from their packaging, where warnings are
provided.
The scope of the standard also makes it insufficient to adequately
address the magnet ingestion hazard. Because it applies only to jewelry
designed or intended primarily for use by consumers over 12 years old,
the standard does not impose requirements on magnet sets or magnet toys
intended for users 14 years and older, which are the most common
products identified in magnet ingestion incidents. It also does not
impose requirements on jewelry intended for users 12 years old and
younger. Although the incident data do not indicate the intended user
age of jewelry involved in magnet ingestions, because many incidents
involve children 12 years old and younger, it is reasonable to conclude
that jewelry intended for such users pose the magnet ingestion hazard
for children and teens.
Another potential issue with ASTM F2999-19 is that it defines a
hazardous magnet, for purposes of determining whether the warning
provisions apply, as having a flux index greater than 50 kG\2\ mm\2\.
In contrast, ASTM F963-17, ASTM F2923-20, and this proposed rule,
define a hazardous magnet as having a flux index greater than or equal
to 50 kG\2\ mm\2\, thereby, addressing magnets with a flux index of
precisely 50 kG\2\ mm\2\. This makes ASTM F2999-19 inconsistent with
the toy standard, which has been in effect for many years and has been
effective at addressing the magnet ingestion hazard for toys.
For these reasons, ASTM F2999-19, alone, is not sufficient to
address the magnet ingestion hazard because it does not impose
performance requirements on magnet sets, magnet toys, or certain
jewelry, which are involved in many magnet ingestion incidents.
D. ASTM F3458-21
In 2019, ASTM Subcommittee F15.77 on Magnets began work to develop
a standard for magnet sets intended for users 14 years and older. On
February 15, 2021, ASTM approved ASTM F3458-21, and published the
standard in March 2021. ASTM F3458-21 consists of marketing, packaging,
labeling, and instructional requirements for magnet sets intended for
users 14 years and older.
Since March 2019, CPSC staff has participated actively in
Subcommittee F15.77 on Magnets. During the development of ASTM F3458-
21, CPSC staff raised several concerns to the subcommittee about the
developing standard, including the reliance on marketing, packaging,
labeling, and warnings requirements, rather than performance
requirements to limit the size and strength of magnets. The assessment
of the standard, below, and Tab C of the NPR briefing package, detail
these concerns; Tab C also includes a letter CPSC staff sent the
subcommittee, expressing these concerns. Based on these issues, CPSC
considered the standard inadequate to address the magnet ingestion
hazard and voted against the final version of the standard that was
ultimately adopted.
In May 2021, after ASTM F3458-21 was adopted, Subcommittee F15.77
on Magnets voted to form a task group to
[[Page 1285]]
consider revising the standard to include performance requirements for
magnet sets intended for users 14 years and older. CPSC staff will
continue to work with the subcommittee, however, whether the standard
will be revised, and what requirements may be added to it, are, as yet,
undetermined.
1. Scope
ASTM F3458-21 aims to minimize the hazards to children and teens
associated with ingesting small, powerful magnets in magnet sets that
are intended for users 14 years and older. The standard defines a
``magnet set'' as ``an aggregation of separable magnetic objects that
are marketed or commonly used as a manipulative or construction item
for puzzle working, sculpture building, mental stimulation, education,
or stress relief.'' It also defines a ``small, powerful magnet'' as an
``individual magnet of a magnet set that is a small object'' and has a
flux index of 50 kG\2\ mm\2\ or more. The criteria for identifying a
small object and the flux index are the same as in ASTM F963-17.
2. Performance Requirements for Magnets
The standard does not include size and strength limits for magnet
sets themselves. The standard includes performance criteria in the form
of test methods to determine if a product is a ``small, powerful
magnet,'' and test methods for assessing label permanence; however, the
standard does not include performance requirements preventing small,
powerful magnets from being used in magnet sets. Instead, ASTM F3458-21
includes requirements for instructional literature, sales/marketing,
labeling, and packaging, discussed below. These requirements seek to
inform and encourage consumers to keep magnets away from children.
3. Instructional Literature Requirements
ASTM F3458-21 requires magnet sets intended for users 14 years and
older to come with instructions that address assembly, maintenance,
cleaning, storage, and use. The instructions must include warnings (as
specified below), the manufacturer's suggested strategy for counting
and storing magnets, a description of typical hazard patterns (e.g.,
young children finding loose magnets), an illustration of the hazard, a
description of typical symptoms associated with magnet ingestion, and
statements regarding medical attention when magnets are ingested.
4. Sales/Marketing Requirements
The standard prohibits manufacturers from knowingly marketing or
selling magnet sets intended for users 14 years and older to children
under 14 years old, and requires them to ``undertake reasonable
efforts'' (with examples) to ensure the product is not marketed or
displayed as a children's toy. For online sales, manufacturers must
``undertake reasonable efforts'' (with examples) to ensure that online
sellers do not sell magnet sets intended for users 14 years and older
to children under 14 years. When selling directly to consumers online,
manufacturers must include warnings (as specified below) and
instructional literature about the hazard pattern.
5. Labeling Requirements
ASTM F3458-21 requires magnet sets intended for users 14 years and
older to bear warnings on the retail packaging and ``permanent storage
container,'' which the standard defines as a container designed to hold
the magnet set when it is not in use. At a minimum, the warnings must
address the hazard associated with magnet ingestions, direct users to
keep the product away from children, and provide information about
medical attention. The standard includes an example warning label, and
specifies design and style requirements for the warning label. In
addition, the standard requires the label to be permanent and provides
a test method for assessing label permanence.
6. Packaging Requirements
The standard requires magnet sets intended for users 14 years and
older to be sold with or in a permanent storage container. The
permanent storage container must include a way to verify that all the
magnets have been returned to the container. In addition, the standard
requires the permanent storage container to be re-closeable and include
one of the following means of restricting the ability to the open the
container: (1) The container requires two consecutive actions, the
first of which must be maintained while the second is carried out, or
requires two separate and independent simultaneous actions to fully
release, withstanding specified testing; (2) the container requires one
action that requires at least 15 lbf to open or requires at least 4
inches lbf of torque to open, withstanding specified testing; or (3)
the container meets the performance requirements in 16 CFR 1700.15 and
the testing requirements of 16 CFR 1700.20 (which are poison preventing
packaging standards, adopted under the Poison Prevention Packaging Act
\76\ and specify packaging that is significantly difficult for children
under 5 years old to open within a reasonable time).
---------------------------------------------------------------------------
\76\ 15 U.S.C. 1471-1477.
---------------------------------------------------------------------------
7. Assessment of Adequacy
CPSC staff does not consider ASTM F3458-21 capable of adequately
reducing the risk of injury and death associated with magnet
ingestions. For one, the limited scope of products subject to the
standard is inadequate to address the hazard. The standard only applies
to magnet sets intended for users 14 years and older. As such, it
imposes no requirements on other products intended for users 14 years
and older, or on jewelry (both children's and adult), which are shown
to be involved in magnet ingestion incidents.
In addition, the types of requirements in the standard make it
inadequate to address the magnet ingestion hazard. For a detailed
discussion of the weaknesses of warnings, instructional, sales/
marketing, and packaging requirements to address the magnet ingestion
hazard, see Tab C of the NPR briefing package. The following is an
overview of these weaknesses.
Throughout the standard development process, CPSC staff emphasized
that performance requirements for magnets are necessary to adequately
address the magnet ingestion hazard. Such requirements typically
include size and strength requirements for the magnets themselves, as
in the toy standard and this proposed rule. However, ASTM F3458-21 does
not include performance requirements to prevent magnet sets intended
for users 14 years and older from containing small, powerful magnets,
and instead, relies on requirements to inform and encourage consumers
to keep magnets away from children. As incident data indicate, children
and teens access magnet products, including magnet sets, that are
intended for older users, making it important to address the magnet
ingestion hazard for magnet sets intended for users 14 years and older.
However, safety messaging (e.g., warnings and instructions) and
packaging requirements, without performance requirements for the
magnets themselves, are not likely to adequately address the hazard.
Safety Messaging. Safety literature has shown that warnings are the
least effective strategy for addressing a hazard, relative to designing
out the hazard or designing guards against the hazard. This is because
safety messaging relies on persuading consumers to avoid
[[Page 1286]]
hazards, but numerous factors can reduce the likelihood that consumers
will read and follow safety messaging.
One factor that weighs against consumers heeding safety warnings is
their perception that magnet products present a low safety risk.
Magnets in products intended for amusement or jewelry are likely to
appear simple, familiar, and non-threatening to children, teens, and
caregivers. Incident data and consumer reviews demonstrate that
consumers commonly recognize these types of magnetic products as
suitable playthings for children, which undermines the perceived
credibility of warnings that state the magnets are hazardous for
children. The availability of children's toys that are similar to
subject magnet products intended for users 14 years and older may also
affect consumers' perception of the hazard because the products appear
similar, and some are marketed for children. Once familiar with a
product, consumers tend to generalize across similar products, and the
more familiar consumers are with a product, the less likely they are to
look for, or read, warnings and instructions. If caregivers observe
their child, or their child's peers using a product or a similar
product without incident, caregivers may conclude that their child can
use the product safely, regardless of what the warnings state. This is
also true for recommendations from others, including online reviews of
products, which can influence the likelihood of consumers disregarding
warnings. Staff reviewed numerous consumer reviews of subject magnet
products, and found that many indicated that consumers purchased the
product for a child, or that their children started playing with it,
despite the product not being intended for users under 14 years old.
Similarly, when a child or teen repeatedly uses the product in or
around their mouth without ingesting a magnet or experiencing
consequences from ingestion, they and their caregivers are likely to
conclude that the hazard is not likely to occur, or is not relevant to
them.
Another reason that safety messaging has limited effectiveness is
that consumers misunderstand the hazard. For small, powerful magnets,
the internal interaction hazard is a hidden hazard, so consumers are
unlikely to anticipate and appreciate the risk to children, especially
older children and teens who do not have a history of mouthing or
ingesting inedible objects. However, of the magnet ingestion cases that
identify whether the ingestions were intentional or accidental, the
majority describe accidental ingestions, which is much more difficult
for consumers to appreciate and prevent.
Similarly, there are developmental factors that predispose older
children and teens to disregard warnings and use the small, powerful
magnet products in and around their mouths and noses. As discussed
above, older children and teens are at a developmental stage in which
they test limits and bend rules. Experimentation and peer influence are
common determinants of behavior for this age group. Small, powerful
magnets offer a seemingly safe and reversible way to try out lip,
tongue, cheek, and nose piercings; and if children and teens see their
peers doing this, they may act similarly, despite being aware of the
risks.
In addition, consumers misunderstand the progression of symptoms
associated with magnet ingestions, which may lead them to disregard
warnings. As incident reports show, many children, teens, and
caregivers wrongly assume that, when ingested, magnets will pass
through the body without causing harm. This contributes to delays
between ingestion and correct treatment, increasing the risks
associated with magnet ingestion.
Another factor that limits the potential effectiveness of safety
messaging is how children and teens obtain magnets they ingest. As
incident data show, children and teens commonly obtain ingested magnets
loose in their environments, from friends, or at school, where the
product is separated from any packaging or instructions that bear
warnings. Because small, powerful magnets themselves are too small to
bear warnings, these children and teens, and their caregivers, may not
be made aware of the hazard.
Finally, safety messaging has been ineffective at reducing the
magnet ingestion hazard, to date. As discussed above, and in Tab C of
the NPR briefing package, staff has examined dozens of incident reports
that indicate children and teens obtained and ingested small, powerful
magnets even when the product was marketed and prominently labeled with
warnings about the hazard and stated that the product was not
appropriate for children. For example, of the CPSRMS incidents reported
to have occurred between January 1, 2010 and December 31, 2020, staff
examined at least 44 incidents in which a child ingested a magnet
product that included warnings about the hazard and cautioned to keep
the product away from children. Similarly, of 41 magnet sets for which
staff assessed consumer reviews, 35 percent of the reviews mentioned
use by children, despite 68 percent including a warning about the
magnet ingestion hazard.
Another indication of the ineffectiveness of safety messaging to
address the magnet ingestion hazard, to date, is the upward trend in
magnet ingestion cases in recent years, despite many years of consumer
awareness campaigns. As discussed above, for many years, CPSC has drawn
attention to the magnet ingestion hazard through recalls, safety
alerts, public safety bulletins, and rulemaking activity. In addition,
there have been numerous public outreach efforts by health
organizations and other consumer advocacy groups to warn consumers
about the internal interaction hazard posed by small, powerful magnets.
Despite these efforts, magnet ingestion incidents have increased in
recent years.
Packaging. Similar to safety messaging, there are several reasons
staff considers packaging requirements inadequate to address the magnet
ingestion hazard. For one, incident data show that children and teens
commonly access ingested magnets loose in their environment and from
friends, in which case the product is likely to be separated from its
packaging, rendering CR packaging or visual cues that all magnets are
in the package ineffective.
In addition, the features provided for in ASTM F3458-21 to make the
packaging difficult for children to open would not be effective at
preventing older children and teens from accessing the magnets in the
packaging. For example, the third packaging option provided in the
standard allows the packaging to meet the requirements in 16 CFR
1700.15 and 1700.20. Those provisions are intended to make packaging
significantly difficult for children under 5 years old to open within a
reasonable time. Thus, such packaging does not prevent all children
under 5 years old from opening it, particularly given ample time, and
it is not intended to prevent any children 5 years and older from
opening the packaging. As the incident data indicate, the majority of
magnet ingestion incidents involved victims 5 years and older, making
this packaging ineffective at restricting their access. Similarly, for
the alternative packaging options in the standard, children and teens
are likely to have cognitive and motor skills sufficient to access the
products.
Even if CR packaging features did prevent children and teens from
opening the packaging, the effectiveness of packaging to address the
hazard would rely on consumers correctly repackaging all the magnets
after every use, which is likely unrealistic. For one,
[[Page 1287]]
the products often are intended for purposes that make repackaging
after each use unlikely. For example, products such as magnet sets are
intended to assemble and display complex sculptures, and some jewelry
may involve creating designs, making consumers unlikely to disassemble
their designs to repackage all the magnets after every use. In
addition, consumers are not likely to perceive the products as
hazardous because they are intended for amusement or jewelry and are
not hazardous in appearance, and therefore, would not consider it
necessary to repackage all the magnets after every use. Even for
products that are obviously hazardous and commonly use CR packaging,
such as chemicals and pharmaceuticals, consumers have inconsistently
used the packaging. Consumers may also consider CR packaging a
nuisance, making them unlikely to store magnets in the packaging after
every use.
In addition, the small size of the magnets and large number of
magnets (particularly in some magnet sets and magnetic jewelry sets),
make it unlikely that consumers would return all the magnets to the
packaging after every use. The small size and often large quantity of
magnets in a set make locating and counting the magnets after every
use, to ensure they are all returned to the package, not feasible or
realistic. For example, staff has identified products that were
involved in magnet ingestion incidents that consisted of thousands of
2.5 mm diameter magnets. Staff has found that it is common for magnets
to be flicked away from one another when they are being handled, such
as when separating magnets, resulting in magnets being dropped. These
actions are foreseeable, particularly for magnets intended for
fidgeting and building. In examining magnet sets, staff found that many
sets are sold with extra pieces, in part, because losing magnets is
expected. In addition, many incident reports and consumer reviews of
magnet sets mention lost magnets. Given the large number of magnets
often included in a set, their small size, and their tendency to be
separated and lost, it is unlikely that consumers will use CR packaging
effectively. The time and effort necessary to locate, assemble, and
repackage such small and numerous magnets is likely to be beyond what
consumers are willing to spend.
For these reasons, ASTM F3458-21, alone, is not sufficient to
address the magnet ingestion hazard because it does not impose
performance requirements on magnets themselves, and it does not apply
to several products that are involved in magnet ingestion incidents.
E. EN 71-1: 2014
The European standard applies to children's toys, which are
products intended for use in play by children younger than 14 years
old. The requirements regarding magnets in EN 71-1: 2014 are
essentially the same as in ASTM F963-17--any loose as-received magnet
and magnetic component must either have a flux index less than 50 kG\2\
mm\2\, or not fit entirely in a small parts cylinder. The flux index is
determined using the same method as in ASTM F963-17, and the small
parts cylinder is the same as in ASTM F963-17. EN 71-1: 2014 also
requires use-and-abuse testing similar to ASTM F963-17, to ensure that
toys do not liberate a hazardous magnet or hazardous magnetic
component. The standard includes a similar exemption to ASTM F963-17
for magnetic/electrical experimental sets intended for children 8 years
of age and older, which need only bear a warning regarding the magnet
ingestion hazard.
Thus, the provisions addressing the magnet ingestion hazard in EN
71-1: 2014 are largely the same as in ASTM F963-17. As discussed above,
for ASTM F963-17, CPSC staff does not consider these provisions capable
of adequately reducing the risk of injury and death associated with
magnet ingestions because of the limited scope of the standard. Because
the standard only applies to toys intended for children under 14 years
old, it does not impose any requirements on products intended for older
users, or products that would not be considered playthings. As the
incident data indicate, magnet ingestion incidents include children and
teens ingesting products intended for older users, and ingesting
jewelry, neither of which this standard addresses.
F. ISO 8124-1: 2018
This standard applies to toys, which are products intended for use
in play by children under 14 years old. The standard requires any loose
as-received magnet and magnetic component to either have a flux index
less than 50 kG\2\ mm\2\ or not fit entirely within a small parts
cylinder. The flux index is determined the same way as in ASTM F963-17,
and the small parts cylinder is the same as in ASTM F963-17. ISO 8124-1
also requires similar use-and--abuse testing to ASTM F963-17, to ensure
that a hazardous magnet or hazardous magnetic component does not
liberate from a toy. Similar to ASTM F963-17, ISO 8124-1 also provides
an exemption for magnetic/electrical experimental sets intended for
children 8 years and older, which need only bear a warning regarding
the magnet ingestion hazard.
Thus, the provisions addressing the magnet ingestion hazard in ISO
8124-1: 2018 are largely the same as in ASTM F963-17. As discussed
above, for ASTM F963-17, CPSC staff does not consider these provisions
capable of adequately reducing the risk of injury and death associated
with magnet ingestions because of the limited scope of the standard.
Because the standard only applies to toys intended for children under
14 years old, it does not impose any requirements on products intended
for older users, or products that would not be considered playthings.
As the incident data indicate, magnet ingestion incidents include
children and teens ingesting products intended for older users, and
ingesting jewelry, neither of which this standard addresses.
G. Compliance With Existing Standards
CPSC has limited information about the extent to which products
comply with existing standards. Based on staff's analysis, only a small
number of magnet ingestion incidents for which a product type could be
identified involved children's toys subject to ASTM F963, which
provides some indication that children's toys commonly comply with the
standard. Of the magnet ingestion incidents that involved children's
toys, staff identified six incidents that involved internal interaction
of the magnets through body tissue, again suggesting there may be a
high level of compliance with the standard. None of the products in
these six incidents complied with the magnet requirements in ASTM F963.
CPSC staff does not have detailed information about the extent to
which products comply with ASTM F2923, F2999, or F3458. Incident
reports commonly do not provide enough detail for staff to identify the
specific product (e.g., brand) to obtain it and assess it for
compliance. In addition, for ASTM F3458, the standard was adopted
recently (March 2021), making it difficult to determine the level of
compliance with it. CPSC seeks comments and data about the level of
compliance with the existing standards that address the magnet
ingestion hazard.
VI. Description of and Basis for the Proposed Rule
A. Scope and Definitions
1. Proposed Requirements
The proposed rule applies to ``subject magnet products,'' defined
as ``a
[[Page 1288]]
consumer product that is designed, marketed, or intended to be used for
entertainment, jewelry (including children's jewelry), mental
stimulation, stress relief, or a combination of these purposes, and
that contains one or more loose or separable magnets.'' The proposed
rule exempts from its scope, toys that are subject to 16 CFR part 1250,
Safety Standard Mandating ASTM F963 for Toys.
The proposed rule only applies to ``consumer products,'' as defined
in the CPSA, which are ``article[s], or component part[s] thereof,
produced or distributed (I) for sale to a consumer for use in or around
a permanent or temporary household or residence, a school, in
recreation, or otherwise, or (ii) for the personal use, consumption or
enjoyment of a consumer in or around a permanent or temporary household
or residence, a school, in recreation, or otherwise.'' 15 U.S.C.
2052(a)(1). Consumer products do not include products that are not
customarily produced or distributed for sale to, or for the use or
consumption by, or enjoyment of, a consumer. Id.
The proposed rule also defines ``hazardous magnets'' as ``a magnet
that fits entirely within the cylinder described in 16 CFR 1501.4 and
that has a flux index of 50 kG\2\ mm\2\ or more when tested in
accordance with the method described in this part 1262.''
2. Basis for Proposed Requirements
To determine the appropriate scope of products to cover in the
proposed rule to adequately reduce the risk of injury and death
associated with magnet ingestions, CPSC staff considered magnet
ingestion incident data, magnet use patterns, magnet ingestion rates
when other mandatory standards took effect, recalls, child development
and behavioral patterns, the uses of hazardous magnets in consumer
products, consumer reviews for products with loose or separable
hazardous magnets, existing standards, contributions from stakeholders
in the ASTM Subcommittee F15.77 on Magnets, and relevant research
literature. The definition of ``subject magnet products'' consists of
several elements that include and exclude certain products from the
scope of the proposed rule. This section discusses the reasons for the
criteria in the definition. The basis for the elements of the proposed
definition of ``hazardous magnets'' is discussed below, as part of the
basis for the performance requirements in the proposed rule.
a. Consumer Products
Subject magnet products are limited to ``consumer products,'' as
that term is defined in the CPSA. Accordingly, any product that is not
customarily produced or distributed for sale to or use by a consumer,
is not within the scope of the proposed rule. This could include
professional, industrial, or commercial products that would not
customarily be available to or used by consumers. This element of the
definition is included because CPSC's authority under the CPSA is
limited to consumer products, and because products that are not
customarily available to consumers would not be likely to pose a magnet
ingestion hazard to children and teens.
b. Loose or Separable Magnets
Subject magnet products are limited to products that contain
``loose or separable magnets.'' This is because magnets that are not
loose or separable, such as non-removable magnets that are integrated
into or attached to a product, would not pose an ingestion hazard. For
example, a magnetic clasp attached to a necklace would not pose an
ingestion hazard because it is connected to a larger object, making it
unlikely to be swallowed.
