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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations products were included within the scope of the rule.
In addition, ASTM members had actual notice of the contents of the 2019
SNPR before and after publication.
Sections V.A.3 and V.B.2 of this preamble discuss staffs work with the ASTM subcommittees and task groups.
Staffs SNPR Briefing Package was posted on the Commissions website on October 16, 2019, before ASTM held fall meetings on voluntary standards for juvenile products, and before the Commission voted on the SNPR, so that ASTM members and other stakeholders could review the package, including the Mannen Study, before the ASTM
meetings, and so that staff could discuss the package and the Mannen Study with ASTM members. The ASTM Agenda for the Infant Inclined Sleep Products meeting that occurred on October 21, 2019 included a link to Staffs SNPR
Briefing Package. CPSC staff discussed the 2019 SNPR Briefing Package at the ASTM meetings in October 2019, including with 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.
The SNPR published in the Federal Register on November 12, 2019. In a December 12, 2019 letter to both the ASTM inclined sleep and bassinet subcommittees, CPSC staff again reiterated its concerns with weakening the safe sleep requirements in the voluntary standard for bassinets and cradles to accommodate unregulated products, such as in-bed sleepers, compact bassinets, and baby boxes.
Thus, the letter represents an additional effort to ensure that the relevant ASTM
subcommittees and thus subcommittee members were aware of CPSC staffs concerns with these products, as well as the content of the 2019 SNPR, which proposed that flat sleep products would need to meet the requirements of the bassinet standard. Even though this letter was in addition to, and not instead of, the notice provided in the 2019
SNPR, the Commission extended the comment period for an additional 30
days, to accommodate any confusion among stakeholders. The final rule addresses scope and data concerns submitted by commenters on the inclusion of unregulated flat sleep products.
With regard to in-bed sleepers, baby boxes, and compact bassinets
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specifically, ASTM members, which include manufacturers of these products, have been well aware of CPSC
staffs concerns with these products for years, based on activity on the bassinet subcommittee which has been developing requirements for these products to include in the bassinet standard, but has thus far been unsuccessful. With regard to in-bed sleepers, ASTM created a separate standards development effort for this product, which CPSC staff has participated in, and provided incident data on the products, including notice of the injuries and fatalities associated with these products. Indeed, through staffs participation in the ASTM
process, including attending meetings, providing incident data, and providing comments and votes on ballot efforts, staffs concerns with unregulated flat sleep products, and the incident data associated with these products, is not unknown to stakeholders and these commenters.
Comment 35: A commenter states that CPSC statutes require the Commission to defer to voluntary standards under certain conditions, and that CPSCs website states that CPSC follows OMB
Circular A119, but the Commission has done neither in this case. Another commenter states that the 2019 SNPR
did not rely on the ASTM consensusdriven process to develop a standard, and that CPSCs data cannot be presented belatedly to ASTM
participants, after or at the same time as the SNPR was provided to the Commission. This commenter states that while CPSC claims the process was a collaborative one, for the 2019 SNPR, the process was not.
Response 35: Rulemaking pursuant to sections 7 and 9 of the CPSA requires the Commission to rely on a voluntary standard, rather than promulgate a rule, if: 1 The voluntary standard adequately addresses the risk of injury associated with a product, and 2 there is likely to be substantial compliance with the voluntary standard. If either of these criteria are not met, the Commission may proceed with rulemaking under sections 7 and 9 of the CPSA, if the Commission can make the other required findings. Those criteria are not relevant under section 104 of the CPSIA, which requires the Commission to consult with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts, examine and assess the effectiveness of any voluntary consumer product safety standards for durable infant or toddler products, and to promulgate rules that are substantially
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the same as the voluntary standards, or more stringent than the voluntary standards, if the Commission finds that more stringent standards would further reduce the risk of injury.
Although CPSC staffs standards development work through the ASTM
process can colloquially be termed collaborative, nothing in section 104
of the CPSIA requires collaboration on a rule outside of the rulemaking process. Under section 104, the Commission is not required to defer to the voluntary standard, rather, the Commission must promulgate rules, and those rules must be substantially the same as the voluntary standard, or more stringent than the voluntary standard, if more stringent requirements would further reduce the risk of injury. Section 104 requires the Commission to consult regarding the effectiveness of a voluntary standard; the Commission is not required to consult on the timing of a proposed rule, the Commissions enforcement work, or on the content of a proposed rule outside of the rulemaking process. In the case of bassinets, unregulated flat sleep products, and inclined sleep products, staff has been consulting on the effectiveness of the voluntary standards, or lack thereof, for these products for many years.
Generally, CPSC staffs work through the ASTM process has improved the safety of durable infant or toddler products. However, nothing in section 104 of the CPSIA requires the Commission to delay addressing risks of harm to the most vulnerable infants in sleep products that parents rely upon as a safe place for an infant, until all ASTM members have reached a consensus on whether and how to create or revise a voluntary standard to address the risk. The Commission would be relinquishing the statutory mandate to protect consumers by ceding product safety to the very industry Congress required the agency to regulate. CPSC
met the requirement to consult on the effectiveness of the voluntary standards.
The lengthy record of staffs participation with the infant inclined sleep committee since the 2017 NPR is available on regulations.gov, as well as through ASTM records. A similarly robust record of staffs participation on the bassinet and cradle committee, outside of the rulemaking process, is available through ASTM, on CPSCs website, and through CPSCs Office of the Secretariat.43
Finally, as reviewed in response to comment 12, the final rule addresses 43 https cpsc.gov/Regulations-Laws--Standards/
Voluntary-Standards.

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