[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\5\ As stated above, one incident reported in the NPR (a
threatened asphyxiation) has been removed as a duplicate.
---------------------------------------------------------------------------
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