[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Rules and Regulations]
[Pages 57756-57792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20200]
[[Page 57755]]
Vol. 87
Wednesday,
No. 182
September 21, 2022
Part II
Consumer Product Safety Commission
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16 CFR Parts 1112 and 1262
Safety Standard for Magnets; Final Rule
Federal Register / Vol. 87, No. 182 / Wednesday, September 21, 2022 /
Rules and Regulations
[[Page 57756]]
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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: Final rule.
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SUMMARY: The U.S. Consumer Product Safety Commission (Commission or
CPSC) is issuing a rule to address the hazard associated with ingestion
of one or more high-powered magnets. The CPSC has determined that
unreasonable risks of injury are associated with small, powerful
magnets that, when ingested, can interact internally through body
tissue, which can lead to acute and long-term health consequences or
death. The rule establishes requirements for subject magnet 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, but the subject products do not
include magnet products sold and/or distributed solely to school
educators, researchers, professionals, and/or commercial or industrial
users exclusively for educational, research, professional, commercial,
and/or industrial purposes. Each loose or separable magnet in a product
that is subject to the rule and that fits entirely within CPSC's small
parts cylinder must have a flux index of less than 50 kG\2\ mm\2\. The
flux index is determined by the method described in the ASTM F963 Toy
Standard. The rule exempts from its requirements toys subject to the
ASTM F963 Toy Standard. The Commission takes this action under the
Consumer Product Safety Act (CPSA).
DATES:
Effective date for magnet rule: This rule is effective on October
21, 2022 and will apply to all subject magnet products manufactured
after that date. The incorporation by reference of the publication
listed in this rule is approved by the Director of the Federal Register
as of October 21, 2022.
Effective date for Notice of Requirements: The Notice of
Requirements for this rule is effective on December 20, 2022 and will
apply to subject magnet products that are children's products required
to be tested by CPSC-accepted third party conformity assessment bodies.
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. CPSC's Prior Work on the Magnet Ingestion Hazard
In 2012, the Commission initiated rulemaking to address the magnet
ingestion hazard for products. The rule focused on magnet sets (which
are among the subject magnet products addressed in this rule) that were
involved in internal interaction injuries in children and teens. 77 FR
53781 (Sep. 4, 2012) (notice of proposed rulemaking); 79 FR 59962 (Oct.
3, 2014) (2014 magnet sets 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, consistent with the magnet size and strength
limits specified in ASTM F963-11, which was in effect when the 2014
magnet sets rule was issued. Subsequently, ASTM F963-17 revised the
definition of ``hazardous magnet'' to have a flux index of 50 kG\2\
mm\2\ or more. 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 CPSC's 2014 magnet sets rule, vacating and remanding
it to the Commission. Zen Magnets, LLC v. Consumer Prod. Safety
Comm'n., 841 F.3d 1141 (10th Cir. 2016).\1\
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\1\ 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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On June 30, 2020, staff provided the Commission with an
informational briefing package discussing the magnet ingestion
hazard.\2\ Staff recommended that CPSC continue to consider performance
requirements for magnets, to address the ingestion hazard to children
and teens.
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\2\ The informational briefing package is available at:
www.cpsc.gov/s3fspublic/Informational%20Briefing%20Package%20Regarding%20Magnet%20Sets.pdf.
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Throughout this period, CPSC's Office of Compliance and Field
Operations investigated and recalled numerous magnet products due to
the magnet internal interaction hazard. CPSC has conducted 20 recalls
involving hazardous magnets, including two recalls, both involving
magnet sets, since preparation of the NPR. Of the 20 recalls, six
involved toys subject to ASTM F963 and four involved products that
would not be subject to the draft final rule (e.g., a helmet with a
magnetic strap). There were substantially fewer recalls of children's
toys for violations of the magnet requirements specified in ASTM F963
after 2010 than before that time, reflecting that ASTM F963 has been
effective in addressing the magnet internal interaction hazard for
children's toys. The Commission previously incorporated by reference
ASTM F963-17, as codified in 16 CFR part 1250, (referred to also as
ASTM F963 Toy Standard) (82 FR 57119) (Dec. 4, 2017).
B. Notice of Proposed Rulemaking
In the Federal Register of January 10, 2022 (87 FR 1260), the
Commission issued a notice of proposed rulemaking (NPR) under sections
7 and 9 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 2051-2089),
to address the unreasonable risk of injury and death associated with
ingestion of loose or separable high-powered magnets.\3\ As described
in the NPR, the incident data showed that hazardous magnets continue to
be ingested, in particular, by children and teens. When ingested, these
powerful magnets can, among other risks, interact through body tissue
with one another, or with a ferromagnetic object (i.e., material
attracted to magnets), leading to acute and long-term adverse health
consequences or death.
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\3\ Staff's NPR briefing package is available at: www.cpsc.gov/s3fs-public/2022-08-17-Final-Rule-Safety-Standards-for-Magnets.pdf?VersionId=QPs8iPwg0w0m5b4qsOF3Ebo.zOXY2cUN.
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The NPR proposed that each loose or separable magnet in a subject
magnet product that fits entirely within a small parts cylinder, as
provided in 16 CFR 1501.4, must have a flux index of less than 50 kG\2\
mm\2\. The NPR proposed the test procedure for determining the flux
index in accordance with the test procedure in section 8.25.1 through
8.25.3 of the ASTM F963 Toy Standard.
The NPR proposed to exempt from the proposed rule, toys that are
subject to the ASTM F963 Toy Standard, because that standard already
includes requirements to adequately address the magnet ingestion
hazard. Specifically,
[[Page 57757]]
ASTM F963-17 applies to ``toys,'' which are defined as objects
``designed, manufactured, or marketed as a plaything for children under
14 years of age.''
The final rule includes the toy exemption and modifies the NPR's
proposal to clarify that the definition of ``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, but does not
include products sold and/or distributed solely to school educators,
researchers, professionals, and/or commercial or industrial users
exclusively for educational, research, professional, commercial, and/or
industrial purposes.
II. Statutory Authority
A. Rulemaking Under the Consumer Product Safety Act
The subject magnet products are ``consumer products'' that can be
regulated by the Commission under the authority of the CPSA. 15 U.S.C.
2052(a). Under section 7 of the CPSA, the Commission is authorized to
promulgate a mandatory consumer product safety standard that sets forth
performance requirements for a consumer product or that sets forth
requirements that a product be marked or accompanied by clear and
adequate warnings or instructions. 15 U.S.C. 2056. A performance,
warning, or instruction standard must be reasonably necessary to
prevent or reduce an unreasonable risk or injury associated with a
consumer product.
Section 9 of the CPSA specifies the procedure that the Commission
must follow to issue a consumer product safety standard under section
7. In accordance with section 9, the Commission commenced this
rulemaking by issuing the NPR, including the proposed rule and a
preliminary regulatory analysis under section 9(c) of the CPSA. In
addition, the Commission requested comments on all aspects of the NPR,
including the risk of injury identified, the regulatory alternatives
under consideration, and other possible alternatives for addressing the
risk. 15 U.S.C. 2058(c). With this notice, the Commission issues a
final rule, along with a final regulatory analysis. 15 U.S.C.
2058(f)(2).\4\
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\4\ The Commission voted 5-0 to publish this notice in the
Federal Register. Chair Hoehn-Saric and Commissioners Trumka and
Boyle issued statements in connection with their votes.
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Section 9 also requires the Commission to provide interested
persons ``an opportunity for the oral presentation of data, views, or
arguments,'' in addition to an opportunity to provide written comments.
Id. 2058(d)(2). On February 15, 2022, the hearing notice was published
in the Federal Register (87 FR 8442). The Commission held an online
public hearing on the proposed rule on March 2, 2022. The submissions
forwarded to the agency by presenters before the hearing, as well as
the transcript of the hearing, can be read online at:
www.regulations.gov under Docket No. CPSC-2021-0037. As discussed in
section VI. of this preamble, the Commission considered all the oral
and written comments received in response to the proposed rule.
B. Findings Required Under the Consumer Product Safety Act
According to 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 on the following
issues: (1) the degree and nature of the risk of injury that the rule
is designed to eliminate or reduce; (2) the approximate number of
consumer products subject to the rule; (3) the public's need for the
products subject to the rule, and the probable effect the rule will
have on utility, cost, or availability of such products; and (4) the
means to achieve the objective of the rule while minimizing adverse
effects on competition, manufacturing, and commercial practices. Id.
2058(f)(1).
Pursuant to section 9(f)(3) of the CPSA, to issue a final rule, the
Commission must find that the rule is ``reasonably necessary to
eliminate or reduce an unreasonable risk of injury associated with such
product'' and find that issuing the rule is in the public interest. Id.
2058(f)(3)(A)&(B). In addition, if a voluntary standard addressing the
risk of injury has been adopted and implemented, the Commission must
find that: (1) the voluntary standard is not likely to eliminate or
adequately reduce the risk of injury, or that (2) substantial
compliance with the voluntary standard is unlikely. Id. 2058(f)(3(D).
The Commission also must find that the expected benefits of the rule
bear a reasonable relationship to the costs of the rule and that the
rule imposes the least burdensome requirements that would adequately
reduce the risk of injury. Id. 2058(f)(3)(E)&(F). These findings are
provided in section 1262.5 of the regulatory text, below.
III. The Product and Market
A. Description of the Product
The final 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, but do not include
products sold and/or distributed solely to school educators,
researchers, professionals, and/or commercial or industrial users
exclusively for educational, research, professional, commercial, and/or
industrial purposes.
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, or used as desk toys, and as
other building sets. One common example of a subject magnet product is
a magnet set intended for users 14 years and older. 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, sizes
(e.g., 2.5 mm, 3 mm, 5 mm), and number of magnets (1 to thousands).
Subject magnet products often consist of numerous identical magnets,
although some products include non-identical magnets, such as 2 or more
different shapes. Subject magnet products commonly include magnets
between 3 mm and 6 mm in size and consist of several hundred magnets.
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. NIB is typically used in smaller magnets used
[[Page 57758]]
for magnet sets and magnetic jewelry sets, and ferrite/hematite is
typically used in larger magnets, such as rock-shaped magnet toys. The
magnetized cores of subject magnet products are coated with a variety
of metals and other materials to make them more attractive to consumers
and to protect the brittle magnetic alloy materials from breaking,
chipping, and corroding.
Staff found that 5 mm diameter NIB magnets (the most common size
identified in magnet ingestion incidents) typically have strong
magnetic properties, ranging between 300 and 400 kG\2\ mm\2\; and
ferrite rock magnets can measure upwards of 700 kG\2\ mm\2\. Staff also
identified products close to the 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.'' 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). Children's products that are toys are exempt from the rule
because they are already required to comply with ASTM F963-17's
requirements addressing the magnet ingestion hazard. One example of a
subject magnet product that is a children's product and not a toy is
children's jewelry.
B. The Product Market
Magnet products intended for the purposes covered in the rule
largely entered the market in 2008, with significant sales beginning in
2009. CPSC's previous efforts to address the magnet ingestion hazard
have focused primarily on magnet sets, given their involvement in
ingestion incidents, their popularity, uses for amusement and jewelry,
and the large number of loose, small, high-powered magnets in the sets.
Accordingly, much of the information CPSC has about the market for
subject magnet products focuses on magnet sets, 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 operate 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 two retailers.\5\ In 2020, CPSC
reviewed the status of previously identified sellers of magnet sets on
leading internet marketplaces and found evidence of the high turnover
rates for these platforms. Only nine 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 identified 29 new sellers that had not been detected in
late 2018.
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\5\ IEc classified manufacturers as firms producing and selling
their own magnet set products, and it classified retailers as firms
that typically sell magnets from multiple manufacturers.
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In 2018, approximately 57 percent of magnet set sellers on one
internet platform fulfilled orders domestically; whereas, in 2020, this
number declined to 25 percent. In 2018, approximately 25 percent of
magnet set sellers on another internet platform were domestic; whereas,
in 2020, this number increased to 87 percent. Non-domestic sellers were
located primarily in China and Hong Kong. Magnet sets purchased from
foreign internet retailers can be shipped to consumers directly, or
from warehouse facilities located domestically.
The most recent review by staff conducted in 2020 indicated that
magnet sets were comprised, most commonly, of 216 magnetic spheres,
with diameters of 5 mm. Retail prices per set average less than $20.
IEc's review in 2018 showed similar findings.\6\ Magnet sets are also
available in larger sets of 512 separable magnets and 1,000 or more
separable magnets. Magnet sets comprised of spheres or cubes with
smaller dimensions (2.5 mm to 3 mm) are also marketed, typically at
lower prices. Some of these magnet sets are advertised as having
magnets with magnetic flux indices less than 50 kG\2\ mm\2\; below the
threshold for being considered hazardous magnets. CPSC staff tested
samples of such smaller magnets and found that although 2.5 mm magnets
typically had flux indices of less than 50 kG\2\ mm\2\, many of the
magnet sets tested failed the ASTM F963-17 requirements because at
least one of the magnets in the set had a flux index of 50 kG\2\ mm\2\
or more. Sets with 3 mm diameter magnets were found to have flux
indices generally above 50 kG\2\ mm\2\.
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\6\ IEc found that magnet sets with 216 magnets accounted for
approximately one-third of the models in their market research, with
an average price of $16.67. However, sets of 216 magnets that
measured 5 mm in diameter averaged $18.62.
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Children's and adult jewelry, and other types of adult magnet
products intended for entertainment, mental stimulation, and stress
relief, which have one or more separable/loose magnets, are also within
the scope of the rule. Magnets are marketed online as jewelry-making
sets, as well as fake studs/piercings. As discussed in section IV of
this preamble, many magnet-ingestion cases involve the use of magnet
products described as jewelry, such as bracelets and necklaces, and
magnets used as jewelry (including those sold as part of a magnet set).
IV. Risk of Injury
A. Magnet Ingestion
For the NPR, CPSC's Directorate for Health Sciences (HS) assessed
the magnet ingestion hazard. Specifically, HS staff found that when a
subject magnet product is ingested, a magnet internal interaction
hazard can occur. The magnet internal interaction hazard is described
in detail in Tab A of Staff's NPR briefing package, as updated for this
final rule in Tab A of the Staff's Final Rule briefing package. The
risk of injury addressed by this rule is damage to intestinal tissue,
caused when someone ingests more than one magnet from a subject magnet
product (or one magnet and a ferromagnetic object). The magnets are
attracted to each other in the digestive system, damaging the
intestinal tissue that becomes trapped between the magnets. In rare
cases, there can be interaction between and among magnets in the
airways and digestive tract (esophagus). These injuries can be
difficult to diagnose and treat because the symptoms of magnet
ingestion often appear similar to entirely unrelated conditions, such
as stomach viruses. Serious injury, and even death, are consequences of
children ingesting magnets.
One of the health threats presented by magnet ingestion is internal
magnet interaction leading to pressure necrosis injuries 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 type of injury associated with the magnet
internal interaction hazard. Volvulus is an obstructive twisting of the
GI tract.
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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 the death of a 20-month-old
child who ingested magnets from a toy construction set, which caused
volvulus, and another 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 outcomes
such as perforation (hole) or fistula in the GI tract. If left
untreated, or otherwise unnoticed (including diagnosis as a stomach
virus as noted previously), 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 received
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 which carries risk of death as
previously noted. Several magnet ingestion incident reports highlight
the threat of perforation with possible outcomes like peritonitis.
Peritonitis is an inflammation of the peritoneum, a membrane lining 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 them 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.
Since the NPR, CPSC staff reviewed a recent multicenter cohort
study that presented data on 596 cases of patients aged 0 to 21 years,
from 25 children's hospitals in a 3-year period following high-powered
magnet sales re-entering the U.S. market after judicial vacatur of
CPSC's 2014 magnet sets rule (2017-2019).\7\ Of the 596 patients
treated for high-powered magnet exposures, 562 children (96.2%)
ingested magnets, 17 children (2.9%) were treated for nasal or aural
magnet foreign bodies, 4 children (0.7%) were treated for magnets in
their genitourinary tract, and 1 patient (0.2%) presented with magnets
in their respiratory tract. Most patients required serial radiography,
with 81.4 percent of children receiving more than one x-ray. Thirty-six
children (6%) required a computed tomography (CT) scan. Although
magnets passed spontaneously in more than half of patients (53.7%), 276
children (46.4%) required a procedure for magnet removal, or to address
complications from magnet ingestion. One hundred ninety-one patients
(32%) required endoscopy alone; 58 patients (9.7%) required surgery
alone; and 27 patients (4.5%) required both endoscopy and surgery.
Magnet exposure led to morbidity in 57 (9.6%) patients, which included
perforation (6%), fistula formation (3.7%), bowel obstruction (2.7%),
bleeding (0.7%), infection (0.5%), volvulus (0.2%), and/or bowel
herniation (0.2%). This study identified 19 children (3.2%) who
developed more than one of these listed morbidities. Approximately 55.7
percent of patients required hospitalization (332 patients) and four
patients (0.7%) were admitted to the ICU. The median length of hospital
stay was 3 days. This study shows that magnet ingestion frequently led
to hospitalization, the need for invasive medical management, and
caused morbidity in nearly 1 in 10 children who ingested magnets.
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\7\ This study can be found at: www.regulations.gov/comment/CPSC-2021-0037-0010.
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B. Incident Data--NEISS
For the NPR, CPSC's Directorate for Epidemiology, Division of
Hazard Analysis analyzed reported incidents related to magnet
ingestion, see Tab B of Staff's NPR briefing package. For the NPR, CPSC
staff analyzed magnet ingestion incident data obtained through the
National Electronic Injury Surveillance System (NEISS) and the Consumer
Product Safety Risk Management System (CPSRMS). The incident data
analyzed for the NPR were extracted on January 8, 2021, and they
included magnet ingestion reports that occurred from January 1, 2010,
through December 31, 2020. CPSC estimated that 23,700 emergency
department (ED)-treated magnet ingestions occurred in that timeframe.
Among other observations, CPSC noted that estimated magnet ingestions,
excluding products considered to be out-of-scope of the proposed rule,
fell during the period the CPSC's 2014 magnet sets rule was in effect,
and the estimated ingestions rose after the 2014 magnet sets rule was
vacated (79 FR 59962). Specifically, CPSC estimated for the NPR
approximately 2,300 ED-treated ingestions of magnets annually from 2010
through 2013 (years prior to the announcement of the magnet sets rule),
approximately 1,300 annually from 2014 through 2016 (years the rule was
[[Page 57760]]
announced and in place), and approximately 2,300 annually from 2017
through 2020 (the years following the removal of the rule).
