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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations VI.A.3a of this preamble, based on the Mannen Study and other factors, the Commission concludes that a flat sleeping surface that does not exceed 10
degrees from horizontal offers infants the safest sleep environment.

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iii. Latching Requirements The Canadian standard requires folding products to contain an autolocking mechanism that requires a dualsimultaneous action to disengage and that does not fold when a 52.91-pound 24kg load is applied on any area most likely to damage the mattress support.
While the Canadian standard requires an auto-locking mechanism that requires a dual-simultaneous action to disengage, it also tests the latching strength by loading the mattress support. The ASTM F219416e1
bassinet standard requires that products without a latching or locking device not fold when a 20-pound force is applied to the top edge of the bassinet in the direction most likely to cause it to fold.
The ASTM F219416e1 bassinet standard requires a lower force than the Canadian standard, but the force is applied at a higher location top side of the bassinet than the Canadian standard force applied to the mattress support. The higher location of the force could create a greater torque at the latch, due to the longer lever arm. For bassinets with a locking hinge or latch, the locking mechanism must withstand a 10-pound force in the direction most likely to release it. Determining which latching requirement is more stringent is difficult because the test parameters are not directly comparable.
The ASTM standard also includes a Removable Bassinet Bed Attachment to Base/Stand requirement and testing to address latching and locking devices intended to secure removable bassinet beds to the base/stand. These requirements and test are unique because they address known incidents of false latching of a removable bassinet bed. By considering the latching, unintentional folding, and bassinet bed attachments to the stand requirements in total, staff assesses that the ASTM
F219416e1 bassinet standards latching requirements are adequate.
iv. Stability Requirements The Canadian requirement in Schedule 11, Test for Stability of Cradles, Bassinets, and Stands, of their regulation is substantially equivalent to the requirement in ASTM F219416e1.
The requirement specifies that the product with a simulated newborn occupant must withstand a 10-kg approximately 22 pounds static vertical load over a period of 5 seconds
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and a 22 N approximately 4.9 pounds horizontal force, without tipping. Staff advises that this test evaluates the same stability hazard and is substantially equivalent to the ASTM F219416e1
bassinets standard, differing slightly due to conversions to metric.
v. SOR/2016152 Summary The Canadian standard has a side height and stability requirement similar to the ASTM F219416e1 bassinet standard. While the Canadian standard has a more stringent sleep surface angle requirement, the ASTM F219416e1
bassinet standard has a more extensive latching requirement. Staff concludes that the requirements in the ASTM
standard are adequate to address the risk of injury demonstrated in the incident data.
B. Flat Sleep Products 35
CPSC received public comments on the 2019 SNPR regarding the safety of currently unregulated flat infant sleep products available in the marketplace.
In response, for the final rule CPSC staff completed a review of CPSCs epidemiological databases, CPSRMS
and NEISS. CPSC received a total of 183
incident reports from January 1, 2019
through December 30, 2020, related to flat sleep products available in the marketplace that are currently not under the purview of any mandatory or voluntary standard that addresses sleep hazards. These flat sleep products include: In-bed sleepers, baskets that can function as hand-held carriers as well, baby boxes, compact bassinets, most of which are portable for travel, and travel tents. All of these unregulated sleep products are flat sleep surface has no incline and most come with mattress pads with the exception of some baby travel tents.
Based on the following analysis, the Commission determines that the performance and labeling requirements of the voluntary standard for bassinets and cradles, ASTM F219416e1, as codified in 16 CFR part 1218, Safety Standard for Bassinets and Cradles, are adequate to address the risk of injury associated with flat infant sleep products, and furthermore, finds that requiring flat products to conform to these requirements would also further reduce the risk of injury associated with flat sleep products.
1. Hazard Pattern Categories Of the 183 reported incidents, 11 are fatalities; among the remaining 172
35 Tab C of Staffs Final Rule Briefing Package contains CPSC staffs assessment of the adequacy of ASTM F219416e1 to address incidents associated with flat sleep products.

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nonfatal incidents, 16 reported an injury. Seven of the 11 fatalities involved suffocation. We identified six hazards related to the risk of injury or death we did not consider patterns that did not relate to injuries or deaths, such as consumer comments. The hazard patterns identified among the 183
incidents are: Lock/latch problems, falls/containment issues, instability, asphyxiation/suffocation, productrelated issues, and undetermined causes.
Engineering staff analyzed whether the voluntary standard for bassinets, ASTM F219416e1, would address the identified hazards for flat sleep products. The voluntary standard for bassinets, ASTM F219416e1, is more applicable to these flat products than ASTM F311817a, because these products have a sleep surface less than 10 degrees, and because, as set forth below, the standard addresses the identified hazards associated with these products. The current voluntary standard for infant inclined sleep products, ASTM F311817a, is not applicable to these flat sleep surface products, and it does not address hazards associated with flat sleep surfaces.
In the 2019 SNPR, the Commission proposed expanding the scope of ASTM
F311817a for the mandatory rule, to include all infant sleep products inclined and flat that are not covered by another CPSC sleep standard, including the bassinets, cribs full-size and non-full size, play yards, or bedside sleepers standards. The 2019
SNPR proposed to require that all products marketed or intended for infant sleep have a seatback angle of 10
degrees or less, and meet 16 CFR part 1218, Safety Standard for Bassinets and Cradles, which includes the performance requirements of ASTM
F219416e1 bassinets. The following are the identified hazards for flat sleep products are discussed below.
a Hazard: Lock/Latch Issue One hundred fifteen of the 183
incidents, and no deaths, were related to latches that control the opening/closing of the cover on the product failed.
Although these latch incidents did not relate to a product folding or collapsing, they illustrate, nevertheless, that these products have latch failures. From analyses on other products, staff is aware that failure of a products latch can cause the product to fold or collapse unintentionally and pose a suffocation hazard to the infant. The ASTM F2194
16e1 bassinets standard addresses hazards posed by a lock/latch failure with an unintentional folding
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