[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Proposed Rules]
[Pages 30295-30296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08605]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1243

[Docket No. CPSC-2023-0047]


Notice of Availability and Request for Comment: Data Regarding 
Incidents Associated With Infant Support Cushions

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule; availability of supplemental information; 
request for comment.

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SUMMARY: The U.S. Consumer Product Safety Commission (Commission or 
CPSC) published a notice of proposed rulemaking (NPR) in January 2024 
regarding a rulemaking to address suffocation, entrapment, fall, and 
other hazards associated with infant support cushions. CPSC is 
announcing the availability of, and seeking comment on, details about 
incident data relevant to the rulemaking that are associated with 
infants and the use of infant support cushions.

DATES: Submit comments by May 23, 2024.

ADDRESSES: Submit comments, identified by Docket No. CPSC-2023-0047, by 
any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. CPSC does not accept comments 
submitted by email, except as described below. CPSC encourages you to 
submit electronic comments by using the Federal eRulemaking Portal.
    Mail/Hand Delivery/Courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Office of the Secretary, U.S. Consumer 
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 
telephone: (301) 504-7479. If you wish to submit confidential business 
information, trade secret information, or other sensitive or protected 
information that you do not want to be available to the public, you may 
submit such comments by mail, hand delivery, or courier, or you may 
email them to [email protected].
    Instructions: All submissions must include the agency name and 
docket number for this notice. CPSC may post all comments without 
change, including any personal identifiers, contact information, or 
other personal information provided, to: https://www.regulations.gov. 
Do not submit electronically: confidential business information, trade 
secret information, or other sensitive or protected information that 
you do not want to be available to the public. If you wish to submit 
such information, please submit it according to the instructions for 
mail/hand delivery/courier written submissions.
    Docket: To read background documents or comments regarding this 
proposed rulemaking, go to: https://www.regulations.gov, insert Docket 
No. CPSC-2023-0047 in the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Ashley Johnson, Project Manager, 
Directorate for Health Sciences, U.S.

[[Page 30296]]

Consumer Product Safety Commission, 5 Research Place, Rockville, MD 
20850; telephone: (301) 504-7872 email: [email protected].

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.
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    \1\ The Commission voted 5-0 on April 16, 2024, to publish this 
document. Commissioners Feldman and Dziak voted to take other action 
to change the comment period from 30 to 60 days, if a majority 
supported the change, and if a majority did not support the change, 
to approve a 30-day comment period. No other Commissioner voted to 
change the 30-day comment period, so the comment period remains 30 
days.
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    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.
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    \2\ CPSRMS includes data primarily from three groups of sources: 
incident reports, death certificates, and in-depth follow-up 
investigation reports. A large portion of CPSRMS data consists of 
incident reports from consumer complaints, media reports, medical 
examiner or coroner reports, retailer or manufacturer reports 
(incident reports received from a retailer or manufacturer involving 
a product they sell or make), safety advocacy groups, law firms, and 
federal, state, or local authorities, among others. It also contains 
death certificates that CPSC purchases from all 50 states, based on 
selected external cause of death codes (ICD-10). The third major 
component of CPSRMS is the collection of in-depth follow-up 
investigation reports. Based on the incident reports, death 
certificates, or NEISS injury reports, CPSC Field staff conduct IDIs 
(on-site, via telephone, or online) of incidents, deaths, and 
injuries, which are then stored in CPSRMS.
    \3\ NEISS is the source of the injury estimates; it is a 
statistically valid injury surveillance system. NEISS injury data 
are gathered from emergency departments of about 100 hospitals, with 
24-hour emergency departments and at least six beds, selected as a 
probability sample of all U.S. hospitals. The surveillance data 
gathered from the sample hospitals enable CPSC staff to make timely 
national estimates of the number of injuries associated with 
specific consumer products.
    \4\ The NPR listed 125 nonfatal incidents, but one of those 
incidents was a duplicate.
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    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.
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    \5\ As stated above, one incident reported in the NPR (a 
threatened asphyxiation) has been removed as a duplicate.
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    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.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-08605 Filed 4-22-24; 8:45 am]
BILLING CODE 6355-01-P