Vol. 79 Friday, 

No. 192 October 3, 2014 

Part IV 

Consumer Product Safety Commission 

16 CFR Part 1240 

Final Rule: Safety Standard for Magnet Sets; Final Rule 

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59962 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

1The Commission voted 4–0–1 to publish this 

notice in the Federal Register. Chairman Elliot F. 

Kaye, Commissioner Robert S. Adler, Commissioner 

Marietta S. Robinson and Commissioner Joseph P. 

Mohorovic voted to approve publication of the final 

rule. Commissioner Ann Marie Buerkle abstained 

from the matter. 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1240 

[CPSC Docket No. CPSC–2012–0050] 

Final Rule: Safety Standard for Magnet 

Sets 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (CPSC, Commission, or we) 

is issuing a rule establishing 

requirements for magnet sets and 

individual magnets that are intended or 

marketed to be used with or as magnet 

sets. As defined in the rule, magnet sets 

are aggregations of separable magnetic 

objects that are marketed or commonly 

used as a manipulative or construction 

item for entertainment, such as puzzle 

working, sculpture building, mental 

stimulation, or stress relief. Under the 

rule, if a magnet set contains a magnet 

that fits within the CPSC’s small parts 

cylinder, each magnet in the magnet set 

must have a flux index of 50 kG2 mm2

or less. An individual magnet that is 

marketed or intended for use as part of 

a magnet set also must meet these 

requirements. The flux index is 

determined by the method described in 

ASTM F963–11, Standard Consumer 

Safety Specification for Toy Safety. 

DATES: This rule will become effective 

on April 1, 2015. The incorporation by 

reference of the publication listed in 

this rule is approved by the Director of 

the Federal Register as of April 1, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Lee, Compliance Officer, Office 

of Compliance and Field Operations, 

Consumer Product Safety Commission, 

4330 East West Highway, Bethesda, MD 

20814; telephone: (301) 504–7737, or 

email: tlee@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The Commission is issuing a safety 

standard under the Consumer Product 

Safety Act (CPSA) establishing 

requirements for magnet sets that have 

been associated with serious injuries 

and one reported death.1 As discussed 

in greater detail in section B of this 

preamble, magnet sets are sets of small, 

powerful magnets marketed for general 

entertainment as construction toys, desk 

toys, sculpture sets, or stress relievers. 

The rule also covers individual magnets 

that are marketed or intended for use 

with or as magnet sets. The Commission 

concludes that this rule is necessary to 

address an unreasonable risk of injury 

and death associated with these magnet 

sets. 

1. Initial Incident Reports to CPSC and 

CPSC’s Response 

Significant U.S. sales of magnet sets 

marketed for general entertainment 

began in 2009. CPSC staff received the 

first consumer incident report involving 

magnet sets in February 2010. No injury 

resulted from this incident. Shortly after 

receiving this report, CPSC staff 

collected and evaluated samples of the 

magnet sets. 

In December 2010, we received our 

first consumer incident report involving 

the surgical removal of magnets that had 

been part of a magnet set. During 2011, 

CPSC staff collected magnet sets 

marketed to children under 13 years 

old, and staff evaluated the compliance 

of these products with ASTM F963–11, 

Standard Consumer Safety 

Specification for Toy Safety. Staff 

evaluated these products under ASTM 

F–963 because some of the products 

were labeled and marketed in a manner 

that appeared to promote use by 

children and this standard includes 

requirements for the strength and size of 

magnets that are part of a toy intended 

for children. For firms whose products 

did not have labeling or marketing 

information, CPSC staff encouraged 

those firms to develop marketing 

programs and labeling content to help 

ensure that these magnet sets were not 

marketed to children. In addition, CPSC 

staff issued Notices of Noncompliance 

to firms that marketed magnet sets to 

children younger than 14 years of age. 

In November 2011, in response to 

continuing reports of injuries associated 

with the products, the CPSC, in 

cooperation with two manufacturers, 

launched a public awareness campaign, 

which included a video public service 

announcement (PSA). The PSA advised 

children: Not to put magnets from 

magnet sets into their mouth; described 

the risk of injury presented by the 

ingestion of high-powered magnets; and 

provided tips to avoid magnet ingestion 

injuries, along with guidance for 

children who had swallowed magnets 

and parents who suspect that their child 

has swallowed magnets. Despite the 

CPSC’s compliance and public 

awareness activities, reported incidents 

of magnet ingestion by children 

increased from 13 in 2010, to 19 in 

2011, and 52 in 2012. Likely due to 

CPSC enforcement and regulatory 

activity beginning in mid-2012, and 

because the largest distributor ceased 

operations at the end of 2012, reported 

incidents declined to 13 incidents in 

2013, including one fatality, and two 

incidents in 2014. We received an 

additional magnet ingestion incident 

report for which there was insufficient 

information to determine the date of the 

incident. As of June 24, 2014, 100 

ingestion incidents involving, or 

possibly involving, ingestion of magnets 

from magnet sets have been reported to 

CPSC. (As discussed in section C of this 

preamble, staff’s analysis of incidents 

reported through the National Electronic 

Injury Surveillance System (NEISS) 

estimates that 2,900 possible magnet set, 

emergency department-treated 

ingestions occurred in the United States 

from January 1, 2009 through December 

31, 2013). 

2. Corrective Actions 

In May 2012, Compliance staff 

contacted a total of 13 independent 

importers of magnet sets and asked 

these importers to provide reports 

required under Section 15 of the CPSA. 

Most of the firms agreed to stop selling 

the products pending the results of 

staff’s evaluation of the products. Given 

the continued injuries to children, staff 

negotiated voluntary corrective action 

plans with 11 of the 13 magnet set 

importers. These firms agreed to cease 

importation, distribution, and sales of 

magnet sets. Two importers did not 

agree to stop selling the magnets and the 

Commission initiated an administrative 

action in July and August 2012 seeking 

a determination that the magnet sets 

present a substantial product hazard 

and an order that the firm cease 

importation and distribution of the 

products. The Commission initiated a 

third administrative action in December 

2012 after one of the firms that had 

agreed to stop sale subsequently 

resumed selling magnet sets. Two of the 

three administrative actions have been 

resolved. In May 2014, the Commission 

settled the administrative action against 

Maxfield & Oberton Holdings, LLC, and 

Craig Zucker, individually, and as an 

officer of Maxfield & Oberton Holdings, 

LLC. The settlement established and 

funded a Recall Trust, which, in 

accordance with a corrective action plan 

(CAP), is recalling the firm’s magnet 

sets. In July 2014, the Commission 

settled the administrative complaint 

against Star Networks USA, LLC (Star). 

Under that settlement, Star has agreed to 

implement a CAP providing for the 

recall of the firm’s magnet sets. The 

third firm, Zen Magnets, LLC, remains 

the subject of a CPSC administrative 

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action and continues to market and sell 

magnet sets. 

3. Notice of Proposed Rulemaking 

In the Federal Register of September 

4, 2012 (77 FR 53781), the Commission 

published a notice of proposed 

rulemaking (NPR) to address the 

unreasonable risk of injury associated 

with magnet sets. The NPR proposed a 

standard that would require magnets 

from magnet sets containing at least one 

magnet that fits within the CPSC’s small 

parts cylinder to have a flux index of 50 

kG2 mm2 or less. The proposed rule 

sought comment on whether the rule 

should include magnets sold 

individually that could be aggregated 

into a magnet set. The final rule 

modifies the proposal to include 

individual magnets marketed or 

intended for the same uses as a magnet 

set, i.e., as a manipulative or 

construction item for entertainment, 

such as puzzle working, sculpture 

building, mental stimulation, or stress 

relief. We discuss this modification and 

other differences between the proposed 

and final rule in Section F of this 

preamble. The information discussed in 

this preamble comes from CPSC staff’s 

briefing packages for the proposed and 

final magnet set rule, which are 

available on the CPSC’s Web site at: 

http://www.cpsc.gov/PageFiles/128934/

magnetstd.pdf (NPR briefing package) 

and http://www.cpsc.gov/Global/

Newsroom/FOIA/

CommissionBriefingPackages/2014/

SafetyStandardforMagnetSetsFinalRule.pdf (final rule briefing 

package). 

B. The Product 

1. Description of the Product 

The magnet sets covered by this rule 

typically are comprised of numerous 

identical, spherical, or cube-shaped 

magnets, approximately 3 millimeters to 

6 millimeters in size, with the majority 

made from NdFeB (Neodymium-IronBoron or NIB). As discussed in section 

F of this preamble, the rule also covers 

individual magnets that are marketed or 

intended for use with or as magnet sets. 

These magnets exhibit strong magnetic 

properties. The magnetized 

neodymium-iron-boron cores 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. 

The magnets that are part of magnet 

sets are often referred to as ‘‘magnet 

balls’’ or ‘‘rare earth magnets.’’ Magnet 

sets are and have been marketed as: 

adult desk toys, the ‘‘puzzles of the 

future,’’ stress relievers, science kits, 

and educational tools for ‘‘brain 

development.’’ As shown in product 

instructions and in videos on related 

Web sites, magnet sets can be used and 

reused to make various two- and threedimensional sculptures and figures, 

jewelry, and toys, such as spinning tops. 

Videos also show how these magnets 

can be used to mimic mouth and tongue 

piercings. 

Magnet sets come with varying 

numbers of magnets, from as few as 27 

magnets, to more than 1,000. Most of the 

magnets have been sold in sets of 125 

balls or sets of 216 to 224 balls. The one 

firm that is currently marketing magnet 

sets that would not meet this rule sells 

one or more balls individually. Based on 

product information provided by 

marketers, the most common magnet 

size is approximately 5 millimeters in 

diameter, although balls as small as 

about 3 millimeters have been sold, as 

have sets of larger magnet balls (perhaps 

15 millimeters to 25 millimeters in 

diameter). In addition to magnetic ball 

sets, magnet sets comprised of small 

magnetic cubes have also been sold, as 

have small magnetic rods. Sets made up 

of rods, however, have comprised a 

relatively small share of the market. 

Most magnet sets contain magnets 

that are glossy and highly reflective 

with the spheres often described as 

similar in appearance to BBs or ball 

bearings. Magnet set magnets come in a 

variety of colors, including silver, blue, 

yellow, green and orange. The products 

are packaged in a variety of ways, 

including fabric pouches, wooden 

boxes, and metal tins. 

The rule defines ‘‘magnet set’’ as: 

‘‘any aggregation of separable magnetic 

objects that is a consumer product 

intended, marketed or commonly used 

as a manipulative or construction item 

for general entertainment, such as 

puzzle working, sculpture, mental 

stimulation, or stress relief.’’ As 

discussed in section F of this preamble, 

the rule also covers individual magnets 

marketed or intended for use with 

magnet sets. 

2. Use of the Product 

For the NPR, CPSC’s Human Factors 

staff provided an assessment that 

discusses the appeal and use of magnet 

sets. Magnet sets have some appeal for 

virtually all age groups. These types of 

magnets tend to capture attention 

because they are shiny and reflect light. 

They are smooth, which gives the 

magnets tactile appeal, and these 

magnets make soft snapping sounds as 

they are manipulated. These properties 

or characteristics of magnets are likely 

to seem magical to younger children and 

may evoke a degree of awe and 

amusement among older children and 

teens. These features are the foundation 

of the magnet sets’ appeal as a 

challenging puzzle, or as a 

manipulative, or as jewelry. These 

magnets may also be used like a stress 

ball and as a way to hold things in 

place. 

Children, from toddlers through teens, 

have been exposed to magnet sets in the 

home setting and elsewhere. As the NPR 

preamble notes, we have reports of 

ingestion incidents that involve 

children 5 years of age and younger. The 

reports reflect similar scenarios to other 

ingestion incidents among this age 

group because mouthing and ingesting 

non-food items is a normal part of 

preschool children’s exploratory 

behavior. In a number of reported 

incidents, the magnets were not in their 

original containers, and caregivers were 

unaware that some of the magnets from 

the set were missing and in the child’s 

possession. 

As noted in the NPR preamble, 

magnet sets also appeal to children of 

early-to-middle elementary school age. 

Younger children in this age group are 

interested in simple three-dimensional 

puzzles, and older elementary school 

children are interested in highly 

complex puzzles. Children in the latter 

age group also can engage in activities 

that require the type of meticulous work 

and attention that would be needed to 

create the complex patterns and 

structures found on paper and in video 

instructions for magnet sets. 

Additionally, magnets typically are 

included in science curricula for 

elementary school children to 

demonstrate the basic concepts of 

magnetism. 

For all of these reasons, and 

consistent with reviews on retail Web 

sites, magnet sets are sometimes 

purchased for children under the age of 

14, despite warnings or labeling to the 

contrary. For example, approximately 

one-third of 53 adults reviewing one 

manufacturer’s product on Amazon.com 

reported purchasing the magnets for 

children 8 through 11 years of age. 

Thus, it is foreseeable that some 

portion of these products will be 

purchased for elementary school 

children and teens. Moreover, given the 

relatively low cost for some magnet sets, 

elementary school children and teens 

may purchase the magnet sets 

themselves. The incident reports reflect 

behaviors that are beyond the intended 

use of the product but that are 

foreseeable for the groups using them. 

For example, it is foreseeable that some 

children will place these magnets in 

their mouth, even if the manufacturer 

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59964 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

2The Commission collects information on 

hospital emergency room-treated injuries through 

the NEISS database. This data can be used to 

provide national estimates of product-related 

injuries treated in U.S. hospital emergency 

departments. Incidents reported to the Commission 

represent a minimum count of injuries. To account 

for incidents that are not reported to the 

Commission, the staff calculates an estimated 

number of such injuries. 

warns against this behavior. The 

mouthing of objects, common among 

younger children, develops into less 

obvious and more socially acceptable 

oral habits, which may continue 

through childhood and adolescence and 

into adulthood (e.g., mouthing or 

chewing a fingertip, fingernail, knuckle, 

pen, pencil, or other object, especially 

while concentrating or worrying). 

Where details are provided, the incident 

reports describe scenarios that are 

consistent with the behaviors of young 

children and teens. Although 

exploratory play is generally associated 

with very young children, people of all 

ages use their senses to explore 

unfamiliar phenomena. 77 FR 53781, 

53783 (Sep. 4, 2012). 

3. The Market 

Based on information reviewed by 

staff on product sales, including reports 

by firms provided to the Office of 

Compliance and Field Operations, the 

number of magnet sets that were sold to 

U.S. consumers from 2009 through mid2012, may have totaled about 2.7 

million sets, with a value of roughly $50 

million. This estimate reflects retail 

sales directly to consumers (through 

company Web sites and other Internet 

retail sites) and sales to retailers who 

market the products. Staff’s review of 

retail prices reported by importers, and 

observed on Internet sites in 2012, 

suggested prices of magnets sets 

typically ranging from about $20 to $45 

per set, with an average price of about 

$25. 

To our knowledge, all of the firms that 

have marketed the products, including 

the firm that continues to sell individual 

magnets and magnet sets, import the 

products packaged and labeled for sale 

to U.S. consumers. Several Chinese 

manufacturers have the facilities and 

production capacity to meet the orders 

of U.S. importers. Additionally, there 

are no major barriers to market entry for 

firms wishing to source products from 

China for sale in the United States. 

Firms may have sales arrangements with 

Internet retailers who hold stock for 

them and process orders. 

We have identified about 25 U.S. 

firms and individuals who imported 

magnet sets for sale in the United States 

in 2012. The combined sales of the top 

seven firms probably have accounted for 

the great majority (perhaps more than 

90%) of units sold. One firm, Maxfield 

& Oberton Holdings, LLC, believed to 

have held a dominant position in the 

market for magnetic desk sets since the 

firm entered the market in 2009, ceased 

operating in December 2012, and is no 

longer an importer of magnet sets. That 

now-defunct firm, along with a few 

larger firms (including a firm based in 

Canada with a branch office in the 

United States), marketed their products 

through accounts with retailers. They 

have also sold their products directly to 

consumers via the Internet, using their 

own Web sites, or other Internet 

shopping sites. In addition to products 

offered for sale by U.S. importers, 

consumers also have the ability to 

purchase magnetic sets directly from 

sources in Hong Kong or China that 

market products through a leading 

Internet shopping site. 

C. Risk of Injury 

The risk of injury addressed by this 

rule is damage to intestinal tissue 

caused when a person ingests more than 

one magnet from a magnet set (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 

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 those of less serious 

conditions, such as the flu, and because 

many doctors are unfamiliar with the 

risks of magnet ingestion. In addition, 

the limitations of standard diagnostic 

tools to identify and evaluate the 

presence of magnets in the body may 

make magnet ingestion difficult to 

identify. Serious injury and even death 

are consequences of ingestion of strong 

magnets by children. 

1. Incident Data 

NEISS data. CPSC staff reviewed data 

from the NEISS database of magnetrelated ingestion cases treated in 

emergency departments from January 1, 

2009 to December 31, 2013.2 CPSC staff 

analyzed 456 magnet-related ingestion 

cases and determined that 121 of the 

cases involved or possibly involved 

ingestion of magnets from magnet sets. 

Staff further determined that an 

estimated 2,900 ingestions of magnets 

from magnet sets were treated in U.S. 

emergency departments during this 5- 

year period—an estimated average of 

580 emergency department-treated 

magnet ingestions per year. The largest 

portion of these incidents involved 

children 4 through 12 years of age. An 

estimated 1,900 of the 2,900 victims are 

in the 4- through 12-year-old age group 

(65.3 percent). For more information 

about the process of developing the 

estimates of incidents, see the 

memorandum from the Directorate for 

Epidemiology, located at Tab B of staff’s 

briefing package: http://www.cpsc.gov/

Global/Newsroom/FOIA/

CommissionBriefingPackages/2014/

SafetyStandardforMagnetSetsFinalRule.pdf. 

Databases other than NEISS. The 

preamble to the proposed rule (77 FR at 

53784 through 53785) summarized the 

data for incidents reported through 

databases other than NEISS from 

January 1, 2009 through June 30, 2012. 

These incidents involved the ingestion 

of magnets by children between the ages 

of 1 and 15. For that period, we received 

reports of 50 incidents involving the 

ingestion of magnets by children in this 

age range. Of those 50 incidents, 38 

involved the ingestion of high-powered, 

ball-shaped magnets contained in 

products that meet the definition above 

of ‘‘magnet set’’; five of the 50 incidents 

possibly involved ingestion of this type 

of magnet. In 35 of the 43 incidents 

involving or possibly involving magnets 

from a magnet set, two or more magnets 

were ingested. Hospitalization was 

required in 29 of the 43 incidents, with 

surgery necessary to remove the 

magnets in 20 of the 29 hospitalizations. 

In the other nine hospitalizations, the 

victim underwent colonoscopic or 

endoscopic procedures to remove the 

magnets. In 37 of the 43 incidents, the 

magnets were ingested by children 

younger than 4 years old or between the 

ages of 4 and 12 years. 

Since publication of the NPR, the 

Commission has received reports of 

additional incidents involving the 

ingestion of magnets by children 

between the ages of 1 year and 15 years 

old, including one report of a fatality 

associated with the ingestion of small 

spherical magnets. We have now 

received reports of a total of 100 

incidents involving or possibly 

involving the ingestion of highpowered, ball-shaped magnets 

contained in products that meet the 

definition of ‘‘magnet set.’’ The reports 

indicate that the incidents occurred 

between January 1, 2009 and June 24, 

2014. Sixty-one of the 100 reported 

incidents required hospitalization. In 87 

of the 100 reported incidents, the 

magnets were ingested by children 

younger than 4 years old or between the 

ages of 4 and 12 years. 

Among the 100 reported incidents is 

one fatality that involved magnets from 

a magnet set. In August 2013, a 19- 

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month-old female died from ischemic 

bowel caused by magnets from magnet 

sets in her small intestine. 

2. Hazard Scenarios 

As discussed in the preamble to the 

proposed rule, the incident reports 

describe scenarios that are consistent 

with behaviors of children in the 

identified age ranges. As noted in the 

NPR, mouthing of objects, which is 

common among younger children, 

develops into less obvious and more 

socially acceptable oral habits, which 

may continue through childhood and 

adolescence and into adulthood (e.g., 

mouthing or chewing a fingertip, 

fingernail, knuckle, pen, pencil, or other 

object, especially while concentrating or 

worrying). 77 FR 53781, 53783 (Sep. 4, 

2012). For example, in the incidents 

reported in the 8 through 12-year-old 

age group, one child described wanting 

to feel the force of the magnets through 

his tongue; one was trying to see if the 

magnets would stick to her braces; and 

another wanted to see if the magnets 

would stick together through her teeth. 