For the final rule, Tab B of Staff's Final Rule briefing package
updated the incident data analysis, covering magnet ingestions reported
to have occurred from January 1, 2010, through December 31, 2021. CPSC
staff reviewed the additional data obtained since the NPR, using the
same characterizations in the NPR, and staff updated the estimates for
ED-treated, magnet ingestions. Staff categorized the data set to assess
the involvement of specific magnet product types in magnet ingestion
cases. Based on the identification and/or description of the products
involved in the cases, staff organized the cases into the following
magnet categories: ``magnet set,'' ``magnet toy,'' ``jewelry,''
``science kit,'' ``home/kitchen,'' ``F963 magnet toy,'' and
``unidentified.'' Staff further combined cases in those magnet
categories into groupings as: ``amusement/jewelry''--cases involving
magnet sets, magnet toys, or jewelry; ``unidentified''--cases involving
unidentified magnet products; and ``exclusions''--cases involving home/
kitchen products, ASTM F963 magnet toys, or science kits. In cases
where magnet ingestion incident reports contained too limited
information for staff to identify the type of product involved in the
magnet ingestion, they were classified as ``unidentified.'' As
explained in the NPR, staff does have additional information about the
incidents in the unidentified product type category; specifically,
these incidents involved ingestion of one or more magnets, based on
product characteristics and use patterns typically consistent with
subject magnet products. 87 FR 1269-75.
To account for the lack of product identification in many magnet
ingestion incidents, staff analyzed magnet ingestion incident data in
several ways. For one, 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 the incidents have increased
in recent years. This indicates the propensity of 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 sufficient to enable identification
of 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 particular 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).\8\ These
categories provide information about the products involved in magnet
ingestions, and the relative frequency of their involvement, to help
determine which products the rule should address.
---------------------------------------------------------------------------
\8\ 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 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 a 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. Staff also included
incidents in the unidentified product type category within these
analyses 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 rule. The following factors were considered.
First, the incident data discussed in this preamble support 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. The same was true
for CPSRMS incidents, 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 established for magnet ingestions applied to the
incidents that lacked product identification as well.
Second, magnet ingestion rates before, during, and after the
vacated 2014 magnet sets rule show that a significant portion of magnet
ingestion cases involved magnet sets. As discussed in the NPR, 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 2014 magnet sets rule. 87 FR 1273-74. Magnet sets were the
only products subject to that rule. As such, the significant decline in
incidents during that time the rule was in effect, 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 conclude 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 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 relating to ``unidentified'' products largely involved subject
magnet products. ASTM F963 magnet toys make up only a small portion of
magnet ingestion incidents where the product can be identified. It is
reasonable to conclude that this holds true for unidentified products
in magnet ingestions as well.
[[Page 57761]]
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
``amusement/jewelry'' (magnet sets, magnet toys, and jewelry) category,
and not the ``exclusions'' (science kit, home/kitchen, or ASTM F963
magnet toys) category. For these reasons, staff included magnet
ingestion incidents from the ``unidentified'' product type category in
many of its analyses; to exclude such incidents likely would vastly
underrepresent ingestions of subject magnet products.
For data extracted since the NPR, staff used the same categories
and groupings for additional incidents. The new data extracted on
January 13, 2022, included: (1) addition of 112 NEISS-reported
incidents that occurred from January 1, 2021, through December 31,
2021, with an estimated 2,500 ED-treated ingestions of magnets from in-
scope products which was higher than most of the preceding years, and
(2) 111 additional CPSRMS-reported incidents that occurred from
February 1, 2016, through December 27, 2021.\9\ Staff provided the
NEISS total estimates for 2010 through 2021, as follows:
---------------------------------------------------------------------------
\9\ The CPSRMS data analyzed in support of the NPR were
extracted on January 13, 2022. Reporting to the CPSRMS database is
ongoing, and therefore, it is common for reports to be received for
incidents from prior years. This also means CPSC in the coming years
may receive additional CPSRMS reports of magnet ingestions within
the studied period, particularly 2021.
---------------------------------------------------------------------------
There were an estimated 26,600 (2,800 in 2021) ED-treated
magnet ingestions involving magnet products of various types from 2010
through 2021.
An estimated 5,000 of the 26,600 (20%) magnet ingestions
involved magnet sets, magnet toys, or jewelry.
An estimated 1,600 of the 26,600 (6%) magnet ingestions
involved products identified as out-of-scope.
An estimated 20,000 of the 26,600 (75.2%) magnet
ingestions involved unidentified products.
An estimated 5,000 victims (20%) were hospitalized or
transferred to another hospital after treatment.
The middle 3 years (2014 through 2016) show significantly
fewer of these magnet ingestions (estimated 1,300 per year), compared
with earlier and more recent years (i.e., compared with 2,300 per year
from 2010 through 2013, and 2,400 per year from 2017 through 2021).
Table 1 provides the number of cases for each magnet category, and
Table 2 provides the estimates of ED-treated magnet ingestions
identified in the NPR, since the NPR, and overall, from 2010 through
2021.
Table 1--Count of Magnet Ingestion Cases Treated in NEISS Hospital Emergency Departments by Magnet Category
[2010-2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2021 (since 2010-2021 Combined magnet 2021 (since 2010-2021
Individual magnet category NPR NPR) (combined) category NPR NPR) (combined)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnet Set........................ 58 7 65 Amusement/Jewelry... 221 24 245
Jewelry *......................... 53 1 54
Magnet Toy........................ 110 16 126
Unidentified...................... 793 81 874 Unidentified........ 794 81 874
Science Kit....................... 1 0 1 Exclusions.......... 57 7 65
F963 magnet toy................... 11 2 13
Home/Kitchen...................... 46 5 51
------------------------------------------------ -----------------------------------------------
Total......................... 1,072 112 1,184 Total............ 1,072 112 1,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Includes cases of uncertain product classification for which the magnets were being used as or like jewelry.
Source: NEISS, CPSC.
Table 2--Estimated Number of Magnet Ingestions Treated in Hospital Emergency Departments by Magnet Category
[2010-2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPR Since NPR Combined
Magnet category --------------------------------------------------------------------------------------------------------------------
Estimate CV N Estimate CV N Estimate CV N
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amusement/Jewelry.................. 4,400 0.17 221 ** ** 24 5,000 0.16 245
Unidentified....................... 18,100 0.14 793 1,900 0.26 81 20,000 0.15 874
Exclusions......................... 1,300 0.20 58 ** ** 7 1,600 0.19 65
--------------------------------------------------------------------------------------------------------------------
Total.......................... 23,700 0.21 1,072 2,500 0.22 105 26,600 0.14 1,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
** This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria, the coefficient of variation (CV)
cannot exceed 0.33, there must be at least 20 sample cases (N), and there must be at least 1,200 estimated injuries.
Source: NEISS, CPSC. Estimates rounded to the nearest 100. Throughout this section, summations of estimates may not add to the total estimates provided
in the tables, due to rounding. Estimates are derived from data in the NEISS sample. Estimates spanning periods of multiple years (such as the 12
years from 2010 to 2021) are total estimates, and not annual averages.
Table 3 provides the estimates for in-scope magnet categories in
ED-treated ingestions in NPR, since NPR, and combined from 2010 through
2021. Combining only the ``amusement/jewelry'' and ``unidentified''
categories, and omitting ``exclusions,'' leaves us with a total of
25,000 estimated magnet ingestions that involved or likely involved the
subject magnet products, as shown in Table 3. Of the 25,000 in-scope
magnet ingestions, at least an estimated 5,000 (20%) correspond to
cases associated with amusement/jewelry category, and an estimated
20,000 (80%) correspond to the unidentified category. When considering
the data received since the NPR, the majority of the cases involved
unidentified products, similar to the NPR data. As discussed above, the
record strongly supports the conclusion that many of these unidentified
magnet products were likely subject magnet products.
[[Page 57762]]
Table 3--Estimated Number of In-Scope Magnet Ingestions Treated in Hospital Emergency Departments by Magnet Category
[2010-2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPR Since NPR Combined
Magnet category --------------------------------------------------------------------------------------------------------------------
Estimate CV N Estimate CV N Estimate CV N
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amusement/Jewelry.................. 4,400 0.17 221 (**) (**) 24 5,000 0.16 245
Unidentified....................... 18,100 0.15 793 1,900 0.26 81 20,000 0.15 874
--------------------------------------------------------------------------------------------------------------------
Total.......................... 22,500 0.14 1,014 2,500 0.22 105 25,000 0.14 1,119
--------------------------------------------------------------------------------------------------------------------------------------------------------
** This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria, the coefficient of variation (CV)
cannot exceed 0.33, there must be at least 20 sample cases (N), and there must be at least 1,200 estimated injuries.
Source: NEISS, CPSC. Estimates rounded to the nearest 100. Throughout this section, summations of estimates may not add to the total estimates provided
in the tables, due to rounding. Estimates are derived from data in the NEISS sample. Estimates spanning periods of multiple years (such as the 12
years from 2010 to 2021) are total estimates, and not annual averages.
Table 4 presents the breakdown by age group.
Table 4--Estimated Number of In-Scope Magnet Ingestions Treated in Hospital Emergency Departments by Age Group
[2010-2021]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimate CV N
Age group --------------------------------------------------------------------------------------------------------------------
NPR Since NPR Combined NPR Since NPR Combined NPR Since NPR Combined
--------------------------------------------------------------------------------------------------------------------------------------------------------
Under 2 years...................... 2,700 (**) 2,800 0.19 (**) 0.18 120 8 128
2 years............................ 2,300 (**) 2,400 0.27 (**) 0.25 89 5 94
3-4 years.......................... 4,700 (**) 5,100 0.16 (**) 0.15 196 26 222
5-7 years.......................... 4,300 (**) 5,200 0.14 (**) 0.14 207 26 233
8-10 years......................... 3,900 (**) 4,800 0.19 (**) 0.20 179 27 206
11-13 years........................ 3,400 (**) 3,600 0.17 (**) 0.18 182 12 194
14 or More years................... (**) (**) (**) (**) (**) (**) 41 1 42
--------------------------------------------------------------------------------------------------------------------
Total.......................... 22,500 2,500 25,000 0.14 0.22 0.14 1,014 105 1,119
--------------------------------------------------------------------------------------------------------------------------------------------------------
** This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria, 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.
Source: NEISS, CPSC; estimates are rounded to nearest 100.
C. Databases Other Than NEISS
CPSC staff also analyzed magnet ingestion incident data obtained
through CPSRMS. Staff's review of the CPSRMS data showed that from 2010
through 2021, there were 395 reported magnet ingestions in the
database. Of these, 111 were reported since the NPR, including 56
magnet ingestions that occurred in 2021. Although the CPSRMS reports
are anecdotal, and therefore, cannot be used for generating nationally
representative estimates, they provide a minimum number of incidents,
and they tend to include more information about the incidents and
products involved, in comparison to the NEISS data. CPSRMS reports may
contain photos, links to websites, detailed narratives, and medical
documents; whereas NEISS reports contain brief narratives culled from
medical records developed during the ED visit. At least 167 CPSRMS-
reported magnet ingestions (including 43 incidents since the NPR)
resulted in surgery, such as laparoscopy, laparotomy, appendectomy,
cecostomy, enterotomy, colostomy, cecectomy, gastrotomy, jejunostomy,
resection, and transplant, among others. At least 140 CPSRMS-reported
magnet ingestions resulted in internal interaction through body tissue
(including 32 incidents since the NPR). In cases that did not result in
surgery, it was still common for victims to receive serial X-rays, and
in many cases, endoscopies, and anesthesia.
D. Magnet Ingestions Incident Trends
As discussed in section 1.A. in the preamble, the Commission issued
a magnet sets rule in 2014 that applied to magnet sets, which are a
subset of the subject magnet products addressed in this rule. The 2014
magnet sets rule took effect in April 2015, and the rule remained in
effect until it was vacated by the U.S. Court of Appeals for the Tenth
Circuit in November 2016. As explained in the NPR, 87 FR 1274, and
after further review of the incidents extracted after the NPR, staff
noted a considerable change in magnet ingestion rates during the period
of the Commission's later-vacated rule on magnet sets. 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
2014 magnet sets rule was announced and in effect, compared to the
periods before and after the rule.
Table 5 provides the annual estimates for ED-treated, magnet
ingestions by year, from 2010 through 2021. Some of the year-to-year
changes may be attributable to random variation in the sample; however,
statistically significant differences emerge. Overall, 2014 through
2016 (when 2014 magnets sets rule had been announced and was in effect)
had the lowest number of estimated annual ED-treated magnet ingestions.
The analysis of the NEISS data showed that there were insufficient
cases in 2014, and only 2014, to provide an estimate. Table 5 further
shows that in-scope magnet ingestions are higher for the 2017 through
2021 period, than the previous periods, with more estimated in-scope
magnet ingestions in 2021 (2,500) than most of the preceding years,
including 2018 through 2020.
[[Page 57763]]
Table 5--Estimated Number of In-Scope * Magnet Ingestions Treated in Hospital Emergency Departments by Year
----------------------------------------------------------------------------------------------------------------
Year Estimate CV N
----------------------------------------------------------------------------------------------------------------
2010............................................................ \a\ 1,900 0.18 91
2011............................................................ \a\ \b\ 2,500 0.18 101
2012............................................................ \a\ 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............................................................ \a\ \b\ 2,900 0.25 112
2018............................................................ \a\ \b\ 2,400 0.18 120
2019............................................................ 1,800 0.22 91
2020............................................................ 2,200 0.21 96
2021............................................................ \a\ \b\ 2,500 0.22 105
-----------------------------------------------
Total....................................................... 25,000 0.14 1,119
----------------------------------------------------------------------------------------------------------------
\a\ Estimate is significantly greater than for the year 2015 (p-value<0.05).
\b\ Estimate is significantly greater than for the year 2016 (p-value<0.05).
* These estimates exclude cases identifying non-subject-product-type magnets, and therefore, do not represent
all magnet ingestions treated in hospital emergency departments.
** This estimate does not meet NEISS reporting criteria. For a NEISS estimate to satisfy all reporting criteria,
the coefficient of variation (CV) cannot exceed 0.33, there must be at least 20 sample cases (N), and there
must be at least 1,200 estimated injuries.
Source: NEISS, CPSC; estimates rounded to nearest 100. Summations of estimates may not add to the total
estimates, due to rounding.
To assess these trends further, CPSC grouped years in relation to
the vacated 2014 magnet sets rule, using the periods: 2010 through 2013
(prior to the announcement of the rule); 2014 through 2016 (when the
final rule was announced and in effect \10\); and 2017 through 2021
(after the rule was vacated by the Court of Appeals). Table 6 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. For 2010
through 2013, there were an estimated 2,300 ED-treated magnet ingestion
incidents per year; for 2014 through 2016, there were an estimated
1,300 ED-treated magnet ingestion incidents per year, and for 2017
through 2021, there were an estimated 2,400 ED-treated magnet ingestion
incidents per year. Thus, during the period when the 2014 magnet sets
rule was announced and in effect (2014-2016), magnet injury ingestion
estimates are lowest by a significant margin, compared with the earlier
and more recent periods. This data is consistent with the annual yearly
estimates provided in Table 5, which shows that the annual estimate for
in-scope magnet ingestions is higher for the 2017 through 2021 period,
than the previous periods, with more estimated in-scope magnet
ingestions (2,500) than most of the preceding years, including 2018
through 2020.
---------------------------------------------------------------------------
\10\ Staff grouped 2014, 2015, and 2016 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.
Table 6--Estimated Number of In-Scope Magnet Ingestions Treated in Hospital Emergency Departments by Period
----------------------------------------------------------------------------------------------------------------
Annual
Period average CV N Years in
estimate period
----------------------------------------------------------------------------------------------------------------
2010-2013....................................... 2,300 0.16 395 4
2014-2016....................................... 1,300 0.20 200 3
2017-2021....................................... 2,400 0.15 524 5
---------------------------------------------------------------
2010-2021....................................... 2,100 0.14 1,119 12
----------------------------------------------------------------------------------------------------------------
Source: NEISS, CPSC; estimates rounded to nearest 100.
Although CPSRMS data cannot be used to draw statistical
conclusions, those data also suggest a similar decline in incidents for
the period when the 2014 magnet sets rule was announced and in effect,
as shown in Figure 1, below.
BILLING CODE 6355-01-P
[[Page 57764]]
[GRAPHIC] [TIFF OMITTED] TR21SE22.000
BILLING CODE 6355-01-C
Table 7 shows CPSRMS-reported magnet ingestions, by period, using
incidents categorized as ``amusement/jewelry'' and ``unidentified''
product types, consistent with the NEISS analysis. Table 7 breaks down
the number of reported magnet ingestions in each category, including
reported incidents from the NPR, and additional reports since the NPR.
Of the 111 newly reported incidents, staff identified 64 additional
incidents as involving a magnet set and 33 additional incidents as an
unidentified product.
Table 7--Magnet Category and Scope for Reported Magnet-Ingestions, January 2010-December 2021 *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reported incidents Reported incidents
------------------------------------------------ -----------------------------------------------
Magnet category 2010-2021 Scope
NPR Since NPR total NPR Since NPR Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnet Set........................ 134 (47.2%) 64 (57.7%) 198 (50.1%) Amusement/Jewelry... 214 (90.5%) 72 (94.6%) 286 (91.6%)
Magnet Toy........................ 49 (17.3%) 7 (6.3%) 56 (14.2%)
Jewelry........................... 31 (10.9%) 1 (0.9%) 32 (8.1%)
Unidentified...................... 43 (15.1%) 33 (29.7%) 76 (19.2%) Unidentified........ 43 (14.8%) 33 (29.7%) 76 (19.0%)
Science Kit....................... 0 0 0
F963 Magnet Toy................... 21 (7.4%) 4 (3.6%) 25 (6.3%) Exclusions.......... 27 (9.5%) 6 (5.4%) 33 (8.4%)
Home/Kitchen...................... 6 (2.1%) 2 (1.8%) 8 (2.0%)
------------------------------------------------ -----------------------------------------------
Total......................... 284 (100%) 111 (100%) 395 (100%) Total............... 284 (100%) 111 (100%) 395 (100%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* CPSRMS reporting for the years 2020-2021 is ongoing.
[[Page 57765]]
Counts of reported incidents may increase, especially for 2020 and
2021, as CPSC continues to collect data. Moreover, due to the anecdotal
nature of the data, the data in this analysis are to be considered a
minimum of all incidents that have actually occurred.
