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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
from the current bassinet standard will result in a safe sleep product.32

VI. Assessment of the Voluntary Standards To Address Identified Hazard Patterns Associated With Infant Sleep Products
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A. Inclined Sleep Products The 2019 SNPR assessed the adequacy of ASTM F311817a to address the risk of injury associated with inclined sleep products. 84 FR
6095556. The assessment relied, in part, on the Mannen Study regarding the safety of inclined sleep surfaces for infant sleep, attached as Tab B to Staffs SNPR Briefing Package, and also summarized in the 2019 SNPR. Id. at 60954. Based on the Mannen Study, CPSC staff advised that a flat sleep surface, meaning one that does not exceed 10 degrees from the horizontal, is the safest sleep surface for infants. Id.
Accordingly, the Commission proposed in the 2019 SNPR to remove the term inclined in CPSCs mandatory standard, and to require that all sleep products not otherwise subject to a CPSC sleep standard full-size cribs, non-full-size cribs, play yards, bedside sleepers, and bassinets and cradles, meet the requirements of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, which, among other requirements, mandates a seat back/
sleep surface angle intended for sleep to be 10 degrees or less from horizontal. Id.
Here, we summarize the results of the Mannen Study again, summarize the assessment of ASTM F311817a in the 2019 SNPR, and update our assessment to determine whether the voluntary standards, ASTM F311817a, or ASTM
F219416e1, are adequate to address the incidents associated with inclined sleep products, including the 71 new incidents reported since the 2019 SNPR.
Based on the following analysis, the Commission determines that ASTM
F311817a is inadequate to address the risk of injury associated with inclined sleep products, and that more stringent requirements are necessary in the final rule to further reduce the risk of injury associated with infant inclined sleep products. Specifically, the Commission determines that the performance requirements in the mandatory standard, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, would adequately address the risk of injury associated with these products.
32 See July 8, 2020 Letter from C. Kish to ASTM
Subcommittee for In-bed Sleepers, available at:
https www.cpsc.gov/s3fs-public/InbedSleepers_
07082020ASTM%20Letter.pdf?3SpzS3cG3zv PjCLFamcCz.9FxNjpUu2s.

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1. Mannen Study Summary During the development of the 2019
SNPR, staff reviewed 450 incidents, 59
were deaths that occurred while in infant inclined sleep products.
Commission staff contracted with Dr.
Erin Mannen, Ph.D., a mechanical engineer with a biomechanics specialization, to conduct infant testing to evaluate the design of inclined sleep products. The Mannen Study examined how the degree of a seatback angle affects an infants ability to move within the products and whether those designs directly impact safety or present a risk factor that could contribute to the suffocation of an infant. The testing compared infants muscle movement and oxygen saturation on a flat crib mattress at 0 degrees, 10 degrees, and 20
degrees, versus seven different inclined sleep products. The Mannen Study concluded that none of the inclined sleep products tested were safe for infant sleep. Id.
The Mannen Study concluded that muscle activity for infants who rolled over in inclined sleep products with a 20-degree incline sleep surface was significantly different than in products with a zero-degree incline surface. The increased demand on the abdominal muscles could lead to increased fatigue and suffocation if an infant is unable to reposition themselves after rolling from a supine to prone position. The Mannen Study also concluded that inclined sleep products with a 10-degree or less sleep surface incline do not significantly impact infant motion or muscle activity.
Based on the Mannen Study, staff recommended that 10 degrees is the maximum sleep surface angle that should be allowed for any product intended for infant sleep, similar to the requirements found in the EN 1130:2019
childrens cribs, EN 1466:2014 carry cots, and the AS/NZS 4385:96 infant rocking cradles international standards.
Id.
2. Hazard Pattern Categories In the 2019 SNPR, CPSC reviewed 451
reported incidents involving inclined sleep products, which included 59
fatalities and 96 injuries. CPSC
identified seven hazards that involved deaths and injuries for this analysis, we did not consider patterns, such as consumer comments, that did not involve injuries or deaths:
Design issues 31 percent. This hazard involved 19 deaths, 17 resulting from infants rolling over into a prone face down position. An additional 71
injuries were reported in this category, including five hospitalizations and four emergency department visits. Thirty-

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three percent of the reported incidents involved infants rolling from their original supine on their back position.
Electrical issues 28 percent. This hazard involved no deaths and two reports of injuries.
Undetermined 8 percent. This hazard involved 28 deaths and six injuries. Among the 28 deaths, staff was unable to determine the products role, but often unsafe sleep environment was cited as a co-contributing condition to sudden infant death syndrome SIDS.
Structural Integrity 6 percent. This hazard involved no deaths and two injuries.
Insufficient information 4 percent.
This hazard involved eight deaths and six injuries. The reports did not provide information on the circumstances of deaths and injuries involved unspecified falls.
Other Product-Related Issues 3
percent. This hazard involved no deaths and nine injuries. The category includes reports of instability product tipping over and inadequacy of restraints, and most of the injuries involved falls.
Infant placement issues 1 percent.
This hazard involved four deaths and no injuries. Three of the four deaths involved infants placed in a prone position.
Id. at 6095253.
Since the 2019 SNPR, CPSC received a total of 71 new incident reports related to inclined sleep products. While the distribution of the data in this update varies somewhat, staff advises that the broader hazard categories are very similar. The 71 new reports included 10
fatalities and 17 injuries. Of the 10
fatalities, three deaths involved an infant who rolled from a supine position, one death involved an overturned sleeper, one death involved an infant placed with a blanket, and five deaths without reports containing information on the circumstances of the death. Of the 17 injuries 12 involved design issues, two involved structural integrity, and two involved unspecified falls.
3. Assessment of ASTM Standards in Addressing Hazards Below we summarize the hazard patterns associated with deaths and injuries from all 522 incident reports related to inclined sleep products CPSC
received and reviewed since the 2017
NPR. CPSC did not consider patterns, such as consumer comments, that did not involve injuries or deaths. The 522
incidents involved 69 deaths and 113
injuries. We assesses the adequacy of the voluntary standard for infant
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