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Daily Rules, Proposed Rules, and Notices of the Federal Government

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1240

Safety Standard for Magnet Sets

AGENCY: Consumer Product Safety Commission.
ACTION: Notice of Proposed Rulemaking.
SUMMARY: 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: 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 throughwww.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, tohttp://www.regulations.gov.Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.

FOR FURTHER INFORMATION CONTACT: Jonathan D. Midgett, Ph.D., Project Manager, Office of Hazard Identification and Reduction, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408; telephone: (301) 504-7692, or email:jmidgett@cpsc.gov.
SUPPLEMENTARY INFORMATION:

A. Background

The Commission is proposing a safety standard that would prohibit magnet sets that have been involved in serious injuries. The Commission believes that this proposed rule is necessary to address an unreasonable risk of injury and death associated with these magnet sets.

1. History With Magnetic Toys

In the mid-2000s, construction toys for children featuring small, powerful magnets were introduced into the toy market. Several children's magnetic construction toys were recalled because the magnets detached from the plastic housing of the toy. (Release #07-164). We received reports of incidents in which children and infants had swallowed the small magnets that had detached from such toys. In some incidents, children swallowed intact magnetic components that were small parts.1 These incidents revealed that if a child swallows more than one small, powerful magnet or one such magnet and a ferromagnetic object, the objects can attract each other across tissue inside the stomach and intestines and cause perforations and/or blockage, which, if not treated immediately, can be fatal. We are aware of one death and numerous cases requiring intestinal surgery following ingestion of multiple small, powerful magnets from these toys.

1The requirements of 16 CFR part 1501 are intended to minimize the hazards from choking, ingestion, or inhalation to children under 36 months of age created by small objects. The requirements state, in part, that no toy (including removable, liberated components, or fragments of toys) shall be small enough without being compressed to fit entirely within a cylinder of the specified dimensions.

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 fora 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 anaggregated mass of 216 BB-size powerful magnets, generally marketed as adult desk toys forgeneral 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 makegeometric 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 warning2 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.

2See 16 CFR § 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 ofneodymium, 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 packagehttp://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.

3The Commission collects information on hospital emergency room-treated injuries through the NEISS database. This data can be used to provide national estimates of product-related injuries treated in U.S. hospital emergency departments. Incidents reported to the Commission represent a minimum count of injuries. To account for incidents that are not reported to the Commission, the staff calculates an estimated number of such injuries.

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

4Six of the remaining seven incidents (out of the 50 incidents) involved ingestion of magnets that were part of, or designed to be, part of jewelry, including beads, faux tongue rings, and earrings. One incident involved the ingestion of a magnetic rock. The rock magnet and magnets in jewelry would not meet the proposed definition of “magnet set” and would not be covered by this proposed rulemaking.

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 toremove 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/newperforations) 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.See15 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 hazardousmagnet 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 ToySafety, 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—§ 1240.1

This section of the proposed rule would state that the proposed requirements in 16 CFR part 1240 are intended to reduce or eliminate an unreasonable risk of injury to children who ingest magnets that are part of hazardous magnet sets. The standard would apply to all magnet sets, as defined in § 1240.2, that are manufactured or imported on or after the date 180 days after publication of a final rule.

2. Definitions—§ 1240.2

This section of the proposed rule would define the term “magnet set” to mean “any aggregation of separable, permanent magnetic objects that is a consumer product intended or marketed by the manufacturer primarily as a manipulative or construction desk toy for general entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief.” This definition would not include other magnetic products that do not meet the definition, such as toys intended for children and jewelry. Magnets that are part of a toy intended for children are already covered by the requirements in ASTM F963-11,Standard Consumer Safety Specification for Toy Safety,which is a mandatory CPSC standard. The Commission seeks comment on the scope of the products proposed to be covered by this proposed rule and, in particular, whether risks are presented by magnets in science kits or craft and hobby kits no matter how they are age graded and labeled.

The Commission also seeks comment on whether the definition of “magnet set” should include single, i.e., individual, magnets in order to ensure that the regulation prohibits the sale of individual magnets for use as aggregated manipulative or construction desk toys. This is because the hazard posed by magnets attracting in the body can occur when magnets are purchased individually or as a set.

3. Requirements—§ 1240.3

This section would set forth the requirements for magnet sets. If a magnet set contains a magnet that fits within the small parts cylinder that CPSC uses for testing toys, magnets from that set would be required to have a flux index of 50 or less. The Commission recognizes the possible hazard that could be posed by magnets that are purchased individually and subsequently aggregated. Therefore, the proposed language in § 1240.3(a) applies to magnet sets that contain a single magnet that fits completely within the small-parts cylinder described in 16 CFR 1501.4.

The Commission seeks comment regarding whether the proposed language in § 1240.3(a) applies to magnet sets that contain one magnet, or more than one magnet, that fits completely within the small-parts cylinder described in 16 CFR 1501.4.

The small parts cylinder referenced in the proposed rule is specified in 16 CFR part 1501—Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years of Age Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts. If an object fits completely within the small parts cylinder, this indicates that the object is small enough to be ingested. If a magnet that is part of a magnet set is too large to fit within the small parts cylinder, it would not be prohibited, regardless of the magnet's flux index. Thus, it might be possible for manufacturers to make magnet sets that contain strong magnets so long as the magnets are sufficiently large, although the large size could reduce their utility.

Small magnets (i.e.,those that fit within the small parts cylinder) that are part of a magnet set must have a flux index of 50 or less. This limit is based on the level that is specified in ASTM F963-11,Standard Consumer Safety Specification for Toy Safety,which is a mandatory CPSC standard. As discussed in section A.1 of this preamble, the flux index of a magnet is an empirical valuedeveloped by ASTM as a way to estimate the attraction force of a magnet.

