Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules 53781 

1The requirements of 16 CFR part 1501 are 

intended to minimize the hazards from choking, 

ingestion, or inhalation to children under 36 

months of age created by small objects. The 

requirements state, in part, that no toy (including 

removable, liberated components, or fragments of 

toys) shall be small enough without being 

compressed to fit entirely within a cylinder of the 

specified dimensions. 

make its decision on the petition on or 

before November 30, 2012. This 

extension will not prejudice the 

petitioner. 

Minority Business Development Agency. 

David Hinson, 

National Director. 

[FR Doc. 2012–21704 Filed 8–31–12; 8:45 am] 

BILLING CODE 3510–21–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1240 

Safety Standard for Magnet Sets 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of Proposed Rulemaking. 

SUMMARY: Based on available data, the 

U.S. Consumer Product Safety 

Commission (the Commission, the 

CPSC, or we) has determined 

preliminarily that there may be an 

unreasonable risk of injury associated 

with children ingesting high-powered 

magnets that are part of magnet sets. 

These magnet sets are aggregations of 

separable, permanent, magnetic objects 

intended or marketed by the 

manufacturer primarily as a 

manipulative or construction desk toy 

for general entertainment, such as 

puzzle working, sculpture building, 

mental stimulation, or stress relief. In 

contrast to ingesting other small parts, 

when a child ingests a magnet, the 

magnetic properties of the object can 

cause serious, life-threatening injuries. 

When children ingest two or more of the 

magnets, the magnetic forces pull the 

magnets together, and the magnets 

pinch or trap the intestinal walls or 

other digestive tissue between them, 

resulting in acute and long-term health 

consequences. Although magnet sets 

have only been available since 2008, we 

have determined that an estimated 1,700 

ingestions of magnets from magnet sets 

were treated in emergency departments 

between January 1, 2009 and December 

31, 2011. 

To address the unreasonable risks of 

serious injury associated with these 

magnet sets, the Commission is issuing 

this notice of proposed rulemaking 

(NPR), which would prohibit such 

magnet sets. Under the proposal, if a 

magnet set contains a magnet that fits 

within the CPSC’s small parts cylinder, 

magnets from that set would be required 

to have a flux index of 50 or less, or they 

would be prohibited. The flux index 

would be determined by the method 

described in ASTM F963–11, Standard 

Consumer Safety Specification for Toy 

Safety. 

The Commission solicits written 

comments concerning the risks of injury 

associated with these magnet sets, the 

regulatory alternatives discussed in this 

NPR, other possible ways to address 

these risks, and the economic impacts of 

the various regulatory alternatives. This 

proposed rule is issued under the 

authority of the Consumer Product 

Safety Act (CPSA). 

DATES: Written comments in response to 

this document must be received by the 

Commission no later than November 19, 

2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2012– 

0050, by any of the following methods: 

Submit electronic comments in the 

following way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (email), except through 

www.regulations.gov. 

Submit written submissions in the 

following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions), 

preferably in five copies, to: Office of 

the Secretary, Consumer Product Safety 

Commission, Room 820, 4330 East West 

Highway, Bethesda, MD 20814; 

telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

comments received may be posted 

without change, including any personal 

identifiers, contact information, or other 

personal information provided, to 

http://www.regulations.gov. Do not 

submit confidential business 

information, trade secret information, or 

other sensitive or protected information 

electronically. Such information should 

be submitted in writing. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan D. Midgett, Ph.D., Project 

Manager, Office of Hazard Identification 

and Reduction, Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, MD 20814–4408; 

telephone: (301) 504–7692, or email: 

jmidgett@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The Commission is proposing a safety 

standard that would prohibit magnet 

sets that have been involved in serious 

injuries. The Commission believes that 

this proposed rule is necessary to 

address an unreasonable risk of injury 

and death associated with these magnet 

sets. 

1. History With Magnetic Toys 

In the mid-2000s, construction toys 

for children featuring small, powerful 

magnets were introduced into the toy 

market. Several children’s magnetic 

construction toys were recalled because 

the magnets detached from the plastic 

housing of the toy. (Release #07–164). 

We received reports of incidents in 

which children and infants had 

swallowed the small magnets that had 

detached from such toys. In some 

incidents, children swallowed intact 

magnetic components that were small 

parts.1 These incidents revealed that if 

a child swallows more than one small, 

powerful magnet or one such magnet 

and a ferromagnetic object, the objects 

can attract each other across tissue 

inside the stomach and intestines and 

cause perforations and/or blockage, 

which, if not treated immediately, can 

be fatal. We are aware of one death and 

numerous cases requiring intestinal 

surgery following ingestion of multiple 

small, powerful magnets from these 

toys. 

To address the hazard in toys, the 

CPSC worked with ASTM to develop 

voluntary standard requirements for 

toys containing magnets. These 

requirements became part of ASTM 

F963, Consumer Safety Specification for 

Toy Safety, which is now a mandatory 

CPSC standard. ASTM F963–11 defines 

a ‘‘hazardous magnet’’ and a ‘‘hazardous 

magnetic component’’ (i.e., a toy piece 

that contains an embedded hazardous 

magnet) as one that has a flux index 

greater than 50 and that is a small 

object. ASTM F963 applies to toys 

intended for children under 14 years of 

age. The flux index of a magnet is an 

empirical value developed by ASTM as 

a way to estimate the attraction force of 

a magnet. The ASTM working group 

established a flux index of 50 as a cutoff 

for what it considered to be a ‘‘safe’’ 

magnet, based on measurements of toys 

on the market. Most of the measured 

magnets were cylindrical in shape, and 

some had been involved in known 

incidents. When the ASTM graphed 

their measurements, they showed a 

good correlation (fairly linear 

relationship) between calculated flux 

index and measured attraction force for 


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a majority of the magnets. Based on this 

graph, ASTM considered the flux index 

a reliable way to gauge a magnet’s 

relative attraction force. Since the 

magnets from toys involved in incidents 

had flux index measurements greater 

than 70, the ASTM working group chose 

a flux index of 50 as a cutoff because it 

was significantly below the values for 

the incident magnets. 

2. Introduction of Magnetic Sets 

In 2008, a new type of magnet product 

came onto the market. The basic 

product was an aggregated mass of 216 

BB-size powerful magnets, generally 

marketed as adult desk toys for general 

amusement. These magnet sets were 

introduced in 2008, but 2009 was the 

first year with significant sales to U.S. 

consumers. The products are described 

more fully in section B of this preamble. 

In February 2010, CPSC staff received 

its first incident report involving this 

product. No injury resulted from this 

incident. Shortly after receiving this 

report, CPSC staff collected and 

evaluated samples of magnet sets. 

In December 2010, we received our 

first consumer incident report involving 

the surgical removal of magnets that 

were part of a magnet set. Information 

about incidents involving magnet sets is 

discussed in section C of this preamble. 

3. Prior Compliance Actions Concerning 

Magnet Sets 

The CPSC has been warning 

consumers about the hazards of magnet 

ingestion since 2006, because of the 

injuries that have occurred to children 

from hazardous magnets that were part 

of construction toys intended for 

children. Several recalls have been 

issued for toys containing magnets. 

In December 2009, we received a 

consumer complaint that the magnet 

sets intended for adults posed hazards 

similar to magnets in toys. As a followup to that complaint, during that month, 

a sample was collected by staff and age 

graded by the Directorate for 

Engineering Sciences, Division of 

Human Factors to be, in developmental 

terms appropriate for children ages 9 

years old and up. 

In February 2010, the CPSC received 

its first consumer incident report 

involving a child and a set of magnets 

intended for adults. A 9-year-old boy 

swallowed 7 spherical magnets while 

mimicking body piercings. He was not 

injured because the magnets passed 

through his system as a single mass. The 

magnets had been purchased for a 13- 

year-old. 

Samples of the product were detained 

and collected at the Customs and Border 

Protection site in February 2010. At the 

time of collection, the product was 

labeled for use by children 13+ years of 

age. Because of the age grade on the 

product and the manufacturer’s intent, 

it was subject to the requirements of the 

toy standard. The Office of Compliance 

and Field Operations (Compliance) 

issued a Notice of Noncompliance to the 

firm in March 2010. At the time, there 

was very little incident data associated 

with this product. The firm agreed to a 

corrective action that included, in part, 

new warnings to keep the product away 

from children, a change in the 

appropriate age for use of the product, 

and requests to retailers to list the 

product as appropriate only for 

consumers over 14 years of age. The 

firm also removed inventories labeled 

‘‘13+.’’ The firm also agreed to ask 

retailers who market products primarily, 

though not exclusively, to children to 

execute a Responsible Sellers 

Agreement prohibiting marketing and 

sales to children; stop the sale of these 

magnets to retailers that market 

products exclusively to children; and 

providing a Responsible Sellers 

Agreement to general use stores for their 

information. 

In December 2010, we received the 

first report of the surgical removal of 

magnets from a child who had ingested 

multiple magnets that came from a 

magnet set intended for adults. During 

2011, Compliance activity included 

evaluation of the marketing and labeling 

of the product category, collecting 

product marketed to children under 13 

and evaluating compliance with ASTM 

F963. In addition, where products did 

not have labeling or marketing 

information, the agency encouraged 

those firms to develop marketing and 

labeling to ensure that they were not 

marketed to children. More firms were 

issued Notices of Noncompliance for 

marketing to children younger than 14 

years. 

In response to continuing injuries 

associated with the products and 

children of various ages, we published 

a public service announcement (PSA) in 

November 2011, concerning the hazard 

in cooperation with two manufacturers. 

Reported incidents involving children 

continued to increase unabated from 8 

cases in 2010, 17 cases in 2011, and 25 

cases in 2012 (as of July 8, 2012). 

Twenty two incidents were reported 

before the PSA; 28 more followed 

during the eight months after it. A high 

percentage of the injuries resulted in 

surgeries or other invasive procedures. 

Of the 50 reports known to staff, 22 

required surgery, and 10 required either 

invasive procedures such as 

endoscopies or colonoscopies. In 2011, 

and into spring 2012, staff continued to 

identify additional firms offering this 

product on the Internet with labeling 

and marketing violations. 

Given the continued injuries to 

children, 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. Two of the importers did 

not agree to stop sale and are the subject 

of administrative actions recently 

initiated by the Commission. As those 

complaints allege, among other things, 

CPSC staff experts do not believe 

warnings will ever be effective in 

protecting children from this hidden 

hazard. 

B. The Product 

1. Description of the Product 

The magnet sets covered by this 

proposed rule typically are comprised of 

numerous identical, spherical, or cubeshaped magnets, approximately 3 to 6 

millimeters in size, with the majority 

made from NdFeB (Neodymium-IronBoron or NIB). These magnets exhibit 

strong attractive qualities. 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. 

Often referred to as ‘‘magnet balls’’ or 

‘‘rare earth magnets,’’ the products 

currently are 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, these 

products can be used and reused to 

make various two- and threedimensional forms, jewelry, and toys, 

such as a spinning top. 

The products are sold in sets of 

varying size, from as few as 27 magnets 

to more than 1,000. Most of the magnets 

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. Based on product information 

provided by marketers, the most 

common magnet size is approximately 5 

mm in diameter, although balls as small 

as about 3 mm have been sold, as have 

sets of larger magnet balls (perhaps 15 

mm to 25 mm in diameter). In addition 

to magnetic ball sets, desk sets of small 

magnetic cubes have also been sold, 

although they have comprised a 

relatively small share of the market. The 

leading marketer of such magnet sets 

recently added small magnetic rods— 

intended to be used with balls to make 


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2See 16 CFR § 1500.19(b)(1). 

geometric shapes—to its desk toy 

product line. 

The most common color of these 

magnets is a glossy, highly reflective 

silver, with the spheres often described 

as similar in appearance to BBs or ball 

bearings. Some firms now include sets 

in a wide range of colors, or 

combinations of colors, ranging from 

bright pink, green, and blue, to darker 

shades, such as purple and black. Most, 

with the exception of the smaller sets, 

are sold with a container, such as a 

square plastic cube, a metal tin, and/or 

a soft pouch. Most brands are sold in 

nondescript containers, such as metal 

tins or black fabric boxes. The largest 

seller uses colorful, transparent 

packaging that simulates the cube 

floating within. 

The age labeling of hazardous magnet 

sets varies; currently, most products 

carry an age label and are marked 

‘‘14+.’’ Some sets have no specific age 

recommendation on the package, even 

though retail Web sites may identify 

them as intended for ages ‘‘13+’’ or 

‘‘14+.’’ The small parts warning 2 is 

sometimes included on the packaging 

(i.e., ‘‘choking hazard, not for children 

under 3’’), as are warnings to keep the 

product away from all children. 

The proposed rule would define 

magnet sets as: ‘‘any aggregation of 

separable, permanent magnetic objects 

that is a consumer product intended or 

marketed by the manufacturer primarily 

as a manipulative or construction desk 

toy for general entertainment, such as 

puzzle working, sculpture, mental 

stimulation, or stress relief.’’ 

