Safety Standard for Infant Support Cushions, 87467-87498 [2024-25181]
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Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
43°22′14″ N, long. 72°22″6 W) for
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a typographical error. This action
corrects the error by correcting the
coordinates (lat. 43°22′14″ N, long.
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Airport.
Correction to the Final Rule
Pursuant to the authority delegated to
me, the amendment of Class E airspace
extending upward from 700 feet above
the surface for Claremont Municipal
Airport, Claremont, NH, in Docket No.
FAA–2024–1650, as published in the
Federal Register on October 3, 2024 (89
FR 80382), is corrected as follows:
§ 71.1
[Corrected]
On page 80383, in the first column,
replace the Claremont Municipal
Airport coordinates (Lat. 43°22′14″ N,
long. 72°22″6 W) with the corrected
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■
Issued in College Park, Georgia, on October
28, 2024.
Patrick Young,
Manager, Airspace & Procedures Team North,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2024–25456 Filed 11–1–24; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112, 1130, and 1243
[CPSC Docket No. 2023–0047]
Safety Standard for Infant Support
Cushions
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, section
104 of the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
requires the U.S. Consumer Product
Safety Commission (Commission or
CPSC) to promulgate consumer product
safety standards for durable infant or
toddler products. Under this statutory
authority, the Commission is issuing a
safety standard for infant support
cushions. The Commission is also
amending CPSC’s consumer registration
requirements to identify infant support
cushions as durable infant or toddler
products and amending CPSC’s list of
notices of requirements (NORs) to
include infant support cushions.
DATES: The rule is effective on May 5,
2025. The incorporation by reference of
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SUMMARY:
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the publication listed in this rule is
approved by the Director of the Federal
Register as of May 5, 2025.
FOR FURTHER INFORMATION CONTACT: Will
Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301)
504–7945 or (888) 531–9070; email:
sbo@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
A. Background
Infant support cushions are filled
with or comprised of resilient material
such as foam, fibrous batting, or
granular material or with a gel, liquid,
or gas, and are 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. CPSC is aware of at
least 79 reported fatalities involving
infant support cushions from January 1,
2010, through December 31, 2022, as
well as 124 nonfatal incidents or reports
involving these products within the
same time period. There were 17 deaths
in 2020, and a minimum of 17 more in
2021.1 More than 80 percent of the
known fatalities associated with these
products involve infants three months
old or younger. In more than 60 percent
of the fatalities, the official cause of
death was asphyxia or probable
asphyxia. These incidents typically
involved the use of an infant support
cushion placed in or on a sleep-related
consumer product such as an adult bed,
futon, crib, bassinet, play yard, or
couch. For the nonfatal incidents, the
most common circumstances involved
an infant falling from an infant support
cushion placed on a raised surface such
as a bed or a sofa, or a threat of asphyxia
or entrapment.
In 1992, pursuant to authority under
the Federal Hazardous Substances Act
(FHSA), 15 U.S.C. 1261–1278, the
Commission issued a ban on certain
infant cushions and pillows filled with
foam, plastic beads, or other granular
material. 57 FR 27912 (June 23, 1992).
That ban prohibits infant cushions,
infant pillows, and similar articles that
are:
• made with a flexible fabric
covering;
• loosely filled with granular
material, including, but not limited to,
polystyrene beads or pellets;
• easily flattened;
1 Due to reporting delays, fatality data reported to
the CPSC is not considered complete until three
years later; thus, the 2021 fatality data were not yet
considered complete when the analysis was
conducted in 2023.
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• capable of conforming to the body
or face of an infant; and
• intended or promoted for use by
children under one year of age.
See 16 CFR 1500.18(a)(16). This final
rule for infant support cushions does
not change the existing FHSA ban. That
ban was limited to products with the
specific hazard presented by loosely
filled granular material such as
polystyrene beads or pellets, and those
products will continue to be banned
under the FHSA. Infant support
cushions that are not subject to the ban
are within the scope of this rule and are
required to comply with the
performance and labeling requirements
of this rule.2
B. Statutory Authority
Section 104(b)(1)(A) of the CPSIA
requires the Commission to (1) examine
and assess the effectiveness of voluntary
consumer product safety standards for
durable infant or toddler products, in
consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts and (2)
promulgate consumer product safety
standards for durable infant and toddler
products. See 15 U.S.C. 2056a(b)(1)(A).
The Commission must continue to
promulgate standards for all categories
of durable infant or toddler products
until the Commission has promulgated
standards for all such product
categories. See 15 U.S.C. 2056a(b)(2).
Consistent with section 104(b)(1)(A)
of the CPSIA, CPSC consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and the
public to develop this rule, including
through participation in the juvenile
products subcommittee meetings of
ASTM.3 However, currently no
voluntary or mandatory safety standard
for infant support cushions exists to
2 An exemption to the infant pillow ban applies
to Boston Billow nursing pillows and substantially
similar nursing pillows that are designed to be used
only as nursing aids for breastfeeding mothers. 16
CFR 1500.86(a)(9). The exemption applies
specifically to the FHSA ban and is not applicable
to this rule or to the final rule for nursing pillows.
89 FR 85388 (October 25, 2024).
3 CPSC formally began the consultation process
for this rulemaking in December 2021, via a letter
from staff requesting that ASTM form a working
group to develop a voluntary standard to reduce the
risk of death and injury from hazards associated
with infant pillow products, including nursing
pillows. In response, ASTM formed two
subcommittees intended to develop two separate
voluntary standards: the F15.16 Infant Feeding
Supports subcommittee, intended to develop a
standard for nursing pillows; and the F15.21 Infant
Loungers subcommittee. Staff has been actively
participating in both ASTM subcommittees to
develop voluntary standards that address hazards
associated with these products.
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address the hazards posed by these
products.
Infant support cushions are durable
infant or toddler products under section
104(f) of the CPSIA. Section 104(f)(1)
defines the term durable infant or
toddler product as a durable product
intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years. See
15 U.S.C. 2056a(f)(1). Section 104(f)(2)
of the CPSIA provides a non-exhaustive
list of product categories within the
definition of durable infant or toddler
products. Although infant support
cushions are not specifically listed in
section 104(f)(2), they are durable infant
or toddler products because (as
explained in Part II, below) they: are not
disposable; have a useful life of up to
several years during which they are
often used by multiple children
successively; are similar to other soft
durable infant and children’s products
such as crib mattresses and sling
carriers (which the Commission has
issued rules for under section 104); are
resold and widely available on
secondary marketplaces; and are
primarily intended to be used by
children five years old or younger.
Section 104(d) of the CPSIA requires
manufacturers of durable infant or
toddler products to establish a product
registration program and comply with
CPSC’s rule for product registration
cards, 16 CFR part 1130. The final rule
amends part 1130 to include infant
support cushions in the list of durable
infant or toddler products that must
comply with these product registration
requirements. See 16 CFR 1130.2(a).
Manufacturers of children’s products
must also comply with the testing and
certification requirements for children’s
products that are codified in 16 CFR
parts 1107 and 1109. Section 14(a)(3) of
the Consumer Product Safety Act
(CPSA) requires the Commission to
publish an NOR for the accreditation of
third party conformity assessment
bodies (test laboratories) to assess
conformity with a children’s product
safety rule to which a children’s product
is subject. The final rule is a children’s
product safety rule that requires
issuance of an NOR.
