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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
resulted in a near-suffocation prevented by a nearby parent.
The voluntary standard for bassinets, ASTM F219416e1, addresses the asphyxiation/suffocation hazard with the following general/performance requirements:
5.10 Corner Posts: This requirement addresses corner post extensions that can entangle ribbons, pacifier cords, necklaces, or occupant clothing. Entanglement of any of these items could lead to the asphyxiation of the occupant. This requirement limits the extension of a bassinets corner post from extending more than .06 inches above the upper edge of an end or side panel. Corner posts that extend at least 16 inches above the top of a side rail are exempt because they are deemed inaccessible to the occupant. These are the same requirements found in the regulated ASTM F40619 non-fullsized cribs and ASTM F116919 fullsized cribs standards that CPSC staff previously concluded adequately address the corner post entanglement hazard.
6.1 Spacing of Rigid-Sided Bassinet/Cradle Components. This requirement limits the distance between slats to less than 238 inches to mitigate the suffocation hazard from feet-first head entrapment.
6.2 Openings for Mesh/FabricSided Bassinets/Cradle. This requirement tests openings in the bassinets mesh for entrapment of fingers, toes, and snaring buttons, often used on infant clothing. The snaring of a button entraps the button and could lead to asphyxiation as the infant becomes entangled and entrapped. In this performance requirement, the mesh-sided bassinets openings cannot allow a 14-inch rod to fit through.
6.5.3 Pad Dimensions. This requirement mitigates the hazard of suffocating when entrapped in the space between the edge of the mattress and the bassinets sidewall, by limiting the available space to less than 1 inch.
6.7 Bassinets with Segmented Mattress: Flatness Test. This requirement limits sleep surface variability of a segmented or folding mattress to 10 degrees or less. This angle was determined to reduce the likelihood of an infants face becoming engulfed by a small V shape formed by the creases in a folded mattress, potentially present in a bassinet that uses a folding play yard mattress as the bassinet mattress.
6.8 Fabric-Sided Enclosed Openings. This requirement addresses the hazard of a feet-first head entrapment through the openings of fabric-sided bassinets. This requirement limits the openings in a fabric-sided
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bassinet to prevent the 5th percentile 0
to 2-year-old torso probe from passing through. This requirement prevents a childs torso from fitting through any openings in the fabric sidewalls;
therefore, staff concludes this requirement would prevent a feet-first head entrapment.
6.9 Rock/Swing Angle. This requirement limits the bassinets sleeping surface angle to less than 20
degrees when rocked, and seven degrees when the bassinet is at rest. In the 2019
SNPR, and in this final rule, the Commission determined that a flat sleep surface that does not exceed 10 degrees offers infants the safest sleep environment. This conclusion is based on the Mannen Study.
In total, these requirements address known suffocation hazards with infant sleep and create a minimally safe sleep environment. Therefore, for the final rule, with respect to the asphyxiation/
suffocation hazard, we finalize the 2019
SNPR proposal, by requiring that all infant sleep products meet general and performance requirements of the voluntary standard for bassinets, ASTM
F219416e1, as provided in 16 CFR part 1218, to further reduce the risk of death from suffocation.
e Hazard: Product-Related Issues Three of the 183 incidents were related to mold or quality of the product material. Two of the three products were in-bed sleepers, while the third was a compact bassinet/travel bed. All three reported an injury. None of the voluntary standards currently address conditions such as mold that manifest due to the conditions under which a product is used. A moisture-resistant requirement has been discussed in the ASTM task group for baby boxes which is under the bassinet subcommittee, but the task group has not reached a consensus on appropriate performance requirements to address mold and moisture resistance. CPSC staff will continue to work with this task group.
f Hazard: Undetermined Issues Three of the 183 incidents did not have enough reported information for us to determine the issue involved. Two of the incidents were fatalities; in both cases, CPSC Field investigation reports indicate that the cause of death is undetermined. The third incident resulted in a hospitalization due to unspecified breathing difficulties suffered by the infant. The reports did not provide sufficient information on the circumstances of deaths, and injury reports involved unspecified falls.
Without information on the circumstances of deaths or injuries, we
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are unable to assess whether the voluntary standard for bassinets, ASTM
F219416e1, would adequately address the hazards in this category.
2. Assessment of International Standards a EN12790:2009 Reclined Cradles The scope of the European Standard, EN 127902009 Child use and care articlesReclined cradles includes inclined bassinets/cradles, car seat carriers, hammocks, and bouncers.
Some of the general requirements could apply, but because the scope of the products that fall within this standard is not the same as the final rule, most of the requirements are not applicable to infant sleep products.
i. Side Height The EN 12790:2009 standard does not have a side height requirement, but it includes a three-point restraint to address the containment hazard. The ASTM F219416e1 bassinet standard is more stringent by requiring a minimum side height of 7.5 inches. Restraints are an active safety feature that might not always be used, while the side height requirement is a passive safety feature.
ii. Sleep Surface Angle The EN 12790:2009 standard requires a seatback angle between 10 degrees and 80 degrees, while the ASTM F2194
16e1 bassinet standard is more stringent by requiring a maximum sleep surface angle of 10 degrees. The EN 12790:2009
standard was written for products that may or may not be intended for sleep, such as car seats, a scope that is broader than the scope of the ASTM bassinet standard. The Mannen Study concluded that a seatback angle of 10 degrees or less is safe. Accordingly, the sleep surface requirement in the final rule remains consistent with the Mannen Study findings, and as already codified in 16 CFR part 1218.
iii. Latching Requirements The EN 12790:2009 standard specifies that infant rocking cradles must have at least one automatic locking latch mechanism, and that the locking mechanisms:
Require 50N 11.24 pounds-force to unlatch after operating the latch 300
times;
Require a tool to unlatch;
Require two consecutive actions to unlatch; or Require two independent and simultaneous actions to unlatch.
The EN 12790:2009 standards latching requirement simulates the action of unintentionally folding the product. The ASTM F219416e1

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