2. Use of the Product 

Although firms that sell magnet sets 

state that they intend them as desk toys 

for adults, these sets are found in offices 

and homes and in locations within the 

home beyond desk tops, such as on 

refrigerators. Magnet sets have some 

appeal for virtually all age groups. They 

tend to capture attention because they 

are shiny and reflect light. They are 

smooth, which gives them tactile 

appeal, and they make soft snapping 

sounds as they are manipulated. They 

have the properties of a novelty, which 

arouses curiosity; incongruity, which 

tends to surprise and amuse; and 

complexity, which tends to challenge 

and maintain interest. Their strong 

magnetic properties cause them to move 

in unexpected ways, with pieces 

snapping together suddenly, and 

moving apart—occasionally quite 

quickly. 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 product’s appeal as a challenging 

puzzle or as a manipulative or jewelry. 

They may also be used as a stress ball 

and as a way to hold things in place. 

Children from toddlers through teens 

have been exposed to these products in 

the home setting and elsewhere. 

Ingestion incidents have been reported 

to involve children 5 years of age and 

younger and follow similar scenarios as 

other ingestion incidents among this age 

group. Mouthing and ingestion of nonfood items is a normal part of the 

exploratory behavior of preschool 

children. Caregivers, in a few cases, said 

they had intended to keep the sets away 

from the victims, but did not realize 

they had failed to do so, until after the 

child became ill and the magnets had 

already caused internal injuries. In other 

incidents, the child reportedly had 

never mouthed or ingested objects 

previously, and as a result, they were 

permitted by the caregiver to play with 

the magnets. As might be expected, in 

a number of cases, the magnets were not 

in their original containers, and 

caregivers were unaware that some were 

missing from the set and in the child’s 

possession. Several importers sell sets of 

spares, small numbers of balls to replace 

those lost or missing from a larger set. 

These products would also be 

appealing to children of early-to-middle 

elementary school age, who might be 

capable of controlling the magnetic 

forces exhibited by the pieces while 

constructing various forms depicted in 

the product instructions and on the 

related Web sites. Simple threedimensional puzzles begin to interest 

children as they approach 8 and 9 years 

of age; and 9 through 12 year olds are 

interested in highly complex puzzles. 

Children in the 9 through 12 year age 

group have the reading skills to follow 

directions for three-dimensional 

puzzles, and they have the fine motor 

skills required to handle small, abstract, 

or interlocking pieces. Nine-year-olds 

can complete puzzles with 100 to 500 

pieces; and 10 through 12 year olds 

enjoy the challenge of puzzles with 500 

to 2,000 pieces. Children in this 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 in the paper and video 

instructions related to the magnet sets. 

Additionally, magnets typically are 

included in elementary school (ages 6 

through 12) science curricula, the age at 

which children are taught the basic 

concepts of magnetism. 

For all of these reasons, magnet sets 

are sometimes purchased for children 

under the age of 14, despite the 

warnings or labeling. This is consistent 

with reviews on retail Web sites, which 

indicate that these products are being 

purchased for children. Approximately 

one-third of 53 adults reviewing one 

manufacturer’s product on Amazon.com 

reported purchasing them 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. Given the relatively 

low cost for some sets, children in these 

age groups also 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. 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). This tendency toward 

mouthing behavior involving magnets 

could account for some reported 

ingestions, where incident details are 

lacking. 

Where details are provided, the 

incident reports describe scenarios that 

are consistent with the behaviors of 

children in this age range. Although 

exploratory play is generally associated 

with very young children, people of all 

ages use their senses to explore 

unfamiliar phenomena. More discussion 

of the hazard scenarios involving these 

products is provided in section C.2 of 

this preamble. 

3. The Market 

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 have been sold to U.S. 

consumers since 2009, the first year of 

significant sales, may have totaled about 

2.7 million sets, with a value of roughly 

$50 million. This 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 ranging from about $20 

to $45, with an average price of about 

$25. 

The small powerful magnets most 

likely to be affected by this proposed 

rule are made from alloys of 


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3The 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. 

4Six of the remaining seven incidents (out of the 

50 incidents) involved ingestion of magnets that 

were part of, or designed to be, part of jewelry, 

including beads, faux tongue rings, and earrings. 

One incident involved the ingestion of a magnetic 

rock. The rock magnet and magnets in jewelry 

would not meet the proposed definition of ‘‘magnet 

set’’ and would not be covered by this proposed 

rulemaking. 

neodymium, iron, and boron. They 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. 

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. 

All of the firms that have marketed 

the products are believed to import 

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, and there are no 

major barriers to market entry for firms 

wishing to source products from China 

for sale in the United States. Firms often 

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 have recently 

imported magnetic sets for sale in the 

United States. The combined sales of 

the top seven firms have probably 

accounted for the great majority 

(perhaps more than 98%) of units sold. 

One firm is believed to have held a 

dominant position in the market for 

magnetic desk sets since it entered the 

market in 2009. 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. 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; many 

that market products through ‘‘stores’’ 

on a leading Internet shopping site. 

C. Risk of Injury 

The risk addressed in this proceeding 

concerns damage to intestinal tissue 

caused by the ingestion of more than 

one magnet from a magnet set, magnets 

that are attracted to each other in the 

digestive system, damaging the 

intestinal tissue trapped between the 

magnets. In rare cases, there can be 

interaction between magnets in the 

airways and digestive tract (esophagus). 

Serious injury and death are likely 

consequences when children ingest 

strong magnets. 

1. Incident Data 

NEISS data. CPSC staff reviewed data 

from the National Electronic 

Surveillance System (NEISS) database of 

magnet-related ingestion cases treated in 

emergency departments from January 1, 

2009 to December 31, 2011.3 To derive 

estimates, CPSC staff considered all 

cases reported through NEISS from 

January 1, 2009 to December 31, 2011, 

which mentioned ‘‘magnet’’ in the 

narrative field of NEISS reports. This 

review produced an estimated 6,100 

magnet-related ingestions for that period 

of time (note that this includes incidents 

involving all types of magnets, not just 

magnet sets). This excludes cases with 

descriptions such as ‘‘kitchen magnet’’ 

or ‘‘plastic-covered magnet.’’ Staff 

further analyzed cases that possibly 

involved magnets that were from 

magnet sets. This review yielded a 

count of 72 magnet ingestion cases 

during this time period, which staff 

determined (based on a review of 

narratives in the NEISS reports) to 

involve or possibly involve magnets 

from magnet sets. Based on the magnet 

ingestion cases treated in NEISS 

hospital emergency departments, staff 

determined that an estimated 1,700 

ingestions of magnets from magnet sets 

were treated in U.S. emergency 

departments during this time period. 

NEISS cases are coded from medical 

records so brand name is rarely 

available, but descriptions of the 

products from the NEISS narrative 

suggests that the magnets involved in 

these cases are magnets from magnet 

sets. For more information about the 

process for developing the estimates of 

incidents, see the memorandum from 

the Directorate for Epidemiology at Tab 

A of staff’s briefing package http:// 

www.cpsc.gov/library/foia/foia12/brief/ 

magnetstd.pdf. It is possible that some 

number of the estimated 4,400 magnet 

ingestion-related injuries not classified 

as high-powered magnets could be 

attributable to the ingestion of magnets 

from high powered magnet sets. 

However, the information provided in 

the NEISS reports did not provide 

sufficient detail to place them into that 

category. 

Staff reviewed the NEISS data to 

obtain more information about incidents 

involving magnet sets. With regard to 

age, the largest portion of these 

incidents involved children 4 through 

12 years of age. Of the estimated 1,700 

ingestion incidents related to magnet 

sets, 1,200 of the victims are in the 4- 

through 12-year-old age group (70.6 

percent). It is quite possible that some 

portion of the estimated 4,400 ‘‘magnets, 

type unknown/other type’’ category of 

incidents also involved magnet sets and 

children in the 4- through 12-year-old 

age group. Of the estimated 1,700 

ingestions, most (approximately 1,600) 

were treated and released from the 

hospital. 

Databases other than NEISS. In 

addition to reviewing NEISS data, staff 

also reviewed incidents reported 

through other CPSC databases, such as 

the Injury or Potential Injury Incident 

database (IPII) and the In-depth 

Investigation database (INDP). These 

databases provided more detailed 

descriptions, and thus, included more 

information about the products involved 

and the incident scenarios. In reviewing 

the initial set of incidents from these 

databases, staff considered all reported 

incidents from January 1, 2009 through 

June 30, 2012, that involved a magnet 

and an ingestion or injury was reported. 

Excluded from this review were 

magnets in children’s toys, as well as 

magnets that were determined to be a 

different type other than small, strong 

magnets from sets of magnets. Staff 

focused on one hazard pattern: ingestion 

of magnets. Other reported hazard 

patterns, such as allergic reactions, ear 

injuries, and a hand injury were 

excluded. 

From review of INDP and IPII 

databases, we are aware of 50 reported 

incidents occurring from January 1, 

2009 through June 30, 2012 involving 

the ingestion of magnets by children 

between the ages of 1 and 15. 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’’; and 5 

of those 50 incidents possibly involved 

ingestion of this type of magnet. We 

discuss these 43 incidents (the 38 

incidents, plus the 5 possible incidents) 

in more detail below.4

In 35 of the 43 incidents, two or more 

magnets were ingested. Hospitalization 

was required in order to treat 29 of the 

43 incidents, with surgery necessary to 


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remove the magnets in 20 of the 29 

hospitalizations. In 9 of the 29 

hospitalizations, the victim underwent 

colonoscopic or endoscopic procedures 

to remove the magnets. In 37 of the 43 

incidents that likely involved magnets 

from hazardous magnet sets, the 

magnets were ingested by children 

younger than 4 years old or between the 

ages of 4 and 12 years. 

In 20 of the 43 incidents, the victims 

reportedly put the magnets in their 

mouths because they thought the 

magnets were edible; they wished to 

emulate jewelry piercings; or they 

simply mouthed the magnets while 

playing with them. In 23 of those 43 

incidents, there is insufficient 

information to determine how the 

magnets were being used at the time of 

the ingestion. 

In 30 of the 43 incidents, the reports 

indicate the source of the magnets 

ingested. In 10 of the incidents, the 

magnets were owned by a relative and 

were obtained, presumably by the 

victim, without the relative’s 

knowledge. In 5 incidents, the magnets 

were given to the child by an adult; and 

in 12 incidents, the magnets were 

obtained from a friend or classmate. In 

three instances, the magnets were 

purchased by the victim. The number of 

ingestion incidents involving magnets 

from magnet sets has increased over 

time, from 7 in 2010, to 16 in 2011, and 

20, as of June 30, 2012. 

2. Hazard Scenarios 

The incident reports describe 

scenarios that are consistent with 

behaviors of children in the age range 

described in the incidents. In the 

incidents reported among 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. Another 

common scenario accounted for half of 

the reported ingestion incidents among 

8 to 15 year olds. Children used at least 

two and as many as seven magnets to 

simulate piercings of their tongue, lips, 

or cheeks. On the tongue or lip, children 

sometimes used more than two magnets 

to form the appearance of a ring. This 

is a type of role-play behavior, 

particularly for the younger children in 

the group, and the magnets serve as 

highly realistic props. 

In this section, we summarize some of 

the incident reports to demonstrate a 

few of the hazard scenarios that have 

been reported in incidents involving 

ingestion of magnets from magnet sets. 

In one incident, a 10-year-old girl 

simulating a tongue piercing, 

accidentally swallowed two magnetic 

balls. That same day, her mother took 

her to the local emergency room, and 

she was admitted for 5 days; during that 

time, the movement of the magnets was 

monitored by 10 x-rays, 3 CT scans, and 

an endoscopy. Ultimately, the magnets 

were manipulated from their eventual 

position in the colon into the appendix 

via laparoscopic surgery and removed 

by an appendectomy. 

In another incident, a 13-year-old girl 

accidentally swallowed five small, 

spherical, high-powered magnets when 

they suddenly snapped together while 

she was mimicking a lip piercing. 

Although her abdominal pains began 

and worsened over the next 2 days, she 

did not tell her mother of the ingestion 

until 3 days later. She was then taken 

to hospital, where abdominal x-rays 

confirmed ingestion of five magnetic 

balls. Medical staff initially tried 

unsuccessfully to remove the magnets 

using an oral bowel cleansing solution 

and then a colonoscopy procedure. 

Eventually she underwent surgery, and 

the magnets—located in three different 

places in her small intestine—were 

removed during a surgical procedure 

that involved resection of damaged 

bowel tissue and removal of her 

appendix. The victim’s complicated 

recovery resulted in hospitalization for 

14 days, and the surgery left a 4-inch 

abdominal scar. 

In another incident, an 18-month-old 

boy sustained life-threatening intestinal 

injuries and will have lasting adverse 

health effects after ingesting three small, 

spherical magnets. The boy exhibited 

symptoms of diarrhea and vomiting and 

was clutching at his right side. When 

his mother took him to the local 

hospital, he was diagnosed with an ear 

infection. When his symptoms did not 

resolve a few days later, she took him 

to a second hospital where, reportedly, 

he was diagnosed with bronchitis, given 

some medication, and released. One or 

2 days later, his mother noticed that his 

stomach was distended and took him to 

a third hospital. Abdominal x-rays 

revealed three small balls, requiring 

immediate surgical intervention to 

remove the foreign objects. The 

procedure required resection of 6 inches 

of the child’s small intestine and 

resection of 3 inches of his large 

intestine. The victim remained in 

intensive care for 1.5 weeks before being 

released. He continued to have diarrhea 

and other intestinal problems (at least 2 

months post-surgery when the IDI was 

completed). 

