Federal Register - June 23, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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TABLE 3REGULATED INFANT SLEEP PRODUCTS AND APPLICABLE STANDARDS
Product
Voluntary standard
Bassinet/Cradle
Full-Size Crib
Non-Full-Size Crib
Play Yard
Bedside Sleeper
Some products currently marketed or intended for infant sleep are not regulated by one of the five existing CPSC sleep standards. Additionally, new products continue to enter the market for infant sleep, but some are also not within the scope of an existing CPSC sleep standard. Such products may not follow safe sleep principles, and are not tested for compliance to a CPSC sleep standard. These unregulated sleep products collectively include products such as: Infant inclined sleep products, in-bed sleepers, baby boxes, compact/travel bassinets without handles or handholds, and infant travel tents. Hand-held bassinet/cradles are regulated as part of 16 CFR part 1225, Safety Standard for Hand-Held Infant Carriers, but part 1225 does not address hazards associated with infant sleep.
Accordingly, hand-held carriers are unregulated if marketed or intended for infant sleep.
The final rule seeks to address hazards associated with infant sleep products, both inclined and flat.
Products that already meet a CPSC sleep standard are, by definition, outside the scope of the rule. The final rule addresses hazards associated with infant sleep products by requiring them to meet the requirements of the bassinet and cradle standard, 16 CFR part 1218, including conforming to the definition of a bassinet/cradle.
V. Voluntary Standards Overview ASTM F3118 and ASTM F2194
A. Infant Inclined Sleep Products ASTM F3118
1. History As a result of incidents associated with the use of inclined sleep products, the Commission directed CPSC staff to work with ASTM to develop voluntary
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22 CPSCs
mandatory standard, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, incorporates by reference ASTM F219413, Standard Consumer Safety Specification for Bassinets and Cradles, with modifications to make the standard more stringent. In 2016, ASTM revised the voluntary standard to include the modifications set forth in the mandatory standard. Accordingly, ASTM F219416e1 is substantially similar to the mandatory standard, and we assess this version of the voluntary standard in this preamble, to simplify our analysis.
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Mandatory standard 16
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2. Description The 2017 NPR described the key provisions of ASTM F311817, including: Scope, terminology, general requirements, performance requirements, test methods, marking and labeling, and instructional literature. 82 FR at 16967. The 2019
SNPR proposed to incorporate by reference the most recent version of the voluntary standard, ASTM F311817a, which is substantially the same as ASTM F311817, except that the accessory definition was updated to match the modification recommended in the 2017 NPR. Like the previous version, ASTM F311817a describes the scope of the voluntary standard, defines terms for various types of infant inclined sleep products, and sets out requirements for performance such as for structural integrity and stability and for warnings and instructions. As discussed elsewhere in this preamble, CPSCs final rule makes substantial modifications to ASTM F311817a.
standard to address hammocks and inclined sleep products, whose product characteristics at that time did not appear to align with bassinets, because the bassinets standard requires a sleep surface of 10 degrees or less, while the inclined product category at that time included products with an incline of 10
to 30 degrees. Staff has been actively participating in the development of the voluntary standard for inclined sleep products since then.
CPSC staff participated in the ASTM
process by attending meetings,23
working on task groups, commenting on ballots,24 and providing incident data.
CPSC staff provided incident data and hazard pattern analysis associated with inclined sleep products for the 2017
NPR and the 2019 SNPR, and updated this information in this final rule preamble. Additionally, staff last provided ASTM with incident data associated with inclined sleep products in May 2018.
Since the SNPR published on November 12, 2019, ASTM has not updated ASTM F311817a to address hazards associated with inclined products. 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 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
3. CPSC Staffs Work Within the ASTM
Process CPSC staffs work on the infant inclined sleep product voluntary standard arose from staffs work through the ASTM process on the voluntary standard for bassinets and cradles in approximately 2011, in preparation for a proposed rule on bassinets and cradles. ASTM began developing the infant inclined sleep products voluntary
23 Meeting logs detailing CPSCs work with ASTM
on the infant inclined sleep product voluntary standard can be found here: https www.cpsc.gov/
Newsroom/FOIA/ReportList?field_nfr_date_value %5Bvalue%5D%5Bmonth%5D=&field_nfr_date_
value_1%5Bvalue%5D%5Byear%5D=&field_nfr_
type_value=meeting&title=incline&=Apply.
24 CPSC staffs correspondence with ASTM since issuing the 2017 NPR regarding these products can be found on www.regulations.gov under supporting materials: https www.regulations.gov/docket/
CPSC-2017-0020/document?documentTypes=
Supporting%20%26%20Related%20Material.
requirements to address the hazard patterns related to the use of inclined sleep products. ASTM first approved ASTM F3118 on April 1, 2015, and published it in May 2015. Through the ASTM process, CPSC staff consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and members of the public. The current standard, ASTM F311817a, was approved on September 1, 2017, and published in October 2017. This is the fourth revision of the standard since it was first published in May 2015. ASTM
F311817a states that it is intended to address hazards from falls, positional asphyxiation, and obstruction of nose and mouth by bedding.
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