Staff Briefing Package Crib Bumpers Petition May 15, 2013 Table of Contents Briefing Memo ............................................................................................................................... iii TAB A: Epidemiology Memorandum .......................................................................................... 11 TAB B: Engineering Memorandum .............................................................................................. 18 TAB C: Economics Memorandum ............................................................................................... 23 TAB D: Compliance Memorandum .............................................................................................. 27 TAB E: Health Sciences Memorandum ........................................................................................ 29 TAB F: Project Manager, Infant Suffocation Project (1992-1995) Memorandum ...................... 78 TAB G: Advice from Other Agencies ........................................................................................ 106 ii Briefing Memo iii UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814 Memorandum Date: May 15, 2013 TO: The Commission Todd A. Stevenson, Secretary THROUGH: Stephanie Tsacoumis, General Counsel Kenneth R. Hinson, Executive Director FROM: DeWane Ray, Assistant Executive Director Office of Hazard Identification and Reduction Jonathan Midgett, PhD, Children’s Hazards Team Leader Office of Hazard Identification and Reduction SUBJECT: Petition Requesting Commission Action Regarding Crib Bumpers I. Introduction In a letter dated May 9, 2012, the Juvenile Products Manufacturers Association (JPMA), requested that the U.S. Consumer Product Safety Commission (CPSC) initiate rulemaking to distinguish and regulate “hazardous pillow-like” crib bumpers from “non-hazardous traditional” crib bumpers under sections 7 and 9 of the Consumer Product Safety Act (CPSA). In support of their request, JPMA asserted the following: • Certain groups are advocating banning crib bumpers from the marketplace. • JPMA’s commissioned third party review, by an engineering and scientific consulting firm, of incidents associated with crib bumper pads failed to support claims of increased risk to infants from traditional crib bumpers. • Banning traditional crib bumpers could have unintended consequences, including encouraging caregivers to add unsafe soft bedding to cribs to prevent infant occupants from getting limbs caught between crib slats and prevent bruises from crib sides caused by falls in the crib. • The most recent proposed ASTM standard performance requirements provide a reasonable basis for a mandatory crib bumper performance standard. On June 18, 2012, the Commission voted unanimously to publish a Federal Register (FR) notice requesting comments on the petition (Docket No. CPSC–2012–0034). The notice was published on June 25, 2012, with a closing date of August 24, 2012, for accepting comments on the petition. Nine comments were received. Commenters included: JPMA; Safe Kids; Go Mama Go Designs; Bebe Chic; Hogan Lovells US LLP, for BreathableBaby, LLC; Kids in Danger; Consumer Federation of America (CFA) and Consumers Union (one comment); Patient, Consumer, and Public Health Coalition; and two individuals. The full comments can be found on the website: www.regulations.gov. The petitioner asks the Commission to initiate rulemaking regarding crib bumpers under section 7 and 9 of the CPSA. For the Commission to issue such a consumer product safety standard, the Commission would need to determine in the final rule that the requirements of the standard are “reasonably necessary to prevent or reduce an unreasonable risk of injury associated with such product.” 15 U.S.C. § 2056(a). This memorandum provides background information and addresses the comments received. Based on the staff’s review of available information and comments, the staff recommends that the Commission grant the petition and direct staff to initiate rulemaking in the Fiscal Year 2014 operating plan. II. Discussion Product Description Crib bumpers are typically, although not universally, padded fabric panels with ties intended for lining the sides of an infant’s crib. Bumpers are generally intended to prevent infants from getting limbs caught between crib slats; to pad crib sides against falls inside the crib; and to provide decoration. They are intended for use until a child begins to pull to a stand (typically around six to nine months of age). Many different types of bumpers are available. Some are a single unit, intended to be wrapped around the inside of a crib. Some have separate long and short panels. Others have many parts that individually cover crib slats. Some are not padded very much, while others appear to be like pillows. Bumpers thicknesses range from a single layer of fabric to several inches of padding. Attachments vary from ties and ribbons to straps with mechanical fasteners. Various combinations of fabric or vinyl stuffed with fiberfill or foam have been used. Less frequently, rigid plastic mesh or firm foam has been used to make a bumper. Market Information The Directorate for Economic Analysis provided information on the market for crib bumpers (Tab C). At least 37 firms produce or distribute crib bumpers to the U.S. market. Thirty-four are domestic firms, including 26 domestic manufacturers, three domestic importers, and five domestic distributors. Three are foreign firms: two are foreign manufacturers, and the supply source of the third firm is unknown. Publicly available information is insufficient to identify the size and dollar sales of most firms. Retail prices for crib bumpers sold separately range from $14.99 to $250, depending on the brand. Bumpers may be sold individually or as one component of a set of infant bedding articles. Prices for crib bumpers sold with bedding collections range from $99.95 to $1,200, depending on the number of items in the set and the brand. 2 Past Agency Actions Prior to the crib regulations in the early 1970s that decreased the width of spaces between crib slats, the Commission recommended that consumers use crib bumpers to prevent entrapments between the crib slats that occurred in older cribs. Staff later provided technical support to the ASTM subcommittee addressing strangulations associated with long ties, which resulted in a restriction on the length of ties used to attach bumper pads to cribs. The agency’s public education materials and statements have repeatedly warned consumers against the use of soft bedding in an infant sleep setting. The most common cause of soft bedding-related fatalities seemed to be pillows used beneath or adjacent to a sleeping infant. In addition to warning caregivers about the dangers of the prone sleep position, the agency’s public health statements advocate a simple, but comprehensive message to “avoid soft bedding” in infant sleep environments. This advice was consistent with other organizations until recently (see Tab G). Recent safety messaging from the Chairman has promoted a “Bare Is Best” approach for parents and caregivers. Compliance Actions Since 1970, CPSC’s actions related to crib bumpers have focused on product defects. There have been two recalls of crib bumpers since 1990. One recall, in 1990, involved reports of ties separating from bumper pads that presented a choking hazard. Another recall, in 2007, involved threads on bumper pads that presented an entanglement hazard (Tab D). Voluntary Standard The voluntary standard referenced by the petitioners, ASTM F 1917-12, Infant Bedding and Related Accessories, includes crib bumpers. In the most recent version, published in 2012, the standard included new requirements for the strength of ties used to install the bumpers inside cribs; warnings; and restrictions on the thickness of bumpers. The voluntary standard includes: (1) tests to ensure that the attachment means of the bumper guards cannot exceed 9 inches; (2) requirements for securing bumper guards to the crib; (3) requirements for maximum bumper thickness; (4) requirements for marking and labeling; (5) requirement for unsupported vinyl used in bedding; and (6) instructions for product labeling and warning labels. Information is unavailable regarding the number of firms that comply with the voluntary standard. The standard states that bumpers must be capable of compressing down to 2 inches of thickness or less, when drawn through an aluminum gauge block with up to 5 pounds of force. Bumpers must meet this criterion before and after three wash cycles performed according to the manufacturer’s recommended washing instructions. According to the rationale ASTM states for this provision, ASTM chose two inches as the maximum thickness because this is the thickness for other padded items that infants interact with, such as play yard pads and because this is a thickness “that has not been known to present a hazard.” However, the rationale does not reference data to support the claim of 2 inches as an acceptable limit. Staff from the Directorate for Laboratory Sciences provides a brief review of the standard (see Tab B). Of particular note, staff’s review found that more research was needed on the rationale for the parameters used for the requirements associated with the thickness of bumpers. 3 State and Municipal Standards Staff is unaware of any international standards that cover crib bumpers. The city of Chicago banned the sale of crib bumpers in 2012, using the following