The flux index limit of 50 was developed by ASTM, with CPSC staff's participation, to address injuries resulting from strong magnets that separated from toys. The limit was based on an analysis of magnets that were involved in incidents. The Commission seeks input on the limit particularly as to whether there may be health risks should a large number of magnets be ingested even if such magnets are at or below the flux limit of 50.

4. Test Procedure for Determining Flux Index—§ 1240.4

This section of the proposed rule would describe how to determine the flux index of magnets that are part of a magnet set. If the magnet set contains more than one shape or size of magnet, at least one of each shape and size would be selected for testing. The flux index of the selected magnets would be measured in accordance with the procedure set forth in section 8.24.1 through 8.24.3 of ASTM F963-11,Standard Consumer Safety Specification for Toy Safety. The flux index of the magnet is calculated by multiplying the square of the magnet's surface flux density (in KGauss) by its maximum cross-sectional area (in mm2). The ASTM standard uses a gauss meter and probe that measures the surface flux density at 0.015 inches (0.38 mm) above the magnet's surface. The area is measured at the largest cross-section of the magnet that is perpendicular to the axis of its magnetic poles.

We are proposing to use the methodology specified in ASTM F963-11 to measure the flux index of magnets that are part of a magnet set. The test method was developed to address hazards posed by magnets that are part of a toy. Such magnets are likely to be individual magnets that separate from a toy. Magnet sets may contain hundreds of magnets. Thus, such magnets are more likely to be aggregated than magnets separated from toys. When magnets are aggregated, their magnetic strength may increase. Children exposed to magnets from these magnet sets may ingest more magnets than they would if a magnet separates from a toy. Thus, it may be desirable to develop a method for testing the strength of aggregated magnets. We are interested in receiving comments that would address this issue.

5. Findings—§ 1240.5

In accordance with the requirements of the CPSA, we are proposing to make the findings stated in section 9 of the CPSA. The proposed findings are discussed in section N of this preamble.

G. Alternatives

The Commission has considered alternatives to reduce the risk of injuries related to the ingestion of magnets contained in magnet sets. However, as discussed below, the Commission does not believe that any of these would adequately reduce the risk of injury.

1. Voluntary Recalls

Although several of the companies that manufacture or import magnet sets have voluntarily agreed to recall (and in some cases, stop selling) these products, and several retailers have agreed to stop sale, the Commission has been unsuccessful in negotiating voluntary recalls and stop sales with several companies that control a significant portion of the magnet set market, including the company that sells more than 70 percent of the magnet sets purchased in the United States. It is extremely unlikely that all manufacturers/importers will voluntarily agree to stop selling and recall their magnet sets. Moreover, recalls would not prevent new entrants into the market in the future.

2. Voluntary Standard

Currently, there is no applicable voluntary standard in effect. A group of magnet set importers and distributors have requested that ASTM International develop a voluntary standard for the labeling and marketing of these products. Specifically, these companies have requested the formation of a voluntary standard to: (1) Provide for appropriate warnings and labels on packages of these magnets sets; and (2) establish guidelines for restricting the sale of these magnet sets to children, by not selling to stores that sell children's products exclusively and not selling the magnet sets in proximity to children's products. However, despite companies' marketing and labeling to attempt to limit children's exposure to magnets, ingestion incidents involving children continue to occur and the labeling does not change the attractiveness of the product to children or the intrinsic play value of the magnet sets. From the date that the firm with the largest share of the market undertook certain labeling enhancements and marketing restrictions through June of 2012, the Commission has learned of 47 additional incidents involving ingestion of magnets from hazardous magnet sets, 26 involving ingestion of the company's hazardous magnets. As discussed more fully in the next section of this preamble, we do not believe that warnings would adequately reduce the injuries associated with this product.

3. Warnings

It is unlikely that additional or different warnings on the packages of magnet sets would significantly reduce the ingestion-related injuries caused by high-powered magnets. Safety and warnings literature consistently identifies warnings as a less effective hazard-control measure than designing out the hazard or guarding the consumer from a hazard. Warnings do not prevent consumer exposure to the hazard, but rely on persuading consumers to alter their behavior in some way to avoid the hazard. With this product, warnings are particularly unlikely to adequately reduce or eliminate the ingestion of these magnets.

Warnings are especially unlikely to be effective among children because children may lack the cognitive ability to appraise a hazard or appreciate the consequences of their own actions and may not understand how to avoid hazards effectively. In addition, warning design guidelines and literature commonly recommend that the text of warnings intended for the general public be written at no higher than the 6th grade reading level, which is equivalent to a child about 11 years old. A warning that met this guideline presumably would not be understood by many children younger than 11.

Older children, more advanced cognitively, are able to appreciate better the hazards described in a warning. However, these children value peer acceptance more than parental guidelines, and social influences and peer pressure can drive adolescent behavior more strongly than their own independent thought processes. Furthermore, adolescents are at a developmental stage in which they test limits and bend rules. Therefore, warnings about keeping the product away from children could have the unintended effect of making the product more appealing to some children. Older children might view such warnings as attempts to restrict personal freedom or self-expression, which could result in responses that are contrary to the warning's recommendations. For example, warnings about not using the product in the specific ways that might place them at risk, such as mimicking piercings, might have the unintended effect of encouraging this behavior among these children. Repeated use of the product in this way, without ingesting the magnets, most likely will convince these children that the hazard is not especially likely or is not relevant to them.

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 ingestedby 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 wit