V. Relevant Existing Standards
In the NPR, CPSC identified six existing safety standards that in
some way address the magnet ingestion hazard. 87 FR 1282. The NPR
described these standards in detail and provided CPSC staff's
assessment of their adequacy in addressing injuries and deaths
associated with magnet ingestions, focusing on provisions that are
relevant to the magnet ingestion hazard. Id. at 1282-87. None of the
standards apply to all subject magnet products, and the standards do
not adequately address the hazard for the subject magnet products.
Since the NPR, there were no changes in the magnet requirements
specified in these standards. The standards are summarized below. Four
of the standards are domestic standards, and all but one (ASTM F963-17)
are voluntary:
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.
A. ASTM F963-17
ASTM F963 was originally approved in 1986, and since then, the
standard has been revised numerous times. In 2007, ASTM updated the
standard to include requirements to address the magnet ingestion hazard
in children's toys. In subsequent revisions, ASTM added requirements
for toys containing magnets. ASTM F963 is a mandatory consumer product
safety standard. ASTM approved ASTM F963-17 on May 1, 2017, and
published it in August 2017. ASTM F963-17, which is the most recent
version of the standard, is incorporated by reference in 16 CFR part
1250.
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.\11\
---------------------------------------------------------------------------
\11\ ASTM F963-17; section A9.4 (Magnets in Toys).
---------------------------------------------------------------------------
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; to
be a small object, the magnet must fit entirely within the cylinder.
The small parts cylinder depicted in ASTM F963-17 is the same as the
small parts cylinder in CPSC's regulations, at 16 CFR 1501.4. Sections
8.25.1 through 8.25.3 describe the test methodology to measure the
maximum absolute flux of a magnet and to calculate the flux index. A
flux index is a calculated value of magnetic density and size. The flux
index of a magnet is calculated by multiplying the square of the
magnet's maximum surface flux density (in KGauss (kG)) by its cross-
sectional area (in mm\2\).
3. Warning Requirements
ASTM F963-17 does not include specific labeling requirements for
toys containing loose as-received hazardous magnets or hazardous
magnetic components, except for ``magnetic/electrical experimental
sets'' intended for children 8 years and older, which are exempt from
the performance requirements and need only meet labeling requirements.
The standard defines a ``magnetic/electrical experimental set'' as a
``toy containing one or more magnets intended for carrying out
educational experiments that involve both magnetism and electricity.''
Section A12.4 (Magnets) 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
The size and strength requirements in ASTM F963-17 are consistent
with the requirements in this rule for subject magnet products.
Although the size and strength requirements are adequate to address the
hazard, 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, the Commission finds that
compliance with the standard is not likely to adequately reduce the
magnet ingestion hazard.
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
[[Page 57766]]
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 ingest 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.\12\
---------------------------------------------------------------------------
\12\ 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.''
---------------------------------------------------------------------------
As such, ASTM F963-17 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 non-toy 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'' by 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 a 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
Although the size and strength requirements in the standard
adequately 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 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 were using magnets as jewelry
at the time of ingestion. As explained further in the discussion of
ASTM F3458-21 below, caregivers and children commonly do not heed
warnings, and children and teens commonly access magnets that are
separated from the packaging on which warnings are provided (the
magnets within the scope of the final rule are too small to have
legible and complete warnings printed on them).
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 the 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.
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.''
[[Page 57767]]
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.'' 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 the warning recommends seeking immediate medical attention.
4. Assessment of Adequacy
CPSC assesses that ASTM F2999-19 does not adequately reduce the
risk of injury and death associated with magnet ingestions. The
standard does not include any requirements for adult jewelry containing
magnets--rather, it suggests complying with the magnet labeling
provisions. As incident data indicate, many magnet ingestion incidents
involve products used as jewelry, and children and teens access
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 discussed further in the ASTM F3458-
21 section below, 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 address
adequately 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 poses a magnet ingestion hazard
for children and teens.
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.
1. Scope
ASTM F3458-21 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 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.
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'' to ensure the product is not marketed or displayed as a
children's toy. For online sales, manufacturers must ``undertake
reasonable efforts'' 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
means of restricting the ability to open the container.
7. Assessment of Adequacy
CPSC assesses that ASTM F3458-21 would not adequately reduce the
risk of injury and death associated with magnet ingestions. 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, 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,
[[Page 57768]]
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. 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.
a. 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
for subject magnet products demonstrate that consumers commonly view
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 of recommendations from others, including
online reviews of products, which can influence the likelihood of
consumers disregarding warnings. CPSC 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 unlikely to occur or is
irrelevant for 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. 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 also may lead them to
disregard warnings. As incident reports show, many children, teens, and
caregivers assume erroneously that, when ingested, magnets will pass
through the body and exit the body without causing harm.
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 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 are too small themselves to carry
warnings, these children and teens, and their caregivers, may not be
alerted to the hazard.
Indeed, to date, safety messaging has been ineffective at reducing
the magnet ingestion hazard. CPSC 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 state that the product was
not appropriate for children. For example, of the CPSRMS incidents that
reportedly occurred between January 1, 2010, and December 31, 2021, at
least 68 incident products had magnet internal interaction warnings, at
least 74 had age labels or warnings indicating the product was not for
children, and at least 66 had both types of relevant safety messages.
In contrast, reports for only 14 incidents (total for both data sets)
mentioned that the product had neither magnet internal interaction
warnings nor age labels or warnings against use by children.
Another indication of the ineffectiveness of safety messaging to
address the magnet ingestion hazard is the upward trend in magnet
ingestion cases in recent years, despite years of consumer awareness
campaigns. 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.
b. Packaging. Similar to safety messaging, there are several
reasons CPSC considers packaging requirements inadequate to address the
magnet ingestion hazard. Incident data show that children and teens
commonly access 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 included in ASTM F3458-21 to make the
packaging difficult for children to open would not be effective in
preventing older children and teens from accessing the magnets in the
packaging and ingesting them. For example, an 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 if 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, most magnet
ingestion incidents involve 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
[[Page 57769]]
of packaging to address the hazard would rely on consumers correctly
repackaging all the magnets after and every use, which is likely
unrealistic. The products often are intended for purposes that make
repackaging after each use unlikely. For example, products like magnet
sets are intended to assemble and display complex sculptures, and some
jewelry may involve creating designs, making it unlikely consumers will
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. Therefore, consumers 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 may not use the
packaging consistently. Consumers may also consider CR packaging a
nuisance, making it unlikely for them to store magnets in the packaging
after every use.
In addition, the small size and large number of magnets
(particularly in some magnet sets and magnetic jewelry sets) make
locating and counting the magnets after every use not feasible or
realistic, leaving it difficult to impossible to ensure all the magnets
in the set are returned to the package. 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 not uncommon for magnets to be flicked away from one another
or dropped when consumers handle or try to separate them. 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 included in
some sets, plus their small size, and the tendency for them to be
separated and lost, it is unlikely that CR packaging will be used
effectively by consumers. 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.
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 the 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 similar use-and-abuse testing as 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.
As discussed above in section V.A. of the preamble, for ASTM F963-
17, CPSC assesses that these provisions do not adequately reduce 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 the 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 as 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. 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 on 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 F963-17. This
provides some indication that children's toys commonly comply with the
standard. Of the magnet ingestion incidents that involved children's
toys, staff identified only 7 incidents that involved internal
interaction of the magnets through body tissue, again showing there may
be a high level of compliance with the standard requiring flux index
below 50 kG\2\ mm\2\. (None of the products in these seven incidents
complied with the magnet requirements in ASTM F963.)
CPSC also 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 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 assess the level of compliance with it.
However, for the reasons discussed in this section, the Commission
finds that none of the existing standards would adequately address the
unreasonable risk of injury associated with subject magnet products.
H. Consideration of the Existing Standards, Collectively
For the same reasons than no existing standard is individually
adequate, the standards collectively fail to adequately reduce the
magnet ingestion hazard. As explained above, each standard contains
critical inadequacies with regard to protecting against ingestion
hazards associated with the particular products that are covered.
Furthermore, there are subject magnet products, such as magnets sets,
or magnet toys, or jewelry kits intended for users 14 years of age and
older, and jewelry (both children and adult), that are not within the
scope of the existing standards. Accordingly, even industry compliance
with all the existing standards, were it achieved,
[[Page 57770]]
would not adequately address the ingestion hazard.
VI. Response to Comments on the Proposed Rule
This section summarizes the issues raised by comments, both oral
and written, on the proposed rule, and it provides the Commission's
responses to those comments.
A. Oral Presentations
On May 2, 2022, the Commission provided the public an opportunity
to present views on the proposed rule in person before the Commission.
Oral comments were presented at the hearing from representatives from
the American Academy of Pediatrics, North American Society for
Pediatric Gastroenterology, Hepatology and Nutrition, Kids in Danger,
Consumer Federation of American, and Consumer Reports. These commenters
provided testimony supporting the CPSC's rulemaking for a safety
standard to address the unreasonable risk of injury and death
associated with ingestion of loose or separable high-powered magnets.
The commenters orally testified that there is overwhelming evidence of
the significant hazards associated with magnets that have a flux of 50
or greater. Commenters testified on the serious medical consequences
when children ingest hazardous magnets, including gastrointestinal
perforations, abdominal abscesses, fistulas in the bowel, and death.
Commenters also testified testimony regarding the ineffectiveness of
regulatory alternatives, including safety messaging, labeling, and
packaging requirements. Commenters recommended that the Commission not
rely on child-resistant containers, bittering agents, or other attempts
to deter children, but rather, they asked CPSC to mandate a standard
that will eliminate the hazard. Specific oral comments that covered the
same issues as the written comments are addressed below in section
VI.B. of the preamble.
B. Written Comments
The preamble to the NPR invited comments concerning all aspects of
the proposed rule. We received written comments from more than 700
commenters in response to the NPR. The Commission reviewed and
considered several late comments that were filed regarding this
rule.\13\ Many of the comments contained more than one issue, and many
of the comments addressed the same or similar issues. Thus, we
organized our responses by issue. All of the comments can be viewed at:
www.regulations.gov, by searching under the docket number for this
rulemaking, CPSC-2021-0037.
---------------------------------------------------------------------------
\13\ CPSC received late-filed comments in support of the
proposed rule from the American Academy of Pediatrics (AAP), and the
North American Society for Pediatric Gastroenterology, Hepatology
and Nutrition (NASPGHAN). Retrospective Goods, LLC, also submitted a
late comment. Shihan Qu also submitted a petition via:
www.change.org. These comments were added to the docket on
www.regulations.gov.
---------------------------------------------------------------------------
In general, most who commented in favor of the proposed rule were
medical professionals and/or representatives of consumer advocacy
groups and medical associations; \14\ there were also some individual
consumers, and a subject magnet product manufacturer, Retrospective
Goods, LLC, who also generally supported the proposed rule. These
commenters argued that safety messaging and safeguards are insufficient
to address the magnet ingestion hazard and that the proposed rule
represents a minimum standard for addressing the hazard. In contrast,
most who commented in opposition to the proposed rule were individual
consumers, along with several subject magnet product manufacturers and
hobbyist groups.\15\
---------------------------------------------------------------------------
\14\ For example, CPSC received a joint letter in support of the
proposed rule by AAP and NASPGHAN.
\15\ For example, CPSC received a letter in opposition to the
proposed rule, which was submitted by the Hobby Manufacturers
Association, representing more than 59 manufacturers, importers,
publishers, producers, and suppliers of hobby products and hobby
accessories.
---------------------------------------------------------------------------
Commission Authority
(Comment 1) Commenters in favor of the proposed rule opined that it
is the Commission's authority and responsibility to address the
ingestion hazard posed by the subject magnet products. These commenters
encouraged the Commission to promulgate the final rule expeditiously as
a minimum standard to address the hazard. Some commenters opined that
the rule violates consumers' constitutional rights, including the right
to freedom of expression through purchasing products they desire, and
that a rule that prohibits the sale of covered magnet sets is
drastically out of proportion to the risks presented by the product.
Many commenters requested alternative regulatory actions to address the
hazard, such as limiting sales for online purchases with restrictions,
such as warnings; prohibiting sales to users under specified ages;
requiring identification or adult signature for purchases; restricting
sales of magnets by certain manufacturers or sellers; or restricting
sales to certain stores or locations.
(Response 1) Section 7 of the CPSA authorizes the Commission to
promulgate consumer product safety standards as performance
requirements or that require products to be marked or accompanied by
clear and adequate warnings and instructions. The requirements of a
standard issued under this provision must be reasonably necessary to
prevent or reduce an unreasonable risk of injury associated with the
product. Determining whether a product presents an unreasonable risk of
injury requires the Commission to consider, among other factors, the
costs and benefits of regulatory action. The regulatory analysis
discusses that assessment (see section VIII. of this preamble). The
Commission must balance several factors, such as the severity of
injury, the likelihood of injury, and the possible harm the regulation
could impose on manufacturers and consumers.
Although some consumers assert that their constitutional rights are
impacted, there is no constitutional right to purchase an unreasonably
dangerous product. Some commenters suggest that the way to address the
hazard of children ingesting magnets from subject magnet products might
be to limit the manner or places where products are sold. The CPSA
authorizes the Commission to issue standards that specify performance
requirements or requirements for labeling and/or instructions. See 15
U.S.C. 2056. Sales restrictions do not fit within either of those
categories. Furthermore, sales limitations or requirements for strong
warning restrictions are unlikely to reduce ingestions significantly,
because, as discussed in detail in section V.D.7 of the preamble, the
Commission has determined that consumers are unlikely to heed safety
warnings if they perceive the product to be low risk or they
misunderstand the hazard and the associated health consequences of
ingestion. Moreover, both children and teens can access magnets of
subject magnet products from many sources other than stores. As the
incident data indicate, magnet ingestion incidents associated with
subject magnet products include children and teens who ingested magnets
from products intended for older users.
(Comment 2) A few commenters stated that there was insufficient
time to consider the NPR and urged that the final rule should be
delayed until more information is obtained.
(Response 2) The Commission has provided stakeholders with
sufficient time to consider and comment on the proposed rule. The NPR
was published in the Federal Register on January 10,
[[Page 57771]]
2022, and the public comment period ended on March 28, 2022. Although a
few commenters requested that the CPSC delay the final rule until more
information is obtained, CPSC has determined that the risk of injury
associated with subject magnet product ingestions increases when there
is no mandatory rule addressing the hazard. In particular, as already
explained, during the years when the 2014 magnet sets rule was
announced and in effect (2014-2016), there were appreciably fewer
magnet ingestions, compared with the earlier and more recent periods.
The years 2017 through 2021 saw an uptick in the number of in-scope
magnet ingestions, with 2021 having more incidents than most of the
preceding years. Waiting for additional data sources to become
available before taking effective action would result in more magnet
ingestion injuries that likely could be preventable with promulgation
of the final rule.
(Comment 3) Nano Magnetics, a manufacturer of subject magnet
products, asserted that CPSC has refused to communicate with
manufacturers, consumers, and representative beneficiaries of the
subject magnet products regarding methods to address the magnet
ingestion hazard, but communicated with organizations and advocacy
groups in favor of the proposed restrictions.
(Response 3) The CPSC provided opportunities for all stakeholders
to present their views in the oral hearing, and in the NPR, we invited
written comments including any opposing views, which the Commission
reviewed and considered in adopting this rule.
Lack of Product Defect
(Comment 4)--Numerous commenters asserted that magnet sets pose no
risk of injury when used properly, that they function as intended, and
therefore, they are not defective. Other commenters argued that the
Commission has no authority to issue a rule that would result in a
prohibition of all subject magnet products currently on the market
simply because certain consumers use magnets in a manner that is
inconsistent with the purpose intended for the product. The commenters
argued that the improper use of a product by a minority of consumers
does not render the product defective and does not warrant promulgating
a rule that would remove the product from the market.
(Response 4)--To promulgate a consumer product safety standard, the
Commission must find that the rule is reasonably necessary to reduce an
unreasonable risk of injury associated with the product. A product may
present an unreasonable risk of injury, even if the product does not
contain a fault, flaw, or irregularity that impacts the manner in which
the product functions. If evidence demonstrates that foreseeable misuse
of a product results in an unreasonable risk of injury, the Commission
has the authority to promulgate a rule reasonably necessary to reduce
or eliminate that risk. When assessing risk, CPSC considers how
consumers may actually use a product, not just the manner of use
intended by the manufacturer. For example, the Commission's cigarette
lighter standard requires disposable and novelty lighters to meet
child-resistance requirements to protect against the misuse of lighters
by children. 16 CFR part 1210. Similarly, the Commission's lawn mower
standard includes requirements to guard against consumers intentionally
removing a shielding safety device from the mower. 16 CFR part 1205.
See Southland Mower v. Consumer Product Safety Commission, 619 F.2d
499, 513 (5th Cir. 1980) (reviewing the Commission's lawn mower
standard, the court stated: ``Congress intended for injuries resulting
from foreseeable misuse of a product to be counted in assessing
risk'').
For this rule, CPSC has analyzed the magnet ingestion incident data
and reviewed the various methods to address the hazard. CPSC determines
that the subject magnet products carry the highest ingestion risk for
children and teens. As detailed in section V.D.7, of the preamble, CPSC
explained that consumers are likely to have a common perception of low
risk pertaining to the subject magnet products and often misunderstand
the magnet ingestion hazard. Safety messaging, including public
awareness-raising efforts, has been insufficient to protect children
and teens from the hazard. Due to factors like the inability of
caregivers to provide constant supervision and manage common sources of
access to hazardous magnets, consumers may be unable to avoid the
hazard even if they are aware of the hazard and are actively trying to
prevent it. After considering various methods by which to address the
hazard, including safety messaging (e.g., warnings, instructional
literature, marketing, and public awareness-raising efforts) and
safeguards (e.g., CR packaging and aversive agents), the Commission
concludes that mandating performance requirements is necessary to
adequately address the hazard.
Risk and Severity of Injury
(Comment 5) Medical professionals and consumer advocacy groups were
largely supportive of the proposed rule as a minimum standard to
adequately protect children from subject magnet products. Many cited
the most current literature on magnet exposure in children (discussed
in section IV of the preamble), and others cited firsthand professional
accounts of treating high-powered magnet exposures in children and
associated medical outcomes from those injuries. AAP \16\ and the
NASPGHAN \17\ expressed strong support for the proposed rule. In their
comments, they highlighted the current medical recommendation for
prompt medical intervention. The Canadian Paediatric Society's Injury
Prevention Committee, Children's Safety Network (CSN) at Education
Development Center (EDC), and the Pacific Institute for Research and
Evaluation (PIRE) also provided comments in support of the proposed
rule. Additionally, a number of medical professionals offered
individual comments in favor of the proposed rule. These commenters
stated that magnets, in general, present a unique health risk because
some level of medical management is warranted for all magnet
ingestions; magnets that have migrated past the esophagus routinely
require serial imaging and surgical intervention; and children are
suffering adverse health outcomes from magnet internal interaction
hazards.
