[Federal Register: July 13, 1994] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Ch. II Strangulation Hazards Associated With Crib Toys; Withdrawal of Advance Notice of Proposed Rulemaking AGENCY: Consumer Product Safety Commission. ACTION: Withdrawal of advance notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Consumer Product Safety Commission has decided to terminate a proceeding for the development of requirements to address strangulation hazards to children associated with crib toys.1 The Commission began this proceeding by publication of an advance notice of proposed rulemaking (ANPR) on October 19, 1990. --------------------------------------------------------------------------- \1\The Commission approved publication of this notice by a 2-1 vote, with Chairman Ann Brown dissenting. A copy of Chairman Brown's separate statement is available upon request from the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0800. --------------------------------------------------------------------------- On October 26, 1993, the Commission voted to terminate this proceeding and to withdraw the ANPR published in 1990. The Commission took this action after considering written comments received in response to the ANPR and correspondence concerning this proceeding; information about strangulation deaths and injuries to children from January, 1973, through February, 1993; annual sales of crib toys and the number of crib toys currently in use; the potential effectiveness of labeling and other mandatory requirements to reduce strangulation deaths and injuries to children associated with crib toys; other written materials prepared by the Commission staff; an oral briefing presented by the Commission staff; and other information. The Commission concluded that evidence is not available at this time to demonstrate that crib toys present an unreasonable risk of strangulation death or injury to children. The Commission also concluded that such evidence would not likely be developed if the proceeding were continued. FOR FURTHER INFORMATION CONTACT: Celestine M. Trainor, Directorate for Epidemiology, Consumer Product Safety Commission, Washington, DC 20207; telephone: (301) 504-0468. SUPPLEMENTARY INFORMATION: A. Background In 1990, the Commission granted a petition which requested issuance of a rule to address risks of strangulation deaths and injuries to children associated with certain crib toys and crib mobiles (1).2 The petition used the term ``crib toy'' to describe a variety of toys which are intended to be strung across a crib or play pen or attached to the side of a crib or play pen and which are intended to be manipulated by infants. ``Crib mobiles'' are decorative articles which are designed to hang above a crib or play pen, but are not intended to be touched or manipulated by infants. The petition requested issuance of a rule to: --------------------------------------------------------------------------- \2\Numbers in parentheses identify reference documents listed in Bibliography at the end of this notice. Requests for inspection of any of these documents should be made at the Commission's Public Reading Room, 4330 East West Highway, Bethesda, Maryland, room 419, or by calling the Office of the Secretary at (301) 492-0800. --------------------------------------------------------------------------- Require that a crib gym or similar manipulative toy intended to be strung across the top of a crib must have a rigid horizontal suspension member attachable at or above the height of the crib side rails with no vertical protrusions; Prohibit any crib toy from having any protrusions which can catch clothing or any other item worn by an infant; Limit the length of any vertical string on any crib toy to six inches; Prohibit on any crib toy any cords or other components which form a perimeter greater than 14 inches; Prohibit on any crib toy any pull ring attached to a cord; Ban any crib mobile that can be located within reach of an infant who is not capable of pushing up on his or her hands and knees inside a crib; Require labeling and instructions for various crib toys and crib mobiles to warn of strangulation hazards associated with those products. On October 19, 1990, the Commission published an advance notice of proposed rulemaking (ANPR) in the Federal Register (55 FR 42402) under the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261 et seq.) to begin a proceeding to develop the rule requested by the petition (2). B. Statutory Authority Section 2(f)1(D) of the FHSA (15 U.S.C. 1261(f)1(D)) defines the term ``hazardous substance'' to include ``[a]ny toy or other article intended for use by children'' which the Commission determines by regulation to present a ``mechanical hazard.'' Section 2(s) of the FHSA (15 U.S.C. 1261(s)) provides that a toy or children's article may be determined to present a mechanical hazard if, in normal use or * * * reasonably foreseeable * * * abuse, its design or manufacture presents an unreasonable risk of personal injury * * * from * * * points or other protrusions, * * * openings, or closures, * * * or * * * because of any other aspect of the article's design or manufacture. The Commission may make a determination that a toy or children's article presents a mechanical hazard by issuance of a regulation in accordance with provisions of sections 3(e) through (i) of the FHSA (15 U.S.C. 1262(e)-(i)). A toy or children's article which is the subject of a rule issued in accordance with provisions of sections 3(e) through (i) and which fails to comply with all requirements of such a rule is a ``banned hazardous substance'' as that term is defined by section 2(q)(1)(A) of the FHSA (15 U.S.C. 1261(q)(1)(A)). The