# Final Rule: Safety Standard for Magnet Sets

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2014-23341

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** October 3, 2014
- **Citation:** 79 FR 59962

## Text

CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1240
[CPSC Docket No. CPSC-2012-0050]
Final Rule: Safety Standard for Magnet Sets

AGENCY:

Consumer Product Safety Commission.

ACTION:

Final rule.

SUMMARY:

The Consumer Product Safety Commission (CPSC, Commission, or we) is issuing a rule establishing requirements for magnet sets and individual magnets that are intended or marketed to be used with or as magnet sets. As defined in the rule, magnet sets are aggregations of separable magnetic objects that are marketed or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief. Under the rule, if a magnet set contains a magnet that fits within the CPSC's small parts cylinder, each magnet in the magnet set must have a flux index of 50 kG
2
mm
2
or less. An individual magnet that is marketed or intended for use as part of a magnet set also must meet these requirements. The flux index is determined by the method described in ASTM F963-11, Standard Consumer Safety Specification for Toy Safety.

DATES:

This rule will become effective on April 1, 2015. The incorporation by reference of the publication listed in this rule is approved by the Director of the
Federal Register
as of April 1, 2015.

FOR FURTHER INFORMATION CONTACT:

Thomas Lee, Compliance Officer, Office of Compliance and Field Operations, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504-7737, or email:
tlee@cpsc.gov.

SUPPLEMENTARY INFORMATION:

A. Background

The Commission is issuing a safety standard under the Consumer Product Safety Act (CPSA) establishing requirements for magnet sets that have been associated with serious injuries and one reported death.
1

As discussed in greater detail in section B of this preamble, magnet sets are sets of small, powerful magnets marketed for general entertainment as construction toys, desk toys, sculpture sets, or stress relievers. The rule also covers individual magnets that are marketed or intended for use with or as magnet sets. The Commission concludes that this rule is necessary to address an unreasonable risk of injury and death associated with these magnet sets.

1
The Commission voted 4-0-1 to publish this notice in the
Federal Register
. Chairman Elliot F. Kaye, Commissioner Robert S. Adler, Commissioner Marietta S. Robinson and Commissioner Joseph P. Mohorovic voted to approve publication of the final rule. Commissioner Ann Marie Buerkle abstained from the matter.

1. Initial Incident Reports to CPSC and CPSC's Response

Significant U.S. sales of magnet sets marketed for general entertainment began in 2009. CPSC staff received the first consumer incident report involving magnet sets in February 2010. No injury resulted from this incident. Shortly after receiving this report, CPSC staff collected and evaluated samples of the magnet sets.

In December 2010, we received our first consumer incident report involving the surgical removal of magnets that had been part of a magnet set. During 2011, CPSC staff collected magnet sets marketed to children under 13 years old, and staff evaluated the compliance of these products with ASTM F963-11,
Standard Consumer Safety Specification for Toy Safety.
Staff evaluated these products under ASTM F-963 because some of the products were labeled and marketed in a manner that appeared to promote use by children and this standard includes requirements for the strength and size of magnets that are part of a toy intended for children. For firms whose products did not have labeling or marketing information, CPSC staff encouraged those firms to develop marketing programs and labeling content to help ensure that these magnet sets were not marketed to children. In addition, CPSC staff issued Notices of Noncompliance to firms that marketed magnet sets to children younger than 14 years of age.

In November 2011, in response to continuing reports of injuries associated with the products, the CPSC, in cooperation with two manufacturers, launched a public awareness campaign, which included a video public service announcement (PSA). The PSA advised children: Not to put magnets from magnet sets into their mouth; described the risk of injury presented by the ingestion of high-powered magnets; and provided tips to avoid magnet ingestion injuries, along with guidance for children who had swallowed magnets and parents who suspect that their child has swallowed magnets. Despite the CPSC's compliance and public awareness activities, reported incidents of magnet ingestion by children increased from 13 in 2010, to 19 in 2011, and 52 in 2012. Likely due to CPSC enforcement and regulatory activity beginning in mid-2012, and because the largest distributor ceased operations at the end of 2012, reported incidents declined to 13 incidents in 2013, including one fatality, and two incidents in 2014. We received an additional magnet ingestion incident report for which there was insufficient information to determine the date of the incident. As of June 24, 2014, 100 ingestion incidents involving, or possibly involving, ingestion of magnets from magnet sets have been reported to CPSC. (As discussed in section C of this preamble, staff's analysis of incidents reported through the National Electronic Injury Surveillance System (NEISS) estimates that 2,900 possible magnet set, emergency department-treated ingestions occurred in the United States from January 1, 2009 through December 31, 2013).

2. Corrective Actions

In May 2012, Compliance staff contacted a total of 13 independent importers of magnet sets and asked these importers to provide reports required under Section 15 of the CPSA. Most of the firms agreed to stop selling the products pending the results of staff's evaluation of the products. Given the continued injuries to children, staff negotiated voluntary corrective action plans with 11 of the 13 magnet set importers. These firms agreed to cease importation, distribution, and sales of magnet sets. Two importers did not agree to stop selling the magnets and the Commission initiated an administrative action in July and August 2012 seeking a determination that the magnet sets present a substantial product hazard and an order that the firm cease importation and distribution of the products. The Commission initiated a third administrative action in December 2012 after one of the firms that had agreed to stop sale subsequently resumed selling magnet sets. Two of the three administrative actions have been resolved. In May 2014, the Commission settled the administrative action against Maxfield & Oberton Holdings, LLC, and Craig Zucker, individually, and as an officer of Maxfield & Oberton Holdings, LLC. The settlement established and funded a Recall Trust, which, in accordance with a corrective action plan (CAP), is recalling the firm's magnet sets. In July 2014, the Commission settled the administrative complaint against Star Networks USA, LLC (Star). Under that settlement, Star has agreed to implement a CAP providing for the recall of the firm's magnet sets. The third firm, Zen Magnets, LLC, remains the subject of a CPSC administrative

action and continues to market and sell magnet sets.

3. Notice of Proposed Rulemaking

In the
Federal Register
of September 4, 2012 (77 FR 53781), the Commission published a notice of proposed rulemaking (NPR) to address the unreasonable risk of injury associated with magnet sets. The NPR proposed a standard that would require magnets from magnet sets containing at least one magnet that fits within the CPSC's small parts cylinder to have a flux index of 50 kG
2
mm
2
or less. The proposed rule sought comment on whether the rule should include magnets sold individually that could be aggregated into a magnet set. The final rule modifies the proposal to include individual magnets marketed or intended for the same uses as a magnet set,
i.e.,
as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief. We discuss this modification and other differences between the proposed and final rule in Section F of this preamble. The information discussed in this preamble comes from CPSC staff's briefing packages for the proposed and final magnet set rule, which are available on the CPSC's Web site at:
http://www.cpsc.gov/PageFiles/128934/magnetstd.pdf
(NPR briefing package) and
http://www.cpsc.gov/Global/Newsroom/FOIA/CommissionBriefingPackages/2014/SafetyStandardforMagnetSets-FinalRule.pdf
(final rule briefing package).

B. The Product

1. Description of the Product

The magnet sets covered by this rule typically are comprised of numerous identical, spherical, or cube-shaped magnets, approximately 3 millimeters to 6 millimeters in size, with the majority made from NdFeB (Neodymium-Iron-Boron or NIB). As discussed in section F of this preamble, the rule also covers individual magnets that are marketed or intended for use with or as magnet sets. These magnets exhibit strong magnetic properties. The magnetized neodymium-iron-boron cores are coated with a variety of metals and other materials to make them more attractive to consumers and to protect the brittle magnetic alloy materials from breaking, chipping, and corroding.

The magnets that are part of magnet sets are often referred to as “magnet balls” or “rare earth magnets.” Magnet sets are and have been marketed as: adult desk toys, the “puzzles of the future,” stress relievers, science kits, and educational tools for “brain development.” As shown in product instructions and in videos on related Web sites, magnet sets can be used and reused to make various two- and three-dimensional sculptures and figures, jewelry, and toys, such as spinning tops. Videos also show how these magnets can be used to mimic mouth and tongue piercings.

Magnet sets come with varying numbers of magnets, from as few as 27 magnets, to more than 1,000. Most of the magnets have been sold in sets of 125 balls or sets of 216 to 224 balls. The one firm that is currently marketing magnet sets that would not meet this rule sells one or more balls individually. Based on product information provided by marketers, the most common magnet size is approximately 5 millimeters in diameter, although balls as small as about 3 millimeters have been sold, as have sets of larger magnet balls (perhaps 15 millimeters to 25 millimeters in diameter). In addition to magnetic ball sets, magnet sets comprised of small magnetic cubes have also been sold, as have small magnetic rods. Sets made up of rods, however, have comprised a relatively small share of the market.

Most magnet sets contain magnets that are glossy and highly reflective with the spheres often described as similar in appearance to BBs or ball bearings. Magnet set magnets come in a variety of colors, including silver, blue, yellow, green and orange. The products are packaged in a variety of ways, including fabric pouches, wooden boxes, and metal tins.

The rule defines “magnet set” as: “any aggregation of separable magnetic objects that is a consumer product intended, marketed or commonly used as a manipulative or construction item for general entertainment, such as puzzle working, sculpture, mental stimulation, or stress relief.” As discussed in section F of this preamble, the rule also covers individual magnets marketed or intended for use with magnet sets.

2. Use of the Product

For the NPR, CPSC's Human Factors staff provided an assessment that discusses the appeal and use of magnet sets. Magnet sets have some appeal for virtually all age groups. These types of magnets tend to capture attention because they are shiny and reflect light. They are smooth, which gives the magnets tactile appeal, and these magnets make soft snapping sounds as they are manipulated. These properties or characteristics of magnets are likely to seem magical to younger children and may evoke a degree of awe and amusement among older children and teens. These features are the foundation of the magnet sets' appeal as a challenging puzzle, or as a manipulative, or as jewelry. These magnets may also be used like a stress ball and as a way to hold things in place.

Children, from toddlers through teens, have been exposed to magnet sets in the home setting and elsewhere. As the NPR preamble notes, we have reports of ingestion incidents that involve children 5 years of age and younger. The reports reflect similar scenarios to other ingestion incidents among this age group because mouthing and ingesting non-food items is a normal part of preschool children's exploratory behavior. In a number of reported incidents, the magnets were not in their original containers, and caregivers were unaware that some of the magnets from the set were missing and in the child's possession.

As noted in the NPR preamble, magnet sets also appeal to children of early-to-middle elementary school age. Younger children in this age group are interested in simple three-dimensional puzzles, and older elementary school children are interested in highly complex puzzles. Children in the latter age group also can engage in activities that require the type of meticulous work and attention that would be needed to create the complex patterns and structures found on paper and in video instructions for magnet sets. Additionally, magnets typically are included in science curricula for elementary school children to demonstrate the basic concepts of magnetism.

For all of these reasons, and consistent with reviews on retail Web sites, magnet sets are sometimes purchased for children under the age of 14, despite warnings or labeling to the contrary. For example, approximately one-third of 53 adults reviewing one manufacturer's product on Amazon.com reported purchasing the magnets for children 8 through 11 years of age.

