[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Proposed Rules]
[Pages 30294-30295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08606]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1242

[Docket No. CPSC-2023-0037]


Notice of Availability and Request for Comments: Data Regarding 
Incidents Associated With Nursing Pillows

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 September 2023 
to address the risk of death and injury associated with infant 
suffocations, entrapments, falls, and other hazards associated with 
nursing pillows. 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 nursing pillows. The 
Commission is also seeking comments on how a final rule should address 
nursing pillow covers.

DATES: Submit comments by May 23, 2024.

ADDRESSES: Submit comments, identified by Docket No. CPSC-2023-0037, 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-2023-0037 in the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Timothy Smith, Project Manager, 
Directorate for Engineering Sciences, U.S. Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; email: 
[email protected]; telephone: (301) 987-2557.

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 September 2023, the 
Commission published an NPR, Safety Standard for Nursing Pillows, to 
reduce the risk of death and injury associated with nursing pillows. 88 
FR 65865 (Sept. 26, 2023).
    A nursing pillow is any product intended, marketed, or designed to 
position and support an infant close to a caregiver's body while 
breastfeeding or bottle feeding. These products rest upon, wrap around, 
or are worn by a caregiver in a seated or reclined position. The 
Commission is considering how slipcovers (i.e., removable nursing 
pillow covers) should be regulated as part of nursing pillows. For 
instance, should the definition of ``nursing pillow'' specifically 
state that a slipcover sold as part of the nursing pillow is included 
within definition of a nursing pillow? Additionally, slipcovers sold 
with the nursing pillows can consist of those that are only intended to 
fit over the nursing pillow to change its look, or it can contain 
buckles or straps needed to attach or wear the nursing pillow. Should 
the Commission distinguish between slipcovers that do or do not contain 
functional attachments such as buckles and straps? Manufacturers of 
nursing pillows often sell replacement slipcovers. Should these 
replacement slipcovers, sold by the original manufacturer of the 
nursing pillow, be included within the definition of ``nursing 
pillow''? The Commission invites public comments answering these 
questions and discussing how slipcovers should be regulated in the 
final rule.
    In addition, the Commission is now making available incident 
reports underlying the data discussed in the NPR.\1\ These reports have 
been redacted to protect personal information, confidential medical 
information, and other information protected from disclosure by section 
6 of the CPSA. 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 contains information about incidents from two databases: 
the Consumer Product Safety Risk Management System (CPSRMS) \2\ and the 
National Electronic Injury Surveillance System (NEISS).\3\ Staff

[[Page 30295]]

searched these databases for fatalities and incidents associated with 
nursing pillows and involving infants up to 12 months old (where the 
age was known), reported to have occurred between January 1, 2010, and 
December 31, 2022. For this timeframe, staff identified 154 fatal and 
34 nonfatal incidents reported to CPSC. The NPR included information 
about the hazard patterns of fatal and nonfatal incidents, such as 
infants' ages, hazard scenarios, nursing pillow/infant placement, and 
product-specific concerns.
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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 to make timely 
national estimates of the number of injuries associated with 
specific consumer products.
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    Relevant data from CPSRMS include incident reports from medical 
examiners, consumers, death certificates, and manufacturers. Some of 
the incident data are obtained from 124 in-depth investigations (IDIs) 
conducted by CPSC. Among these IDIs, 122 involved fatal incidents, and 
two involved nonfatal incidents. Other incident data was reported by 
firms to CPSC under section 15(b) of the CPSA, 15 U.S.C. 2064(b), which 
included 13 non-fatal incidents. CPSC also relied on incidents received 
from the public and state and local government agencies as well as 
medical examiner/coroner reports, which included 24 fatal incidents and 
one nonfatal incident. In addition, the data includes information 
obtained from eight death certificates.
    Data from NEISS contain incidents and injuries treated in U.S. 
hospital emergency departments. CPSC staff performed multiple searches 
consisting of a combination of product codes and narrative keyword 
searches to find nursing pillow incidents in NEISS. The first data 
search included all reports with the product code that includes nursing 
pillows (code 4050 Pillows excl. water pillows). The second data search 
looked for specific keywords \4\ in the narrative field across all 
product codes. Subsequent searches included several infant-related 
product codes \5\ and searches in the narrative field for keywords 
related to known manufacturer names.\6\ Staff then analyzed the results 
and determined that an event was in-scope if the product involved was 
identified as a nursing pillow that played a contributing role in the 
incident. Staff also included events as in-scope only if the infant was 
up to 12 months of age, or age was unknown but the incident likely 
involved an infant based on the description of the incident. The data 
were extracted in January 2023. The Commission relied on 18 records of 
nonfatal incidents from NEISS, associated with nursing pillows, all 
involving injuries resulting from falls.
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    \4\ Nurse pillo/nursi/feeding pillo/feed pillo/shape pillo/
shaped pillo/support pillo/boppy/docka/dock a/atot/baby nest/
flathead/flat head/pillow/pilow/feeding/bop.
    \5\ Code 1513 Playpens and play yards, code 1529 Portable cribs, 
code 1537 Bassinets or cradles, code 1542 Baby mattresses or pads, 
code 1543 Cribs, nonportable, code 1545 Cribs, not specified, code 
1552 Cribs, nonportable or not specified, code 1562 Other soft baby 
carriers, code 4002 Bedding, not specified, code 4010 Mattresses, 
not specified, code 4082 Toddler beds, and code 9101 No clerical 
coding--retailer report.
    \6\ Pilo/pillo/bop/shape/shappe/nurs/loung/docka/dock a/atot/
nest/tofoan/to foan/frida/brest frien/breast frien/bamibi/bambi/
balboa/mombo/lat nurs/miracl/minky/kids n such/snuggle/tillyou/till 
you/maman/doc a/occo/leach/cuddle/podster/nogg/tummy/choice/
elephant/horsesh/horse sho/donut/circular/plush/peanut/doc-a comfy/
kaki/iblin/lyu/yumo/onr/majik/cheer/lovel/humble bee/humble-bee/
graco/luna lul/ergob/ergo b/Infantin/chilling home/chillinghome/
blublu/twinz/twin z/lansino/Beaba/MomCozy/miracle baby/Ingenuity/
Babestellar/Babymoov/Kushies/nesting pill/ecohealth pill/Sustainable 
Baby/zzzpal/zzz pal/Feeding Friend.
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    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/jrUSbYnWGx. 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. 2024-08606 Filed 4-22-24; 8:45 am]
BILLING CODE 6355-01-P