In addition, the definition of ``subject magnet products''
specifically refers to magnets. Although not explicit in the
definition, this refers to permanent magnets, which are magnets that
maintain their magnetic field after being removed from the magnetizing
source. Staff does not consider it necessary to specify that the
standard applies to permanent magnets. For one, products that lose
their magnetism when separated from their magnetizing source (e.g.,
electromagnets that lose their magnetism when separated from the source
of electricity) are unlikely to exceed the size criteria in the
proposed rule when functioning as magnets because, to be magnetized,
the product would have to be attached to its magnetizing source, which
would render the product too large to fit entirely within the small
parts cylinder. When separated from its magnetizing source, thereby
making the item potentially small enough to fit entirely in the small
parts cylinder, the item would lose its magnetism, and no longer be a
``magnet'' subject to the standard. In addition, for the magnet to be
``loose or separable'' it would need to be a magnet (i.e., magnetized)
when loose and separated from other components, including a magnetizing
source. CPSC seeks comments on whether it is necessary for the proposed
rule to specify that it applies only to permanent magnets, or whether
the rule should apply to non-permanent magnets as well.
c. One or More Magnets
The definition also specifies that subject magnet products include
``one or more'' loose or separable magnets; thus, they include products
with only a single loose or separable magnet. There are two reasons for
including this in the definition of ``subject magnet products.'' First,
an individual magnet can interact internally through body tissue with
an unrelated magnet or a ferromagnetic object, resulting an internal
interaction injury. Thus, even a product with a single loose or
separable magnet poses the same internal interaction hazard as products
with multiple magnets. Second, subject magnet products may be sold as
individual magnets or with a choice of how many magnets to include in a
set. Staff identified magnets sets on the market that are sold with
extra pieces to serve as replacements for magnets lost from the set.
Thus, magnets sold individually may be intended as, or may be used as,
part of a set, posing the risk of children and teens ingesting more
than one magnet. Limiting the proposed rule to products that include
two or more loose or separable magnets would not address the hazard
posed by a single magnet, and would leave a gap in the standard to
allow firms to sell magnets individually, without having to comply with
the proposed rule. Moreover, applying the proposed rule to products
that include a single loose or separable magnet is consistent with the
toy standard in 16 CFR part 1250 because ASTM F963-17 applies to
products that contain one or more hazardous magnets.
d. Amusement or Jewelry
The definition of ``subject magnet products'' is limited to
products that are designed, marketed, or intended to be used for
entertainment, jewelry, mental stimulation, stress relief, or a
combination of these purposes. Essentially, this means that the
proposed rule applies to products that are designed, marketed, or
intended for amusement or jewelry. This section discusses the reasons
CPSC considers it appropriate to focus on magnet products intended for
amusement and jewelry to reduce the risk of injury and death associated
with magnet ingestions. The focus on amusement and jewelry products is
also consistent with
[[Page 1289]]
international standards, which address these products, in
particular.\77\
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\77\ As discussed above, Canada's efforts to address the magnet
ingestion hazard have focused on products intended for amusement,
and New Zealand's and Australia's efforts have focused on products
intended for amusement and jewelry.
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Description of Products. Magnets intended for amusement include a
variety of products for consumer entertainment, mental stimulation, and
stress relief. Whether a product is designed, marketed, or intended to
be used for these purposes depends on multiple considerations, such as
how the manufacturer describes the product, marketing and advertising
for the product, product packaging and displays, and how consumers are
reasonably likely to perceive or use the product. Common examples of
products that contain loose or separable magnets intended for
entertainment, mental stimulation, or stress relief (other than
children's toys) include products commonly referred to as ``executive
toys,'' ``desk toys,'' ``magnet sets,'' and ``rock magnets.'' Magnet
sets generally are aggregations of separable magnets commonly used for
manipulating or constructing sculptures. Rock magnets generally are
loose magnets shaped like rocks and intended for entertainment or
fidgeting. These are some examples, and additional products may be
designed, marketed, or intended to be used for entertainment, mental
stimulation, stress relief, or a combination of these purposes.
Subject magnet products that are jewelry also include a variety of
products, such as jewelry intended for adults or for children, jewelry
making sets, and magnetic piercings and studs. For example, staff has
identified necklaces made of numerous small magnets, in multiple
shapes, that consumers can rearrange in various configurations.
Incident Data. As the incident data indicate, magnet ingestion
cases generally involve seven categories of magnet products (see
section IV.A. Incident Data, above, for a detailed description of the
categories): Magnet sets, magnet toys, jewelry, home/kitchen magnets,
ASTM F963 magnet toys, science kits, and unidentified products.
Products categorized as magnet sets, magnet toys, and ASTM F963 magnet
toys are generally intended for amusement, however, ASTM F963 magnet
toys are excluded from the scope of the proposed rule.
As the incident data show, products categorized as amusement and
jewelry, by far, are the most common product categories identified in
magnet ingestion incidents. Table 1 shows that magnet toys, by far,
were the most common product type category identified \78\ in NEISS
magnet ingestion incidents (110 of 279, or 39 percent), followed by
magnet sets (58 of 279, or 21 percent), and jewelry (53 of 279, or 19
percent). The remaining identified product categories made up fewer of
the magnet ingestion cases: Home/kitchen magnets (46 of 279, or 16
percent), ASTM F963 magnet toys (11 of 279, or 4 percent), and science
kits (1 of 279, or less than 1 percent). Thus, for NEISS magnet
ingestion incidents in which the product category could be identified,
79 percent (221 of 279 incidents) involved products in the magnet sets,
magnet toys, or jewelry categories.
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\78\ As explained above, for many NEISS incidents, there was
insufficient information for staff to identify the category of
magnet products involved. Of the 1,072 NEISS magnet ingestion
incidents from 2010 through 2020, staff categorized 793 as
``unidentified'' magnet product types. For this reason, this
analysis focuses on the remaining 279 incidents for which staff
could categorize the product type.
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CPSRMS data similarly show that magnet sets, magnet toys, and
jewelry are the primary categories of products identified in magnet
ingestions reports. As Table 9 shows, magnet sets, by far, were the
most common product type identified \79\ in CPSRMS magnet ingestion
incidents, making up 56 percent (134 of 241) of the incidents for which
product type categories could be identified, followed by magnet toys
(49 of 241, or 20 percent), and jewelry (31 of 241, or 13 percent). The
remaining identified product categories made up fewer of the magnet
ingestion cases: ASTM F963 magnet toys (21 of 241, or 9 percent), home/
kitchen magnets (6 of 241, or 2 percent), and 0 science kits. Thus, for
CPSRMS magnet ingestion incidents in which the product category could
be identified, 89 percent (214 of 241 incidents) involved products in
the magnet sets, magnet toys, or jewelry categories.
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\79\ Like NEISS data, CPSRMS data also includes incidents for
which there was insufficient information for staff to determine the
category of magnet products involved. However, the proportion of
incidents in the unidentified magnet product type category is much
lower in CPSRMS than in NEISS data. Nevertheless, this analysis
focuses on the 241 incidents for which staff could categorize the
product type.
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The severity of health outcomes associated with magnet ingestions
provides further support for focusing on amusement and jewelry products
in the proposed rule. Fatalities are one indication of the severity of
health outcomes. As discussed above, CPSC identified seven fatalities
that involved the ingestion of hazardous magnets between November 24,
2005 and January 5, 2021, 5 of which occurred in the United States.
CPSC was able to definitively identify one of the products involved in
these incidents (a 2005 death in the United States), which was a
children's toy building set, a product intended for amusement. In
addition, the most recent incident (a 2021 death in the United States)
involved a magnet set, which is also a product intended for amusement.
Of the remaining five incidents, three incidents (a 2013 death in the
United States and two deaths in other countries) involved magnets that
matched the characteristics of magnets typically found in magnet sets,
but did not identify the involved product with certainty; one incident
(a 2018 death in the United States) involved magnets that matched the
characteristics of magnets typically found in magnet sets, and the
product was described consistently with magnet sets (i.e., a magnet
fidget toy building set); and one incident (a 2020 death in the United
States) did not provide information about the product type. This
suggests that amusement products, such as magnet sets, are involved in
the most severe magnet ingestion cases.
Whether a victim was hospitalized after ingesting magnets provides
another indication of the severity of injuries or the need for
significant treatment. As Table 10 shows, using CPSRMS data, the most
common product types identified \80\ in magnet ingestion cases that
resulted in hospitalization were magnet sets (88 of 160, or 55
percent), followed by magnet toys (36 of 160, or 23 percent), and
jewelry (21 of 160, or 13 percent). Hospitalizations for the remaining
identified magnet categories were much lower: ASTM F963 magnet toys (10
of 160, or 6 percent), and home/kitchen magnets (5 of 160, or 3
percent).\81\ Thus, for CPSRMS magnet ingestion incidents in which the
product category could be identified, 91 percent (145 of 160 incidents)
of hospitalizations involved magnet sets, magnet toys, or jewelry.
Moreover, as Table 10 shows, magnet ingestions from magnet toys, magnet
sets, and jewelry, all resulted in hospitalization far more often than
they resulted in other non-hospitalization dispositions.
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\80\ To determine the type of products involved in magnet
ingestion hospitalizations, this analysis excludes the 27 incidents
for which there was insufficient information to categorize the type
of magnet ingested.
\81\ There were no incidents in CPSRMS that were identified as
involving science kits.
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Use patterns at the time magnets were ingested also show the need
to address amusement and jewelry products. The most common identified
use pattern at the time of a magnet ingestion was playing, meaning the
victim was playing
[[Page 1290]]
with, fidgeting with, or orally exploring magnets at the time of
ingestion. This use pattern would be expected for products intended for
amusement, since they are intended for play. As Table 13 shows, in both
NEISS and CPSRMS incidents, by far, playing was the most common use
pattern identified,\82\ making up 70 percent (143 of 203) of the NEISS
incidents, and 47 percent (61 of 129) of the CPSRMS incidents with
identified use patterns. The next most common use pattern, after
playing, was jewelry, meaning the magnets were being used as jewelry at
the time of the incident. These made up 15 percent (31 of 203) of the
NEISS incidents, and 33 percent (43 of 129) of the CPSRMS incidents
with identified use patterns. The remaining identified use patterns
made up fewer of the incidents. As discussed in section IV.A.5.
Uncertainties in Incident Data, above, it is reasonable to conclude
that magnet ingestions in the unidentified product type category follow
this same pattern, with most involving products intended for amusement
or jewelry.
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\82\ For many NEISS and CPSRMS incidents, there was insufficient
information for staff to determine the use pattern at the time
magnets were ingested. To identify relevant use patterns, this
analysis focuses on the 203 NEISS incidents and 129 CPSRMS incidents
for which staff could determine the use pattern at the time of
ingestion.
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Together, these factors--the prevalence of magnet ingestion
incidents that involve products categorized as magnet sets, magnet
toys, or jewelry; the higher rate of hospitalizations and deaths for
these product categories; and the fact that the primary uses of magnets
at the time of ingestion were playing and jewelry--demonstrate that
magnet sets, magnet toys, and jewelry are the primary products involved
in magnet ingestion incidents and pose an increased risk of serious
health implications when ingested. For these reasons, CPSC considers a
rule addressing these specific product categories necessary to
adequately reduce the risk of injury and death associated with magnet
ingestions. The definition of ``subject magnets'' in the proposed rule,
which is limited to amusement and jewelry products, focuses the
proposed rule on these most problematic products.
Developmental and Behavioral Factors. Child and teen development
and behavior also support the need to address magnets intended for
amusement and jewelry in the proposed rule. Small, powerful magnets, in
general, are likely to appeal to children and teens. The tactile
appeal, shine, color, snapping/clicking sounds when manipulated,
novelty, unpredictability, and complexity of magnets appeal to children
and teens. For younger children, it is developmentally normal to
explore and put objects in their mouths. Incident data demonstrate
this, with younger children more likely to ingest magnets intentionally
(see Figures 3 and 4). Teens are at a developmental stage that involves
testing limits, experimentation, bending rules, and conforming to peer
pressures. Consistent with this, teens commonly ingested magnets
accidentally when experimenting with them to simulate jewelry or
piercings (see Figures 3 and 4). Magnets offer children and teens a
seemingly safe and reversible way to try lip, tongue, cheek, and nose
piercings.
CPSC staff considers products that are intended for amusement and
jewelry to be more likely to be accessible to and appealing to children
and teens than other magnet products. Products that are intended for
amusement and jewelry are likely to be perceived by children, teens,
and caregivers as appropriate for use by children and teens; that
perception is likely to make them accessible and appealing to children
and teens. In contrast, magnets excluded from the scope of the proposed
rule (e.g., home/kitchen magnets, such as hardware magnets for
fastening items together, or shower curtain magnets) are likely to be
part of common household products, making them less conspicuous,
accessible, and appealing to children and teens, since they are not
intended for amusement or jewelry, and making caregivers less likely to
give them to, purchase them for, or allow their use by children and
teens.
Incident data and consumer reviews support this assessment. As the
incident data indicate, for magnet ingestions in which staff could
identify the product type involved, most products were magnet sets and
magnet toys, neither of which are products intended for use by children
under 14 years old (see Table 1 and Table 9). Despite this, the vast
majority of magnet ingestion incidents involved children under 14 years
old (see Table 5 and Table 12), which demonstrates that children and
teens access these amusement products intended for older users.
Similarly, incident data show that, where the use pattern at the time
of ingestion is known, victims were, by far, most often playing with
the magnet (see Table 13), suggesting that victims may be attracted to
and access products that appear to be playthings. The second most
common identified use pattern was jewelry (see Table 13), suggesting
that children and teens are also particularly likely to interact with
magnets that are part of jewelry.\83\
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\83\ Incidents categorized as involving jewelry included cases
in which the magnet was from a jewelry product or was described as
jewelry at the time of ingestion, but the specific product could not
be identified. For some of these incidents, it is possible that the
magnets did not actually come from jewelry, but rather, came from
other magnet products that children and teens were using as jewelry.
However, staff considers most cases categorized as jewelry to have
involved either jewelry or amusement products, such as magnet sets,
being used as jewelry. This is because, of the cases for which staff
could determine the product being used as jewelry, only one case in
both the NEISS and CPSRMS datasets reported that the magnet being
used as jewelry was actually a home/kitchen magnet, and none
indicated the magnet was from an ASTM F963 magnet toy.
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Of the magnet ingestion incidents for which the source of access
could be identified, 19 percent (26 of 135) involved magnets that were
purchased for the victim (see Table 14), despite most incidents
involving children under 14 years old and products intended for users
14 years and older. This suggests that children, teens, and caregivers
perceive products like magnet sets and magnet toys to be appealing to
and appropriate for children and teens.
Another reason children and teens are particularly likely to be
attracted by and access amusement products that include magnets is that
these products often look the same as products intended as toys for
children. Consumer reviews of products demonstrate this, with consumers
commonly considering subject magnet products suitable playthings for
children, and purchasing them for children, even when warnings state
otherwise. Staff identified numerous incidents in which children
ingested magnets from products that were marketed and labeled as not
intended for children, and bore warnings regarding the magnet ingestion
hazard. For example, staff identified 16 recent incidents in which
children ingested magnets from a magnet set that included warnings and
marketing indicating that the product was intended for adults. For
older children, in particular, parents often do not expect that
children would place magnets in their mouths.
Recalls. Recalls of magnet products further demonstrate the need to
focus on magnets intended for amusement. Of the 18 recalls that
involved the magnet ingestion hazard between January 1, 2010 and August
17, 2021, the vast majority involved products intended for amusement.
The recalls primarily involved magnet sets and desk toys, rather than
children's toys or other non-amusement products.
[[Page 1291]]
e. Excluding Children's Toys
The scope of the proposed rule specifically excludes products that
are subject to 16 CFR part 1250. Currently, 16 CFR part 1250
incorporates by reference ASTM F963-17, which defines a ``toy'' as
``any object designed, manufactured, or marketed as a plaything for
children under 14 years of age.'' As discussed above, ASTM F963-17
includes requirements consistent with the proposed rule, including the
same performance requirements regarding size and strength.
Recall information suggests that the toy standard is largely
complied with and has been effective at addressing the magnet ingestion
hazard in children's toys. As discussed in section IV.A.5.
Uncertainties in Incident Data, since the toy standard became
mandatory, there has been an appreciable decline in recalls of
children's toys related to the magnet ingestion hazard. Of the 18
recalls between 2010 and 2021 that involved the magnet ingestion
hazard, only 4 involved children's toys, and only 2 of those were
confirmed to have been noncompliant with the magnet requirements in
ASTM F963. Recalls generally occur when a company receives information
about a product being hazardous and reports it to CPSC. As such, the
low rate of recalls involving the magnet ingestion hazard in children's
toys suggests that these products largely comply with ASTM F963, and
that the toy standard has been effective at addressing the magnet
ingestion hazard in children's toys.
In addition, as Table 10 suggests, when ASTM F963 magnet toys are
ingested, they appear to result in severe injuries less commonly than
other products. Magnet ingestions of ASTM F963 magnet toys resulted in
hospitalization about as often as they resulted in other non-
hospitalization dispositions; in contrast, magnet toys, magnet sets,
and jewelry all resulted in hospitalization far more often than they
resulted in other non-hospitalization dispositions. This suggests that
when ASTM F963 magnet toys are ingested, they may be less likely to
result in serious health outcomes requiring hospitalization. Of the 108
CPSRMS cases that had evidence of internal interaction through body
tissue, only 6 cases involved products identified as ASTM F963 magnet
toys. Of the 124 CPSRMS cases that indicated surgical procedures were
necessary as a result of magnet ingestion, only 9 cases involved
products identified as ASTM F963 magnet toys. Most, if not all, of the
ingestions of ASTM F963 magnet toys that resulted in surgical
intervention did not meet the requirements of ASTM F963.
For these reasons, CPSC does not consider it necessary to further
address children's toys in this proposed rule. Nevertheless, there are
two elements of the definition of ``toys'' that are noteworthy for this
proposed rule.
First, ``toys'' are products that are intended as ``playthings.''
Thus, toys do not include products that are not playthings, even when
they are intended for children under 14 years old. For example,
children's jewelry, when not intended as a plaything, would not fall
under the definition of a ``toy'' and, therefore, would not be subject
to the toy standard.\84\ As such, children's non-toy jewelry is subject
to the proposed rule. Additional products may also fall under the scope
of the proposed rule, although intended for users under 14 years old,
if they do not constitute ``playthings,'' but otherwise meet the
definition of subject magnet products.
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\84\ Section 1.3 of ASTM F963-17 states that the standard
applies to ``toys intended for use by children under 14 years of
age'' and section 3.1.91 defines a ``toy'' as ``any object designed,
manufactured, or marketed as a plaything for children under 14 years
of age.'' Section 1.3.1 of ASTM F2923-20 specifies that the
standard, which applies to children's jewelry, does not apply to
``toy jewelry or any other products that are intended for use by a
child when the child plays (that is, a necklace worn by a doll or
stuffed animal; novelty jewelry with play value)'' and further
states that ``any product which is predominately used for play value
is a toy'' and ``toys are subject to the requirements of Consumer
Safety Specification F963.''
---------------------------------------------------------------------------
Second, the definition of ``toys'' limits them to products intended
for users under 14 years old. However, as magnet ingestion incident
data show, products that are intended for users 14 years and older are
commonly ingested by children and teens, indicating that the toy
standard, on its own, cannot adequately address the magnet ingestion
hazard. As discussed above, incidents categorized as involving magnet
sets or magnet toys exclude products that staff confirmed were intended
as playthings for children under 14 years old. These two categories
were the most common categories of identified products involved in
magnet ingestion incidents, despite the fact that most incidents
involved children and teens under 14 years old. As Figure 2 shows,
children as young as 11 months, and many children between 1 and 13
years old ingest products in the magnet toys and magnet sets
categories. Staff identified many incidents in which the product
ingested was clearly marketed and labeled as intended for adults, with
warnings regarding the magnet ingestion hazard, but the product was,
nevertheless, ingested by children under the intended user age. In many
cases, caregivers even provided these products to children, despite the
warnings. This demonstrates why it is necessary to adopt a standard for
products intended for users 14 years and older, in addition to the toy
standard, to adequately address the magnet ingestion hazard.
f. Products Not Covered by the Proposed Rule
Based on the definition of ``subject magnet products'' and the
scope of the proposed rule, certain products that contain loose or
separable magnets are not subject to the proposed rule. Home and
kitchen magnets are one such product, if they do not otherwise meet the
definition of subject magnet products. Common examples of home and
kitchen magnets are refrigerator magnets, magnetic decorations,
hardware for kitchen cabinets, and shower curtain accessories. If such
products are not loose or separable or are not designed, marketed, or
intended to be used for entertainment, jewelry, mental stimulation, or
stress relief, they would not fall under the scope of the proposed
rule.