Thus, it is foreseeable that some portion of these products will be purchased for elementary school children and teens. Moreover, given the relatively low cost for some magnet sets, elementary school children and teens may purchase the magnet sets themselves. The incident reports reflect behaviors that are beyond the intended use of the product but that are foreseeable for the groups using them. For example, it is foreseeable that some children will place these magnets in their mouth, even if the manufacturer

warns against this behavior. The mouthing of objects, common among younger children, develops into less obvious and more socially acceptable oral habits, which may continue through childhood and adolescence and into adulthood (
e.g.,
mouthing or chewing a fingertip, fingernail, knuckle, pen, pencil, or other object, especially while concentrating or worrying). Where details are provided, the incident reports describe scenarios that are consistent with the behaviors of young children and teens. Although exploratory play is generally associated with very young children, people of all ages use their senses to explore unfamiliar phenomena. 77 FR 53781, 53783 (Sep. 4, 2012).

3. The Market

Based on information reviewed by staff on product sales, including reports by firms provided to the Office of Compliance and Field Operations, the number of magnet sets that were sold to U.S. consumers from 2009 through mid-2012, may have totaled about 2.7 million sets, with a value of roughly $50 million. This estimate reflects retail sales directly to consumers (through company Web sites and other Internet retail sites) and sales to retailers who market the products. Staff's review of retail prices reported by importers, and observed on Internet sites in 2012, suggested prices of magnets sets typically ranging from about $20 to $45 per set, with an average price of about $25.

To our knowledge, all of the firms that have marketed the products, including the firm that continues to sell individual magnets and magnet sets, import the products packaged and labeled for sale to U.S. consumers. Several Chinese manufacturers have the facilities and production capacity to meet the orders of U.S. importers. Additionally, there are no major barriers to market entry for firms wishing to source products from China for sale in the United States. Firms may have sales arrangements with Internet retailers who hold stock for them and process orders.

We have identified about 25 U.S. firms and individuals who imported magnet sets for sale in the United States in 2012. The combined sales of the top seven firms probably have accounted for the great majority (perhaps more than 90%) of units sold. One firm, Maxfield & Oberton Holdings, LLC, believed to have held a dominant position in the market for magnetic desk sets since the firm entered the market in 2009, ceased operating in December 2012, and is no longer an importer of magnet sets. That now-defunct firm, along with a few larger firms (including a firm based in Canada with a branch office in the United States), marketed their products through accounts with retailers. They have also sold their products directly to consumers via the Internet, using their own Web sites, or other Internet shopping sites. In addition to products offered for sale by U.S. importers, consumers also have the ability to purchase magnetic sets directly from sources in Hong Kong or China that market products through a leading Internet shopping site.

C. Risk of Injury

The risk of injury addressed by this rule is damage to intestinal tissue caused when a person ingests more than one magnet from a magnet set (or one magnet and a ferromagnetic object). The magnets are attracted to each other in the digestive system, damaging the intestinal tissue that becomes trapped between the magnets. In rare cases, there can be interaction between magnets in the airways and digestive tract (esophagus). These injuries can be difficult to diagnose and treat because the symptoms of magnet ingestion often appear similar to those of less serious conditions, such as the flu, and because many doctors are unfamiliar with the risks of magnet ingestion. In addition, the limitations of standard diagnostic tools to identify and evaluate the presence of magnets in the body may make magnet ingestion difficult to identify. Serious injury and even death are consequences of ingestion of strong magnets by children.

1. Incident Data

NEISS data.
CPSC staff reviewed data from the NEISS database of magnet-related ingestion cases treated in emergency departments from January 1, 2009 to December 31, 2013.
2

CPSC staff analyzed 456 magnet-related ingestion cases and determined that 121 of the cases involved or possibly involved ingestion of magnets from magnet sets. Staff further determined that an estimated 2,900 ingestions of magnets from magnet sets were treated in U.S. emergency departments during this 5-year period—an estimated average of 580 emergency department-treated magnet ingestions per year. The largest portion of these incidents involved children 4 through 12 years of age. An estimated 1,900 of the 2,900 victims are in the 4- through 12-year-old age group (65.3 percent). For more information about the process of developing the estimates of incidents, see the memorandum from the Directorate for Epidemiology, located at Tab B of staff's briefing package:
http://www.cpsc.gov/Global/Newsroom/FOIA/CommissionBriefingPackages/2014/SafetyStandardforMagnetSets-FinalRule.pdf
.

2
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.

Databases other than NEISS.
The preamble to the proposed rule (77 FR at 53784 through 53785) summarized the data for incidents reported through databases other than NEISS from January 1, 2009 through June 30, 2012. These incidents involved the ingestion of magnets by children between the ages of 1 and 15. For that period, we received reports of 50 incidents involving the ingestion of magnets by children in this age range. Of those 50 incidents, 38 involved the ingestion of high-powered, ball-shaped magnets contained in products that meet the definition above of “magnet set”; five of the 50 incidents possibly involved ingestion of this type of magnet. In 35 of the 43 incidents involving or possibly involving magnets from a magnet set, two or more magnets were ingested. Hospitalization was required in 29 of the 43 incidents, with surgery necessary to remove the magnets in 20 of the 29 hospitalizations. In the other nine hospitalizations, the victim underwent colonoscopic or endoscopic procedures to remove the magnets. In 37 of the 43 incidents, the magnets were ingested by children younger than 4 years old or between the ages of 4 and 12 years.

Since publication of the NPR, the Commission has received reports of additional incidents involving the ingestion of magnets by children between the ages of 1 year and 15 years old, including one report of a fatality associated with the ingestion of small spherical magnets. We have now received reports of a total of 100 incidents involving or possibly involving the ingestion of high-powered, ball-shaped magnets contained in products that meet the definition of “magnet set.” The reports indicate that the incidents occurred between January 1, 2009 and June 24, 2014. Sixty-one of the 100 reported incidents required hospitalization. In 87 of the 100 reported incidents, the magnets were ingested by children younger than 4 years old or between the ages of 4 and 12 years.

Among the 100 reported incidents is one fatality that involved magnets from a magnet set. In August 2013, a 19-

month-old female died from ischemic bowel caused by magnets from magnet sets in her small intestine.

2. Hazard Scenarios

As discussed in the preamble to the proposed rule, the incident reports describe scenarios that are consistent with behaviors of children in the identified age ranges. As noted in the NPR, mouthing of objects, which is common among younger children, develops into less obvious and more socially acceptable oral habits, which may continue through childhood and adolescence and into adulthood (
e.g.,
mouthing or chewing a fingertip, fingernail, knuckle, pen, pencil, or other object, especially while concentrating or worrying). 77 FR 53781, 53783 (Sep. 4, 2012). For example, in the incidents reported in the 8 through 12-year-old age group, one child described wanting to feel the force of the magnets through his tongue; one was trying to see if the magnets would stick to her braces; and another wanted to see if the magnets would stick together through her teeth. In another common scenario that accounted for half of the reported ingestion incidents among 8 to 15 year olds, children used multiple magnets to simulate piercings of their tongue, lips, or cheeks. In incidents reported among children under the age of 4 years, children put the magnets in their mouths and either intentionally or accidentally swallowed them.

The preamble to the proposed rule provides summaries of several incident reports that demonstrate a few of the reported hazard scenarios (77 FR at 53785 to 53786). These scenarios include two incidents in which young girls (10 and 13 years of age) swallowed multiple magnet balls while using the magnets to simulate tongue and lip piercings. The girls underwent surgical procedures to remove magnet balls from their intestines. In three other scenarios, magnet balls ingested by children under the age of 3 years had to be removed surgically from the children's stomach and intestines. In three of the five incidents described in the preamble to the proposed rule, the child's parent or caregiver did not realize the child had ingested magnets, which resulted in a delay in treatment and an increase in the severity of the injuries from the magnets, which attached to each other across intestinal tissue.

3. Details Concerning Injuries

Multiple factors complicate the diagnosis of injury from magnet ingestion (77 FR 53786). These factors include a lack of awareness by medical professionals of the dangers posed by the ingestion of high-powered magnets; the inability of standard diagnostic tools to demonstrate that the ingested item is a magnet; the similarities between symptoms resulting from magnet ingestion injuries and less serious conditions like the flu; and victims' inability or unwillingness to communicate to their caregivers or medical personnel that they have ingested magnets.

The preamble to the proposed rule discussed the manner in which ingested high-powered magnets can cause harm by compressing intestinal tissue, the specific types of injuries that can result when tissue is trapped between two magnets, and the risks associated with those injuries (77 FR 53786). These injuries include perforations that can result in infection due to leakage of gut contents into the abdominal cavity and obstructions that can lead to intestinal tissue becoming necrotic or rupturing and causing contamination of the abdominal cavity. Surgical procedures often are required to remove magnets from the digestive system. Complications can arise after these procedures, including bleeding, infection, and ileus (temporary paralysis of gut motility). Long-term complications resulting from this type of surgical procedure can include: (1) Adhesions (where bands of intra-abdominal scar tissue form that can interfere with gut movement and can cause obstruction); (2) removal of long sections of injured bowel; and (3) impaired digestive function.

D. Statutory Authority

This rulemaking is conducted pursuant to the Consumer Product Safety Act (CPSA). Magnet sets are “consumer products” that can be regulated by the Commission under the authority of the CPSA. 15 U.S.C. 2052(a).

Under section 7 of the CPSA, the Commission is authorized to promulgate a mandatory consumer product safety standard that sets forth performance requirements for a consumer product or that sets forth requirements that a product be marked or accompanied by clear and adequate warnings or instructions. 15 U.S.C. 2056. A performance, warning, or instruction standard must be reasonably necessary to prevent or reduce an unreasonable risk or injury associated with a consumer product.

Section 9 of the CPSA specifies the procedure that the Commission must follow to issue a consumer product safety standard under section 7. In accordance with section 9, the Commission commenced this rulemaking by issuing an NPR on September 4, 2012 (77 FR 53781), including the proposed rule and a preliminary regulatory analysis under section 9(c) of the CPSA. In addition, the Commission requested comments on the risk of injury identified, the regulatory alternatives under consideration, and other possible alternatives for addressing the risk.
Id.
2058(c). As discussed in section E of this preamble, the Commission considered the comments received in response to the proposed rule.

Section 9 also requires the Commission to provide interested persons “an opportunity for the oral presentation of data, views, or arguments,” in addition to an opportunity to provide written comments.
Id.
2058(d)(2). Accordingly, the Commission held a public hearing on the proposed rule on October 22, 2013, at agency headquarters in Bethesda, MD. The hearing notice was published in the
Federal Register
(78 FR 58491). The submissions forwarded to the agency by presenters before the hearing, can be read online at:
http://www.cpsc.gov/en/Newsroom/Public-Calendar/2014/Public-Hearing/Agenda/Magnet-/.
Videos of the presentations can be viewed at:
http://www.cpsc.gov/Newsroom/Multimedia/?vid=66455.
The Commission also allowed submitters to forward additional written comments for 1 week after the hearing. We considered all of the written and oral comments received.

With this notice, the Commission issues a final rule, along with a final regulatory analysis.
See id.
2058(f)(1). According to section 9(f)(1) of the CPSA, before promulgating a consumer product safety rule, the Commission must consider and make appropriate findings to be included in the rule on the following issues: (1) The degree and nature of the risk of injury that the rule is designed to eliminate or reduce; (2) the approximate number of consumer products subject to the rule; (3) the public's need for the products subject to the rule, and the probable effect the rule will have on utility, cost, or availability of such products; and (4) the means to achieve the objective of the rule while minimizing adverse effects on competition, manufacturing, and commercial practices.
Id.
2058(f)(1).

