[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