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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
products to meet the bassinet standard, instead of creating product specific standards, would have the unintended consequence of stifling innovation.
Response 39: As with all of CPSCs regulations to set performance and labeling requirements, CPSCs mandatory rules for durable infant or toddler products set a floor for safe consumer products. CPSC does not require pre-market approval of consumer products, nor does the agency have the authority to do so. However, CPSC does have the authority to create mandatory performance requirements through rulemaking, and to require that all products offered for sale in the United States meet these requirements to protect consumers from injuries or death. When the Commission is aware of a gap in the regulatory framework for infant sleep products, the Commission can use its authority to address the associated hazards.
Mandating a safety standard for infant sleep products offered for sale in the United States that are not already within the scope of another CPSC sleep standard is not unprecedented and is no different than standards for other durable infant or toddler products that contain different product types within the same standard, such as strollers and high chairs, each of which include a variety of product types. No company can sell a stroller in the United States that does not comply with the stroller standard, simply based on the type of stroller. Similarly, no company can sell a high chair in the United States unless it complies with the high chair standard. This is not a novel idea. The only difference in these product categories is how the voluntary standards evolved. The scope of the stroller and high chair standards are broad for the purpose of encapsulating all products. Standards for sleep products evolved on a different track.
But the Commission is not required to continue a patchwork regulatory scheme that does not serve the interests of consumer safety. In this case, the Commission seeks to ensure that all products marketed or intended for infant sleep, for infants up to 5 months of age, meet the infant sleep product standard to set a floor for safe infant sleep. CPSCs mission is to protect consumers, and the agency will use its authority to protect the most vulnerable infants, up to 5 months old, and their unsuspecting parents, from sleep surfaces that do not follow known safe sleep principles, as set forth in the existing CPSC sleep standards.
Accordingly, the Commissions effort in the 2019 SNPR is consistent with CPSCs statutory mandate to protect
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consumers, and specifically, under section 104, to promulgate standards for product categories that the Commission determines to be of the highest priority, and to ensure that such standards provide the highest level of safety for such products that is feasible.
Because CPSC staff has been working with ASTM members on the bassinet and cradle subcommittee for years, on both inclined sleep products, as well as unregulated flat infant sleep products, ASTM members should be well aware of staffs efforts and concerns with both product types. Once CPSC issues an NPR, CPSCs docket on Regulations.gov includes a record of staffs participation through the ASTM process, and ASTM
records should reflect this participation as well. CPSCs Office of the Secretariat maintains meeting logs summarizing staffs participation with external parties, such as ASTM, outside of the rulemaking process, and these meeting logs are searchable on CPSCs website.
Finally, performance and labeling requirements for consumer products allow for innovation with certain baseline safety requirements. While we understand the concerns that innovation beyond the baseline safety requirements may be discouraged, we note the development of infant inclined sleep products as a prime example of innovation preceding safety. Infant inclined sleep products were first marketed as an innovative sleep solution for parents; however, no safety standard existed for these products when they were introduced to the market. Commenters to the 2010 NPR
and 2012 SNPR for bassinets indicated that hammocks and inclined sleep products should have their own standard because they could not meet the requirements for bassinets, and parents were likely to create their own unsafe alternative if a regulated product was not available. The ASTM
standards development process for inclined sleep products took many years before the standard was published in 2015, and during that time, manufacturers were designing and selling innovative inclined products. As time went on, the hazards posed by inclined products became apparent in the accumulation of infant deaths and incidents associated with this product category. To avoid a repeat of this process, involving the most vulnerable infants up to 5 months old, the Commission is issuing this infant sleep product standard that contains key elements of safe sleep, so that product innovation does not compromise safe sleep for infants up to 5 months old.
Comment 40: A commenter states that section 104 of the CPSIA does not
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permit the application of the bassinet standard to an open-ended and undefined scope of products. The commenter contends that section 104
requires the Commission to consider specific product types, characteristics, and hazards. The commenter states that the 2019 SNPR approach is arbitrary and is a reversal of the Section 104
process for existing and new products that are sleep products, but not bassinets or cradles. The commenter states that CPSC must clearly define the scope of the rule and the products that fall within the scope of the rule.
Response 40: As set forth in response to comment 34, the 2019 SNPR
provided notice that the rulemaking included flat infant sleep products.
Moreover, the preamble to this final rule identifies product types that fall within the scope of the rule, as well incident data, hazard patterns, and an analysis of how the requirements in the bassinet and cradle standard address the risk of injury associated with flat infant sleep products. The purpose of the rule is to regulate any product marketed or intended as a sleeping accommodation for an infant up to five months old that is not already regulated by another CPSC sleep standard. Accordingly, the scope of the rule is not open-ended, and the final rule demonstrates that the bassinet standard provides minimum safe sleep characteristics for these infant sleep products.
Comment 41: A commenter states that to implement a rule that requires specific products to meet the requirements of the bassinet standard, CPSC must provide a rationale that is supported by substantial evidence.
The commenter states that the 2019
SNPR did not provide a rationale for the application of the bassinet standard to specific products within the infant sleep product category.
Response 41: As stated in response to comment 37, CPSC and stakeholders have been working through the ASTM
process regarding requirements for unregulated flat and inclined sleep products for many years, as part of development of the bassinet standard.
Accordingly, based on the 2019 SNPR
and this ongoing work with ASTM, staffs efforts have been to maintain the safe sleep requirements in the bassinet standard and apply them to all sleep products marketed and intended for infants up to 5 months old. In response to comments, the final rule makes clearer the unregulated flat sleep products that fall within the scope of the rule, provides incident data, identifies hazard patterns, analyzes the effectiveness of the bassinet standard to address the hazards, and compares the
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