CPSC considers it reasonable to exclude home/kitchen products from
the scope of the proposed rule for several reasons. For one, incident
data indicate that home/kitchen magnets are far less commonly involved
in magnet ingestion incidents than amusement and jewelry products. As
Table 1 indicates, 16 percent (46 of 279) of NEISS magnet ingestion
incidents for which the product category could be determined involved
home/kitchen magnets; as Table 9 indicates, only 2 percent (6 of 241)
of CPSRMS magnet ingestion incidents for which the product category
could be determined involved home/kitchen magnets. Home/kitchen magnets
also make up a very small portion of incidents that resulted in
hospitalization. Table 10 shows that, only 3 percent (5 of 160) of the
CSPRMS magnet ingestion incidents with identified product types that
resulted in hospitalization, involved home/kitchen magnets. Of the 108
CPSRMS cases that had evidence of internal interaction through body
tissue, only 1 case involved products identified by staff as home/
kitchen products. Of the 124 CPSRMS cases that indicated surgical
procedures were necessary as a result of magnet ingestion, only 2 cases
involved products identified by staff as home/kitchen products.
In addition, as discussed above, CPSC considers it less likely that
children and teens will interact with, play with, or experiment with
home/kitchen magnets,
[[Page 1292]]
particularly in ways that may lead to ingestion. Home/kitchen products
excluded from the proposed rule have intended uses that do not include
amusement or jewelry, and are often part of common household products,
making them less conspicuous, accessible, and appealing to children and
teens, since they are not intended for amusement or jewelry, and making
caregivers less likely to give them to, purchase them for, or allow
their use by children and teens. In contrast, the intended uses of
amusement and jewelry products make them appear less hazardous, and
more likely to be appealing and accessible to children and teens.
Other products that would fall outside the scope of the proposed
rule include research and educational products, or those intended for
commercial or industrial purposes, if they are not also intended for
amusement or jewelry.\85\ CPSC considers it appropriate to exclude
these products for several reasons. As incident data indicate, almost
no magnet ingestion incidents for which product types could be
identified involved products intended for education, research,
commercial, or industrial use. Among NEISS incidents, only one
incident--involving a science kit--potentially involved such a product;
no such incidents were identified in CPSRMS data. For that one
incident, little information was available about the science kit, but
staff considered it possible that the product was intended for
educational purposes.
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\85\ It is also possible that products intended for purposes
such as education, research, or industrial applications would not
meet the definition of a ``consumer product,'' if they are not
commonly sold to or used by consumers. If, for example, magnets for
research purposes were sold through outlets primarily accessible to
and used by laboratories or other research facilities, these may not
be considered consumer products.
---------------------------------------------------------------------------
Staff also considers it less likely that children or teens would
have access to such products. For example, magnets used for research or
industrial applications are likely to be in settings that children do
not frequent. Even if children could access such products, for the same
reasons as home/kitchen magnets, staff considers it less likely that
these products would appeal to children, appear to be playthings or
jewelry to children or caregivers, or for children to interact with
them in ways that would lead to ingestion.
In addition to the likely reduced hazard these out-of-scope
products present to children and teens, CPSC also seeks to limit the
scope of the proposed rule to the extent possible to reduce the impact
on products, such as research, education, and industrial magnet
products, that may have important uses and require magnets that are
small and strong to serve their function. In contrast, amusement and
jewelry products likely serve less critical functions and may still
serve their purpose with slightly larger or slightly weaker magnets, or
non-separable magnets.
g. Other Factors Not Used in the Proposed Rule
CPSC considered using additional criteria, such as magnet
composition or shape, as part of the scope of the proposed rule.
However, CPSC did not limit the scope of the proposed rule to specific
magnet compositions because staff has found that various magnet
compositions have been involved in internal interaction incidents. For
example, NIB is commonly used for smaller magnets from magnet sets and
magnetic jewelry sets, and ferrite/hematite is commonly used for larger
magnets, such as rock-shaped magnet toys. Staff testing of magnets in
consumer products indicates that magnets with various compositions
often have very high flux indexes, far in excess of the proposed limit
of less than 50 kG\2\ mm\2\, warranting a standard for various
compositions. CPSC did not include specific shapes or sizes in the
scope of the proposed rule because staff found that various shapes and
sizes of magnets present the hazard, including rock-shaped magnets, and
most incident reports lack information about the specific shapes and
sizes of the magnets. As such, the performance requirements in the
proposed rule address magnets that could be ingested, regardless of
their shape.
B. Performance Requirements
1. Proposed Requirements
Under the proposed rule, each loose or separable magnet in a
subject magnet product that fits entirely within the small parts
cylinder described in 16 CFR 1501.4 must have a flux index of less than
50 kG\2\ mm\2\ when tested in accordance with a prescribed method.
Thus, the first step is to determine whether each loose or separable
magnet in a subject magnet product fits in the small parts cylinder and
what its flux index is.
The small parts cylinder is described and illustrated in 16 CFR
part 1501.4. Figure 5, below, shows the illustration, including the
dimensions, of the cylinder, provided in the regulation.
BILLING CODE 6355-01-P
[[Page 1293]]
[GRAPHIC] [TIFF OMITTED] TP10JA22.004
If a magnet fits entirely within this cylinder, then its flux index
must be less than 50 kG\2\ mm\2\.
To determine the flux index of a magnet, the proposed rule provides
that at least one loose or separable magnet of each shape and size in
the subject magnet product must have its flux index determined using
the procedure in sections 8.25.1 through 8.25.3 of ASTM F963-17, which
specify test equipment, measurements, the test method, and the
calculation for determining flux index. The test requires a direct
current field gauss meter with a resolution of 5 gauss (G) capable of
determining the field with an accuracy of 1.5 percent or better and an
axial probe with a specified active area diameter and a distance
between the active area and probe tip. Using the meter, the probe tip
is placed in contact with the pole surface of the magnet, the probe is
kept perpendicular to the surface, and the probe is moved across the
surface to find the maximum absolute flux density. The flux index, in
kG\2\ mm\2\, is determined by multiplying the area of the pole surface
(mm\2\) of the magnet by the square of the maximum flux density
(kG\2\). The flux density must be less than 50 kG\2\ mm\2\ to comply
with the proposed rule.
2. Basis for Proposed Requirements
a. Size Requirements
The first portion of the performance requirement in the proposed
rule involves determining whether a magnet fits entirely within the
small parts cylinder described in 16 CFR 1501.4. The purpose of this
requirement is to determine whether a magnet is small enough to be
swallowed. If so, then it is subject to strength requirements to reduce
the risk of internal interaction injuries from strong magnets. However,
if the magnet is too large to be swallowed, as determined by the small
parts cylinder, then it is not subject to any strength requirements.
The small parts cylinder was developed to address choking,
aspiration, and ingestion hazards for children, and was largely based
on research and data regarding the size of objects children ingest. To
address this hazard, since 1980, the Commission's regulations (at 16
CFR part 1501) have specified that certain toys and other articles
intended for use by children must not contain choking, aspiration, or
ingestion hazards for children. Whether these products present such
hazards is determined by whether they fit within the small parts
cylinder described in 16 CFR 1501.4.\86\ Several ASTM standards for
children's products reference these regulations as well, requiring that
products have no small parts as determined by 16 CFR part 1501,\87\ and
the small parts cylinder specified in the ASTM standards that addresses
magnet ingestions is the same as in 16 CFR 1501.4. Similarly, the small
parts cylinders referenced in international standards that address
magnet ingestions, including EN 71-1: 2014 and ISO 8124-1: 2018, are
also the same as in 16 CFR 1501.4. These standards are developed by
consensus of various groups, including consumer groups, children's
product engineers and experts, and manufacturers of children's
products. As such, the small parts cylinder in 16 CFR 1501.4 is
consistent with consensus standards developed with cooperation and
input from various experts, is widely recognized, and has long been
used as a way to identify products that children can ingest.
---------------------------------------------------------------------------
\86\ See 43 FR 47684 (Oct. 16, 1978); 44 FR 34892 (June 15,
1979).
\87\ For example, ASTM F2088-20, Standard Consumer Safety
Specification for Infant and Cradle Swings.
---------------------------------------------------------------------------
Incident data further support the effectiveness of the small parts
cylinder in 16 CFR part 1501.4 to address the magnet ingestion hazard.
As discussed above, magnet ingestion incidents substantially declined
during the years the magnet sets rule was announced and in effect, and
substantially increased after the rule was vacated. The magnet sets
rule included the same performance requirements regarding size and
strength as this proposed rule, including the small parts cylinder. The
marked decline in magnet ingestions during that rule suggests that the
performance requirements in that rule were effective at reducing the
risk of children ingesting magnets.
Similarly, there was a significant decline in recalls involving the
magnet ingestion hazard after the toy standard became mandatory. The
toy standard requires compliance with ASTM F963, which includes the
same small parts cylinder as 16 CFR 1501.4. As such, this decline in
recalled toys that present a magnet ingestion hazard after the toy
standard became mandatory suggests that the requirements in that rule
were effective at reducing the risk of children ingesting magnets. The
low number of magnet ingestion incidents that identify ASTM F963 magnet
toys as the involved product also indicates that the requirements in
the standard have been effective at addressing the magnet ingestion
hazard. Moreover, when magnet ingestions did occur with children's
toys, they rarely resulted in
[[Page 1294]]
the internal interaction hazard, and those that did result in internal
interaction, did not comply with the toy standard.
For these reasons, the proposed rule uses 16 CFR 1501.4 as the
means of determining whether a child could ingest a particular magnet,
thereby subjecting it to performance requirements regarding strength,
to reduce the risk of injury.
b. Strength Requirements
When a magnet is small enough to fit entirely within the small
parts cylinder, the proposed rule requires that the magnet have a flux
index less than 50 kG\2\ mm\2\. This provision consists of two
elements--a method for determining flux index, and a flux index limit
of less than 50 kG\2\ mm\2\. This requirement is intended to reduce the
risk that a magnet is strong enough to cause internal interaction
injuries, if ingested. This section discusses the rationale for both
the flux index methodology and the flux index limit in the proposed
rule.
Flux Index Methodology. The proposed rule incorporates by reference
the provisions in ASTM F963 that specify the method for measuring and
calculating flux index. The ASTM Subcommittee F15.22 on Toy Safety
developed this methodology and ASTM first published it in ASTM F963-07.
The magnetic flux index estimates the magnet attraction force of
individual single-pole magnets.
A magnet's composition, mass, and shape determine its magnetic
field. This field is aligned with its north and south magnetic poles
(see Figure 6). Surface flux density is a measurement of the magnetic
field intensity at a given perpendicular distance above an area
(dimension ``x'' in Figure 6). The maximum flux density is measured
perpendicular to the pole surface of a magnet.
[GRAPHIC] [TIFF OMITTED] TP10JA22.005
BILLING CODE 6355-01-C
The ASTM F963 working group that developed the flux index
methodology aimed to address injuries involving children ingesting
small, powerful magnets. As such, it was designed to address the same
hazard at issue in this proposed rule, and minimize the risk of
internal injuries when magnets are ingested. As part of an ASTM
standard, this methodology was developed by consensus, with input from
various stakeholders, such as children's product manufacturers,
consumer groups, and children's product engineers and experts. In
addition, this methodology is used in multiple ASTM standards that
address the magnet ingestion hazard, international standards (including
EN 71-1: 2014 and ISO 8124-1: 2018), and the mandatory toy standard in
16 CFR part 1250. As part of these standards, the methodology is widely
recognized and accepted, and has been used for many years.
CPSC staff considers this methodology effective for assessing the
strength of subject magnet products. Incident data also support the
effectiveness of the flux index methodology in ASTM F963 to address the
magnet ingestion hazard. Magnet ingestion incidents appreciably
declined during the years the magnet sets rule was announced and in
effect, and appreciably increased after the rule was vacated. The
magnet sets rule included the same size and strength limits as this
proposed rule, and incorporated by reference the flux index methodology
in ASTM F963. The decline in magnet ingestions during that rule
suggests that the performance requirements in that rule were effective
at reducing the risk of injury and death associated with magnet
ingestions. Similarly, there was a significant decline in recalls
involving the magnet ingestion hazard after the toy standard became
mandatory. The toy standard requires compliance with ASTM F963 and,
therefore, includes the same flux index methodology as this proposed
rule. The decline in recalled toys that present a magnet ingestion
hazard after the toy standard became mandatory suggests that the
requirements in that rule were effective at reducing the risk of injury
and death associated with magnet ingestions. The low number of magnet
ingestion incidents that identify ASTM F963 magnet toys as the involved
product also indicates that the requirements in the standard have been
effective at reducing the magnet ingestion hazard. When magnet
ingestions did occur with children's toys, they rarely resulted in the
internal interaction hazard, and those that did result in internal
interaction, did not comply with the toy standard.
For these reasons, the proposed rule uses the flux index
methodology in
[[Page 1295]]
ASTM F963-17 as the means of measuring the strength of magnets for
purposes of limiting the risk of internal interaction injuries when
ingested.
There are two issues that the Commission seeks input on regarding
the flux index methodology. The first issue involves how many magnets
to test. The proposed rule and ASTM F963-17 do not explicitly state how
many magnets from a product to test, or whether to use statistical
sampling. The proposed rule requires at least one loose or separable
magnet of each shape and size to be tested, and specifies that each
loose or separable magnet in a subject magnet product that fits
entirely within the small parts cylinder must have a flux index less
than 50 kG\2\ mm\2\. Similarly, section 4.38.1 of ASTM F963-17 states
that ``toys shall not contain a loose as-received hazardous magnet or a
loose as-received hazardous magnetic component.'' These provisions
indicate that each magnet may need to be tested to ensure that
compliance with the size and strength provisions.
However, subject magnet products may consist of hundreds or
thousands of individual magnets. As such, it may be reasonable to
require that only a ``representative sample'' or ``at least one
representative sample of each shape and size'' be tested. CPSC staff's
testing of magnets, described below, suggests that individual magnets
within the same product may have different flux indexes, which may
suggest that it is important to test each individual magnet in a
product. CPSC seeks comments on how firms would test products to align
with the proposed requirements, whether another requirement regarding
the number of magnets to test is appropriate, and how firms would
satisfy such alternative requirements.
The second issue for which the Commission seeks comments is the
utility of the flux index methodology for certain magnets--in
particular, small spherical magnets. Staff has found the flux index
methodology straightforward and consistent when used for large disc
magnets. However, staff encountered some challenges finding the
location of the poles for magnets smaller than 3 mm in diameter because
of difficulties handling these particularly small spherical magnets.
This may result in inaccurate measurements of the highest flux index
values if the value is not measured above the magnet's pole. Staff
testing of 2.5 mm spherical magnets, described below, illustrates this
potential issue.
To examine possible ways to address this, staff refined the test
procedure in ASTM F963-17 to include additional detail to locate the
magnet pole and secure the magnet on a base, rather than holding it.
This test procedure maintained the flux index methodology in ASTM F963-
17, and merely added information to it, which staff found improved the
accuracy and consistency of flux density measurements and calculations.
This refined procedure is provided in detail in the Appendix to Tab D
of the NPR briefing package. To summarize, the refined test method
consists of the following steps:
(1) Use a flat magnetic or ferromagnetic utensil to attract
spherical magnets into alignment with pole orientation towards the
utensil;
(2) Transfer the spherical magnets from the utensil to a flat
surface covered in at least 2 mm depth of putty that is dense/thick
enough to maintain the configuration of the spherical magnets in the
proper pole orientation (established by magnetic attraction with the
utensil); and
(3) With the spherical magnets aligned in the flat surface putty
with pole orientation facing away from the test surface, use the
gauss meter probe to determine the maximum flux value of each
individual magnet.
The additional detail in this refined procedure is one option for
potentially supplementing the flux index methodology in ASTM F963-17.
However, there are other potential alternatives to the method in ASTM
F963-17, such as considering attraction and repulsion forces. The
Commission requests comments on the variability of flux index results,
issues determining the flux index of smaller magnets, and potential
refinements or alternatives to the proposed methodology for assessing
the strength of magnets.
Flux Index Limit. The proposed rule limits the flux index of
magnets small enough to be swallowed to less than 50 kG\2\ mm\2\. ASTM
introduced this flux index limit in 2007, in ASTM F963-07.\88\ ASTM set
the flux index limit at 50 kG\2\ mm\2\ based on measurements of flux
indexes in magnetic toys that were involved in magnet ingestion
incidents at the time, which generally had flux index measurements over
70 kG\2\ mm\2\. Based on this information, 70 kG\2\ mm\2\ was
determined to be an unsafe flux index measurement, and ASTM set the
limit at 50 kG\2\ mm\2\ to provide a factor of safety.
---------------------------------------------------------------------------
\88\ ASTM F963-2007 specified that prohibited hazardous magnets
had a flux index greater than 50 kG\2\ mm\2\, however, this was
revised in later versions of the standard, and ASTM F963-17 now
prohibits hazardous magnets with a flux index of 50 kG\2\ mm\2\ or
more.
---------------------------------------------------------------------------
As part of an ASTM standard, the flux index limit was developed by
consensus of various groups, including consumer groups, children's
product engineers and experts, and manufacturers of children's
products. Additional ASTM standards, as well as international standards
that address magnet ingestions, including EN 71-1: 2014 and ISO 8124-1:
2018, also include a flux index limit of 50 kG\2\ mm\2\ for ingestible
magnets. As such, the flux index limit of 50 kG\2\ mm\2\ is consistent
with consensus standards developed with cooperation and input from
various experts, is widely recognized, and has long been used as a way
to reduce the internal interaction hazard when magnets are ingested.
Incident data support the effectiveness of this flux index limit to
address the magnet ingestion hazard. Magnet ingestion incidents
substantially declined during the years the magnet sets rule was
announced and in effect, and substantially increased after the rule was
vacated. The magnet sets rule included a flux index limit of 50 kG\2\
mm\2\ for ingestible magnets. The marked decline in magnet ingestions
during that rule suggests that the performance requirements in that
rule were effective at reducing the risk of injury and death associated
with magnet ingestions. Similarly, there was a significant decline in
recalls involving the magnet ingestion hazard after the toy standard
became mandatory. The toy standard requires compliance with ASTM F963
and, therefore, includes the same 50 kG\2\ mm\2\ limit for ingestible
magnets as the proposed rule. This decline in recalled toys for magnet
ingestion hazards suggests that the requirements in that rule were
effective at reducing the risk of injury and death associated with
magnet ingestions. The low number of magnet ingestion incidents that
identify ASTM F963 magnet toys as the involved product also indicate
that the requirements in that standard have been effective at
addressing the magnet ingestion hazard. Moreover, when magnet
ingestions did occur with children's toys, they rarely resulted in
internal interaction, and those that did result in internal
interaction, did not comply with the toy standard.
Staff's assessment of the flux index of subject magnet products,
including those involved in magnet ingestion incidents, and those known
to have involved internal interaction injuries, indicates that subject
magnet products have a wide range of flux indexes. The most common
subject magnet products staff identified are 3 to 6 mm and have flux
indexes of 300 to 400 kG\2\ mm\2\. However, staff's testing of smaller
2.5 mm magnets, some of which resulted in internal interaction injuries
when ingested, yielded flux indexes close to 50 kG\2\ mm\2\. CPSC
expects that, in order
[[Page 1296]]
to comply with the proposed rule, firms will use magnets with flux
indexes sufficiently lower than 50 kG\2\ mm\2\ in subject magnet
products, to account for manufacturing and testing variances/
tolerances, which may result in subject magnet products having flux
indexes even lower than required by the rule.
Based on the widespread and longstanding use of the flux index
limit of 50 kG\2\ mm\2\, its development and acceptance by multiple
stakeholders, the effectiveness of standards that have used this limit
to address magnet ingestion incidents, and staff testing showing that
magnets involved in internal interaction incidents had flux indexes
close to 50 kG\2\ mm\2\, the Commission proposes to require that
magnets that are small enough to ingest have a flux index of less than
50 kG\2\ mm\2\.
However, the Commission seeks comments on this flux index limit,
whether a lower limit may be appropriate, and seeks testing and safety
data supporting an appropriate flux index limit. CPSC testing of a
small sample of subject magnet products suggests that magnets with a
flux index lower than (i.e., weaker than) 50 kG\2\ mm\2\ may be capable
of causing internal interaction injuries, indicating that a flux index
limit lower than 50 kG\2\ mm\2\ may be appropriate to address the
internal interaction hazard; however, this testing did not provide
conclusive evidence that magnets weaker than 50 kG\2\ mm\2\ present an
internal interaction hazard. This testing is described below.
CPSC Testing. To gather information about the flux index
methodology, flux index limit, and what flux index can interact
internally though body tissue, staff conducted testing on a small
number of magnets. Staff tested magnets with diameters smaller than 5
mm because they generally had lower flux indexes than larger magnets,
and because these smaller magnets presented the testing challenges
described above. Staff used the test method in ASTM F963-17 with the
additions described in the Appendix to Tab D of the NPR briefing
package. This testing involved only a small number of samples, and a
limited variety of products, sizes, and shapes. As such, while this
testing is informative and raises potential issues, the broader
significance of these results is limited.
In March, April, and June 2021, CPSC staff tested magnets with
diameters smaller than 5 mm, including 2.5 mm diameter spherical
magnets from nine exemplar samples of one brand of magnet set, and two
incident samples of the same brand.\89\ Additionally, staff tested 3 mm
diameter spherical magnets from two incident samples from unknown
manufacturers. Staff selected these samples because of their
involvement in internal interaction incidents. CPSC is aware of 16
ingestion incidents and one nasal insertion incident involving the 2.5
mm diameter spherical magnets that staff tested.\90\ These 17 incidents
resulted in at least 10 surgeries (such as appendectomy and bowel
resection) and six instances of internal interaction through body
tissue. The nasal insertion incident involved two 2.5 mm diameter
spherical magnets attracting through and perforating the victim's nasal
septum, which is tissue thicker than the GI walls.
---------------------------------------------------------------------------
\89\ Exemplar refers to products that are the same model and
brand as those involved in the incident, but not the actual product
involved in the incident. Incident samples refer to the actual
products involved in an incident.
\90\ Many of these cases occurred after the NEISS and CPSRMS
data extraction used for the NPR briefing package and, therefore,
are not captured in those datasets.