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\16\ AAP represents 67,000 primary care pediatricians, pediatric
medical subspecialists, and pediatric surgical specialists dedicated
to the health, safety, and well-being of infants, children,
adolescents, and young adults.
\17\ NASPGHAN represents more than 2,500 pediatric
gastroenterologists in the United States, Canada, and Mexico and is
the only organization singularly dedicated to advocating for
children with gastrointestinal disease.
---------------------------------------------------------------------------
(Response 5) The Commission agrees that the magnet ingestion data
and most current scientific literature related to magnet ingestion show
that magnet internal interaction hazard and the associated injury
mechanism continue to pose serious and long-lasting adverse health
outcomes.
(Comment 6) Several individual commenters stated that the subject
magnet products are rarely involved in magnet ingestion incidents.
These commenters were typically individual consumers who claimed that
there have been only a ``few,'' ``several,'' or a ``handful of''
injuries, based on outdated magnet ingestion data.
(Response 6) Contrary to these commenters' assertions, magnet
ingestions are common and have increased in recent years. The
Commission estimates that 26,600 magnet ingestions were treated in
hospital EDs from January 1, 2010,
[[Page 57772]]
through December 31, 2021; this represents an estimated 25,000
ingestions, excluding out-of-scope products. An estimated 2,500 ED-
treated ingestions of magnets from in-scope products occurred in 2021,
higher than the majority of the preceding years, including 2018 through
2020. An estimated 5,000 (20% of 25,000) victims were hospitalized or
transferred to another hospital due to incidents that occurred in the
period from 2010 through 2021. These estimates are based on the NEISS
reports, which capture only brief, medically-focused narratives from
the ED visit. Therefore, the estimates do not account for the victims
who were initially released and later sought medical attention for
magnet-related injuries, including treatment for complications arising
from medical management.
In examining CPSRMS data from this 12-year period, CPSC found that
at least 167 CPSRMS-reported magnet ingestions resulted in surgery
(including 43 incidents since the NPR), such as laparoscopy,
laparotomy, appendectomy, cecostomy, enterotomy, colostomy, cecectomy,
gastrotomy, jejunostomy, resection, and transplant, among others. Some
injuries also resulted 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 treated initially in other settings. Using the time period during
2017 through 2021, based on the NEISS annual estimate of about 481
magnet injuries initially treated in hospital EDs involving magnets
identified as amusement/jewelry products, there were 320 injuries that
were treated and released and 161 injuries that required
hospitalization. Based on estimates from the ICM, 185 injuries were
treated outside of hospitals annually and another 78 injuries resulted
in direct hospital admission.
(Comment 7) Several commenters, including Kids in Danger and
Consumer Reports, requested that CPSC continue to conduct research
after the final rule to determine if the excluded products, such as
magnet products sold to school educators for educational purposes,
should also be addressed.
(Response 7) The Commission will continue to assess any new
incident data and review the adequacy of the rule in addressing magnet
ingestion hazards on an ongoing basis, and CPSC staff will continue to
work with the relevant standards groups on magnet ingestion hazards.
Other Approaches To Addressing the Hazard
(Comment 8) Safety Messaging--Several commenters in support of the
proposed rule, including AAP and NASPGHAN, contend that the magnet
internal interaction hazard cannot adequately be addressed with
warnings, instructions, awareness-raising efforts, and other forms of
safety messaging. The commenters explained that children, teens, and
caregivers do not fully comprehend the hazard and risk of children and
teens ingesting magnets.
One commenter, Independent Safety Consulting, LLC, stated that
warnings will not be necessary in combination with the proposed size
and strength limitations and may contribute to the growing issue of
warning fatigue due to the prevalence of product warnings. Other
individual commenters opposing the proposed rule argued that approaches
involving safety messaging are more appropriate than strength and size
limitations. These commenters stated that the CPSC should require
warning labels only for certain products, require specific warnings and
instructions, such as age restrictions, and limit sales and marketing
of such products to specific physical stores or online.
Numerous individual commenters argued that approaches involving
safety messaging and warnings are more appropriate than strength and
size limitations. The majority of these commenters stated that their
personal freedoms should not be restricted because some consumers,
particularly parents, are irresponsible and do not supervise their
children. Several individual commenters asserted that some brands of
subject magnet products already have clear warnings about the hazard
and market the products only to adults, asserting that these products
have been involved in few-to-no magnet ingestion injuries. Most who
oppose the proposed rule requested that adult products be excluded from
the scope of the rule. They compared the magnet internal interaction
hazard to other common hazards, like incidents with trampolines,
fireworks, scissors, knives, firearms, balloons, and toys with small
parts, arguing that these other products present similar or worse
hazards but they are not banned. In addition, they argued that there
are other, more hazardous products on the market for adults to purchase
and use (e.g., guns and cigarettes).
(Response 8) CPSC's assessment of the magnet internal interaction
hazard shows that it is a unique, hidden hazard, unlike common and more
readily apparent hazards, like hazards from trampolines and fireworks.
The hazards identified in the rule involving multi-magnet ingestions
and ingestions of both a magnet and a potentially ferromagnetic object,
all call for some level of medical management. It is foreseeable that
consumers will not anticipate, nor appreciate, the likelihood of
children and teens ingesting magnets. The majority of the incident
reports for the subject magnet products involved victims above the ages
typically associated with ingestion of small objects (under 3 years
old) and hazardous substances (under 5 years old). CPSC finds that it
is unrealistic to expect parental supervision at all times, especially
for these older ages, and ingestions can be quick and difficult to
notice and prevent, considering the small size and sometimes large
number of magnets in the subject magnet products. Many of the reports
indicated that the magnets were ingested accidentally, while children
and teens were attempting to separate the magnets with their teeth or
were using the magnets to simulate oral piercings. Relatively few
reports indicated the magnets were ingested intentionally.
As discussed in detail in section V.D.7. of the preamble, the
Commission has determined that safety messaging has limited
effectiveness for preventing the magnet ingestion hazard. In general,
safety messaging relies on encouraging consumers to avoid hazards, as
opposed to eliminating the hazards by design. For safety messaging to
be effective, it must be seen, read, understood, and heeded. Specific
to the subject magnet products, there are many obstacles to the success
of safety messaging, which include, consumers commonly misperceive risk
associated with the hazard; the hazard patterns and symptomology are
often misunderstood; and the common sources of access to magnets (e.g.,
children and teens sharing magnets when outside the home) make it
difficult, if not impossible, for caregivers to prevent access to the
hazard and likewise, reduce the chances of children and their
caregivers seeing safety messaging provided with the products.
Caregivers may also forego reading warnings if they think they already
know the hazard. Magnet ingestions have continued an upward trend over
the past years since the CPSC's 2014 magnets sets rule was vacated,
despite increased prevalence of safety messaging provided with the
[[Page 57773]]
products, and numerous public outreach efforts by the CPSC, medical
associations, consumer advocacy groups, and news sources.
(Comment 9) Packaging and Aversive Agents -- Commenters who favor
the proposed rule, such as Kids in Danger and Consumer Reports, opined
that the magnet internal interaction hazard cannot adequately be
addressed with packaging requirements. They explained that it is common
for children and teens to acquire magnets without packaging, and that
packaging requirements, such as child-resistant (CR) packaging, are
only effective as long as the packaging is retained and used
consistently to store the product. These commenters note that CR
packaging would not be effective for the majority of victims,
considering the victims' ages. Several individual commenters who are
against the proposed rule opined that, to the contrary, approaches
involving packaging and aversive agents are more appropriate than
strength and size limitations.
(Response 9) The Commission has determined that safeguards, such as
special packaging and aversive agents, are ineffective at addressing
the magnet internal interaction hazard. As discussed in detail in
section V.D.7 of the preamble, in many cases, the magnets do not come
with their original packaging, making packaging features bearing
warning language immaterial (e.g., when children and teens find magnets
in their environment or receive them from friends). CR features, such
as those specified in ASTM F3458-21, are designed to limit access to
products by children under 5 years of age only, and CPSC found that the
majority of magnet ingestion incidents involved victims ages 5 years
and older. Furthermore, CR features would be effective for these
younger ages only if the magnets are repackaged correctly and in their
entirety after every use, which CPSC finds unrealistic, as explained
above. Incident reports and customer reviews further demonstrate that
it is common to lose magnets from the subject magnet products,
particularly from products with numerous magnets (e.g., magnet sets
with hundreds to thousands of tiny magnets).
Similarly, deterrents, such as aversive agents (e.g., foul odors or
bitterants), are unlikely to be effective. Serious injury is possible
when one ingests as few as two magnets, or even a single magnet in the
presence of a ferromagnetic object; in addition, children may ingest
multiple magnets before they detect the aversive agent. Children
frequently ingest unpalatable substances, which indicates that foul
odors and tastes are not sufficient to deter children from ingesting
harmful substances.
Reliance on ASTM standards
(Comment 10) Numerous commenters, including Shihan Qu of Zen
Magnets, LLC, and Hobby Manufacturers Association, recommended
publicizing and enforcing ASTM F3458--21, which includes warning,
instructional literature, marketing, and packaging requirements for
adult magnet sets. Commenters claimed that the combination of
requirements for warnings, instructions, marketing, and packaging is
sufficient to address the hazard. Additionally, one commenter,
Retrospective Goods, LLC, a subject magnet product manufacturer, stated
that CPSC has not undertaken any meaningful safety campaigns regarding
the hazard for 7 years.
(Response 10) The Commission has concluded that the requirements
specified in ASTM F3458-21 are inadequate to address the magnet
internal interaction hazard without size and strength requirements.
Section V.D.7. of the preamble explains that warning, instructional
literature, marketing, and packaging requirements for adult magnet sets
do not address the hazard because the incident data indicates that
children and teens commonly access and ingest magnets from products
intended for older users. Clear and repeated safety messaging and
marketing have been insufficient to discourage magnet ingestion, and CR
packaging is unlikely to address the hazard, particularly given that
most of the known magnet ingestions have involved victims ages 5 years
and older.
Contrary to the assertion that CPSC has not engaged in safety
campaigns, CPSC, in addition to raising awareness of the magnet
ingestion hazard through publicized recalls, has drawn attention to the
hazard through safety alerts and public safety bulletins. CPSC
maintains a ``Magnets Information Center'' website,\18\ which provides
an informational video, a description of the hazard, what 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 what steps to take when magnets are swallowed.
In addition to CPSC's information campaigns, health organizations and
other consumer advocacy groups have made numerous public outreach
efforts to warn consumers about the magnet ingestion hazard.\19\ Some
of the recent efforts include CPSC's annual holiday safety
campaign,\20\ CPSC's Twitter Chat on High-Powered Magnet Safety,\21\
and numerous articles from popular news sources.\22\
---------------------------------------------------------------------------
\18\ Available at: www.cpsc.gov/Safety-Education/Safety-Education-Centers/Magnets.
\19\ Examples include the American Academy of Pediatrics
(https://services.aap.org/en/search/?k=magnets);North American
Society for Pediatric Gastroenterology, Hepatology and Nutrition
(www.naspghan.org/content/72/en/Foreign-Body-Ingestion); Consumer
Reports (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/).
\20\ CPSC's Top Safety Tips for Early Holiday Shoppers Amid
Reports of Expected Toy Shortage (2021): www.cpsc.gov/Newsroom/News-Releases/2021/Top-Safety-Tips-for-Early-Holiday-Shoppers-Amid-Reports-of-Expected-Toy-Shortage.
\21\ On May 19, 2021, CPSC staff provided responses regarding
magnet safety in a public Q&A.
\22\ Examples of recent news articles addressing the hazard
include the following, among others: www.washingtonpost.com/business/2021/08/17/magnet-safety-recall/, www.washingtonpost.com/business/2019/12/27/senator-urges-regulators-take-action-magnet-ingestions/, www.cnn.com/2019/04/12/health/kids-swallow-objects-study/index.html, and www.foxnews.com/health/parts-of-boys-colon-intestines-removed-after-swallowing-toy-magnets-mom-says.
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Scope of the Rule
(Comment 11) Rely on Enforcement Action--Several commenters,
including Magnet Safety Organization, opined that the CPSC enforcement
actions, rather than rulemaking, is the appropriate approach. Other
commenters, such as the Hobby Manufacturers Association, asserted that
CPSC should focus enforcement activities only on manufacturers and
importers that do not use clear marketing and warnings to explain the
hazard and warn against use by children.
(Response 11) From January 1, 2010, through May 25, 2022, CPSC's
Office of Compliance and Field Operations has investigated and recalled
numerous magnet products involving the magnet internal interaction
hazard. CPSC has conducted 20 recalls involving 25 firms/retailers, and
totaling approximately 13,832,901 recalled units, including craft kits,
desk toys, magnet sets, pencil cases, games, bicycle helmets, maps, and
children's products among others. Of these 20 recalls, 10 involved
products that would not be subject to the rule; specifically, 6
involved children's toys that are subject to the ASTM F963 Toy
Standard. Although these 10 recalls did not apply to products that are
subject to the rule, they illustrate the magnet ingestion hazard.
[[Page 57774]]
Despite this active enforcement to remove from the market products
that present a substantial product hazard, such efforts are necessarily
limited to particular entities and products. By contrast, this
rulemaking establishes requirements that all non-exempt subject magnet
products must meet from the effective date of the rule. The magnitude
of the hazard, the similarity of the ingestion hazard across the
subject magnet products, and the relevant similarities of the products
themselves, make the rulemaking approach appropriate here.
(Comment 12) Mental Stimulation Should Be Removed from Definition--
Several commenters, including subject magnet product manufacturers
Retrospective Goods, LLC, and Nano Magnetics, requested clarifications
pertaining to the NPR's proposed product scope and exemptions,
particularly regarding ``mental stimulation.'' These commenters
recommended removing ``mental stimulation'' from the inclusion criteria
for ``subject magnet product.'' Commenters also suggested that the
final rule identify more of the exempted products, such as the products
intended for scientific or technical research, and educational,
professional, and industrial applications. Many individual commenters
mentioned the artistic, educational, entertainment, social, and
therapeutic benefits of small, powerful magnets in consumer products,
such as magnet sets.
(Response 12) The NPR recommended exempting from the proposed rule,
children's toys subject to the ASTM F963 Toy Standard, and the final
rule retains that exemption because that standard is mandatory and
adequately addresses the magnet ingestion hazard associated with
children's toys. The NPR further noted: ``it is reasonable to exclude
home/kitchen products from the proposed rule,'' and ``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.'' 87 FR 1291-92. The NPR specifically sought comment on
whether ``home/kitchen magnets or education products should be
addressed in the rule.'' Id. at 1312.
The Commission disagrees that ``mental stimulation'' should be
removed from the definition of ``subject magnet products.'' Mental
stimulation is an important criterion because it is an apt descriptor
for subject magnet products that appeal to children and teens,
including uses like puzzle working and sculpture building. However, the
Commission agrees that the term ``mental stimulation'' may be
interpreted more broadly than intended, by capturing products not for
home uses that nonetheless may be mentally stimulating, such as
products manufactured, sold, and/or distributed solely for educational
uses at schools and universities. Accordingly, in response to comments,
the final rule clarifies the definition of ``subject magnet product''
to mean 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, but does not
include products sold and/or distributed solely to school educators,
researchers, professionals, and/or commercial or industrial users
exclusively for educational, research, professional, commercial, and/or
industrial purposes.
This clarification addresses potential confusion between in-scope
and out-of-scope products, by specifying in the definition certain
products that are not subject to the final rule, even if the intended
use of these products involves mental stimulation. These excluded
products are intended to be sold and/or distributed solely to school
educators, researchers, professionals, and/or commercial or industrial
users exclusively for educational, research, professional, commercial,
and/or industrial purposes. As shown in the incident data, these types
of applications have not been associated with magnet ingestions, and
would be less likely to pose an unreasonable risk of injury to children
or teens since they would not be sold for or used in home settings and/
or for personal use by children.
Products manufactured, sold, and/or distributed for use in the
home, such as hardware magnets, that contain one or more loose or
separable magnets but that are not designed, marketed, or intended to
be used for entertainment, jewelry (including children's jewelry),
mental stimulation, stress relief, or a combination of these purposes,
would not be subject to the rule because they do not meet the
definition of a ``subject magnet product.'' However, if any of these
products are designed, marketed, or intended to be used, even in part,
for entertainment, jewelry (including children's jewelry), mental
stimulation, stress relief, or a combination of these purposes, such
uses would cause the magnets to be subject to the requirements of the
standard. Unlike magnet products sold and/or distributed solely to
school educators, researchers, professionals, and/or commercial or
industrial users exclusively for educational, research, professional,
commercial, and/or industrial purposes, these products are used in the
home, and if they have subject magnet product uses such as jewelry or
mental stimulation, they may appeal to children or teens, and the
magnet internal interaction hazard may pose the same unreasonable risk
of injury to as identified for other subject magnet products.
(Comment 13) Noncompliant magnets should be widely available. Some
commenters, including Nano Magnetics, contend that that use of small,
aggregated magnetics have resulted in great scientific and medical
innovations and that the proposed rule would prevent scientific
breakthroughs.
(Response 13) The Commission is not persuaded that the final rule
would adversely impact innovation in scientific or medical fields. The
final rule clarifies the definition of subject magnet product to mean 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, but does not
include products sold and/or distributed solely to school educators,
researchers, professionals, and/or commercial or industrial users
exclusively for educational, research, professional, commercial, and/or
industrial purposes. Accordingly, uses for magnets such as scientific
or medical research, as contemplated by the commenters, may continue
under the revised definition.
(Comment 14) Some commenters, including individual consumers,
stated that requiring magnets to be weaker or bigger would limit their
beneficial uses, and the products with only one magnet should be
excluded from the final rule. Other commenters asserted that magnets
that are not spherical or disc-shaped should be excluded from the final
rule.
(Response 14) The scope of the rule includes non-spherical and non-
disc-shaped magnets because the hazard is not limited to these magnets
only; for example, the Commission is aware of cases involving internal
interaction of rock-shaped magnets. The product scope also includes
products with only one magnet because subject magnet products may be
sold per-magnet, and a single magnet can interact internally through
body tissue with an unrelated magnet or ferromagnetic object.