C. Notice of Proposed Rulemaking
(NPR)
On January 16, 2024, the Commission
published an NPR under section 104 of
the CPSIA that proposed a mandatory
consumer product safety standard for
infant support cushions to address the
risk of death and injury associated with
these products. 89 FR 2530. The
proposed rule addressed the suffocation,
entrapment, and fall hazards associated
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with infant support cushions by
including performance, testing, labeling,
and instructional literature
requirements. The proposed
requirements in the NPR were based on
staff’s analysis of the hazards presented
by infant support cushions as well as
incident, injury and fatality data. The
proposed requirements also considered
the recommendations in the June 30,
2022, Pillows Product Characterization
and Testing, Boise State University
Report (BSU Final Report).4 CPSC
awarded a contract to Boise State
University (BSU) for infant
biomechanics and suffocation research
and consultancy services. This research
included an analysis of the risk of injury
or death to infants associated with the
use of nursing pillows and infant
support cushions during activities such
as feeding, nursing, sleeping, propping,
and lounging. The BSU Final Report
provided recommendations and
conclusions related to the performance
and design of infant support cushions,
including recommendations regarding
firmness testing, airflow testing, and
sagittal-plane testing. Tab C of Staff’s
NPR Briefing Package summarizes how
the requirements of the NPR relate to
the conclusions and recommendations
of the BSU Final Report. The
Commission received 18 comments in
response to the NPR.
On April 23, 2024, CPSC published a
notice of availability (NOA) in the
Federal Register that announced the
availability of the incident data relied
upon for the infant support cushions
NPR and sought comments from the
public. 89 FR 30295. The Commission
received one comment in response to
the NOA.
D. Final Rule Overview
Pursuant to section 104 of the CPSIA,
15 U.S.C. 2056a, the Commission is
issuing a mandatory standard for infant
support cushions based on the proposed
requirements in the NPR, with certain
modifications in response to public
comments, which are discussed in
detail in Sections VI and VII of the
preamble.5 The final rule defines an
infant support cushion 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. This definition includes any
removable covers, or slipcovers, sold on
or together with an infant support
cushion. This 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. The final rule
addresses the risk of death and injury
associated with infant support cushions
primarily due to suffocation,
entrapment, and fall hazards. It
addresses positional asphyxiation
hazards by requiring that all surfaces be
sufficiently firm that they are unlikely
to conform to an infant’s face and
occlude the airways,6 and by setting a
maximum incline angle that would
prevent hazardous positioning of an
infant’s head and neck along the
surfaces of the product. The final rule
sets a side angle requirement that
addresses the risk of entrapment
between the sidewall and the occupant
support surface. It addresses fall hazards
by effectively limiting sidewall height to
discourage caregivers from mistakenly
believing these products to be safe for
unsupervised infants. Finally, the final
rule requires a strongly worded,
conspicuous, and permanent on-product
warning label.
Based on comments received on the
NPR, the following changes have been
made in the final rule:
• For clarity, the definition of infant
lounger in § 1243.2 has been revised to
change the term infant product to infant
support cushion.
• For clarity, the definition of infant
support cushion in § 1243.2. has been
revised to add the sentence ‘‘This
definition includes any removable
covers, or slipcovers, sold on or together
with an infant support cushion’’ at the
end of the definition.
• To avoid ambiguity, a new
definition of the term sidewall has been
added in § 1243.2 which is defined as
any wall at the edge of the occupant
support surface.
4 Erin M. Mannen et al; Consumer Prod. Safety
Comm’n. Pillows Product Characterization and
Testing (2022). www.cpsc.gov/content/PillowsProduct-Characterization-and-Testing.
5 On October 16, 2024, the Commission voted (5–
0) to publish this final rule with changes. Chair
Hoehn-Saric issued a statement in connection with
his vote, available at: www.cpsc.gov/About-CPSC/
Chairman/Alexander-Hoehn-Saric/Statement/
Statement-of-Chair-Alexander-Hoehn-Saric-onCommission-Approval-of-a-Final-Rule-Establishinga-Safety-Standard-for-Infant-Support-Cushions.
6 Airways occlusion means to block the passage
of air from the nose and mouth into the lungs, so
that inhaled air cannot reach the lungs. In this case,
the airway occlusion is caused by a soft product
that covers the nose and mouth. Once an infant’s
airflow is compromised, decreased levels of oxygen
in the blood can further impair the ability of the
infant to respond to the situation. If an infant
cannot respond, a feedback loop of decreased heart
and respiration rate develops that can eventually
lead to cessation of breathing and may become fatal
if uninterrupted.
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• For accuracy and consistency, a
reference to infant pillow in § 1243.3(d)
has been changed to infant support
cushion.
• The final rule removes proposed
§ 1243.3(e) regarding side height as this
requirement is redundant with the
maximum incline angle limits in the
rule. The final rule renumbers the
paragraphs following proposed
§ 1243.3(e) to reflect this change. The
rule also removes the corresponding test
in § 1243.5(d)(8) for consistency. To
reflect this change, all numbers after
§ 1243.5(d)(7) have been renumbered in
the final rule.
• The performance requirements in
§ 1243.4(e)(2) and (3) and (f) as well as
the corresponding test methods in
§§ 1243.5(g) and 1243.4(h) and (i) have
been revised to clarify that the
performance requirements and test
methods apply only to products that
contain a sidewall with language
stating, for products with a sidewall.
• The test method in § 1243.5(f) has
been clarified to explain that products
sold with a slipcover on or together with
the product are to be tested as
assembled, with the slipcover on the
product. The test method in § 1243.5(f)
has also been clarified to explain that all
products, including products one inch
or less in thickness, shall be tested.
• Figure 2 (for products without a
tummy time feature) to paragraph (d)(7)
in § 1243.6 has been revised and a new
figure 3 (for products with a tummy
time feature) has been added to reflect
changes in warning content made in
response to public comments. These
changes include adding a statement to
address prone use during tummy time,
removing references to ‘‘an awake
baby,’’ separating the sleep and
suffocating-relating warning content to
provide clarity, adding a warning to
address soft bedding both in and outside
of the product, and deleting some of the
statements to reduce length and increase
clarity. Additionally, § 1243.6(d)(7)
clarifies that all infant support cushions
are required to contain a warning with
the content and format depicted in this
section as figure 2 (for products without
tummy time) or figure 3 (if the product
has a tummy time feature) to paragraph
(d)(7), as applicable.
• Section 1243.6(e) has been revised
to clarify that slipcovers sold on or
together with the product shall contain
the warning statement shown in figures
2 and 3 to paragraph (d)(7), as
applicable.
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II. The Product Category
A. Infant Support Cushions
Infant support cushions are products
that support an infant for lounging,
meaning reclining in a supine, prone, or
recumbent position. Infant products
within this category may or may not
have perimeter sidewalls. Most infant
support cushions currently on the
market are filled with cushy foam or soft
fibrous batting, covered by flexible
fabric. Some infant support cushions are
marketed for use in a crib or other infant
sleep product, notwithstanding
warnings from the Commission and
other institutions, including the
American Academy of Pediatrics (AAP),
that soft objects, such as pillows and
excess bedding, should not be placed in
an infant’s sleep environment.7
Illustrative pictures of infant support
cushions can be found in Tab C of
Staff’s NPR Briefing Package.8 A nonexhaustive list of examples of infant
support cushions includes:
• head positioner pillows;
• flat baby loungers;
• crib pillows;
• wedge pillows for infants;
• infant sleep positioners, unless
regulated as medical devices by the
Food and Drug Administration (FDA);
• stuffed toys marketed for use as an
infant support cushion;
• infant tummy time or lounging
pillows, whether flat or inclined;
• multi-purpose pillows marketed for
both nursing and lounging;
• anti-rollover pillows with or
without straps that fasten the pillow to
the infant;
• infant self-feeding pillows that hold
a bottle in front of the face of a reclining
or lying infant;
• pads and mats; and
• accessory pillows and other padded
accessories, often marketed for use with
an infant car seat, stroller, or bouncer,
but not sold with that product and
therefore not included in the mandatory
safety standard for those products.