---------------------------------------------------------------------------
In March 2021, staff conducted inter-rater reliability testing
(i.e., the extent to which 2 or more observations agree) in which 3
staff members tested the same 21 exemplar 2.5 mm diameter spherical
magnets. Three magnets were tested from each of 7 sets/samples of the
same magnet set brand. Staff chose 3 magnets from each set to analyze
intra-set variability in magnetic flux index. Table 15 shows the
results of this testing.
Table 15--Inter-Rater Reliability Test Measurements of 2.5 mm Spherical Magnets
[March 2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnet 1 (kG\2\ mm\2\) Magnet 2 (kG\2\ mm\2\) Magnet 3 (kG\2\ mm\2\)
Test set -----------------------------------------------------------------------------------------------------------
Tester 1 Tester 2 Tester 3 Tester 1 Tester 2 Tester 3 Tester 1 Tester 2 Tester 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........................................... 53.788 56.294 42.730 48.950 50.797 47.197 50.797 53.246 50.462
2........................................... 59.477 60.876 53.926 52.055 54.175 40.755 53.372 56.197 74.308
3........................................... 29.021 29.627 28.191 29.205 30.752 27.507 39.152 41.192 35.507
4........................................... 33.226 33.932 31.232 51.627 54.623 36.160 53.605 53.705 42.825
5........................................... 42.940 41.681 46.425 52.600 51.631 48.106 46.501 48.576 44.031
6........................................... 34.381 34.838 34.217 40.974 40.279 39.920 35.085 36.197 33.905
7........................................... 55.118 56.522 53.955 56.819 57.577 56.230 40.890 34.274 39.933
--------------------------------------------------------------------------------------------------------------------------------------------------------
These results suggest several points of interest. For one, they
indicate that there was some variation in flux index results across
testers. In addition, these results suggest that magnets from the same
set tend have more similar flux index measurements than magnets from
different sets of the same product. The results also suggest that there
is variation in the flux indexes of magnets from the same set, and the
same products (across sets). The flux index measurements of 21 exemplar
2.5 mm diameter spherical magnets from 7 different magnet sets of the
same brand ranged from 27.507 to 74.308 kG\2\ mm\2\. This variation in
flux indexes, potentially due to manufacturing variation and testing
variation, may necessitate that firms use magnets with flux indexes
sufficiently lower than 50 kG\2\ mm\2\ in subject magnet products, to
account for this potential variation in flux index results.
This variation also may have implications for the number of magnets
in a product that should be tested to assess flux index. Under the
proposed rule, one loose or separable magnet with a flux index of 50
kG\2\ mm\2\ or more in a subject magnet product makes the whole product
violative. However, this above testing suggests that this determination
may be affected by the number or sample of magnets tested from a
product because a product that includes multiple magnets may contain
some magnets that meet and some that exceed the flux index limit. Thus,
this testing may have implications for how many magnets from a product
should be tested (e.g., all magnets in the product,
[[Page 1297]]
a representative sample of magnets in the product).
In addition, because this testing used exemplars, and not the
magnets that were actually ingested, staff cannot determine what flux
index measurements resulted in internal interaction injuries. However,
these results suggest that magnets ranging from approximately 30 to 70
kG\2\ mm\2\ could have resulted in internal interaction injuries. If
the actual magnets involved in the incident had flux indexes of 50
kG\2\ mm\2\ or more, the proposed rule would address these injuries; if
the actual magnets involved in the incident had flux indexes closer to
30 to 40 kG\2\ mm\2\, the proposed rule may not address these injuries.
In March and April 2021, staff conducted similar testing. Three
staff members tested spherical magnets from 4 separate sample/sets that
were involved in internal interaction incidents. Set 1 included a
single 2.5 mm diameter magnet that had not been ingested, but was from
a set of ingested magnets that had interacted internally through a
victim's body tissue. The remaining 3 sets had magnets that were
ingested and removed from the intestines of the victim who swallowed
them (i.e., interacted internally through victims' body tissue). Staff
tested 3 magnets from each of these 3 sets; 2 of the 3 sets were
composed of 3 mm diameter magnets and 1 set was composed of 2.5 mm
diameter magnets. The results are provided in Table 16.
Table 16--Test Measurements of 2.5 mm and 3 mm Spherical Magnet Sets Involved in Ingestion Incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnet 1 (kG\2\ mm\2\) Magnet 2 (kG\2\ mm\2\) Magnet 3 (kG\2\ mm\2\)
Set -----------------------------------------------------------------------------------------------------------
Tester 1 Tester 2 Tester 3 Tester 1 Tester 2 Tester 3 Tester 1 Tester 2 Tester 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........................................... 42.020 45.173 41.766 N/A N/A N/A N/A N/A N/A
2........................................... 76.919 82.469 65.959 72.911 70.882 63.795 70.206 68.475 63.843
3........................................... 46.239 48.513 46.384 47.536 49.427 47.991 48.309 52.135 48.749
4........................................... 93.979 96.426 89.349 90.240 96.383 88.218 89.070 94.970 95.712
--------------------------------------------------------------------------------------------------------------------------------------------------------
The results in Table 16 show similar trends as the testing above,
with there being some variation across testers, less variation within
sets than across sets, and a range of flux indexes across magnets, and
sets. Set 1 in Table 16 was the same brand as the sets shown in Table
15, was a 2.5 mm spherical magnet, and had flux indexes that ranged
from 41.766 to 45.173 kG\2\ mm\2\. Although this magnet was from a set
that was ingested and interacted internally through body tissue, this
exact magnet was not ingested, so staff cannot determine the flux index
of the magnets that were ingested, but it is possible that the magnets
that interacted through body tissue were also in this range, with flux
indexes less than 50 kG\2\ mm\2\.
Sets 2 and 4 in Table 16 were 3 mm diameter spherical magnets from
2 sets from unknown manufacturers. The magnets staff tested for these
sets were actually ingested and had interacted internally through a
victim's body tissue. As such, the results for these sets are
particularly useful for assessing the magnet strength that may attract
internally through body tissue. These magnets had flux indexes that
ranged from 63.795 to 96.426 kG\2\ mm\2\. Thus, the limit of 50 kG\2\
mm\2\ in the proposed rule would address the magnet interaction hazard
these magnets presented, with a factor of safety to account for
potential variation in results across testers, manufacturing variation,
and variation due to the challenges of testing small spherical magnets.
Set 3 in Table 16 included three 2.5 mm diameter spherical magnets
from a magnet set of the same brand as those in Table 15. The tested
magnets had been ingested and interacted internally through the
victim's tissue. Thus, like sets 2 and 4, these results are
particularly useful for assessing the magnet strength that may attract
internally through body tissue. The flux indexes for these magnets
ranged from 46.239 to 52.135 kG\2\ mm\2\. Using only Tester 1 or Tester
3's results, these magnets would comply with the proposed rule because
these testers found flux indexes less than 50 kG\2\ mm\2\ for all 3
magnets. Using Tester 2's results, these magnets would not comply with
the proposed rule because magnet 3 in the set had a flux index of more
than 50 kG\2\ mm\2\. Because, depending on the tester, this set may
comply with the proposed rule but interacted internally through body
tissue, these results raise the question whether a lower flux index
limit may be appropriate. However, even with a flux index limit of 50
kG\2\ mm\2\, it is possible that the proposed rule would address the
incident involving these magnets because the flux indexes for this set
were very close to 50 kG\2\ mm\2\. To comply with the proposed rule,
firms may build in a factor of safety to ensure their magnets are not
close to 50 kG\2\ mm\2\, to account for variation in test results and
testers and ensure their products will comply with the standard.
In June 2021, CPSC staff tested magnets from 2 more exemplar magnet
sets of the same brand shown in Table 15, each of which consisted of
spherical rare-earth magnets that were 2.5 mm in diameter. Magnet sets
of this brand and type were known to have been involved in at least 6
internal interaction incidents. Staff measured the flux index of 3
magnets from each set and calculated the flux index values. The results
are in Table 17.
Table 17--Test Measurements of Two 2.5 mm Diameter Magnet Sets
[June 2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample magnet set 1 Sample magnet set 2
-----------------------------------------------------------------------------------------------------------------------
Magnet Max Max
Max flux flux\2\ Diameter Area Flux index Max flux flux\2\ Diameter Area Flux index
(kG) (kG\2\) (mm) (mm\2\) (kG) (kG\2\) (mm) (mm\2\)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1............................... 2.812 7.907 2.520 4.985 39.417 3.343 11.174 2.520 4.985 55.705
2............................... 2.714 7.363 2.550 5.104 37.585 3.450 11.903 2.590 5.266 62.677
3............................... 2.798 7.826 2.410 4.559 35.683 3.275 10.726 2.530 5.025 53.896
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 1298]]
Again, these results indicate variation in the flux indexes of
magnets within the same set, and that flux indexes are more similar
within a set than across sets. For the 6 magnets tested, flux indexes
ranged from 35.683 to 62.677 kG\2\ mm\2\.
The following provides a summary of the consolidated results of all
of these tests. Staff assessed 2.5 mm and 3 mm diameter spherical
magnets associated with internal interaction incidents. The exemplar
2.5 mm magnets had flux index values between 27.507 to 74.308 kG\2\
mm\2\. Incident samples with magnets involved in internal interaction
injuries had flux index values between 46.239 and 52.135 kG\2\ mm\2\
for the 2.5 mm magnets, and 63.795 to 96.426 kG\2\ mm\2\ for the 3 mm
diameter magnets. In general, these results suggest that the proposed
rule would address the internal interaction hazard associated with
magnet ingestions because many of the sets tested would not comply with
the proposed rule because at least one of the tested magnets had a flux
index of 50 kG\2\ mm\2\ or more. For the reasons described above, staff
considers the flux index methodology and limit in the proposed rule to
be appropriate to adequately address the magnet ingestion hazard.
However, these results also suggest that there is some variability
in the flux index values, which may have implications for the proposed
flux index test methodology. These results also indicate that magnets
that may have flux indexes lower than 50 kG\2\ mm\2\ may have caused
internal interaction injuries, suggesting that a lower flux index limit
than 50 kG\2\ mm\2\ may be appropriate; however, the results are
inconclusive because staff could not identify, with certainty, the flux
indexes of magnets that actually caused internal interaction injuries.
In addition, staff notes the limited scope of this testing, including
the small sample size, and limited variety of products tested. The
Commission seeks comments on the proposed requirements regarding flux
index methodology and limits, including information about whether flux
indexes below 50 kG\2\ mm\2\ present an internal interaction hazard.
VII. Preliminary Regulatory Analysis 91
---------------------------------------------------------------------------
\91\ Further detail regarding the preliminary regulatory
analysis is available in Tab E of the NPR briefing package.
---------------------------------------------------------------------------
The Commission is proposing to issue a rule under sections 7 and 9
of the CPSA. The CPSA requires that the Commission prepare a
preliminary regulatory analysis and publish it with the text of the
proposed rule. 15 U.S.C. 2058(c). The following discussion is extracted
from staff's memorandum, ``Preliminary Regulatory Analysis of a Draft
Proposed Rule that Would Establish a Standard for Hazardous Magnet
Products,'' available in Tab E of the NPR briefing package.
A. Preliminary Description of Potential Costs and Benefits of the
Proposed Rule
The preliminary regulatory analysis must include a description of
the potential benefits and costs of the proposed rule. The benefits of
the rule are measured as the expected reduction in the societal costs
of deaths and injuries that would result from adopting the proposed
rule and any benefits that cannot be quantified. The costs of the rule
consist of the added costs associated with modifying or discontinuing
products that do not comply with the requirements of the rule,
including any impacts on the utility of the products for consumers, as
well as any costs that cannot be quantified.
1. Deaths and Injuries Related to Magnet Ingestions
As discussed above, based on NEISS data, which is a nationally
representative probability sample of about 100 U.S. hospitals, there
were an estimated 4,400 ED-treated magnet ingestions between 2010 and
2020 that involved subject magnet products, and an additional estimated
18,100 ED-treated magnet ingestions that involved unidentified magnet
products, of which CPSC concludes a large portion involved subject
magnet products.
In addition to injuries initially treated in hospital EDs, many
product-related injuries are treated in other medical settings, such
as, physicians' offices, clinics, and ambulatory surgery centers. Some
injuries also result in direct hospital admissions, bypassing hospital
EDs entirely. CPSC estimates the number of subject magnet product
injuries treated outside of hospital EDs with CPSC's Injury Cost Model
(ICM), which uses empirical relationships between the characteristics
of injuries (diagnosis and body part) and victims (age and sex)
initially treated in hospital EDs and the characteristics of those
initially treated in other settings.\92\
---------------------------------------------------------------------------
\92\ A detailed discussion of the ICM and these methods is in:
Miller, T.R., Lawrence, B.A., Jensen, A.F., Waehrer, G.M., Spicer,
R.S., Lestina, D.C., and Cohen, M.A., The Consumer Product Safety
Commission's Revised Injury Cost Model, Calverton, MD: Public
Services Research Institute (2000); Bhattacharya, S., Lawrence, B.,
Miller, T., Zaloshnja, E., Jones, P., Ratios for Computing Medical
Treated Injury Incidence and Its Standard Error from NEISS Data
(Contract CPSC-D-05-0006, Task Order 8), Calverton, MD: Pacific
Institute for Research and Evaluation (2012); and Lawrence, B.A.,
Revised Incidence Estimates for Nonfatal, Non-Hospitalized Consumer
Product Injuries Treated Outside Emergency Departments (Contract
CPSC-D-89-09-0003, Task Order 2), Calverton, MD: Pacific Institute
for Research and Evaluation (2013).
---------------------------------------------------------------------------
The ICM estimate of injuries treated outside of hospitals or
hospital EDs (e.g., in doctors' offices, clinics) is based on data from
the Medical Expenditure Panel Survey (MEPS). The MEPS is a nationally
representative survey of the civilian, non-institutionalized population
that quantifies individuals' use of health services and corresponding
medical expenditures. It combines data from a panel of participants
interviewed quarterly over a two-year period with data from the
respondents' medical providers. The MEPS is administered by the Agency
for Healthcare Research and Quality (AHRQ). The ICM uses the MEPS data,
in combination with a classification tree analysis technique, to
project the number and characteristics of injuries treated outside of
hospitals. To project the number of direct hospital admissions that
bypass hospital EDs, the ICM uses data from the Nationwide Inpatient
Sample of the Healthcare Cost and Utilization Project (HCUP-NIS), which
was also analyzed using a classification tree analysis technique. HCUP
is a family of healthcare databases and related software tools and
products developed through a federal-state-industry partnership and
sponsored by AHRQ. The HCUP-NIS provides information annually on
approximately 3 to 4 million in-patient stays from about 1,000
hospitals.
The classification tree analysis technique (also called decision
tree) is a statistical tool that divides and sorts data into smaller
and smaller groups for estimating the ED share of injuries until no
further gains in predictive power can be obtained. This technique
allows for more precise estimates of injuries treated in doctor visits
or injuries admitted directly to the hospital than other regression
techniques. For example, where data permit, the age and sex of the
victim can have an influence on the estimates of the number of injuries
treated outside the ED. Combining the national estimates of NEISS with
the non-ED estimates from the ICM using classification tree techniques
provides total estimated medically-treated injuries.
Based on the estimate of 2,135 magnet injuries initially treated in
hospital EDs annually during 2017 through 2020, the ICM projects that
another 856 magnet injuries were treated annually outside of hospitals
(e.g., in doctors' offices,
[[Page 1299]]
clinics) and that there were about 264 direct hospital admissions
annually, bypassing the ED. Thus, combined with the ED-treated
injuries, staff estimates that there were a total of 3,255 medically
treated injuries annually involving subject magnets products from 2017
through 2020.
2. Societal Costs of Deaths and Injuries
The ICM is fully integrated with NEISS and provides estimates of
the societal costs of injuries reported through NEISS, as well as the
societal costs of other medically treated injuries estimated by the
ICM. The major aggregated societal cost components provided by the ICM
include medical costs, work losses, and the intangible costs associated
with lost quality of life or pain and suffering.
Medical costs include three categories of expenditures: (1) Medical
and hospital costs associated with treating the injury victim during
the initial recovery period and in the long term, including the costs
associated with corrective surgery, the treatment of chronic injuries,
and rehabilitation services; (2) ancillary costs, such as costs for
prescriptions, medical equipment, and ambulance transport; and (3)
costs of health insurance claims processing. CPSC derived the cost
estimates for these expenditure categories from a number of national
and state databases, including MEPS, HCUP-NIS, the Nationwide Emergency
Department Sample (NEDS), the National Nursing Home Survey (NNHS),
MarketScan[supreg] claims data, and a variety of other federal, state,
and private databases.
Work loss estimates are intended to include: (1) The forgone
earnings of the victim, including lost wage work and household work;
(2) the forgone earnings of parents and visitors, including lost wage
work and household work; (3) imputed long term work losses of the
victim that would be associated with permanent impairment; and (4)
employer productivity losses, such as the costs incurred when employers
spend time juggling schedules or training replacement workers.
Estimates are based on information from HCUP-NIS, NEDS, Detailed Claims
Information (a workers' compensation database), the National Health
Interview Survey, U.S. Bureau of Labor Statistics, and other sources.
The intangible, or non-economic, costs of injury reflect the physical
and emotional trauma of injury, as well as the mental anguish of
victims and caregivers. Intangible costs are difficult to quantify
because they do not represent products or resources traded in the
marketplace. Nevertheless, they typically represent the largest
component of injury cost and need to be accounted for in any benefit-
cost analysis involving health outcomes. The ICM develops a monetary
estimate of these intangible costs from jury awards for pain and
suffering. While these awards can vary widely on a case-by-case basis,
studies have shown them to be systematically related to a number of
factors, including economic losses, the type and severity of injury,
and the age of the victim.\93\ CPSC derived estimates for the ICM from
regression analysis of jury awards in nonfatal product liability cases
involving consumer products compiled by Jury Verdicts Research, Inc.
---------------------------------------------------------------------------
\93\ W. Kip Viscusi (1988), The determinants of the disposition
of product liability cases: Systematic compensation or capricious
awards?, International Review of Law and Economics, 8, 203-220;
Gregory B. Rodgers (1993), Estimating jury compensation for pain and
suffering in product liability cases involving nonfatal personal
injury, Journal of Forensic Economics 6(3), 251-262; and Mark A.
Cohen and Ted R. Miller (2003), ``Willingness to award'' nonmonetary
damages and implied value of life from jury awards, International
Journal of Law and Economics, 23, 165-184.
---------------------------------------------------------------------------
Table 18 provides annual estimates of the injuries and societal
costs associated with ingestions of magnets categorized as magnet sets,
magnet toys, and jewelry.
Table 18--Estimated Average Annual Medically Treated Injuries and
Associated Societal Costs for Ingestions of Products Categorized as
Magnet Sets, Magnet Toys, and Jewelry, for 2017 Through 2020
------------------------------------------------------------------------
Estimated
Injury disposition Estimated No. societal costs
($ millions) *
------------------------------------------------------------------------
Doctor/Clinic........................... 164 $2.2
Treated and Released from Hospital ED... 278 6.2
Admitted to Hospital through ED (NEISS). [dagger] 159 26.4
Direct Hospital Admissions, Bypassing... 77 12.8
-------------------------------
Total Medically Attended Injuries... 678 47.6
------------------------------------------------------------------------
* In 2018 dollars.
[dagger] This estimate may not be reliable because of the small number
of cases on which it is based.
The 2017 through 2020 NEISS estimates suggest an estimated annual
average of about 437 ED-treated injuries, comprised of 278 injuries
that were treated and released and 159 injuries that required
hospitalization. Additionally, based on estimates from the ICM, 164
injuries were treated outside of hospitals annually and another 77
injuries resulted in direct hospital admission.
Based on ICM estimates, these injuries resulted in annual societal
costs of about $47.6 million (in 2018 dollars) during 2017 through
2020. The average estimated societal cost per injury was about $13,000
for injuries treated in physician's offices, clinics, and other non-
hospital settings; about $22,000 for injuries to victims who were
treated and released from EDs; and about $166,000 for injuries that
required admission to the hospital for treatment. Medical costs and
work losses (including work losses of caregivers) accounted for about
44 percent of these injury cost estimates, and the less tangible costs
of injury associated with pain and suffering accounted for about 56
percent of the estimated injury costs.
Table 18 reflects magnet ingestion incidents that involved products
categorized as magnet sets, magnet toys, and jewelry--it does not
include incidents categorized as involving unidentified product types.
However, as discussed in section IV.A.5. Uncertainties in Incident
Data, above, most of the incidents in this unidentified product type
category likely involved subject magnet products. Thus, in addition to
the magnet ingestion incidents upon which Table 15 was based, there
were 322 NEISS cases during 2017 through 2020 (representing about 1,873
ED-treated injuries annually) in the unidentified product type
category. Based on ICM
[[Page 1300]]
estimates for unidentified product types involved in magnet ingestion
injuries, average annual societal costs for 2017-2020 totaled $151.8
million. Consequently, to the extent that the unidentified magnet
products were products that would be covered by the proposed rule,
Table 18 could substantially understate the societal costs associated
with the ingestion of subject magnet products.
3. Potential Benefits of Proposed Rule
The benefits of the proposed rule would be the reduction in the
risk of injury and death from magnet ingestions and the resulting value
of the societal costs of the injuries that the rule would prevent. In
addition to the injuries reflected in the analysis above, staff is
aware of 5 fatalities in the United States resulting from magnet
ingestions. Thus, the rule would reduce the likelihood of future
fatalities as well as injuries.
The annual expected benefits of the rule depend on the exposure to
risk associated with subject magnet products, as well as the estimated
societal costs described in Table 18, above. Although subject magnet
products may retain their magnetism for many years, it is likely that
some are discarded well before that time. Thus, the actual expected
product life of subject magnet products is uncertain; this analysis
presents a range of potential benefit estimates under an assumed
product life of 1.5, 2, and 3 years. Table 19 presents benefit
estimates under the alternative product life assumptions (line (b)).