In another common scenario that 

accounted for half of the reported 

ingestion incidents among 8 to 15 year 

olds, children used multiple magnets to 

simulate piercings of their tongue, lips, 

or cheeks. In incidents reported among 

children under the age of 4 years, 

children put the magnets in their 

mouths and either intentionally or 

accidentally swallowed them. 

The preamble to the proposed rule 

provides summaries of several incident 

reports that demonstrate a few of the 

reported hazard scenarios (77 FR at 

53785 to 53786). These scenarios 

include two incidents in which young 

girls (10 and 13 years of age) swallowed 

multiple magnet balls while using the 

magnets to simulate tongue and lip 

piercings. The girls underwent surgical 

procedures to remove magnet balls from 

their intestines. In three other scenarios, 

magnet balls ingested by children under 

the age of 3 years had to be removed 

surgically from the children’s stomach 

and intestines. In three of the five 

incidents described in the preamble to 

the proposed rule, the child’s parent or 

caregiver did not realize the child had 

ingested magnets, which resulted in a 

delay in treatment and an increase in 

the severity of the injuries from the 

magnets, which attached to each other 

across intestinal tissue. 

3. Details Concerning Injuries 

Multiple factors complicate the 

diagnosis of injury from magnet 

ingestion (77 FR 53786). These factors 

include a lack of awareness by medical 

professionals of the dangers posed by 

the ingestion of high-powered magnets; 

the inability of standard diagnostic tools 

to demonstrate that the ingested item is 

a magnet; the similarities between 

symptoms resulting from magnet 

ingestion injuries and less serious 

conditions like the flu; and victims’ 

inability or unwillingness to 

communicate to their caregivers or 

medical personnel that they have 

ingested magnets. 

The preamble to the proposed rule 

discussed the manner in which ingested 

high-powered magnets can cause harm 

by compressing intestinal tissue, the 

specific types of injuries that can result 

when tissue is trapped between two 

magnets, and the risks associated with 

those injuries (77 FR 53786). These 

injuries include perforations that can 

result in infection due to leakage of gut 

contents into the abdominal cavity and 

obstructions that can lead to intestinal 

tissue becoming necrotic or rupturing 

and causing contamination of the 

abdominal cavity. Surgical procedures 

often are required to remove magnets 

from the digestive system. 

Complications can arise after these 

procedures, including bleeding, 

infection, and ileus (temporary paralysis 

of gut motility). Long-term 

complications resulting from this type 

of surgical procedure can include: (1) 

Adhesions (where bands of intraabdominal scar tissue form that can 

interfere with gut movement and can 

cause obstruction); (2) removal of long 

sections of injured bowel; and (3) 

impaired digestive function. 

D. Statutory Authority 

This rulemaking is conducted 

pursuant to the Consumer Product 

Safety Act (CPSA). Magnet sets 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 an NPR on 

September 4, 2012 (77 FR 53781), 

including the proposed rule and a 

preliminary regulatory analysis under 

section 9(c) of the CPSA. In addition, 

the Commission requested comments on 

the risk of injury identified, the 

regulatory alternatives under 

consideration, and other possible 

alternatives for addressing the risk. Id. 

2058(c). As discussed in section E of 

this preamble, the Commission 

considered the comments received in 

response to the proposed rule. 

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). Accordingly, 

the Commission held a public hearing 

on the proposed rule on October 22, 

2013, at agency headquarters in 

Bethesda, MD. The hearing notice was 

published in the Federal Register (78 

FR 58491). The submissions forwarded 

to the agency by presenters before the 

hearing, can be read online at: http://

www.cpsc.gov/en/Newsroom/PublicCalendar/2014/Public-Hearing/Agenda/

Magnet-/. Videos of the presentations 

can be viewed at: http://www.cpsc.gov/ 

Newsroom/Multimedia/?vid=66455. The 

Commission also allowed submitters to 

forward additional written comments 

for 1 week after the hearing. We 

considered all of the written and oral 

comments received. 

With this notice, the Commission 

issues a final rule, along with a final 

regulatory analysis. See id. 2058(f)(1). 

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 

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59966 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

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 cost 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). 

E. Response to Comments on the 

Proposed Rule 

This section summarizes the issues 

raised by comments on the proposed 

rule and provides that Commission’s 

responses to those comments. 

1. Oral Presentations 

On October 22, 2013, the Commission 

provided the public an opportunity to 

present views on the proposed rule in 

person before the Commission 

Presenters at the hearing included 

representatives from the Consumer 

Federation of American, Consumers 

Union, the American Academy of 

Pediatrics, and the National Association 

of Pediatric Gastroenterology, 

Hepatology, and Nutrition. The medical 

experts reported that the available 

research most likely reflects an 

undercount of the true incidence of 

injuries associated with magnet sets. 

The doctors also stated there was no 

evidence suggesting that the victims’ 

caregivers were negligent or otherwise 

impaired at the time of the ingestion 

incidents. Rather, the doctors noted that 

ingestion-related injuries, such as those 

associated with magnet sets, can be 

experienced in households with the 

most caring and well-educated 

caregivers. The doctors also testified 

that public education campaigns take a 

long time to show effects and that those 

campaigns would not be as effective in 

reducing magnet ingestion injuries as 

the proposed rule, which they strongly 

urged the Commission to finalize. 

2. Written Comments 

The preamble to the NPR invited 

comments concerning all aspects of the 

proposed rule. We received written 

comments from more than 5,000 

commenters in response to the NPR. 

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–2012–0050. 

Commission’s Authority To Promulgate 

the Rule 

(Comment 1)—Many commenters 

opine that promulgating the rule 

exceeds the Commission’s authority. 

More specifically, several commenters 

state that the Commission has no 

authority to issue a rule that would 

result in a prohibition of all magnet sets 

currently on the market simply because 

certain consumers use magnets in a 

manner that is inconsistent with the 

purpose intended for the product. Other 

commenters opine 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. Other 

commenters characterize the safety 

standard as the government usurping 

responsibility for the safety of children, 

which they say should properly reside 

with children’s parents or caregivers. 

(Response 1)—The Commission has 

the authority to issue a rule establishing 

performance requirements that a 

product must meet so that the product 

does not present an unreasonable risk of 

injury to consumers. 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 the costs and benefits of 

regulatory action. The regulatory 

analysis discusses that assessment (see 

Section H of this preamble). The 

Commission must balance such factors 

as the severity of injury, the likelihood 

of injury, and the possible harm the 

regulation could impose on 

manufacturers and consumers. If 

evidence demonstrates that 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. Certainly parents 

and caregivers must be responsible for 

their children’s safety. However, as 

discussed elsewhere, parents and 

caregivers may not be aware of the 

hazards that magnets present. Finally, 

there is no constitutional right to 

purchase a product. 

(Comment 2)—Several commenters 

characterize the Commission’s 

enforcement activities (filing 

administrative complaints, requesting 

certain retailers and importers to stop 

sales of magnet sets, and requesting 

recalls of magnet sets) as improper 

means to prohibit certain magnet sets. 

The commenters suggest that 

rulemaking, rather than these 

enforcement actions, is the appropriate 

approach. 

(Response 2)—Enforcement activities 

are intended to remove products from 

the market that present a substantial 

product hazard. This rulemaking 

proceeding is intended to establish 

requirements that magnet sets must 

meet from the effective date of the rule 

going forward. As such, this rulemaking 

proceeding seeks to impose 

requirements on all magnet sets subject 

to the rule that are sold after the rule 

becomes effective. The administrative 

proceeding and enforcement activities 

address only the products currently or 

previously distributed by specific 

importers and retailers. 

(Comment 3)—Several commenters 

opine that the Commission would be 

acting arbitrarily or capriciously in 

violation of section 706(2) of the 

Administrative Procedures Act (APA) 

by promulgating the rule; that the rule 

violates due process requirements; and 

that the Commission should hold a 

formal hearing under Sections 556 and 

557 of the APA, even if such a hearing 

is not required statutorily. 

(Response 3)—The Commission is 

following the rulemaking procedures set 

forth in sections 7 and 9 of the CPSA 

and in section 553 of the APA. The 

commenters refer to section 556 and 557 

of the APA. These provisions apply to 

formal rulemaking. However, the 

magnet proceeding is governed by 

section 553 of the APA, which codifies 

the procedure for informal rulemaking. 

By following the appropriate procedures 

under the CPSA and the APA, the 

Commission is providing the process 

that is due. 

Lack of Product Defect 

(Comment 4)—Commenters point out 

that magnet sets pose no risk of injury 

when used properly, that they function 

as intended, and therefore, they are not 

defective. The commenters contend that 

the improper use of a safe 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 

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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. 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’’). 

Impact of the Rule on the Availability of 

Magnet Sets for Certain Uses 

(Comment 5)—Commenters state that 

high-powered magnets have many 

laudable uses, including for education 

and research in sciences, such as 

biology, chemistry, and physics. Other 

commenters note that magnet sets are 

used therapeutically for individuals 

with autism or attention-deficit 

disorder. These commenters presume 

that the rule would eliminate from the 

marketplace high-powered magnets 

intended for such uses. 

(Response 5)—Magnets have long 

played a role in education. However, the 

specific products that are covered by the 

rule have been on the market only since 

2008. The rule will cover only ‘‘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.’’ Magnets 

that are not subject to the restrictions of 

the rule would continue to be available. 

For example, less powerful magnets are 

sometimes included in science kits to 

demonstrate magnetism. In addition, 

high-powered magnets that serve 

industrial and commercial needs would 

not be covered by the rule. 

Products that meet the definition of 

the ‘‘magnet sets’’ that do not comply 

with this rule would no longer be 

available for purchase, even if used by 

individuals to manage their attention 

deficit disorder or attention deficit 

hyperactivity disorder (ADD/ADHD) 

symptoms. However, magnets that are 

not restricted by the rule would still be 

available for purchase and perhaps 

could be used to manage ADD/ADHD 

symptoms. More generally, magnets are 

but one of many objects, including 

various types of stress balls, ‘‘worrybeads,’’ and chiming Baoding hand 

exercise balls that are available for the 

uses commenters cite. A variety of other 

products are marketed specifically as 

‘‘fidget toys’’ to help children manage 

ADD/ADHD symptoms. Staff is aware of 

one study in which the authors reported 

successful use of simple stress balls to 

help sixth graders maintain focus in the 

classroom (Stalvey & Brasell, Summer 

2006). In short, some substitutes for 

magnet sets are available for 

management of ADD/ADHD symptoms, 

and successful use of these substitutes 

predates the availability of magnet sets. 

Magnet sets present the same hazards 

to children with ADD/ADHD as they do 

to children who do not have this 

condition. One comment summarizes a 

study of 38 cases of magnet ingestion. 

Among those were two children, a 12- 

year-old and a 14-year-old with ADHD, 

who swallowed strong magnets, 

although of a type different than those 

typically found in magnet sets. The first 

child required a laparoscopy; the other 

child required extensive surgical 

intervention. One teacher who reported 

giving magnets to children with ADD/

ADHD in his middle school classes 

commented that he ‘‘needed to buy a 

new set every year,’’ suggesting the ease 

with which the pieces are lost over time 

and the difficulty adults may have 

maintaining control of the sets. 

(Comment 6)—Commenters note that 

magnet sets are fun stress-relievers and 

have value as an artistic medium. The 

commenters also note that sculpture 

made from the magnet sets that are the 

subject of the rule constitute an art form 

that would be lost if the rule is 

promulgated. 

(Response 6)—The Commission is 

aware that magnet sets are used to 

relieve stress; and likewise, the 

Commission is aware that some 

individuals have developed a form of art 

with the magnets that would be affected 

if the magnet sets used for this purpose 

are prohibited. Although magnet sets of 

the type that have been involved in 

incidents and are currently purchased 

by consumers for stress relief and 

sculpture-making would not comply 

with the rule, magnet sets made from 

weak magnets (i.e., with a flux index 50 

kG2 mm2 or less) or from magnets that 

do not fit within the small parts 

cylinder would be allowed by the rule. 

Magnet sets that comply with the rule 

could serve some of the purposes of 

magnet sets that are currently available. 

For example, Liberty Balls, marketed by 

Assemble, LLC, and sold in sets of eight 

large spheres, are an example of a type 

of magnet set that would meet the 

performance requirements of the rule. 

Due to the large size of the Liberty Balls 

magnets, their uses are more limited 

than the magnet sets that are the subject 

of this rule. However, the existence of 

Liberty Balls demonstrates the 

possibility that companies can develop 

magnet sets that meet the standard and 

serve some of the uses of the magnet 

sets that fail the standard. 

Similarly, children’s magnetic toys 

provide an example of how magnet sets 

might be developed that would meet the 

standard. Children’s toy manufacturers 

have successfully adapted their 

magnetic construction toys since the 

adoption of the requirements for toys 

with magnets in the 2007 edition of 

ASTM F963, ‘‘Standard Consumer 

Safety Specification for Toy Safety.’’ 

Following this example, individual 

magnets with a flux index over 50 could 

be permanently connected by rods or 

other means, such that the resulting 

magnetic objects are not small parts, i.e., 

do not fit entirely within the small parts 

cylinder. Such a magnet set might not 

be a perfect substitute for current 

magnet sets but could fulfill some of the 

uses of current magnet sets, without 

posing the risk of injury or death. 

(Comment 7)—Noting the popularity 

of magnet sets for educational, 

scientific, and therapeutic uses, some 

commenters claim that continued 

demand for small, high-powered 

magnets would result in a ‘‘black 

market’’ for the products after the rule 

is promulgated. Some commenters state 

that there could be consumer-toconsumer sales of used products, and 

others maintain that consumers would 

be able to purchase magnet sets directly 

from noncomplying companies 

(including firms located in China). A 

few commenters note that these black 

market magnet sets are less likely to be 

sold with warning labels or other 

accompanying information related to 

hazards. 

(Response 7)—We acknowledge that 

there would continue to be a demand 

for magnet sets by some consumers, 

which could lead to increases in 

consumer-to-consumer sales and 

potentially black market sales of the 

products. Furthermore, such sales are 

probably less likely to be accompanied 

by labeling and warnings that alert 

buyers to the hazards associated with 

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the products. CPSC enforcement 

activities and continued dissemination 

of consumer information on the hazards 

of magnet sets might be necessary to 

reduce the future sales of noncomplying 

products. 

(Comment 8)—Some commenters 

opine that magnet sets that comply with 

the size and flux index requirements of 

the rule will lose their utility as 

manipulative desk toys. Other 

commenters suggest that weaker 

magnets would be less safe because 

weaker, individual magnets could be 

separated more easily from the magnet 

set during use, or separate more readily 

within the gastrointestinal system if 

ingested while attached to other 

magnets. 

(Response 8)—The intent of the rule 

is to reduce or eliminate the hazard 

presented by magnet sets currently on 

the market by requiring that magnet sets 

and individual magnets for use with 

magnet sets that are small enough to fit 

within the small parts cylinder must 

have a flux index of 50 kG2 mm2 or less. 

The rule would still allow strong 

magnet sets with magnets that do not fit 

entirely within the small parts cylinder. 

Magnetic products sold as toys that 

comply with the toy standard for 

children have included rods, balls, and 

various geometric shapes that do not fit 

within the small parts cylinder. Such 

products offer interesting entertainment, 

such as sculptures and construction 

activities, but they are much larger and 

safer than the subject magnet sets 

intended for adults. Another possibility 

would be to invent a magnet set 

composed of magnets with a flux index 

below 50 kG2 mm. Because there 

currently are no magnet sets on the 

market with magnets that have a flux 

index of less than 50 kG2 mm2, we do 

not know how such magnets would 

perform when used in the same way 

currently available magnet sets perform. 

Magnet sets that comply with the 

requirements of the rule would contain 

magnets that are too large to be 

swallowed easily or would have very 

weak attraction forces that would not 

pose the same ingestion hazards as 

magnet sets currently on the market. 

Review of incident data does not 

indicate that any injuries have been 

caused by magnets with flux index 

values below 50 kG2 mm2. 

(Comment 9)—Some commenters 

disparage the intended uses of magnet 

sets, calling them, for instance, 

‘‘mindless desk ornaments,’’ 

‘‘a diversion,’’ and ‘‘frivolous items.’’ 

These commenters cite the high severity 

of the injuries associated with magnet 

sets and express dismay that the CPSC 

ever allowed them to be sold. 

(Response 9)—The CPSC does not 

perform premarket approvals of 

consumer products; and typically, the 

CPSC will not engage in enforcement or 

regulatory activity regarding a product, 

until information is received or 

developed, which indicates that the 

product may present an unreasonable 

risk of injury to consumers. Reasonable 

parties may differ on the value to 

society of manipulative toys; however, 

many types of manipulative toys exist 

for children and adults. 

Impacts of the Rule on Businesses and 

Jobs 

(Comment 10)—Many commenters 

note that the rule would harm firms that 

import magnet sets and will result in 

lost jobs for employees of these firms. 

(Response 10)—In the preliminary 

initial regulatory analysis, staff noted 

that the economic impact of the rule 

would be most severe for the seven 

firms that account for the great majority 

(perhaps more than 98%) of units sold 

as of June 2012. Five of these importers 

reportedly derived most or all of their 

revenues from the sale of the magnet 

sets that do not meet the performance 

requirements of the rule. The other two 

leading importers of magnet sets 

reportedly had fairly broad product 

offerings, which could lessen the 

severity of the economic impact of the 

rule. As a result of compliance activity 

pursued by the Commission’s Office of 

Compliance and Field Operations, four 

of these seven importers agreed 

voluntarily to stop selling magnet sets 

that would not be compliant under this 

rule. One additional firm, Maxfield & 

Oberton Holdings, LLC, ceased 

operations. This firm (marketer of 

‘‘Buckyballs’’) is believed to account for 

nearly 90 percent of magnet set sales 

through June 2012. Only one of the 

seven small importers, Zen Magnets, 

LLC, continues to market magnet sets 

that are subject to the rule. This firm 

apparently derives all of its revenues 

from the sale of magnet sets. Unless the 

firm can successfully market magnet 

sets that comply with the rule or other 

products, the firm might go out of 

business when the rule takes effect. 

A large share of magnet sets have been 

sold directly to consumers by importers 

who used their own Internet Web sites 

or other Internet shopping sites, but the 

rule would also affect retailers of the 

products, whether the products are sold 

online or physically in stores. However, 

these retailers are not likely to derive 

significant proportions of total revenues 

from sales of affected magnet sets. 

Accordingly, the impacts on individual 

firms should be minimal. 

The commenters are correct that the 

rule, by prohibiting the sale of 

noncompliant magnet sets in the United 

States, may also result in some job 

losses. However, the impact on job 

losses is probably limited because 

magnetic balls generally are produced 

outside the United States and are merely 

packaged and/or distributed by U.S. 

importers. 

Costs and Benefits of the Rule 

(Comment 11)—One commenter 

opines that the preliminary regulatory 

analysis overstates the societal costs of 

injuries from magnet sets because 

incidents involving other small magnets 

are improperly attributed to the magnet 

sets that are the subject of the proposed 

rule. In addition, this commenter opines 

that the injury costs used in the analysis 

were higher than indicated by the 

CPSC’s Revised Injury Cost Model 

(ICM). 

(Response 11)—Both the initial and 

final regulatory analyses acknowledge 

that there is some uncertainty 

concerning the estimated annual 

average of medically attended injuries, 

noting that some of the cases described 

as ‘‘possibly’’ involving magnet injuries, 

actually may not have involved the 

magnets that are the subject of the rule. 

Hence, it is possible that the analyses 

overstate the societal costs associated 

with the magnets included in the rule. 

The final regulatory analysis also points 

out that there were an additional 230 

NEISS cases (representing about 1,500 

emergency department-treated injuries 

annually) in which the magnet type was 

classified as ‘‘unknown or other.’’ Thus, 

to the extent that this category of 

incidents involved magnets covered by 

the rule, the analyses would tend to 

understate the societal costs associated 

with the magnets subject to the rule. 

Therefore, given the uncertainty 

concerning the societal costs associated 

with the magnet sets, the analyses could 

be underestimating or overestimating 

the societal costs. 

Regarding the commenter’s assertion 

that injury costs used in the preliminary 

regulatory analysis were higher than 

indicated by the ICM, we note that the 

commenter fails to take into account 

updates to the ICM based on new and 

improved cost databases. The ICM is 

fully integrated with NEISS and 

provides estimates of the societal costs 

of injuries reported through NEISS. The 

major aggregated components of the 

ICM include: Medical costs; work 

losses; and the intangible costs 

associated with lost quality of life or 

pain and suffering. The ICM is 

described further in section H.3.a of the 

preamble. The commenter also does not 

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take into consideration that the cost 

estimates in the preliminary regulatory 

analysis were age and sex specific and 

involved only those under the age of 15 

who had ingested magnets from magnet 

sets. Furthermore, the commenter 

apparently also includes injury costs 

associated with the diagnosis category 

‘‘foreign body,’’ i.e., foreign objects 

propelled into the victim’s body, which 

is a different hazard pattern than 

‘‘ingested foreign objects.’’ The costs of 

injuries resulting from foreign objects 

being propelled into a victim’s body are 

only about half of the costs of injuries 

associated with ingested foreign objects. 

