By Colleen Kave, J.D.
The agency has reevaluated its proposed safety standard in light of additional infant fatalities.
The Consumer Product Safety Commission (CPSC) issued a supplemental proposed rule (Supplemental NPR) proposing to adopt the current ASTM standard for infant inclined sleep products, with modifications that would make the mandatory standard more stringent than the voluntary standard. The Supplemental NPR relates back to an April 2017 notice of proposed rulemaking (NPR), but contains changes, including a limitation on the seat back angle for sleep to 10 degrees or less. The proposed standard would cover products intended for infant sleep that are not already addressed by another standard. Additionally, CPSC proposes to include the mandatory standard for infant sleep products in its list of notices of requirements (NORs) and to amend the consumer registration rule to identify explicitly infant sleep products as a durable infant or toddler product subject to CPSC’s consumer registration requirements. Comments on the Supplemental NPR are due by January 27, 2020 (CPSC Proposed Rule, 84 FR 60949, November 12, 2019).
Background. In April 2017, CPSC proposed a safety standard for infant inclined sleep products under the Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), which requires CPSC to promulgate consumer product safety standards for durable infant or toddler products [see Products Liability Law Daily’s April 7, 2017 analysis]. The original NPR was an outgrowth of the bassinet/cradle safety standard, intended to address products with an incline between 10 and 30 degrees from horizontal. The proposed rule incorporated by reference the then-current voluntary standard, ASTM F3118-17, as most of the requirements of that standard were sufficient to reduce the risk of injury posed by inclined sleep products. However, CPSC concluded that the definition of "accessory" should be modified by removing "rigid frame" from the language to accommodate a new product that was intended to provide sleeping accommodations for infants or newborns and attached to or was supported by another product, but did not have a rigid frame.
At the time the 2017 NPR was issued, CPSC knew of 14 fatal incidents related to infant inclined sleep products, which were reported to have occurred between January 2005 and September 2016. Staff determined that eight of the 14 infant deaths involved freestanding, framed inclined sleep products. Three infant deaths involved an unrestrained infant who was found to have rolled over into a facedown position; two additional deaths occurred when the infant reportedly rolled over into a facedown position, but the reports did not include any information about use of a restraint; and CPSC staff had little information about the cause or manner of the three remaining infant deaths. The agency’s incident data analysis in the 2017 NPR considered that these 14 fatalities and other reported incidents could be addressed by the requirements in ASTM F3118–17.
Supplemental NPR. On June 12, 2019, CPSC staff submitted a briefing package and a draft Federal Register notice to CPSC recommending that the agency terminate the 2017 NPR. By that time, CPSC had received reports of 42 additional fatalities since issuing the 2017 NPR, which were associated with rocker-like inclined sleep products. Additionally, CPSC had issued additional safety alerts and recalls involving infant inclined sleep products.
In place of the 2017 NPR, CPSC staff presented a briefing package on October 16, 2019, recommending that the agency instead issue this Supplemental NPR. In the revised document, CPSC proposes to issue a standard for infant sleep products, i.e., products that: (1) provide sleeping accommodations for infants and (2) are not currently covered by the safety standards for bassinets/cradles, cribs (full-size and non-full size), play yards, and bedside sleepers. The Supplemental NPR proposes to incorporate by reference ASTM F 3118–17a with modifications requiring that: (1) the seat back angle intended for sleep must be equal to or less than 10 degrees and (2) the infant sleep product must meet the requirements for a bassinet/cradle in the standard at 16 CFR part 1218.
The Supplemental NPR also proposes to amend the consumer registration rule to identify "infant sleep products" as a category of durable infant or toddler products under section 104(f) of the CPSIA. Additionally, the agency proposes to amend its regulation at 16 CFR part 1112 to add infant sleep products to the list of products that require third party testing.
MainStory: TopStory ProposedRules BabyProductsNews
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