These in-scope products must meet
the requirements of the rule. However,
to avoid potentially duplicative or
conflicting obligations, the scope of
products that would be subject to this
7 Rachel Y. Moon, Rebecca F. Carlin, Ivan Hand,
The Task Force On Sudden Infant Death Syndrome
And The Committee On Fetus And Newborn, 150(1)
American Academy of Pediatrics: Evidence Base for
2022 Updated Recommendations for a Safe Infant
Sleeping Environment to Reduce the Risk of SleepRelated Infant Deaths (2022).
8 Staff’s NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
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87469
rule does not include durable infant
products that are already regulated by
the Commission and included in the list
of products at 16 CFR 1130.2(a).
The following products are NOT
infant support cushions within the
scope of this rule:
• pillows not marketed, designed, or
intended for use by infants, such as
adult bed and throw pillows;
• nursing pillows if subject to the
Commission’s final rule for nursing
pillows (89 FR 85388 (October 25,
2024)), unless they are also marketed for
lounging;
• crib and play yard mattresses that
are regulated under the play yard
standard (16 CFR part 1221) and crib
mattress standard (16 CFR part 1241);
• purely decorative nursery pillows,
such as those personalized with a baby’s
name and birthdate, that are not
marketed, designed, or intended for
infant use;
• stuffed toys (unless they meet the
definition of an infant support cushion
in this rule);
• padded seat liners that are sold
with a rocker, stroller, car seat, infant
carrier, swing, highchair, or bouncer
that are specifically designed to fit that
product;
• padded seat liners and inserts for a
rocker, stroller, car seat, infant carrier,
swing, highchair, or bouncer that are
sold separately by the manufacturer as
a replacement part and specifically
designed to fit that product; and
• sleeping accommodations that are
regulated under the Commission’s
infant sleep product rule at 16 CFR part
1236.
B. Market Description
Most types of new infant support
cushions are sold online, including from
general online retailers, online sites for
‘‘big box’’ stores, online baby products
sites, and online marketplaces for handcrafted items. Some types of infant
support cushions, particularly crib
pillows and baby loungers, are also
available from brick-and-mortar baby
specialty stores and general retail stores.
Prices for new infant support cushions
average roughly $30 and range from less
than $15 for a simple head positioner
pillow or crib pillow to more than $250
for a lounger with a removable cover or
a large stuffed toy marketed for use
while an infant sleeps. Several thousand
manufacturers and importers, including
hundreds of handcrafters and direct
foreign shippers, supply infant support
cushions to the U.S. market. See Tab E
of Staff’s NPR Briefing Package.9
9 Staff’s NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-
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Infant support cushions may be reused for multiple children or resold for
use after an infant outgrows the product.
For example, in June 2023, staff found
listings on Mercari for used changing
pads, large stuffed toys marketed for
infant sleep, crib wedge pillows, baby
neck pillows, baby sleep positioners,
baby loungers, baby sleep mats, baby
pillow chairs, infant self-feeding
pillows, baby/toddler bean bag chairs,
and crib pillows. Similar listings were
identified on eBay.
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III. Incident Data and Hazard Patterns
Staff searched the Consumer Product
Safety Risk Management System
(CPSRMS) 10 and National Electronic
Injury Surveillance System (NEISS) 11
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. Staff identified 79 fatal
incidents and 124 nonfatal incidents
and consumer concerns reported to
CPSC from 2010–2022. Of the 124 12
non-fatal reports, 22 consisted of
emergency-department-treated injuries,
three involved hospital admissions, 45
involved no injury, and for 54 the
disposition was either unknown or
unspecified. The incident data and
hazard patterns cited in support of the
NPR support this final rule and are
unchanged from the NPR. For further
discussion of the incident data and
hazard patterns, see the NPR and Tab A
of Staff’s NPR Briefing Package, which
describe the incident and hazard
patterns associated with infant support
cushions,13 and the NOA, which
of-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
EvV00xeX75dsFc.
10 CPSRMS is the epidemiological database that
houses all anecdotal reports of incidents received
by CPSC, ‘‘external cause’’-based death certificates
purchased by CPSC, all in-depth investigations of
these anecdotal reports, as well as investigations of
select NEISS injuries. CPSRMS documents include
hotline reports, online reports, news reports,
medical examiner’s reports, death certificates,
retailer/manufacturer reports, and documents sent
by state and local authorities, among others.
11 NEISS is a statistically valid surveillance
system for collecting injury data. NEISS is based on
a nationally representative probability sample of
hospitals in the U.S. and its territories. Each
participating NEISS hospital reports patient
information for every emergency department visit
associated with a consumer product or a poisoning
to a child younger than five years of age. The total
number of product-related hospital emergency
department visits nationwide can be estimated from
the sample of cases reported in the NEISS. See
www.cpsc.gov/Research—Statistics/NEISS-InjuryData.
12 The NPR listed 125 nonfatal incidents, but one
of those incidents was a duplicate.
13 Staff’s NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-
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describes the incident data and hazard
patterns relied on for the rulemaking.14
IV. International and Voluntary
Standards for Infant Support Cushions
A. International Standards for Infant
Support Cushions
The Commission is aware of two
British standards that contain
performance requirements addressing
suffocation and asphyxiation hazards
associated with infant pillows: BS
1877–8:1974, Specification for Domestic
bedding—Part 8: Pillows and bolsters
for domestic use (excluding cellular
rubber pillows and bolsters) (BS 1877–
8:1974) and BS 4578:1970, Specification
for Methods of test for hardness of, and
for air flow through, infants’ pillows (BS
4578:1970). The scope of BS 1877–
8:1974 includes both adult and cot
pillows (infant pillows) and
recommends that cot pillows be filled
firmly enough to prevent infants’ heads
from sinking into the products and that
the pillow covering not be loose enough
to be drawn into an infant’s mouth. BS
1877–8:1974 has requirements for cot
pillow size, filling, and covering. Under
that standard, cot pillows must be 58 x
38 cm (23 x 15 inches) and their
covering must be of open construction
to allow air permeability. Both the
filling and covering must meet
performance requirements described in
BS 4578:1970 for hardness (i.e.,
firmness) and air permeability.
The hardness test in BS 4578:1970
requires that a 100 mm diameter probe
be placed in the center of the product
with 10 newtons (N) of force for one
minute. BS 1877–8:1974 requires that
displacement of the pillow when the
force is applied shall not exceed 25
percent of the thickness. The
proportional approach used in this
standard allows thicker pillows to have
a greater displacement than thinner
pillows, which staff assesses does not
sufficiently protect against the
suffocation and asphyxia hazards
associated with infant support cushions
because that greater displacement could
allow the product to obstruct the
infant’s airway.
B. ASTM Voluntary Standards Work
Currently, there are no published U.S.
voluntary standards for infant support
cushions. ASTM is working on a
of-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
EvV00xeX75dsFc.