Finally, the commenter applies 

inappropriate inflators in adjusting the 

injury cost estimates to 2011 dollars. 

The Commission maintains that the 

estimated injury costs associated with 

ingestions of small, high-powered 

magnets in the preliminary regulatory 

analysis and final regulatory analysis 

involved proper application of the ICM. 

Risk and Severity of Injury 

(Comment 12)—The Commission 

received a significant number of 

comments from health care 

professionals with personal experience 

in treating children who either narrowly 

avoided, or actually sustained, injuries 

following ingestion of small, highpowered magnets. 

Virtually all comments received from 

medical professionals express support 

for a rule eliminating magnet sets of the 

type that have been involved in 

incidents. The medical professionals 

point out that injuries caused by the 

ingestion of high-powered magnets are 

often difficult to diagnose because of the 

inability of standard diagnostic tools to 

demonstrate that the ingested item is a 

magnet; there are similarities between 

symptoms resulting from magnet 

ingestion injuries and less serious 

conditions like the flu; and the victims 

are unable or unwilling to communicate 

to their caregivers or medical personnel 

that they have ingested magnets. The 

medical professional commenters 

express concern with the rapidly 

growing number of cases and note that 

magnet ingestions often result in rapid 

and severe injuries with devastating and 

costly long-term consequences. 

(Response 12)—The Commission is 

aware of the severity of the injuries that 

often result from the ingestion of small, 

high-powered magnets from magnet sets 

and the difficulties frequently 

encountered by medical professionals in 

diagnosing and treating these injuries. 

The Commission is also aware that there 

are costs associated with the treatment 

of injuries resulting from the ingestion 

of these magnets that will be reduced 

substantially if magnet sets must 

comply with the rule. (See Section H of 

this preamble). 

(Comment 13)—Commenters argue 

that high-powered magnet sets should 

not be prohibited because the number of 

injuries is low—43 reported injuries 

possibly involving magnet sets during 

the period from January 2009 to June 

2012—considering that approximately 

2.7 million magnet sets have been sold 

since 2009. These commenters also note 

that there have been no fatalities 

associated with the product. 

(Response 13)—The number of 

incidents reported to the Commission, 

now totaling 100 cases through June 24, 

2014, cannot be used to estimate the 

number of injuries in the U.S. 

population because case reports are 

anecdotal and are not based on a 

probability based sampling design. The 

anecdotal incidents reported to CPSC 

constitute a minimum number of 

incidents in the U.S. However, the 

incidents reported to CPSC through 

hospital emergency departments and 

captured in the NEISS database can be 

used to estimate the number of 

incidents nationwide because NEISS 

data come from a probability based 

stratified random sample of U.S. 

hospitals with emergency departments. 

An analysis of incidents obtained 

through the NEISS estimates that 2,900 

possible magnet set, emergency 

department-treated ingestions occurred 

in the United States from January 1, 

2009 through December 31, 2013. This 

amounts to approximately one incident 

per 930 magnet sets. We do not agree 

that this is a low figure for injuries. In 

addition, we are aware of one fatality 

involving a 19 month-old female, who 

died from ischemic bowel caused by the 

ingestion of magnets from a magnet set. 

Furthermore, the benefits of the rule, 

notwithstanding the public’s desire for 

current magnet sets that do not meet the 

rule, bear a reasonable relationship to 

the costs of the rule. 

(Comment 14)—Several commenters 

point out that the dangers posed by the 

ingestion of small, high-powered 

magnets are not obvious. 

(Response 14)—Staff agrees that the 

unique hazard resulting from the 

ingestion of small, strong magnets is 

unlikely to be obvious to the general 

public. People are generally aware of the 

choking hazard posed by small balls and 

other small parts, but they do not 

understand how the characteristics of 

magnets can cause injuries that are 

different from, and more severe than, 

swallowing another small object. 

Despite the publicity and response 

generated by the NPR, as well as the 

Commission’s compliance and 

communications activities, some 

commenters misunderstand the hazard. 

Many commenters seem unaware that 

the majority of victims are older 

children and teens, and the commenters 

focus exclusively on the risk to young 

children. Similarly, commenters tend to 

mention magnets as a choking hazard, 

comparable to choking on foods, such as 

hot dogs and non-food small parts. In 

reality, choking is not the injury 

mechanism related to magnets. The 

ways that children and teens interact 

with magnets are not obvious and seem 

unclear to many commenters. For 

example, some commenters write 

derisively about ‘‘people letting their 

children eat magnets.’’ However, most 

incidents are unwitnessed, and based on 

data from choking and poisoning 

incidents in which children 

intentionally ingest non-food items, it is 

likely that only the youngest children 

voluntarily swallow magnets. This is 

because choking on non-food items 

occurs predominantly among children 

younger than three years, and ingestion 

of poisonous substances declines as 

children approach five years of age. 

(Comment 15)—Other commenters 

point out that the Commission has not 

prohibited certain products, such as 

trampolines, balloons, and hazardous 

household chemicals, which 

commenters contend present a greater 

risk of injury to children than magnet 

sets. They assert that this weighs against 

a rule prohibiting certain magnet sets 

that do not meet the rule’s performance 

requirements. 

(Response 15)—Magnet sets, and the 

hazard patterns associated with them, 

are quite different from other products. 

Because of these differences, 

comparisons of injury rates between 

magnet sets and other products are not 

meaningful. Key differences include: the 

obviousness of the hazard; the severity 

of the resulting injury; the difficulty in 

diagnosing the resulting injury; the 

numbers of products in use; the breadth 

of products covered in the product 

category; the age of the victims 

sustaining injuries; and the existence of 

requirements to address the hazard. 

Responsibility of Caregivers for Injuries 

Resulting From Magnet Ingestion 

(Comment 16)—Several commenters 

claim that the incidents involving 

magnet sets are caused by negligent 

caregivers, who should supervise their 

children better. However, other 

commenters opine that caregiver 

supervision was not a relevant factor in 

determining the causation of the 

incidents. 

(Response 16)—The issue of caregiver 

supervision is related to caregiver 

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3Wickens, C. D., & Hollands, J. G. (2000). 

Engineering psychology and human performance 

(3rd Ed.). Upper Saddle River, NJ: Prentice Hall. 

4Brown, T., & Beran, M. (2008). Developmental 

stages of children. In R. Lueder & V. J. B. Rice (Eds.), 

Ergonomics for children: Designing products and 

places for toddlers to teens (pp. 13–30). New York: 

Taylor & Francis. Kalsher, M. J., & Wogalter, M. S. 

(2008). Warnings: Hazard control methods for 

caregivers and children. In R. Lueder & V. J. B. Rice 

(Eds.), Ergonomics for children: Designing products 

and places for toddlers to teens (pp. 509–539). New 

York: Taylor & Francis. Zackowitz, I.B., & 

Vredenburgh, A.G. (2005). Preschoolers, 

adolescents, and seniors: Age-related factors 

pertaining to forensic human factors analyses. In Y. 

I. Noy & W. Karwowski (Eds.), Handbook of human 

factors in litigation (Chapter 35). Boca Raton, FL: 

CRC Press. 

compliance with warnings and other 

hazard communications. Consumers 

may be aware of a hazard, but they may 

not make changes in their behavior that 

would avoid the hazard. Securing or 

preventing access to magnet sets would 

be especially difficult regarding older 

children and adolescents because they 

are strongly independent and 

resourceful. Expecting caregivers to 

supervise these children constantly is 

unrealistic. Magnet ingestions can 

happen quickly, and the Commission 

believes that it is also unrealistic to 

expect caregivers to maintain 

continuous, focused attention on 

younger children, especially children at 

the upper end of the at-risk age range. 

Indeed, research has found that people 

cannot be perfectly attentive, 

particularly over long periods of time, 

regardless of their desire to do so.3

Caregivers are likely to be distracted, at 

least occasionally, because they must 

perform other tasks, are responsible for 

supervising more than one child, are 

exposed to other salient but irrelevant 

stimuli, or are subject to other stressors. 

Moreover, caregivers are unlikely to 

maintain high levels of vigilance, unless 

they believe that such vigilance is 

necessary. If caregivers who own 

magnet sets believe they have properly 

secured the sets or think that their 

children are not aware of the sets, 

caregivers are unlikely to assume that 

constant supervision is needed. 

Furthermore, children may be exposed 

to these magnet sets in locations where 

caregivers cannot supervise the children 

or do not have direct control over the 

amount of supervision required, such as 

at school or in other households. 

Adolescents, in particular, are strongly 

independent, and it is unrealistic to 

expect caregivers to supervise 

adolescents constantly. 

Alternatives to the Rule: Warnings and 

Education Programs 

(Comment 17)—Many commenters 

state that current warnings are sufficient 

to address the risk of injury presented 

by magnet sets, or they express the 

belief that more robust and prevalent 

warnings and educational programs are 

a better alternative than a rule 

prohibiting products that do not meet 

the rule’s performance requirements. 

Some commenters state that the 

assumption that warnings do not work 

undermines past safety standards 

accepted by the CPSC and, in fact, calls 

into question the entire safetymonitoring process. 

(Response 17)—As discussed in the 

Human Factors staff memorandum that 

was part of the NPR briefing package, 

warnings are widely recognized as a less 

reliable approach to controlling hazards 

than design or guarding approaches. 

Unlike these latter approaches, which 

directly limit hazard exposure, warnings 

and other hazard communications must 

first educate consumers about the 

hazard and then persuade consumers to 

change their behavior to avoid the 

hazard. In addition, to be effective, 

warnings must rely on consumers to 

behave consistently, regardless of 

situational or contextual factors (e.g., 

fatigue, stress, social influences) that 

influence precautionary behavior. 

The Commission’s position is not that 

warnings are uniformly ineffective. 

However, consumer compliance with 

warnings depends strongly on the 

specific circumstances surrounding the 

hazard. Several factors suggest that 

compliance with warning labels related 

to magnet sets is likely to be low 

because consumers may not notice and 

attend to the warnings. Exposure to 

ingestion warnings is likely to be very 

limited because: (1) The individual 

magnets are too small to contain onproduct warnings; (2) the magnet sets do 

not inherently require consumers to 

return the magnets to a storage case or 

other package after every use, in 

packaging that might include a warning; 

and (3) the magnet sets can be 

manipulated without the necessity of 

referring to instructions that might 

include a warning. In addition, the 

nature of the magnet-ingestion hazard 

and the resulting injuries can be 

difficult to convey to consumers; and 

the resulting injuries have been 

misunderstood even by medical 

personnel and by commenters to the 

NPR, some of whom erroneously 

identify choking on the magnets as the 

hazard presented by this product. 

Without a clear understanding of this 

information and how magnet ingestions 

differ from other small-part ingestions, 

consumers are unlikely to comply with 

a warning. 

We acknowledge that developing 

understandable warnings aimed at 

parents and other caregivers may be 

possible; and we acknowledge that 

caregivers who receive such warnings 

may attempt to keep these products out 

of the hands of young children. 

However, as noted, consumer 

compliance with warnings depends 

strongly on the specific circumstances 

surrounding the hazard. Several factors 

suggest that compliance with warning 

labels related to magnet sets is likely to 

be low, even if consumers understand 

the hazard and its consequences. For 

example, the cost of compliance 

associated with magnet-ingestion 

warnings is high. ‘‘Cost of compliance’’ 

is defined as any cost, such as time, 

effort, or inconvenience that is required 

to comply with a warning; compliance 

is negatively associated with cost. The 

warnings on the packaging and 

instructional material for some magnet 

sets instruct consumers to secure the 

magnets and keep them away from all 

children ages 14 years and younger. As 

evidenced in the comments, many 

consumers are likely to reject these 

warnings as lacking credibility. We 

recognize that caregivers who receive 

warnings about magnet sets may attempt 

to keep these products out of young 

children’s hands. However, warnings 

are likely to be particularly ineffective 

among caregivers with older children 

and adolescents because caregivers 

would not expect these children to 

mouth toys and other objects as 

frequently as younger children. 

Furthermore, even if caregivers attempt 

to comply with warnings about the 

magnet-ingestion hazard, preventing a 

child’s access to these magnets still 

might prove quite difficult. The time 

and effort to secure the product after 

every use, and the difficulties associated 

with trying to identify a suitably secure 

location to store the product, may deter 

consumers from heeding the warnings. 

Some adolescents have cognitive and 

motor skills similar to an adult’s, 

making it extremely challenging to keep 

the product out of adolescents’ hands, 

despite caregivers’ efforts. Although 

adolescents also may be capable of 

understanding warnings about magnet 

ingestions, their behavior is influenced 

strongly by social and peer pressures, 

and adolescents are known to test limits 

and bend rules.4 Thus, warnings against 

using magnets to simulate tongue or 

facial piercings are unlikely to be very 

effective among this age group, unless 

such piercings are viewed as socially 

unacceptable among their peers. 

Educational programs may offer more 

opportunities to present the information 

in varied ways and in greater detail than 

is possible via a warning label. 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 59971 

5Cf. White, N. C., Litovitz, T., Benson, B. E., 

Horowitz, B. Z., Marr-Lyon, L., & White, M. K. 

(2009). The impact of bittering agents on pediatric 

ingestions of antifreeze. Clinical Pediatrics, 48(9), 

913–921. 

However, mere knowledge or awareness 

of a hazard is not enough. Such 

programs suffer from limitations similar 

to those of warnings because, like all 

hazard communications, the 

effectiveness of educational programs 

depends upon the affected consumers, 

not only in terms of receiving and 

understanding the message, but also in 

being persuaded to heed the message. 

Magnet sets present an especially 

difficult challenge for public education 

programs because the hazard is obscure 

and difficult to convey in simple terms. 

Furthermore, teenagers are a significant 

part of the at-risk population, and they 

provide distinct challenges to the 

effectiveness of public education 

programs. Thus, even education 

programs that clearly communicate the 

hazard to consumers will not 

necessarily motivate appropriate 

behavioral change or reduce the 

frequency of incidents. 

Alternatives to the Rule: Bitterants 

(Comment 18)—A small number of 

commenters discuss bitterants (also 

known as aversives) as an option. Some 

conclude that adding a bitter coating to 

magnets would be an effective 

alternative to the prohibition of magnet 

sets that do not meet the rule’s 

performance requirements. A few 

commenters assert that the method is 

unproven and question that approach 

for various reasons. 

(Response 18)—In principle, adding 

an aversive agent to a product is a 

rational approach to reducing the risk of 

mouthing and ingestion. Laboratory 

studies have shown this approach to be 

effective among children and adults in 

deterring repeated ingestion of various 

substances. Yet, real-world 

investigations have not demonstrated 

the effectiveness of bitterants in 

preventing poisonings.5 CPSC staff’s 

1992 final report of its study of the topic 

(http://www.cpsc.gov/library/foia/

foia99/os/aversive.pdf. at p. 3) 

concluded that because bitterants do not 

deter initial ingestion, ‘‘[a]versive agents 

are unlikely to protect children from 

being harmed after ingesting . . . 

substances that can injure or kill after 

one or two swallows.’’ 

Bitterants are least likely to be 

effective among young children who 

gain access to high-powered magnets. 

Despite rejecting bitter substances in 

testing environments, children in home 

settings, nevertheless, frequently ingest 

unpalatable substances, such as 

gasoline, cleanser, toilet bowl cleaner, 

and ammonia. Younger children, 

particularly those under 3 years of age, 

may swallow a number of magnets at a 

time before reacting to any aversive 

agent applied to the magnets. 

Aversives may be a more effective 

deterrent for older children and young 

teens, presuming these children are 

aware that the agent has been applied to 

the magnets and they are familiar with 

its taste. For older children who are not 

familiar with the taste of an aversive, 

the mere presence of the agent would 

not deter mouthing the magnets or 

trying to use them to mimic pierced lip 

or tongue jewelry. Older children and 

teens may also give magnets to others to 

try as a prank. Preteens and teens are 

prone to test what they have been told, 

particularly when what they have been 

told involves restrictions of any sort. 

Thus, warnings that the products taste 

bad may not prevent children in these 

age groups from tasting the magnets. 

(Some proportion of the population, 

possibly as high as 30 percent, may be 

insensitive to bitterants such as 

denatonium benzoate.) However, 

children are likely to reject magnets 

treated with bitterants, and the bitterant 

may indeed deter repeated attempts 

among most children. 

Ingestions could still occur even if a 

bittering agent is found effective for this 

purpose. Ingestions may be intentional 

among the youngest children, but 

ingestions are likely to be accidental 

among older groups. The power of the 

magnetic forces inherent in these 

products can cause magnets to move 

erratically as pieces repel or attract, and 

movement of magnets toward the back 

of the throat could trigger the reflex to 

swallow the magnets before the person 

can remove them. 

Alternatives to the Rule: Child-Resistant 

Packaging 

(Comment 19)—Several commenters 

state that child-resistant (CR) packaging 

requirements are a better alternative 

than the proposed performance 

requirements. However, others believe 

that such requirements would be 

ineffective in reducing or eliminating 

the risk of injury. 

(Response 19)—CR packaging could 

be devised to make an enclosed magnet 

set inaccessible to most young children. 

However, compliance with CR 

packaging is likely to be low and 

inconsistent; and the effectiveness of 

this approach depends on the caregiver 

and other users securing the magnets in 

the CR packaging after every use. This 

is behavior that we consider unlikely to 

occur. Although CR closures have been 

shown to be effective in reducing 

poisonings with various products (e.g., 

Rodgers, 2002), non-use and incorrect 

use of CR closures on products 

containing chemicals or 

pharmaceuticals—products consumers 

are more likely to understand to be 

hazardous (as opposed to strong magnet 

sets)—can result in many poisonings 

annually among children younger than 

5 years old. Furthermore, CR packaging, 

referred to as ‘‘special packaging’’ under 

the Poison Prevention Packaging Act, is 

designed to be significantly difficult for 

children under 5 years of age to open. 

15 U.S.C. 1471(4). Thus, CR packaging 

is an impractical approach for older 

children, whose cognitive and motor 

skills overlap those of adults. 

Flux Index 

(Comment 20)—One commenter 

questions the relationship of the flux 

index (FI) to anatomical data, which the 

commenter considers to be most 

germane to the hazard. The commenter 

requests that the rule be modified to 

redefine the criteria, ‘‘by relying on 

objective anatomical data tied to the 

potential risks associated with 

swallowing injuries and refine the 

testing protocol to isolate the field 

strength and/or attach forces that can 

reasonably be expected to develop at the 

distances reflected by anatomical data.’’ 

Referencing an ultrasound study, the 

commenter asserts that the minimal gut 

wall thickness in children is 0.5 mm, 

and the commenter suggests that when 

measuring the magnet maximum surface 

gauss reading, instead of measuring at a 

probe distance of 0.25 to 0.51 mm above 

the magnetic pole surface, as currently 

required in ASTM F963–11, it is more 

appropriate to base the measuring 

distance on the minimum gut wall 

thickness. The commenter suggests that 

using a probe separation distance of 1.0 

mm (2 × 0.5 mm = 2 sections of gut wall) 

makes more sense because 1 millimeter 

‘‘is the magnetic field strength at that 

critical distance that may bear a rational 

relationship to injuries.’’ 

(Response 20)—Commission staff 

agrees that the strength of the magnet 

field and the separation of the magnets, 

or lack thereof, are important factors 

contributing to the risk of injury posed 

by any strong magnet. The 

gastrointestinal (GI) system is folded on 

itself within the abdominal cavity, and 

during transit through the GI system, 

there are many opportunities for 

magnets in different GI locations to pass 

nearby to each other and then interact 

when separated by only the thin gut 

walls. Commission staff believes that 

measuring the maximum surface gauss 

reading for the FI input at a set distance 

of 1.0 mm (equivalent to two 

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59972 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

thicknesses/layers of gut wall) is 

oversimplistic and inappropriate, unless 

the maximum surface gauss reading 

measured at that 1.0 millimeter distance 

is essentially zero. 

Although the suggested value of 1.0 

millimeter is anatomically valid, it is 

not particularly meaningful in terms of 

the injury mechanism. This is because 

conventional magnets do not ‘‘wait’’ to 

get within 1 millimeter of each other 

before they begin to interact, and the gut 

wall cannot block magnetic forces. 

Rather, once a pair of magnets comes 

within a distance where the extent or 

reach of their magnetic fields allows 

them to interact, the result is nearinstantaneous attraction, with 

consequent near-instantaneous 

compression of any trapped tissues. 