In another incident, a 3-year-old girl 

swallowed eight small spherical 

magnets from a magnet set, which she 

found on a refrigerator door. An x-ray 

revealed two joined magnets that 

appeared to be located in the victim’s 

esophagus, plus another six magnets 

that appeared to be joined together in 

the victim’s stomach. A second x-ray 

image, taken the next day at a different 

hospital, showed that the magnets had 

not moved. A third x-ray at a Children’s 

Hospital showed no movement of the 

magnet pair (described as 3mm beads) 

in the esophageal area, and some 

movement of the group in the abdomen. 

Pre-intervention, the treating physicians 

correctly recognized that she might have 

aspirated a magnet into her airways that 

was interacting through tissues with a 

magnet located in the esophagus. The 

girl underwent three coordinated 

procedures: (1) A bronchoscopy that 

removed one ‘‘magnetic bead’’ from her 

right bronchus; (2) an esophagogastroduodenoscopy (endoscopy) that 

removed one magnetic bead from the 

mid-esophagus, and five magnetic beads 

from the stomach; and (3) a diagnostic 

laparoscopy, followed by laparoscopicassisted removal of the remaining 

magnet, plus laparoscopic repair of a 

gastric perforation and a small bowel 

perforation. 

In another incident, a 23-month-old 

male ingested eight small spherical 

magnets from a product described as a 

‘‘magnetic puzzle.’’ He started vomiting 

overnight and worsened the next day. 

He was taken to an urgent care facility, 

where a bilateral ear infection initially 

was suspected. A few hours later, as the 

child’s condition worsened and he lost 

consciousness intermittently, an 

abdominal x-ray indicated six small 

balls that the mother recognized 

immediately, and informed the staff, 

were magnets from the puzzle. He was 

transferred to a Children’s Hospital 

where an x-ray revealed some slight 

movement of the magnets. According to 

the mother, the doctors thought the 

magnets would pass naturally. An x-ray 

taken the following day showed the 

magnets to be located between the small 

and large intestine; therefore, surgery 

was undertaken to remove them. During 

surgery, two balls were found in the 

small intestine and six balls were found 

outside of the bowel in the abdominal 

cavity. These were removed and a small 

intestine perforation repaired. Staff does 

not have access to the full medical 

records, but according to the parents, 

extremely serious complications ensued 

after the first surgery. The child 

underwent several sequential surgeries 

over the next 10 days to repair leaks 

(unclear if this involved missed 

perforations/failure of repairs/new 


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perforations) and treat a blood clot, 

ischemic necrotic bowel, and serious 

infection stemming from the initial 

magnet injury. Ultimately, after what 

appears to be at least five or six 

operations, the child was stabilized but 

was still retained in an intensive care 

unit for more than a month, having lost 

all but 10 to 15 centimeters of small 

intestine (HS staff notes the small 

intestine is about 600 to 700 centimeters 

long). He is being fed intravenously and 

has a colostomy bag to remove waste 

products. He will require a bowel 

transplant and his long-term prognosis 

is poor. 

As these scenarios demonstrate (and 

further discussed in the next section), 

parents and caregivers may not realize 

that the child has ingested magnets. 

Thus, diagnosis and treatment is 

delayed, and the severity of the 

resulting injuries increases. 

3. Details Concerning Injuries 

As indicated in the previous section 

describing some of the incident 

scenarios, diagnosis of injury from 

magnet ingestion is complicated by 

multiple factors, and the resulting 

injuries can be very serious. Medical 

professionals may not be aware of the 

dangers posed by ingestion of highpowered magnets and the corresponding 

need for immediate evaluation and 

monitoring. Standard diagnostic tools, 

such as x-rays, may not demonstrate 

fully that the ingested item is a magnet 

and they may not allow medical 

professionals to identify the number of 

magnets ingested. Moreover, magnets 

may appear in an x-ray to be other 

nonmagnetic items that children 

commonly ingest, such as beads, which 

typically are monitored without surgical 

intervention and are allowed to pass 

through the child’s gastrointestinal tract. 

Furthermore, treatment for injuries 

resulting from the ingestion of these 

magnets often is delayed, much to the 

serious detriment of the patient because 

the symptoms associated with damage 

to intestinal tissue resulting from the 

ingestion of these magnets frequently 

resemble the symptoms associated with 

less serious conditions, such as the 

stomach flu. 

Accurate and timely diagnoses also 

are complicated by the fact that children 

and teens may not attribute their 

gastrointestinal symptoms to prior 

ingestion of magnets, and they may be 

unable or unwilling to communicate to 

their parents, caregivers, or medical 

personnel that they have ingested 

magnets. Accordingly, the delay of 

surgical intervention due to the patient’s 

presentation with non-specific 

symptoms and/or medical personnel’s 

lack of awareness of the dangers posed 

by multiple magnet ingestion can 

exacerbate life-threatening internal 

injuries and has resulted in the need for 

a bowel transplant. 

In medical terms, the magnet injuries 

are pressure necrosis injuries. The 

unique mechanism of injury involving 

harmful tissue compression by strong 

magnets has become established in 

recent years. Ingested magnets residing 

in relatively close proximity to one 

other are mutually attracted through 

intestinal walls. The magnets interact 

rapidly and forcefully. The magnetic 

attraction can occur over distances of 

about 10 to 20 mm for a pair of magnets, 

to distances much greater than that, as 

the number of magnets involved 

increases. The attraction forces 

operating between just one pair of 

magnets (or a magnet and another 

ferromagnetic object) is strong enough to 

withstand any normal muscular 

contractions of the gastrointestinal 

tissues (GI) (peristaltic or mixing 

motions), as well as the intermittent 

turbulent flow of the considerable 

volumes of gastrointestinal fluid in the 

small intestine, or the passage of 

semisolid contents in the large intestine. 

The magnets remain coupled, exerting 

strong bilateral compression forces on 

the trapped GI tissues, sufficient to 

block their blood and nutrient supply. 

The extreme pressure exerted on the 

trapped tissues ultimately is directly 

responsible for the progressive tissue 

injury, which starts with local 

inflammation and ulceration, 

progressing to tissue death, then 

perforation, or fistula formation. 

Fistulas (abnormal connections or 

passageways between two organs or 

vessels that normally do not connect) 

cause serious, debilitating symptoms, 

but generally are not as acutely urgent 

as perforations. Perforations present a 

serious risk of leakage of gut contents 

into the abdominal cavity which, within 

hours, can escalate quickly from an area 

of local infection, to peritonitis (an 

inflammation of the peritoneum, the 

thin tissue that lines the inner wall of 

the abdomen and covers most of the 

abdominal organs), then life-threatening 

systemic infection (sepsis). 

In some rare cases, ingested magnets 

have caused loops of the bowels to 

become twisted; this obstructs passage 

of gut contents and deprives the twisted 

gut segment of blood. It is considered an 

extremely urgent situation, requiring 

immediate surgical intervention to 

prevent the trapped segment from 

becoming necrotic, and/or from 

rupturing and causing contamination of 

the abdominal cavity. Magnets have also 

trapped and perforated mesenteric 

tissues, presenting the possibility that 

larger blood vessels in the gut mesentery 

could be damaged, which could cause 

an intra-abdominal hemorrhage. 

Once attracted magnetically to each 

other through intestinal walls, the 

magnets involved in GI injuries are 

unlikely to disengage spontaneously or 

to move position until they are removed 

by clinicians. A pair of magnets might 

be uncoupled by stronger attraction 

forces exerted by a larger number of 

magnets in a separate GI location (which 

then could cause further injury, perhaps 

unrecognized, in a different GI location). 

If magnets fall through perforations into 

the peritoneal cavity, they are expected 

to require surgical intervention and to 

have a relatively high associated 

morbidity. 

Complications after these abdominal 

surgeries include bleeding, infection, 

and ileus (temporary paralysis of gut 

motility). Adhesions (where bands of 

intra-abdominal scar tissue form that 

can interfere with gut movement and 

can cause obstruction) may occur as a 

short-term or long-term (years) 

complication, frequently resulting in 

bowel obstructions requiring additional 

surgeries, and thus, creating a cycle. In 

females, there also can be future fertility 

concerns related to abdominal scar 

tissue and adhesions. In cases where 

long segments of injured bowel have to 

be removed, digestive function of 

victims can be impaired permanently, 

resulting in malabsorption, diarrhea, 

cramping, total parental nutritional 

feeding (and consequent frequent bouts 

of sepsis), need for a bowel transplant, 

and even death. 

D. Statutory Authority 

This proceeding 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. See 15 U.S.C. 

2052(a). 

The Commission is authorized, under 

section 7 of the CPSA, to promulgate a 

mandatory consumer product safety 

standard that sets forth certain 

performance requirements for a 

consumer product or that sets forth 

certain 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. In addition, 

if the Commission finds that no feasible 

consumer product standard under 

section 7 would adequately protect 

consumers from an unreasonable risk or 

injury associated with hazardous 


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magnet sets, the Commission may 

promulgate a rule under section 8 of the 

CPSA declaring hazardous magnet sets 

to be banned products. 15 U.S.C. 2057. 

Section 9 of the CPSA specifies the 

procedure the Commission must follow 

to issue a consumer product safety 

standard under section 7. In accordance 

with section 9, the Commission may 

commence rulemaking by issuing an 

NPR including the proposed rule and a 

preliminary regulatory analysis in 

accordance with section 9(c) of the 

CPSA and requesting comments with 

respect to the risk of injury identified by 

the Commission, the regulatory 

alternatives being considered, and other 

possible alternatives for addressing the 

risk. Id. 2058(c). Next, the Commission 

will consider the comments received in 

response to the proposed rule and 

decide whether to issue a final rule and 

a final regulatory analysis. Id. 2058(c)– 

(f). 

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, 

concerning 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 need of the public 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) means to achieve the 

objective of the rule while minimizing 

adverse effects on competition, 

manufacturing, and commercial 

practices. Id. 2058(f)(1). 

According 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 that 

issuing the rule is in the public interest. 

Id. 2058(f)(3)(A)&(B). In addition, if a 

voluntary standard addressing the risk 

of injury has been adopted and 

implemented, the Commission must 

find that: (1) the voluntary standard is 

not likely to eliminate or adequately 

reduce the risk of injury, or that (2) 

substantial compliance with the 

voluntary standard is unlikely. Id. 

2058(f)(3(D). The Commission also must 

find that expected benefits of the rule 

bear a reasonable relationship to its 

costs and that the rule imposes the least 

burdensome requirements that would 

adequately reduce the risk of injury. Id. 

2058(f)(3)(E)&(F). 

The Commission seeks input on 

whether it should be regulating under 

section 7 and 9 of the CPSA or seeking 

a ban under section 8 of the CPSA or 

under similar provisions of the Federal 

Hazardous Substances Act. 

E. Relevant Existing Standards 

Currently, there is no voluntary 

standard applicable to magnet sets. The 

Consumer Product Safety Improvement 

Act of 2008 (CPSIA) mandated ASTM 

F963–11, Standard Consumer Safety 

Specification for Toy Safety, as a 

consumer product safety standard 

(Section 106 of the CPSIA). Whether the 

toy standard is applicable to magnet sets 

is not the subject of this rulemaking. 

F. Description of the Proposed Rule 

The Commission is proposing a rule 

that would prohibit certain highpowered magnet sets. As described in 

previous sections of this preamble, we 

are aware of serious injuries resulting 

from children ingesting such magnets. 

Magnets that do not have the prohibited 

characteristics and magnets that are not 

parts of magnet sets would still be 

allowed. 

1. Scope, Purpose, and Effective Date— 

§ 1240.1 

This section of the proposed rule 

would state that the proposed 

requirements in 16 CFR part 1240 are 

intended to reduce or eliminate an 

unreasonable risk of injury to children 

who ingest magnets that are part of 

hazardous magnet sets. The standard 

would apply to all magnet sets, as 

defined in § 1240.2, that are 

manufactured or imported on or after 

the date 180 days after publication of a 

final rule. 

2. Definitions—§ 1240.2 

This section of the proposed rule 

would define the term ‘‘magnet set’’ to 

mean ‘‘any aggregation of separable, 

permanent magnetic objects that is a 

consumer product intended or marketed 

by the manufacturer primarily as a 

manipulative or construction desk toy 

for general entertainment, such as 

puzzle working, sculpture building, 

mental stimulation, or stress relief.’’ 

This definition would not include other 

magnetic products that do not meet the 

definition, 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, Standard Consumer 

Safety Specification for Toy Safety, 

which is a mandatory CPSC standard. 

The Commission seeks comment on the 

scope of the products proposed to be 

covered by this proposed rule and, in 

particular, whether risks are presented 

by magnets in science kits or craft and 

hobby kits no matter how they are age 

graded and labeled. 

The Commission also seeks comment 

on whether the definition of ‘‘magnet 

set’’ should include single, i.e., 

individual, magnets in order to ensure 

that the regulation prohibits the sale of 

individual magnets for use as aggregated 

manipulative or construction desk toys. 