Pursuant to section 9(f)(3) of the CPSA, to issue a final rule, the Commission must find that the rule is “reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with such product” and find that issuing the rule is in the public interest.
Id.
2058(f)(3)(A)&(B). In addition, if a voluntary standard

addressing the risk of injury has been adopted and implemented, the Commission must find that: (1) The voluntary standard is not likely to eliminate or adequately reduce the risk of injury, or that (2) substantial compliance with the voluntary standard is unlikely.
Id.
2058(f)(3(D). The Commission also must find that the expected benefits of the rule bear a reasonable relationship to the cost of the rule and that the rule imposes the least burdensome requirements that would adequately reduce the risk of injury.
Id.
2058(f)(3)(E)&(F).

E. Response to Comments on the Proposed Rule

This section summarizes the issues raised by comments on the proposed rule and provides that Commission's responses to those comments.

1. Oral Presentations

On October 22, 2013, the Commission provided the public an opportunity to present views on the proposed rule in person before the Commission Presenters at the hearing included representatives from the Consumer Federation of American, Consumers Union, the American Academy of Pediatrics, and the National Association of Pediatric Gastroenterology, Hepatology, and Nutrition. The medical experts reported that the available research most likely reflects an undercount of the true incidence of injuries associated with magnet sets. The doctors also stated there was no evidence suggesting that the victims' caregivers were negligent or otherwise impaired at the time of the ingestion incidents. Rather, the doctors noted that ingestion-related injuries, such as those associated with magnet sets, can be experienced in households with the most caring and well-educated caregivers. The doctors also testified that public education campaigns take a long time to show effects and that those campaigns would not be as effective in reducing magnet ingestion injuries as the proposed rule, which they strongly urged the Commission to finalize.

2. Written Comments

The preamble to the NPR invited comments concerning all aspects of the proposed rule. We received written comments from more than 5,000 commenters in response to the NPR. Many of the comments contained more than one issue, and many of the comments addressed the same or similar issues. Thus, we organized our responses by issue. All of the comments can be viewed at:
www.regulations.gov,
by searching under the docket number for this rulemaking, CPSC-2012-0050.

Commission's Authority To Promulgate the Rule

(Comment 1)
—Many commenters opine that promulgating the rule exceeds the Commission's authority. More specifically, several commenters state that the Commission has no authority to issue a rule that would result in a prohibition of all magnet sets currently on the market simply because certain consumers use magnets in a manner that is inconsistent with the purpose intended for the product. Other commenters opine that the rule violates consumers' constitutional rights, including the right to freedom of expression through purchasing products they desire, and that a rule that prohibits the sale of covered magnet sets is drastically out of proportion to the risks presented by the product. Other commenters characterize the safety standard as the government usurping responsibility for the safety of children, which they say should properly reside with children's parents or caregivers.

(Response 1)
—The Commission has the authority to issue a rule establishing performance requirements that a product must meet so that the product does not present an unreasonable risk of injury to consumers. Section 7 of the CPSA authorizes the Commission to promulgate consumer product safety standards as performance requirements or that require products to be marked or accompanied by clear and adequate warnings and instructions. The requirements of a standard issued under this provision must be reasonably necessary to prevent or reduce an unreasonable risk of injury associated with the product. Determining whether a product presents an unreasonable risk of injury requires the Commission to consider the costs and benefits of regulatory action. The regulatory analysis discusses that assessment (see Section H of this preamble). The Commission must balance such factors as the severity of injury, the likelihood of injury, and the possible harm the regulation could impose on manufacturers and consumers. If evidence demonstrates that misuse of a product results in an unreasonable risk of injury, the Commission has the authority to promulgate a rule reasonably necessary to reduce or eliminate that risk. Certainly parents and caregivers must be responsible for their children's safety. However, as discussed elsewhere, parents and caregivers may not be aware of the hazards that magnets present. Finally, there is no constitutional right to purchase a product.

(Comment 2)
—Several commenters characterize the Commission's enforcement activities (filing administrative complaints, requesting certain retailers and importers to stop sales of magnet sets, and requesting recalls of magnet sets) as improper means to prohibit certain magnet sets. The commenters suggest that rulemaking, rather than these enforcement actions, is the appropriate approach.

(Response 2)
—Enforcement activities are intended to remove products from the market that present a substantial product hazard. This rulemaking proceeding is intended to establish requirements that magnet sets must meet from the effective date of the rule going forward. As such, this rulemaking proceeding seeks to impose requirements on all magnet sets subject to the rule that are sold after the rule becomes effective. The administrative proceeding and enforcement activities address only the products currently or previously distributed by specific importers and retailers.

(Comment 3
)—Several commenters opine that the Commission would be acting arbitrarily or capriciously in violation of section 706(2) of the Administrative Procedures Act (APA) by promulgating the rule; that the rule violates due process requirements; and that the Commission should hold a formal hearing under Sections 556 and 557 of the APA, even if such a hearing is not required statutorily.

(Response 3)
—The Commission is following the rulemaking procedures set forth in sections 7 and 9 of the CPSA and in section 553 of the APA. The commenters refer to section 556 and 557 of the APA. These provisions apply to formal rulemaking. However, the magnet proceeding is governed by section 553 of the APA, which codifies the procedure for informal rulemaking. By following the appropriate procedures under the CPSA and the APA, the Commission is providing the process that is due.

Lack of Product Defect

(Comment 4)
—Commenters point out that magnet sets pose no risk of injury when used properly, that they function as intended, and therefore, they are not defective. The commenters contend that the improper use of a safe product by a minority of consumers does not render the product defective and does not warrant promulgating a rule that would remove the product from the market.

(Response 4)
—To promulgate a consumer product safety standard, the

Commission must find that the rule is reasonably necessary to reduce an unreasonable risk of injury associated with the product. A product may present an unreasonable risk of injury, even if the product does not contain a fault, flaw, or irregularity that impacts the manner in which the product functions. When assessing risk, CPSC considers how consumers may actually use a product, not just the manner of use intended by the manufacturer. For example, the Commission's cigarette lighter standard requires disposable and novelty lighters to meet child-resistance requirements to protect against the misuse of lighters by children. 16 CFR part 1210. Similarly, the Commission's lawn mower standard includes requirements to guard against consumers intentionally removing a shielding safety device from the mower. 16 CFR part 1205.
See Southland Mower
v.
Consumer Product Safety Commission,
619 F.2d 499, 513 (5th Cir. 1980) (reviewing the Commission's lawn mower standard, the court stated: “Congress intended for injuries resulting from foreseeable misuse of a product to be counted in assessing risk”).

Impact of the Rule on the Availability of Magnet Sets for Certain Uses

(Comment 5)
—Commenters state that high-powered magnets have many laudable uses, including for education and research in sciences, such as biology, chemistry, and physics. Other commenters note that magnet sets are used therapeutically for individuals with autism or attention-deficit disorder. These commenters presume that the rule would eliminate from the marketplace high-powered magnets intended for such uses.

(Response 5)
—Magnets have long played a role in education. However, the specific products that are covered by the rule have been on the market only since 2008. The rule will cover only “any aggregation of separable magnetic objects that is a consumer product intended, marketed or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief.” Magnets that are not subject to the restrictions of the rule would continue to be available. For example, less powerful magnets are sometimes included in science kits to demonstrate magnetism. In addition, high-powered magnets that serve industrial and commercial needs would not be covered by the rule.

Products that meet the definition of the “magnet sets” that do not comply with this rule would no longer be available for purchase, even if used by individuals to manage their attention deficit disorder or attention deficit hyperactivity disorder (ADD/ADHD) symptoms. However, magnets that are not restricted by the rule would still be available for purchase and perhaps could be used to manage ADD/ADHD symptoms. More generally, magnets are but one of many objects, including various types of stress balls, “worry-beads,” and chiming Baoding hand exercise balls that are available for the uses commenters cite. A variety of other products are marketed specifically as “fidget toys” to help children manage ADD/ADHD symptoms. Staff is aware of one study in which the authors reported successful use of simple stress balls to help sixth graders maintain focus in the classroom (Stalvey & Brasell, Summer 2006). In short, some substitutes for magnet sets are available for management of ADD/ADHD symptoms, and successful use of these substitutes predates the availability of magnet sets.

Magnet sets present the same hazards to children with ADD/ADHD as they do to children who do not have this condition. One comment summarizes a study of 38 cases of magnet ingestion. Among those were two children, a 12-year-old and a 14-year-old with ADHD, who swallowed strong magnets, although of a type different than those typically found in magnet sets. The first child required a laparoscopy; the other child required extensive surgical intervention. One teacher who reported giving magnets to children with ADD/ADHD in his middle school classes commented that he “needed to buy a new set every year,” suggesting the ease with which the pieces are lost over time and the difficulty adults may have maintaining control of the sets.

(Comment 6)
—Commenters note that magnet sets are fun stress-relievers and have value as an artistic medium. The commenters also note that sculpture made from the magnet sets that are the subject of the rule constitute an art form that would be lost if the rule is promulgated.

(Response 6)
—The Commission is aware that magnet sets are used to relieve stress; and likewise, the Commission is aware that some individuals have developed a form of art with the magnets that would be affected if the magnet sets used for this purpose are prohibited. Although magnet sets of the type that have been involved in incidents and are currently purchased by consumers for stress relief and sculpture-making would not comply with the rule, magnet sets made from weak magnets (
i.e.,
with a flux index 50 kG
2
mm
2
or less) or from magnets that do not fit within the small parts cylinder would be allowed by the rule. Magnet sets that comply with the rule could serve some of the purposes of magnet sets that are currently available. For example, Liberty Balls, marketed by Assemble, LLC, and sold in sets of eight large spheres, are an example of a type of magnet set that would meet the performance requirements of the rule. Due to the large size of the Liberty Balls magnets, their uses are more limited than the magnet sets that are the subject of this rule. However, the existence of Liberty Balls demonstrates the possibility that companies can develop magnet sets that meet the standard and serve some of the uses of the magnet sets that fail the standard.

Similarly, children's magnetic toys provide an example of how magnet sets might be developed that would meet the standard. Children's toy manufacturers have successfully adapted their magnetic construction toys since the adoption of the requirements for toys with magnets in the 2007 edition of ASTM F963, “
Standard Consumer Safety Specification for Toy Safety.”
Following this example, individual magnets with a flux index over 50 could be permanently connected by rods or other means, such that the resulting magnetic objects are not small parts,
i.e.,
do not fit entirely within the small parts cylinder. Such a magnet set might not be a perfect substitute for current magnet sets but could fulfill some of the uses of current magnet sets, without posing the risk of injury or death.

(Comment 7)
—Noting the popularity of magnet sets for educational, scientific, and therapeutic uses, some commenters claim that continued demand for small, high-powered magnets would result in a “black market” for the products after the rule is promulgated. Some commenters state that there could be consumer-to-consumer sales of used products, and others maintain that consumers would be able to purchase magnet sets directly from noncomplying companies (including firms located in China). A few commenters note that these black market magnet sets are less likely to be sold with warning labels or other accompanying information related to hazards.

(Response 7)—
We acknowledge that there would continue to be a demand for magnet sets by some consumers, which could lead to increases in consumer-to-consumer sales and potentially black market sales of the products. Furthermore, such sales are probably less likely to be accompanied by labeling and warnings that alert buyers to the hazards associated with

the products. CPSC enforcement activities and continued dissemination of consumer information on the hazards of magnet sets might be necessary to reduce the future sales of noncomplying products.

(Comment 8)
—Some commenters opine that magnet sets that comply with the size and flux index requirements of the rule will lose their utility as manipulative desk toys. Other commenters suggest that weaker magnets would be less safe because weaker, individual magnets could be separated more easily from the magnet set during use, or separate more readily within the gastrointestinal system if ingested while attached to other magnets.