14 Notice of Availability and Request for
Comment: Data Regarding Incidents Associated
With Infant Support Cushions, 89 FR 30295 (April
23, 2024), available at: www.federalregister.gov/d/
2024–08605.
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voluntary standard for infant loungers
under the Subcommittee F15.21 on
Infant Carriers, Bouncers, and Baby
Swings.15 On March 25, 2024, ASTM
issued ballot F15.21 (24–01), which
included the latest draft of the infant
lounger’s voluntary standard. The ballot
closed on April 29, 2024, and received
eight negative votes and other
comments including a comment from
staff.16 On September 16, 2024, ASTM
issued ballot F15 (24–18), Item #1
which addressed the negative comments
and other comments on the draft
standard for infant loungers included in
ballot F15 (24–01). That ballot closed on
October 16, 2024.17
In the ASTM draft voluntary standard,
infant loungers would be products with
a raised perimeter, a recess, or other
area that is intended to be placed on the
floor and to provide a place for an infant
to sit, lie, recline, or rest, while
supervised by an adult, but are not
intended or marketed for sleep. The
draft definition would apply to only a
subset of the products covered by this
rule, which includes infant positioners,
nursing pillows with dual use for
lounging, infant cushions, and other
infant pillow-like products, as well as
the infant loungers being considered by
the ASTM draft standard. ASTM’s draft
voluntary standard for infant loungers
includes general requirements typically
found in other ASTM juvenile product
standards, such as requirements
addressing lead content, small parts,
hazardous sharp edges or points,
resistance to collapse and disassembly,
openings, protective components,
permanency of labels and warnings, and
toy accessories that are attached to,
removable from, or sold with the
products. The ASTM draft standard also
specifies that if the lounger can be
converted to another product, it shall
comply with the applicable
requirements of the converted product’s
standard. The general requirements of
the ASTM draft infant lounger standard
also state that the sidewall height of the
15 See Tab B of Staff’s NPR Briefing Package,
available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-Support-Cushions.pdf?
VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
This ASTM standard is still in draft form and has
not completed the full consensus process to become
an approved standard, and thus the draft standard
is subject to change.
16 CPSC Staff Comment to Ballot ASTM F15.21 on
Infant Loungers, available at: www.cpsc.gov/s3fspublic/CPSCStaffCommenttoBallot
ASTMF1521onInfantLoungers.pdf?VersionId
=tGM05rvyA6WCUzQxHFCDkVHVxRLbtQLv.
17 CPSC Staff Comment to Ballot ASTM F15.21 on
Infant Loungers, available at: www.cpsc.gov/s3fspublic/staff-comment-to-ballot-ASTM–F15–21-oninfant-loungers.pdf?VersionId=oMjqKOhKBI0lEWiQ
liiCJ3u3OP2XcB7n.
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product shall be less than two inches on
both the interior and exterior sides of
the sidewall when measured according
to the sidewall height measurement test
method specified in the draft standard.
The ASTM draft voluntary standard
includes performance requirements that
address stability, restraints, occupant
support surface angle, fabric/mesh
integrity, bounded openings, occupant
support surface firmness, sidewall
firmness, side angle measurements, and
deflection at the occupant support
surface and sidewall intersection.
Finally, the ASTM draft voluntary
standard for loungers also includes
marking, labeling, and instructional
literature requirements, such as warning
the consumer about not using the
product for sleep or naps, only using the
product when the occupant baby is
supervised, only using the product on
the floor, keeping soft bedding out of the
product, not using the product on raised
surfaces, and not using the product to
carry or move an infant.
As previously noted, the ASTM draft
standard for infant loungers primarily
differs from the final rule regarding the
scope of products subject to the
standard. Specifically, the final rule
includes all types of infant support
cushions such as infant positioners,
infant loungers, and other types of
infant mats and pads, while the scope
of the ASTM draft standard would
apply only to infant loungers. Given that
the ASTM draft standard for loungers
has not been finalized and published
and would not cover the same scope of
products as the final rule, the
Commission finds that no voluntary
standard currently exists or will likely
exist in the foreseeable future that
would adequately address the hazards
presented by infant support cushions.
This rule is required under section 104
of the CPSIA to address the identified
hazards presented by infant support
cushions. 15 U.S.C. 2056a.
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VI. Response to Public Comments
CPSC received 18 public comments
during the NPR comment period, and
one comment during the NOA comment
period. The comments are available on:
www.regulations.gov, by searching
under docket number CPSC–2023–0047.
This section describes the significant
issues raised in the comments and
CPSC’s responses to them.
A. Scope of the Final Rule
Comment: The Boppy Company, LLC
(Boppy), Best Practice Quality LLC
(BPQ), Heroes Technology (US) LLC d/
b/a Snuggle Me Organic (Heroes
Technology), and Juvenile Products
Manufacturers Association (JPMA)
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object to the broad scope of the
proposed rule and argue that the
proposed rule does not take into
consideration that it is difficult to
develop specific standards because of
the wide range of infant support
cushion designs.
Response: We disagree that
performance requirements and warning
and labeling requirements for a wide
range of infant support cushions cannot
be comprehensively developed to
mitigate the hazards posed to infants
from infant support cushions. Although
infant support cushions include many
different types of products, incident
data relied upon to support the rule
indicate that infants are at risk from falls
and suffocations, and that the hazard
patterns are similar for all types of
infant support cushions. As indicated in
the incident data, caregivers use infant
support cushions, which are not
intended for sleep, in infant sleep
settings and infants tend to fall asleep
in these products. Thus, it is reasonably
foreseeable that caregivers will use
infant support cushions in infant sleep
settings, which poses a suffocation
hazard. Therefore, the performance
requirements and warnings in the rule
are designed to reduce the fall and
suffocation hazards that these products
pose.
Comment: JPMA argues that a rule for
infant support cushions is unnecessary
because CPSC has a safety standard for
infant sleep products, codified at 16
CFR part 1236, addressing infant
support cushions that are primarily
intended or marketed for sleep.
Response: The scope of this rule
includes products that are not subject to
the infant sleep products rule, but that
still present a risk of injury or death to
infants. Infant support cushions do not
meet the definition of infant sleep
products because they are not marketed
or intended to provide sleeping
accommodations. Therefore, this rule is
necessary to addresses the hazards
posed by infant support cushions
because the infant sleep products rule
does not apply to infant support
cushions.
1. Scope Age
Comment: BPQ asserts that the inscope age range in the rule should be
changed to align with the ASTM
Lounger standard in development,
which BPQ states covers infants 0–6
months.
Response: Since publication of the
NPR, the ASTM F15.21 Infant Loungers
Scope Task Group changed the scope of
its draft safety standard to include
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infants up to 12 months of age.18
Incident data, as outlined in the
incident data and hazard pattern section
of the NPR and Tab A of Staff’s NPR
Briefing Package,19 indicate that
incidents associated with infant support
cushions occur with infants up to 12
months old (i.e., 365 days). Based on the
incident data and hazard pattern
analysis, the performance requirements
and warnings were developed to
mitigate the hazards associated with
infant support cushions for infants up to
12 months old. The Commission
declines to limit the scope of the final
rule with a specific age limitation. The
Commission’s approach mitigates the
hazards associated with infant support
cushions for all infants, regardless of
age, and discourages manufacturers
from making age-based marketing
claims specifically to attempt to remove
their products from being subject to the
rule.