Although the thin wall of the small 

intestine can be conveniently defined 

anatomically by its thickness, the tissue 

offers minimal resistance to the 

compression forces of the magnet. Thus, 

the tissue trapped between magnets may 

be compressed so that the distance 

between the magnets is much smaller 

than 1.0 millimeter. The compression 

forces deprive the tissue of its blood 

supply, and they also squeeze out the 

tissue fluids, rapidly reducing the gut 

wall thickness to micron values, and 

essentially mummifying the tissue in 

situ. The measurement distance for the 

FI in the rule is closer to this negligible 

distance than the 1.0 millimeter 

distance that the commenter suggests; 

and therefore, the measurement distance 

for the FI in the rule is more appropriate 

for defining powerful magnets capable 

of causing GI injuries. 

(Comment 21)—Several commenters 

question whether a flux index value of 

50 kG2 mm2 is low enough to prevent 

harm. 

(Response 21)—The development of 

the flux index requirement that appears 

in ASTM F963, Consumer Safety 

Specification for Toy Safety, which is 

now a mandatory CPSC standard, was 

outlined in the NPR. (77 FR 53781–82, 

September 4, 2012). ASTM F963–11 

defines a ‘‘hazardous magnet’’ and a 

‘‘hazardous magnet component’’ as one 

that has a flux index greater than 50 kG2

mm2 and that is a small object. ASTM 

set the flux index value at 50 kG2 mm2, 

by measuring the weakest magnets in 

children’s toys that were suspected of 

causing injuries, and then adding a 

safety factor. Review of incident data 

related to children’s toys and magnet 

sets does not indicate that any injuries 

have been caused by individual magnets 

with flux index values below 70. CPSC 

staff will continue to monitor incidents 

and seek information about the lowerbound limits of the injury mechanism so 

that the established method continues to 

be appropriate. 

(Comment 22)—Several commenters 

question whether the rule is adequate 

for assessing the hazard posed by an 

aggregation of individual magnets, each 

of which has a flux index of 50 or less. 

(Response 22)—The staff 

memorandum included in the NPR 

briefing package acknowledged 

concerns with the existing ASTM F963 

standard method regarding aggregated 

magnets, as follows: ‘‘A toy with 

multiple weak small part magnets could 

present an issue that the existing ASTM 

F963 magnet requirements do not 

address, namely: stacking or stringing of 

magnets. . . . when these small part 

magnets are combined, they could 

create a(n aggregated) magnet with an 

effective flux index over 50 kG2 mm2

depending upon their characteristics.’’ 

(Notice of Proposed Rulemaking for 

Hazardous Magnet Sets, Staff Briefing 

Package, pp. 54¥55). Individual 

magnets with a flux index of 50 kG2

mm2 or less (which currently do not 

exist in the market) would be smaller 

and more difficult to manipulate and 

have less attraction force than magnets 

in existing magnet sets. Individual 

magnets with a flux index of 50 kG2

mm2 or less could be mounted 

permanently or attached side-by-side to 

create a magnetic object with multiple 

magnetic poles on one surface. Doing so 

would create a multipole magnetic 

object that has a higher attraction force 

than the individual magnets on its 

surface. Because there currently are no 

magnet sets on the market with magnets 

that have a 50 kG2 mm2 flux index or 

less, we do not know how they would 

perform when used as a part of a magnet 

set. 

(Comment 23)—One commenter 

disagrees with the proposed flux index 

method, stating that the commenter’s 

proprietary technology could be used to 

make ‘‘safe’’ magnet sets, even if the 

flux index measurement of individual 

magnets is greater than 50. The 

commenter uses a proprietary 

technology to magnetize the surface of 

a single magnet to create multiple poles 

(positive and negative regions) on the 

surface of a single magnet. The 

commenter refers to these proprietary 

magnets as ‘‘Polymagnets.®’’ Essentially, 

this process creates a permanent 

aggregation of north and south poles in 

the surface of a single magnet. The 

commenter requests that the 

Commission narrow the scope of the 

rule to apply only to magnet sets 

comprised of magnets having no more 

than two magnetic pole regions on any 

exposed magnet surface, thereby, 

exempting multiple pole magnets. 

(Response 23)—The commenter’s 

claim that a process exists that could be 

used to make ‘‘safe’’ magnet sets, even 

if the flux index measurement of 

individual magnets is greater than 50 

kG2 mm2, is based on proprietary 

technology, which, to our knowledge, 

has not been applied to any magnet sets 

currently on the market. The commenter 

concedes that he ‘‘has not fully analyzed 

the use of a densely coded pattern’’ on 

small cubes or spheres and claims only 

that ‘‘early indications suggest that 

dramatic improvements to the magnetic 

field * * * can be achieved’’ using the 

proprietary technology. These 

statements indicate that the commenter 

has not applied this technology to small, 

high-powered magnet sets or even 

concluded that such an application is 

scientifically possible or economically 

feasible. CPSC is not aware of any 

magnet set products on the market that 

are comprised of magnets with 

multipole surfaces using the 

commenter’s technology. Moreover, it is 

not likely that this process will be 

applied to small, high-powered magnet 

sets in the foreseeable future. Thus, the 

Commission does not believe that any 

exemption for these types of magnets is 

necessary or appropriate, particularly 

because currently, no Polymagnet®

magnet sets exist that could be tested to 

determine whether such magnet sets 

present an unreasonable risk of injury. 

(Comment 24)—The same commenter 

also states that the flux index 

measurement method is imprecise 

because it provides a range of acceptable 

distances between the gauss meter and 

the magnetic surface being measured. 

(Response 24)—The flux index 

measurement method specifies the use 

of a gauss meter and an axial probe with 

a distance between the active area 

(diameter of 0.76 +/¥ 0.13 mm) and 

probe tip of 0.38 +/¥ 0.13 mm. This 

means the magnetic flux density is 

measured at a distance of between 0.38 

millimeters and 0.51 millimeters above 

the magnet surface. The tolerance cited 

accounts for variations in the length of 

the axial probe tip, which is a function 

of the equipment used, and therefore, 

does not constitute a precise value. 

F. Description of the Final Rule 

The Commission is issuing a rule 

establishing a standard for magnet sets 

and individual magnets that are 

marketed or intended for use with or as 

magnet sets. This section of the 

preamble describes the rule, including 

differences between the proposal and 

the final rule. 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 59973 

1. Scope, Purpose, and Effective Date— 

§ 1240.1 

This section of the final rule states 

that the requirements in 16 CFR part 

1240 are intended to reduce or eliminate 

an unreasonable risk of injury to 

consumers who ingest magnets that are 

part of magnet sets and individual 

magnets that are marketed or intended 

for use with or as a magnet set. The 

standard applies to all magnet sets, as 

defined in § 1240.2, and relevant 

individual magnets manufactured or 

imported on or after the date 180 days 

after publication of the final rule. 

Individual magnets. The scope of the 

final rule has been revised from the 

proposal so that the rule explicitly 

covers magnets that are sold 

individually and are intended or 

marketed to be used in the same way as 

magnet sets or as a part of a magnet set. 

The Commission is aware of one firm 

that sells magnet sets and also sells 

single magnet spheres at a per-magnet 

price through the same Web site on 

which the firm promotes and sells sets 

of magnets. This firm sells individual 

magnet spheres for 10 cents each and 

allows customers to purchase up to 

1,152 magnets in a single order. The 

firm charges a shipping rate of $5.00 for 

any quantity of individual magnets 

purchased. Another firm, Star, which 

recently settled an administrative 

complaint with the Commission, sold 

individual magnet spheres for between 

9 and 19 cents each (depending on the 

number ordered), and allowed 

customers to purchase up to 10,000 

magnets in a single order. 

Because the proposed rule described 

the scope of the rule as covering 

aggregations of magnets, magnets that 

are sold individually, arguably would 

not be subject to the requirements of the 

safety standard under the scope 

provision, as proposed. Thus, under the 

proposed scope, firms might be able to 

circumvent the safety standard 

requirements simply by pricing and 

selling magnet spheres individually that 

are intended to be used as part of an 

aggregation of magnets as a magnet set. 

Under the final rule, all magnet spheres 

intended for use as magnet sets, as 

defined by the rule, are subject to the 

requirements of the safety standard, 

whether they are sold individually or in 

the aggregate. 

Changing the word ‘‘children’’ to 

‘‘consumers.’’ The proposed scope 

section stated that the rule is intended 

to reduce or eliminate an unreasonable 

risk of injury to children. The final rule 

changes the word ‘‘children’’ to 

‘‘consumers’’ to clarify that the rule is 

intended to address risks posed to teens 

as well as young children. As the 

incident data make clear, both teens and 

young children have been harmed when 

swallowing magnets from magnet sets. 

Because the term ‘‘children’’ could be 

subject to interpretations that might 

exclude teens, the final rule uses the 

term ‘‘consumers.’’ 

2. Definitions—§ 1240.2 

This section of the final rule provides 

definitions for the terms ‘‘magnet set’’ 

and ‘‘individual magnet.’’ The final rule 

modifies the proposed definition of 

‘‘magnet set’’ to clarify certain aspects of 

the definition. The Commission does 

not intend for these modifications to 

change the scope of the rule from the 

proposal, but rather, to describe more 

clearly the products subject to the rule. 

The final rule also adds a definition for 

the term ‘‘individual magnet.’’ 

Definition of ‘‘magnet set.’’ To 

respond to comments on the NPR and 

to provide greater precision, the 

Commission has modified the definition 

of ‘‘magnet set’’ in the proposed rule by: 

• Removing the word ‘‘permanent’’; 

• Replacing the phrase ‘‘intended or 

marketed by the manufacturer 

primarily’’ with the phrase ‘‘intended, 

marketed or commonly used’’; 

• Replacing the word ‘‘desk toy’’ with 

‘‘item’’; and 

• Specifying factors that could 

indicate whether a magnet set meets the 

definition. 

The final rule definition removes the 

word ‘‘permanent’’ from the phrase 

‘‘separable, permanent magnetic 

objects’’ because the word ‘‘permanent’’ 

is superfluous. Any magnet, whether it 

maintains its magnetic strength 

permanently or not, can cause serious 

damage to intestinal tissue, if ingested. 

The final rule replaces the phrase, 

‘‘intended or marketed by the 

manufacturer primarily,’’ with the 

phrase: ‘‘intended, marketed or 

commonly used.’’ The revision seeks to 

prevent a manufacturer or importer of 

magnet sets from avoiding the rule by 

simply stating in marketing and other 

materials that the magnets are intended 

for uses other than those specified in the 

definition. For example, this 

modification will preclude firms from 

claiming that their products are 

intended as science kits to avoid the 

rule, if, in fact, the products are 

commonly used as magnet sets (i.e., as 

a manipulative or construction item for 

entertainment, such as puzzle working, 

sculpture building, mental stimulation, 

or stress relief). Common uses may be 

indicated by information found in 

consumer reports to the CPSC, firm 

reports to the CPSC, injury reports, and 

consumer comments/reviews posted on 

product Web sites stating that a product, 

regardless of whether it is intended or 

marketed by the manufacturer as such, 

was, in fact, being used as a 

manipulative or construction item for 

entertainment, such as puzzle working, 

sculpture building, mental stimulation 

or stress relief. This change clarifies that 

the common usage of a firm’s magnet 

products could be a consideration in 

determining whether the magnets are 

intended for use as manipulatives for 

entertainment, irrespective of the firm’s 

stated intentions. 

The final rule definition replaces the 

term ‘‘desk toy’’ with ‘‘item’’ to prevent 

excluding magnet sets from the scope of 

the rule if a particular product is not 

explicitly labeled or expressly marketed 

as a desk toy. 

The final rule specifies factors that are 

relevant in determining the intended 

uses of a magnet set. These are factors 

that Commission staff may consider in 

determining whether a product falls 

under the definition of ‘‘magnet set.’’ 

Explicitly stating these factors in the 

rule should provide clearer direction to 

firms and the public about what 

products will be covered by the rule. We 

may consider the manner in which the 

individual magnet or magnet set is 

promoted, marketed, and advertised. As 

part of this inquiry, staff may review the 

labeling and packaging of the product, 

information on the firm’s Web site about 

intended uses of the product, 

information in other promotional 

materials, and where and how the 

product is displayed at retail stores or 

on the Internet. In addition, we may 

consider the uses for which the product 

is commonly recognized by consumers. 

Information provided by consumers and 

firms, injury reports, and consumers’ 

online reviews or comments for the 

product are examples of sources that 

could be useful to determine what 

consumers consider to be the uses of the 

product. 

In developing this part of the ‘‘magnet 

set’’ definition, the Commission 

considered regulatory and statutory 

provisions that describe factors to be 

used in determining the intended use of 

a product. The Commission’s small 

parts regulation specifies factors 

relevant to a determination of which 

toys and other articles are intended for 

use by children under 3 years of age. 15 

U.S.C. 1501.2(b). The small parts 

regulation states: ‘‘In determining which 

toys and other articles are intended for 

use by children under 3 years (36 

months) of age, for purposes of this 

regulation, the following factors are 

relevant: the manufacturer’s stated 

intent (such as on a label) if it is a 

reasonable one; the advertising, 

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59974 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

promotion, and marketing of the article; 

and whether the article is commonly 

recognized as being intended for 

children under 3.’’ Id. The definition of 

‘‘children’s product’’ in the CPSA lists 

factors to consider in determining 

whether a product is primarily intended 

for children 12 years of age or younger. 

15 U.S.C. 2051(a)(2). The ‘‘magnet set’’ 

definition draws from both the 

regulatory definition in the small parts 

rule and the statutory definition of 

‘‘children’s product’’ to specify factors, 

which include the manufacturer’s stated 

intent, information provided with or on 

the product, and the commonly 

recognized uses of the product. 

The definition does not include other 

magnetic products, such as toys 

intended for children and jewelry. 

Magnets that are part of a toy intended 

for children are already covered by the 

requirements in ASTM F963–11, which 

is a mandatory CPSC standard. The 

definition also does not include magnets 

intended for industrial or commercial 

applications, such as motor 

components, magnetic bearings, 

magnetic couplings, welding clamps, oil 

filters, disc drives, loudspeakers, 

headphones, microphones, 

instrumentation, switches, and relays. 

Definition of ‘‘individual magnet.’’ 

The final rule adds a definition of 

‘‘individual magnet.’’ As discussed 

above, the Commission is aware that the 

firm that currently sells magnet sets that 

would be prohibited by the rule also 

sells individual magnets for use with 

magnet sets. The Commission seeks to 

prevent firms from circumventing the 

rule by selling individual magnets for 

the same uses as the magnet sets that 

have been involved in incidents, and at 

the same time claiming that the 

individual magnets are not subject to 

the rule because the magnets are not 

sold as sets. The individual magnets 

covered by the rule are only the magnets 

that are intended or marketed for use 

with or as a magnet set. The 

Commission does not intend to cover 

the many types of individual magnets 

that are sold for other uses, such as 

refrigerator magnets, collar stays, or 

various commercial and industrial uses. 

3. Requirements—§ 1240.3 

This section sets forth the 

requirements for magnet sets. If a 

magnet set contains a magnet that fits 

within the small parts cylinder that 

CPSC uses for testing toys, all magnets 

from that set must have a flux index of 

50 kG2 mm2 or less. Because the final 

rule covers individual magnets that are 

intended or marketed for use with or as 

a magnet set, the requirements section 

of the final rule states that individual 

magnets, as defined in the rule, must 

meet the requirements. The proposed 

rule set out the small parts and the flux 

index requirements in two subsections 

of § 1240.3. The final rule consolidates 

these provisions into one section. 

The small parts cylinder referenced in 

the rule is specified in 16 CFR part 

1501—Method for Identifying Toys and 

Other Articles Intended for Use by 

Children Under 3 Years of Age Which 

Present Choking, Aspiration, or 

Ingestion Hazards Because of Small 

Parts. If an object fits completely within 

the small parts cylinder, this indicates 

that the object is small enough to be 

ingested. If a magnet that is part of a 

magnet set (or an individual magnet, as 

defined) is too large to fit within the 

small parts cylinder, the magnet meets 

the standard, regardless of the magnet’s 

flux index. 

Small magnets (i.e., those that fit 

within the small parts cylinder) that are 

part of a magnet set (and individual 

magnets, as defined) must have a flux 

index of 50 kG2 mm2 or less. This limit 

is based on the level that is specified in 

ASTM F963–11. As discussed in the 

preamble to the NPR (77 FR 53781), the 

flux index of a magnet is an empirical 

value developed by ASTM to estimate 

the attraction force of a magnet. The flux 

index limit of 50 kG2 mm2 was 

developed by ASTM, with CPSC staff’s 

participation, to address injuries 

resulting from strong magnets that 

separate from toys. Because the magnets 

from toys involved in incidents had flux 

index measurements greater than 70 kG2

mm2,the ASTM working group chose a 

flux index of 50 kG2 mm2 as a cutoff 

because that value was significantly 

below the value for the magnets 

involved in incidents. 

4. Test Procedure for Determining Flux 

Index—§ 1240.4 

This section of the rule describes how 

to determine the flux index of magnets 

that are part of a magnet set. If the 

magnet set contains more than one 

shape or size of magnet, at least one of 

each shape and size is selected for 

testing. The flux index of the selected 

magnets is measured in accordance with 

the procedure set forth in sections 

8.24.1 through 8.24.3 of ASTM F963–11, 

Standard Consumer Safety 

Specification for Toy Safety. The flux 

index of the magnet is calculated by 

multiplying the square of the magnet’s 

surface flux density (in KGauss), by its 

maximum cross-sectional area (in mm2). 

The ASTM standard uses a gauss meter 

and probe that measures the surface flux 

density at 0.015 inches (0.38 mm) above 

the magnet’s surface. The area is 

measured at the largest cross-section of 

the magnet that is perpendicular to the 

axis of its magnetic poles. 

In the NPR, we noted that the 

products at issue are typically 

aggregations of magnets, rather than 

individual magnets that often separate 

from toys. We also observed that when 

magnets are aggregated, their magnetic 

strength may increase. We requested 

comments on whether it may be 

desirable to develop a method for 

testing the strength of aggregated 

magnets in addition to the method for 

testing the strength of individual 

magnets. We received no comments 

proposing methodologies for testing the 

strength of an aggregation of magnets. 

Furthermore, because there are no 

magnet sets currently on the market 

with magnets that have a 50 kG2 mm2

flux index or less, we believe that the 

aggregation scenario is adequately 

addressed in the rule. 

5. Findings—§ 1240.5 

In accordance with the requirements 

of the CPSA, we have made the findings 

stated in section 9 of the CPSA. The 

findings are discussed in section N of 

this preamble. 

G. Alternatives 

The Commission has considered 

alternatives to reduce the risk of injury 

related to the ingestion of magnets 

contained in magnet sets. However, as 

discussed below, the Commission does 

not believe that any of these alternatives 

would adequately reduce the risk of 

injury. 

1. Voluntary Recalls 

Although most of the companies that 

manufacture or import magnet sets have 

voluntarily agreed to stop selling (and in 

some cases recall) these products, and 

several retailers have agreed to recall 

and stop sale, the Commission has been 

unsuccessful in negotiating voluntary 

recalls and stop sales with one company 

that continues to market magnet sets. 

Pursuing voluntary recalls with current 

and possibly future manufacturers and 

importers of magnet sets would be 

reactive and would entail waiting for 

new incidents to occur rather than 

preventing them. Moreover, recalls 

would not prevent new entrants into the 

market in the future; a rule will set 

requirements that all products must 

meet from the effective date of the rule 

going forward. 

2. Voluntary Standard 

Currently, there is no applicable 

voluntary standard in effect. Before 

publication of the NPR, a group of 

magnet set importers and distributors 

requested that ASTM International 

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develop a voluntary standard for the 

labeling and marketing of these 

products. Specifically, these companies 

requested the creation of a voluntary 

standard to: (1) Provide for appropriate 

warnings and labels on packages of 

these magnets sets; and (2) establish 

guidelines for restricting the sale of 

these magnet sets to children, by not 

selling to stores that sell children’s 

products exclusively, and advising 

retailers not to sell the magnet sets in 

proximity to children’s products. To 

date, ASTM has not formed a committee 

to consider the development of a 

voluntary standard for magnet sets. 

Moreover, whether such a voluntary 

standard would be effective in reducing 

or eliminating the risk of injury 

associated with magnet sets is 

questionable. Despite companies’ 

marketing and labeling their products in 

an attempt to limit children’s exposure 

to magnets, ingestion incidents 

involving children have continued to 

occur; and labeling does not change the 

attractiveness of the product to children 

or the intrinsic play value of the magnet 

sets. From March 2010, when the firm 

with the largest share of the market 

undertook certain labeling 

enhancements and marketing 

restrictions, through June 2012, the 

Commission learned of 47 additional 

incidents of ingestion of magnets from 

magnet sets, 26 of which involved 

ingestion of that company’s magnets. As 

discussed more fully in the next section 

of this preamble, we do not believe that 

warnings would adequately reduce the 

injuries associated with magnet sets. 