(Response 8)
—The intent of the rule is to reduce or eliminate the hazard presented by magnet sets currently on the market by requiring that magnet sets and individual magnets for use with magnet sets that are small enough to fit within the small parts cylinder must have a flux index of 50 kG
2
mm
2
or less. The rule would still allow strong magnet sets with magnets that do not fit entirely within the small parts cylinder. Magnetic products sold as toys that comply with the toy standard for children have included rods, balls, and various geometric shapes that do not fit within the small parts cylinder. Such products offer interesting entertainment, such as sculptures and construction activities, but they are much larger and safer than the subject magnet sets intended for adults. Another possibility would be to invent a magnet set composed of magnets with a flux index below 50 kG
2
mm. Because there currently are no magnet sets on the market with magnets that have a flux index of less than 50 kG
2
mm
2
, we do not know how such magnets would perform when used in the same way currently available magnet sets perform.

Magnet sets that comply with the requirements of the rule would contain magnets that are too large to be swallowed easily or would have very weak attraction forces that would not pose the same ingestion hazards as magnet sets currently on the market. Review of incident data does not indicate that any injuries have been caused by magnets with flux index values below 50 kG
2
mm
2
.

(Comment 9)—
Some commenters disparage the intended uses of magnet sets, calling them, for instance, “mindless desk ornaments,” “a diversion,” and “frivolous items.” These commenters cite the high severity of the injuries associated with magnet sets and express dismay that the CPSC ever allowed them to be sold.

(Response 9)—
The CPSC does not perform premarket approvals of consumer products; and typically, the CPSC will not engage in enforcement or regulatory activity regarding a product, until information is received or developed, which indicates that the product may present an unreasonable risk of injury to consumers. Reasonable parties may differ on the value to society of manipulative toys; however, many types of manipulative toys exist for children and adults.

Impacts of the Rule on Businesses and Jobs

(Comment 10)
—Many commenters note that the rule would harm firms that import magnet sets and will result in lost jobs for employees of these firms.

(Response 10)
—In the preliminary initial regulatory analysis, staff noted that the economic impact of the rule would be most severe for the seven firms that account for the great majority (perhaps more than 98%) of units sold as of June 2012. Five of these importers reportedly derived most or all of their revenues from the sale of the magnet sets that do not meet the performance requirements of the rule. The other two leading importers of magnet sets reportedly had fairly broad product offerings, which could lessen the severity of the economic impact of the rule. As a result of compliance activity pursued by the Commission's Office of Compliance and Field Operations, four of these seven importers agreed voluntarily to stop selling magnet sets that would not be compliant under this rule. One additional firm, Maxfield & Oberton Holdings, LLC, ceased operations. This firm (marketer of “Buckyballs”) is believed to account for nearly 90 percent of magnet set sales through June 2012. Only one of the seven small importers, Zen Magnets, LLC, continues to market magnet sets that are subject to the rule. This firm apparently derives all of its revenues from the sale of magnet sets. Unless the firm can successfully market magnet sets that comply with the rule or other products, the firm might go out of business when the rule takes effect.

A large share of magnet sets have been sold directly to consumers by importers who used their own Internet Web sites or other Internet shopping sites, but the rule would also affect retailers of the products, whether the products are sold online or physically in stores. However, these retailers are not likely to derive significant proportions of total revenues from sales of affected magnet sets. Accordingly, the impacts on individual firms should be minimal.

The commenters are correct that the rule, by prohibiting the sale of noncompliant magnet sets in the United States, may also result in some job losses. However, the impact on job losses is probably limited because magnetic balls generally are produced outside the United States and are merely packaged and/or distributed by U.S. importers.

Costs and Benefits of the Rule

(Comment 11)
—One commenter opines that the preliminary regulatory analysis overstates the societal costs of injuries from magnet sets because incidents involving other small magnets are improperly attributed to the magnet sets that are the subject of the proposed rule. In addition, this commenter opines that the injury costs used in the analysis were higher than indicated by the CPSC's Revised Injury Cost Model (ICM).

(Response 11)—
Both the initial and final regulatory analyses acknowledge that there is some uncertainty concerning the estimated annual average of medically attended injuries, noting that some of the cases described as “possibly” involving magnet injuries, actually may not have involved the magnets that are the subject of the rule. Hence, it is possible that the analyses overstate the societal costs associated with the magnets included in the rule. The final regulatory analysis also points out that there were an additional 230 NEISS cases (representing about 1,500 emergency department-treated injuries annually) in which the magnet type was classified as “unknown or other.” Thus, to the extent that this category of incidents involved magnets covered by the rule, the analyses would tend to understate the societal costs associated with the magnets subject to the rule. Therefore, given the uncertainty concerning the societal costs associated with the magnet sets, the analyses could be underestimating or overestimating the societal costs.

Regarding the commenter's assertion that injury costs used in the preliminary regulatory analysis were higher than indicated by the ICM, we note that the commenter fails to take into account updates to the ICM based on new and improved cost databases. The ICM is fully integrated with NEISS and provides estimates of the societal costs of injuries reported through NEISS. The major aggregated components of the ICM include: Medical costs; work losses; and the intangible costs associated with lost quality of life or pain and suffering. The ICM is described further in section H.3.a of the preamble. The commenter also does not

take into consideration that the cost estimates in the preliminary regulatory analysis were age and sex specific and involved only those under the age of 15 who had ingested magnets from magnet sets. Furthermore, the commenter apparently also includes injury costs associated with the diagnosis category “foreign body,”
i.e.,
foreign objects propelled into the victim's body, which is a different hazard pattern than “ingested foreign objects.” The costs of injuries resulting from foreign objects being propelled into a victim's body are only about half of the costs of injuries associated with ingested foreign objects. Finally, the commenter applies inappropriate inflators in adjusting the injury cost estimates to 2011 dollars. The Commission maintains that the estimated injury costs associated with ingestions of small, high-powered magnets in the preliminary regulatory analysis and final regulatory analysis involved proper application of the ICM.

Risk and Severity of Injury

(Comment 12)
—The Commission received a significant number of comments from health care professionals with personal experience in treating children who either narrowly avoided, or actually sustained, injuries following ingestion of small, high-powered magnets.

Virtually all comments received from medical professionals express support for a rule eliminating magnet sets of the type that have been involved in incidents. The medical professionals point out that injuries caused by the ingestion of high-powered magnets are often difficult to diagnose because of the inability of standard diagnostic tools to demonstrate that the ingested item is a magnet; there are similarities between symptoms resulting from magnet ingestion injuries and less serious conditions like the flu; and the victims are unable or unwilling to communicate to their caregivers or medical personnel that they have ingested magnets. The medical professional commenters express concern with the rapidly growing number of cases and note that magnet ingestions often result in rapid and severe injuries with devastating and costly long-term consequences.

(Response 12)
—The Commission is aware of the severity of the injuries that often result from the ingestion of small, high-powered magnets from magnet sets and the difficulties frequently encountered by medical professionals in diagnosing and treating these injuries. The Commission is also aware that there are costs associated with the treatment of injuries resulting from the ingestion of these magnets that will be reduced substantially if magnet sets must comply with the rule. (See Section H of this preamble).

(Comment 13)
—Commenters argue that high-powered magnet sets should not be prohibited because the number of injuries is low—43 reported injuries possibly involving magnet sets during the period from January 2009 to June 2012—considering that approximately 2.7 million magnet sets have been sold since 2009. These commenters also note that there have been no fatalities associated with the product.

(Response 13)
—The number of incidents reported to the Commission, now totaling 100 cases through June 24, 2014, cannot be used to estimate the number of injuries in the U.S. population because case reports are anecdotal and are not based on a probability based sampling design. The anecdotal incidents reported to CPSC constitute a minimum number of incidents in the U.S. However, the incidents reported to CPSC through hospital emergency departments and captured in the NEISS database can be used to estimate the number of incidents nationwide because NEISS data come from a probability based stratified random sample of U.S. hospitals with emergency departments. An analysis of incidents obtained through the NEISS estimates that 2,900 possible magnet set, emergency department-treated ingestions occurred in the United States from January 1, 2009 through December 31, 2013. This amounts to approximately one incident per 930 magnet sets. We do not agree that this is a low figure for injuries. In addition, we are aware of one fatality involving a 19 month-old female, who died from ischemic bowel caused by the ingestion of magnets from a magnet set.

Furthermore, the benefits of the rule, notwithstanding the public's desire for current magnet sets that do not meet the rule, bear a reasonable relationship to the costs of the rule.

(Comment 14)
—Several commenters point out that the dangers posed by the ingestion of small, high-powered magnets are not obvious.

(Response 14)
—Staff agrees that the unique hazard resulting from the ingestion of small, strong magnets is unlikely to be obvious to the general public. People are generally aware of the choking hazard posed by small balls and other small parts, but they do not understand how the characteristics of magnets can cause injuries that are different from, and more severe than, swallowing another small object. Despite the publicity and response generated by the NPR, as well as the Commission's compliance and communications activities, some commenters misunderstand the hazard. Many commenters seem unaware that the majority of victims are older children and teens, and the commenters focus exclusively on the risk to young children. Similarly, commenters tend to mention magnets as a choking hazard, comparable to choking on foods, such as hot dogs and non-food small parts. In reality, choking is not the injury mechanism related to magnets. The ways that children and teens interact with magnets are not obvious and seem unclear to many commenters. For example, some commenters write derisively about “people letting their children eat magnets.” However, most incidents are unwitnessed, and based on data from choking and poisoning incidents in which children intentionally ingest non-food items, it is likely that only the youngest children voluntarily swallow magnets. This is because choking on non-food items occurs predominantly among children younger than three years, and ingestion of poisonous substances declines as children approach five years of age.

(Comment 15)
—Other commenters point out that the Commission has not prohibited certain products, such as trampolines, balloons, and hazardous household chemicals, which commenters contend present a greater risk of injury to children than magnet sets. They assert that this weighs against a rule prohibiting certain magnet sets that do not meet the rule's performance requirements.

(Response 15)
—Magnet sets, and the hazard patterns associated with them, are quite different from other products. Because of these differences, comparisons of injury rates between magnet sets and other products are not meaningful. Key differences include: the obviousness of the hazard; the severity of the resulting injury; the difficulty in diagnosing the resulting injury; the numbers of products in use; the breadth of products covered in the product category; the age of the victims sustaining injuries; and the existence of requirements to address the hazard.

Responsibility of Caregivers for Injuries Resulting From Magnet Ingestion

(Comment 16)
—Several commenters claim that the incidents involving magnet sets are caused by negligent caregivers, who should supervise their children better. However, other commenters opine that caregiver supervision was not a relevant factor in determining the causation of the incidents.

(Response 16)
—The issue of caregiver supervision is related to caregiver

compliance with warnings and other hazard communications. Consumers may be aware of a hazard, but they may not make changes in their behavior that would avoid the hazard. Securing or preventing access to magnet sets would be especially difficult regarding older children and adolescents because they are strongly independent and resourceful. Expecting caregivers to supervise these children constantly is unrealistic. Magnet ingestions can happen quickly, and the Commission believes that it is also unrealistic to expect caregivers to maintain continuous, focused attention on younger children, especially children at the upper end of the at-risk age range. Indeed, research has found that people cannot be perfectly attentive, particularly over long periods of time, regardless of their desire to do so.
3

Caregivers are likely to be distracted, at least occasionally, because they must perform other tasks, are responsible for supervising more than one child, are exposed to other salient but irrelevant stimuli, or are subject to other stressors.