Table 19--Present Value of Societal Costs Per Subject Magnet Product in Use (or Gross Benefits of a Rule), for
Three Expected Product Lives From 2017 Through 2020.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
(a) Aggregate Annual Societal Costs (millions $)................ $47.6 $47.6 $47.6
(b) Expected Useful Product Life (years)........................ 1.5 2 3
(c) Magnet Products in Use, Average Annual...................... 444,000 545,000 701,000
(d) Annual Societal Costs per Subject Magnet Product [(a) / (c)] $107 $87 $68
(e) Present Value of Societal Costs, per Subject Magnet Product $160 $171 $190
(3% Discount Rate).............................................
(f) Present Value of Societal Costs, per Subject Magnet Product $154 $162 $178
(7% Discount Rate).............................................
----------------------------------------------------------------------------------------------------------------
In Table 19, line (a) shows the average annual aggregate societal
costs from Table 18. Line (c) presents the average annual estimated
number of subject magnet products in use from 2017 through 2020, based
on producer-reported annual magnet set sales \94\ collected by the
Directorate for Compliance through mid-2012 and assumptions of annual
sales of all subject magnet products through 2020 (including an
assumption of 500,000 units per year for 2018-2020), an assumed
expected product life of 1.5, 2, and 3 years (line b), and the
application of the CPSC's Product Population Model, a computer
algorithm that projects the number of products in use given estimates
of annual product sales and product failure rates. The Commission
requests information on annual sales and expected product life of
subject magnet products.
---------------------------------------------------------------------------
\94\ Although this information is for magnet sets, and not all
subject magnet products, staff primarily had information about
magnet sets, and magnet sets likely make up a large portion of
subject magnet products.
---------------------------------------------------------------------------
Figure 7 shows changes in the estimated number of subject magnet
products in use, from 2009 through 2020.
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[GRAPHIC] [TIFF OMITTED] TP10JA22.006
[[Page 1301]]
In Table 19, the annual estimated societal costs per subject magnet
product in use (line d) are presented as the quotient of the annual
societal costs (line a), per product in use, and the estimated average
number of products in use (line c). Based on these estimates, and an
assumed average product life ranging from 1.5 to 3 years, the present
value of societal costs, per subject magnet product, ranges from about
$160 to about $190 using a 3 percent discount rate (line e), or from
about $154 to $178 using a 7 percent discount rate (line f).
The first order estimate of benefits would be equal to the present
value of societal costs, presented in lines (e) and (f) and would range
from about $154 (with a 1.5-year product life and a 7 percent discount
rate) to $190 (with a 3-year product life and a 3 percent discount
rate) per subject magnet product. The aggregate benefits would range
from $80 million to $95 million using the 500,000 units assumption from
Table 19 and 3 percent discount rate.\95\ If the proposed rule allows
some products to remain on the market that present the magnet ingestion
hazard, the benefits of the rule would be reduced by some unknown
amount and would be measured as the net reduction in injuries and the
concomitant reduction in societal costs that would result.
---------------------------------------------------------------------------
\95\ Aggregate benefits are the product of the per-unit benefit
($160 and $190 for a 1.5-year and 3-year useful life discounted at 3
percent), and 500,000 estimated annual units.
---------------------------------------------------------------------------
4. Costs Associated With the Proposed Rule
This section discusses the costs associated with the proposed rule,
which include costs to consumers and to manufacturers/importers of
subject magnet products. Both consumers and producers benefit from the
production and sale of consumer products. The consuming public obtains
the use value or utility associated with the consumption of products;
producers obtain income and profits from the production and sale of
products. Consequently, the costs of requiring that subject magnet
products comply with the proposed rule would consist of: (1) The lost
use value experienced by consumers who would no longer be able to
purchase magnets that do not meet the standard (lost consumer surplus);
and (2) the lost income and profits to firms that could not produce and
sell non-complying products (lost producer surplus).
Both consumer and producer surplus depend on product sales, among
other things. However, CPSC does not know the unit sales of subject
magnet products. Therefore, this analysis considers possible costs
associated with several estimates of sales, ranging from about 250,000
to 1 million subject magnet products per year. For purposes of
discussion, the analysis below assumes annual sales of 500,000 per
year.
a. Costs to Consumers
The primary cost associated with the proposed rule is lost utility
to consumers. Subject magnet products may be used for a variety of
purposes, including amusement and jewelry. Previous comments CPSC has
received regarding magnet sets, which likely comprise the majority of
subject magnet products on the market, indicate that consumers use them
as a manipulative or construction item for entertainment, such as
puzzle working, sculpture building, mental stimulation, or stress
relief. CPSC is also aware of claims that the magnets can have
beneficial therapeutic value for children with attention-deficit/
hyperactivity disorder. Incident data also suggests that magnet sets
are used as jewelry. The individual magnets in subject magnet products
might also have additional uses, apart from those for which they are
intended (e.g., using magnets from a magnet set on a refrigerator).
However, there would presumably be little lost utility for these
unintended product uses since products intended for those purposes
(e.g., refrigerator magnets) would be unaffected by the proposed rule.
If products that comply with the proposed rule do not serve the
identical utility (e.g., consumers prefer smaller, stronger magnets),
this represents lost utility to consumers. CPSC notes that the proposed
rule applies to amusement and jewelry products and, therefore, would
not affect products intended for research, education, industrial, or
commercial uses, if they do not otherwise meet the definition of
subject magnet products.
CPSC cannot estimate the use value that consumers receive from
subject magnet products, so the following discussion instead describes
use value conceptually. In general, use value includes the amount of:
(1) Consumer expenditures for the product, plus (2) consumer surplus.
Assuming annual sales of about 500,000 subject magnet products
annually, and assuming an average retail price of about $20 (based on
price data for magnet sets), consumer expenditures would amount to
about $10 million annually. These expenditures represent the minimum
value that consumers would expect to get from these products. It is
represented by the area of the rectangle OBDE in the standard supply
and demand graph in Figure 8, where B equals $20, and E equals 500,000
units.
[[Page 1302]]
[GRAPHIC] [TIFF OMITTED] TP10JA22.007
BILLING CODE 6355-01-C
In Figure 8, consumer surplus is given by the area of the triangle
BCD under the graph's demand function, and represents the difference
between the market-clearing price and the maximum amount consumers
would have been willing to pay for the product. This consumer surplus
will vary for individual consumers, but it represents a benefit to
consumers over and above what they paid.\96\ For example, tickets to a
concert might sell for $100 each, but some consumers who buy them for
$100 would have been willing to pay $150 per ticket. Those consumers
paid $100 and received benefits that they value at $150, thereby
receiving a consumer surplus of $50.\97\
---------------------------------------------------------------------------
\96\ The concept of consumer surplus is discussed in the Office
of Management and Budget's Circular A-4, Regulatory Analysis,
available through 68 FR 58366 (Oct. 9, 2003), and has been applied
in a number of CPSC staff analyses.
\97\ If the above graph represents the market for tickets, the
demand curve describes the quantity of tickets demanded at each
price (i.e., the quantity of tickets consumers are willing and able
to purchase at each price). In this example, the $150 that the
consumer would have been willing to pay for the ticket is
represented on the demand curve at a point to the left of point D.
The consumer surplus is given by the relevant point on the demand
curve (i.e., where price = $150), minus the market clearing price of
$100.
---------------------------------------------------------------------------
In general, the use value of the subject magnet products obtained
by consumers is represented by the area of the trapezoid OCDE in Figure
8. However, the prospective loss in use value associated with the
proposed rule would amount to, at most, the area of the triangle
representing the consumer surplus. This is because consumers would no
longer be able to obtain utility from the products that do not comply
with the proposed rule, but they would have the $10 million
(represented by the rectangle OBDE) that they would have spent on non-
complying subject magnet products in the absence of a rule. The net
loss in consumer surplus associated with the proposed rule would be
reduced by consumers' ability to purchase replacement products that
comply with the proposed rule and provide the same utility, or by their
ability to purchase other products that provide use-value.
CPSC does not have information regarding aggregate consumer surplus
or, by extension, the amount of utility that would be lost as a result
of the proposed rule. However, if, for example, consumers who purchased
subject magnet products that do not comply with the proposed rule at an
average price of $20 would have been willing to spend, on average, $35
to $45 per product (i.e., an additional $15 to $25 per product), the
lost utility might amount to about $7.5 million (i.e., [$35-$20] x
500,000 units annually) to $12.5 million (i.e., [$45-$20] x 500,000
units annually) on an annual basis.
However, the loss in consumer surplus described above represents
the maximum loss of consumer utility from the proposed rule because
consumers are likely to gain some amount of consumer surplus from
products that are purchased as an alternative to subject magnet
products that would no longer be available because of the rule. If, for
example, there were close substitutes (e.g., products that are
similarly satisfying and priced) for the subject magnet products that
do not meet the standard, the overall loss in consumer surplus (and,
hence, the costs of the proposed rule) likely would be small. Staff is
aware of subject magnet products that comply with the proposed rule.
For example, there are magnet sets with flux indexes less than 50 kG\2\
mm\2\, magnetic desk sculptures that use a magnetic base and
ferromagnetic pieces, sets of large magnetic balls, and a wide variety
of fidget toys. Manufacturers of magnetic jewelry with loose or
separable magnets have options for complying with the rule, including
using magnets that are not hazardous, or close substitutes that are
nonmagnetic. If jewelry manufacturers wish to offer separable pieces on
necklaces or bracelets, they might offer nonmagnetic pieces that attach
to a bracelet or necklace incorporating attached magnets. Additionally,
magnetic stud earrings and faux piercing jewelry have clip-on
alternatives and pierced jewelry as substitutes. These products and
alternatives suggest that compliant products may provide similar
utility to non-compliant subject magnet products.
b. Costs to Manufacturers/Importers
The lost benefits to firms that could result from the proposed rule
are measured by a loss in producer surplus. Producer surplus is a
profit measure that is somewhat analogous to consumer surplus. Whereas
consumer surplus is a measure of benefits received by individuals who
consume products, net of the cost of purchasing the products, producer
surplus is a measure of the
[[Page 1303]]
benefits accrued to firms that produce and sell products, net of the
costs of producing them. Producer surplus is defined as the total
revenue (TR) of firms selling subject magnet products, less the total
variable costs (TVC) of production. Variable costs are costs that vary
with the level of output and usually include expenditures for raw
materials, wages, distribution of the product, and similar costs.
In Figure 8, above, total revenue is given by the area OBDE, which
is the product of sales and price. The total variable costs of
production are given by the area under the supply function, OADE.
Consequently, producer surplus is given by the triangle ABD, which is
the area under the market clearing price and above the supply function.
Note that this represents the maximum loss to producers; if there were
product alternatives that were similar to subject magnet products that
suppliers could produce and sell, the lost producer surplus could be
less.
Following the example above, if sales of the subject magnet
products average about 500,000 units annually, with an average retail
price of about $20 per product, then total industry revenues have
averaged about $10 million annually (i.e., 500,000 units x $20 per
product). Information provided by magnet set sellers suggests that the
average import cost of magnet sets to U.S. importers, a major variable
cost, may amount to about $10 per set, or an average of about $5
million annually (i.e., 500,000 sets x $10 import cost per set). Apart
from the import costs, the variable costs of production are probably
relatively small. Because subject magnet products are often packaged
and shipped from China and sometimes sent directly to the importers
point of sale, U.S. labor costs may be low; and because subject magnet
products are small, storage costs are probably low. If, for example,
the variable costs of production account for about half of the
difference between total revenues ($10 million) and import costs ($5
million), producer surplus would amount to about $2.5 million (i.e.,
($10 million-$5 million) / 2) annually. At most, the lost producer
surplus would amount to about $5 million annually, if there were no
variable costs other than the costs of importing the magnets (i.e.,
total revenue of $10 million for 500,000 units annually less the import
costs of about $5 million). While this information is specifically
related to magnet sets, a similar relationship could apply to other
subject magnet products.
Like costs to consumers, lost producer surplus could be offset by
products that comply with the proposed rule. That is, although firms
could not offer subject magnet products that do not comply with the
proposed rule, they could offer substitutions that serve the same or
similar purpose but comply with the proposed rule.
As noted above, CPSC does not know the actual sales levels of non-
complying subject magnet products, and does not have information to
reliably estimate either consumer surplus or producer surplus. Table
20, below, provides rough estimates of the possible costs of the rule,
for various hypothetical sales levels ranging from 250,000 to 1 million
products annually. The cost estimates are based on a number of
assumptions described above, and are made for illustrative purposes.
Nevertheless, because the range of sales is wide, and is likely to
include actual sales levels on an annual basis, it is reasonable to
assume that the costs of the proposed rule could range from about $5 to
$8.75 million (if sales amount to about 250,000 products annually), to
about $20 to $35 million (if sales amount to about 1 million products
annually). As noted above, these costs could be partially offset by
products that comply with the proposed rule.
Table 20--Possible Costs of the Proposed Rule, for Various Levels of Non-Complying Subject Magnet Product Sales
----------------------------------------------------------------------------------------------------------------
Consumer surplus Producer surplus Total costs (millions
Magnet product sales (annually) (millions $) (millions $) $)
----------------------------------------------------------------------------------------------------------------
250,000.............................. $3.75 to $6.25......... $1.25 to $2.5.......... $5 to $8.75.
500,000.............................. $7.5 to $12.5.......... $2.5 to $5............. $10 to $17.5.
750,000.............................. $11.25 to $18.75....... $3.75 to $7.5.......... $15 to $26.25.
1,000,000............................ $15 to $25............. $5 to $10.............. $20 to $35.
----------------------------------------------------------------------------------------------------------------
In addition to lost producer surplus, manufacturers/importers of
subject magnet products that comply with the proposed rule would likely
incur some additional costs associated with certifying that their
products comply with the rule. Section XII. Testing, Certification, and
Notice of Requirements, below, describes the requirements in section 14
of the CPSA regarding certifications. To summarize, consumer products
that are subject to a mandatory standard must be certified as complying
with the standard. Certification must be based on a test of each
product or a reasonable testing program. For subject magnet products,
the costs of this testing may be minimal, especially for manufacturers
that currently have product testing done for products subject to the
requirements in ASTM F963-17, which is mandated in 16 CFR part 1250.
Importers may rely upon testing completed by other parties, such as
their foreign suppliers, if those tests provide sufficient information
for the manufacturers or importers to certify that the magnets in their
products comply with the proposed rule. For subject magnet products
that are children's products, such as children's jewelry, the
certification must be based on testing by an accredited third-party
conformity assessment body, at somewhat higher costs.
B. Reasons for Not Relying on a Voluntary Standard
When the Commission issues an ANPR, it must invite interested
parties to submit existing standards or provide a statement of
intention to modify or develop a standard that would address the hazard
at issue. 15 U.S.C. 2058(a). When CPSC receives such standards or
statements in response to an ANPR, the preliminary regulatory analysis
must provide reasons that the proposed rule does not include such
standards. Id. 2058(c). In the present rulemaking, the Commission did
not issue an ANPR. Accordingly, CPSC did not receive submissions of
standards or statement of intention to develop standards regarding the
magnet ingestion hazard.
Nevertheless, staff evaluated existing standards relevant to magnet
ingestions and determined that these standards would not adequately
reduce the risk of injury associated with magnet ingestions because
they do not cover the products most often involved in incidents or do
not include adequate performance requirements to reduce the risk of
injury. A detailed discussion of these standards, and why staff
considers
[[Page 1304]]
them inadequate, is in section V. Relevant Existing Standards.
C. Alternatives to the Proposed Rule
Finally, a preliminary regulatory analysis must describe
alternatives to the proposed rule that CPSC considered, their potential
costs and benefits, and a brief explanation of the reasons the
alternatives were not chosen. CPSC considered several alternatives to
the proposed rule. These alternatives, their potential costs and
benefits, and the reasons the Commission did not select them, are
described in detail in section VIII. Alternatives to the Proposed Rule,
below, and Tab F of the NPR briefing package.
VIII. Alternatives to the Proposed Rule
CPSC considered several alternatives to reduce the risk of injuries
and death associated with ingestion of subject magnet products.
However, as discussed below, CPSC does not consider any of these
alternatives capable of adequately reducing the risk of injury and
death.
A. No Mandatory Standard
One alternative to the proposed rule is to take no regulatory
action and, instead, rely on the ASTM standards to address the magnet
ingestion hazard. As discussed above, there are four ASTM standards
that address the magnet ingestion hazard, covering children's toys,
jewelry, and magnet sets. Relying on these standards would eliminate
the costs associated with the proposed rule because it would not
mandate compliance. ASTM F3458, in particular, has the potential to
address the magnet ingestion hazard because it applies to magnet sets,
which are involved in a large portion of magnet ingestion incidents
where the product type could be identified.
However, there are considerable limitations and unknowns associated
with this alternative. The shortcomings of the ASTM standards are
discussed in detail in section V. Relevant Existing Standards. For one,
CPSC does not consider ASTM F3458 capable of adequately reducing the
magnet ingestion hazard because of its limited scope and lack of size
and strength requirements for magnets. Although Subcommittee F15.77 on
Magnets formed a task group to consider revising ASTM F3458-21 to
include performance requirements for magnet sets intended for users 14
years and older, CPSC does not know whether the standard will be
revised or what requirements may be added to it.
Moreover, ASTM F3458 applies only to magnets sets, which are not
the only products implicated in magnet ingestion incidents. Additional
magnet toys intended for users 14 years and older, as well as jewelry
are also implicated. Although ASTM has standards regarding the magnet
ingestion hazard in jewelry, CPSC considers those standards inadequate
because they do not impose size and strength limits on all jewelry with
loose or separable magnets. In addition, CPSC does not know the level
of compliance with ASTM F3458, ASTM F2999, or ASTM F2923; if the rate
of compliance is low, these would not be an effective way to address
the hazard, even if the requirements in these standards were adequate.
Finally, waiting for ASTM to revise its standards to adequately address
the hazard would delay the safety benefits of the proposed rule. For
these reasons, the Commission did not select this alternative.
B. Alternative Performance Requirements
Another alternative to the proposed rule is to adopt a mandatory
standard with less stringent requirements than the proposed rule, such
as a higher flux index limit, or different requirements for certain
shapes and sizes of magnets. This may reduce the costs associated with
the rule by allowing firms to market and consumers to use a wider
variety of products than under the proposed rule. The reduction in
costs would depend on the specific requirements adopted.
However, this option would likely reduce the safety benefits of the
rule. If the alternative performance requirements reduced costs by
allowing more products to remain on the market, it likely would also
leave more hazardous products on the market, thereby decreasing the
safety benefits. Therefore, the Commission did not select this
alternative. The Commission seeks comments on what potential
alternative performance requirements may adequately reduce the risk of
injury associated with magnet ingestions, while reducing costs to firms
and impacts on consumer utility.
C. Safety Messaging
Instead of performance requirements, the Commission could require
safety messaging on products to address the magnet ingestion hazard,
such as through requirements for labeling and instructional literature.
This alternative would reduce the costs associated with the proposed
rule because it would allow firms to continue to sell subject magnet
products with loose or separable hazardous magnets and the costs of
warnings and instructional information likely would be small.
However, CPSC does not consider this alternative effective for
adequately reducing the risk of injury and death associated with magnet
ingestions. For a detailed discussion of why labeling and instructional
literature requirements are insufficient to adequately address the
magnet ingestion hazard, see section V.D. ASTM F3458-21. To summarize,
warnings are the least effective strategy for addressing a hazard,
relative to designing out the hazard or designing guards against the
hazard. The effectiveness of warnings depends on convincing consumers
to avoid the hazard, and there are numerous reasons consumers may
disregard warnings for these products. Caregivers do not expect older
children and teens to ingest inedible objects; the magnet ingestion
hazard is not readily apparent; caregivers and children underappreciate
the likelihood and severity of the hazard; magnets are often ingested
accidentally; and children and teens commonly access magnets without
their packaging, such as from friends or at school.
Warning information on labels and instructional literature, as well
as public outreach efforts to inform consumers of the hazard, have been
used to try to address the magnet ingestion hazard for many years.
However, these efforts have been unsuccessful at reducing the magnet
ingestion hazard, as evidenced by the increase in magnet ingestion
incidents in recent years, and magnet ingestion incidents involving
products with clear warnings.
For these reasons, the Commission did not select this alternative.
D. Packaging Requirements
Another alternative is for the Commission to require special
packaging for subject magnet products that contain hazardous magnets to
limit children's access to the products. Such packaging could, for
example, help consumers determine if all magnets have been returned to
the packaging and include child-resistant features. Although this
alternative would create some costs associated with packaging, those
costs likely would be lower than the proposed rule because they would
allow subject magnet products to remain unchanged. Staff estimates that
the cost of safety packaging may amount to about $1 per magnet product,
depending on the requirements and features of the packaging.
However, CPSC does not consider this alternative effective for
adequately reducing the risk of injury and death associated with magnet
ingestions. For a detailed discussion of why packaging requirements are
insufficient to
[[Page 1305]]
adequately address the magnet ingestion hazard, see section V.D. ASTM
F3458-21. To summarize, for packaging requirements to be effective at
preventing the magnet ingestion hazard, users would have to repackage
all magnets after each use, and the packaging would have to prevent
children and teens from accessing the magnets. Neither of these are
likely to occur to a sufficient extent to address the hazard.
For one, consumers are unlikely to repackage all magnets after each
use. After assembling structures or jewelry, or using the magnets for
other purposes, consumers would be unlikely to disassemble their
creations to return them to the package. In addition, products often
contain hundreds or thousands of magnets, making it time consuming and
difficult to ensure all of the magnets are returned to the package.
