February 26, 2020 Division of the Secretariat U.S. Consumer Product Safety Commission Room 820 4330 East West Highway Bethesda, MD 20814 Comments of Consumer Reports to the Consumer Product Safety Commission on the Supplemental Notice of Proposed Rulemaking: “Safety Standard for Infant Sleep Products” Docket No. CPSC-2017-0020 Consumer Reports, the independent, non-profit member organization,1 welcomes the opportunity to submit comments to the Consumer Product Safety Commission (CPSC) regarding the agency’s supplemental notice of proposed rulemaking to establish a safety standard for infant sleep products. We commend the CPSC for proposing a rule that would strengthen safety standards for infant sleep products nationwide and align with medical experts’ safe sleep recommendations, all based on a robust and growing body of evidence for how to keep infants safe. Parents and caregivers should be able to trust that all products for infant sleep must meet strong standards to keep babies safe, and right now, this simply is not the case. Accordingly, Consumer Reports strongly supports the proposed standard, with minor modifications, and urges the CPSC to finalize it expeditiously. As a part of CR’s ongoing work to improve infant sleep safety, and working together side by side with consumers across the country, Consumer Reports received approximately 22,650 signatures from people who wished to petition the CPSC in support of the proposed safety standard for infant sleep products. Attached to these comments, please find the names of these people, who collectively send the Commission the following message: We urge the Consumer Product Safety Commission to finalize its strong proposed rules on infant sleep products. These rules would effectively stop the manufacture and sale of all infant inclined sleepers with inclined angles greater than 10 degrees. Not one more child or parent should suffer from this dangerous type of product. 1 Founded in 1936, Consumer Reports uses its dozens of labs, auto test center, and survey research center to rate thousands of products and services annually. CR works together with its more than 6 million members for a fairer, safer, and healthier world, and reaches nearly 20 million people each month across our print and digital media properties. Indeed, in the supplemental notice of proposed rulemaking, the Commission proposes promulgating a mandatory safety standard under section 104 of the Consumer Product Safety Improvement Act (CPSIA)2 for infant sleep products that would expand, build on, and substantially strengthen the current ASTM International voluntary standard for infant inclined sleep products (ASTM F3118-17). The proposed standard would apply to infant sleep products not governed by current mandatory standards—specifically, those pertaining to bassinets/cradles, cribs, play yards, and bedside sleepers—and would limit infant sleep products to a back incline angle of 10 degrees or less. The proposed rule generally aligns with American Academy of Pediatrics (AAP) safe sleep recommendations and clear evidence establishing the dangers of infant sleep at an incline. Consumer Reports recommends minor modifications to the proposed rule to help ensure that the new infant sleep products safety standard would apply to all infant products that are for sleep. This includes infant products intended, marketed, or otherwise indicated for sleep, including products described using substitute language for sleep, such as “napping” or “snoozing.” The final rule should ensure that every infant sleep product entering commerce aligns with safe sleep recommendations by medical experts, particularly the AAP, in order to keep babies safe and minimize confusion for parents and caregivers. Our more detailed comments follow. I. The proposed safety standard aligns with American Academy of Pediatrics safe sleep recommendations and accounts for strong evidence, including recent studies, that products with inclined back surfaces are not safe for infant sleep. II. Further research into infant inclined sleepers is unnecessary and likely would lead to unwarranted delays in removing inclined sleep products from the marketplace. III. The proposed rule must send a clear message to consumers about safe sleep best practices and apply to all products marketed, intended, promoted, or otherwise indicated as being for any kind of sleep, including “snoozing” and “napping.” IV. The CPSC should finalize the proposed safety standard expeditiously, including an effective date that is as early as possible and not more than six months after the final rule, and prohibit the sale of nonconforming infant sleep products as of that date. 2 Section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be substantially the same as relevant voluntary standards or more stringent than the voluntary standards if the Commission determines that more stringent standards would further reduce the risk of injury associated with such products. 15 U.S.C. 2056a(b)(1)(B). 