3
Wickens, C. D., & Hollands, J. G. (2000). Engineering
psychology and human performance
(3rd Ed.). Upper Saddle River, NJ: Prentice Hall.

Moreover, caregivers are unlikely to maintain high levels of vigilance, unless they believe that such vigilance is necessary. If caregivers who own magnet sets believe they have properly secured the sets or think that their children are not aware of the sets, caregivers are unlikely to assume that constant supervision is needed. Furthermore, children may be exposed to these magnet sets in locations where caregivers cannot supervise the children or do not have direct control over the amount of supervision required, such as at school or in other households. Adolescents, in particular, are strongly independent, and it is unrealistic to expect caregivers to supervise adolescents constantly.

Alternatives to the Rule: Warnings and Education Programs

(Comment 17)
—Many commenters state that current warnings are sufficient to address the risk of injury presented by magnet sets, or they express the belief that more robust and prevalent warnings and educational programs are a better alternative than a rule prohibiting products that do not meet the rule's performance requirements. Some commenters state that the assumption that warnings do not work undermines past safety standards accepted by the CPSC and, in fact, calls into question the entire safety-monitoring process.

(Response 17)
—As discussed in the Human Factors staff memorandum that was part of the NPR briefing package, warnings are widely recognized as a less reliable approach to controlling hazards than design or guarding approaches. Unlike these latter approaches, which directly limit hazard exposure, warnings and other hazard communications must first educate consumers about the hazard and then persuade consumers to change their behavior to avoid the hazard. In addition, to be effective, warnings must rely on consumers to behave consistently, regardless of situational or contextual factors (
e.g.,
fatigue, stress, social influences) that influence precautionary behavior.

The Commission's position is not that warnings are uniformly ineffective. However, consumer compliance with warnings depends strongly on the specific circumstances surrounding the hazard. Several factors suggest that compliance with warning labels related to magnet sets is likely to be low because consumers may not notice and attend to the warnings. Exposure to ingestion warnings is likely to be very limited because: (1) The individual magnets are too small to contain on-product warnings; (2) the magnet sets do not inherently require consumers to return the magnets to a storage case or other package after every use, in packaging that might include a warning; and (3) the magnet sets can be manipulated without the necessity of referring to instructions that might include a warning. In addition, the nature of the magnet-ingestion hazard and the resulting injuries can be difficult to convey to consumers; and the resulting injuries have been misunderstood even by medical personnel and by commenters to the NPR, some of whom erroneously identify choking on the magnets as the hazard presented by this product. Without a clear understanding of this information and how magnet ingestions differ from other small-part ingestions, consumers are unlikely to comply with a warning.

We acknowledge that developing understandable warnings aimed at parents and other caregivers may be possible; and we acknowledge that caregivers who receive such warnings may attempt to keep these products out of the hands of young children. However, as noted, consumer compliance with warnings depends strongly on the specific circumstances surrounding the hazard. Several factors suggest that compliance with warning labels related to magnet sets is likely to be low, even if consumers understand the hazard and its consequences. For example, the cost of compliance associated with magnet-ingestion warnings is high. “Cost of compliance” is defined as any cost, such as time, effort, or inconvenience that is required to comply with a warning; compliance is negatively associated with cost. The warnings on the packaging and instructional material for some magnet sets instruct consumers to secure the magnets and keep them away from all children ages 14 years and younger. As evidenced in the comments, many consumers are likely to reject these warnings as lacking credibility. We recognize that caregivers who receive warnings about magnet sets may attempt to keep these products out of young children's hands. However, warnings are likely to be particularly ineffective among caregivers with older children and adolescents because caregivers would not expect these children to mouth toys and other objects as frequently as younger children. Furthermore, even if caregivers attempt to comply with warnings about the magnet-ingestion hazard, preventing a child's access to these magnets still might prove quite difficult. The time and effort to secure the product after every use, and the difficulties associated with trying to identify a suitably secure location to store the product, may deter consumers from heeding the warnings.

Some adolescents have cognitive and motor skills similar to an adult's, making it extremely challenging to keep the product out of adolescents' hands, despite caregivers' efforts. Although adolescents also may be capable of understanding warnings about magnet ingestions, their behavior is influenced strongly by social and peer pressures, and adolescents are known to test limits and bend rules.
4

Thus, warnings against using magnets to simulate tongue or facial piercings are unlikely to be very effective among this age group, unless such piercings are viewed as socially unacceptable among their peers.

4
Brown, T., & Beran, M. (2008). Developmental stages of children. In R. Lueder & V. J. B. Rice (Eds.),
Ergonomics for children: Designing products and places for toddlers to teens
(pp. 13-30). New York: Taylor & Francis. Kalsher, M. J., & Wogalter, M. S. (2008). Warnings: Hazard control methods for caregivers and children. In R. Lueder & V. J. B. Rice (Eds.),
Ergonomics for children: Designing products and places for toddlers to teens
(pp. 509-539). New York: Taylor & Francis. Zackowitz, I.B., & Vredenburgh, A.G. (2005). Preschoolers, adolescents, and seniors: Age-related factors pertaining to forensic human factors analyses. In Y. I. Noy & W. Karwowski (Eds.),
Handbook of human factors in litigation
(Chapter 35). Boca Raton, FL: CRC Press.

Educational programs may offer more opportunities to present the information in varied ways and in greater detail than is possible via a warning label.

However, mere knowledge or awareness of a hazard is not enough. Such programs suffer from limitations similar to those of warnings because, like all hazard communications, the effectiveness of educational programs depends upon the affected consumers, not only in terms of receiving and understanding the message, but also in being persuaded to heed the message. Magnet sets present an especially difficult challenge for public education programs because the hazard is obscure and difficult to convey in simple terms. Furthermore, teenagers are a significant part of the at-risk population, and they provide distinct challenges to the effectiveness of public education programs. Thus, even education programs that clearly communicate the hazard to consumers will not necessarily motivate appropriate behavioral change or reduce the frequency of incidents.

Alternatives to the Rule: Bitterants

(Comment 18)
—A small number of commenters discuss bitterants (also known as aversives) as an option. Some conclude that adding a bitter coating to magnets would be an effective alternative to the prohibition of magnet sets that do not meet the rule's performance requirements. A few commenters assert that the method is unproven and question that approach for various reasons.

(Response 18)
—In principle, adding an aversive agent to a product is a rational approach to reducing the risk of mouthing and ingestion. Laboratory studies have shown this approach to be effective among children and adults in deterring repeated ingestion of various substances. Yet, real-world investigations have not demonstrated the effectiveness of bitterants in preventing poisonings.
5

CPSC staff's 1992 final report of its study of the topic (
http://www.cpsc.gov/library/foia/foia99/os/aversive.pdf.
at p. 3) concluded that because bitterants do not deter initial ingestion, “[a]versive agents are unlikely to protect children from being harmed after ingesting . . . substances that can injure or kill after one or two swallows.”

5
Cf. White, N. C., Litovitz, T., Benson, B. E., Horowitz, B. Z., Marr-Lyon, L., & White, M. K. (2009). The impact of bittering agents on pediatric ingestions of antifreeze.
Clinical Pediatrics, 48
(9), 913-921.

Bitterants are least likely to be effective among young children who gain access to high-powered magnets. Despite rejecting bitter substances in testing environments, children in home settings, nevertheless, frequently ingest unpalatable substances, such as gasoline, cleanser, toilet bowl cleaner, and ammonia. Younger children, particularly those under 3 years of age, may swallow a number of magnets at a time before reacting to any aversive agent applied to the magnets.

Aversives may be a more effective deterrent for older children and young teens, presuming these children are aware that the agent has been applied to the magnets and they are familiar with its taste. For older children who are not familiar with the taste of an aversive, the mere presence of the agent would not deter mouthing the magnets or trying to use them to mimic pierced lip or tongue jewelry. Older children and teens may also give magnets to others to try as a prank. Preteens and teens are prone to test what they have been told, particularly when what they have been told involves restrictions of any sort. Thus, warnings that the products taste bad may not prevent children in these age groups from tasting the magnets. (Some proportion of the population, possibly as high as 30 percent, may be insensitive to bitterants such as denatonium benzoate.) However, children are likely to reject magnets treated with bitterants, and the bitterant may indeed deter repeated attempts among most children.

Ingestions could still occur even if a bittering agent is found effective for this purpose. Ingestions may be intentional among the youngest children, but ingestions are likely to be accidental among older groups. The power of the magnetic forces inherent in these products can cause magnets to move erratically as pieces repel or attract, and movement of magnets toward the back of the throat could trigger the reflex to swallow the magnets before the person can remove them.

Alternatives to the Rule: Child-Resistant Packaging

(Comment 19)—
Several commenters state that child-resistant (CR) packaging requirements are a better alternative than the proposed performance requirements. However, others believe that such requirements would be ineffective in reducing or eliminating the risk of injury.

(Response 19)
—CR packaging could be devised to make an enclosed magnet set inaccessible to most young children. However, compliance with CR packaging is likely to be low and inconsistent; and the effectiveness of this approach depends on the caregiver and other users securing the magnets in the CR packaging after every use. This is behavior that we consider unlikely to occur. Although CR closures have been shown to be effective in reducing poisonings with various products (
e.g.,
Rodgers, 2002), non-use and incorrect use of CR closures on products containing chemicals or pharmaceuticals—products consumers are more likely to understand to be hazardous (as opposed to strong magnet sets)—can result in many poisonings annually among children younger than 5 years old. Furthermore, CR packaging, referred to as “special packaging” under the Poison Prevention Packaging Act, is designed to be significantly difficult for children under 5 years of age to open. 15 U.S.C. 1471(4). Thus, CR packaging is an impractical approach for older children, whose cognitive and motor skills overlap those of adults.

Flux Index

(Comment 20)
—One commenter questions the relationship of the flux index (FI) to anatomical data, which the commenter considers to be most germane to the hazard. The commenter requests that the rule be modified to redefine the criteria, “by relying on objective anatomical data tied to the potential risks associated with swallowing injuries and refine the testing protocol to isolate the field strength and/or attach forces that can reasonably be expected to develop at the distances reflected by anatomical data.” Referencing an ultrasound study, the commenter asserts that the minimal gut wall thickness in children is 0.5 mm, and the commenter suggests that when measuring the magnet maximum surface gauss reading, instead of measuring at a probe distance of 0.25 to 0.51 mm above the magnetic pole surface, as currently required in ASTM F963-11, it is more appropriate to base the measuring distance on the minimum gut wall thickness. The commenter suggests that using a probe separation distance of 1.0 mm (2 × 0.5 mm = 2 sections of gut wall) makes more sense because 1 millimeter “is the magnetic field strength at that critical distance that may bear a rational relationship to injuries.”

(Response 20)
—Commission staff agrees that the strength of the magnet field and the separation of the magnets, or lack thereof, are important factors contributing to the risk of injury posed by any strong magnet. The gastrointestinal (GI) system is folded on itself within the abdominal cavity, and during transit through the GI system, there are many opportunities for magnets in different GI locations to pass nearby to each other and then interact when separated by only the thin gut walls. Commission staff believes that measuring the maximum surface gauss reading for the FI input at a set distance of 1.0 mm (equivalent to two

thicknesses/layers of gut wall) is oversimplistic and inappropriate, unless the maximum surface gauss reading measured at that 1.0 millimeter distance is essentially zero.