introduction into interstate commerce of a banned hazardous substance is prohibited by section 4 of the FHSA (15 U.S.C. 1263). Section 3(f) of the FHSA (15 U.S.C. 1262(f)) requires publication of an ANPR to begin a proceeding for issuance of a rule in accordance with sections 3(e) through (i) to make a determination that a toy or children's article presents a ``mechanical hazard.'' Section 3(f) also sets forth requirements for the content of the ANPR. In accordance with section 3(f) of the FHSA, the ANPR for crib toys identified the products and the risk of injury which are the subject of the rulemaking proceeding, and set forth the regulatory options under consideration by the Commission. The ANPR stated that the Commission was considering issuance of any or all of the requirements requested by the petition. The ANPR also summarized provisions applicable to crib toys in a voluntary standard published by ASTM (formerly the American Society for Testing and Materials), designated F963-86, Standard Consumer Safety Specification for Toy Safety. In addition, the ANPR stated that the Commission was also considering the possibility that this voluntary standard could be revised to address additional hazards associated with crib toys, or that a new voluntary standard could be developed to address those hazards (2). As required by section 3(f) of the FHSA, the ANPR solicited comments from interested persons about the products and risk of injury under consideration; invited interested persons to submit an existing standard as the proposed regulation; and invited interested persons to submit a statement of intention to develop or modify a voluntary standard to address risks of strangulation death and injury associated with crib toys. (2) In response to the ANPR, the Commission received comments from 17 organizations and individuals (3-19). The Commission also received a joint-communication from six organizations concerning the proceeding for crib toys after the close of the comment period for the ANPR (20). On September 21, 1993, the Commission staff transmitted to the Commissioners a briefing package of information concerning the development of requirements to address strangulation hazards associated with crib toys (21). On October 22, 1993, the staff presented an oral briefing to the Commission concerning this proceeding. C. Action by the Commission On October 26, 1993, the Commission voted to terminate the rulemaking proceeding applicable to crib toys and to withdraw the ANPR published on October 19, 1990. To make a determination that a product presents an ``unreasonable risk of injury'' under the FHSA, the Commission considers: The nature and severity of the risk of injury associated with the product; The potential of mandatory requirements for the product to reduce the frequency and severity of the injury; and The effect of mandatory requirements on the cost, utility, or availability of the product. Additionally, section 3(i) of the FHSA (15 U.S.C. 1262(i)) provides that in order to issue a final rule expressing the Commission's determination that a toy presents a ``mechanical hazard,'' the Commission must prepare a regulatory analysis which includes a description of potential benefits and potential costs of the rule and identifies those parties likely to receive the benefits and to bear the costs. Section 3(i) provides further that the Commission may not issue a final rule unless it makes a finding that ``the benefits expected from the regulation bear a reasonable relationship to its costs.'' Applying the factors involved in the determination of an unreasonable risk of injury to the information developed during this proceeding, the Commission finds the following: The Nature and Severity of the Risk of Injury The nature of the risk of injury associated with crib toys is strangulation on the product. Strangulation injuries may result in death or permanent brain damage. For this reason, strangulation injuries have the potential to be of the utmost severity. However, the likelihood of a strangulation incident involving a crib toy is relatively small. During the period from January, 1973, through February, 1993, 28 children died in strangulation accidents associated with crib toys, an average of three deaths every two years (22). During the same period, one child sustained permanent brain damage from a strangulation accident associated with a crib toy (22). At the same time, however, an estimated 10 to 25 million crib toys were sold each year, and an estimated 50 million crib toys were in use on any given date (23). The Potential of Mandatory Requirements To Reduce the Frequency and Severity of the Risk of Injury The information considered by the Commission indicates that the potential of mandatory requirements to reduce risks of strangulation death and injury associated with crib toys is limited. A 1987 analysis of strangulation injuries associated with crib toys identified three hazard patterns involved in 32 fatalities. In seven of these fatalities, an article worn by the child, such as a bib or a necklace, caught on a protrusion of a crib toy (24). After publication of the ANPR, the Commission undertook additional work to identify characteristics of hazardous protrusions. However, the Commission has not been able to develop an objective test to distinguish those protrusions which present a strangulation hazard from those which do not (21, 25). Another hazard pattern identified in the 1987 analysis was that of postural strangulation. In six of the fatalities described in that analysis, the child's head and neck were suspended over a horizontal cord. All but one of these cases involved crib gyms. The 1987 analysis recommended that