Moreover, small magnets become loose in the environment and are hard to
locate to return to the package. In addition, consumers often do not
perceive subject magnet products as hazardous, making it less likely
that they would repackage all of the magnets. Even for products that
are obviously hazardous and commonly use CR packaging, such as
chemicals and pharmaceuticals, consumers use the packaging
inconsistently. Consumers may also consider CR packaging a nuisance,
making them unlikely to store magnets in the packaging after every use.
Even if consumers return all magnets to a package after each use,
safety features to prevent easy access to the contents of the package
would only address a minority of the vulnerable population. Safety
packaging is generally intended to restrict children under 5 years old
from accessing package contents. Older children and teens are likely to
have the cognitive and motor skills necessary to access products in
special packaging. This is problematic because incident data show that
older children and teens make up the majority of magnet ingestion
victims. In addition, many incidents involve children and teens
acquiring magnets without the product packaging, such as from friends,
at school, or loose in the environment. For these reasons, the
Commission did not select this alternative.
E. Aversive Agents
Instead of the size and strength requirements in the proposed rule,
the Commission could require manufacturers to coat loose or separable
hazardous magnets in subject magnet products with aversive agents, such
foul odors or bitterants. Aversive agents may dissuade some children
and teens from placing hazardous magnets in their mouths. This
alternative would reduce the costs associated with the proposed rule
because it would allow firms to continue to sell subject magnet
products with loose or separable hazardous magnets, would allow
consumers to continue to use them, and the costs of such coatings
likely would be small.
However, real-world investigations have not demonstrated that
bitterants are effective at preventing ingestions.\98\ Bitterants do
not deter initial ingestion because the user has not yet tasted the
bitterant; this makes them ineffective at protecting users from harms
that can result from a single ingestion. Incident reports indicate that
ingesting a single magnet (and ferromagnetic object), or multiple
magnets at once or in quick succession, can result in serious injuries.
Thus, the ineffectiveness of bitterants to prevent an initial ingestion
makes them ineffective for addressing the magnet ingestion hazard.
---------------------------------------------------------------------------
\98\ This alternative is discussed in detail in the Final Rule
briefing package for the 2014 rule on magnet sets, available at:
https://www.cpsc.gov/s3fs-public/pdfs/foia_SafetyStandardforMagnetSets-FinalRule.pdf.
---------------------------------------------------------------------------
Similarly, once a magnet is in a person's mouth, they may not be
able to prevent ingestion even if deterred by a bitterant. The power of
the magnetic forces can cause magnets to move erratically as pieces
repel or attract, and movement of magnets toward the back of the throat
can trigger the reflex to swallow the magnets before the person can
remove them. Bitterants would be particularly ineffective for
accidental ingestions, where victims did not intentionally place
magnets in their mouths; incident data indicate that some magnet
ingestions involve unintentional ingestions, particularly for older
victims. Moreover, incidents involving ingestion of other hazardous
substances demonstrates the ineffectiveness of aversive agents to
prevent ingestions. Children frequently ingest unpalatable substances,
such as gasoline, cleaners, and ammonia, indicating that unpleasant
taste or odor, alone, is not sufficient to deter children from
ingesting items or substances. In addition, some portion of the
population, possibly as high as 30 percent, may be insensitive to
certain bitterants.
For these reasons, the Commission did not select this alternative.
F. Longer Effective Date
Another alternative is to provide a longer effective date for a
final rule. In this proposed rule, the Commission proposes to make a
final rule effective 30 days after the final rule is published. A
longer effective date would reduce the impact of the rule on
manufacturers and importers by extending the time firms have to develop
products that comply with the rule or modify products to comply with
the rule. However, delaying the effective date would delay the safety
benefits of the rule as well. As such, the Commission did not select
this alternative. However, the Commission requests comments about the
proposed effective date.
IX. Paperwork Reduction Act
This proposed rule does not contain a collection of information
that is subject to public comment and review by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521).\99\
---------------------------------------------------------------------------
\99\ There is an Office of Management and Budget control number,
under the Paperwork Reduction Act, for collection of information
regarding third-party testing for children's products, addressed in
16 CFR part 1107.
---------------------------------------------------------------------------
X. Initial Regulatory Flexibility Analysis 100
---------------------------------------------------------------------------
\100\ Further details about the initial regulatory flexibility
analysis are available in Tab F of the NPR briefing package.
Additional information about costs associated with the rule are
available in Tab E of the NPR briefing package.
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When an agency is required to publish a proposed rule, section 603
of the Regulatory Flexibility Act (5 U.S.C. 601-612) requires that the
agency prepare an initial regulatory flexibility analysis (IRFA) that
describes the impact that the rule would have on small businesses and
other entities. An IRFA is not required if the head of an agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities. 5 U.S.C. 605. The
IRFA must contain:
(1) A description of why action by the agency is being
considered;
(2) a succinct statement of the objectives of, and legal basis
for, the proposed rule;
(3) a description of and, where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
(4) a description of the projected reporting, recordkeeping and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities that will be subject to
the requirement and the type of professional skills necessary for
preparation of the report or record; and
(5) identification, to the extent practicable, of relevant
Federal rules that may duplicate, overlap, or conflict with the
proposed rule.
An IRFA must also describe any significant alternatives that would
accomplish the objectives of the applicable statutes and minimize any
significant economic impact on small
[[Page 1306]]
entities. Alternatives could include: (1) Establishing different
compliance or reporting requirements that consider the resources
available to small businesses; (2) clarification, consolidation, or
simplification of compliance and reporting requirements for small
entities; (3) use of performance rather than design standards; and (4)
an exemption from coverage of the rule, or any part of the rule
thereof, for small entities.
The IRFA for this proposed rule is available in Tab F of the NPR
briefing package; this section provides an overview of the impact of
the proposed rule on small businesses.
A. Reason for Agency Action
The intent of this rulemaking is to reduce deaths and injuries
resulting from magnet ingestions. As incident data show, magnet
ingestion incidents have increased in recent years, and commonly
involve products categorized as amusement or jewelry products. Most
incidents involve children and teens, particularly under 14 years old.
If ingested, some magnets are powerful enough to interact internally
with one another through body tissue, and resist natural bodily forces
to separate the magnets. This interaction has led to serious injuries
and several deaths in the United States. The internal interaction
hazard is a hidden hazard, which children and caregivers are unlikely
to anticipate, appreciate, and avoid, as demonstrated by incident data.
Incident data and the health outcomes of magnet ingestions demonstrate
the need for agency action.
B. Objectives of and Legal Basis for the Rule
The objective of the proposed rule is to reduce the risk of injury
and death associated with ingestion of hazardous magnets, as discussed
above. The proposed rule would be issued under the authority of
sections 7 and 9 of the CPSA.
C. Small Entities to Which the Rule Will Apply
The proposed rule would apply to small entities that manufacture,
import, or sell subject magnet products, which are products with one or
more magnets, which are loose or separable, and designed, marketed, or
intended to be used by consumers for entertainment, jewelry (including
children's jewelry), mental stimulation, stress relief, or a
combination of these purposes. Examples of subject magnet products
include magnet sets, other types of magnet toys intended for users 14
years and older, and jewelry with separable magnets that can be
arranged by the consumer.
Because CPSC's previous rulemaking work regarding magnet ingestions
has focused on magnet sets, CPSC staff has more detailed information
about magnet sets than other subject magnet products. For this reason,
this analysis provides detailed information about magnet sets; however,
staff also provides information about additional subject magnet
products, to the extent information about these products is available.
All of the importers of magnet sets are small businesses under U.S.
Small Business Administration (SBA) size standards, and CPSC expects
that this is also true for manufacturers and importers of other subject
magnet products. Currently, nearly all marketers (firms or individuals)
of magnet sets sell through internet sites, rather than through
physical retail stores such as bookstores, gift shops and other outlets
(which commonly sold magnet sets from 2009 through mid-2012). Some of
these internet sites are operated by the importers, but the majority of
sellers (in terms of distinct firms or individuals, if not unit sales)
appear to sell through their stores, operated on the sites of other
internet platforms. These online retail outlets may also be used
commonly by manufacturers and sellers of other subject magnet products.
As discussed above, in late 2018, IEc examined the market for
magnet sets. In its review of internet platforms, IEc found a total of
69 sellers. IEc also identified 10 manufacturers and 2 retailers, which
also are small businesses.\101\ CPSC staff provided IEc with staff's
prior research, which identified at least 121 sellers of magnet sets on
two major internet retail platforms. IEc reviewed these sellers with
the intention of merging CPSC's research with newer information but
found that the vast majority of sellers CPSC identified no longer sold
magnet sets, indicating high turnover rates.
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\101\ IEc classified manufacturers as firms producing and
selling their own magnet set products, and retailers as firms that
typically sell magnets from multiple manufacturers.
---------------------------------------------------------------------------
In 2020, CPSC staff reviewed the status of previously identified
sellers of magnet sets on two major internet platforms and found
further evidence of high turnover rates: Most of the sellers identified
in late 2018 no longer sold magnet sets or had abandoned their stores.
Only 9 of 69 sellers were still selling magnet sets. The remaining
sellers no longer offered magnet sets or no longer operated on the
platforms. In addition, staff identified 29 sellers that IEc had not
identified as active in the market in late 2018.
Based on this information, CPSC staff expects the dominant business
model for importers of magnet sets will be direct sales to consumers
using their own internet websites or other internet shopping sites.
However, the proposed rule could also affect some third-party retailers
of the products, whether selling them online or in physical stores.
Such retailers sell a wide variety of consumer products; retailers
classified as small businesses that sell the products would not be
likely to derive significant proportions of total revenues from sales
of affected magnet sets, and the impacts on individual firms should be
minimal.
D. Compliance, Reporting, and Recordkeeping Requirements in the
Proposed Rule
The proposed rule would establish a mandatory standard that all
subject magnet products would have to meet to be sold in the United
States. As stated above, the proposed rule would require consumer
products that are designed, marketed, or intended to be used for
entertainment, jewelry, mental stimulation, stress relief, or a
combination of these purposes, and that contain one or more loose or
separable magnets to meet performance requirements. The proposed
performance requirements specify that each loose or separable magnet in
a subject magnet product that is small enough to fit entirely in the
small parts cylinder must have a flux index less than 50 kG\2\ mm\2\.
The requirements of the proposed standard are described, in detail, in
this preamble, and the proposed regulatory text is at the end of this
notice.
In addition, certification requirements, which are discussed in
section XII. Testing, Certification, and Notification of Requirements,
below, would apply to subject magnet products. To summarize, section 14
of the CPSA requires manufacturers, importers, or private labelers of a
consumer product that is subject to a consumer product safety rule to
certify, based on a test of each product or a reasonable testing
program, that the product complies with all rules, bans or standards
applicable to the product. The proposed rule specifies the test
procedure to use to determine whether a subject magnet product complies
with the requirements. For products that manufacturers certify,
manufacturers would issue a general certificate of conformity (GCC). In
the case of subject magnet products that could be considered children's
products, the certification must be based on testing by
[[Page 1307]]
an accredited third-party conformity assessment body.
The requirements for the GCC are stated in section 14 of the CPSA.
Among other requirements, each certificate must identify the
manufacturer or private labeler issuing the certificate and any third-
party conformity assessment body on whose testing the certificate
relies; the date and place of manufacture; the date and place where the
product was tested; each party's name, full mailing address, telephone
number; and contact information for the individual responsible for
maintaining records of test results. The certificates must be furnished
to each distributor or retailer of the product and to CPSC, if
requested.
1. Costs of the Proposed Rule That Would Be Incurred by Small
Manufacturers
Small manufacturers and importers of subject magnet products would
likely incur some costs to certify that their products meet the
requirements of the proposed rule, as required by section 14 of the
CPSA. The certification must be based on a test of each product or a
reasonable testing program. The costs of the testing might be minimal,
especially for small manufacturers that currently have product testing
done for products subject to the requirements in ASTM F963-17, which is
mandated by 16 CFR part 1250. Importers may also rely on testing
completed by other parties, such as their foreign suppliers, if those
tests provide sufficient information for the manufacturers or importers
to certify that the magnets in their products comply with the proposed
rule. As noted above, for subject magnet products that could be
considered children's products, such as children's jewelry, the
certification must be based on testing by an accredited third-party
conformity assessment body, at somewhat higher costs. The Commission
requests comments regarding the costs or other impacts of the
certification requirements under section 14 of the CPSA.
2. Impact on Small Businesses
As discussed in the preliminary regulatory analysis, the primary
impact of the proposed rule on small businesses would be the lost
income and profits to firms that could not produce, import, and sell
non-complying products in the future. The lost benefits to firms
resulting from a proposed rule are measured by a loss in producer
surplus, which is a measure of the total revenue of firms selling the
magnets, less the total variable costs of production. As predominantly
imported products, the variable costs for small businesses handling
subject magnet products are mainly the import costs. The producer
surplus for magnet sets could average about $5 to $10 per unit, based
on an average price of $20. A similar relationship could apply to other
subject magnet products affected by the proposed rule.
A few small firms whose businesses focus on sales of subject magnet
products that would not comply with the proposed rule, including some
of the firms selling products on their own websites, would face
relatively greater losses in producer surplus. These and other small
businesses could respond to the rule by marketing magnets that comply
with or are not subject to the proposed rule. Such measures could
offset losses in producer surplus.
E. Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rule
CPSC did not identify any federal rules that duplicate, overlap, or
conflict with the proposed rule.
F. Alternatives Considered To Reduce the Burden on Small Entities
As discussed in section VIII. Alternatives to the Proposed Rule,
above, CPSC examined several alternatives to the proposed rule, which
could reduce the burden on firms, including small entities. For the
reasons described in that section, the Commission concluded that those
alternatives would not adequately reduce the risk of injury and death
associated with magnet ingestions, and is not proposing those
alternatives. See Tab F of the NPR briefing package for further
discussion of alternatives to the proposed rule. The Commission seeks
comments on any alternatives that would reduce the impact on small
entities, while adequately reducing the risk of injury and death
associated magnet ingestions.
XI. Incorporation by Reference
The proposed rule incorporates by reference ASTM F963-17. The
Office of the Federal Register (OFR) has regulations regarding
incorporation by reference. 1 CFR part 51. Under these regulations, in
the preamble of an NPR, an agency must summarize the incorporated
material, and discuss the ways in which the material is reasonably
available to interested parties or how the agency worked to make the
materials reasonably available. 1 CFR 51.5(a). In accordance with the
OFR requirements, this preamble summarizes the provisions of ASTM F963-
17 that the Commission proposes to incorporate by reference.
The standard is reasonably available to interested parties and
interested parties can purchase a copy of ASTM F963-17 from ASTM
International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken,
PA 19428-2959 USA; telephone: (610) 832-9585; www.astm.org.
Additionally, during the NPR comment period, a read-only copy of ASTM
F963-17 is available for viewing on ASTM's website at: https://www.astm.org/CPSC.htm. Once a final rule takes effect, a read-only copy
of the standard will be available for viewing on the ASTM website at:
https://www.astm.org/READINGLIBRARY/. Interested parties can also
schedule an appointment to inspect a copy of the standard at CPSC's
Division of the Secretariat, U.S. Consumer Product Safety Commission,
4330 East-West Highway, Bethesda, MD 20814, telephone: (301) 504-7479;
email: [email protected].
XII. Testing, Certification, and Notice of Requirements
Section 14(a) of the CPSA includes requirements for certifying that
children's products and non-children's products comply with applicable
mandatory standards. 15 U.S.C. 2063(a). Section 14(a)(1) addresses
required certifications for non-children's products, and sections
14(a)(2) and (a)(3) address certification requirements specific to
children's products.
A ``children's product'' is a consumer product that is ``designed
or intended primarily for children 12 years of age or younger.'' Id.
2052(a)(2). The following factors are relevant when determining whether
a product is a children's product:
Manufacturer statements about the intended use of the
product, including a label on the product if such statement is
reasonable;
whether the product is represented in its packaging,
display, promotion, or advertising as appropriate for use by children
12 years of age or younger;
whether the product is commonly recognized by consumers as
being intended for use by a child 12 years of age or younger; and
the Age Determination Guidelines issued by CPSC staff in
September 2002, and any successor to such guidelines.
Id. ``For use'' by children 12 years and younger generally means that
children will interact physically with the product based on reasonably
foreseeable use. 16 CFR 1200.2(a)(2). Children's products may be
decorated or embellished with a childish theme, be sized for children,
or
[[Page 1308]]
be marketed to appeal primarily to children. Id. 1200.2(d)(1).
As discussed above, some subject magnet products (e.g., children's
jewelry) are children's products and some are not. Therefore, a final
rule would require subject magnet products that are not children's
products to meet the certification requirements under section 14(a)(1)
of the CPSA and would require subject magnet products that are
children's products to meet the certification requirements under
sections 14(a)(2) and (a)(3) of the CPSA. The Commission's requirements
for certificates of compliance are codified in 16 CFR part 1110.
Non-Children's Products. Section 14(a)(1) of the CPSA requires
every manufacturer (which includes importers \102\) of a non-children's
product that is subject to a consumer product safety rule under the
CPSA or a similar rule, ban, standard, or regulation under any other
law enforced by the Commission to certify that the product complies
with all applicable CPSC requirements. 15 U.S.C. 2063(a)(1).
---------------------------------------------------------------------------
\102\ The CPSA defines a ``manufacturer'' as ``any person who
manufactures or imports a consumer product.'' 15 U.S.C. 2052(a)(11).
---------------------------------------------------------------------------
Children's Products. Section 14(a)(2) of the CPSA requires the
manufacturer or private labeler of a children's product that is subject
to a children's product safety rule to certify that, based on testing
by a third-party conformity assessment body (i.e., testing laboratory),
the product complies with the applicable children's product safety
rule. Id. 2063(a)(2). Section 14(a) also requires the Commission to
publish a notice of requirements (NOR) for a testing laboratory to
obtain accreditation to assess conformity with a children's product
safety rule. Id. 2063(a)(3)(A). Because some subject magnet products
are children's products, the proposed rule is a children's product
safety rule, as applied to those products. Accordingly, if the
Commission issues a final rule, it must also issue an NOR.
The Commission published a final rule, codified at 16 CFR part
1112, entitled Requirements Pertaining to Third Party Conformity
Assessment Bodies, which established requirements and criteria
concerning testing laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112
includes procedures for CPSC to accept a testing laboratory's
accreditation and lists the children's product safety rules for which
CPSC has published NORs. When CPSC issues a new NOR, it must amend part
1112 to include that NOR. Accordingly, as part of this NPR, the
Commission proposes to amend part 1112 to add this proposed standard
for magnets to the list of children's product safety rules for which
CPSC has issued an NOR.
Testing laboratories that apply for CPSC acceptance to test subject
magnet products that are children's products for compliance with the
new rule would have to meet the requirements in part 1112. When a
laboratory meets the requirements of a CPSC-accepted third party
conformity assessment body, the laboratory can apply to CPSC to include
16 CFR part 1262, Safety Standard for Magnets, in the laboratory's
scope of accreditation of CPSC safety rules listed on the CPSC website
at: www.cpsc.gov/labsearch.
XIII. Environmental Considerations
The Commission's regulations address whether CPSC is required to
prepare an environmental assessment (EA) or an environmental impact
statement (EIS). 16 CFR 1021.5. Those regulations list CPSC actions
that ``normally have little or no potential for affecting the human
environment,'' and, therefore, fall within a ``categorical exclusion''
under the National Environmental Policy Act (42 U.S.C. 4231-4370h) and
the regulations implementing it (40 CFR parts 1500-1508) and do not
require an EA or EIS. 16 CFR 1021.5(c). Among those actions are rules
that provide performance standards for products. Id. 1021.5(c)(1).
Because this proposed rule would create performance requirements for
subject magnet products, the proposed rule falls within the categorical
exclusion, and thus, no EA or EIS is required.
XIV. Preemption
Executive Order (E.O.) 12988, Civil Justice Reform (Feb. 5, 1996),
directs agencies to specify the preemptive effect of a rule in the
regulation. 61 FR 4729 (Feb. 7, 1996), section 3(b)(2)(A). In
accordance with E.O. 12988, CPSC states the preemptive effect of the
proposed rule, as follows:
The regulation for subject magnet products is proposed under
authority of the CPSA. 15 U.S.C. 2051-2089. Section 26 of the CPSA
provides that ``whenever a consumer product safety standard under this
Act is in effect and applies to a risk of injury associated with a
consumer product, no State or political subdivision of a State shall
have any authority either to establish or to continue in effect any
provision of a safety standard or regulation which prescribes any
requirements as to the performance, composition, contents, design,
finish, construction, packaging or labeling of such product which are
designed to deal with the same risk of injury associated with such
consumer product, unless such requirements are identical to the
requirements of the Federal Standard.'' 15 U.S.C. 2075(a). The federal
government, or a state or local government, may establish or continue
in effect a non-identical requirement for its own use that is designed
to protect against the same risk of injury as the CPSC standard if the
federal, state, or local requirement provides a higher degree of
protection than the CPSA requirement. Id. 2075(b). In addition, states
or political subdivisions of a state may apply for an exemption from
preemption regarding a consumer product safety standard, and the
Commission may issue a rule granting the exemption if it finds that the
state or local standard: (1) Provides a significantly higher degree of
protection from the risk of injury or illness than the CPSA standard,
and (2) does not unduly burden interstate commerce. Id. 2075(c).
Thus, the requirements proposed in today's Federal Register would,
if finalized, preempt non-identical state or local requirements for
subject magnet products designed to protect against the same risk of
injury and prescribing requirements regarding the performance,
composition, contents, design, finish, construction, packaging or
labeling of subject magnet products.
XV. Effective Date
The CPSA requires that consumer product safety rules take effect at
least 30 days after the date the rule is promulgated, but not later
than 180 days after the date the rule is promulgated unless the
Commission finds, for good cause shown, that an earlier or later
effective date is in the public interest and, in the case of a later
effective date, publishes the reasons for that finding. 15 U.S.C.