Although the suggested value of 1.0 millimeter is anatomically valid, it is not particularly meaningful in terms of the injury mechanism. This is because conventional magnets do not “wait” to get within 1 millimeter of each other before they begin to interact, and the gut wall cannot block magnetic forces. Rather, once a pair of magnets comes within a distance where the extent or reach of their magnetic fields allows them to interact, the result is near-instantaneous attraction, with consequent near-instantaneous compression of any trapped tissues. Although the thin wall of the small intestine can be conveniently defined anatomically by its thickness, the tissue offers minimal resistance to the compression forces of the magnet. Thus, the tissue trapped between magnets may be compressed so that the distance between the magnets is much smaller than 1.0 millimeter. The compression forces deprive the tissue of its blood supply, and they also squeeze out the tissue fluids, rapidly reducing the gut wall thickness to micron values, and essentially mummifying the tissue
in situ.
The measurement distance for the FI in the rule is closer to this negligible distance than the 1.0 millimeter distance that the commenter suggests; and therefore, the measurement distance for the FI in the rule is more appropriate for defining powerful magnets capable of causing GI injuries.

(Comment 21)
—Several commenters question whether a flux index value of 50 kG
2
mm
2
is low enough to prevent harm.

(Response 21)
—The development of the flux index requirement that appears in ASTM F963,
Consumer Safety Specification for Toy Safety,
which is now a mandatory CPSC standard, was outlined in the NPR. (77 FR 53781-82, September 4, 2012). ASTM F963-11 defines a “hazardous magnet” and a “hazardous magnet component” as one that has a flux index greater than 50 kG
2
mm
2
and that is a small object. ASTM set the flux index value at 50 kG
2
mm
2
, by measuring the weakest magnets in children's toys that were suspected of causing injuries, and then adding a safety factor. Review of incident data related to children's toys and magnet sets does not indicate that any injuries have been caused by individual magnets with flux index values below 70. CPSC staff will continue to monitor incidents and seek information about the lower-bound limits of the injury mechanism so that the established method continues to be appropriate.

(Comment 22)
—Several commenters question whether the rule is adequate for assessing the hazard posed by an aggregation of individual magnets, each of which has a flux index of 50 or less.

(Response 22)
—The staff memorandum included in the NPR briefing package acknowledged concerns with the existing ASTM F963 standard method regarding aggregated magnets, as follows: “A toy with multiple weak small part magnets could present an issue that the existing ASTM F963 magnet requirements do not address, namely: stacking or stringing of magnets. . . . when these small part magnets are combined, they could create a(n aggregated) magnet with an effective flux index over 50 kG
2
mm
2
depending upon their characteristics.” (Notice of Proposed Rulemaking for Hazardous Magnet Sets, Staff Briefing Package, pp. 54−55). Individual magnets with a flux index of 50 kG
2
mm
2
or less (which currently do not exist in the market) would be smaller and more difficult to manipulate and have less attraction force than magnets in existing magnet sets. Individual magnets with a flux index of 50 kG
2
mm
2
or less could be mounted permanently or attached side-by-side to create a magnetic object with multiple magnetic poles on one surface. Doing so would create a multipole magnetic object that has a higher attraction force than the individual magnets on its surface. Because there currently are no magnet sets on the market with magnets that have a 50 kG
2
mm
2
flux index or less, we do not know how they would perform when used as a part of a magnet set.

(Comment 23)
—One commenter disagrees with the proposed flux index method, stating that the commenter's proprietary technology could be used to make “safe” magnet sets, even if the flux index measurement of individual magnets is greater than 50. The commenter uses a proprietary technology to magnetize the surface of a single magnet to create multiple poles (positive and negative regions) on the surface of a single magnet. The commenter refers to these proprietary magnets as “Polymagnets.®” Essentially, this process creates a permanent aggregation of north and south poles in the surface of a single magnet. The commenter requests that the Commission narrow the scope of the rule to apply only to magnet sets comprised of magnets having no more than two magnetic pole regions on any exposed magnet surface, thereby, exempting multiple pole magnets.

(
Response 23)
—The commenter's claim that a process exists that could be used to make “safe” magnet sets, even if the flux index measurement of individual magnets is greater than 50 kG
2
mm
2
, is based on proprietary technology, which, to our knowledge, has not been applied to any magnet sets currently on the market. The commenter concedes that he “has not fully analyzed the use of a densely coded pattern” on small cubes or spheres and claims only that “early indications suggest that dramatic improvements to the magnetic field * * * can be achieved” using the proprietary technology. These statements indicate that the commenter has not applied this technology to small, high-powered magnet sets or even concluded that such an application is scientifically possible or economically feasible. CPSC is not aware of any magnet set products on the market that are comprised of magnets with multipole surfaces using the commenter's technology. Moreover, it is not likely that this process will be applied to small, high-powered magnet sets in the foreseeable future. Thus, the Commission does not believe that any exemption for these types of magnets is necessary or appropriate, particularly because currently, no Polymagnet® magnet sets exist that could be tested to determine whether such magnet sets present an unreasonable risk of injury.

(Comment 24)
—The same commenter also states that the flux index measurement method is imprecise because it provides a range of acceptable distances between the gauss meter and the magnetic surface being measured.

(Response 24)
—The flux index measurement method specifies the use of a gauss meter and an axial probe with a distance between the active area (diameter of 0.76 +/− 0.13 mm) and probe tip of 0.38 +/− 0.13 mm. This means the magnetic flux density is measured at a distance of between 0.38 millimeters and 0.51 millimeters above the magnet surface. The tolerance cited accounts for variations in the length of the axial probe tip, which is a function of the equipment used, and therefore, does not constitute a precise value.

F. Description of the Final Rule

The Commission is issuing a rule establishing a standard for magnet sets and individual magnets that are marketed or intended for use with or as magnet sets. This section of the preamble describes the rule, including differences between the proposal and the final rule.

1. Scope, Purpose, and Effective Date—§ 1240.1

This section of the final rule states that the requirements in 16 CFR part 1240 are intended to reduce or eliminate an unreasonable risk of injury to consumers who ingest magnets that are part of magnet sets and individual magnets that are marketed or intended for use with or as a magnet set. The standard applies to all magnet sets, as defined in § 1240.2, and relevant individual magnets manufactured or imported on or after the date 180 days after publication of the final rule.

Individual magnets.
The scope of the final rule has been revised from the proposal so that the rule explicitly covers magnets that are sold individually and are intended or marketed to be used in the same way as magnet sets or as a part of a magnet set. The Commission is aware of one firm that sells magnet sets and also sells single magnet spheres at a per-magnet price through the same Web site on which the firm promotes and sells sets of magnets. This firm sells individual magnet spheres for 10 cents each and allows customers to purchase up to 1,152 magnets in a single order. The firm charges a shipping rate of $5.00 for any quantity of individual magnets purchased. Another firm, Star, which recently settled an administrative complaint with the Commission, sold individual magnet spheres for between 9 and 19 cents each (depending on the number ordered), and allowed customers to purchase up to 10,000 magnets in a single order.

Because the proposed rule described the scope of the rule as covering aggregations of magnets, magnets that are sold individually, arguably would not be subject to the requirements of the safety standard under the scope provision, as proposed. Thus, under the proposed scope, firms might be able to circumvent the safety standard requirements simply by pricing and selling magnet spheres individually that are intended to be used as part of an aggregation of magnets as a magnet set. Under the final rule, all magnet spheres intended for use as magnet sets, as defined by the rule, are subject to the requirements of the safety standard, whether they are sold individually or in the aggregate.

Changing the word “children” to “consumers.”
The proposed scope section stated that the rule is intended to reduce or eliminate an unreasonable risk of injury to children. The final rule changes the word “children” to “consumers” to clarify that the rule is intended to address risks posed to teens as well as young children. As the incident data make clear, both teens and young children have been harmed when swallowing magnets from magnet sets. Because the term “children” could be subject to interpretations that might exclude teens, the final rule uses the term “consumers.”

2. Definitions—§ 1240.2

This section of the final rule provides definitions for the terms “magnet set” and “individual magnet.” The final rule modifies the proposed definition of “magnet set” to clarify certain aspects of the definition. The Commission does not intend for these modifications to change the scope of the rule from the proposal, but rather, to describe more clearly the products subject to the rule. The final rule also adds a definition for the term “individual magnet.”

Definition of “magnet set.”
To respond to comments on the NPR and to provide greater precision, the Commission has modified the definition of “magnet set” in the proposed rule by:

• Removing the word “permanent”;

• Replacing the phrase “intended or marketed by the manufacturer primarily” with the phrase “intended, marketed or commonly used”;

• Replacing the word “desk toy” with “item”; and

• Specifying factors that could indicate whether a magnet set meets the definition.

The final rule definition removes the word “permanent” from the phrase “separable, permanent magnetic objects” because the word “permanent” is superfluous. Any magnet, whether it maintains its magnetic strength permanently or not, can cause serious damage to intestinal tissue, if ingested.

The final rule replaces the phrase, “intended or marketed by the manufacturer primarily,” with the phrase: “intended, marketed or commonly used.” The revision seeks to prevent a manufacturer or importer of magnet sets from avoiding the rule by simply stating in marketing and other materials that the magnets are intended for uses other than those specified in the definition. For example, this modification will preclude firms from claiming that their products are intended as science kits to avoid the rule, if, in fact, the products are commonly used as magnet sets (
i.e.,
as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief). Common uses may be indicated by information found in consumer reports to the CPSC, firm reports to the CPSC, injury reports, and consumer comments/reviews posted on product Web sites stating that a product, regardless of whether it is intended or marketed by the manufacturer as such, was, in fact, being used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation or stress relief. This change clarifies that the common usage of a firm's magnet products could be a consideration in determining whether the magnets are intended for use as manipulatives for entertainment, irrespective of the firm's stated intentions.

The final rule definition replaces the term “desk toy” with “item” to prevent excluding magnet sets from the scope of the rule if a particular product is not explicitly labeled or expressly marketed as a desk toy.

The final rule specifies factors that are relevant in determining the intended uses of a magnet set. These are factors that Commission staff may consider in determining whether a product falls under the definition of “magnet set.” Explicitly stating these factors in the rule should provide clearer direction to firms and the public about what products will be covered by the rule. We may consider the manner in which the individual magnet or magnet set is promoted, marketed, and advertised. As part of this inquiry, staff may review the labeling and packaging of the product, information on the firm's Web site about intended uses of the product, information in other promotional materials, and where and how the product is displayed at retail stores or on the Internet. In addition, we may consider the uses for which the product is commonly recognized by consumers. Information provided by consumers and firms, injury reports, and consumers' online reviews or comments for the product are examples of sources that could be useful to determine what consumers consider to be the uses of the product.

In developing this part of the “magnet set” definition, the Commission considered regulatory and statutory provisions that describe factors to be used in determining the intended use of a product. The Commission's small parts regulation specifies factors relevant to a determination of which toys and other articles are intended for use by children under 3 years of age. 15 U.S.C. 1501.2(b). The small parts regulation states: “In determining which toys and other articles are intended for use by children under 3 years (36 months) of age, for purposes of this regulation, the following factors are relevant: the manufacturer's stated intent (such as on a label) if it is a reasonable one; the advertising,

promotion, and marketing of the article; and whether the article is commonly recognized as being intended for children under 3.”
Id.
The definition of “children's product” in the CPSA lists factors to consider in determining whether a product is primarily intended for children 12 years of age or younger. 15 U.S.C. 2051(a)(2). The “magnet set” definition draws from both the regulatory definition in the small parts rule and the statutory definition of “children's product” to specify factors, which include the manufacturer's stated intent, information provided with or on the product, and the commonly recognized uses of the product.