We also note that Zen Magnets has 

announced its own ‘‘voluntary 

standard’’ for magnet sets requiring that: 

• Customers must be 18 years of age 

or older to purchase magnets and that 

the sales location must have an age floor 

for persons 18 and older or 21 and 

older, or age must be otherwise verified 

by Government ID; and 

• All stores must verbally remind 

customers to keep magnets away from 

mouths. 

We do not consider a standard issued 

by one company to be a ‘‘voluntary 

standard’’ as that term is used in the 

CPSA. Moreover, the measures that Zen 

magnets announced would have the 

same limitations discussed above. 

3. Warnings 

A possible alternative to the rule 

would be to require warnings with or on 

magnet sets. As discussed in the NPR 

preamble and in response to comments 

set forth in section E of this preamble, 

it is unlikely that warnings on the 

packages of magnet sets would 

significantly reduce the ingestionrelated injuries caused by high-powered 

magnets. Safety and warnings literature 

consistently identifies warnings as a less 

effective hazard-control measure than 

eliminating the hazard through design 

or guarding the consumer from a hazard. 

Warnings do not prevent consumer 

exposure to the hazard but rely on 

persuading consumers to alter their 

behavior in some way to avoid the 

hazard. With this product, warnings are 

particularly unlikely to reduce or 

eliminate the ingestion of these 

magnets. Warnings are especially 

unlikely to be effective among young 

children because children may lack the 

cognitive ability to appraise a hazard or 

appreciate the consequences of their 

own actions and may not understand 

how to avoid hazards effectively. 

Although older children are better at 

appreciating the hazards described in a 

warning, peer acceptance and social 

influences can strongly influence 

adolescent behavior. Because 

adolescents have a tendency to test 

limits and bend rules, warnings about 

keeping the product away from children 

could have the unintended effect of 

making the product more appealing to 

some children. For example, warnings 

against specific uses, such as mimicking 

piercings, might actually encourage this 

behavior among older children. If 

children repeatedly use the product in 

this way, without ingesting the magnets, 

these children most likely will become 

convinced that the hazard is not 

especially likely, or is not relevant to 

them. 

In the NPR, we noted that staff 

generally found the content of warnings 

accompanying magnet sets to be lacking 

in several ways. For example, the 

warnings often did not describe the 

incident scenarios prevalent among 

older children and adolescents, whom 

caregivers may not believe are likely to 

put magnets into their mouth. Warnings 

lacked detailed information that would 

allow consumers to understand how 

swallowing magnets differs from 

swallowing other small parts, or how 

magnets sticking together could pose a 

hazard because the magnets will not 

simply pass through the child’s system. 

Without a clear, explicit, and accurate 

description of the nature of the hazard 

and its consequences, consumers may 

find the warning implausible. Moreover, 

even with enhanced warnings, 

consumers are unlikely to comply with 

the action recommended in the warning. 

Even if warnings could effectively 

communicate the ingestion hazard, the 

consequences of ingesting magnets, and 

appropriate hazard-avoidance measures, 

warnings still may not be effective if 

consumers do not concur with the 

content of the warning. Warnings are 

particularly likely to be ineffective 

among caregivers of older children. 

Unless caregivers are convinced that 

their older child is likely to mimic lip, 

nose, or similar piercings, or perform 

other activities that might lead these 

adolescents to place magnets into their 

mouth or nose, caregivers may doubt 

that the warnings are relevant to their 

child, despite the warnings’ assertions 

to the contrary. 

As noted in the NPR preamble and in 

section E of this preamble, even if 

caregivers believe the warnings, several 

factors may limit compliance. 

Caregivers, particularly those with older 

children, might feel significant social 

pressure from children who are 

accustomed to using the magnet sets. 

Caregivers who own the product and 

attempt to heed the warnings might find 

it quite difficult to prevent their child’s 

access to the magnets and still keep the 

product reasonably accessible for their 

own use. 

The cost of compliance with warnings 

for these products is high. Caregivers 

may be reluctant to secure the product 

from a child after every use. Identifying 

an appropriate location to store the 

magnet sets may dissuade consumers 

from doing so, particularly for a product 

often marketed to be for ‘‘stress relief.’’ 

Caregivers may underestimate their 

child’s abilities and place the product in 

locations that seem secure but that are 

still accessible to the child. All of these 

factors may lead caregivers to reject the 

warning message. 

Based on these concerns about the 

likely ineffectiveness of warnings for 

magnet sets, we do not believe that 

warning labels would adequately reduce 

the risk of injury presented by these 

products. 

4. Packaging Restrictions 

Theoretically, magnet sets could be 

sold with special storage containers to 

reduce the likelihood that children 

would access the magnets. Possible 

storage might include a container that 

would clearly indicate when a magnet is 

missing from the set. Such a 

requirement might prevent injuries 

resulting from a small number of 

magnets being separated from a set 

without the owner being aware. 

However, many consumers may not use 

such containers because using them 

could require time to gather the magnets 

and put them in the container, or 

consumers may be reluctant to 

dismantle a shape or structure that took 

them time and effort to construct. Thus, 

the effectiveness of such special 

containers to reduce ingestions is 

doubtful. Finally, it is not clear that the 

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59976 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

6Sedney, C.A., & Smith, T.P. (2012). Human 

factors assessment of strong magnet sets. CPSC 

memorandum to Jonathan D. Midgett, Project 

Manager, U.S. Consumer Product Safety 

Commission, Bethesda, MD. 

7Although the definition of ‘‘magnet set’’ 

changed slightly from the NPR, and the rule extends 

to the individual magnets sold for use as or with 

a magnet set, these changes did not affect the scope 

of products considered in conducting the Final 

Regulatory Analysis. 

Commission would have the regulatory 

authority to issue a rule prescribing 

requirements for packaging, other than 

child-resistance requirements 

(discussed below). 

Another alternative might be to 

require that magnet sets be sold in 

child-resistant packaging. Childresistant packaging, also called ‘‘special 

packaging,’’ is packaging that is 

significantly difficult for children under 

five years of age to open or obtain a 

harmful amount of the substance. 15 

U.S.C. 1471(4). The ability of such an 

approach to reduce ingestion injuries of 

magnets from magnet sets would be 

limited. Child-resistant packaging 

would not prevent teens and 

adolescents (and even some younger 

children) from opening the packaging. 

Additionally, the packaging would have 

to be secured after each use. According 

to the Division of Human Factors, it is 

unlikely that adults would accept childresistant packaging for a product like 

the magnet sets because of the level of 

inconvenience involved in returning the 

magnets to the package.6 Additionally, 

for the reasons described above, 

consumers may leave magnets out of 

their container. 

5. Restrictions on Sales of Magnet Sets 

Another possible alternative to 

address the hazard of children ingesting 

magnets from magnet sets might be to 

limit the places where magnet sets are 

sold, keeping magnet sets away from toy 

stores, children’s sections of stores, and 

other such locations. Sales limitations 

or requirements for strong warnings 

might also be required on Web sites that 

offer magnet sets for sale on the Internet. 

However, these restrictions are unlikely 

to reduce ingestions significantly 

because children can access magnet sets 

from many sources other than stores. 

Moreover, sales restrictions are unlikely 

to deter teens. Finally, the Commission 

does not have the regulatory authority to 

impose such sales restrictions by rule. 

6. Adoption of a Standard With 

Different Performance Requirements 

Another alternative to the rule would 

be to establish a different set of 

requirements. For example, such 

requirements might allow a different 

flux index for magnet sets, different 

specifications regarding shapes and 

sizes of magnets within the scope of the 

standard, or some other criteria that 

have yet to be developed (but would not 

be as stringent as the rule requires). If 

different requirements would be 

effective, they could reduce the risk of 

injury associated with magnet sets, and 

at the same time, potentially allow the 

product to maintain the qualities that 

would facilitate use by adults. It is 

unclear, however, whether alternative 

requirements for the sizes and flux 

index of magnets would eliminate or 

substantially affect the physical 

qualities of the products that make them 

enjoyable for adults. 

A competing concern is whether an 

alternative set of requirements could 

reasonably be expected to reduce or 

eliminate the risk of injury associated 

with magnet sets. Because the hazard 

presented by these magnet sets is 

ingestion by children, we are concerned 

that any requirements that allow 

magnets with a greater attractive force 

and permit sizes or shapes that could fit 

through the small parts cylinder would 

not address the risk of injury 

adequately. 

As noted in Section E, some 

commenters suggest that, as an 

alternative to the rule, the Commission 

could require manufacturers to add an 

aversive (bittering) agent to the product. 

However, as discussed in the response 

to Comment 18, aversives are unlikely 

to be effective in deterring initial 

ingestion by young children because 

children frequently ingest unpalatable 

substances. 

7. No Action 

Another option for the Commission is 

to take no regulatory action to address 

the risk of injury posed by magnet sets. 

As the NPR preamble mentioned, it is 

possible that, over time, increased 

awareness of the hazard could result in 

some reduction in ingestions. The 

magnitude of any such reduction in 

incidents is uncertain. The Commission 

could rely entirely on enforcement 

activities, rather than regulatory action, 

to address the risk of injury posed by 

magnet sets. However, as discussed in 

the ‘‘voluntary recall’’ section above, 

several manufacturers/importers of 

magnet sets have refused to participate 

in any recall or stop sale of their 

products; and in any event, recalls and/ 

or stop sales conducted by these 

companies would not prevent new 

entrants into the market in the future. 

H. Final Regulatory Analysis 

The Commission is issuing this rule 

under sections 7 and 9 of the CPSA. The 

CPSA requires that the Commission 

prepare a final regulatory analysis and 

publish the final regulatory analysis 

with the text of the final rule. 15 U.S.C. 

2058(f). This section of the preamble 

presents the final regulatory analysis of 

the rule. 

1. Need for and Description of the Rule 

The CPSC has received information 

regarding injuries with, and hazards 

posed by, sets of small, powerful 

magnets. Some of these injuries have 

required surgical removal of individual 

magnets originally contained in the sets 

and ultimately ingested by children. 

Reported magnet ingestions have ranged 

from young children, who put the 

magnets in their mouths, to adolescents 

and teens, who experimented with the 

sensation of magnets (e.g., on their 

braces), or paired magnets to mimic 

tongue or lip piercings. These behaviors 

have led to the accidental swallowing of 

the powerful magnets, with unexpected, 

and sometimes severe, medical 

consequences, including significant 

damage to the gastrointestinal tract 

(Inkster, 2012) and death. From January 

1, 2009 through December 31, 2013, 

there were an estimated 2,900 possible 

magnet set, emergency departmenttreated ingestions. There was also one 

fatal incident in 2013 (Garland, 2014). 

The final rule establishes a standard 

limiting the size and strength of magnets 

in a magnet set. The rule applies to 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.7 Under the 

rule, magnet sets would not comply 

with the standard if: (1) The individual 

magnets are small enough to fit into the 

small parts cylinder (e.g., a ball-shaped 

magnet with a diameter of less than 31.7 

mm, or 1.25 inches); and (2) the 

individual magnets have a flux index of 

more than 50 kG2 mm2, as measured by 

the procedures for determining the flux 

index described in the toy standard. 

Because these requirements already 

apply to magnets used in products 

marketed as toys for children, the rule 

essentially extends the toy requirements 

to the subject magnet sets. 

The current designs of magnet sets 

containing small powerful magnets of 

the type that are the subject of this 

regulatory proceeding (which are 

typically comprised of individual ballshaped magnets with diameters of 5mm 

and, based on testing by CPSC staff, 

having flux index values in the range of 

400–500) would not meet the 

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8Sales of Liberty Balls have not come close to 

matching the levels observed for the subject magnet 

sets (estimated at 800,000 sets and $20 million 

annually, and discussed below). Based upon 

available information, sales revenue for Liberty 

Balls appears to have amounted to about $200,000 

during October and November 2013, or about 

$100,000 per month. (See http://unitedweball.org/, 

accessed February 25, 2014). By March 2014, 

reported sales revenue from Liberty Balls had 

increased to about $250,000 (Helm, 2014), 

suggesting that for December 2013 through February 

2014, sales were only about $15,000 (($250,000– 

$200,000)/3) per month. By comparison, monthly 

sales for the subject magnet sets were about $1.7 

million on average. (CPSC staff conducted no 

independent evaluation of the accuracy of these 

figures for Liberty Balls.) 

9However, small neodymium-iron-boron magnets 

previously have been, and continue to be, marketed 

by firms such as magnet suppliers and distributors 

of educational products. 

10One firm’s larger magnet balls are reportedly 

made with cores of strontium ferrite (SrO·6Fe2O3), 

rather than neodymium-iron-boron. 

11One importer reported to a CPSC Compliance 

investigator that some of the magnet sets it sold and 

shipped to U.S. consumers were made from bulk 

magnets received from its supplier in China that the 

importer packaged for sale. 

requirements of the standard. To meet 

the requirements, the individual 

magnets would have to be much weaker 

(i.e., have a flux index of 50 kG2 mm2

or less, rather than an index of 400 to 

500); or the magnets would have to be 

much larger (i.e., be at least 31.7 mm 

(1.25 inches) in diameter rather than 5 

mm). Either requirement eliminates a 

distinctive product attribute and would 

limit greatly the magnet sets as 

candidates for manipulative novelty 

products. Magnets with a flux index of 

50 kG2 mm2 or less may be too weak for 

building sculptures or too weak to be 

used in other construction activities; 

magnets with diameters of 1.25 inches 

or more would be too large to have any 

practical value in such activities. 

Staff has identified magnet sets in the 

market, Liberty Balls, marketed by 

Assemble, LLC, that would meet the 

definition of magnet sets, would meet 

the performance standard, and might 

serve some of the uses of magnet sets 

that would not meet the standard. The 

Liberty Balls magnet sets consist of a set 

of eight large ball-shaped magnets. The 

Liberty Balls magnet sets consist of a set 

of eight large ball-shaped magnets 

selling for $30 to $40 per set. The Ball 

of Rights generally consists of a set of 

two large ball-shaped magnets selling 

for $10 to $13 per set. The balls in these 

sets are 33 mm (1.3 inches) in diameter, 

and consist of ferrite magnets, rather 

than rare earth materials (See http://

unitedweball.org/, accessed February 

25, 2014). 

Even though these products satisfy 

the performance requirements of the 

rule, for purposes of the economic 

analysis, we do not consider any 

impacts due to the entry of Liberty Balls 

and Ball of Rights in the market because 

we do not consider these sets to be good 

substitutes for the subject magnet sets. 

To be considered a good or close 

substitute, we would need to observe 

that consumers, who would have 

purchased the subject magnet sets (if 

they had remained available at 

historical prices and quantities) are 

now, to a large degree, purchasing the 

Liberty Balls sets instead, and the 

available data suggest otherwise.8

Moreover, Liberty Balls magnet sets are 

not marketed as a substitute for the 

smaller and powerful neodymium 

magnets sets. Rather, Liberty Balls 

apparently have been sold specifically 

to generate funds to defend the producer 

against the recently settled lawsuit with 

the CPSC (Helm, 2014). 

Rather than develop a complying 

alternative that serves the same niche as 

the subject magnet sets, producers of 

magnet sets have opted to exit the 

market altogether. Although Liberty 

Balls comply with the standard, we base 

the benefit cost analysis presented 

below on the disappearance of the 

noncompliant magnet sets containing 

small powerful magnets from the 

market. 

2. Description of the Product and 

Market 

Magnet sets that would be affected by 

the scope of the rule are comprised of 

small, powerful magnetic balls, cubes, 

and/or cylinders that can be arranged in 

many different geometric shapes. These 

magnet sets were introduced in 2008, 

but 2009 marked the first year with 

significant sales to U.S. consumers.9

Most magnet sets have been sold in sets 

of either 125 balls or sets of 216 to 224 

balls; although some firms have sold 

just a few balls as extras or 

replacements, others have sold large sets 

of more than 1,000 magnetic balls. 

Product information provided by 

marketers indicates that the most 

common magnet size is approximately 5 

millimeters in diameter; although balls 

as small as about 3 millimeters have 

been sold, in addition to sets of larger 

magnet balls (perhaps 15 millimeters to 

25 millimeters in diameter).10 In 

addition to magnetic ball sets, sets of 

small magnetic cubes have also been 

sold, although magnetic cubes have 

comprised a relatively small share of the 

market. In 2012, the leading marketer of 

magnet sets also added to its desk toy 

product line small magnetic rods 

intended to be used with magnetic balls 

to make geometric shapes. 

Based on information reviewed on 

product sales, including reports by firms 

provided to the Office of Compliance 

and Field Operations, the number of 

such magnet sets that were sold to U.S. 

consumers from 2009 through mid-2012 

may have totaled about 2.7 million sets, 

with a value of roughly $50 million. 

This value reflects a combination of 

retail sales directly to consumers 

(through company Web sites and other 

Internet retail sites) and sales to retailers 

who marketed the products. A review of 

retail prices reported by importers, and 

observed on Internet sites during that 

period, suggested prices typically 

ranging from about $20 to $45 per set, 

with an average price of about $25. 

Larger sets of more than 1,000 

individual magnets reportedly were sold 

at prices as high as $300, depending on 

the number of magnets and the type of 

packaging. Such larger sets only 

accounted for about 0.5 percent of all 

sets (and a little over 2 percent of all 

magnets) sold to consumers during the 

period from 2009 to mid-2012. 

The small, powerful magnets to be 

affected by the rule are made of alloys 

of neodymium, iron, boron, or other rare 

earth metals. This composition has been 

confirmed in analyses of product 

samples by CPSC staff from the 

Directorate for Laboratory Sciences. The 

magnetized neodymium-iron-boron 

cores 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. 

Nearly 100 percent of neodymium and 

other rare earth metals are now mined 

in China, which also reportedly holds 

close to a worldwide monopoly on the 

production of neodymium-iron-boron 

magnets (Dent, 2012). Based on 

available information, all of the small 

magnets used in magnet sets, as well as 

most of the finished and packaged 

products that would be subject to CPSC 

regulation, are produced by 

manufacturers located in China.11

a. Importers of Magnet Sets 

As noted above, none of the magnets 

found in sets that are within the scope 

of the rule are produced domestically. 

Nearly all of the firms that have 

marketed magnet sets are believed to 

have imported them packaged and 

labeled for sale to U.S. consumers. 

Several Chinese manufacturers have the 

facilities and production capacity to 

meet the orders of U.S. importers. 

The Directorate for Economic 

Analysis identified about 25 U.S. firms 

and individuals who imported magnet 

sets for sale in the United States in 

2012. The combined sales of the top 

seven firms have probably accounted for 

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59978 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

12More than 40 such stores shipping magnet sets 

directly from Hong Kong or China were identified 

in a brief review of product offerings on the Internet 

site in 2012. 

13Although other importers were identified, these 

other importers were believed to sell so few magnet 

sets that staff did not have the resources to pursue 

these matters on a case-by-case basis against all 

known importers. Thus, targeting for corrective 

actions was limited to 13 firms believed to account 

for the largest portion of the market. 

14For example, see the December 19, 2012, CPSC 

press release related to the administrative 

complaint filed against Star Networks (http://

www.cpsc.gov/en/Newsroom/News-Releases/2013/

CPSC-Sues-Star-Networks-USA-Over-HazardousHigh-Powered-Magnetic-Balls-and-Cubes/). 

the great majority (perhaps more than 

98%) of units sold since the product 

was introduced in 2008. One firm, 

Maxfield & Oberton Holdings, LLC, is 

believed to have held a dominant 

position in the market for magnet sets 

from its entry in the market in 2009, 

until it ceased operations late in 2012. 

That firm, and a few of the larger firms 

(including a firm based in Canada with 

a branch office in the United States), 

have marketed the products through 

accounts with retailers, in addition to 

selling directly to consumers on the 

Internet, using their own Web sites or 

other Internet shopping sites. 

Some of the firms with smaller sales 

volumes reported to Compliance staff 

that they mainly marketed products 

(sourced from manufacturers in China) 

through Internet sales arrangements 

with Amazon.com, which held stock for 

them and processed orders. A review of 

the product listings of the Internet 

retailer found that several other firms 

had similar business models. Other U.S. 

firms and individuals have sold magnet 

sets they imported from China through 

Internet ‘‘stores’’ they maintain on eBay. 

