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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations degrees or less from horizontal, and they must meet the requirements of the bassinet and cradle standard.

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b Adopt Canadian Standard of 7
Degrees Comment 18: One commenter stated that Canada only allows up to 7-degree seat back angle in sleep products, and suggested CPSC should consider adopting the Canadian standard.
Another commenter supported the SNPR proposal that infant sleep surfaces be no more than 10 degrees from horizontal.
Response 18: The Mannen Study concluded that a seatback angle of 10
degrees or less is safe. This seatback angle is consistent with CPSCs Safety Standard for Bassinets and Cradles, which also requires a 10 degree or less incline. We recognize that Health Canada is using a 7-degree maximum incline; however, that requirement is based on a side-to-side tilt study of infants in rocking cradles published in 1995. The 2019 Mannen Study compared infant muscle and breathing behavior on a flat crib mattress and on a crib mattress, head-to-toe 10 degrees from horizontal, and determined that infant responses were essentially the same on both sleep surfaces.
Accordingly, based on the Mannen Study findings, to provide a safe sleep surface, the final rule is consistent with the current requirement in the bassinet and cradle standard, requiring that infant sleep products must have a headto-toe incline angle of 10 degrees or less.
c Highest Seat Back Angle Clarification Comment 19: A commenter requested that CPSC replace the phrase: the manufacturers recommended highest seat back angle position intended for sleep, with the seat back angle position that is the highest position intended for sleep or that is the highest position that a reasonable consumer would consider as being for infant sleep, whichever is higher.
Response 19: The commenters suggestion, by focusing on the seat back of an infant sleep product, illustrates some confusion with terminology. The 2019 SNPR applied to infant sleep products, and required all infant sleep products to be 10 degrees or less from horizontalthe same as the sleep surface in bassinets. However, the safe sleep principle requirement from the Mannen Study, and already reflected in the bassinet standard, is that infants should sleep flat on their backs.
Accordingly, the SNPR term seat back created confusion, because the term implies that infant sleep products are for sitting in a device with a seat.

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Thus, to reduce this confusion in the final rule, we replace the term seat back with the term Seat Back/Sleep Surface.
4. Safe Sleep Principles a Request to Ban Infant Inclined Sleep Products Comment 20: Approximately 25
commenters requested that CPSC ban or remove infant inclined sleep products from store shelves. Of those commenters, three indicated that their child died while sleeping in an inclined sleep product.
Response 20: Many products with an incline greater than 10 degrees from horizontal have been removed from the market through CPSC recalls. To address newly manufactured products, the final rule does not ban all infant sleep products with an angle, but addresses the hazards associated with inclined sleep products by requiring that any product marketed or intended for sleep for infants up to 5 months old must not have a sleep surface angle greater than 10 degrees, and that any currently unregulated infant sleep product meet the bassinet standard. The purpose of these requirements is to ensure that all infant sleep products meet minimum safe-sleep principles, including the sleep surface angle, as addressed through an existing CPSC
sleep standard.
b Aligning with AAP Safe Sleep Practices Comment 21: One commenter acknowledged that the 2019 SNPR
aligns with the AAPs safe sleep recommendations, and encourages CPSC to ensure that the proposed rule sends a clear message addressing safe sleep practices.
Response 21: The Commission is committed to addressing safe sleep practices in this rulemaking and ensuring that all products marketed, intended, promoted, or otherwise indicated as being for any kind of infant sleep for infants up to 5 months old are addressed. Therefore, the final rule requires that all infant sleep products, including inclined and flat products, be subject to 16 CFR part 1218, Safety Standard for Bassinets and Cradles, because part 1218 includes safe sleep requirements. Additionally, CPSCs website provides extensive information regarding best practices for safe sleep through its CPSCs Safe Sleep Campaign and Baby Safety information at: https
www.cpsc.gov/SafeSleep.

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c Use of Unsafe Products by Sleep Deprived Parents Comment 22: One commenter expressed concern that parents, particularly those who are sleep deprived, cannot reasonably be expected to use a product that is unsafe by design in a safe manner.
Response 22: Lack of sleep may have a detrimental effect on a parents judgment when using an infant sleep product. Research demonstrates that fatigue can negatively affect memory, concentration, and decision making.42
The final rule is the most effective method of ensuring that infant sleep products for infants up to 5 months of age are safe for use.
5. Definitions a Remove Intended From Definitions Comment 23: A commenter requested that the word intended be struck from the definitions of infant and newborn sleep products.
Response 23: We disagree with the request to remove intended from the definitions. Manufacturers intent, which can be evaluated through stated warning messages, marketing photos, product instructions and other factors, must remain a factor for staffs consideration. As the commenter noted, some products are marketed for swinging or bouncing. If infant products are not intended for sleep and are not marketed in ways that imply they are for sleeping or napping, they are not subject to the infant sleep product standard.
CPSC will evaluate a manufacturers intent using all available materials, including marketing. Accordingly, the final rule maintains the word intended and also broadens the definition of an infant sleep product to include the word marketed.
b Define or Clarify Free Standing Infant Sleep Products Comment 24: One commenter contended that free standing is an ambiguous term.
Response 24: A free-standing infant sleep product is a sleep product that can be used by itself, without the need of another product, such as a portable play yard. ASTM F311817a contains a separate definition for accessory inclined sleep product, which applies to products that are supported by another product, such as a play yard.
The term free-standing is used without issue in other ASTM and CPSC
standards. For the final rule, the 42 https www.sleepfoundation.org/sleepdeprivation.

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