[[Page 57775]]
ASTM F963 Test Method
(Comment 15) Commenters in favor of the proposed rule, including
Safe Kids Worldwide, Consumers Union, AAP, and NASPHAN, generally
supported incorporation of the ASTM F963 testing requirements as a
minimum approach for addressing the magnet ingestion hazard. One
manufacturer, Retrospective Goods, LLC, stated that the ASTM test
method for measuring flux is widely used internationally and is well-
understood; therefore, they assert, ``there is no need to change the
current ASTM test procedure for measuring a magnet's flux.'' As an
example, the commenter provided a method from an international test lab
that describes a procedure for locating the pole of a small magnet. The
procedure uses a magnet's attraction to a ferromagnetic bar to orient
and identify the poles, and it uses an adhesive surface to hold the
magnet during testing. The commenter questioned whether the CPSC test
procedure provided in Tab D of the NPR has been tested by other
laboratories and stated: ``changing the ASTM test procedure could lead
to confusion and potentially uneven or conflicting results.''
(Response 15) CPSC staff developed a test procedure consistent with
ASTM F963-17 to locate the magnet pole of small diameter magnets and to
secure the magnet during the flux density measurement. This test
procedure is provided for informative purposes and is not specified in
the performance requirement. Therefore, testing of the procedure by
other laboratories is not warranted. CPSC staff's procedure does not
change the ASTM test procedure because there is no test procedure
specified in ASTM F963-17 for locating the pole surface of a magnet;
nor is there a test procedure for how to secure the magnet while
measuring the maximum flux density. The exemplar method cited by the
commenter for locating the pole of a small diameter magnet and holding
the magnet during testing is similar in concept to the test method
developed by CPSC staff.
(Comment 16) One commenter, Kids in Danger, supported the wider
use-and-abuse testing from ASTM F963, to ensure products do not
liberate magnets. A manufacturer, Retrospective Goods, LLC, conversely
stated that ``no data has been presented that liberated magnets with a
flux over 50 kG\2\ mm\2\ in adult products, which also meet the scope
of the Rule, are posing a problem. Any such requirement should be
supported by data.''
(Response 16) CPSC's review of magnet ingestion incident data has
not identified a pattern of children ingesting hazardous magnets that
liberated from products not subject to ASTM F963-17. However, CPSC will
continue to monitor new incident data to assess if new patterns develop
that indicate use-and-abuse testing is necessary for products that are
outside the scope of ASTM F963-17.
(Comment 17) One trade association, Magnet Safety Association,
stated that the measurement of flux was created by ASTM as high-level
guidance for voluntary safety measures and ``was not designed to be
used to determine whether magnets will present injury if ingested
multiply.'' The commenter stated that the flux measurement in ASTM does
not represent attractive force, and the ratings do not appropriately
scale with the strength or shapes of magnets. Therefore, the commenter
asserted that the Commission should use a measurement that is
appropriately created for such usage and properly reviewed by experts.
(Response 17) The performance requirement in the final rule
duplicates the ASTM F963-17 approach to addressing the magnet internal
interaction hazard in children. The current ASTM test to determine flux
index is a method that has been used by test laboratories to determine
compliance with the toy standard and it is a method also used by other
domestic and international standards for identifying hazardous magnets.
The Commission has determined that the requirement effectively
addresses magnet internal interaction hazard in toy products.
(Comment 18) One commenter, Joshua Pruett, suggested that a test
method to measure the force applied to a membrane sandwiched between
two magnets (presumably the attractive force of two magnets across body
tissue) is an alternative that would be a closer analog to the hazard
the agency wishes to prevent than the current method in ASTM F963-17,
which measures a magnet's flux index.
(Response 18) The method proposed by the commenter is not a
currently accepted test procedure, and it would not be reasonable
because a specific attractive force between two magnets has not been
correlated to tissue damage and severity of injury.
(Comment 19) Comments from Consumer Reports, Joshua Pruett, and
Retrospective Goods, LLC, made statements regarding sampling
requirements for testing magnets. Consumer Reports stated that, given
the variation in flux strength across magnets due to variation in
density, CPSC should require manufacturers to produce products that are
consistent and uniform, adding that CPSC should require large sample
sizes. Mr. Pruett suggested a representative sample consisting of 10 to
20 percent of the magnets in a set, but no less than 1 to 3 magnets per
set, would provide robust test results. Retrospective Goods, LLC,
stated that manufacturers should be allowed the flexibility to
determine the appropriate sampling for their product. Retrospective
Goods requested that the final rule include an acceptable tolerance
range for magnets.
(Response 19) The performance requirement in the final rule
duplicates the ASTM F963-17 approach to addressing the magnet internal
interaction hazard for children. The final rule requires all loose
magnets subject to the rule to be either too large for children to
swallow, or, if they are small enough to be swallowed, to have a
measured flux index under 50 kG\2\ mm\2\. The performance requirement
does not impose production requirements on the manufacturer; and it is
the manufacturer's responsibility to have processes in place to ensure
each magnet produced will meet the proposed requirements. Manufacturers
may choose sampling methods that are appropriate to their production
setting and demonstrate confidence in complying with the proposed rule.
Consistent with the ASTM F963-17 test method, and to prevent a hazard
to children, a subject magnet product fails the proposed requirement if
at least one magnet from the product has a magnetic flux index of 50
kG\2\ mm\2\ or greater.
(Comment 20) Numerous commenters opined on whether the proposed
flux index limit is sufficient to address the magnet internal
interaction hazard. Most supported the limit; however, several
commenters, including Consumer Reports, stated that CPSC should
continue to study whether magnets with flux indexes lower than 50 kG\2\
mm\2\ may also pose an unreasonable risk of injury to children, and
should be brought within the scope of this rule at a later time.
Additionally, Consumer Reports recommended that CPSC study whether
larger magnets pose an unreasonable risk of injury.
(Response 20) The current ASTM test to measure flux index is the
method accepted by domestic and international standards development
bodies that has been used by test labs to determine compliance with
ASTM F963, EN 71-1 and ISO 8124-1. CPSC's review indicates that the
requirement effectively addresses the magnet internal interaction
hazard in toy
[[Page 57776]]
products. Recall information further supports this conclusion. Recalls
of children's toys involving the magnet ingestion hazard have declined
substantially since the ASTM F963 Toy Standard took effect. 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. In contrast, from January
2010 through May 2022--a period approximately three times as long--
there were a total of 20 recalls related to the magnet ingestion
hazard, only six involving children's toys. Recalls provide some
indication of the products involved in magnet ingestions, because
products are recalled when they present a hazard. This marked decline
in recalls of children's toys for magnet ingestion hazards indicates
that children's toys largely comply with the ASTM F963 Toy Standard and
are not involved in hazardous incidents. Although CPSC is currently not
aware of demonstrable evidence indicating that magnets with a flux
index below 50 kG\2\ mm\2\ are hazardous, CPSC staff will continue to
review magnet ingestion incidents to assess whether magnets with flux
indexes lower than 50 kG\2\ mm\2\ pose an unreasonable risk of injury.
However, the Commission concludes that further study of whether larger
magnets pose an unreasonable risk of ingestion injury is unwarranted at
this time because the rule requires loose or separable magnets in the
subject magnet products to have a flux index under 50 kG\2\ mm\2\ if
the magnets are small enough to be ingested.
(Comment 21) Several commenters requested that, following
promulgation of the final rule, the CPSC investigate whether, and to
what extent, the number of magnets ingested affects the likelihood of
internal interaction injuries. One manufacturer, Retrospective Goods,
LLC, stated that there are no data showing that magnets in aggregate
clumps increase the risk of internal interaction injury. This commenter
explained that x-rays taken of ingestion incidents involving multiple
magnets show that the pattern is limited to strings or rings of
magnets.
(Response 21) The existing flux index method was developed to
estimate the magnetic attraction force of individual conventional
dipole magnets. Individual magnets stacked together with their magnetic
poles aligned, or connected side-by-side, could potentially have a
stronger flux index or otherwise be more difficult to separate than
each individual magnet. A clump of magnets could be less powerful than
an ordered aggregation, as the magnetic poles could overlap, interact,
and counteract one another. CPSC's review of NEISS and CPSRMS-reported
incidents did not show evidence demonstrating that internal interaction
injuries occurred because of increased strength from magnets in
aggregate.
(Comment 22) One manufacturer, Retrospective Goods, LLC, asserted
that the flux index is not an accurate measurement of magnetic
attractive force because magnets of different size, shape, and
composition can have the same flux densities but different points of
contact (convex surface likes spheres and cylinder ends have a single
point of contact versus flat surfaces of disks) and/or different pole
surface areas. The commenter stated the result is that magnets of
different size and shape can have the same flux index but different
attractive forces; therefore, the commenter claimed the flux index is
an arbitrary way of measuring safety risk. However, the commenter also
concluded that historical health data indicate that a flux index less
than 50 kG\2\mm\2\ is an appropriate predictor of safety for all disk
magnets and spherical magnets composed of neodymium; therefore, the
commenter asserted the belief that the rule should be limited to disk-
and sphere-shaped neodymium magnets.
(Response 22) The commenter's analysis of attractive force does not
consider the area over which the force is dispersed when two magnets
attract to apply pressure (force divided by area) on the pinched
tissue; attractive force, by itself, is not the only factor to
consider. The commenter also did not provide evidence, and CPSC is not
aware of any, that correlates tissue damage to a specific magnetic
attractive force over a specific area. The Commission proposed a
performance requirement that duplicates the ASTM F963-17 approach to
addressing the magnet internal interaction hazard in children. The
current ASTM test to determine flux index is a method that has been
used by test labs to determine compliance with the toy standard, and it
is a method that is also used by other domestic and international
standards for identifying hazardous magnets. CPSC's rationale for using
the 50 kG\2\mm\2\ flux index is based on historical incident data
indicating that the ASTM F963 requirement effectively addresses the
magnet internal interaction hazard in toy products. In fact, the same
commenter concluded that the proposed rule is effective for certain
magnets, based on incident data, but the commenter did not provide an
adequate rationale for excluding other magnets. Therefore, the
commenter's analysis does not change our conclusion that loose or
separable magnets in the subject magnet products should either be too
large to fit in the small parts cylinder described in 16 CFR 1501.4, or
they must have a flux index of less than 50 kG\2\ mm\2\, when tested in
accordance with the procedures described in the ASTM F963-17.
Impacts on Businesses and Jobs
(Comment 23) Several individual commenters who are opposed to the
proposed rule claim that U.S. companies will go out of business as a
result of the rule.
(Response 23) In the initial regulatory flexibility analysis
(IRFA), CPSC noted that a few small firms whose businesses focus on
sales of magnet products that do not comply with the final rule,
including some small firms selling products on their own websites,
would face relatively greater losses in producer surplus (estimated to
average about $5 to $10 per unit for magnet sets). 87 FR 1303. These
and other small businesses could respond to the rule by undertaking
measures, such as marketing or incorporating magnets that comply with
the rule, or increase their marketing of products that do not have
loose or separable hazardous magnets. Such measures could partially
offset losses in producer surplus resulting from firms' inability to
continue marketing noncomplying magnet products. A review of products
currently offered by current or former sellers of products that would
not meet the rule found that most of these current or former sellers
also market products that either would comply with the rule or are not
within the scope of the rule. One of the leading importers of magnet
sets that recalled and stopped sales of the products in March 2022,
still markets a variety of magnetic products that would comply with the
final rule (if the product marketing is accurate regarding the size and
strength of the loose or separable magnets). These facts indicate that
sellers of magnet products subject to the rule should be able to remain
in business, even if the rule becomes effective.
(Comment 24) The NPR proposed that the rule take effect 30 days
following its publication in the Federal Register. CPSC sought comments
on the advantages and disadvantages of a different effective date,
including extending the period before the rule becomes effective. Id.
at 1305. Retrospective Goods, LLC, a manufacturer of subject magnet
[[Page 57777]]
products, commented that a 30-day effective date would be workable for
the firm if the rule is limited to size and strength requirements as
proposed. However, the commenter asserted, if amendments change the
flux index, the test method, or add additional tests or requirements,
the firm, and likely other sellers, would need time to make those
changes and a 90-day effective date would be more appropriate. This
commenter also noted that the portion of the rule that regulates
children's products requires that the Notice of Requirements (NOR) for
the testing rule be amended, and the statute requires a 90-day
effective date after that amendment. The commenter opined that it would
make little sense, from a public safety standpoint, to have more
stringent requirements for adult products than for children's products
while the new rule is being fully implemented.
(Response 24) As noted in the IRFA, the alternatives to the
proposed rule that the Commission considered included setting a longer
period before the rule becomes effective. Although a later effective
date could give firms additional time to develop complying products, or
to shift marketing to nonmagnetic products, most current sellers of
noncompliant subject magnet products already market other products that
either comply with the rule or do not constitute subject magnet
products. Furthermore, the NPR itself alerted sellers to the potential
need to adjust their marketing focus. Given the facts and the nature of
the market, a 30-day effective date for the final rule should not
present significant hardships to small businesses. Additionally, the
30-day effective date is consistent with the requirements in section
9(g)(1) of the CPSC, which states: ``each consumer product safety rule
shall specify the date such rule is to take effect,'' which generally
``shall be set at a date at least 30 days after the date of
promulgation.'' 15 U.S.C. 2085(g)(1),
The NPR noted that certain subject magnet products would be
considered children's products if they are ``designed or intended
primarily for children 12 years of age or younger.'' For example, some
jewelry items that are subject magnet products may be children's
products, while others may not be. Accordingly, the NPR proposed to
amend part 1112 to add a NOR to include procedures for accreditation of
testing laboratories to test subject magnet products that are
children's products for compliance with the new standard. Under section
14(a)(3), the testing and certificate requirements apply to any
children's product manufactured more than 90 days after the Commission
has established and published an NOR for accreditation of third party
conformity assessment bodies to assess conformity with an applicable
children's product safety rule.
Accordingly, although the effective date of the final rule for both
children's and non-children's subject magnet products is 30 days after
publication of the final rule, the effective date under 16 CFR part
1112 is 90 days after the publication of the final rule. All the
subject magnet products must comply with the new standard, but for
children's products, such as children's jewelry, that currently are not
subject to the mandatory standard under ASTM F963-17, testing
laboratories also must go through the process of applying for
accreditation and obtain approval to become a CPSC-accepted third party
conformity assessment body. Ninety days provides sufficient time for
testing laboratories to apply for, and comply with, the CPSC's
procedures.
Regulatory Analysis
(Comment 25) The Magnet Safety Organization (MSO) submitted comment
on the preliminary regulatory analysis. MSO asserts that CPSC's
economic analysis does not account for the variety of quantities in
which sets are sold. MSO's proposed regulatory alternative would set a
performance standard that requires a minimum quantity of small rare
earth magnets per set.
(Response 25) CPSC's review of product offerings over the years
shows that magnet sets with 216 to 224 spheres have been most common
(and the commenter acknowledges this) in households. If magnet products
(i.e., magnet sets) contain large numbers of individual magnets, or
have magnets with high mass or volume that would result in costs of the
rule (in the form of lost consumer surplus and producer surplus)
greater than the estimated value of benefits (in the form of reduced
societal costs) per set, then significant price increases for hazardous
magnet products might reduce--but not eliminate--future exposure to the
unreasonably dangerous products. Additionally, the Commission must
assess all of the costs and benefits of the rule to address the risk of
injury associated with magnet ingestion from subject magnet products.
The commenter's proposed regulatory alternative that would limit sales
to a minimum number of magnets per set could greatly increase prices
and result in lost consumer surplus for consumers who would prefer
products with smaller numbers of magnets and lower prices. Loss of that
segment of the market would also decrease the producer surplus for
manufacturers and importers of the products.
(Comment 26) Regarding the NPR's cost/benefit analysis, MSO stated:
``According to the NPR, the range in Consumer surplus is equal to the
annual magnet product sales, multiplied by the range of product price
from $15 to $25. And the Producer surplus is curiously calculated with
a fixed product price of $20, minus a variable cost between $10 and
$15.'' MSO also claims that, based on the preliminary regulatory
analysis's estimate of annual societal costs of $47.6 million, ``above
1,904,000 units of Annual Sales is when societal benefit exceeds
societal cost.'' Furthermore, MSO claims: '' if the sales were
comparable to 2009, `the first year of significant sales, may have
totaled about 2.7 million sets,' then societal benefit handily exceeds
societal costs.''
(Response 26) The commenter's conclusions appear to be based on
several misinterpretations of the preliminary regulatory analysis. In
the absence of precise data on annual sales of hazardous magnet
products, CPSC presented estimates of the costs of the rule in the form
of lost consumer surplus and lost producer surplus for a wide range of
annual sales. When the preliminary analysis was prepared, CPSC noted
that, because the assumed range of annual sales is wide and likely
includes the actual sales levels, it is reasonable to conclude that the
costs of the proposed rule could range from about $5 million to $8.75
million (if sales amount to about 250,000 products annually), to about
$20 million to $35 million (if sales amount to about 1 million products
annually). CPSC's intent was to provide estimates of costs of the rule
in a range of annual sales that would capture likely costs. For the
final rule, CPSC determines that it is reasonable to assume that the
costs of the rule could range from about $2 million to $3.5 million (if
sales amount to about 100,000 products annually), to about $20 million
to $35 million (if sales amount to about 1 million products annually).
MSO is incorrect regarding CPSC's analysis of the consumer/producer
surplus. The $15 to $25 figure was the assumed consumer surplus per
unit, not the assumed price range. CPSC presented the example in which
consumers who purchased the noncomplying subject magnet products 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 set).
[[Page 57778]]
In addition, MSO speculates on sales data that, if comparable to
2009, ``the first year of significant sales, may have totaled about 2.7
million sets.'' Contrary to MSO's assertions, the final regulatory
analysis for the 2014 magnet sets rule was based on sales of about
800,000 sets annually during the 2009 to June 2012 period. MSO did not
provide, and CPSC does not have, any information or basis for
determining that annual sales of hazardous magnet products would
approach the very high level of 2.7 million sets MSO tosses out. The
NPR requested commenters to provide information on sales of subject
magnet products, but commenters offered no additional information. 87
FR 1312.
(Comment 27) We received comments from MSO and the Hobby
Manufacturers Association, among others, asserting that if the rule is
passed, it will be ineffectual because previous CPSC corrective actions
have pushed domestic suppliers of subject products out of CPSC's
authority, and caused ``nearly all'' of these products to enter the
U.S. from overseas.