2. Tummy Time Pillows
Comment: BPQ, the Toy Association
(TA), Boppy, and Graco Children’s
Products Inc (Graco) argue that the rule
should exempt tummy time pillows.
Response: We disagree that tummy
time pillows should be exempted from
the rule. Tummy time pillows, which
are pillow products on which infants
may be propped, present the same
suffocation and fall hazards as other
types of infant support cushions, as
indicated in the incident data discussed
above. Infants can suffocate when
tummy time pillows conform to an
infant’s face and occlude the airways;
further, infants can roll from a tummy
time pillow, creating a fall risk if the
tummy time pillow is placed on an
elevated surface. Therefore, tummy time
pillows are subject to the requirements
of the rule because allowing an
exemption for tummy time pillows
would allow those products to present
the same suffocation and fall hazards to
infants that this rule is intended to
address. We note that AAP and National
Institute of Child Health and Human
Development (NICHD), while endorsing
tummy time, do not specifically
18 ASTM F15.21 Infant Loungers Scope Task
Group—MeetingLog, available at: www.cpsc.gov/
content/ASTM–F1521-Infant-Loungers-Scope-TaskGroup-Meeting%E2%80%AFLog-1.
19 Staff’s NPR Briefing Package available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-for-Infant
-Support-Cushions.pdf?VersionId=
rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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recommend tummy time pillows for that
activity.20 21
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3. Dual Use Products
Comment: AAP supports the scope of
the proposed rule and specifically
asserts that dual use products marketed
for both nursing and lounging should be
within the scope of the rule. BPQ and
Boppy state that the rule should exempt
dual use products. Boppy asserts that
there are distinct differences between
nursing pillows and infant support
cushions; it further states that the intent
of the nursing pillows rule is to limit
nursing pillow use to solely breast
feeding and bottle feeding, obviating the
need to cover nursing pillows of any
type, including dual use, in this rule.
BPQ further argues that because the
draft ASTM nursing pillows standard, at
the time of the comment, specifically
states that nursing pillows may not be
marketed for multipurpose use, nursing
pillows should be exempt from this rule
even if they otherwise would meet the
definition of an infant lounger.
Response: We disagree that the rule
should exempt dual use products
marketed for both nursing and lounging.
A nursing pillow that is also marketed
for lounging is an infant support
cushion subject to this rule. The new
nursing pillow standard, ASTM F3669–
24, published on September 10, 2024,
specifies that if a nursing pillow can be
converted into another product or has
use features for which a consumer safety
specification exists, the product shall
comply with the requirements of all
applicable voluntary standards. On
October 25, 2024, the Commission final
rule for nursing pillows published (89
FR 85388), which does not have a
requirement for convertible products.
Nursing pillows that meet the definition
of infant lounger in § 1243.2 must also
meet the requirements of this rule
because the two rules are intended to
address different hazard patterns. While
the nursing pillow performance
requirements and warnings discourage
lounging, the infant support cushion
rule requirements are intended to
mitigate suffocation hazard while
lounging. It is common for multiple
CPSC mandatory safety regulations to
apply to a single children’s product,
such as the existing regulations for
20 Benefits of Tummy Time | Safe to Sleep®
(nih.gov), available at: https://safetosleep.
nichd.nih.gov/reduce-risk/tummytime#:∼:text=Babies%20benefit%20from%
20having%20two,of%20total%20tummy%20time%
20daily .
21 American Academy of Pediatrics (2017). Back
to sleep, tummy to play. Retrieved August 28, 2018,
from www.healthychildren.org/English/ages-stages/
baby/sleep/Pages/Back-to-Sleep-Tummy-toPlay.aspx.
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small parts, phthalates, and lead
content.
Comment: BPQ recommends the
following statement should be added to
the rule: If the infant lounger can be
converted into another product for
which a consumer safety specification
exists, the product shall comply with
the applicable requirements of that
standard.
Response: The commenter’s requested
statement is unnecessary because
§ 1243.3(g) of the rule regarding
convertible products already states that
if the infant support cushion can be
converted into another product for
which a consumer product safety
standard exists, the product also shall
comply with the applicable
requirements of that standard.
4. Playmats
Comments: Bureau Veritas (BV)
requests clarification regarding whether
playmats are intended to be classified as
infant support cushions. Dorel Juvenile
Group, Inc. asserts that playmat
products subject to the requirements for
toys in ASTM F963 and 16 CFR part
1250 and whose base ‘‘pad or mat’’ is a
flat layer no greater than one inch in
thickness should be exempt from the
rule. TA and Graco also assert that
playmats that are subject to ASTM F963
and 16 CFR part 1250 should be exempt
from the rule.
Response: We disagree that the rule
should exempt playmats. While
playmats must meet the requirements of
ASTM F963 and 16 CFR part 1250,
those requirements do not address the
infant suffocation hazards presented by
playmats. Additionally, a playmat could
have a flat layer no greater than one
inch in thickness but still have greater
than 1-inch sides or borders presenting
a potential suffocation hazard. Finally,
not providing the requested exemption
is consistent with the ASTM draft
voluntary standard for infant loungers,
which currently also does not contain
an exemption for playmats.
5. Accessory Pillows and Other Padded
Accessories
Comment: BV requests clarification
on the scope of the final rule regarding
accessory pillows and other padded
accessories sold with a juvenile product,
or accessories sold separately from a
juvenile product but intended to be
used on a juvenile product. Boppy and
Graco assert that the rule should exempt
accessory pillows and other padded
accessories for durable nursery products
that are sold separately. Boppy
additionally states that infants are
seated while in contact with these
pillows and padded accessories, so they
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do not meet the definition of an infant
support cushion. Dorel Juvenile Group
argues that the rule should exempt
padded seat liners and inserts included
with a car seat. BPQ argues that
products that are used to keep an
infant’s head positioned in an infant
carrier should be out of scope of this
rule.
Response: Padded seat liners that are
sold with a rocker, stroller, car seat,
infant carrier, swing, highchair, or
bouncer and are specifically designed to
fit that product are not subject to the
rule. However, we agree with BV,
Boppy, Graco, and Dorel Juvenile Group
that replacement padded seat liners and
inserts for these products that are sold
separately by the manufacturer as a
replacement part and specifically
designed to fit a rocker, stroller, car seat,
infant carrier, swing, highchair, or
bouncer would meet the rule’s
definition of an infant support cushion,
even though they would be subject to
the rules for those specific products as
well. To avoid this unintended result,
we have added these products to the list
of products not within the scope of the
rule because they are subject to the
specific safety standard for those
products discussed in section II.A of the
preamble. Under § 1243.1, products
subject to another standard listed in 16
CFR 1130.2(a) are exempt from the rule.
Aftermarket accessory pillows and
other padded accessories, often
marketed for use with a rocker, stroller,
infant car seat, infant carrier, swing,
highchair, or bouncer, but not sold with
that specific product or as a replacement
part, are subject to this rule, and thus
must meet the requirements of the rule.
