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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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feasible. Congress specifically included five products intended for infant sleep in the statutory list of durable infant or toddler products full-size cribs, nonfull-size cribs, play yards, and bassinets and cradles, demonstrating intent for CPSC to regulate such products.
Currently, multiple flat and inclined sleep products are not subject to a CPSC
regulation, but CPSC has the authority to add infant sleep products as a durable infant or toddler product, and to regulate this product category.
Accordingly, the final rule regulates any product marketed or intended as a sleeping accommodation for an infant up to 5 months old, that is not already regulated by another CPSC sleep standard. In response to comments, the final rule expands the justification from the 2019 SNPR to demonstrate that the bassinet standard provides the minimum safe sleep characteristics for these infant sleep products. Finally, the scope of the final rule is well-defined, and allows a manufacturer to intentionally design and market a product as an infant sleep product, or to choose not to design and market a product as an infant sleep product.
VIII. Final Rule Establishing a Safety Standard for Infant Sleep Products This final rule establishes a childrens product safety standard for infant sleep products as a type of durable infant or toddler product under section 104 of the CPSIA. The Mannen Study and CPSC
staffs analysis of the incident reports, hazard patterns, and adequacy of the voluntary standard, demonstrate that ASTM F311817a is inadequate to address the risk of injury associated with inclined sleep products. ASTM
F311817a is inadequate to address the risk of injury associated with inclined sleep products, because it allows products with a seat back angle greater than 10 degrees, and does not address additional hazard patterns associated with inclined sleep products, such as containing the infant. The Commission determines that more stringent requirements are necessary in the mandatory standard to further reduce the risk of injury associated with inclined sleep products. Staffs assessment in the 2019 SNPR, and section VI of this preamble, demonstrate that the performance requirements in the current voluntary standard for bassinets and cradles, ASTM F2194, which is incorporated into the Commissions mandatory standard, 16
CFR part 1218, is adequate to address the risk of injury associated with infant inclined sleep products, and will further reduce the risk of injury associated with inclined sleep products.

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As proposed in the 2019 SNPR, the definition of an infant sleep product in the final rule also includes flat sleep products, such as in-bed sleepers, baby boxes, compact bassinets, and baby tents, which currently do not fall within the scope of any voluntary or mandatory standard. Staffs assessment of the incident reports and hazard patterns associated with flat sleep products in this final rule demonstrates that the risk of injury and death associated with flat sleep products are similar, and can be addressed by meeting the requirements in the current voluntary standard for bassinets and cradles, ASTM F2194, which is incorporated into the Commissions mandatory standard, 16
CFR part 1218.
Accordingly, the final rule incorporates by reference ASTM F3118
17a as the mandatory standard for infant sleep products, both inclined and flat, with the following modifications to the voluntary standard:
Revise the introduction of the standard, to state the purpose of the standard is to address infant sleep products not already covered by traditional sleep product standards, to reduce deaths associated with known sleep hazards, including but not limited to, a seat back or sleep surface angle that is greater than 10 degrees from the horizontal. This requirement is intended to broaden the purpose of the standard to more clearly address inclined and flat sleep products, including known hazards associated with infant sleep.
Revise the scope of the standard, to remove the term inclined and broaden the scope to include infant sleep products, including inclined and flat sleep surfaces, marketed or intended to provide a sleeping accommodation for an infant up to 5 months old, and that are not already subject to a mandatory CPSC sleep standard:
16 CFR part 1218Safety Standard for Bassinets and Cradles, incorporating by reference ASTM F2194, Standard Consumer Safety Specification for Bassinets and Cradles;
16 CFR part 1219Safety Standard for Full-Size Baby Cribs, incorporating by reference ASTM F1169, Standard Consumer Safety Specification for FullSize Baby Cribs;
16 CFR part 1220Safety Standard for Non-Full-Size Baby Cribs, incorporating by reference applicable requirements in ASTM F406, Standard Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards;
16 CFR part 1221Safety Standard for Play Yards, incorporating by reference applicable requirements in ASTM F406, Standard Consumer Safety
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Specification for Non-Full-Size Baby Cribs/Play Yards;
16 CFR part 1222Safety Standard for Bedside Sleepers, incorporating by reference ASTM F2906, Standard Consumer Safety Specification for Bedside Sleepers.
The purpose of this revision is to more clearly establish the scope of the final rule, which includes all products marketed or intended for infant sleep for children up to 5 months of age, so that these products that are currently unregulated must now meet one of the mandatory standards for infant sleep.
Revise the scope of the standard to explicitly state that crib mattresses that meet the requirements of ASTM F2933
do not fall within the scope of the standard. This exclusion clarifies that crib mattresses that meet the voluntary standard do not meet the definition of an infant sleep product, and are always used in conjunction with a sleep product, such as a crib or play yard, that falls within one of CPSCs sleep standards. The final rule also modifies referenced documents in the standard, to add the voluntary standard for crib mattresses, ASTM F2933;
Modify the definition of infant inclined sleep product to remove the term inclined and revise the definition to state that an infant sleep product is a product marketed or intended to provide a sleeping accommodation for an infant up to 5
months of age, and that is not subject to any of the following:
16 CFR part 1218Safety Standard for Bassinets and Cradles 16 CFR part 1219Safety Standard for Full-Size Baby Cribs 16 CFR part 1220Safety Standard for Non-Full-Size Baby Cribs 16 CFR part 1221Safety Standard for Play Yards 16 CFR part 1222Safety Standard for Bedside Sleepers This requirement aligns the definition of infant sleep product with the scope of the rule, including the intent of the rule to ensure that all infant sleep products, inclined and flat, are subject to a mandatory CPSC sleep standard, to address the risk of injury associated with infant sleep products.
Remove the definitions of accessory, compact, and newborn inclined sleep products because they are no longer necessary and have no unique requirements in the standard, because all infant sleep products are subsumed under the definition of infant sleep product.
Modify seat back/sleep surface angle so the maximum allowable angle, as tested per the rule, must be equal to
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