This is because the hazard posed by 

magnets attracting in the body can occur 

when magnets are purchased 

individually or as a set. 

3. Requirements—§ 1240.3 

This section would set 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, magnets from 

that set would be required to have a flux 

index of 50 or less. The Commission 

recognizes the possible hazard that 

could be posed by magnets that are 

purchased individually and 

subsequently aggregated. Therefore, the 

proposed language in § 1240.3(a) applies 

to magnet sets that contain a single 

magnet that fits completely within the 

small-parts cylinder described in 16 

CFR 1501.4. 

The Commission seeks comment 

regarding whether the proposed 

language in § 1240.3(a) applies to 

magnet sets that contain one magnet, or 

more than one magnet, that fits 

completely within the small-parts 

cylinder described in 16 CFR 1501.4. 

The small parts cylinder referenced in 

the proposed 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 is too large to fit within the 

small parts cylinder, it would not be 

prohibited, regardless of the magnet’s 

flux index. Thus, it might be possible 

for manufacturers to make magnet sets 

that contain strong magnets so long as 

the magnets are sufficiently large, 

although the large size could reduce 

their utility. 

Small magnets (i.e., those that fit 

within the small parts cylinder) that are 

part of a magnet set must have a flux 

index of 50 or less. This limit is based 

on the level that is specified in ASTM 

F963–11, Standard Consumer Safety 

Specification for Toy Safety, which is a 

mandatory CPSC standard. As discussed 

in section A.1 of this preamble, the flux 

index of a magnet is an empirical value 


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developed by ASTM as a way to 

estimate the attraction force of a magnet. 

The flux index limit of 50 was 

developed by ASTM, with CPSC staff’s 

participation, to address injuries 

resulting from strong magnets that 

separated from toys. The limit was 

based on an analysis of magnets that 

were involved in incidents. The 

Commission seeks input on the limit 

particularly as to whether there may be 

health risks should a large number of 

magnets be ingested even if such 

magnets are at or below the flux limit of 

50. 

4. Test Procedure for Determining Flux 

Index—§ 1240.4 

This section of the proposed rule 

would describe 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 

would be selected for testing. The flux 

index of the selected magnets would be 

measured in accordance with the 

procedure set forth in section 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. 

We are proposing to use the 

methodology specified in ASTM F963– 

11 to measure the flux index of magnets 

that are part of a magnet set. The test 

method was developed to address 

hazards posed by magnets that are part 

of a toy. Such magnets are likely to be 

individual magnets that separate from a 

toy. Magnet sets may contain hundreds 

of magnets. Thus, such magnets are 

more likely to be aggregated than 

magnets separated from toys. When 

magnets are aggregated, their magnetic 

strength may increase. Children exposed 

to magnets from these magnet sets may 

ingest more magnets than they would if 

a magnet separates from a toy. Thus, it 

may be desirable to develop a method 

for testing the strength of aggregated 

magnets. We are interested in receiving 

comments that would address this issue. 

5. Findings—§ 1240.5 

In accordance with the requirements 

of the CPSA, we are proposing to make 

the findings stated in section 9 of the 

CPSA. The proposed findings are 

discussed in section N of this preamble. 

G. Alternatives 

The Commission has considered 

alternatives to reduce the risk of injuries 

related to the ingestion of magnets 

contained in magnet sets. However, as 

discussed below, the Commission does 

not believe that any of these would 

adequately reduce the risk of injury. 

1. Voluntary Recalls 

Although several of the companies 

that manufacture or import magnet sets 

have voluntarily agreed to recall (and in 

some cases, stop selling) these products, 

and several retailers have agreed to stop 

sale, the Commission has been 

unsuccessful in negotiating voluntary 

recalls and stop sales with several 

companies that control a significant 

portion of the magnet set market, 

including the company that sells more 

than 70 percent of the magnet sets 

purchased in the United States. It is 

extremely unlikely that all 

manufacturers/importers will 

voluntarily agree to stop selling and 

recall their magnet sets. Moreover, 

recalls would not prevent new entrants 

into the market in the future. 

2. Voluntary Standard 

Currently, there is no applicable 

voluntary standard in effect. A group of 

magnet set importers and distributors 

have requested that ASTM International 

develop a voluntary standard for the 

labeling and marketing of these 

products. Specifically, these companies 

have requested the formation 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 not selling the 

magnet sets in proximity to children’s 

products. However, despite companies’ 

marketing and labeling to attempt to 

limit children’s exposure to magnets, 

ingestion incidents involving children 

continue to occur and the labeling does 

not change the attractiveness of the 

product to children or the intrinsic play 

value of the magnet sets. From the date 

that the firm with the largest share of 

the market undertook certain labeling 

enhancements and marketing 

restrictions through June of 2012, the 

Commission has learned of 47 

additional incidents involving ingestion 

of magnets from hazardous magnet sets, 

26 involving ingestion of the company’s 

hazardous 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 this product. 

3. Warnings 

It is unlikely that additional or 

different warnings on the packages of 

magnet sets would significantly reduce 

the ingestion-related injuries caused by 

high-powered magnets. Safety and 

warnings literature consistently 

identifies warnings as a less effective 

hazard-control measure than designing 

out the hazard 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 adequately 

reduce or eliminate the ingestion of 

these magnets. 

Warnings are especially unlikely to be 

effective among 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. In addition, warning 

design guidelines and literature 

commonly recommend that the text of 

warnings intended for the general 

public be written at no higher than the 

6th grade reading level, which is 

equivalent to a child about 11 years old. 

A warning that met this guideline 

presumably would not be understood by 

many children younger than 11. 

Older children, more advanced 

cognitively, are able to appreciate better 

the hazards described in a warning. 

However, these children value peer 

acceptance more than parental 

guidelines, and social influences and 

peer pressure can drive adolescent 

behavior more strongly than their own 

independent thought processes. 

Furthermore, adolescents are at a 

developmental stage in which they test 

limits and bend rules. Therefore, 

warnings about keeping the product 

away from children could have the 

unintended effect of making the product 

more appealing to some children. Older 

children might view such warnings as 

attempts to restrict personal freedom or 

self-expression, which could result in 

responses that are contrary to the 

warning’s recommendations. For 

example, warnings about not using the 

product in the specific ways that might 

place them at risk, such as mimicking 

piercings, might have the unintended 

effect of encouraging this behavior 

among these children. Repeated use of 

the product in this way, without 

ingesting the magnets, most likely will 

convince these children that the hazard 

is not especially likely or is not relevant 

to them. 


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The ingestion warnings that currently 

accompany these products appear to be 

aimed at adults, primarily parents and 

other caregivers. Staff generally found 

the content of these warnings to be 

lacking in the following ways. The 

warnings often refer to children 

swallowing the magnets, without 

describing the incident scenarios that 

might lead to ingestion among older 

children and adolescents, whom 

caregivers may not believe are likely to 

put magnets into their mouths. Some 

warnings refer to the potential for 

swallowed magnets to stick to 

intestines, without referring to other 

magnets or ferromagnetic objects. Other 

warnings refer to magnets sticking 

together or attaching to other metallic 

objects inside the body, but they fail to 

explain that the magnets can attract 

through the walls of the intestines and 

forcefully compress these tissues. 

Without detailed information such as 

this, consumers may not understand 

how swallowing magnets differs from 

swallowing other small parts, or how 

magnets sticking together could pose a 

hazard rather than simply pass through 

the child’s system. In sum, without a 

clear, explicit, and accurate description 

of the nature of the hazard and its 

consequences, consumers may have 

difficulty developing an accurate mental 

model of the hazard scenario and might 

find the warning implausible. In such 

situations, consumers are unlikely to 

comply with the action recommended 

in the warning. 

Even if warnings could communicate 

the ingestion hazard, its consequences, 

and appropriate hazard-avoidance 

measures in a way that would be 

understood by most parents and other 

caregivers, the resulting warnings may 

not be effective at substantially reducing 

the incidence of magnet ingestions if 

consumers do not concur with what the 

warning states. Avoiding the ingestion 

hazard requires consumers to keep the 

product away from all children, or at 

least children in the incident age group, 

which is 15 years old and younger. 

Caregivers who read and understand the 

warnings may attempt to keep this 

product out of the hands of young 

children, but are not likely to be so 

diligent about heeding the warning with 

older children and adolescents. Unless 

caregivers are convinced that their child 

is likely to mimic lip, nose, or similar 

piercings or to perform other activities 

that might lead them 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. 

Even if caregivers believe the 

warnings, several factors may prevent 

compliance. Some children, especially 

those who are older, may have peers 

who already own and use magnets from 

magnet sets. Some personally may have 

used the product before. Knowing this, 

caregivers might feel significant social 

pressure from the child, other family 

members and friends, to purchase the 

product for their children, or allow their 

children to use the product, especially 

if magnet sets are very popular among 

the child’s peers. 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. 

Moreover, securing the product from 

a child after every use requires time and 

effort, and warnings research has shown 

that even small increases in time and 

effort can prevent compliance with 

warnings. If the caregiver cannot secure 

the product properly—without 

dismantling the shapes and forms 

created during use—and the caregiver 

has created especially challenging or 

interesting designs with the magnets, 

the caregiver might feel compelled to 

keep the forms intact and, as a result, 

fail to secure the product properly. In 

addition, the difficulty of attempting to 

identify 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.’’ Attempts to secure the 

product also may fail because the 

caregiver underestimates the abilities of 

their child and places the product in 

locations that seem secure but are still 

accessible to the child. Teens may have 

cognitive and motor skills similar to an 

adult’s, making it extremely challenging 

to keep the magnet sets out of their 

hands. Furthermore, if caregivers know 

that their children have friends who 

own and use magnet sets, caregivers are 

likely to conclude that securing their 

magnet set will not prevent exposure to 

other identical or similar products. This 

may lead caregivers to reject the 

warning message. 

Based on these concerns about the 

likely effectiveness of warnings for 

magnet sets, we do not believe that 

warning labels would adequately reduce 

the risk of injury presented by these 

products. We are interested in receiving 

comments on the warnings issues. 

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, or a package that 

is child resistant. Aside from the 

evident challenges in developing such 

containers, their effectiveness at 

reducing ingestions is doubtful. Such 

approaches would depend on 

consumers securing the packaging after 

each use. As discussed above, 

consumers may be reluctant to place the 

product back in its packaging after they 

have created designs with the magnets. 

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 them away from toy 

stores, children’s sections of stores, and 

other such locations. It is not clear that 

the Commission would have the 

regulatory authority to impose such 

sales restrictions by rule. In any event, 

such restrictions are unlikely to reduce 

ingestions significantly. As discussed in 

section B.2 of this preamble, children 

access these magnets from sources other 

than stores. The magnet sets may be 

available in the home after a caregiver 

has purchased them. Such sales 

restrictions are unlikely to deter teens. 

Moreover, restrictions on in-store sale of 

magnet sets would not affect Internet 

sales. 

6. No Action 

Another option is for the Commission 

to take no regulatory action to address 

the risk of injury posed by magnet sets. 

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, but would likely 

be smaller than if the Commission 

issues the proposed rule. 

H. Preliminary Regulatory Analysis 

The Commission is proposing to issue 

a rule under sections 7 and 9 of the 

CPSA. The CPSA requires that the 

Commission prepare a preliminary 

regulatory analysis and that it be 

published with the text of the proposed 

rule. 15 U.S.C. 2058(c). The following 

discussion is extracted from staff’s 

memo, ‘‘Preliminary Regulatory 

Analysis of a Proposed Rule that Would 

Prohibit Certain Small Powerful Magnet 

Sets.’’ 

1. Introduction 

The Commission has preliminarily 

determined to issue a rule prohibiting 

magnet sets that have been involved in 

incidents resulting in serious injuries to 

children who have ingested magnets 

that are part of these magnet sets. Some 

of these incidents have required surgery 

to remove individual magnets ingested 


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5However, small neodymium-iron-boron magnets 

previously have been, and continue to be, marketed 

by firms, such as magnet suppliers and distributors 

of educational products. 

6One firm’s larger magnet balls are reportedly 

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

rather than neodymium-iron-boron. 

7One importer reported that some of the magnet 

sets it sells and ships to U.S. consumers are made 

from bulk magnets received from its supplier in 

China that it repackages in its U.S. office. 

8More than 40 such stores shipping magnetic 

desk toys directly from Hong Kong or China were 

identified in a brief review of product offerings on 

the Internet site. 

by children. Reported incidents of 

magnet ingestion involved young 

children who put the magnets in their 

mouth and adolescents and teens who 

paired magnets to mimic tongue or lip 

piercings. This behavior has led to the 

powerful magnets being swallowed, 

resulting sometimes in severe medical 

consequences, including significant 

damage to the gastrointestinal tract. 

The proposed rule would prohibit 

magnet sets that do not meet the 

requirements of the proposed rule. 

Thus, for magnet sets that contain more 

than one magnet, if any of the magnets 

would fit within the small parts 

cylinder, the magnet set would be 

prohibited, unless the small magnets 

meet the specified flux index limit. This 

performance standard for magnet sets 

would effectively ban current designs of 

magnetic desk sets of the type that have 

become popular in recent years. 