2058(g)(1). The Commission proposes that this rule, and the amendment
to part 1112, become effective 30 days after publication of the final
rule in the Federal Register. The rule would apply to all subject
magnet products manufactured or imported on or after the effective
date. The Commission requests comments on the proposed effective date.
XVI. Proposed Findings
As discussed in section II. Statutory Authority, above, the CPSA
requires the Commission to make certain findings when issuing a
consumer product safety standard. 15 U.S.C. 2058(f)(1), (f)(3). This
section discusses preliminary support for those findings.
[[Page 1309]]
A. Degree and Nature of the Risk of Injury
To issue a final rule, the CPSA requires the Commission to make
findings regarding the degree and nature of the risk of injury the rule
is designed to eliminate or reduce. NEISS incident data indicate that
there were an estimated 4,400 magnet ingestions treated in U.S.
hospital EDs between January 1, 2010 and December 31, 2020 that
involved products categorized as being for amusement or jewelry, which
are the products subject to this rule. An additional estimated 18,100
ED-treated magnet ingestions during this period involved unidentified
magnet products. CPSC concludes that a large portion of these
unidentified magnet product incidents likely involved subject magnet
products, for the reasons stated below.
In addition to magnet ingestion injuries treated in U.S. hospital
EDs, the ICM projects that there were an estimated 3,255 magnet
ingestion injuries per year treated in medical settings other than EDs
from 2017 through 2020. Incident reports available through CPSRMS
indicate that there were at least 284 magnet ingestions between January
1, 2010 and December 31, 2020, 75 percent of which involved products
categorized as being for amusement or jewelry, which are the products
subject to this rule, and an additional 15 percent involved
unidentified magnet products, which CPSC concludes are likely to have
involved subject magnet products for the reasons stated below.
The potential injuries when a person ingests one or more magnets
are serious. Health threats posed by magnet ingestion include pressure
necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia,
inflammation, perforation, peritonitis, sepsis, ileus, ulceration,
aspiration, and death, among others. These conditions can result from
magnets attracting to each other through internal body tissue, or a
single magnet attracting to a ferromagnetic object. CPSC is aware of
several fatal magnet ingestion incidents resulting from internal
interaction of the magnets.
As indicated above, CPSC concludes that many of the magnet
ingestion incidents for which information was insufficient to identify
the specific product type involved subject magnet products. This
conclusion is supported by incident data, trends in magnet ingestion
rates and recalls surrounding mandatory standards, and behavioral and
developmental considerations. Incident data indicate that, of the
magnet ingestion incidents for which CPSC could identify a product
type, the primary products involved were magnet sets, magnet toys, and
jewelry; this is likely to apply to incidents that lacked product
identification information as well.
Trends in magnet ingestion rates surrounding a previous Commission
rule on magnet sets indicate that magnet ingestions significantly
declined during the time the rule was in effect, and significantly
increased after the rule was vacated. This indicates that a large
portion of magnet ingestions involved magnet sets, which are subject
magnet products. Similarly, incident data and recalls surrounding the
Commission's mandatory standard for magnets in children's toys, in 16
CFR part 1250, indicate that, while amusement products are involved in
most magnet ingestion incidents with identifiable product types, those
amusement products are not children's toys. Relatively few magnet
ingestion incidents identify children's toys as the product involved,
suggesting that these make up few of the unidentified product type
incidents as well. And the number of recalls of children's products for
magnet-related hazards has appreciably declined since 16 CFR part 1250
took effect, suggesting that these products do not make up a large
portion of magnet ingestion incidents.
Finally, behavioral and developmental factors support the
conclusion that many magnet ingestions with unidentified product types
involve subject magnet products. These include the attractiveness of
magnetic products and their features to children and teens, consumers'
perception that amusement and jewelry products are appropriate and safe
for children, and consumers' underappreciation of the magnet ingestion
hazard.
B. Number of Consumer Products Subject to the Proposed Rule
To issue a final rule, the CPSA requires the Commission to make
findings regarding the approximate number of consumer products subject
to the rule. Staff estimates that there are approximately 500,000
subject magnet products sold annually in the United States. However, to
account for a range of sales estimates, staff also provided information
for sales ranging from 250,000 to 1 million units annually.
C. The Public Need for Subject Magnet Products and the Effects of the
Proposed Rule on Their Utility, Cost, and Availability
To issue a final rule, the CPSA requires the Commission to make
findings regarding the public's need for the products subject to the
rule and the probable effect of the rule on the cost, availability, and
utility of such products. Consumers use subject magnet products for
entertainment, mental stimulation, stress relief, and jewelry. The
proposed rule requires subject magnet products to meet performance
requirements regarding size or strength, but does not restrict the
design of products. As such, subject magnet products that meet the
standard would continue to serve the purpose of amusement or jewelry
for consumers. Magnets that comply with the proposed rule, such as non-
separable magnets, larger magnets, weaker magnets, or non-permanent
magnets, would likely still be useful for amusement or jewelry.
However, it is possible that there may be some negative effect on the
utility of subject magnet products if compliant products function
differently or do not include certain desired characteristics.
Retail prices of subject magnet products generally average under
$20. CPSC has identified subject magnet products that comply with the
proposed rule, indicating that the costs of compliant and non-compliant
products are comparable.
If the costs associated with redesigning or modifying subject
magnet products to comply with the proposed rule result in
manufacturers discontinuing products, there may be some loss in
availability to consumers. However, this would be mitigated to the
extent that compliant products meet the same consumer needs.
D. Other Means To Achieve the Objective of the Proposed Rule, While
Minimizing Adverse Effects on Competition and Manufacturing
To issue a final rule, the CPSA requires the Commission to make
findings regarding ways to achieve the objective of the rule while
minimizing adverse effects on competition, manufacturing, and
commercial practices. CPSC considered several alternatives to achieve
the objective of reducing unreasonable risks of injury and death
associated with magnet ingestions.
One alternative is to take no regulatory action and instead rely on
existing ASTM standards to address the magnet ingestion hazard. This
would eliminate costs associated with the rule by avoiding a mandatory
standard; however, this alternative is unlikely to adequately reduce
the risk of injury and death associated with magnet ingestions. For
one, none of the existing standards address all of the products most
commonly identified in magnet ingestion incidents, and several of the
standards provide exceptions to
[[Page 1310]]
performance requirements for certain subject magnet products. In
addition, under the existing standards, certain subject magnet products
would not be subject to performance requirements regarding size and
strength, instead relying on alternative requirements, such as safety
messaging, which is unlikely to adequately reduce the magnet ingestion
hazard.
Another alternative is a mandatory standard with less stringent
requirements than the proposed rule, such as a higher flux index limit,
or different requirements for certain shapes and sizes of magnets. This
could reduce the costs associated with a rule by allowing firms to
market a wider variety of products than under the proposed rule.
However, for this alternative to reduce costs, it would allow more
products to remain on the market, thereby decreasing the safety
benefits.
Safety messaging requirements are another alternative to the
proposed rule. This would reduce the costs associated with the rule
because it would not require modifying or discontinuing subject magnet
products, and the costs of warnings and instructional information
likely would be small. However, this alternative is not likely to
adequately reduce the risk of injury and death associated with magnet
ingestions because the effectiveness of safety messaging depends on
consumers seeing the messaging and being convinced to avoid the hazard.
Incident data indicate that children commonly access ingested magnets
from sources that are unlikely to include the product packaging bearing
instructions or warnings. Moreover, consumers are unlikely to
consistently heed warnings because of the perception that subject
magnet products are appropriate for children, and underappreciation of
the magnet ingestion hazard. Safety messaging is generally considered
the least effective way to address product hazards, and has been
ineffective at addressing the magnet ingestion hazard, to date.
Another alternative is to require special packaging to limit
children's access to subject magnet products. Such packaging could help
consumers determine if all magnets have been returned to the container
and include child-resistant features. Although this alternative would
create some packaging costs, those likely would be lower than the costs
associated with the proposed rule because it would allow subject magnet
products to remain unchanged. However, this alternative is not likely
to adequately reduce the risk of injury and death associated with
magnet ingestions. For packaging requirements to be effective, users
would have to repackage all magnets after each use, which is unlikely
given the size and number of magnets in a product, the potential to
lose magnets, and consumers' demonstrated underappreciation of the
hazard. In addition, packaging is unlikely to be effective because it
generally only restricts young children (under 5 years old) from
accessing package contents, and would not prevent older children or
teens from accessing the package contents, although the majority of
magnet ingestion incidents involved children 5 years and older.
Another alternative is to require subject magnet products to be
coated with aversive agents. This alternative would reduce the costs
associated with the rule because it would allow firms to continue to
sell subject magnet products and the costs of such coatings likely
would be small. However, such requirements are not likely to adequately
reduce the risk of injury and death associated with magnet ingestions
because they do not address ingestions that occur when the first magnet
is placed in the victim's mouth, before the aversive agent is detected,
accidental ingestions, or children who are developmentally inclined to
place objects in their mouths.
Another alternative is to provide a longer effective date for the
final rule. This may reduce the costs associated with the rule by
spreading them over a longer period, but it would also delay the safety
benefits of the rule.
E. Unreasonable Risk
To issue a final rule, the CPSA requires the Commission to find
that the rule, including the effective date, is reasonably necessary to
eliminate or reduce an unreasonable risk of injury associated with the
product. Factors the Commission considered with respect to this
preliminary finding include the likelihood and severity of the risk,
and the potential costs and benefits associated with the proposed rule.
As described above, there were an estimated 23,700 magnet
ingestions treated in U.S. hospital EDs from January 1, 2010 to
December 31, 2020. Although this includes ingestions of all magnet
types, and is not limited to subject magnet products, it provides an
indication of the frequency with which children and teens ingest
magnets, and the need to address the magnet ingestion hazard. Of these
estimated 23,700 ED-treated magnet ingestions, an estimated 4,400
involved products categorized as being used for amusement or jewelry,
which are the products subject to this rule, and an additional
estimated 18,100 involved unidentified magnet product types. As
discussed with respect to the finding regarding the degree and nature
of the risk of injury, a large portion of the incidents involving
unidentified magnet products likely involve subject magnet products. In
addition, the ICM projects that there were an additional estimated
3,255 magnet ingestion injuries per year treated in medical settings
other than EDs from 2017 through 2020. Trend analysis indicates that
magnet ingestions have significantly increased in recent years.
The potential injuries when a person ingests one or more magnets
are serious. Health threats posed by magnet ingestion include pressure
necrosis, volvulus, bowel obstruction, bleeding, fistulae, ischemia,
inflammation, perforation, peritonitis, sepsis, ileus, ulceration,
aspiration, and death, among others. These conditions can result from
magnets attracting to each other through internal body tissue, or a
single magnet attracting to a ferromagnetic object. One indication of
the potential severity of magnet ingestions is hospitalization rates.
Considering NEISS data, approximately 18 percent of estimated ED-
treated magnet ingestions result in hospitalization. Of the 284 CPSRMS
magnet ingestion cases, approximately twice as many resulted in
hospitalization as other non-hospitalization treatment (187
hospitalizations, 94 other treatments). For subject magnet products, in
particular, hospitalization was two to three times as common as other
treatments. Specifically, for magnet set ingestions, 88 resulted in
hospitalization and 46 resulted in other treatment; for magnet toys, 36
resulted in hospitalization and 13 resulted in other treatment; and for
jewelry, 21 resulted in hospitalization, and 10 resulted in other
treatment.
Another clear indication of the severity of health risks are fatal
incidents. Staff identified five fatal magnet ingestion incidents that
occurred in the United States between November 24, 2005 and January 5,
2021.\103\ All of these incidents involved victims who died from
injuries resulting from internal interaction of the magnets. Four of
the five incidents involved children 2 years old or younger (the
additional death involved an adult). At least one of these fatal
incidents involved a magnet set, one involved an
[[Page 1311]]
amusement product, and two fatal incidents provided product
descriptions consistent with subject magnet products.
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\103\ CPSC is also aware of two deaths in other countries, which
involved ingestion of hazardous magnets. Although staff does not
know the specific products involved in these incidents, the magnets
were similar, if not identical to magnets typically found in magnet
sets.
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CPSC staff estimates that the rule could result in aggregate
benefits of about $80 million to $95 million annually; this estimate
excludes magnet ingestion incidents involving unidentified magnet
products, which are likely to commonly involve subject magnet products,
making the benefits of the rule substantially greater. CPSC staff
estimates that the costs to consumers and manufacturers associated with
the rule could range from $10 million to $17.5 million annually,
assuming annual sales of 500,000 units.
For these reasons, the Commission concludes preliminarily that
ingestion of subject magnet products poses an unreasonable risk of
injury and finds that the proposed rule is reasonably necessary to
reduce that unreasonable risk of injury.
F. Public Interest
To issue a final rule, the CPSA requires the Commission to find
that issuing the rule is in the public interest. This proposed rule is
intended to address an unreasonable risk of injury and death posed by
magnet ingestions. The Commission believes that compliance with the
requirements of the proposed rule will significantly reduce magnet
ingestion deaths and injuries in the future; thus, the rule is in the
public interest.
G. Voluntary Standards
To issue a final rule, the CPSA requires the Commission to find
that, if a voluntary standard addressing the risk of injury has been
adopted and implemented, that either compliance with the voluntary
standard is not likely to result in the elimination or adequate
reduction of the risk or injury, or there is unlikely to be substantial
compliance with the voluntary standard.
The Commission is aware of six voluntary and international
standards that address the magnet ingestion hazard: ASTM F963-17,
Standard Consumer Safety Specification for Toy Safety; ASTM F2923-20,
Standard Specification for Consumer Product Safety for Children's
Jewelry; ASTM F2999-19, Standard Consumer Safety Specification for
Adult Jewelry; ASTM F3458-21, Standard Specification for Marketing,
Packaging, and Labeling Adult Magnet Sets Containing Small, Loose,
Powerful Magnets (with a Flux Index = 50 kG\2\ mm\2\); EN-
71-1: 2014, Safety of Toys; Part 1: Mechanical and Physical Properties;
and ISO 8124-1: 2018, Safety of Toys--Part 1: Safety Aspects Related to
Mechanical and Physical Properties. The Commission does not consider
the standards likely to result in an adequate reduction of the risk of
injury associated with magnet ingestions because of the scope of
products each standard covers, and the types of requirements included
in them.
None of these standards apply to all of the products most commonly
identified in magnet ingestion incidents--magnet sets intended for
users 14 years and older, magnet toys intended for users 14 years and
older, and jewelry. Moreover, even for the products the standards do
address, several standards provide exceptions for certain amusement and
jewelry products, imposing only warning requirements for those
products.
In addition, several of the standards do not impose performance
requirements on magnets themselves, such as size and strength
requirements, instead recommending or requiring safety messaging or
packaging. CPSC does not consider safety messaging or packaging
requirements sufficient, without additional performance requirements,
to adequately reduce the risk of injury and death associated with
magnet ingestions. Incident data indicate that children commonly access
ingested magnets from sources that do not include packaging or safety
messaging; children and caregivers have commonly disregarded safety
messaging to date; safety packaging only limits young children from
accessing its contents, which does not address the majority of magnet
ingestions, which involve older children and teens; and safety
packaging requires users to repackage all magnets after every use to be
effective, which is unlikely given the large number and small size of
magnets often in subject magnet products.
H. Relationship of Benefits to Costs
On a per unit basis (as shown in Table 19), CPSC estimates the
expected benefits per unit to range from $160 (assuming a 1.5-year
product life and a 3 percent discount rate) to $190 (assuming a 3-year
product life and a 3 percent discount rate). The estimated expected
cost to manufacturers per unit is between about $5 and $10, and there
is an unquantifiable cost to consumers associated with lost utility and
availability.
CPSC estimates the aggregate benefits of the rule to be $80 million
to $95 million annually and estimates the cost of the rule to be
between $10 million to $17.5 million annually, assuming sales of
500,000 units annually (estimated costs range from $5 million to $35
million annually, depending on annual sales between 250,000 and 1
million units). The Commission believes, preliminarily, that the
benefits expected from the proposed rule bear a reasonable relationship
to its costs.
I. Least Burdensome Requirement That Would Adequately Reduce the Risk
of Injury
CPSC considered several less-burdensome alternatives to the
proposed rule. One alternative is to take no regulatory action and,
instead, rely on existing standards to address the magnet ingestion
hazard. This would reduce the burden associated with the rule by
avoiding a mandatory standard; however, this alternative is unlikely to
adequately address the magnet ingestion hazard because none of the
existing standards apply performance requirements to all of the
products most commonly involved in magnet ingestions incidents.
Another alternative is a mandatory standard with less stringent
requirements than the proposed rule, such as a higher flux index limit,
or different requirements for certain shapes and sizes of magnets. This
could reduce the burden associated with a rule by allowing firms to
market a wider variety of products than under the proposed rule.
However, this alternative would reduce the safety benefits because
allowing certain hazardous magnets in subject magnet products to remain
on the market does not address the hazard such products pose.
Safety messaging is another alternative to the proposed rule. This
alternative would reduce the burdens associated with the rule because
it would not require modifying or discontinuing subject magnet
products, and the costs of such warnings and instructional information
likely would be small. However, this alternative is not likely to
adequately reduce the magnet ingestion hazard. Safety messaging is
generally the least effective way to reduce hazards associated with
consumer products; incident data shows children commonly access
ingested magnets from sources that do not include product packaging,
where warnings are provided; incident data, behavioral and
developmental factors, and other information indicate that children and
caregivers commonly disregard safety messaging regarding the magnet
ingestion hazard; and this approach has not been effective at
adequately reducing the hazard, to date.
Another alternative is to require special packaging to limit
children's access to subject magnet products. Such packaging could help
consumers determine if all magnets have been
[[Page 1312]]
returned to the container and include child-resistant features.
Although this alternative would create some packaging costs, those
costs likely would be lower than the proposed rule because it would
allow subject magnet products to remain unchanged. However, this
alternative is not likely to adequately reduce the risk of injury and
death associated with magnet ingestions. Consumers are unlikely to
repackage all magnets after each use, given the small size and large
number of magnets in products, the potential to lose magnets, and
consumers' demonstrated underappreciation of the hazard. In addition,
packaging requirements are unlikely to be effective because they
generally only restrict young children (under 5 years old) from
accessing package contents, and would not prevent older children or
teens from accessing the package contents, although the majority of
magnet ingestion incidents involved children 5 years and older.
Another alternative is to require subject magnet products to be
coated with aversive agents. This alternative would reduce the burden
associated with the rule because it would allow firms to continue to
sell subject magnet products and the costs of such coatings likely
would be small. However, such requirements are not likely to adequately
address the hazard because they do not address ingestions that occur
when the first magnet is placed in the victim's mouth, before the
aversive agent is detected, accidental ingestions, or children who are
developmentally inclined to place objects in their mouths.
Another alternative is to provide a longer effective date for the
final rule. This may reduce the burdens associated with the rule by
spreading them over a longer period, but it would also delay the safety
benefits of the rule.
XVII. Request for Comments
The Commission requests comments on all aspects of the proposed
rule. Comments should be submitted in accordance with the instructions
in the ADDRESSES section at the beginning of this notice. The following
are specific comment topics that the Commission would find helpful:
A. Scope and Definitions
The scope of products covered by the proposed rule, and
whether additional products should be included or excluded from the
scope;
Specifically, whether home/kitchen magnets or education
products should be addressed in the rule;
Data supporting any recommendations to include or exclude
products from the scope of the rule; and
Information and data about magnets involved in ingestion
incidents that are categorized as unidentified product types in staff's
analysis.
B. Performance Requirements
Application of the ASTM F963 test method for measuring
flux density, particularly to test small diameter spherical magnets in
the 2 to 3 mm diameter range;
Variances in flux density measurements of small spherical
magnets, including correct identification of pole surfaces, accurate
measurement of maximum absolute flux density, and accurate calculation
of maximum cross section of the magnetic poles;
Potential alternative methods of assessing the strength of
magnets or their ability to cause internal interaction injuries;
How many magnets should be tested, including whether all
loose or separable magnets in subject magnet products should be tested,
or only a representative sample or at least one representative sample
of each shape and size should be tested, and how firms may satisfy such
requirements;
Whether statistical sampling should be used to determine
how many magnets to test in a subject magnet product and to reasonably
verify the tested sample is representative, particularly for products
made up of numerous individual magnets;
The proposed flux index limit of 50 kG\2\ mm\2\, including
data on whether magnets with flux indexes less than 50 kG\2\ mm\2\ pose
concern for the internal interaction hazard; and
Whether the rule should include requirements similar to
ASTM F963 to ensure that products do not liberate hazardous magnets
after use and abuse testing.
C. Safety Messaging and Packaging Requirements
Whether the rule should include requirements for safety
messaging, particularly for products with flux indexes within the
permissible range for which there is uncertainty about the flux indexes
that can cause internal interaction hazards;
Whether the rule should include requirements for
packaging, particularly for products with flux indexes within the
permissible range for which there is uncertainty about the flux indexes
that can cause internal interaction hazards;
What safety messaging requirements should include, and why
they should be included; and
What packaging requirements should include, and why they
should be included.
D. Existing Standards
Data regarding the level of compliance with existing
standards that address magnet ingestions, including ASTM standards.