The definition does not include other magnetic products, such as toys intended for children and jewelry. Magnets that are part of a toy intended for children are already covered by the requirements in ASTM F963-11, which is a mandatory CPSC standard. The definition also does not include magnets intended for industrial or commercial applications, such as motor components, magnetic bearings, magnetic couplings, welding clamps, oil filters, disc drives, loudspeakers, headphones, microphones, instrumentation, switches, and relays.

Definition of “individual magnet.”
The final rule adds a definition of “individual magnet.” As discussed above, the Commission is aware that the firm that currently sells magnet sets that would be prohibited by the rule also sells individual magnets for use with magnet sets. The Commission seeks to prevent firms from circumventing the rule by selling individual magnets for the same uses as the magnet sets that have been involved in incidents, and at the same time claiming that the individual magnets are not subject to the rule because the magnets are not sold as sets. The individual magnets covered by the rule are only the magnets that are intended or marketed for use with or as a magnet set. The Commission does not intend to cover the many types of individual magnets that are sold for other uses, such as refrigerator magnets, collar stays, or various commercial and industrial uses.

3. Requirements—§ 1240.3

This section sets forth the requirements for magnet sets. If a magnet set contains a magnet that fits within the small parts cylinder that CPSC uses for testing toys, all magnets from that set must have a flux index of 50 kG
2
mm
2
or less. Because the final rule covers individual magnets that are intended or marketed for use with or as a magnet set, the requirements section of the final rule states that individual magnets, as defined in the rule, must meet the requirements. The proposed rule set out the small parts and the flux index requirements in two subsections of § 1240.3. The final rule consolidates these provisions into one section.

The small parts cylinder referenced in the rule is specified in 16 CFR part 1501—Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years of Age Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts. If an object fits completely within the small parts cylinder, this indicates that the object is small enough to be ingested. If a magnet that is part of a magnet set (or an individual magnet, as defined) is too large to fit within the small parts cylinder, the magnet meets the standard, regardless of the magnet's flux index.

Small magnets (
i.e.,
those that fit within the small parts cylinder) that are part of a magnet set (and individual magnets, as defined) must have a flux index of 50 kG
2
mm
2
or less. This limit is based on the level that is specified in ASTM F963-11. As discussed in the preamble to the NPR (77 FR 53781), the flux index of a magnet is an empirical value developed by ASTM to estimate the attraction force of a magnet. The flux index limit of 50 kG
2
mm
2
was developed by ASTM, with CPSC staff's participation, to address injuries resulting from strong magnets that separate from toys. Because the magnets from toys involved in incidents had flux index measurements greater than 70 kG
2
mm
2
,the ASTM working group chose a flux index of 50 kG
2
mm
2
as a cutoff because that value was significantly below the value for the magnets involved in incidents.

4. Test Procedure for Determining Flux Index—§ 1240.4

This section of the rule describes how to determine the flux index of magnets that are part of a magnet set. If the magnet set contains more than one shape or size of magnet, at least one of each shape and size is selected for testing. The flux index of the selected magnets is measured in accordance with the procedure set forth in sections 8.24.1 through 8.24.3 of ASTM F963-11,
Standard Consumer Safety Specification for Toy Safety.
The flux index of the magnet is calculated by multiplying the square of the magnet's surface flux density (in KGauss), by its maximum cross-sectional area (in 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.

In the NPR, we noted that the products at issue are typically aggregations of magnets, rather than individual magnets that often separate from toys. We also observed that when magnets are aggregated, their magnetic strength may increase. We requested comments on whether it may be desirable to develop a method for testing the strength of aggregated magnets in addition to the method for testing the strength of individual magnets. We received no comments proposing methodologies for testing the strength of an aggregation of magnets. Furthermore, because there are no magnet sets currently on the market with magnets that have a 50 kG
2
mm
2
flux index or less, we believe that the aggregation scenario is adequately addressed in the rule.

5. Findings—§ 1240.5

In accordance with the requirements of the CPSA, we have made the findings stated in section 9 of the CPSA. The findings are discussed in section N of this preamble.

G. Alternatives

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

1. Voluntary Recalls

Although most of the companies that manufacture or import magnet sets have voluntarily agreed to stop selling (and in some cases recall) these products, and several retailers have agreed to recall and stop sale, the Commission has been unsuccessful in negotiating voluntary recalls and stop sales with one company that continues to market magnet sets. Pursuing voluntary recalls with current and possibly future manufacturers and importers of magnet sets would be reactive and would entail waiting for new incidents to occur rather than preventing them. Moreover, recalls would not prevent new entrants into the market in the future; a rule will set requirements that all products must meet from the effective date of the rule going forward.

2. Voluntary Standard

Currently, there is no applicable voluntary standard in effect. Before publication of the NPR, a group of magnet set importers and distributors requested that ASTM International

develop a voluntary standard for the labeling and marketing of these products. Specifically, these companies requested the creation of a voluntary standard to: (1) Provide for appropriate warnings and labels on packages of these magnets sets; and (2) establish guidelines for restricting the sale of these magnet sets to children, by not selling to stores that sell children's products exclusively, and advising retailers not to sell the magnet sets in proximity to children's products. To date, ASTM has not formed a committee to consider the development of a voluntary standard for magnet sets.

Moreover, whether such a voluntary standard would be effective in reducing or eliminating the risk of injury associated with magnet sets is questionable. Despite companies' marketing and labeling their products in an attempt to limit children's exposure to magnets, ingestion incidents involving children have continued to occur; and labeling does not change the attractiveness of the product to children or the intrinsic play value of the magnet sets. From March 2010, when the firm with the largest share of the market undertook certain labeling enhancements and marketing restrictions, through June 2012, the Commission learned of 47 additional incidents of ingestion of magnets from magnet sets, 26 of which involved ingestion of that company's magnets. As discussed more fully in the next section of this preamble, we do not believe that warnings would adequately reduce the injuries associated with magnet sets.

We also note that Zen Magnets has announced its own “voluntary standard” for magnet sets requiring that:

• Customers must be 18 years of age or older to purchase magnets and that the sales location must have an age floor for persons 18 and older or 21 and older, or age must be otherwise verified by Government ID; and

• All stores must verbally remind customers to keep magnets away from mouths.

We do not consider a standard issued by one company to be a “voluntary standard” as that term is used in the CPSA. Moreover, the measures that Zen magnets announced would have the same limitations discussed above.

3. Warnings

A possible alternative to the rule would be to require warnings with or on magnet sets. As discussed in the NPR preamble and in response to comments set forth in section E of this preamble, it is unlikely that warnings on the packages of magnet sets would significantly reduce the ingestion-related injuries caused by high-powered magnets. Safety and warnings literature consistently identifies warnings as a less effective hazard-control measure than eliminating the hazard through design or guarding the consumer from a hazard. Warnings do not prevent consumer exposure to the hazard but rely on persuading consumers to alter their behavior in some way to avoid the hazard. With this product, warnings are particularly unlikely to reduce or eliminate the ingestion of these magnets. Warnings are especially unlikely to be effective among young children because children may lack the cognitive ability to appraise a hazard or appreciate the consequences of their own actions and may not understand how to avoid hazards effectively.

Although older children are better at appreciating the hazards described in a warning, peer acceptance and social influences can strongly influence adolescent behavior. Because adolescents have a tendency to test limits and bend rules, warnings about keeping the product away from children could have the unintended effect of making the product more appealing to some children. For example, warnings against specific uses, such as mimicking piercings, might actually encourage this behavior among older children. If children repeatedly use the product in this way, without ingesting the magnets, these children most likely will become convinced that the hazard is not especially likely, or is not relevant to them.

In the NPR, we noted that staff generally found the content of warnings accompanying magnet sets to be lacking in several ways. For example, the warnings often did not describe the incident scenarios prevalent among older children and adolescents, whom caregivers may not believe are likely to put magnets into their mouth. Warnings lacked detailed information that would allow consumers to understand how swallowing magnets differs from swallowing other small parts, or how magnets sticking together could pose a hazard because the magnets will not simply pass through the child's system. Without a clear, explicit, and accurate description of the nature of the hazard and its consequences, consumers may find the warning implausible. Moreover, even with enhanced warnings, consumers are unlikely to comply with the action recommended in the warning.

Even if warnings could effectively communicate the ingestion hazard, the consequences of ingesting magnets, and appropriate hazard-avoidance measures, warnings still may not be effective if consumers do not concur with the content of the warning. Warnings are particularly likely to be ineffective among caregivers of older children. Unless caregivers are convinced that their older child is likely to mimic lip, nose, or similar piercings, or perform other activities that might lead these adolescents to place magnets into their mouth or nose, caregivers may doubt that the warnings are relevant to their child, despite the warnings' assertions to the contrary.

As noted in the NPR preamble and in section E of this preamble, even if caregivers believe the warnings, several factors may limit compliance. Caregivers, particularly those with older children, might feel significant social pressure from children who are accustomed to using the magnet sets. Caregivers who own the product and attempt to heed the warnings might find it quite difficult to prevent their child's access to the magnets and still keep the product reasonably accessible for their own use.

The cost of compliance with warnings for these products is high. Caregivers may be reluctant to secure the product from a child after every use. Identifying an appropriate location to store the magnet sets may dissuade consumers from doing so, particularly for a product often marketed to be for “stress relief.” Caregivers may underestimate their child's abilities and place the product in locations that seem secure but that are still accessible to the child. All of these factors may lead caregivers to reject the warning message.

Based on these concerns about the likely ineffectiveness of warnings for magnet sets, we do not believe that warning labels would adequately reduce the risk of injury presented by these products.

4. Packaging Restrictions

Theoretically, magnet sets could be sold with special storage containers to reduce the likelihood that children would access the magnets. Possible storage might include a container that would clearly indicate when a magnet is missing from the set. Such a requirement might prevent injuries resulting from a small number of magnets being separated from a set without the owner being aware. However, many consumers may not use such containers because using them could require time to gather the magnets and put them in the container, or consumers may be reluctant to dismantle a shape or structure that took them time and effort to construct. Thus, the effectiveness of such special containers to reduce ingestions is doubtful. Finally, it is not clear that the

Commission would have the regulatory authority to issue a rule prescribing requirements for packaging, other than child-resistance requirements (discussed below).

Another alternative might be to require that magnet sets be sold in child-resistant packaging. Child-resistant packaging, also called “special packaging,” is packaging that is significantly difficult for children under five years of age to open or obtain a harmful amount of the substance. 15 U.S.C. 1471(4). The ability of such an approach to reduce ingestion injuries of magnets from magnet sets would be limited. Child-resistant packaging would not prevent teens and adolescents (and even some younger children) from opening the packaging. Additionally, the packaging would have to be secured after each use. According to the Division of Human Factors, it is unlikely that adults would accept child-resistant packaging for a product like the magnet sets because of the level of inconvenience involved in returning the magnets to the package.
6

Additionally, for the reasons described above, consumers may leave magnets out of their container.

6
Sedney, C.A., & Smith, T.P. (2012).
Human factors assessment of strong magnet sets.
CPSC memorandum to Jonathan D. Midgett, Project Manager, U.S. Consumer Product Safety Commission, Bethesda, MD.

5. Restrictions on Sales of Magnet Sets

Another possible alternative to address the hazard of children ingesting magnets from magnet sets might be to limit the places where magnet sets are sold, keeping magnet sets away from toy stores, children's sections of stores, and other such locations. Sales limitations or requirements for strong warnings might also be required on Web sites that offer magnet sets for sale on the Internet. However, these restrictions are unlikely to reduce ingestions significantly because children can access magnet sets from many sources other than stores. Moreover, sales restrictions are unlikely to deter teens. Finally, the Commission does not have the regulatory authority to impose such sales restrictions by rule.