2. Description of the Product and 

Market 

Magnetic desk sets that would be 

affected by the scope of the proposed 

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 the first 

year with significant sales to U.S. 

consumers was 2009.5 Most 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, and 

others have sold large sets of more than 

1,000 magnetic balls. Based on product 

information provided by marketers, the 

most common magnet size is 

approximately 5 mm in diameter; 

although balls as small as about 3 mm 

have been sold, as have sets of larger 

magnet balls (perhaps 15 mm to 25 mm 

in diameter).6 In addition to magnetic 

ball sets, desk sets of small magnetic 

cubes have also been sold, although 

they have comprised a relatively small 

share of the market. The leading 

marketer of such magnet sets has 

recently added small magnetic rods— 

intended to be used with balls to make 

geometric shapes—to its desk toy 

product line. 

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 have been sold to U.S. 

consumers since 2009, the first year of 

significant sales, may have totaled about 

2.7 million sets, with a value of roughly 

$50 million. This value range 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 

suggest prices typically ranging from 

about $20 to $45, with an average price 

of about $25. 

The small powerful magnets most 

likely to be affected by this proposed 

rule are made from alloys of 

neodymium, iron, and boron. 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 now are mined 

in China, which also reportedly holds a 

nearly worldwide monopoly on the 

production of neodymium-iron-boron 

magnets. 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.7

As noted above, none of the magnetic 

sets within the scope of the proposed 

rule are produced domestically. All of 

the firms that have marketed the 

products are believed to import 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; and there are no 

major barriers to market entry for firms 

wishing to source products from China 

for sale in the United States. For 

example, some of the firms with smaller 

sales volumes reported to Compliance 

staff that they mainly marketed products 

(sourced from manufacturers in China) 

through sales arrangements with a 

leading Internet retailer, which held 

stock for them and processed orders. A 

review of the product listings of the 

Internet retailer found that several other 

firms have similar business models. 

Other U.S. firms and individuals sell 

magnetic sets they have imported from 

China through ‘‘stores’’ they maintain 

on another major Internet shopping site. 

To date, the Directorate for Economic 

Analysis has identified about 25 U.S. 

firms and individuals who have recently 

imported magnetic desk sets for sale in 

the United States. The combined sales 

of the top seven firms have probably 

accounted for the great majority 

(perhaps over 98%) of units sold. Due 

to resource constraints, the compliance 

division targeted 13 firms for corrective 

action. Eleven agreed to stop sale 

pending negotiations for a corrective 

action plan, two are now the subject of 

administrative cases recently initiated 

by the Commission. One firm is 

believed to have held a dominant 

position in the market for magnetic desk 

sets since it entered the market in 2009. 

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. 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, many of which market products 

through ‘‘stores’’ on a leading Internet 

shopping site.8

3. Evaluation of the Proposed Rule 

Societal Costs and the Potential Benefits 

of a Rule Prohibiting Certain Magnetic 

Desk Sets 

Estimated Societal Costs of Injuries 

The purpose of the proposed rule is 

to prevent serious intestinal injuries that 

can result when children ingest two or 

more of the magnets in the subject 

magnet sets (or one magnet and another 

ferromagnetic object) (Inkster, 2012). 

The draft proposed rule would prohibit 

magnet sets that do not meet specified 

performance requirements. Therefore, 

benefits of the proposed rule would be 

the resulting reduction in injuries. 

Based on a review of magnet ingestion 

incidents reported through CPSC 

databases that include the Injury or 

Potential Injury Incident database (IPII) 

and the In-depth Investigation database 

(INDP), CPSC staff is aware of 38 

confirmed incidents involving ingestion 

of one or more powerful magnets from 

a subject magnetic desk set since the 

product was introduced in 2008 

(Garland, 2012). An additional five 

incidents possibly involved magnets 

from such magnet sets. No fatalities 

involving the products are known to the 

CPSC. 

Our analysis of the potential benefits 

of the proposed rule focuses on injuries 


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9 In contrast to the available evidence on the 

number of magnets ingested from the NEISS 

estimates, 37 of 40 non-NEISS incidents reported to 

the CPSC involved the ingestion of more than one 

magnet (see Garland, Table 10). The difference may 

be related to the number of cases upon which the 

NEISS estimate was based, which may have been 

too small to provide reliable estimates. 

Alternatively, it is possible that the non-NEISS 

injury reports to the CPSC tended to involve the 

more serious cases with multiple magnets. 

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. 

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 72 magnet ingestions 

from 2009 through 2011, which 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, 

three of the 72 NEISS-reported cases 

(4.2%) did mention a brand name of 

magnet sets that are the magnets of 

interest; 69 cases (95.8%) were 

determined to have possibly 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, 2012). 

Based on the 72 NEISS-reported 

magnet cases, there were an estimated 

1,716 injuries treated in U.S. hospital 

emergency departments during the 2009 

through 2011 study period. Roughly 6 

percent were hospitalized injuries, as 

opposed to being treated and released. 

The benefits of the proposed rule can be 

estimated as the reduction in the 

societal costs associated with the 

injuries that would be prevented by the 

proposed rule. The 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 it estimates 

the societal costs of injuries reported 

through NEISS. Additionally, based on 

empirical relationships between the 

number of medically attended injuries 

treated in emergency departments and 

the number of injuries treated in other 

settings, the ICM also estimates the 

number and societal costs of medically 

attended injuries treated outside of 

emergency departments, such as in 

doctors’ offices and clinics. The 

estimates of societal costs provided by 

the ICM depend upon (and vary by) the 

injury diagnosis, the body part affected, 

the injury disposition (i.e., treated in a 

doctor’s office, treated and released 

from a hospital emergency department, 

or hospitalized), and the age and sex of 

the victim. 

Table 1 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 proposed rule. 

As shown in the table, the 2009 through 

2011 NEISS estimates suggest an 

estimated annual average of about 572 

emergency department-treated injuries, 

including 537 injuries that were treated 

and released and 35 injuries that were 

hospitalized. About 70 percent of these 

emergency department-treated 

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.9 Additionally, based 

on estimates from the ICM, there were 

another 870 injuries treated annually 

outside of hospital emergency 

departments. 

After including the injuries treated 

outside of hospital emergency 

departments, there was an annual 

average of about 1,442 medically 

attended injuries involving ingestions of 

magnets that were defined as at least 

‘‘possibly of interest.’’ These injuries 

resulted in annual societal costs of 

about $24.8 million (in 2011 dollars) 

during the 2009–2011 time period. The 

average estimated societal costs per 

injury were about $13,000 for injuries 

treated outside of emergency 

departments and hospitals (such as in a 

doctor’s office or clinics), about $17,000 

for those that were treated and released 

from emergency departments, and about 

$112,000 for those that were admitted to 

hospitals for treatment. Medical costs 

and work losses (including work losses 

of caregivers) accounted for about 25 

percent of these injury cost estimates, 

and the less tangible costs of injury 

associated with pain and suffering 

accounted for about 75 percent of the 

estimated injury costs (Miller et al., 

2000). 

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, 2009–2011 

Injury disposition Estimated No. 

Estimated 

societal 

costs 

($ millions) *

Treated and Released from Hospital Emergency Department (NEISS) ......................................................... 537 $9.1 

Admitted to Hospital Through the Emergency Department (NEISS) .............................................................. † 35 3.9 

Medically Treated Outside of Hospital Emergency Department (ICM) ........................................................... 870 11.7 

Total Medically Attended Injuries ............................................................................................................. 1,442 24.8 

* In 2011 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. 

It should be noted that there is 

uncertainty concerning these estimates. 

Some of the cases described as 

‘‘possibly’’ involving the magnet 

injuries that were included in Table 1 

may not have involved the magnets that 

are the subject of the NPR. As noted 

above, about 95.8 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 

proposed rule. 


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10While most of these potential profits would 

accrue to importers, who also sell the magnetic desk 

toys directly to consumers, some portion would 

accrue to other retailers. 

On the other hand, in addition to the 

magnet cases upon which the table was 

based, there were also 175 NEISS cases 

(representing about 1,440 emergency 

department-treated injuries annually) in 

which the magnet type was unknown. 

These cases included those in which the 

case narrative 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 those 

that would be covered by the proposed 

rule, the Table 1 results would tend to 

understate the societal costs associated 

with the magnets subject to the 

proposed rule. 

Estimated Benefits of the Proposed Rule 

As noted above, the benefits of a 

proposed magnet rule would be the 

reduction in the societal costs of the 

injuries that would be prevented. In 

general, because the proposed rule 

would effectively ban certain types of 

magnet sets, all ingestion injuries that 

would have involved magnets that, in 

the absence of the proposed rule, would 

have been sold after the effective date of 

the proposed rule, will be prevented. 

However, if children, adolescents, and 

teens cannot play with or use the 

prohibited magnets, they could play 

with or use substitute products that may 

also result in injury. Hence, the overall 

benefits of the proposed rule should be 

measured as the net reduction in 

injuries, and the concomitant reduction 

in societal costs, that would result. 

These issues make it difficult to 

estimate with much certainty the 

prospective benefits of a proposed rule. 

However, if we assume that the injuries 

presented in Table 1 provide a generally 

accurate estimate of the annual injuries 

that would be prevented by the 

proposed rule, and that the risk 

associated with the use of substitute 

products is small, the expected benefits 

might amount to roughly $25 million 

annually. 

Potential Costs of a Rule Prohibiting 

Certain Magnetic Desk Sets 

The profits of firms represent a 

measure of the benefits to businesses 

that result from the production and sale 

of products. Similarly, the use value or 

‘‘utility’’ that consumers receive from 

products represent the benefits of 

product use by the consuming public. 

Consequently, the costs of a proposed 

rule that effectively bans certain 

magnetic sets would consist of: (1) the 

lost profits of firms that would be barred 

from producing and selling the product 

in the future, and (2) the lost use value 

experienced by consumers who would 

no longer be able to purchase the 

prohibited magnets at any price. 

Market Wide Profits 

First consider ‘‘profits,’’ which would 

be defined as the total revenue (TR) 

received by firms resulting from the sale 

of the subject magnets, less the total 

costs (TC) needed to produce, distribute, 

and market them. We do not have 

firsthand knowledge of the profits of 

firms marketing the magnetic desk sets, 

but we do have information that may 

help us provide an upper limit. 

Based on the available information 

described earlier, sales of the magnetic 

desk sets may have averaged roughly 1 

million annually during the 2009–2011 

study period, with an average retail 

price of about $25 per set. Thus, total 

industry revenues may have averaged 

about $25 million annually (i.e., 1 

million sets × $25 per set). 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 may have amounted to about 

$10 per set, or an annual average of 

about $10 million (i.e., 1 million sets × 

$10 import cost per set). Thus, total 

revenues, less import costs, might have 

averaged about $15 million annually 

(i.e., $25 million¥$10 million). While 

the share of profits from this $15 million 

in net revenues is unknown, it seems 

unlikely that profits would amount to 

more than about half, or about $7.5 

million annually. Thus, the costs of a 

proposed rule in terms of reduced 

profits might amount to as much as $7.5 

million on an annual basis.10

Lost Utility to Consumers 

We cannot estimate in any precise 

way the use value that consumers 

receive from these products, but we can 

describe it 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 magnetic 

desk sets, given sales of about 1 million 

sets annually, and an average retail 

price of about $25 per set, consumer 

expenditures would amount to about 

$25 million annually. This $25 million 

represents the minimum value that 

consumers would expect to get from 

these products. It is represented by the 

area of the rectangle CPBQ in the 

standard supply and demand graph 

below, where P equals $25, and Q 

equals 1 million units. 


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11 If the above graph represents the market for 

tickets, the demand curve (AD) 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 

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 B. 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. 

12To 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, meaning 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 PAB 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. For example, 

while 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 $50.11

In general, the use value for the 

magnetic desk sets obtained by 

consumers is represented by the area of 

the trapezoid CABQ. However, the 

prospective loss in use value associated 

with the proposed rule prohibiting 

certain magnetic desk sets 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 $25 

million (represented by the rectangle 

CPBQ) that they would have spent on 

magnetic sets in the absence of a ban. 

While they can no longer purchase 

magnetic desk 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, 

the amount of utility that would be lost 

from a ban of magnetic sets. While the 

magnetic desk sets clearly provide 

‘‘utility’’ to purchasers, they are not 

necessities. Consequently, the demand 

for magnetic desk sets is probably not 

price inelastic, a factor that would tend 

to reduce estimates of utility losses.12

Additionally, if the magnetic sets are 

‘‘faddish,’’ they may not be the type of 

product that will be used intensively 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 desk sets 

might amount to about $10 million on 

an annual basis (i.e., [$35¥$25] × 1 

million units annually). 

Finally, it should be noted that the 

loss in consumer surplus just described 

represents the maximum loss of 

consumer utility from the proposed 

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 in the 

place of magnetic desk sets. If, for 

example, there were close substitutes for 

magnetic desk sets (i.e., desk sets that 

are almost as satisfying and similarly 

priced), the overall loss in consumer 

surplus (and hence, the costs of the 

proposed rule) would probably tend to 

be small. On the other hand, if there are 

no close substitutes, the costs of the 

proposed rule would tend to be higher. 

