[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.

[[Page 57759]]

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.
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    (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.
---------------------------------------------------------------------------

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

    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.
---------------------------------------------------------------------------

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

    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.
---------------------------------------------------------------------------

    \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%).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

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

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

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

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