6. Adoption of a Standard With Different Performance Requirements

Another alternative to the rule would be to establish a different set of requirements. For example, such requirements might allow a different flux index for magnet sets, different specifications regarding shapes and sizes of magnets within the scope of the standard, or some other criteria that have yet to be developed (but would not be as stringent as the rule requires). If different requirements would be effective, they could reduce the risk of injury associated with magnet sets, and at the same time, potentially allow the product to maintain the qualities that would facilitate use by adults. It is unclear, however, whether alternative requirements for the sizes and flux index of magnets would eliminate or substantially affect the physical qualities of the products that make them enjoyable for adults.

A competing concern is whether an alternative set of requirements could reasonably be expected to reduce or eliminate the risk of injury associated with magnet sets. Because the hazard presented by these magnet sets is ingestion by children, we are concerned that any requirements that allow magnets with a greater attractive force and permit sizes or shapes that could fit through the small parts cylinder would not address the risk of injury adequately.

As noted in Section E, some commenters suggest that, as an alternative to the rule, the Commission could require manufacturers to add an aversive (bittering) agent to the product. However, as discussed in the response to Comment 18, aversives are unlikely to be effective in deterring initial ingestion by young children because children frequently ingest unpalatable substances.

7. No Action

Another option for the Commission is to take no regulatory action to address the risk of injury posed by magnet sets. As the NPR preamble mentioned, it is possible that, over time, increased awareness of the hazard could result in some reduction in ingestions. The magnitude of any such reduction in incidents is uncertain. The Commission could rely entirely on enforcement activities, rather than regulatory action, to address the risk of injury posed by magnet sets. However, as discussed in the “voluntary recall” section above, several manufacturers/importers of magnet sets have refused to participate in any recall or stop sale of their products; and in any event, recalls and/or stop sales conducted by these companies would not prevent new entrants into the market in the future.

H. Final Regulatory Analysis

The Commission is issuing this rule under sections 7 and 9 of the CPSA. The CPSA requires that the Commission prepare a final regulatory analysis and publish the final regulatory analysis with the text of the final rule. 15 U.S.C. 2058(f). This section of the preamble presents the final regulatory analysis of the rule.

1. Need for and Description of the Rule

The CPSC has received information regarding injuries with, and hazards posed by, sets of small, powerful magnets. Some of these injuries have required surgical removal of individual magnets originally contained in the sets and ultimately ingested by children. Reported magnet ingestions have ranged from young children, who put the magnets in their mouths, to adolescents and teens, who experimented with the sensation of magnets (
e.g.,
on their braces), or paired magnets to mimic tongue or lip piercings. These behaviors have led to the accidental swallowing of the powerful magnets, with unexpected, and sometimes severe, medical consequences, including significant damage to the gastrointestinal tract (Inkster, 2012) and death. From January 1, 2009 through December 31, 2013, there were an estimated 2,900 possible magnet set, emergency department-treated ingestions. There was also one fatal incident in 2013 (Garland, 2014).

The final rule establishes a standard limiting the size and strength of magnets in a magnet set. The rule applies to any aggregation of separable, magnetic objects that is a consumer product intended, marketed, or commonly used as a manipulative or construction item for entertainment, such as puzzle working, sculpture building, mental stimulation, or stress relief.
7

Under the rule, magnet sets would not comply with the standard if: (1) The individual magnets are small enough to fit into the small parts cylinder (
e.g.,
a ball-shaped magnet with a diameter of less than 31.7 mm, or 1.25 inches); and (2) the individual magnets have a flux index of more than 50 kG
2
mm
2
, as measured by the procedures for determining the flux index described in the toy standard. Because these requirements already apply to magnets used in products marketed as toys for children, the rule essentially extends the toy requirements to the subject magnet sets.

7
Although the definition of “magnet set” changed slightly from the NPR, and the rule extends to the individual magnets sold for use as or with a magnet set, these changes did not affect the scope of products considered in conducting the Final Regulatory Analysis.

The current designs of magnet sets containing small powerful magnets of the type that are the subject of this regulatory proceeding (which are typically comprised of individual ball-shaped magnets with diameters of 5mm and, based on testing by CPSC staff, having flux index values in the range of 400-500) would not meet the

requirements of the standard. To meet the requirements, the individual magnets would have to be much weaker (
i.e.,
have a flux index of 50 kG
2
mm
2
or less, rather than an index of 400 to 500); or the magnets would have to be much larger (
i.e.,
be at least 31.7 mm (1.25 inches) in diameter rather than 5 mm). Either requirement eliminates a distinctive product attribute and would limit greatly the magnet sets as candidates for manipulative novelty products. Magnets with a flux index of 50 kG
2
mm
2
or less may be too weak for building sculptures or too weak to be used in other construction activities; magnets with diameters of 1.25 inches or more would be too large to have any practical value in such activities.

Staff has identified magnet sets in the market, Liberty Balls, marketed by Assemble, LLC, that would meet the definition of magnet sets, would meet the performance standard, and might serve some of the uses of magnet sets that would not meet the standard. The Liberty Balls magnet sets consist of a set of eight large ball-shaped magnets. The Liberty Balls magnet sets consist of a set of eight large ball-shaped magnets selling for $30 to $40 per set. The Ball of Rights generally consists of a set of two large ball-shaped magnets selling for $10 to $13 per set. The balls in these sets are 33 mm (1.3 inches) in diameter, and consist of ferrite magnets, rather than rare earth materials (See
http://unitedweball.org/,
accessed February 25, 2014).

Even though these products satisfy the performance requirements of the rule, for purposes of the economic analysis, we do not consider any impacts due to the entry of Liberty Balls and Ball of Rights in the market because we do not consider these sets to be good substitutes for the subject magnet sets. To be considered a good or close substitute, we would need to observe that consumers, who would have purchased the subject magnet sets (if they had remained available at historical prices and quantities) are now, to a large degree, purchasing the Liberty Balls sets instead, and the available data suggest otherwise.
8

Moreover, Liberty Balls magnet sets are not marketed as a substitute for the smaller and powerful neodymium magnets sets. Rather, Liberty Balls apparently have been sold specifically to generate funds to defend the producer against the recently settled lawsuit with the CPSC (Helm, 2014).

8
Sales of Liberty Balls have not come close to matching the levels observed for the subject magnet sets (estimated at 800,000 sets and $20 million annually, and discussed below). Based upon available information, sales revenue for Liberty Balls appears to have amounted to about $200,000 during October and November 2013, or about $100,000 per month. (See
http://unitedweball.org/,
accessed February 25, 2014). By March 2014, reported sales revenue from Liberty Balls had increased to about $250,000 (Helm, 2014), suggesting that for December 2013 through February 2014, sales were only about $15,000 (($250,000-$200,000)/3) per month. By comparison, monthly sales for the subject magnet sets were about $1.7 million on average. (CPSC staff conducted no independent evaluation of the accuracy of these figures for Liberty Balls.)

Rather than develop a complying alternative that serves the same niche as the subject magnet sets, producers of magnet sets have opted to exit the market altogether. Although Liberty Balls comply with the standard, we base the benefit cost analysis presented below on the disappearance of the noncompliant magnet sets containing small powerful magnets from the market.

2. Description of the Product and Market

Magnet sets that would be affected by the scope of the rule are comprised of small, powerful magnetic balls, cubes, and/or cylinders that can be arranged in many different geometric shapes. These magnet sets were introduced in 2008, but 2009 marked the first year with significant sales to U.S. consumers.
9

Most magnet sets have been sold in sets of either 125 balls or sets of 216 to 224 balls; although some firms have sold just a few balls as extras or replacements, others have sold large sets of more than 1,000 magnetic balls.

9
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.

Product information provided by marketers indicates that the most common magnet size is approximately 5 millimeters in diameter; although balls as small as about 3 millimeters have been sold, in addition to sets of larger magnet balls (perhaps 15 millimeters to 25 millimeters in diameter).
10

In addition to magnetic ball sets, sets of small magnetic cubes have also been sold, although magnetic cubes have comprised a relatively small share of the market. In 2012, the leading marketer of magnet sets also added to its desk toy product line small magnetic rods intended to be used with magnetic balls to make geometric shapes.

10
One firm's larger magnet balls are reportedly made with cores of strontium ferrite (SrO·6Fe
2
O
3
), rather than neodymium-iron-boron.

Based on information reviewed on product sales, including reports by firms provided to the Office of Compliance and Field Operations, the number of such magnet sets that were sold to U.S. consumers from 2009 through mid-2012 may have totaled about 2.7 million sets, with a value of roughly $50 million. This value reflects a combination of retail sales directly to consumers (through company Web sites and other Internet retail sites) and sales to retailers who marketed the products. A review of retail prices reported by importers, and observed on Internet sites during that period, suggested prices typically ranging from about $20 to $45 per set, with an average price of about $25. Larger sets of more than 1,000 individual magnets reportedly were sold at prices as high as $300, depending on the number of magnets and the type of packaging. Such larger sets only accounted for about 0.5 percent of all sets (and a little over 2 percent of all magnets) sold to consumers during the period from 2009 to mid-2012.

The small, powerful magnets to be affected by the rule are made of alloys of neodymium, iron, boron, or other rare earth metals. This composition has been confirmed in analyses of product samples by CPSC staff from the Directorate for Laboratory Sciences. The magnetized neodymium-iron-boron cores are coated with a variety of metals and other materials to make them more attractive to consumers and to protect the brittle magnetic alloy materials from breaking, chipping, and corroding. Nearly 100 percent of neodymium and other rare earth metals are now mined in China, which also reportedly holds close to a worldwide monopoly on the production of neodymium-iron-boron magnets (Dent, 2012). Based on available information, all of the small magnets used in magnet sets, as well as most of the finished and packaged products that would be subject to CPSC regulation, are produced by manufacturers located in China.
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One importer reported to a CPSC Compliance investigator that some of the magnet sets it sold and shipped to U.S. consumers were made from bulk magnets received from its supplier in China that the importer packaged for sale.

a. Importers of Magnet Sets

As noted above, none of the magnets found in sets that are within the scope of the rule are produced domestically. Nearly all of the firms that have marketed magnet sets are believed to have imported them packaged and labeled for sale to U.S. consumers. Several Chinese manufacturers have the facilities and production capacity to meet the orders of U.S. importers.

The Directorate for Economic Analysis identified about 25 U.S. firms and individuals who imported magnet sets for sale in the United States in 2012. The combined sales of the top seven firms have probably accounted for

the great majority (perhaps more than 98%) of units sold since the product was introduced in 2008. One firm, Maxfield & Oberton Holdings, LLC, is believed to have held a dominant position in the market for magnet sets from its entry in the market in 2009, until it ceased operations late in 2012. That firm, and a few of the larger firms (including a firm based in Canada with a branch office in the United States), have marketed the products through accounts with retailers, in addition to selling directly to consumers on the Internet, using their own Web sites or other Internet shopping sites.

Some of the firms with smaller sales volumes reported to Compliance staff that they mainly marketed products (sourced from manufacturers in China) through Internet sales arrangements with Amazon.com, which held stock for them and processed orders. A review of the product listings of the Internet retailer found that several other firms had similar business models. Other U.S. firms and individuals have sold magnet sets they

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2014-23341. Public record. Not legal advice.