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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
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inclined sleep products ASTM F3118
and the adequacy of the voluntary standard for bassinets ASTM F2194 in addressing hazards associated with injuries and deaths.
In the 2019 SNPR, CPSC determined that the voluntary standard for infant inclined sleep products, ASTM F3118
17a, is inadequate to address the risk of injury associated with the incline of sleep products, because the standard allows for products with a seatback angle greater than 10 degrees. Id. at 6095556. The majority of deaths in which the circumstances were known were due to suffocation after the infant rolled over in the product, and the same hazard pattern was reported in nonfatal incidents. For the mandatory standard, CPSC proposed to modify ASTM
F311817a to limit the seatback angle for all infant sleep products to 10
degrees or less, and to replace the performance requirements with the performance requirements in 16 CFR
part 1218, Safety Standard for Bassinets and Cradles, which incorporates by reference ASTM F219413 Standard Consumer Safety Specification for Bassinets and Cradles, with modifications. With the modifications in the mandatory standard, the standard is substantially similar to ASTM F2194
16e1, which we use for the assessment here.
a Hazard: Design Issues When combining the data from the 2019 SNPR with new incident data received since the SNPR, the design issues hazard is associated with 22
deaths and 83 injuries. At least 20
deaths involved infants rolling into a prone position face down and suffocating. More than one-third of the incidents also reported that infants rolled overfully or partiallyfrom their original supine on their back position.
In the 2019 SNPR, we concluded that a flat sleeping surface that does not exceed 10 degrees from horizontal offers infants the safest sleep environment.
This conclusion was based on findings from the Mannen Study. 84 FR at 6095556. Although some comments to the 2019 SNPR stated that more testing should be done to determine if the maximum angle for safe sleep may be between 10 degrees to 20 degrees, the Mannen Study suggested if future work were done on safe sleep angles, one area of study would be additional biomechanical testing to determine which, if any, angles between 10- and 20-degrees may be safe for infant sleep.
The Mannen Study recommendations do not imply that an incline angle between 10 and 20 degrees may be safe
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for infant sleep, merely that if higher angles are considered, additional biomechanical testing is required. The Mannen Study also stated that its testing of awake infants was a limitation because while the muscle use and motion may be similar, it is likely that infants who find themselves in a compromised position in an inclined sleep product during a nap or overnight sleep may not have enough energy or alertness to achieve self-correction and may succumb to suffocation earlier or more easily than infants who are fully awake.
Given the vulnerability of newborn infants and infant fatalities who were most likely asleep at the time of incidents in inclined products, we conclude that additional research of inclines above 10 degrees is unnecessary for the final rule. Based on the biomechanical results of the Mannen Study, and its conclusion that 10 degrees is likely a safe incline for infant sleep, which supports the 10
degrees stated in the scope of ASTM
F219416e1, the Commission concludes that 10 degrees is the maximum sleep surface angle that should be allowed for any product intended for infant sleep for young infants up to 5 months old.
Additionally, other research 33 has demonstrated a discernable difference in infant ability between 5, 7, and 10
degrees in a side-to-side tilt, which formed the basis of the 7-degree maximum sleep surface angle in Health Canadas regulations. Staff advises that additional research at angles higher than 10 degrees is unlikely to alter their assessment that 10 degrees is the maximum safe incline for infant sleep.
The current voluntary standard for infant inclined sleep products, ASTM
F311817a, defines an inclined sleep product, in part, as having a seatback angle greater than 10 degrees and not exceeding 30 degrees. Based on the Mannen Study and the other factors discussed above, we conclude that ASTM F311817a does not adequately address the risk of injury related to a sleep surface incline greater than 10
degrees, because the voluntary standard does not limit the sleep surface to a safe incline angle. In comparison, the voluntary standard for bassinets, ASTM
F219416e1, defines a sleep surface as being less than or equal to 10 degrees, and includes performance requirements for mattress flatness that limit measured
angles to 10 degrees or less.34 Therefore, for the mandatory standard specified in this final rule, with respect to sleep surfaces, all infant sleep products, including inclined sleep products, must meet the more stringent sleep surface angle requirement of the voluntary standard for bassinets, ASTM F2194
16e1, as codified in 16 CFR part 1218, to further reduce the risk of death from suffocation.

33 Beal SM, Moore L, Collett M, Montgomery B, Sprod C, Beal A. The danger of freely rocking cradles. J Paediatr Child Health. 1995 Feb;311:38
40. doi: 10.1111/j.14401754.1995.tb02910.x. PMID:
7748688.

34 In the final rule for bassinets, the Commission stated they intended to limit the scope of the bassinet standard to exclude all inclined products when the incline is more than 10 degrees from horizontal. 78 FR 63,021.

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b Hazard: Undetermined Product Issue This hazard category is associated with 28 deaths and six injuries. Among the 28 deaths and six injuries, staff was unable to determine the products role.
Without information on the products role in deaths or injuries, we are unable to assess whether the voluntary standard for infant inclined sleep, ASTM F311817a, or the voluntary standard for bassinets, ASTM F2194
16e1, would adequately address the hazards in this category.
c Hazard: Insufficient Information This hazard category is associated with 13 deaths and eight injuries. The reports did not provide information on the circumstances of deaths and injury reports involving unspecified falls.
Without information on the circumstances of deaths or injuries, staff is unable to assess if the voluntary standard for infant inclined sleep, ASTM F311817a, or the voluntary standard for bassinets, ASTM F2194
16e1, would adequately address the hazards in this category. Falls are discussed in more detail in Other Product-Related Issues, below.
d Hazard: Infant Placement This hazard category is associated with five deaths and no injuries. Three of the deaths involved infants placed in a prone position, and one death involved an infant placed in a supine position with a blanket covering the face. Based on the Mannen study, sleep surfaces with a 20-degree incline significantly increased the demand on abdominal muscles and could lead to increased fatigue and suffocation if an infant is unable to reposition themselves after rolling from a supine to prone position. In three of the deaths in this hazard category, the infant was placed in the prone position and the inclined sleep surface may have contributed to suffocation if the angle of the sleep surface led to fatigue that prevented the infant from rolling to a supine position.

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