Source: http://thefederalregister.com/2012/09/04/2012-21608.html
Timestamp: 2017-12-15 15:56:00
Document Index: 753730867

Matched Legal Cases: ['art 1240', 'art 1501', '§ 1500', '§ 1240', 'art 1240', '§ 1240', '§ 1240', '§ 1240', '§ 1240', '§ 1240', '§ 1240', '§ 1240']

Federal Register | Safety Standard for Magnet Sets
16 CFR Part 1240
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.
DATES: Written comments in response to this document must be received by the Commission no later than November 19, 2012.
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.
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.
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.
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.
B. The Product 1. Description of the Product
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 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).
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.
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.
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.
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 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.
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).
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.
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.
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.
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.
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.
5. Findings—§ 1240.5
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