In addition to products offered for sale 

by U.S. importers, consumers have also 

been able to purchase magnet sets 

directly from sources in Hong Kong or 

China, many of which marketed 

products through ‘‘stores’’ on eBay.12

b. Market Disruption Related to Other 

CPSC Actions on Magnet Sets 

CPSC Compliance staff contacted 13 

magnet set importers for corrective 

actions before the Commission 

published the NPR.13 At staff’s request 

in July 2012, 10 firms agreed to stop the 

manufacture, importation, distribution, 

and sale of high-powered, manipulative 

magnetic products of the types that 

would be subject to the rule. Three other 

firms did not stop selling the products 

(although one of these firms initially 

had agreed to cease sales voluntarily). 

The Commission voted to initiate 

administrative actions seeking a 

determination that certain magnet sets 

are a substantial product hazard, along 

with an order requiring the firms that 

import these products cease sales and 

offer refunds to customers.14 The three 

firms that have been subject to the 

administrative complaints by the CPSC, 

and the 10 firms that have agreed to stop 

sales voluntarily, accounted for virtually 

all sales of the products during the 

period from 2009 to mid-2012. 

Additionally, the largest importer of 

magnet sets subject to the rule (one of 

the three firms sued in administrative 

complaints), Maxfield & Oberton 

Holdings, LLC, announced that it ceased 

operations, effective December 27, 2012. 

Another of the three firms sued in 

administrative complaints, Star 

Networks USA, LLC, agreed to stop 

further sales of magnet sets in July 2014, 

leaving just one major magnet set 

importer, Zen Magnets, LLC. As a result 

of these actions and events, sales of the 

subject magnet sets currently are 

dramatically lower than they were at the 

time of the enforcement actions. 

3. Evaluation of the Rule 

a. Societal Costs and the Potential 

Benefits 

i. Estimated Societal Costs of Injuries 

The purpose of the final rule is to 

prevent serious intestinal injuries that 

can result when children ingest two or 

more of the magnets from a subject 

magnet set (or one magnet and another 

metallic object). The final rule would 

establish a standard for magnet sets and 

individual magnets that are marketed or 

intended for use as parts of a magnet set. 

Distributing magnet sets and individual 

magnets intended for magnet sets that 

do not meet specified requirements 

would be prohibited. Therefore, a 

reduction in injuries would be the 

resulting benefit of the rule. 

Baseline. Our analysis of the potential 

benefits of the rule focuses on injuries 

reported through the National Electronic 

Injury Surveillance System (NEISS), a 

probability sample of U.S. hospital 

emergency departments that can be used 

to provide national estimates of 

product-related injuries initially treated 

in U.S. hospital emergency departments. 

The expected benefits of a product 

safety regulation must be measured 

against a baseline representing the best 

assessment of how the market would 

operate and how products would be 

used in the absence of the intervention. 

In the case of the rule prohibiting the 

subject magnet sets, the baseline would 

represent the time period before the 

actions by which the CPSC: (1) 

Requested that importers and retailers 

stop selling the magnet sets; (2) initiated 

administrative actions against importers 

that refused to stop selling the magnet 

sets (each of which seeks an order 

directing the importer to offer refunds in 

exchange for the return of purchased 

magnet sets); (3) publicized corrective 

actions, whereby certain importers and 

retailers of magnet sets agreed to 

provide refunds to consumers in 

exchange for the return of purchased 

magnet sets; and (4) issued warnings to 

the public regarding the grave dangers 

that the subject magnet sets posed to 

children. Because CPSC compliance 

actions have significantly altered the 

state of the market, the environment 

before these actions occurred represents 

the best approximation of how the 

market would have operated in the 

absence of CPSC intervention and is the 

appropriate reference baseline for 

evaluating the impact of the rule. 

Consequently, although the Directorate 

for Epidemiology’s hazard analysis 

described injuries involving magnets 

that occurred from 2009 through 

December 2013 (Garland, 2014), our 

analysis will be limited to the period 

from 2009 through June 2012, before the 

request to stop sales, administrative 

actions, recalls, and public warnings 

ensued. 

Based on a review of incident 

narratives coded from emergency 

department medical records for magnet 

ingestion cases obtained from NEISS 

hospitals, the Directorate for 

Epidemiology staff has identified 86 

ingestions of high-powered and/or ballshaped magnets, which occurred from 

2009 through June 2012. These 

incidents were determined to involve, 

or possibly involve, the magnets of 

interest. Although manufacturer or 

brand name information is rarely 

available in the medical records 

extracted for NEISS, nine of the 86 

NEISS-reported cases (10.5%) 

mentioned a brand name of magnet sets 

that are the magnets of interest; 77 cases 

(89.5%) were determined possibly to 

have involved the magnets of interest 

because the case narratives included 

terms such as ‘‘high powered,’’ 

‘‘magnetic ball,’’ ‘‘magnetic marble,’’ 

‘‘BB size magnet,’’ or ‘‘magnetic beads’’ 

(Garland, 2014). 

Injuries and Societal Costs. Based on 

the 86 NEISS-reported magnet cases, 

there were an estimated 2,138 injuries 

treated in U.S. hospital emergency 

departments from 2009 through June 

2012. About 11 percent of these NEISSreported cases were injuries requiring 

hospitalization, as opposed to the 89 

percent that were treated and released. 

The benefits of the rule can be estimated 

as the reduction in the societal costs 

associated with the injuries that would 

be prevented by the rule. The 

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15A detailed description of the cost components, 

and the general methodology and data sources used 

to develop the CPSC’s Injury Cost Model, can be 

found in Miller et al. (2000). 

16Although no deaths were reported during the 

baseline time period for this analysis, one death 

involving the subject magnets was reported in 2013. 

Directorate for Economic Analysis bases 

estimates of the societal costs of 

emergency department-treated magnet 

injuries on the CPSC’s Injury Cost 

Model (ICM) (Miller et al., 2000). 

The ICM is fully integrated with 

NEISS and provides estimates of the 

societal costs of injuries reported 

through NEISS. The major aggregated 

components of the ICM include: 

medical costs; work losses; and the 

intangible costs associated with lost 

quality of life or pain and suffering.15

Medical costs include three categories 

of expenditure: (1) Medical and hospital 

costs associated with treating the injury 

victim during the initial recovery period 

and in the long run, 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. Cost estimates for these 

expenditure categories were derived 

from a number of national and state 

databases, including the National 

Healthcare Cost and Utilization 

Project—National Inpatient Sample and 

the Medical Expenditure Panel Survey, 

both sponsored by the Agency for 

Healthcare Research and Quality. 

Work loss estimates, based on 

information from the National Health 

Interview Survey and the U.S. Bureau of 

Labor Statistics, as well as a number of 

published wage studies, include: (1) The 

forgone earnings of parents and visitors, 

including lost wage work and 

household work, (2) imputed long term 

work losses of the victim that would be 

associated with permanent impairment, 

and (3) employer productivity losses, 

such as the costs incurred when 

employers spend time juggling 

schedules or training replacement 

workers. The earnings estimates were 

updated most recently with weekly 

earnings data from the Current 

Population Survey conducted by the 

Bureau of the Census in conjunction 

with the Bureau of Labor Statistics. 

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 

(Rice et al., 1989). The Injury Cost 

Model develops a monetary estimate of 

these intangible costs from jury awards 

for pain and suffering. While these 

awards can vary widely on a case-bycase basis, studies have shown them to 

be systematically related to a number of 

factors, including economic losses, the 

type and severity of injury, and the age 

of the victim (Viscusi, 1988; Rodgers, 

1993). Estimates for the Injury Cost 

Model were derived from a regression 

analysis of about 2,000 jury awards in 

nonfatal product liability cases 

involving consumer products compiled 

by Jury Verdicts Research, Inc. 

In addition to estimating the costs of 

injuries treated in U.S. hospital 

emergency departments and reported 

through NEISS, the Injury Cost Model 

uses empirical relationships between 

emergency department injuries and 

those treated in other settings (e.g., 

physicians’ offices, clinics, ambulatory 

surgery centers, and direct hospital 

admissions) to estimate the number, 

types, and costs of injuries treated 

outside of hospital emergency 

departments (Miller et al., 2000; 

Lawrence, 2013). Thus, the Injury Cost 

Model allows us to expand on NEISS by 

combining (1) the number and costs of 

emergency department injuries with (2) 

the number and costs of medically 

attended injuries treated in other 

settings to estimate the total number of 

medically attended injuries and their 

costs across all treatment levels. 

Table 1 below provides annual 

estimates of the injuries and the societal 

costs associated with ‘‘high-powered 

and/or ball-shaped magnet ingestions’’ 

that involve, or possibly involve, the 

magnets that are the subject of the rule. 

As shown in Table 1, the 2009 through 

June 2012 NEISS estimates suggest an 

estimated annual average of about 610 

emergency department-treated injuries, 

including 544 injuries that were treated 

and released and 66 injuries that 

required hospitalization. About 60 

percent of these emergency departmenttreated ingestions involved children 

ages 4 through 12 years. Just over half 

of the magnet cases from the emergency 

departments of the hospitals that 

comprise the NEISS sample appear to 

have involved the ingestion of more 

than one magnet. Additionally, based on 

estimates from the ICM, there were 

another 319 injuries treated annually in 

locations other than hospital emergency 

departments.16

TABLE 1—ESTIMATED AVERAGE ANNUAL MEDICALLY ATTENDED INJURIES AND ASSOCIATED SOCIETAL COSTS FOR HIGHPOWERED AND/OR BALL-SHAPED MAGNET INGESTIONS THAT WERE DETERMINED TO INVOLVE, OR POSSIBLY INVOLVE, THE MAGNETS OF INTEREST, 2009–JUNE 2012 

Injury disposition Estimated 

number 

Estimated 

societal costs 

($ millions) * 

Treated and Released from Hospital Emergency Department (NEISS) ................................................................. 544 11.4 

Admitted to Hospital Through the Emergency Department (NEISS) ...................................................................... † 66 8.6 

Medically Treated Outside of Hospital Emergency Department (ICM) ............................................................ 319 8.6 

Total Medically Attended Injuries ............................................................................................................................ 929 28.6 

* In 2012 dollars. 

† According to the Directorate for Epidemiology, the estimated number of hospital-admitted, emergency department-treated injuries is a not a 

reliable estimate because of the small number of cases upon which the estimate was based. 

After including the injuries treated 

outside of hospital emergency 

departments, there was an estimated 

annual average of about 929 medically 

attended injuries involving ingestions of 

the magnets of interest. Based on the 

ICM, these injuries resulted in annual 

societal costs of about $28.6 million (in 

2012 dollars) during the 2009 to June 

2012 time period. The injury cost 

estimates differ from those presented in 

the preliminary regulatory analysis 

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59980 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

17Common commercial and industrial 

applications of small neodymium-iron-boron 

magnets include their use in holding systems, 

motors (DC, servo, linear, and voice coil), magnetic 

bearings, magnetic couplings, jewelry, welding 

clamps, oil filters, disc drives, loudspeakers, 

headphones, microphones, instrumentation, 

switches, and relays. 

because of an expansion of the baseline 

time period from 2009 through 2011 to 

2009 through June 2012 and because of 

updates to the CPSC’s Injury Cost Model 

(Lawrence, 2013). The injury cost 

estimates were also inflated from 2011 

to 2012 dollars. 

The average estimated societal costs 

per injury was about $27,000 for injuries 

treated in locations other than 

emergency departments (such as 

physicians’ offices, clinics, ambulatory 

surgery centers, or direct hospital 

admissions); about $21,000 for injuries 

that were treated and released from 

emergency departments; and about 

$130,000 for injuries that required 

admission to the hospital for treatment. 

Medical costs and work losses 

(including work losses of caregivers) 

accounted for about 30 percent of these 

injury cost estimates, and the less 

tangible costs of injury associated with 

pain and suffering accounted for about 

70 percent of the estimated injury costs. 

Uncertainty. As noted in the 

preliminary regulatory analysis, there is 

uncertainty concerning these estimates. 

Some of the cases described as 

involving the magnets of interest that 

were included in Table 1 may not have 

involved the magnets that are the 

subject of the rule. As noted above, 

about 90 percent of the cases upon 

which the table was based were 

described as only possibly involving the 

magnets of interest because NEISS 

narratives are not required to list 

manufacturer or brand name. Hence, it 

is possible that Table 1 overstates the 

societal costs associated with the 

magnets that would be included in the 

rule. 

On the other hand, in addition to the 

magnet cases upon which the table was 

based, there were also 230 NEISS cases 

(representing about 1,526 emergency 

department-treated injuries annually), 

in which the magnet type was classified 

as ‘‘unknown or other.’’ These cases 

included narratives that mentioned that 

a magnet was involved but presented 

insufficient information to classify the 

magnet type. Consequently, to the 

extent that the unknown magnet types 

involved magnets that would be covered 

by the rule, the Table 1 results would 

tend to understate the societal costs 

associated with the magnets subject to 

the rule. 

ii. Estimated Benefits of the Rule 

As noted above, the benefits of the 

magnet rule would be the reduction in 

the societal costs of the injuries that 

would be prevented. Because the rule 

will eliminate from the market all 

magnet sets involved in the ingestion 

injuries described above, all injuries 

that would have occurred in the absence 

of a rule would be prevented. Although 

no deaths involving magnet sets 

occurred during the time period covered 

by our analysis, we know of a magnet 

set related fatality that occurred in 2013. 

Thus, we anticipate that the rule would 

prevent future fatalities as well as 

injuries. However, if children, 

adolescents, and teens cannot play with 

or use the prohibited magnets, they 

could play with or use substitute 

products (including high-powered 

magnets intended for other uses 17) that 

also may result in injury. Hence, the 

overall benefits of the rule should be 

measured as the net reduction in 

injuries and the concomitant reduction 

in societal costs that would result. 

Based on the injury estimates presented 

in Table 1, and given the absence of 

information on expected use and risks 

of alternative products or activities, the 

expected benefits of the rule might 

amount to about $28.6 million annually. 

b. Potential Costs of the Rule 

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 a 

rule that eliminates certain magnetic 

sets would consist of: (1) The lost use 

value experienced by consumers who 

would no longer be able to purchase 

magnets that do not meet the standard 

at any price; and (2) the lost income and 

profits to firms that could not produce 

and sell non-complying products in the 

future. The same baseline used in the 

benefits assessment, 2009 to June 2012, 

is used for the cost analysis. 

i. Lost Utility to Consumers 

First, consider the lost utility to 

consumers. We cannot estimate in any 

precise way the use value that 

consumers receive from these products, 

but 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.’’ In 

the case of the magnet sets, given sales 

of about 800,000 sets annually during 

the 2009 to June 2012 time period, and 

assuming an average retail price of 

about $25 in 2012, consumer 

expenditures would amount to about 

$20 million annually in 2012 dollars. 

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, where B equals 

$25, and E equals 800,000 units. 

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18The concept of consumer surplus is discussed 

in OMB’s Circular A–4 (OMB, 2003) and has been 

applied in several CPSC staff analyses, including 

Tohamy (2006) and Rodgers (2004). 19 If the above graph represents the market for 

tickets, the demand curve describes the quantity of 

tickets demanded at each price (i.e., the quantity of 

tickets consumers are willing and able to purchase 

at each price). In this example, the $150 that the 

consumer would have been willing to pay for the 

ticket is represented on the demand curve at a point 

to the left of point D. The consumer surplus is given 

by the relevant point on the demand curve (i.e., 

where price = $150), minus the market clearing 

price of $100. 

20To say that the demand for a product is price 

‘‘inelastic’’ means that the quantity demanded tends 

to be insensitive to changes in the price of the 

product. Gasoline is an example of a product with 

an inelastic demand. Consumers are not likely to 

reduce substantially their purchase of gasoline (at 

least in the short run), even if the price increases 

substantially. 

The 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 had to pay (McCloskey, 

1982).18 For example, although tickets 

to a concert or football game might sell 

for $100 each, some consumers who buy 

them for $100 would have been willing 

to pay $150 per ticket. In other words, 

they paid $100 and received benefits 

that they value at $150. Hence, each of 

these consumers would receive a 

consumer surplus of $50.19

In general, the use value of the magnet 

sets obtained by consumers is 

represented by the area of the trapezoid 

OCDE. However, the prospective loss in 

use value associated with the rule, 

which would prohibit certain magnet 

sets that do not comply 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 prohibited product, but they 

would, nevertheless, still have the $20 

million (represented by the rectangle 

OBDE) that they would have spent on 

magnet sets in the absence of a rule. 

Although consumers would no longer 

be able to purchase magnet sets, which 

would have been their first choice, they 

can use this money to buy other 

products providing use value. 

We have no information regarding 

aggregate consumer surplus; and hence, 

no information on the amount of utility 

that would be lost from a magnet set 

rule. Although the magnet sets clearly 

provide ‘‘utility’’ to purchasers, magnet 

sets are not necessities. Consequently, 

the demand for magnet sets is probably 

not price inelastic, a factor that would 

tend to reduce estimates of utility 

losses.20 Additionally, if the magnetic 

sets are ‘‘faddish,’’ they may not be the 

type of product that will be used 

intensely by consumers over long 

periods of time. However, if, for 

example, consumers who purchased the 

magnetic sets at an average price of $25 

would have been willing to spend, on 

average, $35 per set, the lost utility from 

the magnet sets might amount to about 

$8 million on an annual basis (i.e., 

[$35¥$25] × 800,000 units annually). 

Finally, we note that the loss in 

consumer surplus just described 

represents the maximum loss of 

consumer utility from the rule; the 

actual loss is likely to be lower. This is 

because consumers are likely to gain 

some amount of consumer surplus from 

products that are purchased as an 

alternative to those magnet sets that 

would no longer be available because of 

the rule. If, for example, there were 

close substitutes for the magnet sets that 

do not meet the standard (e.g., desk toys 

that are almost as satisfying and 

similarly priced), the overall loss in 

consumer surplus (and, hence, the costs 

of the rule) would probably tend to be 

small. On the other hand, if there are no 

close substitutes, the costs of the rule 

would tend to be higher. 


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59982 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

21Note that although producer surplus (PS) is a 

measure of profits, it is not the same as profits. 

Whereas PS = TR¥TVC, profits (p) = TR¥(TFC + 

TVC), where TFC represents total fixed costs (i.e., 

those costs borne by the firm regardless of the level 

of output). If we substitute PS into the profit 

equation, and rearrange terms, we have PS = p + 

TFC. Thus, producer surplus is equal to profits, 

plus total fixed costs. In the case of the market for 

magnet sets, the fixed costs of production for 

American importers are small. The magnet sets 

were generally produced, packaged, and shipped 

from China and sometimes sent directly to the 

importer’s point of sale. Even when the magnet sets 

were shipped directly to importers, most additional 

costs incurred by importers, such as shipping and 

marketing costs, would be considered variable. 

Consequently, in the case of the market for magnet 

sets, lost profits would be approximately equal to 

lost producer surplus. 

22This value is lower than the value presented in 

the preliminary regulatory analysis, due to the use 

of more refined sales figures for the affected 

producers. 

Some alternative products might serve 

some of the same uses of the subject 

magnet sets. For example, consider the 

Liberty Balls mentioned earlier, which 

are comprised of large (1.3 inch) ferrite 

magnetic objects. Their size, weight, and 

relatively high price per ball make 

Liberty Balls unsuitable and impractical 

for use in most sculpturing and other 

construction activities for which the 

subject magnet sets are used. They 

might still be used by some for 

‘‘fidgeting,’’ but there does not seem to 

be any unique attribute of this product 

that would cause a consumer to 

purchase Liberty Balls specifically for 

fidgeting; common objects, such as 

paper clips or ball bearings, could serve 

the same fidgeting purpose at a lower 

price. 

Another possible alternative product 

discussed by the Directorate for 

Engineering Sciences (Amodeo, 2013) 

could be magnet sets comprised of 

individual magnets permanently 

connected by rods or other means, such 

that the resulting magnetic objects are 

not small parts. Such sets are marketed 

as children’s toys because the 

individual pieces in the set do not fit 

into the small parts cylinder. Although 

these products have not been marketed 

for adults, and we have no evidence that 

they could be considered a good 

substitute for the subject magnet sets, if 

such sets could satisfy some consumers’ 

needs in constructing geometric shapes, 

then the lost consumer surplus might be 

reduced. 

Notwithstanding the availability of 

alternatives to the subject magnet sets, 

the rule will still result in some level of 

lost utility. By purchasing the products 

in question, rather than other products, 

consumers are revealing that they have 

a preference for the subject magnet sets 

that they believe are likely to provide 

them more utility than a substitute 

purchase. 

ii. Lost Benefits to Producers 

The lost benefits to firms resulting 

from a rule that effectively eliminates a 

product they produce are measured by 

a loss in what is called producer 

surplus. Producer surplus is a profit 

measure that is somewhat analogous to 

consumer surplus. Whereas consumer 

surplus is a measure of benefits received 

by individuals who consume products, 

net of the cost of purchasing the 

products, producer surplus is a measure 

of the 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 

magnet sets, 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.21

In Figure 1, 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. 

