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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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While infants can die in flat products when placed to sleep in the prone position, based on the Mannen Study, an inclined surface could further contribute to deaths in the prone position. A sleep surface limited to a 10degree or less incline, as required in the bassinet standard ASTM F219416e1, could reduce the risk of injury associated with the prone position, when compared to an inclined sleep product. Therefore, with respect to sleep surfaces, for the mandatory rule, all infant sleep products, including inclined sleep products, must meet the more stringent sleep surface angle requirement of the voluntary standard for bassinets, ASTM F219416e1, as set forth in 16 CFR part 1218, to further reduce the risk of death from suffocation.
e Hazard: Other Product-Related Issues Instability, Restraints, etc.
This hazard category includes reports of instability product tipping over and containment; the category is associated with one death and nine injuries. One death occurred when a foam-type reclined product tipped over and fell from the adult bed to the floor, trapping the infant underneath. Most of the injuries involved falls and at least 10
reports with no injury reported related to nearly or completely flipped over products.
The death, and most likely the injuries, relate to the stability of the product and how easy it is to tip the product over into a hazardous situation.
The voluntary standard for infant inclined sleep products, ASTM F3118
17a, includes two stability performance requirements that apply to Compact Inclined Sleep Products and Infant or Newborn Inclined Sleep Products. For the Compact Inclined Sleep Products, the product must remain upright when placed on a 20-degree inclined test platform. For the Infant or Newborn Inclined Sleep Products, a 23-lb.
vertical force and 5-lb. horizontal force are applied to the products side with a newborn CAMI dummy occupant to simulate an older sibling pulling up on the side to view the infant in the bassinet, and the product must remain upright containing the CAMI dummy.
The Compact Inclined Sleep Products are exempt from the 23- and 5-pound force requirements, with the rationale that the compact products are intended to sit on a floor and are unlikely to have an older sibling attempt to pull up to see the infant inside.
The current voluntary standard for bassinets, ASTM F219416e1, includes an identical stability requirement that applies a 23-lb. vertical force and a 5-

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lb. horizontal force to the product with a newborn CAMI dummy occupant, and this requirement applies to all products;
it does not provide exemptions for Compact Inclined Sleep Products to meet only the less stringent 20-degree inclined test platform test. The rationale in ASTM F2194 states the dual application of forces simulates a 2-yearold male pulling on the side of the product; staff advises that sibling interaction is a reasonable scenario which may cause the product to tip over. Due to the portability of some of the unregulated compact sleep products, incident data confirm that the products are used on raised surfaces from which infants and product may fall. Therefore, regarding the products stability, in the final rule, all infant sleep products, including inclined products, must meet the more stringent stability requirement of the voluntary standard for bassinets, ASTM F219416e1, as codified in 16
CFR part 1218, to further reduce the risk of injury from tip over of the product.
f Hazard: Structural Integrity This hazard category includes reports of some component failures on the product such as buckles/straps, hardware coming loose, hub/rail/leg coming loose, or other unspecified components breaking. This hazard category involved no deaths and four injuries. All injuries were related to falls, and include one hospitalization and three emergency department visits.
The voluntary standard for infant inclined sleep products, ASTM F3118
17a, includes performance requirements to assess the integrity of inclined sleep products. The requirements specify a dynamic test in which an 18-lb. load, consisting of a 6- to 8-inch steel shot bag, is dropped 50 times from a height of 1.0 inch onto the seat surface. The requirements also specify a static test in which a 50-lb. load or three times the products maximum recommended weight, whichever is greater, is gradually applied through a 6-inch square wooden block to the seat surface for 60 seconds. The current voluntary standard for bassinets, ASTM F2194
16e1, has a performance requirement to address structural integrity that specifies a static load test that applies a 54-lb. load or three times the manufacturers recommended weight, whichever is greater, through a 6-inch aluminum block to the sleep surface for 60 seconds. The rationale in ASTM
F2194 states 54 lbs. is three times the weight of the 95th percentile of a 3- to 5-month-old infant.
Although the voluntary standard for infant inclined sleep products, ASTM
F311817a, requires a dynamic test for
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structural integrity, its effectiveness in evaluating the products strength is minimal, compared to the static test.
The load in the dynamic test being onethird of the static load, the low drop height, short test timeframe, and presence of energy-absorbing material shot bag and flexible product material, combine to minimize the effect of this test on the products structural integrity.
In contrast, the static test applies a much larger load, three times the heaviest infant in the product, with a rigid applicator applied continuously for 60 seconds. Therefore, staff advises that the static test is the more stringent evaluator of product integrity than the dynamic test.
The static load in ASTM F219416e1
is 54 lbs., which is a more stringent load compared to the static load of 50 lbs. in ASTM F311817a. Therefore, to further reduce the risk of injury associated with structural defects, for the final rule, the Commission concludes that the static load test in ASTM F2194 is adequate to assess structural integrity of infant sleep products, and is more stringent than the static load test in ASTM F311817a.
The final rule requires that all infant sleep products, including inclined sleep products, meet the more stringent structural integrity requirement of the voluntary standard for bassinets, ASTM
F219416e1, as codified in 16 CFR part 1218.
g Hazard: Electrical Issues This hazard category involved no deaths and two reports of injuries related to electric shock. Non-injury incidents reported overheating/melting of components and issues with batteries.
As noted in the 2019 SNPR, the infant inclined sleep products standard, ASTM
F311817a, does not include any performance requirements for electrical components. 84 FR at 60956. The voluntary standard for bassinets, ASTM
F219416e1, also does not address electrical hazards. However, CPSC staff advises that they raised this issue with ASTM, and that the ASTM Ad Hoc task group is developing performance requirements to address electrical hazards across juvenile products. As these electrical requirements are added during the ASTM voluntary standard updates, CPSC can review the updated voluntary standard pursuant to the update provision in Public Law 11228, and determine whether to revise the mandatory standard based on a revised voluntary standard.

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