2 I. The proposed safety standard aligns with American Academy of Pediatrics safe sleep recommendations and accounts for strong evidence, including recent studies, that products with inclined back surfaces are not safe for infant sleep. In 2016, the American Academy of Pediatrics (AAP) formally updated and published its recommendations for a safe infant sleeping environment, following a thorough, multi-year process by pediatricians to evaluate the state of the medical evidence. Medical studies and experts have concluded since the 1990s that infants should sleep on their backs, on firm and flat surfaces. The AAP’s safe sleep recommendations include that babies should be placed alone to bed on a firm, flat surface in their own space, with no extra bedding.3 Following the lead of the AAP, Consumer Reports and our partner organizations have called for the removal of products that do not conform to the AAP’s safe sleep recommendations from the marketplace. CR and our partners expressed concerns over the CPSC’s 2017 proposed rule to make the ASTM International infant inclined sleep product standard mandatory, stressing “the hazards posed by the entire product class of infant inclined sleepers ... because [they] do not align with the trusted safe sleep recommendations advised by both medical practitioners and other safety experts.”4 In 2019, CR conducted an extensive investigation into the safety of infant inclined sleep products and revealed that dozens of previously undisclosed infant deaths were linked to inclined sleepers.5 After CR published its first article in April 2019, Fisher-Price recalled all 4.7 million Rock ‘n Play Sleepers in the U.S. and Kids II recalled nearly 700,000 rocking sleepers.6 Since CR’s initial reporting, the number of reported infant deaths is now at least 73, and since April 2019, the CPSC has announced seven more recalls of infant inclined sleep products and accessories. In addition to our coverage, CR sent letters to various manufacturers, retailers, and online e-commerce platforms and helped more than 13,000 individual consumers send almost 3 AAP, “SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment.” (Nov. 2016) (online at: pediatrics.aappublications.org/content/pediatrics/early/2016/10/20/ peds.2016-2938.full.pdf). 4 Comments from Kids in Danger, Consumer Federation of America, Consumers Union, U.S. PIRG, and Public Citizen to the CPSC on Proposed Safety Standard for Infant Inclined Sleep Products (June 27, 2017) (online at: www.regulations.gov/document?D=CPSC-2017-0020-0006). 5 CR’s investigation was based in part on our analysis of previously undisclosed, manufacturer-specific data that the CPSC released in error to CR, as well as reviews of lawsuits and interviews with numerous medical experts, product engineers, government and industry officials, and parents. CR, “Fisher-Price Rock 'n Play Sleeper Should Be Recalled, Consumer Reports Says” (Apr. 8, 2019; last updated May 16, 2019) (online at: www.consumerreports.org/ recalls/fisher-price-rock-n-play-sleeper-should-be-recalled-consumer-reports-says); CR, “Four More Deaths Linked to Infant Sleepers Like the Fisher-Price Rock 'n Play Sleeper” (Apr. 11, 2019; last updated May 16, 2019) (online at: www.consumerreports.org/child-safety/more-deaths-linked-to-infant-sleepers-like-fisher-price-rock-n-play-sleeper); CR, “While They Were Sleeping” (Dec. 30, 2019) (online at: www.consumerreports.org/child-safety/while-they- were-sleeping). 6 CR, “Fisher-Price Recalls the Rock 'n Play Sleeper After It Was Tied to Infant Deaths” (Apr. 12, 2019; last updated May 16, 2019) (online at: www.consumerreports.org/recalls/fisher-price-recalls-rock-n-play-sleeper); CR, “Kids II Recalls Inclined Sleepers Linked to Infant Deaths” (Apr. 26, 2019) (online at: www.consumerreports.org/ recalls/kids-ii-inclined-sleeper-recall-rocking-sleepers-linked-with-infant-deaths). 3 124,000 messages urging major manufacturers to issue recalls and get all inclined sleep products off the market and out of homes.7 In October 2019, a CPSC-commissioned study led by Dr. Erin M. Mannen, Ph.D., an expert in biomechanics and a professor at the University of Arkansas for Medical Sciences, concluded that “[b]ased on the results of the biomechanical testing, product analysis, and incident report analysis, none of the Inclined Sleep Products that were tested and evaluated as a part of this study are safe for infant sleep” (emphasis added).8 Dr. Mannen’s study focused on how infants’ muscle activity and muscle synergies differed significantly at inclines of 10 and 20 degrees. The report found that “inclined surfaces and inclined sleep products may lead to quicker fatigue and suffocation if an infant finds themselves prone in an inclined product.”9 Based on the study’s findings, Dr. Mannen recommended that the entire inclined sleep product category “should be completely eliminated, or ... significantly modified to ensure a safe environment and mitigate risk.”10 CR agrees with these findings and considers the CPSC’s proposed rule for infant sleep products consistent with Dr.