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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
scope and data concerns submitted by commenters on the inclusion of unregulated flat sleep products, by specifically listing the products included within the scope of the final rule in this preamble, reviewing incident data and hazard patterns associated with flat products, and by demonstrating that the requirements in the bassinet standard are adequate to address the risk of injury associated with flat infant sleep products. CPSCs description of the scope of the rule throughout the 2019 SNPR and Staffs SNPR Briefing Package, and the request for comment on these products including a 30 day comment extension, were sufficient to inform stakeholders that these unregulated flat sleep products were included within the scope of the rule. Moreover, the Commission received comments on the inclusion of flat sleep products within the scope of the rule, demonstrating knowledge of their inclusion.
Comment 36: A commenter states that CPSC had been participating collaboratively with the ASTM
committee for ASTM F3118 before the summer of 2019, when the commenter states the Commission rescinded its rulemaking to adopt ASTM F3118 as a mandatory standard, and to modify the standard through the SNPR. The commenter states that the better practice would be to issue an advanced notice of proposed rulemaking ANPR while also seeking modifications to ASTM F3118
through the ASTM process, so that stakeholders can work with urgency toward addressing CPSC incident data to develop a performance-based standard, versus a design restrictive standard. The commenter also expressed disappointment that CPSC is subverting the ASTM process, which has a proven track record for resolving product problems. The commenter requests that CPSC correct its course and provide the relevant data to the ASTM committee, so that the committee can address the problems associated with inclined sleep products through the ASTM process. The commenter requests that CPSC hold the SNPR in abeyance while proceeding as the commenter has suggested, with an ANPR and working through the ASTM
process.
Response 36: Although staff submitted an NPR termination package for infant inclined sleep products to the Commission on June 12, 2019, the Commission never voted on the termination package. Instead, the Commission voted 50 on October 25, 2019 to issue the SNPR for infant sleep products.

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Generally, CPSC staffs work through the ASTM process to improve the requirements of voluntary standards to address hazards associated with durable infant or toddler products has improved the safety of these products, and CPSC
will continue its work through the ASTM process. Accordingly, CPSC did not, and is not, subverting the ASTM
process to address the hazards associated with inclined and flat sleep products. CPSC staff has been participating in the infant inclined sleep product standards development process, as well as the bassinet and cradle standards development committee, for many years, both before and after the Commission issued the 2019 SNPR.
ASTM did not hold subcommittee meetings or task group meetings on inclined sleep products or the SNPR for almost one full year after the October 2019 ASTM meetings, and did not schedule any meetings until after CPSC
staff sent a letter to the ASTM
subcommittee for infant inclined sleep products on July 16, 2020. 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. A more detailed description of this ballot is in section V.A.3 of this preamble.
However, in January 2021, the ballot did not pass due to six negative votes. 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.
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. However, we note that a task group to review safe sleep requirements across infant sleep product standards the comparison task group has met four times since the January 27, 2021
meeting. CPSC staff has participated in all of these ASTM efforts, including commenting on ASTMs ballot.
The December 2020 ASTM ballot to revise the title, introduction, and scope of ASTM F3118, and the January 2021
meeting to discuss the negatives on the ballot, demonstrate that ASTM members
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do not have a consensus on moving forward to address the hazards associated with infant sleep products, despite CPSCs 2019 SNPR and staffs continued participation in the process.
Although ASTM task groups continue to work on revisions to the voluntary standard, staff reports that the ASTM
process is not close to completing their work, and staff was not confident that ASTM would achieve consensus on revisions to the standard in the near term.
In a recent ASTM task group meeting on revisions to the title, introduction, and scope of the standard April 22, 2021, task group members discussed balloting the proposed regulatory text in the 2019 SNPR to replace ASTM F3118
17a, 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. However, the task group did not plan to ballot the requirement that all infant sleep products meet the bassinet standard, because an ASTM task group is attempting to identify minimum safe sleep requirements that could apply to infant sleep products to include in F3118. Staff is participating in this effort as well, but, based on the assessment in this final rule, does not believe 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.
Section 104 of the CPSIA requires CPSC to consult regarding the effectiveness of the voluntary standard;
it does not require CPSC to consult on the timing of rulemaking, the content of a rule outside the rulemaking process, or to delay rulemaking until ASTM
members achieve consensus. Moreover, stakeholders have now had sufficient time to consider and comment on the Mannen Study, which has been available on CPSCs website as an attachment to Staffs SNPR Briefing Package since October 2019, and how to address hazards associated with products within the scope of the SNPR, through the rulemaking and the ASTM
processes. Despite having a year and a half to make progress through the ASTM
process, stakeholders have not achieved consensus on how to move forward.
When ASTM members do not have, or cannot achieve, consensus on whether or how a voluntary standard can address associated hazards, product safety is not improved.
The Commissions statutory mandate under section 104 of the CPSIA is to ensure that durable infant or toddler
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