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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
g Undetermined issues: In three of the 183 incident reports 2 percent, staff could not definitively identify the issue involved. Two of the incidents were fatalities; in both cases, CPSC
Field investigation reports indicate that the cause of death is undetermined. The third incident resulted in a hospitalization due to unspecified breathing difficulties suffered by the infant.
C. Safety Alerts, Press Releases, and Product Recalls The Commission issued two safety alerts involving infant inclined sleep products. A May 31, 2018 safety alert 16
advised of infant rollover deaths in inclined sleep products, and reminded caregivers to always use restraints and to stop using the product as soon as an infant can roll over. An April 5, 2019
safety alert 17 advised consumers to stop using the inclined sleep product when an infant reaches 3 months of age, or as soon as an infant exhibits rollover capabilities. Since issuing the 2019
SNPR, the Commission issued two press releases regarding infant inclined sleep products. A January 16, 2020 press release warned the public about the risk of suffocation associated with the Summer Infant SwaddleMe By Your Bed Sleeper, an infant inclined sleeper.
The release advised consumers to stop using the product immediately.18 An October 31, 2020 press release warned consumers that infant inclined sleep products were not safe for infant sleep based on the results of the Mannen Study, and advised caregivers to stop using infant sleep products with an inclined seat back of more than 10
degrees.19
The Commission also conducted numerous recalls involving infant
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16 https www.cpsc.gov/content/cpsc-consumeralert-caregivers-urged-to-use-restraints-withinclined-sleep-products.
17 https www.cpsc.gov/Newsroom/NewsReleases/2019/CPSC-ALERT-CPSC-and-FisherPrice-Warn-Consumers-About-Fisher-Price-Rock-NPlay-Due-to-Reports-of-Death-When-Infants-RollOver-in-the-Product.
18 https www.cpsc.gov/Newsroom/NewsReleases/2020/CPSC-Warns-Consumers-to-StopUsing-Summer-Infant-USA-Inc-s-SwaddleMe-ByYour-Bed-Sleeper.
19 https www.cpsc.gov/Newsroom/NewsReleases/2020/CPSC-Cautions-Consumers-Not-toUse-Inclined-Infant-Sleep-Products.

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inclined sleep products. The 2019 SNPR
stated that from May 10, 2000 to August 20, 2019, CPSC conducted 13 consumerlevel recalls involving infant inclined sleep products. 84 FR at 6095354.
CPSC conducted recalls in response to hazards involving strangulation, suffocation, falls, structural stability, entrapment, exposure to mold, and death. Six recalls involved infant hammocks, six recalls involved infant inclined sleep products, and one recall involved an infant inclined sleep accessory included with a play yard. Id.
Tab G in the October 2019 Staff SNPR
Briefing Package contains a detailed chart outlining recalls involving infant inclined sleep products up through August 20, 2019.
Since the issuance of the 2019 SNPR, CPSC conducted six additional recalls for a suffocation hazard involving infant inclined sleep products. These six recalls affected approximately 268,300
units. Tab F of Staffs Final Rule Briefing Package contains a chart outlining these recalls. CPSC did not conduct any recalls for flat sleep products from August 2019 through January 2021.
IV. Overview of CPSC Sleep Standards The final rule would require that any infant sleep product, defined as a product marketed or intended to provide a sleeping accommodation for an infant up to 5 months old, and that is not already subject to one of CPSCs mandatory standards for infant sleep, must meet the requirements of the mandatory standard for bassinets and cradles, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a bassinet/cradle. Currently, the five mandatory CPSC sleep standards are: 20
16 CFR part 1218Safety Standard for Bassinets and Cradles 16 CFR part 1219Safety Standard for Full-Size Baby Cribs 16 CFR part 1220Safety Standards for Non-Full-Size Baby Cribs 16 CFR part 1221Safety Standards for Play Yards, and 20 Tab E of Staffs Final Rule Briefing Package contains a description of each CPSC sleep standard and the associated voluntary standard the rule is based upon.

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16 CFR part 1222Safety Standard for Bedside Sleepers.
The Commission considers products that fall within the scope of a CPSC
sleep standard to generally follow safe sleep principles. Additionally, caregivers can expect that regulated products intended for infant sleep are tested for compliance to the applicable standard, as well as to any other applicable CPSC rule, such as lead in paint and lead content. Pursuant to section 14 of the CPSA, products within the scope of a childrens product safety rule, which includes all of CPSCs sleep standards, must be tested for compliance to the standard by a CPSCaccepted third party laboratory, and such compliance must be certified by the manufacturer or importer of the product. Staff regularly participates in ASTM subcommittees for these products, and routinely updates incident data associated with regulated products, to address identified hazards through the ASTM process. If a voluntary standard that has been adopted by the Commission is revised to address identified hazards, section 104b4B of the CPSIA provides an update process, whereby the revised voluntary standard becomes the new mandatory standard.21 Additionally, section 104b2 of the CPSIA requires the Commission to periodically review and revise rules issued under section 104, to ensure that such rules provide the highest level of safety for such products that is feasible. Table 3
summarizes CPSC sleep standards applicable to regulated infant sleep products.

21 Under section 104b4B of the CPSIA, the organization must notify the Commission of a revised voluntary standard, and the revised standard becomes a consumer product safety standard issued by the Commission unless within 90 days after notification, the Commission determines that the revised standard does not improve the safety of the consumer product covered by the standard, and the Commission is retaining the existing consumer product safety standard. The revised voluntary standard will become the mandatory standard, effective 180 days after the Commission received notification of the revision or a later date specified by the Commission in the Federal Register. 15 U.S.C. 2056ab4B.

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