E. Economic Analysis (Preliminary Regulatory Analysis and IRFA)
The estimates and other valuations used in CPSC's analysis
regarding benefits and costs associated with the proposed rule;
The annual unit sales of subject magnet products;
The expected product life of subject magnet products;
The number of subject magnet products subject to the
proposed rule;
The accuracy and reasonableness of the benefits estimates;
Information about the costs to consumers associated with
the proposed rule, including consumer needs for subject magnet
products, and the potential impact of the proposed rule on the utility,
cost, and availability of subject magnet products for those needs;
The accuracy and reasonableness of the cost estimates for
manufacturers and importers (if available, sales or other shipment data
would be helpful);
The potential impact of the proposed rule on small
entities;
Costs associated with testing and certification
requirements, including requirements in section 14 of the CPSA,
particularly for small businesses;
Potential modifications to subject magnet products to
comply with the proposed rule, and the costs associated with those
modifications;
The types and magnitude of manufacturing costs that might
disproportionately impact small businesses or were not considered in
the agency's analysis;
The different impacts on small businesses associated with
different effective dates; and
Other alternatives that would minimize the impact on small
businesses while reducing the magnet ingestion hazard.
F. Effective Date
The reasonableness of the proposed 30-day effective date
and recommendations for a different effective date, if justified.
Comments recommending a longer effective date should describe the
problems associated with meeting the proposed effective
[[Page 1313]]
date and the justification for a longer one.
G. Anti-Stockpiling
Whether the Commission should consider including in the
rule anti-stockpiling provisions to prevent manufacturing or importing
of non-compliant subject magnet products at an increased rate during
the period between announcing a final rule and the effective date of
the rule; and
Information relevant to whether an anti-stockpiling
provision is necessary.
XVIII. Promulgation of a Final Rule
Section 9(d)(1) of the CPSA requires the Commission to promulgate a
final consumer product safety rule within 60 days of publishing a
proposed rule. 15 U.S.C. 2058(d)(1). Otherwise, the Commission must
withdraw the proposed rule if it determines that the rule is not
reasonably necessary to eliminate or reduce an unreasonable risk of
injury associated with the product, or is not in the public interest.
Id. However, the Commission can extend the 60-day period, for good
cause shown, if it publishes the reasons for doing so in the Federal
Register. Id.
The Commission finds that there is good cause to extend the 60-day
period for this rulemaking. Under both the Administrative Procedure Act
and the CPSA, the Commission must provide an opportunity for interested
parties to submit written comments on a proposed rule. 5 U.S.C. 553; 15
U.S.C. 2058(d)(2). The Commission typically provides 75 days for
interested parties to submit written comments. A shorter comment period
may limit the quality and utility of information CPSC receives in
comments, particularly for areas where it seeks data and other detailed
information that may take time for commenters to compile. In addition,
the CPSA requires the Commission to provide interested parties with an
opportunity to make oral presentations of data, views, or arguments. 15
U.S.C. 2058. This requires time for the Commission to arrange a public
meeting for this purpose, and provide notice to interested parties in
advance of that meeting. After receiving written and oral comments,
CPSC staff must have time to review and evaluate those comments.
These factors make it impractical for the Commission to issue a
final rule within 60 days of this proposed rule. Moreover, issuing a
final rule within 60 days of the NPR may limit commenters' ability to
provide useful input on the rule, and CPSC's ability to evaluate and
take that information into consideration in developing a final rule.
Accordingly, the Commission finds that there is good cause to extend
the 60-day period.
XIX. Conclusion
For the reasons stated in this preamble, the Commission proposes
requirements for subject magnet products to address an unreasonable
risk of injury associated with ingestion of such products.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third-party conformity
assessment body.
16 CFR Part 1262
Consumer protection, Imports, Incorporation by reference, Safety.
For the reasons discussed in the preamble, the Commission proposes
to amend Title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(52) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?
* * * * *
(b) * * *
(52) 16 CFR part 1262, Safety Standard for Magnets.
* * * * *
0
3. Add part 1262 to read as follows:
PART 1262--SAFETY STANDARD FOR MAGNETS
Sec.
1262.1 Scope, purpose, application, and exemptions.
1262.2 Definitions.
1262.3 Requirements.
1262.4 Test procedure for determining flux index.
1262.5 Findings.
Authority: 15 U.S.C. 2056, 2058
Sec. 1262.1 Scope, purpose, application, and exemptions.
(a) Scope and purpose. This part 1262, a consumer product safety
standard, prescribes the safety requirements for a subject magnet
product, as defined in Sec. 1262.2(b). These requirements are intended
to reduce or eliminate an unreasonable risk of death or injury to
consumers who ingest one or more hazardous magnets (as defined in Sec.
1262.2(a)) from a subject magnet product.
(b) Application. Except as provided in paragraph (c) of this
section, all subject magnet products that are manufactured in the
United States, or imported, on or after [effective date], are subject
to the requirements of this part 1262, if they are consumer products.
Section 3(a)(1) of the Consumer Product Safety Act (15 U.S.C.
2052(a)(1)) defines the term consumer product as an ``article, or
component part thereof, produced or distributed
(i) for sale to a consumer for use in or around a permanent or
temporary household or residence, a school, in recreation, or
otherwise, or
(ii) for the personal use, consumption or enjoyment of a consumer
in or around a permanent or temporary household or residence, a school,
in recreation, or otherwise.'' The term does not include products that
are not customarily produced or distributed for sale to, or for the use
or consumption by, or enjoyment of, a consumer.
(c) Exemptions. Toys that are subject to 16 CFR part 1250, Safety
Standard Mandating ASTM F963 for Toys, are exempt from this part 1262.
Sec. 1262.2 Definitions.
In addition to the definitions given in section 3 of the Consumer
Product Safety Act (15 U.S.C. 2052), the following definitions apply
for purposes of this part 1262:
(a) Hazardous magnet means a magnet that fits entirely within the
cylinder described in 16 CFR 1501.4 and that has a flux index of 50
kG\2\ mm\2\ or more when tested in accordance with the method described
in this part 1262.
(b) Subject magnet product means a consumer product that is
designed, marketed, or intended to be used for entertainment, jewelry
(including children's jewelry), mental stimulation, stress relief, or a
combination of these purposes, and that contains one or more loose or
separable magnets.
Sec. 1262.3 Requirements.
Each loose or separable magnet in a subject magnet product that
fits entirely within the cylinder described in 16 CFR 1501.4 must have
a flux index of less than 50 kG\2\ mm\2\ when tested in accordance with
the method described in 1262.4.
Sec. 1262.4 Test procedure for determining flux index.
(a) Select at least one loose or separable magnet of each shape and
size in the subject magnet product.
[[Page 1314]]
(b) Measure the flux index of each selected magnet in accordance
with the procedure in section 8.25.1 through 8.25.3 of ASTM F963-17,
Standard Consumer Safety Specification for Toy Safety, approved on May
1, 2017. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain a copy from ASTM International, 100 Barr Harbor
Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; phone: (610)
832-9585; www.astm.org. A read-only copy of the standard is available
for viewing on the ASTM website at https://www.astm.org/READINGLIBRARY/. You may inspect a copy at the Division of the
Secretariat, U.S. Consumer Product Safety Commission, 4330 East-West
Highway, Bethesda, MD 20814, telephone (301) 504-7479, email: [email protected], or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
Sec. 1262.5 Findings.
(a) General. Section 9(f) of the Consumer Product Safety Act (15
U.S.C. 2058(f)) requires the Commission to make findings concerning the
following topics and to include the findings in the rule. Because the
findings are required to be published in the rule, they reflect the
information that was available to the Consumer Product Safety
Commission (Commission, CPSC) when the standard was issued on [final
rule publication date].
(b) Degree and nature of the risk of injury. (1) The standard is
designed to reduce the risk of death and injury associated with magnet
ingestions. The Commission has identified 284 magnet ingestions that
were reported to have occurred between January 1, 2010 and December 31,
2020. Seventy-five percent of these incidents involved amusement or
jewelry products, which are the products covered by this rule, and an
additional 15 percent involved unidentified magnet products, a large
portion of which CPSC concludes are likely to have involved subject
magnet products, based on developmental and behavioral factors,
identified products involved in magnet ingestion incidents, products
involved in recalls for magnet ingestion hazards, and trend analyses
indicating a significant decrease in magnet ingestion incidents when
there was a mandatory standard for certain subject magnet products.
There were an estimated 4,400 magnet ingestions treated in U.S.
hospital emergency departments between January 1, 2010 and December 31,
2020 that involved products categorized as being for amusement or
jewelry, which are the products subject to this rule, and an additional
estimated 18,100 emergency department treated magnet ingestions
involving unidentified magnet products, a large portion of which CPSC
concludes are likely to have involved subject magnet products for the
reasons stated above. In addition, the Injury Cost Model projects that
there were an additional estimated 3,255 magnet ingestion injuries per
year treated in medical settings other than emergency departments from
2017 through 2020.
(2) The potential injuries when a child or teen ingests one or more
magnets are serious. Health threats posed by magnet ingestion include
pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae,
ischemia, inflammation, perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among others. These conditions can
result from magnets attracting to each other through internal body
tissue, or a single magnet attracting to a ferromagnetic object. CPSC
is aware of several fatal magnet ingestion incidents that occurred in
the United States, resulting from internal interaction of the magnets
(small intestine ischemia and volvulus).
(c) Number of consumer products subject to the rule. Approximately
500,000 subject magnet products are estimated to be sold annually in
the United States.
(d) The need of the public for subject magnet products and the
effects of the rule on their cost, availability, and utility. (1)
Consumers use subject magnet products for entertainment, mental
stimulation, stress relief, and jewelry. The proposed rule requires
subject magnet products to meet performance requirements regarding size
or strength, but does not restrict the design of products. As such,
subject magnet products that meet the standard would continue to serve
the purpose of amusement or jewelry for consumers. Magnets that comply
with the proposed rule, such as non-separable magnets, larger magnets,
weaker magnets, or non-permanent magnets, would likely still be useful
for amusement or jewelry. However, it is possible that there may be
some negative effect on the utility of subject magnet products if
compliant products function differently or do not include certain
desired characteristics.
(2) Retail prices of subject magnet products generally average
under $20. CPSC has identified subject magnet products that comply with
the proposed rule, indicating that the cost of compliant and non-
compliant products are comparable.
(3) If the costs associated with redesigning or modifying subject
magnet products to comply with the proposed rule results in
manufacturers discontinuing products, there may be some loss in
availability to consumers. However, this would be mitigated to the
extent that compliant products meet the same consumer needs.
(e) Other means to achieve the objective of the rule while
minimizing adverse effects on competition, manufacturing, and
commercial practices. (1) The Commission considered several
alternatives to achieve the objective of reducing unreasonable risks of
injury and death associated with magnet ingestions. One alternative is
to take no regulatory action and, instead rely on existing voluntary
standards to address the magnet ingestion hazard. This would eliminate
costs associated with the rule by avoiding a mandatory standard;
however, this alternative is unlikely to adequately reduce the risk of
injury and death associated with magnet ingestions. For one, none of
the existing standards address all of the products most commonly
identified in magnet ingestion incidents, and several of the standards
provide exceptions to performance requirements for certain subject
magnet products. In addition, under the existing standards, certain
subject magnet products would not be subject to performance
requirements regarding size and strength, instead relying on
alternative requirements, such as safety messaging, which is unlikely
to adequately reduce the magnet ingestion hazard.
(2) Another alternative is a mandatory standard with less stringent
requirements than the proposed rule, such as a higher flux index limit,
or different requirements for certain shapes and sizes of magnets. This
could reduce the costs associated with a rule by allowing firms to
market a wider variety of products than under the proposed rule.
However, for this alternative to reduce costs, it would allow more
products to remain on the market, thereby decreasing the safety
benefits.
(3) Safety messaging requirements are another alternative to the
proposed rule. This would reduce the costs associated with the rule
because it would not require modifying or discontinuing subject magnet
products, and the costs of warnings and instructional information
likely would be small. However, this alternative is not likely to
adequately reduce the risk of injury and death associated with magnet
ingestion because the effectiveness of safety
[[Page 1315]]
messaging depends on consumer seeing the messaging and convincing them
to avoid the hazard. Incident data indicate that children commonly
access ingested magnets from sources that are unlikely to include the
product packaging bearing instructions or warnings. Moreover, consumers
are unlikely to consistently heed warnings because of the perception
that subject magnet products are appropriate for children, and
underappreciation of the magnet ingestion hazard. Safety messaging is
generally considered the least effective way to address product
hazards, and has been ineffective at addressing the magnet ingestion
hazard, to date.
(4) Another alternative is to require special packaging to limit
children's access to subject magnet products. Such packaging could help
consumers determine if all magnets have been returned to the container
and include child-resistant features. Although this alternative would
create some packaging costs, those likely would be lower than the costs
associated with the proposed rule because it would allow subject magnet
products to remain unchanged. However, this alternative is not likely
to adequately reduce the risk of injury and death associated with
magnet ingestions. For packaging requirements to be effective, users
would have to repackage all magnets after each use, which is unlikely
given the small size and large number of magnets often in a product,
the potential to lose magnets, and consumers' demonstrated
underappreciation of the hazard. In addition, packaging requirements
are unlikely to be effective because they generally only restrict young
children (under 5 years old) from accessing package contents, and would
not prevent older children or teens from accessing the package
contents, although the majority of magnet ingestion incidents involved
children 5 years and older.
(5) Another alternative is to require subject magnet products to be
coated with aversive agents. This alternative would reduce the costs
associated with the rule because it would allow firms to continue to
sell subject magnet products and the costs of such coatings likely
would be small. However, such requirements are not likely to adequately
reduce the risk of injury and death associated with magnet ingestions
because they do not address ingestions that occur when the first magnet
is placed in the victim's mouth, before the aversive agent is detected,
accidental ingestions, or children who are developmentally inclined to
place objects, including unpalatable substances, in their mouths.
(6) Another alternative is to provide a longer effective date for
the final rule. This may reduce the costs associated with the rule by
spreading them over a longer period, but it would also delay the safety
benefits of the rule.
(f) Unreasonable risk. (1) Incident data indicate that there were
an estimated 23,700 magnet ingestions treated in U.S. hospital
emergency departments from January 1, 2010 to December 31, 2020.
Although this includes ingestions of all magnet types, and is not
limited to subject magnet products, it provides an indication of the
frequency with which children and teens ingest magnets, and the need to
address the magnet ingestion hazard. Of these estimated 23,700
emergency department treated magnet ingestions, an estimated 4,400
involved products categorized as being for amusement or jewelry, which
are the products subject to this rule, and an additional estimated
18,100 involved unidentified magnet product types. The Commission
considers a large portion of the incidents involving unidentified
magnet products to have been subject magnet products, based on the
factors described above with respect to the finding regarding the
degree and nature of the risk of injury. In addition, the Injury Cost
Model projects that there were an additional estimated 3,255 magnet
ingestion injuries per year treated in medical settings other than
emergency departments from 2017 through 2020. Trend analysis indicates
that magnet ingestions have significantly increased in recent years.
(2) The potential injuries when a person ingests one or more
magnets are serious. Health threats posed by magnet ingestion include
pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae,
ischemia, inflammation, perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among others. These conditions can
result from magnets attracting to each other through internal body
tissue, or a single magnet attracting to a ferromagnetic object. Magnet
ingestion incidents commonly result in hospitalization, particularly
when subject magnet products are ingested. The Commission is aware of
five fatal magnet ingestion incidents that occurred in the United
States between November 24, 2005 and January 5, 2021. Four of these
incidents involved children 2 years old or younger, and all five
victims died from injuries resulting from internal interaction of the
magnets. Four of the five incidents identified the products as magnet
sets, amusement products, or described them as having characteristics
that are consistent with subject magnet products.
(3) For these reasons, the Commission preliminarily concludes that
the rule is reasonably necessary to eliminate or reduce an unreasonable
risk of injury associated with the product.
(g) Public interest. This rule is intended to address an
unreasonable risk of injury and death posed by magnet ingestions. The
Commission believes that compliance with the requirements of the rule
will significantly reduce magnet ingestion deaths and injuries in the
future; thus, the rule is in the public interest. For these reasons,
the Commission preliminarily concludes that issuing the rule is in the
public interest.
(h) Voluntary standards. (1) The Commission is aware of six
voluntary and international standards that address the magnet ingestion
hazard: ASTM F963-17, Standard Consumer Safety Specification for Toy
Safety; ASTM F2923-20, Standard Specification for Consumer Product
Safety for Children's Jewelry; ASTM F2999-19, Standard Consumer Safety
Specification for Adult Jewelry; ASTM F3458-21, Standard Specification
for Marketing, Packaging, and Labeling Adult Magnet Sets Containing
Small, Loose, Powerful Magnets (with a Flux Index =50 kG\2\
mm\2\); EN-71-1: 2014, Safety of Toys; Part 1: Mechanical and Physical
Properties; and ISO 8124-1: 2018, Safety of Toys--Part 1: Safety
Aspects Related to Mechanical and Physical Properties. The Commission
does not consider the standards likely to result in an adequate
reduction of the risk of injury associated with magnet ingestions
because of the scope of products each standard covers, and the types of
requirements included in them.
(2) None of these standards apply to all of the products most
commonly identified in magnet ingestion incidents--magnet sets intended
for users 14 years and older, magnet toys intended for users 14 years
and older, and jewelry. Even for the products the standards do address,
several standards provide exceptions for certain amusement and jewelry
products, imposing only warning requirements for those products.
(3) In addition, several of the standards do not impose performance
requirements on magnet themselves, such as size and strength
requirements, instead recommending or requiring safety messaging or
packaging. CPSC does not consider safety messaging or packaging
requirements sufficient, without additional performance requirements,
to adequately reduce the risk of injury and death associated with
[[Page 1316]]
magnet ingestions. Incident data indicate that children commonly access
ingested magnets from sources that do not include packaging or safety
messaging; children and caregivers have commonly disregarded safety
messaging to date; safety packaging only limits young children
(typically, children under 5 years old) from accessing its contents,
which does not address magnet ingestions by older children and teens,
which make up the majority of incidents; and safety packaging requires
users to repackage all magnets after every use to be effective, which
is unlikely given the large number and small size of magnets often in
subject magnet products.
(4) For these reasons, the Commission preliminarily concludes that
compliance with existing standards is not likely to result in the
elimination or adequate reduction of the risk of injury associated with
magnet ingestion.
(i) Relationship of benefits to costs. (1) CPSC estimates the
aggregate benefits of the rule to be $80 million to $95 million
annually and estimates the cost of the rule to be between $10 million
to $17.5 million annually, assuming sales of 500,000 units annually
(estimated costs range from $5 million to $35 million annually,
depending on annual sales between 250,000 and 1 million units).
(2) On a per unit basis, CPSC estimates the expected benefits per
unit to range from $160 (assuming a 1.5-year product life and a 3
percent discount rate) to $190 (assuming a 3-year product life and a 3
percent discount rate). The estimated expected cost to manufacturers
per unit is between about $5 and $10, and there is an unquantifiable
cost to consumers associated with lost utility and availability.
(3) Based on this analysis, the Commission preliminarily finds that
the benefits expected from the rule bear a reasonable relationship to
its anticipated costs.
(j) Least burdensome requirement that would adequately reduce the
risk of injury. (1) CPSC considered several less-burdensome
alternatives to the proposed rule. One alternative is to take no
regulatory action and, instead, rely on existing standards to address
the magnet ingestion hazard. This would reduce the burden associated
with the rule by avoiding a mandatory standard, however, this
alternative is unlikely to adequately address the magnet ingestion
hazard because none of the existing standards apply performance
requirements to all of the products most commonly involved in magnet
ingestions incidents.
(2) Another alternative is a mandatory standard with less stringent
requirements than the proposed rule, such as a higher flux index limit,
or different requirements for certain shapes and sizes of magnets. This
could reduce the burden associated with a rule by allowing firms to
market a wider variety of products than under the proposed rule.
However, this alternative would reduce the safety benefits because
allowing certain hazardous magnets in subject magnet products to remain
on the market does not address the hazard such products pose.
(3) Safety messaging is another alternative to the proposed rule.
This alternative would reduce the burdens associated with the rule
because it would not require modifying or discontinuing subject magnet
products, and the costs of such warnings and instructional information
likely would be small. However, this alternative is not likely to
adequately reduce the magnet ingestion hazard. Safety messaging is
generally the least effective way to reduce hazards associated with
consumer products; incident data shows children commonly access
ingested magnets from sources that do not include product packaging,
where warnings are provided; incident data, behavioral and
developmental factors, and other information indicate that children and
caregivers commonly disregard safety messaging regarding the magnet
ingestion hazard; and this approach has not been effective at
adequately reducing the hazard, to date.
(4) Another alternative is to require special packaging to limit
children's access to subject magnet products. Such packaging could help
consumers determine if all magnets have been returned to the container
and include child-resistant features. Although this alternative would
create some packaging costs, those costs likely would be lower than the
proposed rule because it would allow subject magnet products to remain
unchanged. However, this alternative is not likely to adequately reduce
the risk of injury and death associated with magnet ingestions.
Consumers are unlikely to repackage all magnets after each use, given
the small size and large number of magnets in products, the potential
to lose magnets, and consumers' demonstrated underappreciation of the
hazard. In addition, packaging requirements would only prevent young
children (typically, children under 5 years old) from accessing the
product, not older children or teens, who are involved in the majority
of magnet ingestion incidents.
(5) Another alternative is to require subject magnet products to be
coated with aversive agents. This alternative would reduce the burden
associated with the rule because it would allow firms to continue to
sell subject magnet products and the costs of such coatings likely
would be small. However, such requirements are not likely to adequately
address the hazard because they do not address ingestions that occur
when the first magnet is placed in the victim's mouth, before the
aversive agent is detected, accidental ingestions, or children who are
developmentally inclined to place objects in their mouths.
(6) Another alternative is to provide a longer effective date for
the final rule. This may reduce the burdens associated with the rule by
spreading them over a longer period, but it would also delay the safety
benefits of the rule.
(7) For these reasons, the Commission preliminarily finds that the
rule imposes the least burdensome requirement that prevents or
adequately reduces the risk of injury associated with magnet
ingestions.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2021-27826 Filed 1-7-22; 8:45 am]
BILLING CODE 6355-01-P