As described earlier, sales of the 

magnet sets averaged roughly 800,000 

sets annually during the 2009 through 

mid-2012 time period, with an average 

retail price of about $25 per set in 2012. 

Thus, total industry revenues averaged 

about $20 million annually (i.e., 800,000 

sets × $25 per set) in 2012 dollars. 

Additional information provided by 

firms to the Office of Compliance and 

Field Operations suggests that the 

average import cost of the magnets to 

U.S. importers, a major variable cost, 

may have amounted to about $10 per 

set, or an average of about $8 million 

annually (i.e., 800,000 sets × $10 import 

cost per set). We have no information on 

other variable costs associated with the 

production, packaging, marketing, and 

distribution of the magnet sets. 

However, it seems likely that variable 

costs would constitute a significant 

proportion of the remaining difference 

between revenues ($20 million) and 

import costs ($8 million). If we assume 

that variable costs amount to about half 

of the difference, lost producer surplus 

would amount to about $6 million.22

iii. Summary of Costs of the Rule 

The costs of the rule, in terms of 

reduced benefits for firms and lost 

utility by consumers, are uncertain. 

However, based on annual sales 

estimates available for 2009 through 

mid-2012, these costs could amount to 

as much as $6 million in lost producer 

surplus and some unknown quantity of 

lost utility. The estimate of lost 

producer surplus differs from impacts 

estimated in the NPR (7.5 million, 

expressed as lost profits) because of a 

revised estimate of annual sales, and 

different assumptions regarding profit 

rates and variable costs. 

c. Sensitivity of Results to Product Life 

Assumptions 

Implicit in this analysis is the 

assumption that the expected useful life 

of the magnet sets is about 1 year. 

Because this product has only been in 

widespread consumer use since 2009, 

this assumption is made without 

extensive knowledge about the actual 

use of the magnetic sets by consumers. 

We consider magnet sets to be novelty 

products, which means for many 

consumers, they may lose much of their 

appeal quite quickly. Accordingly, we 

chose a one-year rather than a longer 

useful life even though the magnets may 

be physically durable products. Even if 

some of the products remain in homes 

or offices longer than a year, the risk of 

ingestion by children may be much 

higher in the first month or two after the 

magnet sets are purchased, when the 

appeal of the product is at its highest 

and the consumer actively uses or plays 

with the product frequently. Once 

novelty products lose their appeal, they 

are likely to be put away and stored 

indefinitely or perhaps even discarded. 

However, we note that the results of 

our analysis are not particularly 

sensitive to this product life 

assumption. For example, had we 

assumed that the average product life 

was about 2 years, rather than 1 year, 

estimates of the number of sets in use 

at any given time would approximately 

double, reducing the estimated annual 

risk of injury, per magnet set in use (and 

hence, reduce estimated societal costs 

per set), by about half. However, this 

reduced estimate of annual societal 

costs would be offset by the fact that the 

sets remain in use for 2 years, rather 

than 1 year. Thus, annual benefits, per 

magnet set in use, would be about 

halved, but the present value of benefits 

would be accrued over 2 years, rather 

than 1 year. Consequently, even if we 

had doubled the assumed product life, 

the relationship between benefits and 

costs would have remained roughly the 

same. Estimated benefits would be 

slightly lower under a two year useful 

product life due to discounting second 

year benefits. 

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d. Alternatives to the Rule 

There are several possible alternatives 

to the rule. We are unable to quantify 

either the costs or the benefits of these 

alternatives, in part because the 

requirements of such alternatives have 

not been specified. To estimate the 

potential costs of the alternatives, we 

would need a precise description of 

what the requirements would be. 

Moreover, even with this information, it 

would still be difficult to determine the 

expected injury reduction from the 

various alternatives. 

Nevertheless, the costs of each of the 

alternatives discussed below are 

expected to be substantially lower than 

the costs of the rule. This is because, 

generally speaking, the alternatives 

would allow consumers and businesses 

to continue buying, selling, and using 

the magnet sets that would no longer be 

available under the rule. Similarly, the 

benefits of these alternatives, in terms of 

injury reduction, would also be 

expected to be lower than the benefits 

for the rule. This is because, under these 

alternatives, some children would 

continue to have access to the magnet 

sets. 

The Commission may not have 

authority for some of the alternatives 

discussed. None of the alternatives was 

chosen because the expected injury 

reduction from each was believed to 

address the hazard inadequately. 

Comments on the NPR did not alter this 

decision. 

i. Alternative Performance 

Requirements 

As an alternative to the rule, the 

Commission could consider 

promulgating an alternative set of 

requirements that could reduce the risk 

of injury from magnet sets but not 

necessarily eliminate the risk. For 

example, some alternatives to the rule 

might include: Setting a different flux 

index for the magnets sold as 

manipulative desk sets; requiring 

different specifications for shapes and 

sizes of magnets within the scope of the 

standard; or setting forth some other 

criteria that have not yet been 

developed (but are not as stringent as in 

the final rule). If these alternative 

requirements led to the production of 

magnet sets with physical 

characteristics that appealed to 

consumers, the cost of the rule for both 

consumers and businesses would be 

reduced. Businesses would continue to 

be able to produce and sell magnet sets, 

and consumers would continue to be 

able to buy and use them. However, 

these alternative requirements would 

likely reduce the benefits of a rule: 

Magnets that present a risk of harm 

would still be available and some 

children would undoubtedly have 

access to them and be injured by them. 

One practical question, however, is 

whether alternative requirements for the 

sizes and flux index of magnets would 

eliminate or substantially affect the 

physical qualities of the products that 

make them enjoyable for adults. 

Regarding the alternative size 

requirements, consumers can use 

magnet sets of 216 or more 5mm balls 

to make a variety of constructions. 

Larger individual magnets that would 

meet an alternative (that is smaller than 

the 1.25-inch diameter specified in the 

final rule) might be determined to 

reduce the risk associated with 

ingestions somewhat, but, depending 

upon their size, might make them 

unsuitable for many of the uses of the 

sets with smaller magnets. 

Similarly, allowing a flux index 

greater than the 50 kG2 mm2 flux limit 

of the rule might improve the usefulness 

of the magnet sets in construction 

activities. However, given that the 

subject magnet sets have flux index 

values typically in the range of 400–500 

for spherical magnets, the flux index 

limit might have to be increased 

substantially higher than the flux index 

limit of 50 kG2 mm2 to provide levels 

of satisfaction that are similar to those 

of the subject magnet sets. Moreover, a 

flux index limit of substantially more 

than 50 kG2 mm2 could, relative to the 

proposed rule, substantially increase the 

harms associated with the ingestion 

risk—the harms the rule is intended to 

prevent. 

Another alternative might be to create 

specifications for the application of 

bittering agents on the magnets to make 

them less appealing to young children. 

However, the effectiveness of bittering 

agents in reducing magnet ingestions is 

questionable (Sedney & Smith, 2012). 

Neither the costs, nor the benefits of 

these alternative sets of requirements 

are quantifiable with available 

information. The staff is reasonably 

certain that magnets with a flux index 

of less than 50 kG2 mm2 will 

substantially reduce the risk injury. 

However, the risk associated with flux 

indices greater than 50 kG2 mm2 but less 

than the indices of 400 to 500 for the 

subject magnet sets are unknown and 

cannot be estimated with available data. 

The staff is also reasonably certain that 

the risk of ingesting magnets is 

substantially reduced if the magnets are 

too large for the small parts container. 

However, the increased risk of ingestion 

with smaller sized magnets is unknown. 

Require Safer Packaging 

The Commission could require 

magnet sets to be sold with special 

storage containers that are fitted to the 

product so that consumers would be 

able to determine whether any of the 

magnets were missing from the sets. 

Such a requirement might prevent 

injuries resulting from a small number 

of magnets being separated from a set 

without the owner being aware. In 

reality, however, many consumers may 

not use such containers because using 

them could require time to form the 

magnets into a shape, such as a cube; or 

consumers might wish to keep the 

magnets out of their container to 

preserve a shape or structure that took 

time and effort to construct. 

Alternatively (or in combination), the 

Commission could require the magnets 

to be sold in child-resistant packaging. 

The benefit of such an approach is the 

potential to reduce ingestion injuries. 

However, the benefits of this approach 

would be limited. Child-resistant 

packaging would not prevent teens and 

adolescents (and even some younger 

children) from opening the packaging. 

Additionally, the packaging would have 

to be secured after each use. According 

to the Division of Human Factors, it is 

unlikely that adults would accept childresistant packaging for a product like 

the magnet sets because of the level of 

inconvenience involved in returning the 

magnets to the package (Sedney & 

Smith, 2012). Additionally, for the 

reasons described above, consumers 

may leave magnets out of their 

container. 

The costs of this alternative would 

depend upon the packaging 

requirements but would be substantially 

less costly than the rule, which 

eliminates the subject magnet sets from 

the marketplace. It seems unlikely that 

the costs would amount to more than a 

dollar or so per magnet set, although 

these costs might be somewhat higher if 

child-resistant packaging was required. 

The benefits of requiring safer packaging 

are unknown, but based on the HF 

discussion above, the benefits may be 

relatively small if consumers would not 

use the packaging containers 

appropriately. 

ii. Warnings 

The Commission could require strong 

warnings on labels and on-product 

instructions designed to prevent the use 

of the magnet sets by children. Based on 

HF staff’s examination, the ingestion 

warnings that currently accompany 

magnet sets are generally aimed at 

adults, but the warnings are deficient in 

their content. For example, some 

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59984 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

23As noted in the NPR (77 FR 53781), one firm 

agreed to a corrective action in 2010, which 

included provisions for controlling distribution by 

agreeing to ask retailers who market products 

primarily to children to execute a Responsible 

Sellers Agreement prohibiting marketing and sales 

to children, as well as agreeing to stop the sale of 

magnet sets to retailers who market products 

exclusively to children. However, with a 

subsequent increase in ingestion injuries involving 

the products, Compliance began negotiation of 

corrective action plans with 11 of 13 magnet set 

importers that voluntarily agreed to cease the 

importation, distribution, and continued sale of 

their magnet sets, and administrative actions were 

initiated by the Commission against two firms that 

did not agree to cease sales voluntarily. By 

implication, sales restrictions (combined with 

warnings and other measures) have not been judged 

to address the risk posed by the subject magnet sets 

adequately. 

warnings caution against children 

swallowing the magnets, but the 

warnings do not describe the incident 

scenarios. Some warnings refer to the 

propensity of swallowed magnets to 

stick to intestines, without referring to 

the presence of other magnets or metal 

objects. Other warnings refer to magnets 

sticking together or attaching to other 

metallic objects inside the body, but the 

warnings do not explain that the 

magnets can attract through the walls of 

the intestines and forcefully compress 

these tissues, resulting in serious 

injuries. According to HF staff, without 

detailed information in the warnings, 

consumers may not really understand 

how swallowing magnets differs from 

swallowing other small parts or how 

magnets sticking together could pose a 

hazard. 

HF staff believes that it may be 

possible to develop warnings that could 

communicate the ingestion hazard, the 

consequences of ingestion, and how to 

avoid the hazard. To the extent that the 

subject magnets present a ‘‘hidden’’ 

hazard about which consumers are 

unaware, explicit and adequate 

warnings could reduce ingestions and 

allow adults to continue to enjoy the use 

of the product. 

The costs of such warnings would 

most likely be small, and consumers 

could make informed decisions about 

the purchase and use of magnet sets. 

However, although HF staff believes 

warnings could be developed to 

communicate the hazard, HF staff also 

believes that injury reduction would be 

limited. They point out that avoiding 

the ingestion hazard requires consumers 

to keep the product away from all 

children in the incident age group, and 

while caregivers who read and 

understand the warnings may attempt to 

keep this product out of the hands of 

young children, HF staff doubts that 

many caregivers are likely to be so 

diligent about heeding the warning with 

older children and adolescents (Sedney 

& Smith, 2012). Also, HF staff doubts 

that caregivers will think that constant 

supervision is needed if they believe the 

sets have been properly secured or that 

their children are not aware of the sets 

(Sedney & Smith, 2013). As noted in the 

NPR (77 FR 53781), a corrective action 

in 2010, which included stronger 

warnings combined with provisions for 

controlling distribution of magnet sets, 

was found to be inadequate because of 

a subsequent increase in ingestion 

injuries involving the products. 

Consequently, warnings (combined with 

sales restrictions and other measures) 

have not been judged to address the risk 

posed by the subject magnet sets 

adequately. 

iv. Restrictions on the Sale of Magnet 

Sets 

Another lower-cost option the 

Commission could consider is to 

prohibit sales of magnet sets in toy 

stores, children’s sections of general 

purpose stores, and near cash registers 

of stores that sell any children’s 

products. The costs of this option would 

be lower than the rule because this 

would allow the magnet sets to be 

marketed to and used by consumers. 

Sales limitations or requirements for 

strong warnings might also be required 

on Web sites advertising the sale of 

magnets on the Internet. 

The details of developing a set of sales 

limitations and requirements would 

need to be worked out, but the idea 

would be to make sure that magnet sets, 

to the extent possible, are not sold at 

locations where children are likely to be 

present. Sales requirements might also 

be combined with strong and explicit 

warnings that HF staff has suggested 

could be developed. 

However, the benefits of this option 

are probably limited. Some parents 

would still allow their children 

(especially older children and 

adolescents) to play with the magnet 

sets, despite the warnings.23 In addition, 

some children will get into the 

packaging, even if parents try to restrict 

the use of the desk toys. 

v. Address Through Corrective Actions 

Rather Than Regulatory Action 

The Commission could continue to 

address the hazard through corrective 

action plans. However, this approach 

may be inadequate because this 

approach is reactive and would entail 

waiting for new incidents to occur 

rather than preventing them. 

vi. Take No Action 

The Commission could determine that 

no rule is reasonably necessary to 

reduce the risk of ingestion injuries 

associated with small, powerful magnet 

sets. Under this alternative, future 

societal losses would be determined by 

the numbers of products in use, and 

other factors that affect the likelihood 

that young children, adolescents, and 

teens will ingest the magnets. Although 

there would be no costs, such a 

determination would not reduce 

injuries. 

4. Summary 

Based on reports to the CPSC, 

ingestions of small magnets contained 

in certain magnet sets have caused 

multiple, high-severity injuries that 

require surgery to remove the magnets 

and repair internal damage. Based on 

the NEISS cases identified by the 

Directorate for Epidemiology staff as 

involving high-powered and/or ballshaped magnet ingestions, the estimated 

benefits of the rule might amount to 

about $28.6 million annually. 

The costs of the rule consist of the 

reduced producer surplus for firms and 

lost utility by consumers, also are 

uncertain. Based on annual sales 

estimates available for 2009 through 

mid-2012, these costs could amount to 

as much as $6 million in lost producer 

surplus and some unknown quantity of 

lost utility. 

There are alternative regulatory 

actions that might allow the magnet sets 

to continue to be marketed. For 

example, the Commission, by 

regulation, could issue alternative 

requirements; issue requirements for the 

packaging of the magnet sets (e.g., 

develop requirements for child-resistant 

packaging); require warnings that 

describe explicitly the hazard and how 

to avoid it; and/or place limitations on 

how and where the magnet sets can be 

sold. These alternative actions—which 

might be considered alone, or in 

combination—would have varying 

levels of effectiveness, but all of them 

would be result in lower reductions in 

injuries associated with magnet 

ingestion. 

I. Paperwork Reduction Act 

The rule does not require 

manufacturers (including importers) to 

perform testing or require manufacturers 

or retailers to keep records. For this 

reason, the rule does not contain 

‘‘collection of information 

requirements,’’ as that term is used in 

the Paperwork Reduction Act, 44 U.S.C. 

3501–3520. Therefore, the rule need not 

be submitted to the Office of 

Management and Budget (OMB) in 

accordance with 44 U.S.C. 3507(d) and 

implementing regulations codified at 5 

CFR 1320.11. 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 59985 

J. Regulatory Flexibility Analysis 

1. Introduction 

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. The final regulatory 

flexibility analysis is to contain: 

(1) A statement of the need for, and 

objectives of, the rule; 

(2) a statement of the significant 

issues raised by the public comments in 

response to the initial regulatory 

flexibility analysis, a statement of the 

agency’s assessment of those issues, and 

a statement of any changes made to the 

proposed rule as a result of such 

comments; 

(3) the response of the agency to any 

comments filed by the Chief Counsel for 

Advocacy of the Small Business 

Administration in response to the 

proposed rule, and a statement of any 

changes made in the final rule as a 

result of the comments; 

(4) a description of, and where 

feasible, an estimate of the number of 

small entities to which the proposed 

rule will apply; 

(5) a description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the 

proposed rule, including an estimate of 

the classes of small entities that will be 

subject to the requirement and the types 

of professional skills necessary for the 

preparation of the report or record; and 

(6) a description of the steps the 

agency has taken to minimize the 

significant economic impact on small 

entities consistent with the stated 

objectives of applicable statutes, 

including a statement of the factual, 

policy, and legal reasons for selecting 

the alternative adopted in the final rule 

and why each one of the other 

alternatives to the rule considered by 

the agency which affect the impact on 

small entities was rejected. 

Accordingly, staff prepared a final 

regulatory flexibility analysis, which is 

summarized below. 

2. Statement of the Need for, and 

Objectives of, the Rule 

The rule prohibits the sale or 

distribution in commerce of magnet sets 

and individual magnets intended to be 

used with or as magnet sets that do not 

meet the specific requirements 

described in section F of this preamble. 

The current designs of magnet sets of 

the type that became popular in recent 

years would not meet the rule’s 

requirements. The CPSC has received 

information, described in section C of 

this preamble, regarding incidents with, 

and hazards posed by, sets of small, 

powerful magnets. According to the 

final regulatory analysis, there was an 

annual average of about 929 medically 

attended magnet ingestions that were 

defined as at least ‘‘possibly of interest’’ 

during the period from 2009 through 

June 2012. These ingestions resulted in 

societal costs of about $28.6 million per 

year. 

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 consumer 

products. Because the magnet sets that 

have been involved in incidents would 

not meet the rule’s requirements, the 

rule will substantially reduce the future 

incidence and cost to society of 

ingestions of magnet sets. 

3. Comments on the Initial Regulatory 

Flexibility Analysis 

The Commission received comments 

from more than 5,000 people in 

response to the NPR. Many of the 

comments related to issues that have a 

bearing on the economic impacts of the 

proposed rule on small businesses. The 

Commission’s responses to comments 

that address issues that were mentioned 

in the initial regulatory flexibility 

analysis (IRFA) are in included in 

Section E of this notice. 

4. Small Entities Subject to the Rule and 

Possible Economic Impacts 

The final rule would impact U.S. 

importers and retailers of magnet sets 

comprised of small, powerful magnets 

of the size and magnetic force 

proscribed by the rule. None of the 

magnet sets within the scope of the rule 

is produced domestically. All of the 

U.S. firms that have marketed the 

products are believed to have imported 

them from manufacturers in China. The 

one remaining firm that currently 

imports magnet sets is a small business 

under U.S. Small Business 

Administration (SBA) size standards 

(SBA, 2012). 

Based on information reviewed on 

product sales, including reports by firms 

to the Office of Compliance and Field 

Operations, the number of such magnet 

sets that were sold to U.S. consumers 

from 2009 through mid-2012 may have 

totaled about 2.7 million sets, with a 

value of roughly $50 million in 2012 

dollars. This value reflects a 

combination of retail sales directly to 

consumers (through company Web sites 

and other Internet retail sites) and sales 

to retailers who market the products. A 

review of retail prices reported by 

importers and observed on Internet sites 

suggests prices typically ranged from 

about $20 to $45, with an average price 

of about $25 for magnet sets that 

commonly contain 216 to 224 magnets. 

Larger sets of more than 1,000 

individual magnets have reportedly 

been sold at prices up to $300, 

depending on the number of magnets 

and the type of packaging. 

We noted in the IRFA that the 

economic impact of the rule would be 

most severe for seven small importing 

firms, which account for the great 

majority (perhaps more than 98%) of 

units sold according to sales 

information provided to CPSC 

Compliance staff; and five of these 

importers reportedly derived most or all 

of their revenues from the sale of the 

magnet sets or related products. We 

judged that these firms could go out of 

business as a result of the rule. Two of 

the other leading importers of magnet 

sets apparently had fairly broad product 

offerings, which could lessen the 

severity of the economic impact of a 

rule. Nevertheless, we noted that the 

expected impacts of a final rule could 

also be significant for these small 

importers. 