This can include products that are used
to keep an infant’s head positioned in
an infant carrier, unless they are sold
with that product or as a manufacturer’s
replacement part. Such portable
products can be used for purposes other
than their intended use, including as an
infant sleep product. Therefore, we
disagree with BPQ that products that are
used to keep an infant’s head positioned
in an infant carrier should be outside
the scope of this rule. We also disagree
with Boppy that accessory pillows and
other padded accessories, used with
seated products, should be excluded
from the scope of the rule. These
accessories present a suffocation hazard
to infants because they are highly
portable, and therefore can be used not
only in the product for which they were
intended but also in a variety of other
products in which infants sleep, such as
cribs, bassinets, and play yards. Because
infants sleep for a majority of the day
and tend to fall asleep in products
intended for lounging, it is reasonably
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foreseeable that caregivers will use these
accessory products in an infant sleep
environment or that infants will fall
asleep on them. Therefore, the rule has
requirements and warnings to reduce
the suffocation hazard presented by
infant support cushions.
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6. Infant Sleep Positioners, AntiRollover Pillows, and Wedge Pillows for
Infants
Comment: BPQ and Boppy argue that
the rule should exempt infant sleep
positioners and anti-rollover pillows.
Boppy states that the rule should
exempt wedge pillows for infants.
Boppy and Graco additionally state
infant wedge pillows, infant sleep
positioners, and anti-rollover pillows
are all sleep products and thus should
be subject to the infant sleep products
rule, not this rule. BPQ additionally
states that there is precedent to have
discrete standards for each product
category.
Response: We disagree with the
commenters’ assertion that infant wedge
pillows, infant sleep positioners, and
anti-rollover pillows should be outside
the scope of the rule because all of these
products are sleep products.22 Infant
wedge pillows, infant sleep positioners,
and anti-rollover pillows do not meet
the definition of infant sleep products in
16 CFR part 1236 because they are not
marketed or intended to provide
sleeping accommodations. Nevertheless,
it is reasonably foreseeable that
caregivers will use these products in an
infant sleep environment. CPSC and
FDA have warned against using infant
positioning products in an infant sleep
environment because they pose
suffocation hazards.23 24 The incident
data, which includes both fatal and
nonfatal incidents, show that infants
can suffocate when wedges, sleep
positioners, and anti-rollover pillows
conform to an infant’s face. Therefore,
the performance requirements and
warnings of the rule are intended to
mitigate the suffocation hazard posed by
these products. Because the incident
data hazard patterns associated with
these products are the same and show
that all infant support cushions are used
for lounging, we disagree that it is
22 See Safety Standard for Infant Sleep Products,
86 FR 33022 (June 23, 2021), available at:
www.federalregister.gov/d/2021–12723.
23 Recommendations for Parents/Caregivers
About the Use of Baby Products | FDA, available at:
www.fda.gov/medical-devices/baby-products-sidsprevention-claims/recommendationsparentscaregivers-about-use-baby-products.
24 Deaths prompt CPSC, FDA warning on infant
sleep positioners | CPSC.gov, available at:
www.cpsc.gov/Newsroom/News-Releases/2010/
Deaths-prompt-CPSC–FDA-warning-on-infantsleep-positioners.
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necessary to develop separate standards
specifically for these products.
7. Pads and Mats
Comments: An anonymous
commenter requests clarification on the
type of pads and mats subject to the rule
because they assert that the term is
generic and could apply to products
beyond those on which a child could
sleep.
Response: Pads and mats that are
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 are subject to the rule. These
pads and mats pose a suffocation hazard
because they can be used in a variety of
products in which infants sleep such as
cribs, bassinets, and play yards. In
addition, because infants sleep for a
majority of the day and tend to fall
asleep in products intended for
lounging, it is reasonably foreseeable
that infants will fall asleep on pads and
mats. Pads and mats are associated with
both fatal and nonfatal incidents in the
incident data, and the performance
requirements of the final rule are
intended to mitigate the suffocation
hazard to infants from these products.
8. Framed Seating Products
Comment: Graco argues that framed
seating products should be exempt from
the rule because these types of framed
products do not present the same
hazards as soft cushioned infant pillow
products and because the NPR did not
specifically address hazards associated
with seated infant products that have
rigid frame containment.
Response: We agree with the
commenter that framed seating
products, including infant floor seats,
rockers, strollers, car seats, infant
carriers, swings, highchairs, bouncers,
or other infant products with rigid
components are not infant support
cushions as defined in § 1243.2 of the
rule. Thus, an exemption is unnecessary
because these products are not subject
to the requirements of the final rule.
B. Definitions
Comment: TA requests the term
‘‘infant pillow’’ used in § 1243.3(d), but
nowhere else in the proposed rule, be
amended to reference the defined term
of infant support cushion for
consistency. Alternatively, TA argues
that ‘‘infant pillow’’ could be included
as a discrete term in § 1243.2.
Response: For consistency and clarity,
the reference to infant pillow in
§ 1243.3(d) of the proposed rule has
been changed to infant support cushion
in the final rule.
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Comment: Graco requests that the
definition of infant lounger be modified
by to substitute the term infant support
cushion for infant product. Graco also
requests that the phrase ‘‘infant loungers
do not include seated infant products
with a rigid frame used as containment’’
be added to the definition of an infant
lounger.
Response: We agree with the
commenter’s recommended change to
the definition of infant lounger in
§ 1243.2 and have replaced the phrase
infant product with infant support
cushion in the final rule. We disagree
that it is necessary to specify that infant
loungers do not include seated products
with a rigid frame used as containment
as these products are not within the
scope of infant support cushions and
thus are not subject to the requirements
of the rule.
Comment: JPMA asserts that the
definitions used in the rule should align
with the ASTM standard, in
development, for infant loungers.
Response: The draft ASTM standard
for infant loungers is in draft form and
subject to change as part of the
consensus process. Therefore, we
decline to align the definitions in the
final rule with the ASTM standard in
development. Additionally, the final
rule’s definition of infant support
cushion addresses the hazards
presented by different types of infant
support cushions, not just the infant
loungers under consideration by the
ASTM draft standard.
Comment: Heroes Technology argues
that many of the products within the
scope of the rule do not have an
occupant support surface and the rule
does not address how to test products
without an occupant support surface.
Response: All infant support cushions
contain an occupant support surface,
which is defined in § 1243.2 as the area
that holds up and bears the infant or any
portion of the infant to support the
infant’s weight or any portion of the
infant while reclining or in a supine,
prone, or recumbent position. By
definition, every infant support cushion
subject to the rule contains an occupant
support surface, and thus is required to
meet the performance requirements of
the rule that involve testing the
occupant support surface.
Comment: Boppy notes that the
proposed rule does not define the term
sidewall.
Response: The Commission agrees
that a definition of the term sidewall is
needed for clarity. Thus, a new
definition for sidewall, which means
any wall at the edge of the occupant
support surface, has been added to
§ 1243.2 of the final rule.
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C. Use of Substitute Products
Comment: Boppy, Heroes Technology
and JPMA raised a concern about the
potential for consumers to use substitute
products such as adult pillows or
blankets, instead of infant support
cushions. The commenters note that
such products would fall outside the
scope of the rule but could pose similar
suffocation and fall hazards to infants.
Response: None of the commenters
provide data to support the claim that
the requirements in the proposed rule
would lead consumers to use substitute
products. The rule is intended to ensure
that consumers have access to infant
support cushions that do not present the
same risks of death or injury as some
current products, and this rule should
not cause consumers to seek out
alternative products. The rule also
contains warnings that explain why soft
surfaces, blankets, and other soft items
present a hazard when placed in and
around the product, which can further
educate consumers on the risks posed
by substitute products with soft
surfaces.
Comment: Boppy questions whether
the performance requirements in the
proposed rule could negatively impact
tummy time rates.