Nevertheless, the proposed rule will 

result in some level of lost utility. By 

purchasing magnetic desk sets rather 

than other products, consumers are 

revealing that they have a preference for 

the magnetic desk sets that are likely to 

provide more utility than a substitute 

purchase. 

Sensitivity of Results to Product Life 

Assumptions 

Implicit in this analysis has been the 

assumption that the expected useful life 

of the magnetic desk 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. 

Magnetic desk sets are relatively durable 

products, purchased at an average price 

of about $25. However, many consumers 

may find them to be novelties that soon 

lose much of their appeal. Thus, 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 

they are purchased. On the other hand, 

the magnets may be put away in a place 

accessible by children at some later 

date. Although it is somewhat 

speculative, it seems reasonable to 

assume that the effective useful product 

life of magnetic desk sets is, on average, 

no more than about a year. 


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However, it should also be noted 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 magnetic desk set in 

use (and hence, reduce estimated 

societal costs per set) by about half. 

However, this reduced estimate of 

annual societal costs would itself be 

offset by the fact that the sets remain in 

use for 2 years, rather than 1 year. Thus, 

annual benefits would be halved, but 

benefits would be accrued over a 2-year 

period rather than 1 year. Consequently, 

even if we had doubled the assumed 

product life, the relationship between 

benefits and costs would have remained 

about the same. 

Alternatives to the Proposed Rule 

There are several possible alternatives 

that the Commission might consider 

instead of a proposed rule prohibiting 

certain magnetic desk sets. 

Alternative Performance Requirements 

As an alternative to the proposed rule, 

the Commission could consider 

promulgating an alternative set of 

requirements that could reduce the risk 

of injury from magnetic desk sets. 

Performance requirements might allow a 

different flux index for the magnets sold 

as manipulative desk sets; different 

specifications regarding shapes and 

sizes of magnets within the scope of the 

standard; or some other criteria that 

have not yet been developed (but not as 

stringent as in the proposed rule). The 

advantage of such an approach is that it 

could reduce the potentially 

unreasonable risk of injury associated 

with magnetic desk sets and at the same 

time allow adults to continue to use the 

product. One practical question, 

however, is whether such a standard 

would eliminate or substantially affect 

the physical qualities of the products 

that make them enjoyable for adults. 

Additionally, the expected injury 

reduction would depend upon the 

parameters of the performance 

requirements that are established. 

Safer Packaging 

A possible alternative might be for 

magnetic desk 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 an approach might prevent 

injuries resulting from a small number 

of magnets being separated from a set 

without the owner knowing. In reality, 

though, many consumers may not use 

such containers because it could require 

time to form the magnets into a shape 

(e.g., a cube) to make them fit in the 

containers; or they might want to keep 

the magnets out of their container in a 

shape or structure that took time and 

effort to construct. 

Alternatively (or in combination), the 

magnets could be sold in child-resistant 

packaging. Such an approach has the 

potential to reduce ingestion injuries, 

but it may result in several practical 

problems. Child-resistant packaging 

would not prevent teens and 

adolescents (and even some younger 

children) from opening the packaging. 

Additionally, the child-resistant 

packaging would have to be secured 

after each use. According to the Division 

of Human Factors, it is unlikely that 

adults would accept child-resistant 

packaging for a product like the 

magnetic desk sets because of the level 

of inconvenience it would involve 

(Sedney & Smith, 2012). Also, for the 

reasons described above, consumers 

may leave magnets outside of their 

container. 

Warnings 

The Commission could require strong 

warnings on labels and on product 

instructions designed to prevent the use 

of the magnetic desk sets by children. 

The Division of Human Factors, 

Directorate for Engineering Sciences 

(HF) memorandum contains an 

extensive discussion concerning 

warnings and their potential 

effectiveness (Sedney & Smith, 2012). 

Based on HF staff’s examination, the 

ingestion warnings that currently 

accompany magnetic desk sets are 

generally aimed at adults, but appear to 

be deficient in terms of their content. 

For example, some warn against 

children swallowing the magnets 

without describing the incident 

scenarios. Some warnings refer to the 

propensity for swallowed magnets to 

stick to intestines without referring to 

the presence of other magnets or metal 

objects. Others warnings did refer to 

magnets sticking together or attaching to 

other metallic objects inside the body, 

but without explaining that the magnets 

can attract through the walls of the 

intestines and forcefully compress these 

tissues, resulting in serious injuries. 

According to CPSC 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. 

CPSC staff believes that it may be 

possible to develop warnings that could 

adequately 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. 

However, the effectiveness of such 

warnings is unknown, and CPSC staff 

doubts that even well-written warnings 

would substantially reduce the 

incidence of magnet ingestions. Some 

caregivers who read and understand the 

message may attempt to keep the 

magnets out of the hands of young 

children, but staff doubts many 

caregivers would attempt to keep the 

product away from older children and 

adolescents. Additionally, staff is 

doubtful that children old enough to 

understand the warnings would abide 

by them. 

Restrictions on the Sale of Magnetic 

Desk Sets 

Another option for the Commission to 

consider might be to prohibit sales of 

magnetic desk sets in toy stores, 

children’s sections of general purpose 

stores, and near cash registers of stores 

that sell any children’s products. Sales 

limitations or requirements for strong 

warnings might also be required on Web 

sites advertising the sale of magnets on 

the Internet. 

The details for developing a set of 

sales limitations and requirements 

would need to be worked out, but the 

idea would be to make sure that 

magnetic desk 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 could 

be developed although the staff has 

expressed serious concern as to whether 

such warnings can ever overcome the 

attractiveness of the magnets and their 

intrinsic play value. 

Such sales limitations, in combination 

with adequate and explicit warnings, 

may increase consumer awareness of the 

hazard, and possibly reduce the number 

of ingestions. Some parents would still 

allow their children (especially older 

children and adolescents) to play with 

the magnetic desk sets despite the 

warnings. Also, some young children 

will get into the packaging, even if 

parents try to restrict the use of the desk 

sets. Nevertheless, combining sales 

limitations with explicit warnings might 

educate parents about the hidden nature 

of the hazard, while at the same time 

allow adults to continue to use a 


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13Average annual estimates are from the Injury 

Cost Model evaluation of 72 emergency departmenttreated injuries during 2009–2011 determined to 

have involved, or possibly having involved, 

magnets of interest (Garland, 2012). 

product that they apparently enjoy. We 

are interested in receiving comments 

that would address this issue. 

Address Through Corrective Actions 

Rather Than Regulatory Action 

Alternatively, the Commission could 

continue to address the hazard by 

means of Corrective Action Plans. While 

staff believes this approach may be 

deficient, such a strategy might be 

combined with other actions described 

above to achieve some reductions in the 

hazard. 

Summary 

Based on reports to the CPSC, 

ingestions of small magnets contained 

in magnetic desk sets have caused 

multiple, high severity injuries that 

require surgery to remove the magnets 

and repair internal damage. However, 

because of the lack of definitive 

information on the number of injuries 

involving magnetic desk sets that would 

be prevented by a proposed rule, there 

is uncertainty concerning the benefits 

that would result. If we assume that the 

NEISS cases identified by the 

Directorate for Epidemiology staff as 

involving high-powered and/or ballshaped magnet ingestions actually 

involved the magnets that would be 

prohibited, then the estimated benefits 

of the rule might amount to about $25 

million annually. 

The costs of the proposed rule, in 

terms of reduced profits for firms and 

lost utility by consumers, are also 

uncertain. However, based on annual 

estimates available for the 2009¥2011 

study period, these costs could amount 

to about $7.5 million in lost profits and 

some unknown quantity of lost utility. 

There are alternative regulatory 

actions that the Commission could 

consider that might allow the magnetic 

desk sets to continue to be marketed. 

For example, the Commission, by 

regulation, could issue alternative 

performance requirements or require 

warnings that explicitly describe the 

hazard and how to avoid it. Other 

options might be to develop 

requirements for the packaging of the 

magnetic desk sets (e.g., develop 

requirements for child-resistant 

packaging); and/or place limitations on 

how and where the magnetic desk sets 

can be sold. These alternative actions— 

which might be considered alone, or in 

combination—would have varying 

levels of effectiveness. 

I. Paperwork Reduction Act 

The proposed rule would not require 

manufacturers (including importers) to 

perform testing or require manufacturers 

or retailers to keep records. For this 

reason, the proposed 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 proposed 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. 

J. Initial Regulatory Flexibility Analysis 

1. Introduction 

The Regulatory Flexibility Act (RFA) 

generally requires that agencies review 

proposed rules for their potential 

economic impact on small entities, 

including small businesses. Section 603 

of the RFA calls for agencies to prepare 

and make available for public comment 

an initial regulatory flexibility analysis 

describing the impact of the proposed 

rule on small entities and identifying 

impact-reducing alternatives. The initial 

regulatory flexibility analysis is to 

contain: 

(1) A description of the reasons why 

the action is being considered; 

(2) A succinct statement of the 

objectives of, and legal basis for, the 

proposed rule; 

(3) A description of and, where 

feasible, an estimate of the number of 

small entities to which the proposed 

rule will apply; 

(4) A description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the 

proposed rule, including an estimate of 

the classes of small entities that will be 

subject to the requirement and the types 

of professional skills necessary for the 

preparation of the report or record; and 

(5) An identification, to the extent 

possible, of all relevant federal rules 

that may duplicate, overlap, or conflict 

with the proposed rule. 

Accordingly, staff prepared an initial 

regulatory flexibility analysis, which is 

summarized below. 

2. Description of the Proposed Rule and 

Reasons for Considering It 

As discussed previously, the 

proposed rule would prohibit magnet 

sets that do not meet the specified 

requirements described in section F of 

this preamble. Some of the incidents 

that have come to the attention of the 

Commission involving ingestions of 

magnets from desk sets have resulted in 

severe medical consequences, including 

significant damage to the stomach or 

intestines. Based on a review of 

emergency department-treated magnet 

ingestions obtained through the NEISS, 

the Directorate for Epidemiology staff 

has identified 72 magnet ingestions 

from 2009 through 2011, which were 

determined to involve, or possibly 

involve, the magnets of interest. Based 

on these injuries, staff estimates that 

there has been an annual average of 

about 572 emergency departmenttreated injuries involving the products, 

including 537 injuries that were treated 

and released and 35 injuries that were 

hospitalized.13 Additionally, based on 

estimates from the CPSC’s Injury Cost 

Model (ICM), which is integrated with 

NEISS, there were 870 other injuries 

treated annually outside of hospital 

emergency departments, such as in 

doctors’ offices and clinics. The 

estimated total of 1,442 medically 

attended injuries involving magnet 

ingestions, which were defined as at 

least ‘‘possibly of interest,’’ resulted in 

average annual societal costs of nearly 

$25 million during 2009 through 2011, 

based on estimates provided by the ICM. 

3. Products Within the Scope of the 

Proposed Rule 

This proposed rule would cover 

magnet sets that are comprised of sets of 

small powerful magnetic balls, cubes, 

and/or cylinders that can be arranged in 

many different geometric shapes. The 

products have been described as desk 

toys, games, puzzles, and stress 

relievers. The small powerful magnets 

most likely to be affected by the 

proposed rule are made from alloys of 

neodymium, iron, and boron. We are 

interested in receiving comments that 

would address this issue both as to the 

type of products that should be covered 

and the composition of the magnets. 

More information concerning the 

product and the market is provided in 

section B of the preamble. 

4. Small Businesses Subject to the 

Proposed Rule and Possible Economic 

Impacts 

The proposed rule would impact U.S. 

importers and retailers of manipulative 

desk sets that are comprised of small 

powerful magnets of the size and 

magnetic force proscribed by the 

proposed rule. None of the magnetic 

desk sets within the scope of the 

proposed rule are produced 

domestically. All of the firms that have 

marketed the products are believed to 

import them from manufacturers in 

China, packaged and labeled for sale to 

U.S. consumers. The Directorate for 

Economic Analysis has indentified 

about 25 firms and individuals in the 

United States who have recently 


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14The SBA size standard for ‘‘Other 

Miscellaneous Nondurable Goods Merchant 

Wholesalers’’ (which includes importers) is 100 

employees and the size standard for ‘‘Non-store 

Retailers—Electronic Shopping’’ is $30 million in 

average annual receipts (SBA, 2012). 

imported the product for sale to 

consumers. All of the importers are 

small businesses under U.S. Small 

Business Administration (SBA) size 

standards (SBA, 2012).14

Based on information on product 

sales reviewed by the Directorate for 

Economic Analysis staff, including 

reports by firms to the Office of 

Compliance and Field Operations 

(Compliance), the number of 

manipulative magnetic desk sets that 

have been sold by U.S. importers since 

the products were introduced in 2008 

may total about 2.7 million sets, with a 

value to the firms of roughly $50 

million. This value range 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. 

