Federal Register - June 23, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations the final rule to clarify the applicability of the rule to any infant sleep product not covered by another CPSC sleep standard.
While newborns can and do fall asleep in many products, because young infants sleep for extended hours throughout the day, certain products are designed, marketed, and intended for infant sleep. Therefore, sleep and sleeping accommodations refer to products that are marketed or intended for both extended, unattended sleep, and also napping, snoozing, and other types of sleep in which a parent may or may not be present, awake, and attentive. Additionally, if a product name implies the product is for use as an infant sleep product, such as use of the terms bed, bassinet, or crib, but does not already comply with the bassinet or crib regulation, the product falls within the scope of the final rule.
If a product, through marketing, pictures, and written description, indicates that the product is being sold as an infant sleep product for infants up to 5 months old, that product will be covered by this regulation if it is not already subject to a CPSC sleep standard.
The 2019 SNPR included four definitions, infant sleep products, newborn sleep products, compact sleep products, and accessory sleep products. However, this distinction is not necessary and creates confusion when identifying infant sleep products, because there are no unique requirements in this rule based on these definitions. Accordingly, for the final rule, to clarify which infant sleep products are subject to the rule, the Commission removed the separate definitions of newborn, compact, and accessory sleep products, and will rely solely on the definition of an infant sleep product:
3.1.7 infant sleep product, na 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 b Distinguishing Non-Sleep Products Comment 5: A commenter stated that infant car seats, swings, and rockers typically have seatback angles greater than 30 degrees, adding that these
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products have use patterns very similar to products that fall within the scope of ASTM F3118. The commenter requested clarification of the distinguishing features or characteristics that differentiate these two types of products with very similar usage patterns.
Response 5: The purpose of the final rule is to regulate all products marketed or intended for infant sleep for infants up to 5 months old. Accordingly, the products within the scope of the final rule are all marketed and intended for sleep, and do not include car seats, swings, or rockers, unless a product is marketed or intended for sleep.
Newborns can and do fall asleep in many products, because young infants typically sleep 16 to 17 hours a day, 1
to 2 hours at a time. By 3 months, infants can sleep 4 to 5 hours during the day and 9 to 10 hours during the night.37 However, products such as car seats, swings, and rockers typically are not marketed for use as an infant sleep product; these products are intended for use while the child is awake. Moreover, regarding car seats, CPSC has jurisdiction only for use outside of an automobile, when the product is being used as an infant carrier; while the National Highway Traffic Safety Administration NHTSA has jurisdiction over car seats being used in an automobile, including the car seats angle and design for safe use in an automobile.
Comment 6: Several commenters stated that the scope of the 2019 SNPR
was too broad, and expressed concerns that non-sleep products would be included. Some of the comments requested specific exclusions or inclusions to the scope of the final rule.
Response 6: The final rule does not apply to products that are not marketed or intended for infant sleep, such as bouncer seats, swings, infant chairs, or other similar durable infant or toddler products that are marketed for use while a child is awake. In addition, the Commission is specifically excluding crib mattresses that fall within the scope of the voluntary standard for crib mattresses, ASTM F2933, from the scope of the final rule. A crib mattress, alone, does not meet the definition of an infant sleep product, and is always used in conjunction with a sleep product, such as a crib or play yard, which are within one of the five existing CPSC sleep standards. The Commission issued a notice of proposed rulemaking for crib mattresses in 2020, and we intend to finalize a separate rule on crib mattresses this fiscal year.
37 https www.stanfordchildrens.org/en/topic/
default?id=infant-sleep-90-P02237.

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The purpose of the rule is to set minimum safe sleep requirements for products that are marketed or intended for infant sleep up to 5 months old. The Commission is aware that infant sleep products share hazard patterns that can be addressed by performance and labeling requirements; but currently, a gap exists between regulated and unregulated products. Therefore, the scope of the final rule includes all infant sleep products not already covered by a mandatory CPSC sleep standard bassinets, full-sized cribs, non-fullsized cribs, play yards, or bedside sleepers, and requires the product to be tested to the bassinet standard as a default, so that all infant sleep products follow a mandatory safety standard for infant sleep, specifically and minimally the standard for bassinets and cradles. Based on staffs evaluation, following the requirements of the bassinet and cradle standard would address the hazard patterns found in the incident data for unregulated inclined and flat sleep products see section VI
of this preamble and Tab B and C of Staffs Final Rule Briefing Package.
The Commission is also concerned about new infant sleep products that come on the market and that do not follow any CPSC sleep standard. The concern is that caregivers may view these products as safe because they are on the market, even though these products may not address known infant sleep hazards or may not be tested to an appropriate standard. Accordingly, the final rule requires all products marketed or intended for sleep for infants up to 5 months old to follow core safe sleep principles, which the Commission, in agreement with AAP, states are: Place infants alone, on their back, and on a flat, firm surface with no restraints or loose fabric nearby.
Rather than list specific inclusions and exclusions, other than excluding crib mattresses, the scope and definitions in the final rule address potential confusion about which infant sleep products are covered. For example, the definition of an infant sleep product states:
3.1.7 infant sleep product, na 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
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Federal Register - June 23, 2021

TitreFederal Register

PaysÉtats-Unis

Date23/06/2021

Page count369

Edition count7798

Première édition14/03/1936

Dernière édition18/06/2026

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