Response: The rule is not likely to
reduce beneficial tummy time.
Regarding tummy time, AAP and
NICHD, while endorsing tummy time,
do not recommend specifically using
tummy time pillows. Additionally, this
rule would allow the manufacture and
sale of tummy time products as long as
those products meet the requirements of
the rule. Therefore, tummy time
guidance is not likely to change based
on this rule.
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D. Product Misuse and Education
Comment: BPQ recommends CPSC
develop educational campaigns to
address the unsafe sleep settings and
misuse of products not intended for
infant sleep exhibited in the incident
data. Commenter Julian Dreest asks
what strategies are currently in place to
educate consumers about the proper use
of infant support cushions.
Response: The use of infant support
cushions for sleep, or in an infant sleep
setting, is not appropriate. Consumer
education campaigns about safe sleep
and the safe use of infant support
cushions are useful and necessary to
assist new parents and older generations
of caregivers about safe sleep practices.
CPSC actively promotes safe sleep
outreach and education throughout the
year to reach parents, grandparents, and
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caregivers on our website 25 and by
engaging in targeted safe sleep
messaging during Baby Safety month
(September).
However, education campaigns alone
are not enough to address the hazards
associated with infant support cushions.
Data generally indicate that consumers
believe if an infant product is on the
market, it must be safe for use with
infants—an assumption that is not
always true. Therefore, this final rule for
infant support cushions, paired with
educational campaigns, is needed to
better ensure safe uses of these
products.
Comment: Julian Dreest, BPQ, and
Heroes Technology assert that
educational strategies should reflect the
new requirement for a maximum incline
angle of 10 degrees or less, which limits
the side height of the product to
approximately 1.9 inches. The
commenters assert this new requirement
will invite some caregivers to improvise
or modify the product to achieve the
containment level they desire, increase
consumer complacency, and provide a
false sense of security leading to less
supervision. Therefore, they argue, the
rule will increase falls from elevated
surfaces and the likelihood of roll-out
from the product into an unsafe setting.
AAP and the Joint Consumer Advocate
Commenters strongly support the
maximum incline angle requirement of
10 degrees or less in the proposed rule.
Response: We disagree that limiting
the maximum incline angle to 10
degrees or less will lead to increased
falls or suffocations due to decreased
supervision. As discussed in Tab D of
Staff’s NPR Briefing Package,26 a
cushioned sidewall with a height of up
to four inches may give caregivers the
false perception that the product can
safely contain a child without
supervision, regardless of what the
product warnings might say. The
presence of a distinct, raised perimeter
surrounding the occupant support
surface, as observed in various products
on the market, provides a visual cue to
consumers that the infant is safely
contained in the product. Infant support
cushions currently marketed for sale
often display images of infants sleeping
or resting in such products, and thus
convey the appearance of effective
containment of infants. The incident
data shows that parents may mistakenly
25 Safe Sleep—Cribs and Infant Products,
available at: www.cpsc.gov/SafeSleep.
26 See Tab D of Staff’s NPR Briefing Package,
available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
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believe that products with cushioned
sidewalls greater than two inches
surrounding the infant would make
them safe on elevated surfaces, that the
infant can be left alone on the product,
and that the product will safety contain
their infant. The incident data further
shows that infants suffer falls from
products with cushioned sidewalls that
are higher than 2 inches surrounding
the occupant. Specifically, infants roll
out of products with cushioned
sidewalls greater than two inches into
hazardous settings. With infant support
cushions with cushioned sidewalls less
than 2 inches, parents can see their
infant is not secure in the product, that
the product does not contain their
infant, and that the infant should not be
left alone on the product, particularly
on elevated surfaces. Furthermore, the
accompanying warnings alert users to
the risks of leaving infants unattended
or allowing use of the products for sleep
or using on elevated surfaces. We note
that AAP and the Joint Consumer
Advocate Commenters strongly support
the maximum incline angle requirement
of 10 degrees or less in the proposed
rule.
Comment: Graco states that in
addition to the current infant pillows
that are already banned under 16 CFR
1500.18, the CPSC had considered an
‘‘Infant Pillow Ban’’ in former operating
plans that would take these dangerous
products off the market, but instead has
pivoted to allow the very same types of
products in the NPR, without sufficient
requirements that would address the
inherent misuse and hazards.
Response: The Commission finds that
the requirements in this rule will
mitigate the suffocation and fall hazards
to infants posed by infant support
cushions. Therefore, the Commission
concludes, that this rule will better
address the known hazards posed by
infant support cushions rather than just
merely expanding the existing infant
pillow ban, while still providing
consumers with the utility of infant
support cushions for supervised infant
use.
Comment: JPMA asserts that improper
use of infant support cushions has
contributed to the majority of incidents
associated with these products since
2010. JPMA also contends that the
majority of the products in the scope of
this rule are not marketed or intended
for sleep and have recognized utility for
parents who need a safe product in
which to place their child during awake
time interaction, play, and engagement.
Response: The incident data clearly
indicate a pattern of use of infant
support cushions in infant sleep settings
and for sleep. The designs of infant
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support cushions currently on the
market encourage the use of these
products for sleep. These products are
often used for sleep because of the false
perception that the soft, pillow-like
design, with high borders/sides, are
appropriate for infant sleep and will
safely contain an infant, including on
elevated surfaces. Further, staff is aware
of infant support cushions that are or
have previously been marketed and
promoted as sleep products. Changing
only the marketing of the product,
without changing the design of the
product, will not adequately discourage
the behavior of caregivers allowing
infants to sleep on infant support
cushions unsupervised. We agree that
infant support cushions have utility for
parents to place their infant when
actively supervised.
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E. Incident Data
Comment: BPQ, Boppy, Heroes
Technology, and JPMA state that the
percentages of incidents by product
category are not provided in the NPR
and Tab A of Staff’s NPR Briefing
Package. BPQ also argues that the two
largest nonfatal hazard patterns, falls
and threatened asphyxia, are not broken
down by age.
Response: The Commission published
an NOA announcing the availability of
incident data relied upon for the NPR
and seeking comment. The data in the
NOA released for public comment
shows that for fatal incidents, 63
incidents were associated with loungers,
10 incidents were associated with sleep
positioners, four incidents were
associated with pads/mats, one incident
was associated with an infant wedge,
and one incident was associated with a
tummy time pillow. For nonfatal
incidents, 104 incidents were associated
with loungers, 13 incidents were
associated with sleep positioners, three
incidents were associated with infant
wedges, two incidents were associated
with pads/mats, one incident was
associated with a tummy time pillow,
and one incident was associated with a
small infant pillow. As described above,
the hazard patterns throughout these
incidents are consistent with the risks of
suffocation and falls presented by infant
support cushions. Based on the data
made available to commenters in the
NOA, for incidents involving threatened
asphyxia, 21 victims were up to 4
months old, two were 4–6 months old,
and in three incidents the age was
unreported. For incidents involving
falls, 15 victims were up to 4 months
old, nine were 4–6 months old, four
were over 6 months old, and in one
incident the age was unreported.
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Comment: Boppy argues in a
comment on the NPR that CPSC
provided insufficient data to support
that all products proposed to be covered
by the rule, and specifically tummy time
pillows, need regulation with a
mandatory rule. Boppy also argues in a
comment on the NOA that there are zero
reported incidents related to tummy
time pillows, so there is no justification
for any inclusion of tummy time pillows
within the scope of this proposed rule.
