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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
definition of infant sleep product is broadened to cover all inclined and flat products marketed or intended as a sleeping accommodation, regardless of whether the product is free-standing or attached to another product.
Accordingly, we removed the term free-standing from the definition of infant sleep product in the final rule, to reduce confusion about which infant sleep products are subject to the rule.
6. Warnings and Instructions a Provide Information About Scoliosis and Torticollis Comment 25: One commenter recommended that information about deformities, such as scoliosis and torticollis, be included on an insert with all infant sleep products.
Response 25: Providing parents with information and resources regarding various infant deformities is beneficial, and manufacturers are not prevented from including this information if they desire. However, as indicated in the 2019 SNPR, increases in the number of children with plagiocephaly may actually be attributed to the AAPs recommendation to place infants to sleep on their backs to decrease the risk of SIDS. The final rule does not contain any modifications to the voluntary standard to address this issue.

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b Placement of Warnings Comment 26: One commenter recommended that warnings should be placed on the outside and inside of the packaging, as well as on the product.
The commenter also recommended that packaging should be labeled, easily visible, and easy to read/understand.
Response 26: Consistent with the 2019 SNPR, the final rule requires that infant sleep products not already subject to a CPSC sleep standard, be subject to the warning requirements set forth in the bassinet standard, ASTM F2194
16e1, which requires that warning labels be present on the product and its packaging, and that warning information be present in the instructional literature. ASTM F2194
16e1 also requires that the warnings be conspicuous, permanent, and easy to read/understand.
7. Economic Analysis Comment 27: A commenter suggested that CPSC conduct an exposure study to research the relative risks of these different sleep products. This commenter also suggested that CPSC
perform a full cost-benefit analysis of the final rule.
Response 27: CPSC is continuing research topics related to safe sleep, which may potentially involve types of
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infant sleep products. Although an exposure study is an effective means to estimate exposure, we can estimate exposure by comparing annual sales of products to the number of live births, and staff identifies the hazard patterns from the incident data. The Commission is not required to conduct cost-benefit analyses under section 104 of the CPSIA, and has not done so for any durable infant or toddler rulemaking.
We are uncertain what the purpose of such an analysis would accomplish for a rule promulgated under section 104 of the CPSIA, where cost/benefit considerations are not germane to the Commissions rulemaking authority.
8. Effective Date Comment 28: Commenters both supported and opposed the 12-month effective date. Some opposing commenters supported a 6-month effective date instead, because additional time for the rule to become effective puts infants at risk, while other opposing commenters wanted a longer effective date, or an indefinite delay until ASTM completes additional standards for specific products. The 2019 SNPR proposed that the effective date would apply to products manufactured or imported after the final rule effective date. We received multiple comments that the effective date should apply to products sold after the final rule effective date instead of the sold by date, to prevent stockpiling and remove the hazards as soon as possible.
Response 28: For the final rule, the Commission will maintain the 2019
SNPR proposed effective date of 12
months after the date of publication in the Federal Register. A 6-month effective date may seem reasonable because suppliers have had ample lead time to prepare for this rule since the SNPR was published in 2019, and many of the products within the scope of the final rule have been withdrawn from the market or redesigned, particularly for inclined sleep products. However, for manufacturers of other unregulated flat sleep products that remain in the market, there will likely be a significant economic impact as a result of this final rule. While some suppliers can reduce the impact of this rule by relabeling their products as not for infant sleep, not all manufacturers can simply remarket the product if the physical form of the product demonstrates that it is intended for sleep. For some of these products, manufacturers could relabel them as intended for infants older than five months, or, in some cases, for pets.
However, the demand for infant sleep products for pet use is probably limited.

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The final rule is considered a consumer product safety standard issued under the Commissions authority in section 104 of the CPSIA.
Section 104b1B. We are unclear regarding what the commenters sold by date references. The Consumer Product Safety Act CPSA sets forth requirements for manufacturers and importers once a rule becomes effective.
Section 19a1 of the CPSA states:
a It shall be unlawful for any person to 1 sell, offer for sale, manufacture for sale, distribute in commerce, or import into the United States any consumer product, or other product or substance that is regulated under this Act or any other Act enforced by the Commission, that is not in conformity with an applicable consumer product safety rule under this Act, or any similar rule, regulation, standard, or ban under any other Act enforced by the Commission;
15 U.S.C. 2068a1. Accordingly, the CPSA provides that, as of the effective date of the final rule, it is unlawful to sell, offer for sale, manufacture for sale, distribute in commerce, or import into the United States, any infant sleep product, as defined in the rule, that is not in conformity with the final rule.
9. Procedural Comments a Products Subject to the Final Rule Comment 29: A commenter stated that the proposed rule would apply to domestic products, and not to products made overseas. The commenter stated that the rule should apply to products made overseas and sold in the United States, for optimal consumer safety.
Response 29: The commenter appears to misunderstand the scope of products subject to the final rule. If finalized, the rule would make it unlawful to sell, offer for sale, manufacture for sale, distribute in commerce, or import into the United States, an infant sleep product that is not in conformity with this rule, regardless of whether the product was manufactured in the United States or overseas.
b Incorporation by Reference Comment 30: A commenter states that the Commission should publish the legal standard for infant sleep products, rather than incorporate the standard by reference. The commenter stated:
Publishing the legal standard will advance fundamental principles of fair notice and due process by ensuring that the public has open and unimpeded access to the law.
The law belongs to the people, regardless of who drafts the law, and thus citizens have a fundamental right to know what the law contains.

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