As discussed in section H.2.b. of this 

preamble, due to CPSC’s enforcement 

actions, current sales of magnet sets are 

dramatically smaller than at the time of 

the enforcement actions. We are aware 

of only one major importer of magnet 

sets that remains active in the market. 

The rule will likely have an adverse 

impact on this remaining firm. That firm 

might go out of business, unless the firm 

successfully markets other products, 

including magnet sets that would 

comply. 

5. Projected Reporting, Recordkeeping, 

and Other Compliance Requirements of 

the Rule 

The rule does not contain any 

reporting or record keeping 

requirements. 

6. Alternatives to the Rule 

The Commission could pursue other 

options, including: Adopting 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; imposing 

restrictions on the locations where 

magnet sets can be sold; addressing the 

risk of injury presented by magnet sets 

through corrective actions; and taking 

no action at all. Each of these 

alternatives is addressed in Section G of 

this preamble and in the Final 

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59986 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

Regulatory Analysis at Section H of this 

preamble. All of these alternatives 

would reduce the expected impact of 

the rule on small business. However, as 

discussed in Sections G and H of this 

preamble, these alternatives would not 

be expected to achieve the same injury 

reductions as the rule, and some of the 

suggested alternatives would be beyond 

the Commission’s authority. 

K. Environmental Considerations 

CPSC rules establishing performance 

requirements are considered to ‘‘have 

little or no potential for affecting the 

human environment,’’ and 

environmental assessments are not 

usually prepared for these rules (16 CFR 

1021.5 (c)(1)). This rule falls within the 

categorical exemption. 

L. Executive Order 12988 (Preemption) 

As required by Executive Order 12988 

(February 5, 1996), the CPSC states the 

preemptive effect of the rule as follows: 

The rule is promulgated under 

authority of the CPSA. 15 U.S.C. 2051– 

2089. Section 26 of the CPSA provides 

that ‘‘whenever a consumer product 

safety standard under this Act is in 

effect and applies to a risk of injury 

associated with a consumer product, no 

State or political subdivision of a State 

shall have any authority either to 

establish or to continue in effect any 

provision of a safety standard or 

regulation which prescribes any 

requirements as 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). Upon application to 

the Commission, a state or local 

standard may be excepted from this 

preemptive effect, if the state or local 

standard: (1) Provides a higher degree of 

protection from the risk of injury or 

illness than the CPSA standard, and (2) 

does not unduly burden interstate 

commerce. In addition, the federal 

government, or a state or local 

government, may establish and continue 

in effect a nonidentical requirement that 

provides a higher degree of protection 

than the CPSA requirement for the 

hazardous substance for the federal, 

state, or local government’s use. 15 

U.S.C. 2075(b). 

Thus, with the exceptions noted 

above, the magnet set requirements 

would preempt nonidentical state or 

local requirements for magnet sets 

designed to protect against the same risk 

of injury. 

M. Effective Date 

The Commission has determined that 

the rule will become effective 180 days 

from publication of the final rule in the 

Federal Register and will apply to all 

magnet sets imported into or otherwise 

distributed in the United States that are 

manufactured or imported on or after 

that date. The CPSA requires that 

consumer product safety rules take 

effect not later than 180 days from their 

promulgation, unless the Commission 

finds there is good cause for a later date. 

15 U.S.C. 2058(g)(1). In the NPR, the 

Commission proposed that the rule 

would take effect 180 days after 

promulgation of a final rule. The 

Commission received no comments on 

the proposed effective date. 

N. Findings 

The CPSA requires the Commission to 

make certain findings when issuing a 

consumer product safety standard. 

Specifically, the CPSA requires that the 

Commission 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, that 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) that 

benefits expected from the regulation 

bear a reasonable relationship to the 

regulation’s costs; and (3) that the 

regulation imposes the least 

burdensome requirement that would 

prevent or adequately reduce the risk of 

injury. Id. These findings are stated in 

§ 1240.5 of the rule and are based on 

information provided throughout this 

preamble and the staff’s briefing 

packages for the proposed and final 

rules. 

O. Conclusion 

For the reasons stated in this 

preamble, the Commission concludes 

that magnet sets and individual magnets 

that do not meet the requirements 

specified in this rule present an 

unreasonable risk of injury. 

List of Subjects in 16 CFR Part 1240 

Consumer protection, Imports, Infants 

and children, Labeling, Law 

enforcement, Incorporation by 

reference. 

For the reasons stated in the 

preamble, the Commission amends Title 

16 of the Code of Federal Regulations by 

adding part 1240 to read as follows: 

PART 1240—SAFETY STANDARD FOR 

MAGNET SETS 

Sec. 

1240.1 Scope, purpose, and effective date. 

1240.2 Definitions. 

1240.3 Requirements. 

1240.4 Test procedure for determining flux 

index. 

1240.5 Findings. 

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

§ 1240.1 Scope, purpose, and effective 

date. 

This part 1240, a consumer product 

safety standard, prescribes requirements 

for magnet sets, as defined in § 1240.2, 

and for individual magnets that are 

marketed or intended for use with or as 

magnet sets. These requirements are 

intended to reduce or eliminate an 

unreasonable risk of injury to 

consumers who ingest magnets that are 

part of magnet sets. This standard takes 

effect on April 1, 2015 and applies to all 

magnet sets and individual magnets, as 

defined in § 1240.2, that are 

manufactured or imported on or after 

that date. 

§ 1240.2 Definitions. 

(a) The definitions in section 3 of the 

Consumer Product Safety Act (15 U.S.C. 

2052) apply to this part 1240. 

(b) Magnet set means: 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. Relevant factors in determining 

intended uses of a magnet set include, 

but are not limited to: The 

manufacturer’s stated intent (such as on 

a label or Web site), if reasonable under 

the circumstances; the content and 

nature of advertising, promotion, 

marketing, packaging, or display 

relating to the product; and the uses for 

which the product is commonly 

recognized by consumers. 

(c) Individual magnet means: An 

individual magnetic object intended or 

marketed for use with or as a magnet set 

as defined in paragraph (b) of this 

section. 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 59987 

§ 1240.3 Requirements. 

Each magnet in a magnet set, and any 

individual magnet, that fits completely 

within the cylinder described in 16 CFR 

1501.4 must have a flux index of 50 kG2

mm2 or less when tested in accordance 

with the method described in § 1240.4. 

§ 1240.4 Test procedure for determining 

flux index. 

(a) Select at least one magnet of each 

shape and size in the magnet set. 

(b) Measure the flux index of each 

selected magnet in accordance with the 

procedure in sections 8.24.1 through 

8.24.3 of ASTM F963–11, Standard 

Consumer Safety Specification for Toy 

Safety, approved on December 1, 2011. 

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, PO Box 0700, West 

Conshohocken, PA 19428; telephone 

610–832–9585; www.astm.org. You may 

inspect a copy at the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone 301–504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

§ 1240.5 Findings. 

(a) Degree and nature of the risk of 

injury. (1) Based on a review of National 

Electronic Injury Surveillance System 

(NEISS) data, we have determined that 

an estimated 2,900 ingestions of 

magnets from magnet sets were treated 

in emergency departments during the 

period from January 1, 2009 to 

December 31, 2013, an average of about 

580 ingestion incidents per year. From 

review of databases other than NEISS, 

we are aware of 109 reported incidents 

occurring from January 1, 2009 through 

June 24, 2014, involving the ingestion of 

magnets by children between the ages of 

1 and 15. Of those 109 incidents, 83 

involved the ingestion of high-powered, 

ball-shaped magnets that were 

contained in products that meet the 

above definition of ‘‘magnet set,’’ and 17 

of those 109 incidents possibly involved 

ingestion of this type of magnet. Thus, 

100 reported incidents of ingestions 

involved or possibly involved magnets 

from magnet sets. Hospitalization was 

required to treat 61 of the 100 incidents. 

In 81 of the 100 incidents, the magnets 

were ingested by children younger than 

four years old, or between the ages of 

four and 12 years. 

(2) Once ingested, these strong 

magnets begin to interact in the 

gastrointestinal tract, which can lead to 

tissue death, perforations, and/or 

fistulas, and possibly intestinal twisting 

and obstruction. If left untreated, these 

injuries can lead to infection of the 

peritoneal cavity and other lifethreatening conditions. The number of 

magnets swallowed increases the risk of 

attraction and injury; but as few as two 

magnets can cause serious internal 

damage in a very short time. The fact 

that many medical professionals do not 

appreciate the health consequences of 

magnet ingestion increases the severity 

of the risk because a doctor who is 

unfamiliar with these strong magnets 

may send a child home and expect the 

magnets to pass naturally. There are also 

health consequences to the treatment 

and surgery for removal of ingested 

magnets. There may be a risk of 

gastrointestinal bleeding; leakage of 

holes that were repaired; rupturing of 

resectioned bowels; temporary paralysis 

of the bowels; use of a colostomy bag; 

IV feeding initially, or for some longer 

time period; and compromise of 

nutrition and digestive function. Longterm health consequences can be severe, 

as well: loss of intestinal tissue; 

compromised nutrition absorption; 

adhesions and scarring of intestines; 

need for a bowel transplant; and 

possible impediments to fertility for 

girls. Even children who pass the 

magnets naturally and do not require 

surgery still need close observation by 

doctors and may undergo sequential xrays, thus, exposing children to repeated 

dosages of radiation. 

(b) Number of consumer products 

subject to this part. The market for 

magnet sets increased substantially from 

the time magnet sets were first 

introduced, through mid-2012. We 

estimate that the number of magnet sets 

that have been sold to U.S. consumers 

since 2009, the first year of significant 

sales, may have totaled about 2.7 

million sets, representing a value of 

roughly $50 million. Because of CPSC 

enforcement activity and actions taken 

by firms since mid-2012, most firms 

have ceased selling the magnet sets. 

Actual sales since the end of 2012 by 

the firms remaining in the market are 

unknown but believed to be small. The 

remaining major importing firm that 

continues to sell the products is 

estimated to hold a market share of less 

than 2 percent of pre-enforcement 

action sales. The approximate number 

of products subject to this part (in terms 

of unit sales) could be fewer 25,000 sets 

per year. 

(c) The need of the public for magnet 

sets and the effects of this part on their 

utility, cost, and availability. (1) We 

cannot estimate precisely the use value 

that consumers receive from magnet 

sets. In general, use value would be the 

amount of money that consumers 

expend on the product, plus the 

consumer surplus (i.e., the difference 

between the market price and the 

maximum amount consumers would 

have been willing to pay for the 

product). Magnet sets of the type that 

have been involved in incidents would 

not comply with this part. Therefore, 

consumers will no longer be able to 

obtain utility from these magnet sets. 

Although magnet sets clearly provide 

utility to purchasers, magnet sets are not 

necessities. Products that meet the 

requirements of this part might be 

developed that would serve some of the 

purposes of magnet sets. This part 

would continue to allow strong magnets 

for other uses, such as commercial or 

industrial uses. 

(2) Individual magnets that are 

intended or marketed for use with or as 

magnet sets also must comply with the 

requirements of this part. The 

Commission is aware that firms selling 

magnet sets have offered individual 

magnets. To avoid firms circumventing 

the rule by selling individual magnets 

that are nevertheless intended or 

marketed to be used as magnet sets, this 

part covers such individual magnets. 

Individual magnets sold for other uses 

are not subject to this part. Thus, this 

part does not affect the need for, utility, 

or availability of individual magnets 

that are sold for uses other than as 

magnet sets. 

(d) Other means to achieve the 

objective of this part, while minimizing 

the impact on competition and 

manufacturing. (1) The Commission 

considered various alternatives to the 

requirements specified in this part. This 

part requires that if a magnet set 

contains a magnet that fits within the 

small parts cylinder that CPSC uses for 

testing toys, all magnets from that set 

must have a flux index of 50 kG2 mm2

or less. In addition, individual magnets 

intended or marketed for use with or as 

magnet sets must meet these 

requirements. We do not believe that 

options other than a rule establishing 

these requirements would sufficiently 

reduce the number and severity of 

injuries resulting from the ingestion of 

magnets from these magnet sets. The 

circumstances associated with this 

product limit the likely effectiveness of 

warning labels. Despite existing warning 

labels and market restrictions, ingestion 

incidents have continued to occur. 

Parents and caregivers may not 

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59988 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 

appreciate the hazard associated with 

magnet sets. Accordingly, parents and 

caregivers will continue to allow 

children access to the product. Children 

may not appreciate the hazard and will 

continue to mouth the items, swallow 

them, or in the case of young 

adolescents and teens, use the magnets 

to mimic body piercings. Once the 

magnets are removed from their carrying 

case, the magnets bear no warnings to 

guard against ingestion or aspiration; 

the small size of the individual magnets 

precludes the addition of any warning. 

Because individual magnets from 

magnet sets are shared easily among 

children, many end users of the product 

are likely to have had no exposure to 

any warning. 

(2) The Commission has considered 

other alternatives to reduce the risk 

from magnet sets: alternative 

performance requirements, such as 

setting a different flux limit or requiring 

bittering agents; safer packaging 

requirements, such as requiring a 

specific design for storage containers or 

requiring child resistant packaging; 

sales restrictions; continued corrective 

actions; and taking no action. Some of 

these alternatives may not be within the 

Commission’s authority. 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 magnet sets. 

(e) Unreasonable risk. (1) As stated in 

paragraph (a) of this section, according 

to NEISS, an estimated 2,900 ingestions 

of magnets from magnet sets were 

treated in emergency departments 

during the period from January 1, 2009 

to December 31, 2013, an average of 

about 580 ingestion incidents per year. 

From sources other than NEISS, CPSC 

has reports of 100 incidents of 

ingestions that involved or possibly 

involved magnets from magnet sets, 

including one fatality. 

(2) For the regulatory analysis, we 

considered the period of time, 2009 

through June 2012, before CPSC’s 

compliance activities affected the 

market. We identified 86 ingestions of 

high-powered and/or ball-shaped 

magnets, which occurred from 2009 

through June 2012 reported through 

NEISS. These incidents were 

determined to involve, or possibly 

involve, magnet sets. Based on these 86 

incidents, we have determined that an 

estimated 2,138 ingestions of magnets 

from magnet sets were treated in 

emergency departments from January 1, 

2009 to June 2012. About 11 percent of 

the victims of these ingestion incidents 

required hospitalization, as opposed to 

victims who were treated and released. 

The 2009 through June 2012 NEISS 

estimates suggest an estimated annual 

average of about 610 emergency 

department-treated injuries, including 

544 injuries that were treated and 

released and 66 injuries that required 

hospitalization. About 60 percent of 

these emergency department-treated 

ingestions involved children ages 4 

through 12 years. Additionally, based 

on estimates from the Commission’s 

injury cost model (ICM), there were 

another 319 injuries treated annually in 

locations other than hospital emergency 

departments (such as doctors’ offices, 

clinics, ambulatory surgery centers, or 

direct hospital admissions). 

(3) After including the injuries treated 

outside of hospital emergency 

departments, there was an annual 

average of about 929 medically attended 

injuries involving ingestions of magnets 

that were defined as at least ‘‘possibly 

of interest’’ during the period from 2009 

through June 2012. Injuries resulting 

from such ingestions of magnets can be 

severe and life threatening. The risk 

posed by these magnets may not be 

appreciated by children or caregivers, 

who may assume, mistakenly, that the 

consequences of ingesting magnets 

would be similar to ingesting any other 

small object. However, once ingested, 

these strong magnets do not pass 

naturally. Rather, these magnets are 

mutually attracted to each other and 

exert compression forces on the trapped 

gastrointestinal tissue. 

(4) We estimate that these injuries 

resulted in annual societal costs of 

about $28.6 million (in 2012 dollars) 

during the 2009 through June 2012 time 

period. The average estimated societal 

costs per injury was about $27,000 for 

injuries treated in locations other than 

emergency departments (such as 

physicians’ offices, clinics, ambulatory 

surgery centers, or direct hospital 

admissions); about $21,000 for injuries 

that were treated and released from 

emergency departments; and about 

$130,000 for injuries that required 

admission to the hospital for treatment. 

Preventing these injuries would be the 

expected benefit resulting from the rule. 

(5) The costs of the rule would consist 

of the lost producer surplus to firms that 

produce and sell magnet sets, plus the 

lost use value that consumers would 

experience when magnet sets that do 

not comply with the rule are no longer 

available. Sales of magnet sets averaged 

roughly 800,000 sets annually during 

the 2009 through mid-2012 time period, 

with an average retail price of about $25 

per set in 2012. Thus, total industry 

revenues averaged about $20 million 

annually (i.e., 800,000 sets × $25 per set) 

in 2012 dollars. The average import cost 

of the magnet sets to U.S. importers, a 

major variable cost, may have amounted 

to about $10 per set, or an average of 

about $8 million annually (i.e., 800,000 

sets × $10 import cost per set). We 

estimate other variable costs associated 

with the production, packaging, 

marketing, and distribution of the 

magnet sets would constitute a 

significant proportion of the remaining 

difference between revenues ($20 

million) and import costs ($8 million). 

If we assume that variable costs amount 

to about half of the difference, lost 

producer surplus would amount to 

about $6 million. 

(6) Thus, we estimate costs of the rule 

to be about $6 million in lost producer 

surplus and some unknown quantity of 

lost utility. Considering the injuries 

associated with magnet sets—and the 

resulting societal costs, balanced against 

the likely impact that the rule would 

have on firms producing and selling the 

product, and on consumers who would 

lose the utility of the product—we 

conclude that magnet sets pose an 

unreasonable risk of injury and that the 

rule is reasonably necessary to reduce 

that risk. 

(f) Public interest. The regulations in 

this part are in the public interest 

because they would reduce deaths and 

injuries associated with magnet sets in 

the future. A rule establishing 

requirements that would eliminate 

magnet sets of the type that have been 

involved in incidents will mean that 

children will have less access to this 

product, thereby reducing the number of 

incidents of children swallowing the 

magnets and the resulting cost to society 

of treating these injuries. 

(g) Voluntary standards. Currently, 

there is no voluntary standard for 

magnet sets, nor any activity to develop 

a voluntary standard for magnet sets. 

(h) Relationship of benefits to costs. 

(1) Based on reports to the CPSC, 

ingestions of small magnets contained 

in magnet sets have caused multiple, 

high-severity injuries that require 

surgery to remove the magnets and 

repair internal damage. Based on the 

information discussed in paragraph (e) 

of this section, we estimate that the 

benefits of this part might amount to 

about $28.6 million annually. 

(2) The costs of the rule, in terms of 

reduced profits for firms and lost utility 

by consumers, also are uncertain. 

However, based on annual sales 

estimates available for the 2009 through 

June, 2012, study period, these costs 

could amount to about $6 million in lost 

producer surplus and some unknown 

quantity of lost utility. 

(i) Least burdensome requirement. We 

have considered several alternatives to 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Rules and Regulations 59989 

this part. We conclude that none of 

these alternatives would adequately 

reduce the risk of injury. Alternative 

performance requirements might allow a 

different flux index for magnets 

contained in magnetic sets or require 

the addition of an aversive (bittering) 

agent to the magnets. Theoretically, 

these alternatives might allow 

continued production of some current 

products. However, it is unclear 

whether a different flux index would 

succeed in making products that have 

the desired physical qualities that make 

them sufficiently enjoyable to adults, 

and at the same time eliminate the 

characteristics that make these strong 

magnets hazardous to children. 

Furthermore, the effectiveness of 

aversive agents in reducing magnet 

ingestions is questionable. We have 

considered the possibility of requiring 

rigorous warnings on the products or in 

the instructions for the products. 

However, magnet sets currently and 

formerly on the market provide 

warnings concerning the potential 

hazard to children. Accordingly, it is 

unlikely that even strengthened 

warnings would substantially reduce 

the incidence of magnet ingestions. This 

is particularly true for incidents 

involving older children and 

adolescents. Moreover, children who are 

old enough to understand the warnings 

may still not abide by them. Some type 

of sales restriction, limiting the location 

where magnet sets could be sold, might 

be possible. However, even with 

restrictions on sales, ingestions are still 

likely to occur as children encounter 

these magnets in the home, at school, or 

other locations where adults have 

brought them and made them available 

to children. The Commission could 

continue to address the hazard from 

magnet sets through corrective actions, 

i.e., recalls of the product. However, 

these actions would not prevent 

additional companies from entering the 

market and importing magnet sets into 

the country in the future. The 

Commission also has the option of 

taking no regulatory action. Although it 

is possible that, with increased 

awareness of the hazard over time, some 

reduction in ingestions could occur, the 

magnitude of any such reduction in 

incidents is uncertain and would likely 

be smaller than those resulting from the 

requirements of this part. 

Dated: September 26, 2014. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2014–23341 Filed 10–2–14; 8:45 am] 

BILLING CODE 6355–01–P 

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