(Response 27) The NPR's preliminary regulatory analysis noted that
an unusual aspect of the market for the subject magnets is the ability
of consumers to order magnets directly, mainly from suppliers located
in China. However, not all hazardous magnet products are being sold by
overseas sellers. In fact, a review of sellers on two major internet
platforms in 2020 and 2021 found that most sellers were domestic. The
numbers of hazardous magnet products directly imported from overseas
sources under the mandatory rule that are not stopped through
enforcement efforts, would likely comprise a small fraction of what
total sales have been in recent years. The dramatic decline in magnet
ingestion incidents during the period of the 2014 magnet sets rule
supports this conclusion that the rule will be effective.
VII. Description of the Final Rule
The Commission is issuing a rule establishing a standard for
subject magnet products. This section of the preamble describes the
rule, including differences between the NPR's proposal and the final
rule.
A. Scope, Purpose, Application, and Exemptions--Sec. 1262.1
Scope and purpose. This section of the rule states that the
requirements of 16 CFR part 1262 are intended are intended to reduce or
eliminate an unreasonable risk of death or injury to consumers who
ingest one or more hazardous magnets from a subject magnet 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.
Application. Except as provided under the toy exemption, all
subject magnet products that are manufactured after the effective date,
are subject to the requirements of this part 1262. This section makes
several editorial changes to the proposed rule. The language ``in the
United States, or imported, on or'' has been deleted to reflect the
statutory language of CPSA section 9(g)(1), which provides that a
safety standard subject to that section shall be applicable to consumer
products ``manufactured after the effective date.'' 15 U.S.C.
2058(g)(1). Another editorial change deletes the definition of
``consumer product.'' Because the statutory citation is provided for
the definition of ``consumer product,'' 15 U.S.C. 2052(a)(1), a
recitation of that definition is unnecessary.
Exemption. This section of the rule also provides an exemption from
the requirements of new 16 CFR part 1262, specifically: Toys that are
subject to 16 CFR part 1250, Safety Standard Mandating ASTM F963 for
Toys. Because the ASTM F963 Toy Standard already includes requirements
to adequately address the magnet ingestion hazard associated with
children's toys, the final rule retains the exemption as proposed in
the NPR.
B. Definitions--Sec. 1262.2
This section of the rule provides definitions for the terms
``hazardous magnet'' and ``subject magnet product.'' Hazardous magnet
is defined 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.'' In the NPR, subject magnet product was defined as 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. The final rule
adds clarifying language to the definition of subject magnet product,
as explained below.
In the NPR, the Commission specifically sought comment on products
that might be excluded from the proposed rule, including magnets used
for education, research, commercial, and industrial uses. 87 FR 1312.
As discussed in section VI.B. of the preamble, several commenters,
including magnet set manufacturers, requested clarifications pertaining
to the product scope and exemptions, particularly regarding products
that might meet the definition of ``mental stimulation.'' They asserted
that ``mental stimulation'' should be removed from the inclusion
criteria for ``subject magnet product'' because the rule otherwise
would include products primarily intended for use in scientific,
technical, and professional settings, as well as educational purposes.
Commenters also requested that the final rule should identify more
clearly the exempted products, such as products intended only for
scientific or technical research, and educational, professional, and/or
industrial applications.
In response to comments, the final rule clarifies that the
definition of ``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, but does not include products sold
and/or distributed solely to school educators, researchers,
professionals, and/or commercial or industrial users exclusively for
educational, research, professional, commercial, and/or industrial
purposes.
C. Requirements--Sec. 1262.3
Each loose or separable magnet in a subject magnet product, if it
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 test procedure for determining flux index. 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 CPSC testing showing that some magnets involved in
internal interaction incidents had flux indexes close to 50 kG\2\
mm\2\, the final rule requires that magnets that are small enough to
ingest have a flux index of less than 50 kG\2\ mm.
D. Test Procedure for Determining Flux Index--Sec. 1262.4
This section of the rule describes how to determine the flux index
of subject product magnets. Under the final rule, each loose or
separable magnet in a subject magnet product that fits entirely within
the small parts cylinder
[[Page 57779]]
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. In practice,
the first step is to determine whether each loose or separable magnet
in a subject magnet product fits in the small parts cylinder, and the
second step is to determine what is its flux index.
The small parts cylinder is described and illustrated in 16 CFR
part 1501.4. Figure 2, below, shows the illustration, including the
dimensions of the cylinder provided in the regulation.
[GRAPHIC] [TIFF OMITTED] TR21SE22.001
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 final 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 final rule.
As detailed in the memorandum in Tab D of Staff's NPR briefing
package and in Tab D of Staff's Final Rule briefing package, CPSC staff
developed a test methodology that is consistent with the test methods
specified in ASTM F963-17, to assist testing laboratories in improving
the accuracy and consistency in measuring the maximum flux density and
calculating the maximum flux index for small diameter magnets. This
test procedure is not mandatory, but it is provided as an example of
how to measure flux index of small spherical magnets less than 3 mm in
diameter. This example test method is available in the Appendix to Tab
D of Staff's Final Rule briefing package.
E. Findings--Sec. 1262.5
Section 9 of the CPSA requires the Commission to make certain
findings when issuing a consumer product safety standard. Specifically,
the Commission must consider and make findings about the degree and
nature of the risk of injury; the number of consumer products subject
to the rule; the need of the public for the rule and the probable
effect on utility, cost, and availability of the product; and other
means to achieve the objective of the rule, while minimizing the impact
on competition, manufacturing, and commercial practices. The CPSA also
requires the rule to be reasonably necessary to eliminate or reduce an
unreasonable risk of injury associated with the product; and issuing
the rule must be in the public interest. 15 U.S.C. 2058(f)(3).
In addition, the Commission must find that: (1) if an applicable
voluntary standard has been adopted and implemented, compliance with
the voluntary standard is not likely to adequately reduce the risk of
injury, or compliance with the voluntary standard is not likely to be
substantial; (2) the benefits expected from the regulation bear a
reasonable relationship to the regulation's costs; and (3) the
regulation imposes the least burdensome requirement that would prevent
or adequately reduce the risk of injury. Id. These findings are stated
in Sec. 1262.5 of the rule and are based on information provided
throughout this preamble and the staff's briefing packages for the
proposed and final rules.
[[Page 57780]]
VIII. Final Regulatory Analysis
The Commission is issuing this rule under sections 7 and 9 of the
CPSA. The CPSA requires that the Commission publish a final regulatory
analysis with the text of the final rule. 15 U.S.C. 2058(f)(2). This
section of the preamble provides the final regulatory analysis of the
rule, which is discussed further in Tab F of Staff's Final Rule
briefing package.
A. Societal Costs of Deaths and Injuries
The Commission's ICM provides estimates of the societal costs of
injuries reported through NEISS, as well as the societal costs of other
medically treated injuries. 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. For the ICM, CPSC derives
the cost estimates for these expenditure categories from national and
state databases including Medical Expenditure Panel Survey (MEPS), the
Nationwide Inpatient Sample of the Healthcare Cost and Utilization
Project (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. Although 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.\23\ 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.
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\23\ 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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Table 8 below provides annual estimates of the injuries and
societal costs associated with ingestions of magnets categorized as
magnet sets, magnet toys, and jewelry. Based on NEISS estimates for
2017 through 2021, there were an estimated annual average of about 481
ED-treated injuries, comprised of 320 injuries that were treated and
released and 161 injuries that required hospitalization. Additionally,
based on annual estimates from the ICM, 185 injuries were treated
outside of hospitals, and another 78 injuries resulted in direct
hospital admission.
Based on ICM estimates, these injuries resulted in annual societal
costs of $51.8 million (in 2020 dollars) during the period 2017 through
2021. The average estimated societal cost per injury was about $14,000
for injuries treated in physician's offices, clinics, and other non-
hospital settings; about $24,000 for injuries that were treated and
released from EDs; and about $175,000 for injuries that required
admission to the hospital for treatment. Medical costs and work losses
(including work losses of caregivers) accounted for about 43 percent of
these injury cost estimates, and the less tangible costs of injury
associated with pain and suffering accounted for about 57 percent of
the estimated injury costs.
In addition to the magnet cases upon which Table 8 was based, for
which identifying information was reported (i.e., magnets from magnet
sets, magnet toys, or jewelry), there were also 403 NEISS cases during
2017 through 2021 (representing about 1,873 ED-treated injuries
annually), in which the magnet type was classified as ``unidentified.''
These cases included narratives that mentioned that at least one magnet
was ingested but presented insufficient information to classify the
magnet product type. CPSC's analysis of the data, the trends in NEISS,
CPSRMS, and poison center-reported,\24\ magnet-related incidents
relative to the vacated 2014 rule on magnet sets, support the
conclusion that the ``unidentified'' magnet products generally involved
magnets considered within scope of the rule; that is, intended for
subject magnet product uses. Based on ICM estimates for all magnet
products involved in ingestion injuries, including unidentified,
average annual societal costs for 2017-2021 were $167.9 million.
Because CPSC does not know precisely how many of these products would
fall within the scope of this rule, CPSC conservatively has not
included them in the primary benefit analysis summarized above.
Instead, CPSC includes the benefits from unidentified magnet products
in this final rule's sensitivity analysis to illustrate the theoretical
upper bounds of benefits from this rule.
---------------------------------------------------------------------------
\24\ As discussed in the NPR, annual national poison center
magnet exposure calls increased by 344 percent from 281 per year
(2012-2017) to 1,249 per year (2018-2019). Considering incidents
dating back to 2008 (5,738 total), the incidents from 2018 and 2019,
alone, accounted for 39 percent of the magnet incidents since 2008.
These researchers drew conclusions similar to CPSC's, asserting that
significant increases in magnet injuries correspond to periods in
which high-powered magnet sets were allowed to be sold. 87 FR 1274.
[[Page 57781]]
Table 8--Estimated Average Annual Medically Treated Injuries and
Associated Societal Costs for Ingestions of Products Categorized as
Magnet Sets, Magnet Toys, and Jewelry, Including Those for Unidentified
Magnets for 2017 Through 2021
------------------------------------------------------------------------
Estimated
Injury disposition Estimated No. societal costs
($ millions) *
------------------------------------------------------------------------
Doctor/Clinic........................... 185 $2.6
Treated and Released from Hospital ED... 320 7.5
Admitted to Hospital through ED (NEISS). [dagger] 161 28.1
Direct Hospital Admissions, Bypassing... 78 13.6
-------------------------------
Total Medically Attended Injuries... 743 51.8
------------------------------------------------------------------------
* In 2020 dollars.
[dagger] This estimate may not be reliable because of the small number
of cases on which it is based.
B. Benefits of the Rule
The benefits of the rule account for the reduction in the risk of
injury 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 four
fatalities in the United States resulting from magnet ingestions,
excluding one death involving a toy subject to ASTM F963.\25\ Given
that nearly all incidents result in injuries as opposed to deaths, CPSC
focuses its benefits assessment on the mitigation of injuries. However,
CPSC does include the mitigation of deaths in the benefits assessment
in a sensitivity analysis in this regulatory evaluation.
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\25\ Staff is aware of seven deaths that occurred in the period
November 24, 2005, to January 5, 2021, involving ingestion of
hazardous magnets. Two of these deaths occurred abroad, and one of
the five U.S. ingestion cases occurred before 2010, and that case
involved a children's toy subject to ASTM F963.
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The annual expected benefits of the rule, on a per-product basis,
depend on the exposure to risk associated with subject magnet products,
as well as the estimated societal costs described in Table 8, 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, per subject magnet product, under an assumed product life of
1.5, 2, and 3 years. Table 9 presents benefit estimates under the
alternative product life assumptions (line (b)).
Table 9--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 2021
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
(a) Aggregate Annual Societal Costs (millions $)................ $51.8 $51.8 $51.8
(b) Expected Useful Product Life (years)........................ 1.5 2 3
(c) Magnet Products in Use, Average Annual...................... 515,000 626,000 818,000
(d) Annual Societal Costs per Subject Magnet Product [(a) / (c)] $101 $83 $63
(e) Present Value of Societal Costs, per Subject Magnet Product $150 $162 $180
\26\ (3% Discount Rate)........................................
(f) Present Value of Societal Costs, per Subject Magnet Product $144 $154 $167
(7% Discount Rate).............................................
----------------------------------------------------------------------------------------------------------------
Line c presents the average annual estimated number of subject
magnet products in use during the period 2017 through 2021, based on
producer-reported annual magnet set sales collected by CPSC's Office of
Compliance and Field Operations up through mid-2012. The estimate also
includes assumptions of annual sales of all subject magnet products
through 2021 (including an assumption of 500,000 units per year for
2017-2021 as explained below), an expected product life of 1.5, 2, and
3 years (line b), and the application of the CPSC's Product Population
Model, a statistical model that projects the number of products in use,
given estimates of annual product sales and product failure rates. In
the NPR, the Commission requested comments with information on annual
sales and expected product life of magnet products subject to the
proposed rule. No commenter provided specific sales or product life
information, however.
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\26\ These calculations are based on estimated product survival
by month after purchase, which is multiplied by monthly societal
costs per unit. The streams of expected societal costs are then
discounted to their present values (at 3% and 7%).
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The annual estimated societal costs per subject magnet product in
use (line d of Table 2) are presented as the quotient of the annual
societal costs (line a), 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 $150 to about
$180, using a 3 percent discount rate (line e), or from about $144 to
$167, using a 7 percent discount rate (line f).
Because the rule would prohibit the sale of the subject magnet
products with one or more loose or separable hazardous magnets, the
approximation of benefits would be equal to the present value of
societal costs presented in lines (e) and (f) and would range from
about $144 (with a 1.5-year product life and a 7 percent discount rate)
to $180 (with a 3-year product life and a 3 percent discount rate) per
product.
C. Costs Associated With the Rule
This section discusses the costs associated with the 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
[[Page 57782]]
subject magnet products comply with the rule would consist of: (1) the
lost use value experienced by consumers who would no longer be able to
purchase subject magnet products that do not meet the standard (at any
price) and who cannot find an appropriate substitute; and (2) the lost
income and profits to firms that could not produce, import, or sell
noncomplying products in the future.
Both consumer and producer surplus depend on product sales, among
other things. The unit sales of subject magnet products are not known.
This analysis accordingly considers possible costs associated with
several plausible estimates of sales, ranging from about 100,000 to 1
million subject magnet products per year. The lower bound of 100,000
units \27\ and upper bound of 1 million units are based on information
from reports by firms to CPSC's Office of Compliance and Field
Operations.\28\ For purposes of exposition, CPSC uses an assumption of
annual sales of 500,000 units per year, in the midpoint of the range of
estimates. CPSC uses a wide range, not because of the appropriate
endpoints of that range are precisely determined, but instead to
demonstrate that, even at the extremes of a reasonable range, the
overall result of preliminary regulatory analysis is that the rule's
benefits outweigh the costs.
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\27\ The lower bound estimate in the NPR was 250,000. 87 FR
1303. Since the NPR, a leading seller was subject to a recall. To
account for this change, an adjustment to 100,000 was made.
\28\ For the 2014 magnet sets rule CPSC assessed that 2.7
million magnet sets were sold to U.S. consumers from 2009 through
mid-2012, or an average of about 800,000 annually. Since 2012,
administrative actions and recalls have set the market in a state of
flux and sales have likely decreased. To capture this change in lieu
of industry data (of which none was subsequently provided by
commenters during the NPR comment period) CPSC made an adjustment
from 800,000 to 500,000 magnets sets sold on an annual basis. CPSC
then added a range of -50% (250,000) and +100% (1 million) to
represent the theoretical extremes. More weight was given to the
upside to account for CPSC's assessment that a rebound back to 2012
sales level and beyond was likelier than the same magnitude of
decline.
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1. Costs to Consumers
The primary cost associated with the rule is lost utility to
consumers. Subject magnet products may be used for a variety of
purposes, including amusement and jewelry. CPSC has received comments
regarding subject magnet products, including magnet sets, citing
usefulness of the magnets as a manipulative or construction item for
entertainment, such as puzzle working, sculpture building, or stress
relief. Others have claimed that the magnets can have beneficial
artistic, educational, social, innovative, and therapeutic values. In
addition to consumer uses promoted by sellers, and uses reported in
comments by consumers, use of magnets as jewelry from magnet sets is a
common hazard pattern. The individual magnets might also have other
uses, apart from their intended uses (e.g., using magnets from a magnet
set to post items on a refrigerator door). Thus, CPSC concludes that
consumers derive utility from magnet sets and other subject magnet
products within the scope of the rule from a wide variety of uses, even
those not promoted by sellers.
CPSC cannot estimate with any precision the use value that
consumers receive from these products. However, we can describe use
value conceptually. In general, use value includes the amount of: (1)
consumer expenditures for the product, plus (2) what is called
``consumer surplus.'' Assuming annual sales of about 500,000 subject
magnet products as explained above, and 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 below (Figure 3), where B equals
$20, and E equals 500,000 units.
[GRAPHIC] [TIFF OMITTED] TR21SE22.002
[[Page 57783]]
In Figure 3, 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. 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.
In general, the use value of the subject magnet products obtained
by consumers is represented by the area of the trapezoid OCDE in Figure
3. However, the prospective loss in use value associated with the 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 rule, but
they would have the $10 million (represented by the rectangle OBDE)
that they would have spent on noncomplying subject magnet products in
the absence of a rule. The net loss in consumer surplus associated with
the rule would be reduced by consumers' ability to purchase replacement
products that comply with the rule and provide the same utility, or by
their ability to purchase other products that provide use-value.
CPSC does not have, and no commenter offered, information regarding
aggregate consumer surplus, or, by extension, the amount of utility
that would be lost as a result of the rule. However, if, for example,
consumers who purchased subject magnet products that do not comply with
the 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), then the lost utility would 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) annually.
Finally, we note that the loss in consumer surplus just described
represents the maximum loss of consumer utility from the rule. This is
because consumers are likely to gain some amount of consumer surplus
from products that are purchased as an alternative to those subject
magnet products that would no longer be available because of the rule.
If, for example, consumers purchased close substitutes (e.g., products
that are almost as satisfying and similarly priced) for the subject
magnet products that do not meet the standard, the overall loss in
consumer surplus (and, hence, the costs of the rule) would tend to be
small. On the other hand, if consumers do not purchase close
substitutes, the costs of the rule would be higher.
2. Costs to Manufacturers/Importers
The lost benefits to firms that could result from the rule are
measured by a loss in what is called producer surplus. Producer surplus
is a profit measure that is 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 benefits accruing to firms that produce and
sell products, net of the costs of producing them. More formally,
``producer surplus'' is defined as the total revenue (TR) of firms
selling the magnets, 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 the like.
