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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations bassinets standard similarly includes requirements that address the unintentional folding hazard and requirements that address the false latching of a removable bassinet bed.
Therefore, staff assesses that the ASTM
F219416e1 bassinets standards latching requirements are adequate.
iv. Stability Requirements The EN 12790:2009 standard requires products with a test mass not to tip over when placed on a 15-degree surface.
The test mass for cradles designed for occupants up to 13.22 pounds is 19.84
pounds. The test mass for cradles designed for occupants up to 19.87
pounds is 33.06 pounds. This standard simulates the stability of an occupied
reclined cradle on an uneven surface.
This is different compared to the ASTM
F219416e1 bassinets standard, which requires the product with simulated newborn occupant to withstand a 23-lb.
vertical force and 5-lb. horizontal force along its side, without tipping. The rationale in ASTM F2194 states the dual application of forces simulates a 2-yearold male pulling on the side of the product; staff concludes that this is a reasonable scenario in which the product may tip over.
v. EN 12790:2009 Summary The EN 12790:2009 reclined cradle standard is less stringent than the ASTM F219416e1 bassinets standard by not requiring any minimum side
height for containment and permits a more inclined sleep surface angle for products that include reclined cradles and car seats for children up to 19.84
pounds.
C. Applicability of ASTM F219416e1 to Flat Sleep Product Hazards Table 5 summarizes the hazards associated with flat sleep products and how each hazard category is addressed by the voluntary standard for bassinets, ASTM F219416e1. Table 5
demonstrates that four hazard categories shaded are addressed by ASTM
F219416e1: Latching, Falls/
Containment, Instability, and Asphyxiation/Suffocation.

TABLE 5FLAT SLEEP PRODUCT HAZARDS ADDRESSED BY BASSINETS VOLUNTARY STANDARD
Infant sleep hazards
Applicable voluntary standard
Product
Latching
Asphyxiation/
suffocation
Instability
Miscellaneous product-related
Flat Sleep Products flat and inclined.

115 incidents:
Not currently addressed.

12 incidents: 1
death. Not currently addressed.

12 incidents: 2
injuries. Not currently addressed.

9 incidents: 8 deaths; not currently addressed.

3 mold-related incidents; not currently addressed.

Bassinet/Cradle

ASTM F2194
16e1.

Unintentional folding requirement.

Side height requirement.

Stability requirement.

Max sleep surface angle defined in definition;
Restraints not allowed;
Flatness/hazardous Vs identified; Pad dimensions; Corner posts;
fabric sided enclosed openings; Spacing;
Mesh openings.

Not currently addressed; task group work.

Based on this assessment of the hazards associated with flat sleep products, and consistent with the 2019
SNPR, the final rule requires that all infant sleep products not already regulated by a CPSC sleep standard meet the requirements in the ASTM
F219416e1 bassinets standard, as provided in 16 CFR part 1218, to address the risk of injury associated with these sleep products. Specifically, the final rule requires that infant sleep products, meaning products that are marketed or intended as a sleeping accommodation for an infant up to 5
months of age, and that are not subject to a CPSC sleep standard bassinets and cradles, cribs full-size and non-fullsize, play yards, or bedside sleepers, meet the requirements of 16 CFR part 1218, including conforming to the definition of a bassinet/cradle.
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Falls/
containment
VII. Response to Comments The Commission collected comments on the 2017 NPR, which proposed to incorporate by reference the thencurrent voluntary standard for infant inclined sleep products, ASTM F3118
17, with a modification to the standards
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definition of accessory. 82 FR 16964
April 7, 2017. The Commission also collected comments on the 2019 SNPR, which proposed to incorporate by reference the current voluntary standard for infant inclined sleep products ASTM F311817a, with modifications to make the standard more stringent, to further reduce the risk of injury. 84 FR
60949 Nov. 12, 2019. The 2019 SNPR
proposed to expand the scope of the rule to include all unregulated infant sleep products, including inclined products and non-inclined, flat products. The 2019 SNPR invited the public to submit written comments during a 75-day comment period, beginning on the SNPR publication date, and ending on January 27, 2020. In response to a request for an extension of the comment period, the Commission extended the comment period by 30
days, closing on February 26, 2020. 85
FR 4918 Jan. 28, 2020.
Below we consolidate the Commissions responses to comments on the 2017 NPR and the 2019 SNPR.
In response to the 2017 NPR, the Commission received seven comments.
In response to the 2019 SNPR, the
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Undetermined 3 incidents: Two deaths. Too little information to determine addressability.
Too little information to determine addressability.

Commission received 56 comments within the comment period. We also considered two late-filed documents, one received on February 2, 2021, and one received on April 30, 2021. We organized the comments by rulemaking notice 2017 NPR or 2019 SNPR, and then by topic.
Numerous commenters on the 2019
SNPR, such as the American Academy of Pediatrics AAP, consumer groups, and individual parents, supported the SNPR, because the products covered in the final rule will be required to follow the AAP safe sleep guidelines. Based on consideration of the comments received, for the final rule, the Commission will maintain the proposed 12-month effective date, and make several clarifications, as listed in section I.F of this preamble.
A. Comments on the 2017 NPR
1. Safety of Inclined Products Comment 1: Three commenters disagreed with the 2017 NPR, stating that infant sleep products with a 30degree seat back angle are not safe and contradict the AAPs safe sleep
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