[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Proposed Rules]
[Pages 53781-53801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21608]
=======================================================================
-----------------------------------------------------------------------
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: [email protected].
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.
---------------------------------------------------------------------------
\1\ The 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.
---------------------------------------------------------------------------
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
[[Page 53782]]
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
follow-up 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 cube-shaped magnets,
approximately 3 to 6 millimeters in size, with the majority made from
NdFeB (Neodymium-Iron-Boron 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 three-dimensional 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
[[Page 53783]]
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.
---------------------------------------------------------------------------
\2\ See 16 CFR Sec. 1500.19(b)(1).
---------------------------------------------------------------------------
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 non-food 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 three-dimensional 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
[[Page 53784]]
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.
---------------------------------------------------------------------------
\3\ The 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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\4\ Six 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.
---------------------------------------------------------------------------
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
[[Page 53785]]
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 esophagogastro-duodenoscopy (endoscopy) that
removed one magnetic bead from the mid-esophagus, and five magnetic
beads from the stomach; and (3) a diagnostic laparoscopy, followed by
laparoscopic-assisted 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
[[Page 53786]]
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 high-powered 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
[[Page 53787]]
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
high-powered 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--Sec. 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 Sec. 1240.2, that are manufactured or imported on
or after the date 180 days after publication of a final rule.
2. Definitions--Sec. 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--Sec. 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 Sec. 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 Sec. 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
[[Page 53788]]
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--Sec. 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
mm\2\). 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--Sec. 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.
[[Page 53789]]
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
[[Page 53790]]
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.
---------------------------------------------------------------------------
\5\ However, small neodymium-iron-boron magnets previously have
been, and continue to be, marketed by firms, such as magnet
suppliers and distributors of educational products.
\6\ One firm's larger magnet balls are reportedly made with
cores of strontium ferrite
(SrO[middot]6Fe2O3), rather than neodymium-
iron-boron.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\7\ One 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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\8\ More 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.
---------------------------------------------------------------------------
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
[[Page 53791]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 $112,000 for those that were admitted to
hospitals for treatment. Medical costs and work losses (including work
losses of caregivers) accounted for about 25 percent of these injury
cost estimates, and the less tangible costs of injury associated with
pain and suffering accounted for about 75 percent of the estimated
injury costs (Miller et al., 2000).
Table 1--Estimated Average Annual Medically Attended Injuries and
Associated Societal Costs for High-Powered and/or Ball-Shaped Magnet
Ingestions That Were Determined To Involve or Possibly Involve the
Magnets of Interest, 2009-2011
------------------------------------------------------------------------
Estimated
Injury disposition Estimated No. societal costs
($ millions) \*\
------------------------------------------------------------------------
Treated and Released from Hospital 537 $9.1
Emergency Department (NEISS).......
Admitted to Hospital Through the [dagger] 35 3.9
Emergency Department (NEISS).......
Medically Treated Outside of 870 11.7
Hospital Emergency Department (ICM)
-----------------------------------
Total Medically Attended 1,442 24.8
Injuries.......................
------------------------------------------------------------------------
\*\ In 2011 dollars.
[dagger] 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.
[[Page 53792]]
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 x $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 x $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\
---------------------------------------------------------------------------
\10\ While 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.
---------------------------------------------------------------------------
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.
[[Page 53793]]
[GRAPHIC] [TIFF OMITTED] TP04SE12.001
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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] x 1 million units
annually).
---------------------------------------------------------------------------
\12\ To 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.
---------------------------------------------------------------------------
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.
[[Page 53794]]
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
[[Page 53795]]
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 ball-shaped
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
department-treated 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.
---------------------------------------------------------------------------
\13\ Average annual estimates are from the Injury Cost Model
evaluation of 72 emergency department-treated injuries during 2009-
2011 determined to have involved, or possibly having involved,
magnets of interest (Garland, 2012).
---------------------------------------------------------------------------
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
[[Page 53796]]
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\
---------------------------------------------------------------------------
\14\ The 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).
---------------------------------------------------------------------------
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. Child-
resistant packaging would not prevent teens and adolescents (and even
some younger children) from opening the packaging. Additionally, the
packaging would have to be secured after each use. According to the
Division of Human Factors, it is unlikely that adults would accept
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
[[Page 53797]]
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
[[Page 53798]]
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 life-threatening 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 x-rays, 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
[[Page 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 Sec. 1240.3(a) would apply to magnet sets that
contain a magnet that fits completely within the small-parts 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.
Sec. 1240.1 Scope, purpose, and effective date.
This part 1240, a consumer product safety standard, prescribes
requirements
[[Page 53800]]
for magnet sets, as defined in Sec. 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 Sec. 1240.2,
that are manufactured or imported on or after [180 days after
publication of a final rule].
Sec. 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.
Sec. 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 Sec. 1240.4, small magnets, as determined in paragraph (a) of this
section, must have a flux index of 50 or less.
Sec. 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.
Sec. 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. 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 x-rays, 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
[[Page 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