Although there are about 25 U.S. 

importers of magnet sets that would fall 

within the scope of the rule, the 

economic impact of the rule will be 

most severe for the seven firms that 

account for the great majority (perhaps 

over 98%) of units sold. Perhaps five of 

these larger importers derive most or all 

of their revenues from the sale of 

magnetic desk toys falling within the 

scope of the rule, or related products, 

such as books and surfaces upon which 

magnetic designs are constructed. These 

firms would be severely affected by the 

proposed rule, which would effectively 

ban the magnet sets that they have been 

importing and selling. Consequently, 

they may go out of business. Two of the 

other leading importers of magnetic 

desk sets apparently have fairly broad 

product offerings, which could lessen 

the severity of the economic impact of 

a rule. Nevertheless, the impacts of the 

proposed rule could be considered 

significant for these small importers. 

Nearly all of the perhaps 18 other 

recent U.S. importers of magnetic desk 

sets have sold relatively few of the 

products. These importers sourced the 

products from manufacturers in China 

and have marketed the magnet sets 

through online ‘‘stores’’ maintained on 

Internet retail sites. Many of these 

importers are individuals who may also 

market a variety of other products 

through the same Internet outlets. For 

individuals and firms with these 

business models, the discontinuance of 

certain magnetic desk sets as a source of 

revenue as a result of the rule is less 

likely to cause significant economic 

hardship, unlike the firms or 

individuals who derive most, or all, of 

their revenue from sales of magnetic 

desk sets and related products. 

Although a large share of magnetic 

desk sets are sold directly to consumers 

by the importers using their own 

Internet Web sites or other Internet 

shopping sites, a rule prohibiting these 

products would also affect retailers of 

the products, whether selling them 

online or physically in stores. However, 

these retailers are not likely to derive 

significant proportions of total revenues 

from sales of affected desk sets, and the 

impacts on individual firms should be 

minimal. 

5. Objectives of, and Legal Basis for, the 

Proposed Rule 

The purpose of the proposed rule is 

to reduce the risk of injury from 

ingestion of one or more small, powerful 

magnets that comprise the subject 

consumer products. As noted above, the 

estimated total of 1,442 medically 

attended injuries involving magnet 

ingestions that were defined as at least 

‘‘possibly of interest’’ resulted in annual 

societal costs of about $25 million 

during the 2009 to 2011 time period. 

These incident numbers may change 

over the course of the rulemaking 

because the North American Society for 

Pediatric Gastroenterology, Hepatology 

and Nutrition (NASPGHAN) has 

provided the Commission with some 

additional incident data and is currently 

surveying their members regarding any 

additional incident data they may have 

to share with the Commission. After 

receiving this data the Commission may 

conduct its own survey to collect 

additional data similar to the exposure 

surveys the Commission has conducted 

in the ATV rulemaking. However, it is 

expected that the proposed rule would 

substantially reduce the future 

incidence and cost to society of 

ingestions of the subject magnetic desk 

sets. As discussed in section D of this 

preamble, the rule is being proposed 

under the authority of the CPSA. 

6. Other Federal Rules 

We are not aware of any federal rules 

that may duplicate, overlap, or conflict 

with the proposed rule. 

7. Alternatives to the Proposed Rule 

There are possible alternatives to the 

proposed rule that would reduce the 

impact of a rule on small businesses. 

These alternatives would include the 

following: 

a. Adoption of a Performance Standard 

With Different Provisions 

As an alternative to the proposed rule, 

the Commission could consider 

promulgating a different set of 

performance requirements to reduce the 

risk of injury from magnetic desk sets. 

Performance requirements might require 

a different flux index for the magnets 

sold as manipulative desk sets, different 

specifications regarding shapes and 

sizes of magnets within the scope of the 

standard, or some other criteria that 

have not been developed yet. The 

advantage of such an approach is that, 

theoretically, it could reduce the 

potentially unreasonable risk of injury 

associated with magnetic desk sets, and 

at the same time, allow adults to 

continue to use the product. One 

practical question, however, is whether 

such a standard would eliminate or 

substantially reduce the physical 

qualities of the products that make them 

enjoyable for adults. 

b. Safer Packaging Options 

In theory, magnetic desk sets could 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 that 

result from a small number of magnets 

becoming separated from a set without 

the owner knowing. In reality, though, 

many consumers might be unlikely to 

use such containers because using a 

container could require consumers to 

take time to form the magnets into a 

shape (e.g., a cube) in order for the 

magnets to fit back into the container, or 

consumers might wish to keep the 

magnets in a formation that took time 

and effort to construct. 

Alternatively, the magnets could be 

sold in child-resistant packaging. Such 

an approach has the potential to reduce 

ingestion injuries, but it may suffer from 

several practical problems. Childresistant 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 child-resistant packaging for a 

product such as the magnetic desk set 

because of the level of inconvenience it 

would involve. 

It is not clear that the Commission 

would have the authority to require 

either of these approaches through 

regulation. 

c. Warnings/Labeling Requirements 

The Commission could require 

labeling on affected magnetic desk sets 

to warn consumers in lieu of a rule that 

prohibits the products. Following its 

evaluation of this alternative, the 


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Division of Human Factors, Directorate 

for Engineering Sciences, concluded: ‘‘it 

may be possible to develop warnings 

that could inform parents and other 

caregivers better about the ingestion 

hazard, its consequences, and 

appropriate hazard-avoidance measures. 

Nevertheless, the resulting warnings 

may not be effective at motivating 

caregivers to comply, and therefore, 

they may not reduce substantially the 

incidence of magnet ingestions.’’ 

d. Restrictions on the Sale of Magnetic 

Desk Sets 

Another option might be to prohibit 

sales of magnetic desk sets in toy stores, 

children’s sections of general purpose 

stores, and near cash registers of stores 

that sell any children’s products. 

Advertising and sales limitations or 

requirements for strong warnings might 

also be required at Web sites advertising 

the sale of magnets on the Internet. 

The details for developing a set of 

sales limitations and requirements 

would need to be worked out (and the 

legal authority to impose such 

restrictions by regulation is uncertain), 

but the idea would be to make sure that 

magnetic desk 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 of the 

sort that CPSC staff has suggested could 

be developed. 

Such sales limitations, in combination 

with adequate and explicit warnings, 

may increase consumer awareness of the 

hazard, and possibly reduce ingestions. 

Some parents would still allow their 

children (especially older children and 

adolescents) to play with the magnetic 

desk sets despite the warnings. Also, 

some young children will get into the 

packaging even if parents try to restrict 

the use of the products. Nevertheless, 

combining sales limitations with 

explicit warnings might educate parents 

about the hidden nature of the hazard, 

while at the same time allow adults to 

continue to use a product that 

apparently they enjoy. 

e. Address Through Corrective Actions 

Rather Than Regulatory Action 

Alternatively, the Commission could 

continue to address the hazard by 

means of Corrective Action Plans. While 

we believe this approach may be 

deficient, such a strategy might be 

combined with other actions described 

above to achieve some reductions in the 

hazard. 

f. Taking No Action 

The Commission could take no 

regulatory action to reduce the risk of 

ingestion injuries associated with 

magnetic desk sets. Under this 

alternative, future societal losses would 

be determined by the numbers of 

products in use, other factors that affect 

the likelihood that young children, 

adolescents, and teens will ingest the 

magnets, and the awareness and 

response of the medical community to 

the hazards presented by ingested 

magnets. Theoretically, over time, 

increased awareness of the hazards by 

caregivers could make it more likely 

that the magnets will be kept away from 

young children and older children, and 

school personnel could be made more 

aware of the hidden dangers of using 

strong magnets to mimic tongue or lip 

piercings. Also, the medical community 

seems to be taking steps to become 

better educated about the risks of 

ingested magnets, which should lead to 

monitoring of patients’ medical status 

more quickly, which would reduce the 

adverse medical consequences of 

magnet ingestions. 

8. Summary 

The results of this initial regulatory 

flexibility analysis suggest that the 

proposed rule would likely have a 

significant adverse impact on seven of 

the small importers of magnetic desk 

sets, and perhaps five of these firms that 

derive most or all of their revenue from 

the sale of magnetic desk sets might go 

out of business. Some possible 

alternatives to a rule prohibiting the 

products have been identified. All of 

these alternatives would reduce the 

expected impact of the rule on small 

businesses. However, these alternatives 

might not achieve the same level of 

benefits as the proposed rule. 

K. Environmental Considerations 

Usually, 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 (see 16 CFR 1021.5(c)(1)). 

This proposed 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 proposed rule 

as follows: 

The regulation for hazardous magnet 

sets is proposed under authority of the 

CPSA. 15 U.S.C. 2051–2089). Section 26 

of the CPSA provides that ‘‘whenever a 

consumer product safety standard under 

this Act is in effect and applies to a risk 

of injury associated with a consumer 

product, no State or political 

subdivision of a State shall have any 

authority either to establish or to 

continue in effect any provision of a 

safety standard or regulation which 

prescribes any requirements as 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 non-identical 

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 

proposed in today’s Federal Register 

would preempt non-identical state or 

local requirements for magnet sets 

designed to protect against the same risk 

of injury. 

M. Effective Date 

The Commission proposes that this 

rule would become effective 180 days 

from publication of a final rule in the 

Federal Register and would apply to all 

magnet sets 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). 

N. Proposed 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 that the rule must be 

reasonably necessary to eliminate or 

reduce an unreasonable risk of injury 


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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 its 

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 discussed below. 

Degree and nature of the risk of 

injury. Based on a review of NEISS data, 

we have determined that an estimated 

1,700 ingestions of magnets from 

magnet sets were treated in emergency 

departments during the period from 

January 1, 2009 to December 31, 2011. 

From review of INDP and IPII databases, 

we are aware of 50 reported incidents 

occurring from January 1, 2009 through 

June 30, 2012, involving the ingestion of 

magnets by children between the ages of 

1 and 15. Of those 50 incidents, 38 

involved the ingestion of high-powered, 

ball-shaped magnets that were 

contained in products that meet the 

above definition of ‘‘magnet set,’’ and 5 

of those 50 incidents possibly involved 

ingestion of this type of magnet. 

Hospitalization was required in order to 

treat 29 of the 43 incidents, with surgery 

necessary to remove the magnets in 20 

of the 29 hospitalizations. In 10 of the 

29 hospitalizations, the victim 

underwent colonoscopic or endoscopic 

procedures to remove the magnets. In 37 

of the 43 incidents that likely involved 

magnets from hazardous magnet sets, 

the magnets were ingested by children 

younger than 4 years old, or between the 

ages of 4 and 12. 

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 period of 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. Long-term 

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 with 

girls. Even those 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. 

Number of consumer products subject 

to the rule. The market has increased 

substantially since magnet sets were 

first introduced. We estimate that the 

number of such 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, with 

a value of roughly $50 million. 

The need of the public for magnet sets 

and the effects of the rule on their 

utility, cost, and availability. We cannot 

estimate, in any precise way, the use 

value that consumers receive from these 

products. In general, this 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). Although the proposed rule 

would prohibit the magnet sets 

currently on the market, it is 

conceivable that a similar product that 

meets the requirements of the proposed 

rule could be developed that would 

serve a similar purpose of the magnet 

sets that the proposed rule would 

prohibit. 

Other means to achieve the objective 

of the rule, while minimizing the impact 

on competition and manufacturing. 

Various alternatives to the proposed 

rule are discussed in previous sections 

of this preamble. We do not believe that 

options other than the proposed rule 

prohibiting certain magnet sets would 

sufficiently reduce the number and 

severity of injuries resulting from the 

ingestion of magnets from these magnet 

sets. As discussed above, 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 

appreciate the hazard associated with 

magnet sets, and as a result, they 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, 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 such a warning. Because 

individual magnets are shared easily 

among children, many end users of the 

product are likely to have had no 

exposure to any warning. 

Unreasonable risk. As noted 

previously, we have determined that an 

estimated 1,700 ingestions of magnets 

from magnet sets were treated in 

emergency departments during the 

period from January 1, 2009 to 

December 31, 2011. Injuries resulting 

from such ingestions of magnets can be 

severe and life-threatening. The risk 

posed by these magnets may not be 

appreciated by caregivers and children, 

as they may assume, mistakenly, that 

the consequences of ingesting magnets 

would be similar to ingesting any other 

small object. However, once ingested, 

these strong magnets are mutually 

attracted to each other and exert 

compression forces on the trapped 

gastrointestinal tissue. 

We estimate that the societal costs of 

resulting injuries could amount to $25 

million annually. This would be the 

expected benefits that could result from 

the proposed rule. The costs of the 

proposed rule would consist of the lost 

profits to firms that produce and sell 

magnet sets, plus the lost use value that 

consumers would experience when the 

product is no longer available. We 

estimate these costs to be about $7.5 

million in lost profits 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 proposed rule would have on 

firms producing and selling the product, 

and on consumers who would lose the 

utility of the product— we preliminarily 

conclude that magnet sets pose an 

unreasonable risk of injury and that the 

proposed rule is reasonably necessary to 

reduce that risk. 

Public interest. This proposed rule is 

in the public interest because it would 

reduce magnet-related deaths and 

injuries in the future. A rule prohibiting 

certain magnet sets from the chain of 

commerce will mean that children will 

have less access to this product, thereby 


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Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules 53799 

reducing the number of incidents of 

children swallowing the magnets and 

the resulting cost to society of treating 

these injuries. The Commission seeks 

comment on this issue and also whether 

similar actions regarding lawn darts and 

dive sticks have had the effect of 

reducing injuries by reducing the access 

to the product. 

