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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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recommendations. One commenter also indicated that the Commission should:
Conduct more research on the 30degree seat back angle;
Conduct more research on developmental implications when an infant is restrained while sleeping;
Provide performance requirements to address product misassembly;
Make the side height requirement match the 7.5 side height requirement in the bassinets and cradles standard;
Develop performance or design changes for compact units so they cannot be placed on a raised surface, in crib, or on soft surface;
Add seat back height requirement for infant products like newborn products;
Add requirements for hammocks to increase stability;
Add requirements for flat sleep products, so an infant cannot move into an unsafe chin to chest position;
Add pictograms to warnings like slings and hand-held carriers;
Include marking on products to show compliance with new regulations;
Conduct market surveillance after a regulation becomes effective; and Have a 6-month effective date for the final rule.
Response 1: We agree, based on the Mannen Study, that infant sleep products, as defined in the final rule, should not have a seat back/sleep surface angle greater than 10 degrees.
The Commission proposed to address many of the commenters in-scope recommendations noted above in the 2019 SNPR, and is now finalizing the requirements, by requiring inclined and flat sleep products that are marketed or intended to provide a sleeping accommodation for an infant up to 5
months old, to meet the bassinet standard. Due to the expected significant economic impact on some manufacturers, the Commission will maintain the proposed 12-month effective date for the final rule.
2. Definition of Infant Inclined Sleep Product Comment 2: A commenter stated that the phrase, primarily intended and marketed to provide sleeping accommodations, in the proposed definition of an infant inclined sleep product, is not needed, because incorporating a manufacturers marketing intentions into a definition of a product which impacts the safety standard of that product opens the door to potential conflicts of interests. The commenter reasoned that a childs age and the product incline are objective factors, while a manufacturers intent is more subjective, and could allow
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manufacturers to market the product in a way to avoid meeting the requirements of the rule.
Response 2: Although the definition the commenter refers to in the standard no longer includes the term inclined, we respond here to the concept of including the phrase marketed or intended in the definition of infant sleep product in the final rule. A
manufacturers intended use of the product and marketing guide informs caregivers about the products safe use.
Manufacturers of products that are not designed or marketed for use as an infant sleep product should provide caregivers with instructions and warnings regarding safe use of the product. Including a manufacturers marketing and intent in the definition also assists the Commission to enforce the regulation, because it provides objective criteria for CPSC staff to apply to a products name, packaging, warnings, labeling, and marketing materials about whether the product falls within the scope of the rule. CPSC
staff has experience using marketing materials to enforce CPSCs regulations, and CPSC is required to use such materials in some cases. For example, section 3 of the CPSA provides factors for determining whether a product is a childrens product, and includes several factors that require reviewing labeling, promotion, and advertising, to determine whether a product is designed or intended primarily for children 12 years of age or younger. 15
U.S.C. 2052a2. Products that have no use other than infant sleep, based on the products design, cannot be labelled as not intended for infant sleep to avoid meeting the requirements of the final rule.
3. Comments Superseded by the 2019
SNPR
Comment 3: Two commenters agreed with the modification of the accessory definition in the 2017 NPR, and with the 12-month effective date. One commenter had a specific comment related to restraint requirements in the NPR.
Response 3: The 2019 SNPR
supersedes the 2017 NPR. The proposed modification to the definition of accessory is no longer at issue in the final rule, because this definition has been removed, along with other requirements related to inclined sleep products. The Commission will maintain the 12-month effective date for the final rule, to provide manufacturers and importers sufficient time to come into compliance. Allowance of a restraint requirement in an infant sleep product was unique to inclined sleep
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products to contain the infant in the product. Consistent with the 2019
SNPR, the Commission removed the restraint requirement in the final rule, because restraints can create a strangulation hazard. The passive containment provision in the bassinet and cradle standard, which requires a product side height of 7.5 inches and a flat below 10 degree sleep surface, follows safe sleep practices for containment: A bare, flat, infant sleep surface.
B. Comments on the 2019 SNPR
1. Scope of the Final Rule a All Products Marketed, Promoted, or Otherwise Indicated for Sleep Comment 4: A commenter suggested:
the new standard should apply not just to those infant products intended by the manufacturer for sleep or certified as being for sleep, but also any product that is marketed, promoted, or otherwise indicatedor may be reasonably interpreted as indicatingas being for any kind of sleep, including products described using substitute language for sleep, such as nap or snooze.
Several other commenters expressed concern that various terms used in the 2019 SNPR were vague, and recommended that more precise definitions be provided for sleep and sleeping accommodations. In addition, commenters requested clarification regarding which products are included in the definitions.
Response 4: In response to this comment, the preamble and regulation text for the final rule: 1 Clarify that the scope of the rule includes products with inclined and flat sleep surfaces, and 2
more precisely explain the definition of an infant sleep product. For example, to clarify that the scope of the rule includes inclined and flat sleep products, the scope of CPSCs regulation text in 1236.2, and the scope of the revised voluntary standard in section 1.3, explain that the scope of the infant sleep products rule includes products with inclined and flat sleep surfaces.
The final rule also broadens the definition of an infant sleep product to include the term marketed: Which is a product marketed or intended to provide sleeping accommodations for an infant up to 5 months old that is not subject to any of the following . . . .
The definition then lists CPSCs five infant sleep standards, to ensure that all infant products marketed or intended for infant sleep meet the requirements of a CPSC sleep standard, so that all products meet minimum safe sleep requirements. Staff modified the introduction, scope, and definitions in
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