the horizontal member of a crib gym should consist of a rigid structure rather than a cord, and that the design of a crib gym should not allow installation of the product below the height of the top rails of the crib sides (24). These recommendations were intended to eliminate the risk of postural strangulation associated with a crib gym left in a crib occupied by a child who is able to push up on his or her hands and knees (typically, a child older than five months of age). However, after consideration of more recently developed information, the Commission is concerned that a design requirement for a rigid horizontal member on a crib gym could create other risks of injury to a child who is able to push up on his or her hands and knees. If one end of a crib gym with a rigid horizontal member became detached from the side of the crib and rested on the crib mattress, the crib gym might provide a means by which such a child could climb over the side rail of the crib (21). Additionally, if a crib gym with a rigid horizontal member were installed near the end panel of a crib, another risk of strangulation injury might result if that placement created an opening which would be large enough to allow a child's head to enter, but which would be too small for the head to exit if turned to another orientation (21). The third hazard pattern discussed in the 1987 analysis of strangulation incidents associated with crib toys resulted when a child's neck became entangled in one or more strings or cords of a crib toy. Four of the fatalities discussed in that analysis resulted when a child's neck became entangled in two or more cords attached to a stuffed toy animal (24). A comment on the ANPR from an association of toy manufacturers observed that stuffed animal toys with attached suspension cords are prohibited by the voluntary toy safety standard, and that such toys have not been manufactured for several years (8). Two other fatalities discussed in the 1987 analysis resulted when a child's neck became entangled in a single vertical cord which extended from a crib toy (24). To address that risk of strangulation, the 1987 analysis recommended that the length of any vertical string attached to a crib toy should not exceed six inches. However, the comment from the association of toy manufacturers states that no report of any fatality resulting from entanglement in a single vertical cord extending from a crib toy has been received since 1986 when the voluntary toy safety standard was revised to restrict the length of such cords to less than 12 inches. (8) The 1987 analysis of crib toy strangulation incidents also recommended that crib mobiles should be labeled to warn that the article should be kept out of the reach of infants, and should be removed when the infant attains the age of five months or is able to push up on his or her hands and knees. That analysis further recommended instructions accompanying crib toys should include warnings to place the crib mattress in one of the lower positions and to raise the crib drop side when attaching a crib toy. (24) However, the Commission has received newer information indicating that labeling alone cannot be expected to reduce strangulation hazards associated with crib toys (25). The Effect of Mandatory Requirements on the Cost, Utility, and Availability of the Product The Commission was unable to obtain information about the costs which might result to manufacturers or consumers from imposing any of the requirements for crib toys discussed in the ANPR. The Commission did not attempt to make cost estimates because of uncertainty about the numbers and specific kinds of crib toys which might be affected by each of the requirements discussed in the ANPR. D. Voluntary Standard The Commission also considered alternatives to development of mandatory requirements for crib toys. These alternatives included existing provisions of a voluntary standard for toy safety intended to address risks of strangulation injury associated with crib toys, and revisions of that voluntary standard which were under consideration at the time the Commission decided to terminate this proceeding. The proposed revisions included the addition of design guidelines to the voluntary standard to minimize strangulation hazards from protrusions on crib toys. The guidelines are intended to be used by manufacturers in the development of crib toys (27, 28). As noted above, the Commission staff was not able to devise objective criteria to identify protrusions on crib toys which present a strangulation hazard. In the absence of objective criteria to identify hazardous protrusions, the Commission concludes that addition of the proposed design guidelines to the voluntary standard would be worthwhile (27). The revisions of the voluntary standard under consideration also included: Language to limit to 14 inches the perimeter formed by strings or cords which can tangle to form a loop; Improved warning labels concerning strangulation hazards associated with crib gyms and similar toys intended to be strung across the top of a crib or playpen; Addition of labeling requirements for crib mobiles to advise parents of precautions needed to minimize strangulation hazards associated with those products; Addition of language to the instructions to accompany crib gyms and similar toys to advise parents of precautions to be taken to minimize strangulation hazards associated with those products. (27) After considering information about the voluntary standard and proposed revisions of that standard, the Commission concludes that the proposed changes would adequately address the hazards identified in the ANPR. Section 3(g)(2) of the FHSA requires the Commission to