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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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TABLE 4SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTSContinued Standard
Side height requirement
Age range
16 CFR 1220Safety Standards for Non-Full-Size Baby Cribs
16 CFR 1221Safety Standards for Play Yards.
ASTM F 40619, Standard Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards.
16 CFR 1222Safety Standard for Bedside Sleepers
ASTM F290613, Standard Consumer Safety Specification for Bedside Sleepers.
ASTM F311817a, Standard Consumer Safety Specification for Infant Inclined Sleep Products.
16 CFR part 1225 Safety Standard for Hand-Held Infant Carrier
ASTM F205019 Standard Consumer Safety Specification for HandHeld Infant Carrier.

9 inches

035 inches tall 95th percentile 21-month old.

4 inches on side next to adult bed.
7.5 inches for other 3 sides.

05 months, or sit up.

3 inches
2 inches
No requirements.

05 months, or sit up.
03 months.

Inclined sleep products covered in ASTM F311817a can meet the standard with a minimum side height of 3-inches, for products intended for newborns, to 5-month of age and a minimum side height of 2-inches, for products intended for newborns up to 3-months old.
Upon review of applicable standards, CPSC staff determined that the ASTM
F219416e1 bassinets standards 7.5inch side height requirement provided the greatest safety for the intended use for newborns to 5-months of age. Staff assesses that the minimum side height requirement of 2-inches and 3-inches in ASTM F311817a is inadequate to address the incidents of infants failing to be contained in low-sided products, and the 3-inch side height is lower than the center of gravity of a 5-month-old infant on its side. Staff determined that because most flat sleep products are intended for infants under 5 months, who cannot sit upright unassisted, the side height requirement in ASTM
F219416e1 is adequate to address containment incidents. Based on staffs analysis, the Commission determines that flat sleep products with no side height requirements pose a potential fall hazard, as reflected in the incident data.
Staffs analysis demonstrates that the ASTM F219416e1 bassinets standards 7.5-inch side height requirement is appropriate and would adequately address the falls/containment hazard in flat sleep products for infants up to 5
months old or who cannot sit up unassisted. Therefore, consistent with the 2019 SNPR, the final rule requires that all infant sleep products, inclined and flat, meet the side height requirement of the ASTM F219416e1
bassinets standard, as provided in 16
CFR part 1218, to address fall/
containment hazards.
c Hazard: Instability Twelve of the 183 incidents were related to the instability of the product.
An unstable product can lead to tip-over
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incidents. Of the 12 incidents, two resulted in injuries, one involved an ED
visit. The data summarized in Tab B of the Staffs Final Rule Briefing Package includes at least one incident in a small, portable infant sleep product involving a sibling interaction resulting in a fall.
Specifically, the NEISS report states:
7WKOF WITH HEAD INJURY, FELL
FROM PORTABLE BASSINET THAT
WAS ON COUCH, APPROX 1.5FT, YOUNGER BROTHER PULLED THE
BASSINET AND IT FLIPPED ONTO
THE PLAYMAT, PT LANDED ON RT
SIDE OF HEAD. This sibling interaction-type incident is addressed by the bassinet standard, as discussed below.
Unregulated flat sleep products are not required to have a stand. Therefore, these products can be placed directly on the floor or on potentially hazardous or unstable elevated surfaces, such as tables, countertops, soft mattresses, or couches. The ASTM F219416e1
bassinets standard addresses this hazard scenario by requiring bassinets to have a stand/base/frame. ASTM F219416e1
defines a bassinet as a small bed supported by free standing legs, a stationary frame/stand, a wheeled base, a rocking base, or which can swing relative to a stationary base. This requirement to have a stand, and be raised off the floor, increases the stability of a portable product by discouraging or preventing use of the product on other, less stable, surfaces, such as elevated surfaces or soft surfaces couches and adult beds. Therefore, with respect to this hazard scenario, and as proposed in the 2019 SNPR, the final rule requires that all infant sleep products, flat and inclined, meet the ASTM F219416e1 bassinets standards requirements, including requiring products to have a stand, to further reduce the risk of injury from a product placed on a hazardous elevated surface or an unstable surface, such as a couch or adult bed. This requirement in the
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final rule is codified by requiring products to meet the definitional requirement of a bassinet/cradle.
Additionally, the ASTM F219416e1
bassinets standard addresses hazards posed by the products instability with a stability requirement. The requirement specifies that the product with simulated newborn occupant 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-year-old male pulling on the side of the product; staff assesses that this is a reasonable scenario in which the product may tip over.
Incident data also demonstrate that these compact products are used on elevated surfaces, such as beds and couches, from which the infant and product fell. Therefore, with respect to the products stability, the final rule requires that all infant sleep products meet the stability requirement of the voluntary standard for bassinets, ASTM
F219416e1, as provided in 16 CFR part 1218, to further reduce the risk of injury associated with product tip-over.
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 withstand a 10-kg approximately 22 pounds static vertical load over a period of 5 seconds and a 22 newton approximately 4.9
pounds horizontal force without tipping. Staff advises that this test is substantially equivalent to the ASTM
test, differing slightly due to conversions to metric.
d Hazard: Asphyxiation/Suffocation Nine of the 183 incidents were related to infants that partially or fully rolled over from their initial position in infant sleep products. Of the nine incidents, eight resulted in a death, and one
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