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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
Package at the ASTM meetings in October 2019, including the ASTM
subcommittees for infant inclined sleep products, in-bed sleepers, and bassinets, discussing the Mannen Study findings, as well as addressing the fact that flat sleep products were covered by the SNPR. Dr. Mannen attended the subcommittee meeting for infant inclined sleep products via telephone, to discuss the Mannen Study and to answer questions.
After the SNPR published in the Federal Register on November 12, 2019, CPSC staff urged the ASTM
subcommittee for ASTM F3118 to meet and discuss how to address issues presented in the 2019 SNPR. However, the F3118 subcommittee did not meet again until August 26, 2020, following a July 16, 2020 letter from CPSC staff.25
After staffs letter, the ASTM F3118
subcommittee established a task group to revise the infant inclined sleep standards title, introduction, and scope, to be more in line with the proposal in the 2019 SNPR. In December 2020, the ASTM subcommittee introduced ballot F1518 201 to change the standards title, introduction, and scope to include all infant sleep products and not just inclined sleep products. The ballot sought to:
Remove the word inclined throughout the standard.
Include in the scope, products intended for infants up to 12 months old.
Include in the scope, products marketed or intended to provide sleeping accommodations.
Change the scope to include all infant sleep products that do not fall within the scope of an existing infant sleep product standard:
D Full-Sized Cribs F1169
D Bassinets F2194
D Bedside Sleepers F2906
D Non-Full-Size Cribs/Play Yards F406
Exempt crib mattresses from the scope of the standard.
Limit the sleep surface in all positions to be 10 degrees or less.
However, in January 2021, the ballot did not pass due to six negative votes. The negative votes objected to a variety of different aspects of the ballot, including four broad categories:
1. That the proposal would discourage innovation and be too broad;
2. That the ballot appeared to allow products that fall under other sleep standards to opt to meet ASTM F3118
instead;
25 Available at: https www.cpsc.gov/s3fs-public/
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3. That the voter could not support changing the title, introduction, and scope without seeing the underlying requirements; and 4. Editorial comments.
The ASTM F3118 subcommittee discussed the ballot results at a meeting on January 27, 2021. During this meeting, ASTM members disagreed on the intent and consequences of changes to the voluntary standard, and the meeting ended without a consensus on a path forward. However, CPSC staff participates on an ASTM task group to review safe sleep requirements across infant sleep product standards the comparison task group, and reports that this task group has met at least four times since the January 27, 2021
meeting. Based on the ballot results and the discussions in these ASTM
meetings, staff advises that it is unlikely that ASTM will be able to move forward with changes to ASTM F3118 that address safe sleep requirements in the near term.26
Recently, on April 22, 2021, at an ASTM task group meeting on the title, introduction, and scope of the voluntary standard, task group members discussed balloting the proposed regulatory text in the 2019 SNPR for the voluntary standard, to prevent the sale of infant inclined sleep products that purport to certify to ASTM F311817a, meaning products with an incline above 10
degrees, while ASTM works to revise the voluntary standard to be more in line with the 2019 SNPR. However, the task group does not plan to ballot the 2019 SNPR requirement that infant sleep products meet the requirements of the bassinet standard, because ASTM is working to create minimum safe sleep requirements in a revised ASTM F3118
standard. Staff is participating in this effort as well, but staff has advised the task group that staffs expertise does not suggest that requirements that are different and less stringent than the requirements in the bassinet standard will adequately address the risk of injury associated with infant sleep products. Additionally, staffs conclusion that the Safety Standard for Bassinets and Cradles contains the 26 The ASTM task group approach is different than CPSCs approach in this final rule, because ASTM is attempting to put safe sleep requirements in ASTM F3118, rather than rely on the performance and labeling requirements in the bassinets and cradles standard. The Commission determines in this final rule that the performance and labeling requirements in the bassinet standard are the minimum safe sleep requirements for infant sleep products. Thus, it remains unclear whether ASTMs approach can be successful. However, if the ASTM committee revises ASTM F311817a and notifies the Commission, the staff will evaluate the revised voluntary standard at that time.

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minimum safe sleep requirements for these products is supported by the assessment presented in Staffs Final Rule Briefing Package and in this final rule.
B. Bassinets and CradlesASTM F3194
1. History and Description The voluntary standard for bassinets and cradles, ASTM F2194, was first approved and published by ASTM in 2002, as ASTM 2194, Standard Consumer Safety Specification for Bassinets and Cradles. The voluntary standard was revised several times between 2002 and CPSCs promulgation of a mandatory standard for bassinets in 2013. CPSCs mandatory standard for bassinets and cradles, codified at 16
CFR part 1218, incorporates by reference ASTM F219413, with the following modifications to the voluntary standard:
1. Clarify the scope of the standard to include multi-mode products in which a mode meets the definition of a bassinet/cradle seat incline is 10
degrees or less from horizontal 2. Modify the stability test procedure to require the use of a newborn CAMI
dummy, rather than an infant CAMI
dummy.
3. Add stability requirements for removable bassinet beds.
4. Add more stringent mattress flatness performance requirements to limit measured angle to 10 degrees versus 14 degrees allowed in ASTM
F219413.
5. Exempt bassinets that are less than 15 inches across from the mattress flatness requirement.
In 2016, ASTM approved and published the most recent version of the standard, ASTM F219416e1, with new requirements to bring the voluntary ASTM standard in line with the mandatory standard for bassinets in 16
CFR part 1218. In developing ASTM
F219416e1, ASTM harmonized the voluntary standard with all modifications specified in part 1218. In addition to including all modifications contained in part 1218, ASTM added:
1. Additional clarification that strollers with a removable bassinet must be tested to the bassinet standard, 2. Minor formatting and editorial changes, and 3. An additional warning statement to be applied to bassinet bed products that are removable from the base/stand without the use of tools and that contain a lock/latch mechanism that secures the bassinet bed to the base/stand.
Staff assessed the additional changes to the voluntary standard, beyond harmonization with 16 CFR part 1218,
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