terminate a proceeding for the development of a rule to address an unreasonable risk of injury associated with a toy or children's article if the Commission determines that a voluntary standard developed or modified after publication of the ANPR adequately addresses the risk of injury under consideration and that substantial compliance with such a voluntary standard is likely to be achieved. However, provisions of section 3(g)(2) apply only to a voluntary standard which has been ``finally approved'' by the organization which developed the standard. The proposed revisions of the ASTM voluntary standard for toys discussed above have not yet been finally approved by ASTM. For that reason, the Commission is not required by section 3(g)(2) of the FHSA to terminate this proceeding. E. Conclusions by the Commission From its consideration of all available information about risks of strangulation injuries to children associated with crib toys and mandatory requirements to address those risks, the Commission concludes that: (1) To date, information has not been developed to establish that crib toys present an unreasonable risk of strangulation injury to children; (2) Consequently, information has not been developed to establish that issuance of a mandatory rule for crib toys to address that risk of injury is reasonably necessary; and (3) If this proceeding were continued, such information would not likely be developed. The Commission also concludes that information is not now available or likely to be developed to support a finding that the expected benefits from a mandatory rule to address strangulation hazards associated with crib toys would bear a reasonable relationship to the costs imposed by such a rule. Such a finding is required by section 3(i) of the FHSA to issue a rule for crib toys. Accordingly, the Commission hereby withdraws the ANPR published in the Federal Register of October 19, 1993 (55 FR 42402) to initiate a proceeding for development of requirements to address risks of strangulation deaths and injuries associated with crib toys. Dated: July 7, 1994. Sadye E. Dunn, Secretary, Consumer Product Safety Commission. Bibliography 1. Petition from Consumer Federation of America and the New York State Attorney General's Office requesting issuance of a rule to ban certain crib toys, 74 pages, November 17, 1988. 2. Federal Register notice, ``Strangulation Hazards Associated With Crib Toys; Advance Notice of Proposed Rulemaking,'' published by the Consumer Product Safety Commission, 4 pages, October 19, 1990 (55 F.R. 42402). 3. Comment from Daniel Chaucer, P.E., 3 pages, October 28, 1990. 4. Comment from Sligo International, 1 page, November 6, 1990. 5. Comment from The First Years, 2 pages, December 5, 1990. 6. Comment from U.S. Public Interest Research Group, 3 pages, December 12, 1990. 7. Comment from Fisher-Price, 8 pages, December 13, 1990. 8. Comment from Toy Manufacturers of America, Inc., 17 Pages, October 19, 1990. 9. Comment from Oregon State Public Interest Research Group, 4 pages, December 14, 1990. 10. Comment from Dolly, Inc., 2 pages, December 17, 1990. 11. Comment from Massachusetts Public Interest Research Group, 2 pages, December 17, 1990. 12. Comment from the Coalition for Consumer Health & Safety, 2 pages, December 18, 1990. 13. Comment from Consumer Federation of America, 9 pages, December 18, 1990. 14. Comment from Marcella V. Ridenour, 1 page, December 1, 1990. 15. Comment from Jolly Jumper, Inc., 2 pages, December 17, 1990. 16. Comment from J. M. Miller Engineering, Inc., 6 pages, November 17, 1990. 17. Comment from Allegheny County Health Department, 2 pages, December 18, 1990. 18. Comment from American Society of Safety Engineers, 2 pages, December 19, 1990. 19. Comment from Dorothy A. Drago, 2 pages, January 8, 1991. 20. Letter from Consumer Federation of America, Consumes Union, The Danny Foundation, National Safe Kids Campaign, Public Citizen Congress Watch, and U.S. Public Interest Research Group to Jacqueline Jones-Smith, Chairman, Consumer Product Safety Commission, 4 pages, October 25, 1993. 21. Memorandum from Celestine Trainor, Project Manager, to the Commission, subject ``Options on Crib Toys,'' 15 Pages, September 21, 1993. 22. Memorandum from Suzanne P. Cassidy, EPHA, and Debbie Tinsworth, EPHA, to Celestine Trainor, EPHF, subject ``Crib Toys-- Data Update and Response to ANPR Comments on Strangulation Hazards,'' 2 pages, March 27, 1993. 23. Memorandum from Anthony C. Homan, ECPA, to Celestine Trainor, Project Manager, subject ``Crib Toys--Regulatory Discussion,'' 2 pages, April 19, 1993. 24. Human Factors Evaluation of Provisions Which Address Crib Toy Strangulations in the Toy Safety Voluntary Standard,'' by Shelley Waters Deppa, 20 pages, July, 1987. 25. ``Characteristics of Catch Point Incidents Contributing to Strangulation on Crib Toys and Other Children's Products,'' by Shelley Waters Deppa, 30 pages, October, 1992. 26. Letter from John Preston, ESME, to Charles A. Brooks, Fisher-Price, 2 pages, February 17, 1993. 27. Memorandum from Celestine Trainor, EPHF, to Jacqueline Elder, Director, EPHF, subject ``Comparison of Current and Proposed Voluntary Standard Requirements for Crib Toys and Staff Response,'' 6 pages, July 7, 1993. 28. Design Criteria, 1 page. 29. Press Release of Chairman Jacqueline Jones-Smith on Strangulation Hazards Associated with Crib Toys, 1 page, October 16, 1993. 30. Statement of Commissioner Carol G. Dawson on The Termination of Rulemaking on Crib Toys, 2 pages, October 26, 1993. 31. Statement of Mary Sheila Gall on Termination of the Rulemaking Proceedings Related to Crib Toys, 1 page, October 26, 1993. [FR Doc. 94-16876 Filed 7-12-94; 8:45 am] BILLING CODE 6355-01-P