Quiero saber acerca de...

33050

Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
yards, and bedside sleepers, and we encourage consumers to use these products for infant sleep. The Commission is aware that deaths occur in these products, but as noted, infant deaths are not always associated with the product. We particularly urge consumers to follow the AAP safe sleep recommendations when using any product intended for infant sleep. CPSC
data, in section III of this preamble Tab B of Staffs Final Rule Briefing Package, and evaluated in section VI of this preamble Tabs C and D of Staffs Final Rule Briefing Package, show that deaths and injuries occur in untested and unregulated infant sleep products, including inclined and flat sleep products, and sometimes these incidents involve a use contrary to AAP
recommendations. However, CPSCs evaluation of the incidents in section VI
of this preamble demonstrates that requiring currently unregulated infant sleep products to meet the requirements of the bassinet standard will further reduce the risk of death and injury associated with these products Tab C of Staffs Final Rule Briefing Package.
The argument that parents will use soft bedding and other tools to replace products taken off the market is the same argument used in support of creating a separate voluntary and mandatory standard for infant inclined sleep products, and infants died in these products that did not meet AAP safe sleep guidelines. Accordingly, to further reduce the risk of death and injury, the final rule requires that all products marketed or intended as a sleeping accommodation for infants up to 5
months old be tested and certified to an existing CPSC sleep standard, and that CPSC, the AAP, and the industry, continue to promote and educate caregivers about safe sleep practices for infants.

jbell on DSKJLSW7X2PROD with RULES2

b Statistically Significant Data Comment 16: One commenter questioned whether the data presented in the 2019 SNPR are statistically significant for inclined sleep products, or are the deaths due to SIDS?
Response 16: The analysis presented in the 2019 SNPR and in this final rule is based on reported incidents, and therefore, anecdotal in nature. This means that the data do not constitute a statistical sample representing all incidents related to inclined and flat sleep products; nor do the data represent a complete set of incidents that may have occurred involving the products. As such, no statistical inference is possible. However, the data do provide at least a minimum count for
VerDate Sep<11>2014

17:56 Jun 22, 2021

Jkt 253001

the number of incidents related to each type of product reviewed.
Many of the fatality reports contain unclear, conflicting, and/or inconsistent information. For example, for some deaths, medical examiners may have concluded the cause of death to be SIDS
or Sudden Unexpected Infant Death SUID, but they also may mention cocontributing conditions, such as an unsafe sleep environment e.g., soft bedding, inclined sleep surface or other pre-existing medical conditions. This can confound CPSCs ability to determine a predominant factor in the fatality. Staff used a consensus-based decision-making process to review incident data. If an unsafe sleep environment or a product design was one of the factors, staff classified the death under that category. Otherwise, staff classified the reported incident under the undetermined category, when no one factor stood out, or staff classified the incident under the insufficient information category, when staff did not have enough information to classify the incident in another category to avoid overestimating the risk.
a Additional Testing for Inclines Between 10 and 20 Degrees Comment 17: Several commenters stated that the Commission should conduct additional research on the safety of inclines between 10 and 20
degrees for infant sleep products. A
commenter stated that CPSC has failed to provide relevant data to support the 2019 SNPRs approach regarding inclined sleep products, to limit the seat back angle to 10 degrees or less, and not to conduct additional study on the 10 to 20 degree angle, or to provide information or incidents to support this decision.
Response 17: During the development of the 2019 SNPR, Commission staff contracted with Dr. Erin Mannen to examine how the degree of a seat back angle affects an infants ability to move within inclined sleep products, and if the incline angle directly impacts safety or presents a risk factor that could contribute to the suffocation of an infant.40 The Mannen Study findings showed that infants in products with a seat back angle greater than 20 degrees exhibit increased demand on their abdominal muscles. The Mannen Study concluded that this could lead to
increased fatigue and suffocation, if an infant is unable to reposition themselves after an accidental roll from supine to prone. The Mannen Study concluded that a sleep surface that is 10 degrees or less, is comparable to a crib mattress surface and can be considered a safe sleep surface. 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 above 10 degrees may be safe; rather, the Mannen Study merely suggests that if higher angles are considered, additional biomechanical testing is required. We are not aware of existing research that suggests that an inclined sleep surface between 10 and 20 degrees is safe, nor is CPSC currently conducting similar research. 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 selfcorrection and may succumb to suffocation earlier or more easily than infants who are fully awake. Given the vulnerability of newborn infants and the precedence of fatalities of infants who were most likely asleep in inclined products at the time of incidents, additional research of inclines above 10
degrees is unnecessary for the final rule.
Additionally, other research 41 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 and the 5-degree limit in the Australian requirement. The 10-degree sleep surface limit in the final rule is a slightly higher allowed sleep surface angle than other countries.
Based on the Mannen Study and the research that supports sleep surface angles in international standards reviewed by CPSC staff, staff believes that it is unlikely that additional research at angles higher than 10
degrees will demonstrate that an angle greater than 10 degrees is safe for infant sleep. Accordingly, for the final rule, infant sleep products must be tested for a seat back or sleep surface angle of 10

40 Read the full report from Dr. Mannen beginning on page 91, Tab B, of CPSC Staffs SNPR Briefing Package: https cpsc.gov/s3fs-public/
SupplementalNoticeofProposedRulemaking forInfantSleepProducts_10_16_2019.pdf.

41 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.

3. Degree of Incline
PO 00000

Frm 00030

Fmt 4701

Sfmt 4700

E:FRFM23JNR2.SGM

23JNR2