In Figure 3, total revenue is given by the area OBDE, which is
simply 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 suppliers
produce and sell alternatives that are similar to the subject magnet
products, the lost producer surplus could be less.
Following our example above, assuming sales of the subject magnet
products average 500,000 units annually, with an average retail price
of $20 per product total industry revenues have averaged about $10
million annually (i.e., 500,000 units x $20 per product). Information
provided by magnet set sellers to CPSC's Office of Compliance and Field
Operations suggested 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 of the magnets, the
variable costs of production are probably relatively small. Because
magnet sets are often packaged and shipped from China and sometimes
sent directly to the importer's point of sale, U.S. labor costs may be
low; and because the magnets sets are small, non-perishable, and not
particularly valuable, storage costs likewise are low. For example,
assuming 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). Although this information is
specifically related to magnet sets, a similar relationship could apply
to other subject magnet products affected by the rule.
Manufacturers and importers might be able to respond to the rule by
measures such as marketing or incorporating magnets that comply with
the rule or increased marketing of products that do not have loose or
separable magnets. Such measures would offset losses in producer
surplus resulting from firms' inability to continue marketing
noncomplying magnet products.
As noted above, actual sales levels of non-complying subject magnet
products are not known with certainty. Additionally, CPSC cannot
estimate precisely either consumer surplus or producer surplus; nor
were any such data provided in response to the NPR's request for such
information. Table 10 below provides rough estimates of the possible
costs of the rule for various future hypothetical sales levels ranging
from 100,000 to 1 million products annually. The cost estimates are
based on the assumptions described above and are made for illustrative
purposes. Nevertheless, because the range of sales is wide, and the
range provide here is likely to include the actual annual sales levels,
it is reasonable to assume that the costs of the rule are within the
range from approximately $2 million to $3.5 million (if sales amount to
about 100,000 products annually), to about $20 million to $35 million
(if sales amount to about 1 million products annually). As noted above,
these costs could be offset by increased marketing of products that
incorporate complying magnets or by incorporating products that do not
include loose or separable magnets.
[[Page 57784]]
Table 10--Possible Costs of the Rule, for Various Levels of Noncomplying Subject Magnet Product Sales
----------------------------------------------------------------------------------------------------------------
Consumer surplus Producer surplus Total costs (millions
Magnet product sales (annually) (millions $) (millions $) $)
----------------------------------------------------------------------------------------------------------------
100,000.............................. $1.5 to $2.5........... $0.5 to $1............. $2 to $3.5
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 and importers
of subject magnet products that comply with the rule would incur some
additional costs to certify that their products meet the requirements
of Section 14 of the CPSA. The certification must be based on a test of
each product model or a reasonable testing program. The costs of the
testing might be minimal, especially for manufacturers that currently
have product testing done for products subject to the requirements in
ASTM F963. Importers may also 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 rule. As noted
above, 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.
D. Sensitivity Analysis
The foregoing base-case analysis of potential costs and benefits of
the rule presents estimated costs for a wide range of prospective sales
in the absence of a rule, 100,000 to 1 million units. Estimated
potential benefits/societal costs of injuries per unit are based on
expected useful product life of 18 months, 2 years, and 3 years. The
present value of expected injury costs occurring over the lives of
products are discounted at 3 percent and 7 percent. Thus, the base
analysis incorporates sensitivity analysis for some important
parameters and assumptions. Staff conducted additional sensitivity
analysis to evaluate the impact of variations in some other important
parameters. Alternative inputs for the sensitivity analysis included:
Assuming lower and higher unit sales in recent years than
the base case of 500,000 units for 2017 through 2022;
Assuming 25 percent, 50 percent, and 100 percent of
estimated injury costs involving unidentified magnet products would be
addressed by the rule, and;
Including an estimate of societal costs of fatal ingestion
injuries in the potential benefits calculation.
Staff's sensitivity analysis shows that per-unit injury costs being
addressed by the rule vary greatly for the wide range of assumed annual
unit sales. However, for all scenarios examined, the potential benefits
well exceed the estimated costs of the rule, in the form of lost
consumer surplus and lost producer surplus, estimated to range
generally from $20 to $35 per subject magnet product. In addition, the
sensitivity analysis shows that including even a relatively small
portion of NEISS cases involving unidentified magnet products to the
base case, which is limited to in-scope identified products,
substantially increase the estimated gross benefits of the rule.
If 100 percent of unidentified magnet injuries were within the
scope of the draft final rule, average estimated annual magnet
ingestion societal costs would be an additional $167.9 million.
Including these societal costs with those estimated for in-scope
identified subject magnet products ($51.8 million) results in average
annual societal costs of magnet ingestion injuries of $219.7 million
for the period 2017 through 2021, an increase of 324 percent. Including
these cases as addressable societal costs would lead to a corresponding
increase the estimated gross benefits of the rule.
In estimating the benefits of the rule associated with reduced
mortality, we assume that the standard will avoid two to four deaths
over a 10-year period, the average annual statistical value of the
rule's life-saving could be about $2.1 million to $4.2 million. Adding
these potential societal costs to those associated with nonfatal magnet
ingestions would increase the expected gross benefits of the proposed
standard by about 4 percent to 7 percent over the base estimate.
E. Summary of the Final Regulatory Analysis Results
Estimated aggregate annual societal costs from ingestion injuries
involving subject magnet products for 2017 through 2021 total $51.8
million. Assumptions about annual product sales and expected product
life of 1.5, 2, and 3 years yields estimated numbers of products in use
during those years ranging from 515,000 to 818,000. The estimated
present value of societal costs per subject magnet product (at a 3%
discount rate) ranges from $150 per unit (at a 1.5-year expected life)
to $180 per unit (at a 3-year expected life). On the cost side,
estimates of consumer and producer surplus were uncertain, but they
might range from about $2-$3.5 million to about $20-$35 million, based
on unit sales ranging from 100,000 to 1 million.
Based on annual unit sales of noncomplying subject magnet products
of 500,000, expected aggregate benefits total $51.8 million annually,
while costs (lost consumer and producer surplus) range from $10 million
to $17.5 million annually. Thus, although both the benefits and costs
of the rule are uncertain, based on a range of assumptions, our
estimates suggest that the potential benefits of the rule are projected
to exceed the potential costs. These estimated benefits exclude cases
involving in-scope magnet products that have not been identified as
amusement/jewelry products. As discussed, the sensitivity analysis
shows that including NEISS cases involving unidentified magnet products
to the base case substantially increases the estimated gross benefits
of the rule.
Table 11, below, shows a comparison of the estimated benefits and
costs of the rule.
[[Page 57785]]
Table 11--Comparison of Estimated Benefits and Costs of the Rule
----------------------------------------------------------------------------------------------------------------
Benefits (millions $)
----------------------------------
Including 100%
Annual magnet product sales \1\ Identified as of Total costs from lost consumer &
amusement and/ unidentified producer surplus (millions $)
or jewelry magnet
incidents
----------------------------------------------------------------------------------------------------------------
500,000................................... $51.8 $167.9 $10 to $17.5.
----------------------------------------------------------------------------------------------------------------
IX. Alternatives to the 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. Rely on Voluntary Standards
One alternative to the rule is to take no regulatory action and,
instead, rely on voluntary safety standards to address the magnet
ingestion hazard. As discussed above, there are four ASTM standards and
two international 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 rule because it
would not mandate compliance.
However, there are considerable limitations and unknowns associated
with this alternative. The shortcomings of the standards are discussed
in detail in section V. in the preamble. CPSC does not consider the
existing voluntary standards capable of adequately reducing the magnet
ingestion hazard, either individually or collectively, because their
limited scope fails to cover all of the subject magnet products
associated with injuries and deaths, and/or the voluntary standards do
not impose size and strength limits on subject magnet products 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 final rule. For these
reasons, the Commission did not select this alternative.
B. Alternative Performance Requirements
Another alternative to the rule is to adopt a mandatory standard
with less stringent requirements than the 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 permit consumers to use a wider variety of
products than under the rule. The reduction in costs would depend on
the specific requirements adopted. As discussed in section V of the
preamble, no other performance requirements in the currently applicable
voluntary standards, aside from flux method test requirements in ASTM
F963 Toy Standard, have been shown to adequately address the ingestion
hazards associated with subject magnet products. Accordingly, on the
record before us, choosing alternative performance requirements would
reduce the safety benefits of the rule. If the alternative performance
requirements reduced costs by allowing more products to remain on the
market, it would also leave more hazardous products on the market,
thereby decreasing the safety benefits.
The rule mandates a performance requirement that duplicates the
ASTM F963 Toy Standard's approach to addressing magnet internal
interaction hazard in children, which has been shown to be effective.
The current ASTM test to determine flux index is a method that has been
used by test labs to determine compliance with ASTM F963 and is a
method that is also used by other domestic and international standards
for identifying hazardous magnets. Importers may also 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 rule.
Firms that magnetize the products would have equipment to measure the
magnetic force of their products; and many of these firms should be
familiar with the test methodology or have access to testing firms that
can perform the tests. The increased costs related to testing therefore
should be relatively minor, 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.
For these reasons, the Commission did not select alternative
performance requirements.
C. Require Safety Messaging
Instead of performance requirements, the Commission could require
safety messaging on products to address the magnet ingestion hazard,
such as through labeling and instructional literature. This alternative
would reduce the costs associated with the rule, because it would allow
firms to continue to sell subject magnet products with loose or
separable hazardous magnets and the costs of providing 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, as discussed in section V of the preamble. To summarize,
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.
Warning information on labels and instructional literature, as well
as public outreach efforts to inform consumers of the hazard, have been
used for many years to try to address the magnet ingestion hazard.
However, these efforts have not addressed the magnet ingestion hazard
successfully, as evidenced by the increase in magnet ingestion
incidents in recent years, including magnet ingestion incidents
involving products with clear warnings. For all these reasons, the
Commission did not select this alternative.
[[Page 57786]]
D. Require Special Packaging
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 package and include child-resistant features. Although this
alternative would create some costs associated with packaging, those
costs likely would be lower than the cost of the rule because they
would allow the subject magnets 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.
CPSC does not consider this alternative effective for adequately
reducing the risk of injury and death associated with magnet
ingestions. To summarize the detailed discussion in section V. of the
preamble, consumers are unlikely to repackage all magnets after each
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 address only 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. Require Aversive Agents
Instead of the size and strength requirements in the 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 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.
CPSC does not consider this alternative effective for adequately
reducing the risk of injury and death associated with magnet
ingestions. To summarize the detailed discussion in section V. of the
preamble, real-world investigations have not demonstrated that
bitterants are effective at preventing ingestions. Bitterants do not
deter initial ingestion because the user has not yet tasted the
bitterant; this makes bitterants 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. In addition, once a magnet is in a person's mouth, they may
not be able to prevent ingestion, even if deterred by a bitterant.
Bitterants would be particularly ineffective for accidental ingestions,
where victims do not intentionally place magnets in their mouth;
incident data indicate that some magnet ingestions involve
unintentional ingestions, particularly for older victims. Moreover,
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.
Finally, 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. Later Effective Date
Another alternative is to provide a later effective date for a
final rule. In the NPR, the Commission proposed a final rule effective
30 days after it is published. A later effective date would reduce the
impact of the rule on manufacturers and importers, by providing
additional time for firms 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.
Additionally, one commenter, Retrospective Goods, LLC, stated that 30
days is adequate for manufacturers and importers to come into
compliance with the rule. As such, the Commission did not select this
alternative.
X. Paperwork Reduction Act
This rule does not contain a ``collection of information'' as that
term is used in the Paperwork Reduction Act (44 U.S.C. 3501-3521).
Therefore, the rule need not be submitted to the Office of Management
and Budget in accordance with 44 U.S.C. 3507(d) and implementing
regulations codified at 5 CFR 1320.11.\29\
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\29\ 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.
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XI. Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act (RFA) requires that agencies review
rules for their potential economic impact on small entities, including
small businesses. Section 604 of the RFA calls for agencies to prepare
a final regulatory flexibility analysis, describing the impact of the
rule on small entities and identifying impact-reducing alternatives.
Further details about the initial regulatory flexibility analysis are
available in Tab F of Staff's NPR briefing package, as updated in Tab F
of Staff's Final Rule briefing package. Additional information about
costs associated with the rule are available in Tab E of Staff's NPR
briefing package, as updated in Tab E of Staff's Final Rule briefing
package.
A. The Need for, and Objectives of, the Rule
The rule prohibits the sale or distribution in commerce of subject
magnet products that do not meet the specific requirements described in
section VII of this preamble. CPSC has received information, as
described in section IV of this preamble, regarding the hazards posed
by, and growing numbers of injuries with, hazardous magnets in consumer
products. These interactions have led to serious injuries and deaths,
typically by causing intestinal twisting (volvulus injuries), fistulae,
and perforations. Many of these ingestions resulted in surgical removal
of magnets and surgical repair of injuries, and others required non-
surgical medical interventions, such as emergency endoscopies and
colonoscopies.
The objective of the rule is to eliminate or reduce the risk of
injury to consumers from the ingestion of one or more small, powerful
magnets that comprise the subject magnet products, and thereby reduce
the future incidence and cost to society of magnet ingestions.
B. Comments on the Initial Regulatory Flexibility Analysis
CPSC received comments from more than 700 parties in response to
the NPR. The Commission's responses to comments that address issues
that were mentioned in the IRFA are included in section VI.B. of the
preamble. None of the comments resulted in changes to the
[[Page 57787]]
regulatory analysis or regulatory flexibility analysis.
C. Comments From the Chief Counsel for Advocacy of the U.S. Small
Business Administration
The U.S. Small Business Administration (SBA) did not file comments
on the proposed rule.
D. Small Entities Subject to the Rule
The rule would affect firms or individuals who manufacture, import,
and sell subject magnet products. All of the identified importers of
magnet sets are small businesses under applicable SBA size standards,
and we expect this is also true for manufacturers and importers of
other subject magnet products, such as jewelry with loose/separable
magnets.
As discussed in section III.B. of the preamble, reviews of the
online market for magnet sets from 2018 to July 2021 by CPSC staff and
IEc found that the leading internet marketplaces have high turnover
rates for magnet set sellers and magnet set products offered on their
sites. The most recent review in 2021 found that the great majority of
sellers of magnet sets (in terms of distinct firms or individuals, if
not unit sales) appeared to sell through their stores operated on the
sites of other internet retailer platforms. The dominant business model
for importers of magnet sets is expected to be direct sales to
consumers using their own internet websites or other internet shopping
sites. However, the rule could also affect some third party retailers
of the products, whether selling them online or physically in ``brick &
mortar'' stores, such as bookstores, gift shops, or stores that sell
novelty items.
E. Projected Reporting, Recordkeeping, and Other Compliance
Requirements
Section 14(a)(1) of the CPSA requires manufacturers, importers, or
private labelers of a consumer product (that is not a children's
product) 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. 15 U.S.C. 2063(a)(1). The rule specifies the procedure to use
to determine whether a subject magnet product complies with those
requirements. For products that manufacturers certify based on a test
of each product or a reasonable testing program, manufacturers would
issue a general certificate of conformity (GCC). Section 14(a)(2) of
the CPSA, 15 U.S.C. 2063(a)(2), requires manufacturers, importers, or
private labelers of any product subject to a children's product safety
rule to submit sufficient samples of the children's product, or samples
that are identical in all material respects to the product, to a CPSC-
accepted, third party conformity body for testing. Based on passing
test results from the CPSC-accepted, third party conformity body, the
manufacturer, importer, or private labeler issues a Children's Product
Certificate (CPC) indicating the children's product is compliant with
the children's product safety rule. For example, in the case of subject
magnet products that are children's products, such as children's
jewelry, the CPC must be based on testing by a CPSC-accepted third
party conformity assessment body. The CPC must be furnished to each
distributor or retailer of the product and to the CPSC, if requested.
F. Steps Taken To Minimize Significant Impact on Small Entities
Small manufacturers/importers of subject magnet products would
likely incur some additional costs to certify that their products meet
the requirements of the 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. CPSC is mandating a performance requirement
that duplicates the ASTM F963 Toy Standard approach to addressing
magnet internal interaction hazard in children. The current ASTM test
to determine flux index is a method that has been used by test labs to
determine compliance with the ASTM F963 and in other domestic and
international standards for identifying hazardous magnets. The
increased costs related to testing should be relatively minor,
especially for manufacturers that currently have product testing done
for products subject to the requirements in the ASTM F963. As noted
above, for subject magnet products that are children's products other
than toys, such as children's jewelry, the certification must be based
on testing by an accredited third party conformity assessment body, at
somewhat higher costs.
As discussed in section VIII of the preamble, the main impact on
small businesses of a rule would be the lost income and profits to
firms that could not produce, import, and sell noncomplying products in
the future. The lost benefits to firms results from producer surplus 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 retail
price of $20. A similar relationship could apply to other subject
magnet products affected by the rule, such as jewelry with separable
magnets.
A few small firms whose businesses focus on sales of magnet
products that would not comply with the 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 measures such as marketing or
incorporating magnets that comply with the rule or increased marketing
of products that do not have loose or separable magnets. Such measures
could offset losses in producer surplus resulting from firms' inability
to continue marketing noncomplying magnet products.
As discussed in the analysis above, all domestic firms that are
expected to manufacture or import subject magnet products are small
businesses. Therefore, an exemption for small manufacturers/importers
is not possible, because all manufacturers/importers that would be
subject to the rule are small.
G. Alternatives to the Rule
CPSC considered several other alternatives that might reduce the
impact of a rule on small businesses, including promulgating an
alternative set of requirements for the flux index or size of the
magnets; requiring safer packaging; requiring warnings on the packaging
and promotional materials; requiring aversive agents on magnets;
relying on voluntary standards; delaying the effective date; and taking
no action. Each of these alternatives is addressed in section IX of the
preamble. All of these alternatives would reduce the expected impact of
the rule on small business. However, as discussed in section IX of this
preamble, these alternatives would not achieve the same injury
reductions as the rule, and their adoption would not result in a rule
that adequately addresses the risk of serious injury or death caused by
ingestions of magnets from the subject magnet products.
XII. Incorporation by Reference
The 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, an
agency must summarize the incorporated material
[[Page 57788]]
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 incorporates by reference in section VII of the
preamble.
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. Once this
rule takes effect, a read-only copy of the standard will be available
for viewing at no charge on the ASTM website at: www.astm.org/READINGLIBRARY/. Interested parties can also schedule an appointment to
inspect a copy of the standard at CPSC's Office of the Secretary, U.S.