Voluntary standards. Currently, there 

is no voluntary standard for magnetic 

sets. A group of magnet set importers 

and distributors have requested the 

formation of a voluntary standard by 

ASTM International for the labeling and 

marketing of these products. The 

companies have requested the formation 

of a voluntary standard to: (1) Provide 

for appropriate warnings and labeling 

on packages of these magnet sets, and 

(2) establish guidelines for restricting 

the sale of these magnet sets to, or for 

the use of children, such as: not selling 

to stores that sell children’s products 

exclusively, and not selling the magnets 

in proximity to children’s products. 

Such a voluntary standard would have 

many of the same limitations as would 

a labeling standard. 

Relationship of benefits to costs. 

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. 

Although there is some uncertainty 

concerning the benefits that would 

result from the proposed rule, we 

estimate that benefits of the rule might 

amount to about $25 million annually. 

The costs of the proposed rule, in 

terms of reduced profits for firms and 

lost utility by consumers, also are 

uncertain. However, based on annual 

estimates available for the 2009–2011 

study period, these costs could amount 

to about $7.5 million in lost profits and 

some unknown quantity of lost utility. 

Least burdensome requirement. We 

have considered several alternatives to 

the proposed rule prohibiting certain 

magnet sets. 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. 

Theoretically, this might allow some 

current products to continue to be 

produced. However, it is unclear that a 

different flux index would permit 

products that have the desired physical 

qualities to make them sufficiently 

enjoyable to adults while adequately 

reducing the characteristics that make 

these strong magnets hazardous to 

children. Some type of special storage 

containers or other packaging 

requirements might be possible. 

However, it is unlikely that consumers 

would use such containers, particularly 

if they wish to keep the magnets out of 

the container and maintain whatever 

shape they have constructed with the 

magnets. We have considered the 

possibility of requiring rigorous 

warnings on the products or in the 

instructions for the products. However, 

magnet sets currently on the market 

provide warnings concerning the 

potential hazard to children. 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 when adults have bought 

them and they are available to children. 

The Commission could continue to 

address the hazard from magnet sets 

through corrective actions, i.e., recalls of 

the product. However, such action 

would do nothing to prevent additional 

companies from continuing to enter the 

market and import magnet sets into the 

country. The Commission 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 if the 

Commission issues the proposed rule. 

O. Request for Comments 

We request comments on all aspects 

of this proposed rule. We ask for 

comments concerning the risks of injury 

associated with these magnet sets; the 

regulatory alternatives discussed; other 

possible ways to address these risks; 

and the economic impacts of the various 

regulatory alternatives. We specifically 

seek comments concerning the 

following issues: 

• The proposed definition of ‘‘magnet 

sets’’ that would be covered by the 

rulemaking and other issues related to 

scope of the proposal 

• The appropriateness of the 

proposed flux index limit of 50 or less 

• The adequacy of the proposed test 

procedure for determining the flux 

index, particularly whether it would be 

sufficient to account for the strength of 

aggregated magnets 

• Alternatives to the small parts 

cylinder that limits the size of the 

magnets at issue 

• The likelihood that a magnet set 

could function as entertainment for 

adults and meet the proposed 

requirements 

• All alternatives to the proposed 

regulatory action 

• Issues related to warnings for these 

products 

• The options of conducting the 

rulemaking under section 8 of the CPSA 

or under provisions of the FHSA 

• Whether the definition of magnet 

set should include magnets sold 

individually with the possibility that 

they could be aggregated into a set of 

two or more magnets by consumers, and 

if so, whether such individually sold 

magnets are already covered by the 

definition of magnet set contained in the 

proposed rule at 16 CFR 1240.2(b), or 

whether the definition should be 

amended with additional language such 

as ‘‘whether sold individually or as part 

of a set.’’ 

• Proposed § 1240.3(a) would apply 

to magnet sets that contain a magnet 

that fits completely within the smallparts cylinder described in 16 CFR 

1501.4. Should it instead apply to sets 

with at least two magnets that fit 

completely within the small parts 

cylinder? 

P. Conclusion 

For the reasons stated in this 

preamble, the Commission preliminarily 

concludes that magnet sets that do not 

meet the specified proposed 

requirements present an unreasonable 

risk of injury. 

List of Subjects in 16 CFR Part 1240 

Consumer protection, Imports, Infants 

and children, Labeling, Law 

enforcement. 

For the reasons stated in the 

preamble, the Commission proposes to 

amend Title 16 of the Code of Federal 

Regulations as follows: 

1. Add 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 


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53800 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules 

for magnet sets, as defined in § 1240.2. 

These requirements are intended to 

reduce or eliminate an unreasonable 

risk of injury to children who ingest 

magnets that are part of hazardous 

magnet sets. This standard applies to all 

magnet sets, as defined in § 1240.2, that 

are manufactured or imported on or 

after [180 days after publication of a 

final rule]. 

§ 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, permanent, magnetic 

objects that is a consumer product 

intended or marketed by the 

manufacturer primarily as a 

manipulative or construction desk toy 

for general entertainment, such as 

puzzle working, sculpture building, 

mental stimulation, or stress relief. 

§ 1240.3 Requirements. 

(a) Small parts. Magnet sets 

containing a magnet that fits completely 

within the cylinder described in 16 CFR 

1501.4, must meet the requirement in 

paragraph (b) of this section. 

(b) Flux index. When tested in 

accordance with the method described 

in § 1240.4, small magnets, as 

determined in paragraph (a) of this 

section, must have a flux index of 50 or 

less. 

§ 1240.4 Test procedure for determining 

flux index. 

(a) Select at least one magnet of each 

shape and size that the magnet set 

contains. 

(b) Measure the flux index of the 

selected magnets 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 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) The degree and nature of the risk 

of injury. Based on a review of NEISS 

data, we have determined that an 

estimated 1,700 ingestions of magnets 

from magnet sets were treated in 

emergency departments during the 

period from January 1, 2009 to 

December 31, 2011. From review of 

INDP and IPII databases, we are aware 

of 50 reported incidents occurring from 

January 1, 2009 through June 30, 2012, 

involving the ingestion of magnets by 

children between the ages of 1 and 15 

years. Of those 50 incidents, 38 

involved the ingestion of high-powered, 

ball-shaped magnets that were 

contained in products that meet the 

above definition of ‘‘magnet set,’’ and 

five of those 50 incidents possibly 

involved ingestion of this type of 

magnet. Hospitalization was required in 

order to treat 29 of the 43 incidents, 

with surgery necessary to remove the 

magnets in 20 of the 29 hospitalizations. 

In 9 of the 29 hospitalizations, the 

victim underwent colonoscopic or 

endoscopic procedures to remove the 

magnets. In 37 of the 43 incidents that 

likely involved magnets from hazardous 

magnet sets, the magnets were ingested 

by children who were less than 4 years 

old or between the ages of 4 and 12 

years old. 

Once ingested, these strong magnets 

begin to interact in the gastrointestinal 

tract, which can lead to tissue death, 

perforations, and/or fistulas, and 

possibly bowel twisting and obstruction. 

If left untreated, these injuries can lead 

to infection of the peritoneal cavity and 

other life-threatening conditions. The 

number of magnets swallowed increases 

the risk of attraction and injury; 

however, as few as two magnets can 

cause serious internal damage in a very 

short period of 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 associated with 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 with 

girls. Even those 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. 

Number of consumer products subject 

to the rule. The market has increased 

substantially since magnet sets were 

first introduced. We estimate that the 

number of such 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, with 

a value of roughly $50 million. 

The need of the public for magnet sets 

and the effects of the rule on their 

utility, cost and availability. We cannot 

estimate in any precise way the use 

value that consumers receive from these 

products. In general, this 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 of money that 

consumers would have been willing to 

pay for the product). Although the 

proposed rule would prohibit the 

magnet sets currently on the market, it 

is conceivable that a similar product 

that meets the requirements of the 

proposed rule could be developed that 

would serve a similar purpose as the 

magnet sets that the proposed rule 

would prohibit. 

Other means to achieve the objective 

of the rule, while minimizing the impact 

on competition and manufacturing. 

Various alternatives to the proposed 

rule are discussed in previous sections 

of this preamble. We do not believe that 

options other than the proposed rule 

prohibiting certain magnet sets would 

sufficiently reduce the number and 

severity of injuries resulting from the 

ingestion of magnets from these magnet 

sets. As discussed above, 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 

appreciate the hazards associated with 

magnet sets, and as a result, they will 

continue to allow children access to the 

product. Children may not appreciate 

the hazards, and they will continue to 

mouth the items, swallow them, or, in 

the case of young adolescents and teens, 

mimic body piercings. Once the 

magnets are removed from their carrying 

case, the magnets bear no warnings to 

guard against ingestion or aspiration; 

and the small size of the individual 

magnets precludes the addition of such 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules 53801 

a warning. Because individual magnets 

are easily shared among children, many 

end users of the product are likely to 

have had no exposure to any warning. 

Unreasonable risk. As noted 

previously, we have determined that an 

estimated 1,700 ingestions of magnets 

from magnet sets were treated in 

emergency departments during the 

period from January 1, 2009 to 

December 31, 2011. Injuries resulting 

from such ingestions of magnets can be 

severe and life-threatening. The risk 

posed by these magnets may not be 

appreciated by caregivers and children, 

as they may assume, mistakenly, that 

the consequences of ingesting magnets 

would be similar to ingesting any other 

small object. However, once ingested, 

these strong magnets are mutually 

attracted to each other and exert 

compression forces on the trapped 

gastrointestinal tissue. 

We estimate that the societal costs of 

resulting injuries could amount to $25 

million annually. This would be the 

expected benefits that could result from 

the proposed rule. The costs of the 

proposed rule would consist of the lost 

profits of firms that produce and sell 

magnet sets, plus the lost use value that 

consumers would experience when the 

product is no longer available. We 

estimate these costs to be about $7.5 

million in lost profits 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 proposed rule would have on 

firms producing and selling the product, 

and the impact on consumers who 

would lose the utility of the product, we 

conclude, preliminarily, that magnet 

sets pose an unreasonable risk of injury. 

Additionally, we conclude that the 

proposed rule is reasonably necessary to 

reduce that risk. 

Public interest. This proposed rule is 

in the public interest because it may 

reduce magnet-related deaths and 

injuries in the future. A rule prohibiting 

certain magnet sets from the chain of 

commerce 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. 

Voluntary standards. Currently, there 

is no voluntary standard for magnetic 

sets. A group of magnet set importers 

and distributors have requested the 

formation of a voluntary standard by 

ASTM International for the labeling and 

marketing of these products. The 

companies have requested the formation 

of a voluntary standard to: (1) Provide 

for appropriate warnings and labeling 

on packages of these magnet sets, and 

(2) establish guidelines for restricting 

the sale of these magnet sets to, or for 

the use of children, such as by not 

selling to stores that sell children’s 

products exclusively, and by not selling 

magnet sets in proximity to children’s 

products. Such a voluntary standard 

would have many of the same 

limitations as a labeling standard. 

Relationship of benefits to costs. 

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. 

Although there is some uncertainty 

concerning the benefits that would 

result from the proposed rule, we 

estimate that benefits of the rule might 

amount to about $25 million annually. 

The costs of the proposed rule, in terms 

of reduced profits for firms and lost 

utility by consumers, are also uncertain. 

However, based on annual estimates 

available for the 2009–2011 study 

period, these costs could amount to 

about $7.5 million in lost profits and 

some unknown quantity of lost utility. 

We believe that there would be a 

reasonable relationship between the 

anticipated benefits and costs of the 

proposed rule. 

Least burdensome requirement. We 

have considered several alternatives to 

the proposed rule prohibiting certain 

magnet sets. 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. 

Theoretically, this might allow some 

current products to continue to be 

produced. However, it is unclear 

whether a different flux index would 

permit products that have the desired 

physical qualities to make them 

enjoyable to adults would reduce 

adequately the characteristics that make 

these strong magnets hazardous to 

children. Some type of special storage 

containers or other packaging 

requirements might be possible. 

However, it is unlikely that consumers 

would use such containers, particularly 

if they wish to keep the magnets out of 

the container and maintain whatever 

shape they have constructed with the 

magnets. We have considered the 

possibility of requiring rigorous 

warnings on the products or in the 

instructions for the products. However, 

magnet sets currently on the market 

provide warnings concerning the 

potential hazard to children. 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 

still may 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 

in other locations when adults have 

bought them and they are available to 

children. Finally, the Commission could 

continue to address the hazard from 

magnet sets through corrective actions, 

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

such action would do nothing to 

prevent additional companies from 

continuing to enter the market and 

import magnet sets into the country. 

The Commission 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 if the Commission 

issues the proposed rule. 

Dated: August 28, 2012. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2012–21608 Filed 8–31–12; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. FDA–2011–F–0765] 

Nexira; Filing of Food Additive 

Petition; Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of petition. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

filing notice for a food additive petition 

filed by Nexira proposing that the food 

additive regulations be amended to 

provide for the expanded safe use of 

acacia gum (gum arabic) in foods. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by October 4, 

2012. 

ADDRESSES: Submit electronic 

comments to http://www.regulations.

gov. Submit written comments to the 

Division of Dockets Management (HFA– 


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