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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations products, as a subcategory of bassinets and cradles.

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2. Incident Data a Inclusion of Flat Sleep Products Comment 12: Multiple commenters expressed concern about in-bed sleepers, baby boxes, and compact bassinets being subject to the standard.
Concerns included:
In-bed sleepers, baby boxes, and compact bassinets are not identified in CPSC data;
Bed-sharing is a common practice in the United States and abroad;
Potential disparity in safety among inbed sleepers versus a potential ban of in-bed sleepers;
Interest in increased advocacy regarding bed-sharing; and Differences among products necessitates different requirements based on demonstrable hazard data.
Commenters objected to including noninclined sleep products in this rulemaking, including objecting to replacing the term infant inclined sleep products, with the more general infant sleep products. Instead, these commenters urged the Commission to focus on inclined products for this rulemaking and to review requirements for non-inclined products in separate rulemaking efforts. A commenter stated that it is inappropriate to require all products not subject to an existing standard to comply with the bassinet standard.
Response 12: The Commission recognizes that bed-sharing is a common practice of parents, both in the United States and abroad. However, we cannot recommend bed-sharing as a safe sleep practice, due to the increased risk of SIDS, overlay, and other hazards. AAP
safe sleep recommendations encourage infants to room-share with parents, but to provide infants with their own firm, flat space, near the parents, but not in the same bed. For a more detailed discussion on bed-sharing, please see CPSC human factors staff memorandum at Tab D of Staffs Final Rule Briefing Package.
As discussed in section III of this preamble, in response to the comments, the Directorate for Epidemiology staff identified 183 incident reports related to non-inclined, flat products marketed as infant sleep products, such as in-bed sleepers, and compact bassinets. The incident data, reported to have occurred during the period from January 1, 2019
through December 31, 2020, identified 11 fatalities and 16 injury reports. Seven of the 11 fatalities described a suffocation death. The other deaths involved the infant rolling over to a
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prone position, or rolling out of the product and becoming entrapped. The final rule identifies the flat sleep products that fall within the scope of the rule, provides incident data, describes hazard patterns, analyzes the effectiveness of the bassinet standard to address the hazards, and compares the performance requirements in international standards to demonstrate that these products have similar hazard patterns that can be addressed by the requirements in the bassinet standard.
Comment 13: Several commenters urged the Commission to work with ASTM to develop product-specific safety standards for each of the identified flat products, such as in-bed sleepers, baby boxes, and compact bassinets, and to do so in a separate effort.
Response 13: The ASTM process for developing the voluntary standard for infant inclined sleep products took close to 5 years before the standard was published. The bassinet subcommittee also has been working about 5 years to add compact bassinets to the standard, which has not been completed. CPSC staff has participated in these efforts and provided incident data to the ASTM committees and task groups. Throughout all this time, inclined and compact infant sleep products have entered the retail market without meeting any safe sleep testing, voluntary or mandatory. The incident data discussed in section III of this preamble Tab B of Staffs Final Rule Briefing Package, and the engineering and human factors analysis in section VI
of this preamble Tabs C and D of Staffs Final Rule Briefing Package, demonstrate that inclined, compact, and in-bed sleep products pose risks to infants and therefore, should not be allowed to be sold as infant sleep products without meeting one of CPSCs mandatory sleep standards.
Comment 14: A commenter stated that no data indicate that overlay injuries or fatalities exist while using an infant inbed sleeper.
Response 14: As part of CPSC staffs participation with ASTM voluntary standards groups, in fall 2017 38 and summer 2019,39 CPSC staff provided the ASTM in-bed sleeper working group with incident data that identified fatal and nonfatal incidents involving in-bed sleepers. This data demonstrated 11
fatalities and 22 nonfatalities associated with in-bed sleepers. The primary 38 October 2, 2017 email from Hope Nesteruk to Lisa Trofe and Meredith Thomas, JPMA contacts for ASTM meetings.
39 Email dated June 4, 2019, from Hope Nesteruk to Meredith Thomas, JPMA contact for ASTM
meetings.

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hazard patterns, consistent with the incident data discussed in this final rule, involved infants falling out of inbed sleepers, rolling into the side, bedsharing, and consumer complaints.
An overlay hazard typically occurs during bed-sharing, when a parent lays over their infant, and typically does not realize they have done so because they are asleep. Accordingly, during task group and subcommittee meetings, staff expressed additional concerns with low side height, soft-sided, in-bed sleepers, because use of such products may provide parents with a potentially false sense of security when bed-sharing.
Based on this information, and bedsharing concerns generally, CPSC has substantial concerns that a low, softsided, in-bed sleeper may not prevent a parent from inadvertently laying over an infant and suffocating the baby. CPSC
data for in-bed sleepers is anecdotal in nature, and therefore, we may not have received overlay incidents that involve an in-bed sleeper, but the large number of overlay incidents reported to the CPSC generally indicate that bedsharing can be hazardous.
Comment 15: A commenter stated that the 2019 SNPR is well-intentioned, but that it is premature, and that the scope of the rule ultimately may harm consumer safety, because consumers will use soft bedding and other tools to replace an entire category of products that effectively are banned under the SNPR. The commenter stated that the data necessary to support the rule is either missing or incorrect. Another commenter stated that the data on inbed sleepers, and the existing CPSC
sleep standards, do not support CPSCs approach in the 2019 SNPR, noting that babies die in all types of infant sleep products despite having an existing standard, citing bassinets, cribs, and play yards. Infants die for reasons not associated with the product, the commenter asserted, adding that CPSC
has not presented data to warrant all infant sleep products without a standard to comply with the bassinet standard.
This commenter maintained that CPSC
is using a back-door method to remove infant products from the market without the data to support or justify this action. The commenter opined that CPSC should write safety standards that will ensure safe sleep for each product type, and not funnel various products into one standard, bassinets and cradles, which was not intended for these products.
Response 15: In coordination with a range of stakeholders, CPSC has carefully developed safety regulations for five infant sleep products cribs: fullsize and non-full-size, bassinets, play
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