Consumer Product Safety Commission, 4330 East West Highway, Bethesda,
MD 20814, telephone: (301) 504-7479; email: [email protected].
XIII. 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 be marketed to appeal primarily to children. Id. 1200.2(d)(1).
As discussed in section III of the preamble, some subject magnet
products (e.g., children's jewelry) are children's products and some
are not. Therefore, this rule requires subject magnet products that are
not children's products to meet the certification requirements under
section 14(a)(1) of the CPSA and requires 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 \30\) 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).
---------------------------------------------------------------------------
\30\ 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, based on testing by a
third-party conformity assessment body (i.e., testing laboratory), that
the product complies with the applicable children's product safety
rule. Id. 2063(a)(2). Section 14(a) also requires the Commission to
publish an 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 rule is a children's product safety rule, as applied to
those products.
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, in this rule, the Commission
amends part 1112 to add this 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 must 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 on the CPSC website at: www.cpsc.gov/labsearch.
XIV. Environmental Considerations
The Commission's regulations address when 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 rule would create performance requirements for subject
magnet products, the rule falls within the categorical exclusion, and
thus, no EA or EIS is required.
XV. 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). The
regulation for subject magnet products is promulgated under the
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). States or
political subdivisions of a state may, however, apply for an exemption
[[Page 57789]]
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, absent grant of an exemption, the requirements of part 1262
preempt non-identical state or local requirements for subject magnet
products designed to protect against the same risk of magnet ingestion.
XVI. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that
before a rule may take effect, the agency issuing the rule must submit
the rule, and certain related information, to each House of Congress
and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission
must indicate whether the rule is a ``major rule.'' The CRA states that
the Office of Information and Regulatory Affairs determines whether a
rule qualifies as a ``major rule.''
Pursuant to the CRA, this rule does not qualify as a ``major
rule,'' as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC
will submit the required information to each House of Congress and the
Comptroller General.
XVII. Effective Date
The CPSA requires that consumer product safety rules promulgated
under sections 7 and 9 shall 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 NPR proposed a 30-
day effective date after the rule is published in the Federal Register,
and no comments were received in opposition to the effective date.\31\
Accordingly, the rule will go into effect October 21, 2022 and will
apply to all non-exempt subject magnet products manufactured after that
date.
---------------------------------------------------------------------------
\31\ The CPSC did not propose an anti-stockpiling provision, but
sought comments in the NPR on whether to include one in the rule. No
commenter supported inclusion of anti-stockpiling language. Given
the absence of record support as well as the relatively brief 30-day
effective date period, CPSC finds it unnecessary to provide such a
provision in the final rule.
---------------------------------------------------------------------------
Under section 14(a)(3), 15 U.S.C. 2063(a)(3), the testing and
certificate requirements apply to any children's product manufactured
more than 90 days after the Commission has established and published
notice of the requirements for accreditation of third-party conformity
assessment bodies to assess conformity with a children's product safety
rule to which such children's product is submitted. Accordingly,
although the effective date of the rule for both children's and non-
children's subject magnet products is 30 days after publication of the
rule, the effective date for application of 16 CFR part 1112 is 90 days
after the publication of the rule. Testing laboratories that meet the
requirements of a CPSC-accepted third party conformity assessment body
will have 90 days to become accredited to include 16 CFR part 1262,
Safety Standard for Magnets, in the scope of the accreditation to test
subject magnet products that are children's product for compliance with
the new rule. Although all of the subject magnet products must comply
with the standard, for children's products such as children's jewelry,
that are not currently subject to the mandatory standard under ASTM
F963-17, testing laboratories must go through the process of applying
for accreditation and obtaining approval to become a CPSC-accepted
third party conformity assessment body. We conclude that 90 days
provides sufficient time for testing laboratories to apply for and
comply with the CPSC's procedures. Accordingly, the notice of
requirements will go into effect December 20, 2022.
XVIII. Conclusion
For the reasons stated in this preamble, the Commission concludes
that subject magnet products that do not meet the requirements
specified in this rule, and are not exempt from the rule, present an
unreasonable risk of injury associated with ingestion of such products.
The Commission finds that the rule imposes the least burdensome
requirement that prevents or adequately reduces the risk of injury
associated with magnet ingestions.
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 amends
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, 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 after
October 21, 2022, are subject to the requirements of this part.
(c) Exemption. The following consumer products are exempt from the
requirements of this part: Toys that are subject to 16 CFR part 1250.
Sec. 1262.2 Definitions.
The following definitions apply for purposes of this part:
(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 1262.4.
(b) Subject magnet product means a consumer product that is
designed, marketed, or intended to be used for
[[Page 57790]]
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, but does not
include products sold and/or distributed solely to school educators,
researchers, professionals, and/or commercial or industrial users
exclusively for educational, research, professional, commercial, and/or
industrial purposes.
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 Sec. 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.
(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 www.astm.org/READINGLIBRARY/. You
may inspect a copy at the Office of the Secretary, 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.
(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. There were an estimated 26,600 magnet ingestions were
treated in hospital EDs from January 1, 2010, through December 31,
2021. There were an estimated 5,000 magnet ingestions treated in U.S.
hospital EDs between January 1, 2010, and December 31, 2021, that
involved in-scope identified subject magnet products, and an additional
estimated 20,000 ED-treated magnet ingestions involving unidentified
magnet products, which are likely to have involved subject magnet
products. There were an estimated 2,500 ED-treated ingestions of
magnets from identified magnet products in year 2021, higher than the
majority of the preceding years, including 2018 through 2020. In this
same period, January 1, 2010, through December 31, 2021, there were an
estimated 286 CPSRMS-reported magnet ingestions involving identified
subject magnet products and 76 CPSRMS-reported magnet ingestions
involving unidentified subject magnet products. In addition, based on
NEISS annual estimates from 2017-2021, ICM showed that there were an
additional estimated 263 magnet ingestion injuries per year involving
identified subject magnet products, which were treated in medical
settings other than EDs (185 injuries treated outside of hospitals and
78 resulted in direct hospital admission).
(2) The potential injuries when a child or teen ingests one or more
hazardous magnets are serious. Health threats posed by hazardous magnet
ingestion include pressure necrosis, volvulus, bowel obstruction,
bleeding, fistulae, ischemia, inflammation, perforation, peritonitis,
sepsis, ileus, ulceration, aspiration, and death, among others. These
conditions can result from magnets attracting to each other through
internal body tissue, or a single magnet attracting to a ferromagnetic
object. CPSC is aware of serious injuries and several fatal magnet
ingestion incidents that occurred in the United States, resulting from
internal interaction of magnets.
(c) Number of consumer products subject to the rule. The CPSC
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 provided information for sales ranging from
100,000 to 1 million units annually.
(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 rule requires subject
magnet products to meet performance requirements regarding size or
strength, but it does not restrict the design of products. As such,
subject magnet products that meet the standard can continue to serve
the purpose of amusement or jewelry for consumers. Magnets that comply
with the performance requirements of the rule, such as non-separable
magnets, larger magnets, weaker magnets, or non-permanent magnets, may
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 rule, and the prices of compliant and non-compliant products are
comparable.
(3) If the costs associated with redesigning or modifying subject
magnet products to comply with the rule results in manufacturers
discontinuing products, there may be some loss in availability to
consumers. However, this would be mitigated to the extent that
compliant products meet the same consumer needs, and there are
compliant products currently available for sale to consumers.
(4) Manufacturers may sell complying products to mitigate costs. In
addition to products that comply with the performance requirements,
there are products that are not subject to the performance
requirements. Products sold and/or distributed solely to school
educators, researchers, professionals, and/or commercial or industrial
users exclusively for educational, research, professional, commercial,
and/or industrial purposes are not subject magnet products, and firms
may continue to manufacture, sell, and distribute such magnet products.
(e) Other means to achieve the objective of the rule while
minimizing adverse effects on competition, manufacturing, and
commercial practices. The Commission considered other alternatives that
might reduce the impact of a rule on small businesses, including
promulgating an alternative set of requirements for the flux index or
size of the magnets; requiring safer packaging; requiring warnings on
the packaging and promotional materials; requiring aversive agents on
magnets; relying on voluntary standards; delaying the effective date;
and taking no action. Although each of the alternative actions would
have lower costs and less impact on small business, none is likely to
significantly reduce the injuries associated with ingestion of magnets
from subject magnet products.
[[Page 57791]]
(f) Unreasonable risk. (1) Incident data indicate that there were
an estimated 25,000 magnet ingestions treated in U.S. hospital EDs from
January 1, 2010, to December 31, 2021, which involved in-scope magnet
products. Of these estimated 25,000 ED-treated magnet ingestions, an
estimated 5,000 involved in-scope identified subject magnet products,
and an estimated 20,000 involved ``unidentified'' magnet product types
that, based on incident data and factors considered by the Commission,
are likely to be subject magnet products. During 2017 through 2021,
based on the NEISS annual estimate of about 481 magnet injuries
initially treated in hospital EDs involving in-scope identified magnets
there were 320 injuries that were treated and released and 161 injuries
that required hospitalization. Additionally, based on estimates from
the ICM, 185 injuries were treated outside of hospitals annually and
another 78 injuries resulted in direct hospital admission. These
incidents indicate the frequency with which children and teens ingest
magnets, and the need to address the magnet ingestion hazard.
(2) The potential injuries when a person ingests one or more
magnets are serious. Health threats posed by magnet ingestion include
pressure necrosis, volvulus, bowel obstruction, bleeding, fistulae,
ischemia, inflammation, perforation, peritonitis, sepsis, ileus,
ulceration, aspiration, and death, among others. These conditions can
result from magnets attracting to each other through internal body
tissue, or a single magnet attracting to a ferromagnetic object. Magnet
ingestion incidents commonly result in hospitalization, particularly
when subject magnet products are ingested. The Commission is aware of
serious injuries as well as five fatal magnet ingestion incidents that
occurred in the United States between November 24, 2005, and January 5,
2021. Four of these incidents involved children 2 years old or younger,
and all five victims died from injuries resulting from internal
interaction of the magnets. Four of the five incidents identified the
products as magnet sets, amusement products, or described them as
having characteristics that are consistent with subject magnet
products.
(3) CPSC's trend analysis of the incident data indicates that
magnet ingestions have significantly increased in recent years. In
2014, Commission issued a rule that applied to magnet sets, which are a
subset of the subject magnet products addressed in this rule. The 2014
magnet sets rule took effect in April 2015 and remained in effect until
it was vacated and remanded by the U.S. Court of Appeals for the Tenth
Circuit Court in November 2016. Zen Magnets, LLC v. Consumer Prod.
Safety Comm'n., 841 F.3d 1141 (10th Cir. 2016). ED-treated ingestions
of magnets from subject magnet products continued to rise since the
2014 magnets set rule was vacated. A review of the annual estimates for
ED-treated, magnet ingestions by year, from 2010 through 2021 showed
that magnet ingestions are higher for the 2017 through 2021 period,
than the previous periods, with more in-scope magnet ingestions in 2021
(2,500) than most of the preceding years, including 2018 through 2020.
To assess these trends further, CPSC grouped the years in relation to
the vacated 2014 magnet sets rule, using three separate periods. CPSC
reviewed the magnet ingestions treated in U.S. hospital EDs for the
periods 2010 through 2013 (years prior to the announcement of the 2014
magnet sets rule), 2014 through 2016 (years when the 2014 magnet sets
rule was announced and in effect), and 2017 through 2021 (years after
the magnet set rule was vacated). For 2010-2013, there were
approximately 2,300 ED-treated magnet ingestion incidents per year; for
2014-2016, there were an approximately 1,300 ED-treated magnet
ingestion incidents per year; for 2017-2021, there were approximately
2,400 ED-treated magnet ingestion incidents per year. Thus, during the
period when the 2014 magnet sets rule was announced and in effect
(2014-2016), magnet injury ingestion estimates are lowest by a
significant margin, compared with the earlier and more recent periods.
CPSRMS data also showed a similar decline in incidents for the period
when the magnet sets rule was announced and in effect. CPSC's
assessment of incident data, as well as other researchers' assessments
of NEISS data, and national poison center data, all indicated that
magnet ingestion cases significantly declined during the years when the
2014 magnet sets rule was announced and in effect, compared to the
periods before and after the 2014 magnet sets rule.
(4) For these reasons, the Commission finds that the rule is
reasonably necessary to eliminate or reduce an unreasonable risk of
injury associated with the product.
(g) Public interest. This rule is intended to address an
unreasonable risk of injury and death posed by magnet ingestions. The
Commission finds that compliance with the requirements of the rule will
significantly reduce magnet ingestion deaths and injuries in the
future; thus, the Commission finds that promulgation of the rule is in
the public interest.
(h) Voluntary standards. (1) The Commission is aware of six
relevant standards, four domestic and two international, that address
the magnet ingestion hazard. One standard is mandatory, ASTM F963-17,
Standard Consumer Safety Specification for Toy Safety (incorporated by
reference at Sec. Sec. 1262.4 and 1250.2 of this chapter). The other
voluntary standards include: 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\) (see Sec. 1262.4 for the
availability of ASTM standards from ASTM International); EN-71-1: 2014,
Safety of Toys; Part 1: Mechanical and Physical Properties (available
from EN European Standards; Krimicka 134, 318 00 Pilsen, Czech
Republic, phone: 420 377 921 379; www.en-standard.eu); and ISO 8124-1:
2018, Safety of Toys--Part 1: Safety Aspects Related to Mechanical and
Physical Properties (available from International Organization for
Standardization; Chemin de Blandonnet 8, CP 401-1214 Vernier, Geneva,
Switzerland; phone: 41 22 749 01 11; www.iso.org).
(2) The Commission finds that compliance with existing standards is
not likely to result in the elimination or adequate reduction of the
risk of injury associated with ingestion of subject magnet products.
(i) Relationship of benefits to costs. (1) CPSC estimates that
aggregate annual societal costs from ingestion injuries involving
subject magnet products for 2017 through 2021 totaled $51.8 million,
even when ingestion injuries involving unidentified magnet products are
excluded. The expected costs of the rule include the lost value
experienced by consumers who would no longer be able to purchase
subject magnet products with loose or separable hazardous magnets, as
well as the lost profits to firms that could not produce and sell non-
complying products in the future. Estimates of consumer and producer
surplus range from about $2 million to $3.5 million to about $20
million to $35 million, based on unit sales ranging from 100,000 to 1
million. If annual unit sales of non-complying subject magnet products
are 500,000, expected aggregate benefits from the rule would total
$51.8 million annually as noted above; costs (lost consumer and
producer surplus) would range from $10
[[Page 57792]]
million to $17.5 million annually. Thus, the benefits of the rule would
greatly exceed the costs.
(2) If unidentified magnet products involved in ingestion injuries,
which are also likely to be subject magnet products, are considered as
well, average annual societal costs for 2017 through 2021 would
increase by $167.9 million. A sensitivity analysis shows that adding
even a relatively small portion of NEISS cases involving unidentified
magnet products to the base case substantially increases the estimated
gross benefits of the rule. Although CPSC's analysis of the data, the
trends in NEISS, CPSRMS, and poison center-reported, magnet-related
incidents support the conclusion that the unidentified magnet products
generally involved magnets considered within the scope of the rule,
because CPSC does not know precisely how many of these products would
fall within the scope of this rule, CPSC has not included them in the
primary benefit analysis. Instead, CPSC includes the benefits from
unidentified magnet products in this final rule's sensitivity analysis
to illustrate the theoretical upper bounds of benefits from this rule.
Theoretically, including 100 percent of these societal costs with those
estimated for identified subject magnet products ($51.8 million) could
yield average annual societal costs of magnet ingestion injuries of
$219.7 million for the period 2017 through 2021.
(j) Least burdensome requirement that would adequately reduce the
risk of injury. CPSC considered several less-burdensome alternatives to
the rule.
(1) One alternative is to take no regulatory action and, instead,
rely on existing standards to address the magnet ingestion hazard. This
alternative would reduce the burden associated with the rule by
avoiding a mandatory standard, but it is unlikely to adequately address
the magnet ingestion hazard due to the limited scope and requirements
of existing standards and uncertainty regarding compliance with them.
(2) Another alternative is a mandatory standard with less stringent
requirements than the proposed rule, such as a higher flux index limit,
or different requirements for certain shapes and sizes of magnets. This
could reduce the burden associated with a rule by allowing firms to
market a wider variety of products than under the rule. However, this
alternative would reduce the safety benefits because allowing certain
hazardous magnets in subject magnet products to remain on the market
does not address the hazard such products pose.
(3) Safety messaging is another alternative to the rule. This
alternative would reduce the burdens associated with the rule because
it would not require modifying or discontinuing subject magnet
products, and the costs of such warnings and instructional information
likely would be small. However, this alternative is not likely to
adequately reduce the magnet ingestion hazard. Incident data shows
children commonly access ingested magnets from sources that do not
include the product packaging where warnings are provided. Incident
data, behavioral and developmental factors, and other information
indicate that children and caregivers commonly disregard safety
messaging regarding the magnet ingestion hazard. Finally, this approach
has not been effective at adequately reducing the hazard, to date.
(4) Another alternative is to require special packaging to limit
children's access to subject magnet products. Although this alternative
would create some packaging costs, those costs likely would be lower
than the costs of the rule because this alternative would allow subject
magnet products to remain unchanged. However, this alternative is not
likely to adequately reduce the risk of injury and death associated
with magnet ingestions. Consumers are unlikely to repackage all magnets
after each use, given the small size and large number of magnets in
products, the potential to lose magnets, and consumers'
underappreciation of the hazard. In addition, commercially reasonable
packaging requirements would only prevent young children (typically,
children under 5 years old) from accessing the product, not older
children, or teens, who are involved in the majority of magnet
ingestion incidents.
(5) Another alternative is to require subject magnet products to be
coated with aversive agents. This alternative would reduce the burden
associated with the rule because it would allow firms to continue to
sell subject magnet products and the costs of such coatings likely
would be small. However, such requirements are not likely to adequately
address the hazard because they do not address ingestions that occur
when the first magnet is placed in the victim's mouth, before the
aversive agent is detected, accidental ingestions, or children who are
developmentally inclined to place objects in their mouths.
(6) Another alternative is to provide a later effective date for
the final rule. This may reduce the burdens associated with the rule by
spreading them over a longer period, but it would also delay the safety
benefits of the rule.
(7) For these reasons, the Commission finds that the rule imposes
the least burdensome requirement that prevents or adequately reduces
the risk of injury associated with magnet ingestions.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-20200 Filed 9-20-22; 8:45 am]
BILLING CODE 6355-01-P