SUPPLEMENTARY INFORMATION:

Section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. Under this statutory direction, in January 2024 the Commission published an NPR, Safety Standard for Infant Support Cushions, to reduce the risk of death and injury associated with infant support cushions. 89 FR 2530 (Jan. 16, 2024).

An infant support cushion is defined in the NPR as “an infant product that is filled with or comprised of resilient material such as foam, fibrous batting, or granular material or with a gel, liquid, or gas, and which is marketed, designed, or intended to support an infant's weight or any portion of an infant while reclining or in a supine, prone, or recumbent position.” 89 FR 2544. This definition includes infant pillows, infant loungers, nursing pillows with a lounging function, infant props or cushions used to support an infant for activities such as “tummy time,” and other similar products. 89 FR 2530.

The Commission is now making available incident reports underlying the data discussed in the NPR, as described below.^[1] These reports have been redacted to protect personal information, confidential medical information, and other information protected from disclosure by section 6 of the Consumer Product Safety Act. 15 U.S.C. 2055.

The NPR discussed information about incidents from two databases: the Consumer Product Safety Risk Management System (CPSRMS) ^[2] and the National Electronic Injury Surveillance System (NEISS).^[3] CPSC staff searched these databases for fatalities, incidents, and concerns associated with infant support cushions and involving infants up to 12 months old, reported to have occurred between January 1, 2010, and December 31, 2022. The data for this timeframe pertained to at least 79 fatal and 124 nonfatal incidents reported to CPSC.^[4] The NPR included information about the hazard patterns of fatal and nonfatal incidents such as infants' ages, hazard scenarios, infant support cushion/infant placement, and product-specific concerns. 89 FR 2532-34.

Relevant data from CPSRMS include incident reports from medical examiners, consumers, death certificates, and manufacturers. Some of the incident data relied on for the rulemaking were obtained from 83 in-depth investigations (IDIs) conducted by CPSC. Among these IDIs, 73 were fatal incidents and 10 were nonfatal incidents. The Commission also obtained information from reports submitted by consumers, medical examiners, and the Food and Drug Administration concerning five other fatal incidents and 58 nonfatal incidents involving falls (29 incidents), threatened asphyxiation (26 incidents), and one incident report each of limb entrapment, choking and near strangulation. 89 FR 2533.^[5] Incident data has been redacted for personally identifiable information or confidential information, as required by law and any applicable confidentiality agreements.

The Commission also relied on data from NEISS that contains incidents and injuries treated in U.S. hospital emergency departments. One of these incidents resulted in a fatality. The Commission relied on 26 NEISS records associated with infant support cushions, as summarized in a spreadsheet of these NEISS incidents.

The Commission invites comments on the incident data and analysis of this data in the NPR. CPSC is making available for review and comment the incident reports relied upon and discussed in the NPR, to the extent allowed by applicable law, along with the associated IDIs. To obtain access to the data, submit a request to: https://forms.office.com/​g/​AJ1JCDNuKD. You will then receive a website link to access the data for this rulemaking at the email address you provide. Information on how to submit comments and contact information for CPSC's Office of the Secretary are in the ADDRESSES section of this notice.

89 FR 30295