Response: The Commission disagrees
that tummy time pillows should be
excluded from the scope of the rule.
Tummy time pillows are products on
which infants may be propped, and
therefore they must meet the
requirements of this rule. Tummy time
pillows were associated with one fatal
incident and one nonfatal incident as
reflected in the incident data and
present the same hazards as other infant
support cushions. So, allowing a tummy
time pillow for infants to be exempted
from this regulation is contrary to the
regulation’s intent and would allow
manufacturers to remarket other types of
infant support cushions as tummy time
pillows to avoid regulation. We note
AAP and NICHD, while endorsing
tummy time, do not specifically
recommend pillows for tummy time.
F. General Requirements
Comments: Consumer Federation of
America, Consumer Reports, Kids In
Danger, National Center for Health
Research, Public Citizen, U.S. Public
Interest Research Group (Joint
Consumer Advocate Commenters), and
Safe Infant Sleep recommend that the
rule prohibit any type of electronics
used inside or attached to an infant
support cushion. The commenters also
recommend prohibiting battery powered
features, including vibration and white
noise that can encourage sleep or may
overheat presenting a burn risk, or
features that contain cords which
present a strangulation risk.
Response: Some vibrations and
music/sounds may lull infants to sleep.
However, other music and sounds may
engage infants during awake time. Staff
has not identified any products in the
incident data where an electronic
component caused an injury or a death
through fire, heat, or otherwise. Because
no such products were identified in the
incident data as presenting a hazard,
this rule does not include a requirement
related to electronics.
G. Performance Requirements
Comment: Heroes Technology
requests that CPSC conduct round robin
studies of the performance requirements
and test methods involving multiple
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laboratories and multiple exemplar
products in each category, with a view
to reproposing and ultimately adopting
test methods and performance
requirements.
Response: The Commission considers
the performance requirements and test
methods in this rule to adequately
address the hazards associated with
infant support cushions without a need
for the type of round robin process
suggested by Heroes Technology, which
could take years to complete while
injuries and deaths continue to occur.
The Commission concludes that the
urgency of addressing the hazards
associated with infant support cushions,
and the requirement in CPSIA section
104 to promulgate safety standards,
supports the Commission’s
promulgation of this rule. The factual
and scientific basis for the performance
requirements and test methods in the
rule are described in Tab C of Staff’s
NPR Briefing Package.27
1. Restraint
Comments: Graco asserts that the
presence of a restraint system on an
infant support cushion or lounger
would further deter consumers from
using them for sleep because the safety
standards for sleep products do not
allow restraint systems or cords or
straps in the occupant area. On this
basis, Graco suggests that the rule’s
prohibition on restraints could indicate
to caregivers that infant support
cushions are intended for sleep.
Response: The Commission’s yearly
report of injuries and deaths associated
with nursery products demonstrates that
consumers use infant products, both
with and without restraints, for infant
sleep.28 In addition, restraints indicate
to consumers that the infant is secure in
the product and will not move, and thus
the caregiver can leave the infant
unsupervised. Because fall-related
incidents have involved unattended
infants who were left propped or
lounging in the product, consumers are
likely to interpret the presence of an
infant restraint as meaning that
unattended use is acceptable when an
infant is restrained. Additionally, as is
the case with several other children’s
product areas, loops, cords, or strings
27 Staff’s NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
EvV00xeX75dsFc.
28 Injuries and Deaths Associated with Nursery
Products Among Children Younger than Age Five,
August 2023, available at: www.cpsc.gov/content/
Injuries-and-Deaths-Associated-with-NurseryProducts-Among-Children-Younger-than-Age-Five12.
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that enter into the occupant space can
create an entanglement hazard, as seen
in the incident data. Infant support
cushions should be used with constant
adult supervision, so prohibiting
restraints in the rule is appropriate.
2. Maximum Incline Angle
Comment: Heroes Technology argues
that it is not clear in the rule what
‘‘approximately 1.9 inches’’ means and
asserts that this is an arbitrary value.
Graco argues that figure 6 in the text of
the proposed rule alludes to a side
height measurement, without criteria
stipulated for the side height.
Response: The rule does not include
a side height performance requirement
or a side height test method. Instead, the
maximum incline angle performance
requirement of 10 degrees or less in the
rule effectively limits the height of the
product to approximately 1.9 inches,
which reduces the hazard from falls and
suffocation when the product could
otherwise give the false perception of
containment to a caregiver that the
product will safely contain the infant.
The maximum incline angle test in the
rule, as compared to a side height test,
can more effectively be applied to all
the different types of infant support
cushions subject to the rule, which
include infant support cushion products
other than loungers and even products
without a sidewall. Some products
subject to the rule contain occupant
support surfaces that allow an infant to
be placed in various locations on the
product. The maximum incline angle
requirement applies to all the
manufacturer’s recommended use
positions, and also to all other infant
support cushion surfaces that can
feasibly support an infant’s head
(occupant support surface-head),
including the angle from the sidewall (if
present) to the occupant support
surface, or from the occupant support
surface-head to the floor when no
elevated sidewall is present, or from the
sidewall to the floor when an elevated
sidewall is present. Staff calculated that
the side height for very firm products
which meet the 10-degree angle
requirements would likely be
approximately 1.9 inches (4.8 cm) or
less based on the geometry of the
newborn hinged weight gauge. The side
height was not recommended
arbitrarily, and is not itself a
requirement, but rather describes the
geometric calculations of the likely
height of a product just meeting the
required incline angle of 10 degrees.
Comment: BPQ recommends the
sidewall height should be set at 2
inches, as in the draft ASTM infant
loungers standard, and not 1.9 inches.
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BPQ contends that if the height of the
product is set at 1.9 inches, then there
would be no need to measure the
incline angle. The commenter also
recommends that the inclined angle of
10 degrees or less should be applied on
the support surface of the base and only
if the side height is greater than 2
inches.
Response: The Commission disagrees
that a maximum sidewall height of 2
inches should be required. The NPR did
not propose a maximum side height
requirement but instead proposed a
maximum incline angle performance
requirement. As discussed in the
response to the previous comment, the
maximum incline angle performance
requirement in the rule is based on the
varying designs of products and is
expected to geometrically result in the
height of the product being no more
than 1.9 inches in order to comply with
the incline angle requirement.
Comment: Graco argues that
subjecting infant support cushions to a
maximum incline angle requirement for
products that are not intended for sleep
would incorrectly result in them sharing
a critical characteristic of infant sleep
products, that are also required to have
a sleep surface of 10 degrees or less.
Response: Infant support cushions are
not sleep products, but infants fall
asleep in many types of products other
than sleep products, including infant
support cushions. The maximum
incline angle requirement in the rule
addresses the suffocation hazard that
could result if an infant sleeps in an
infant support cushion. Section
1243.5(d) of the rule requires infant
support cushions to have an incline
angle of 10 degrees or less in order to
reduce the hazard of suffocation if an
infant falls asleep in the product.
Comment: Heroes Technology argues
that if there is no incline in the
manufacturer’s recommended use
location for the product, and other use
locations represent misuse, then the
product should not be subject to a
maximum incline angle requirement.
Response: We disagree that products
with no incline in the manufacturer’s
recommended use location should not
be subject to the maximum incline angle
requirement of the rule. Some products
subject to the rule contain occupant
support surfaces that allow a variety of
use modes, so the infant may be placed
in various locations on the product,
while some products do not have
sidewalls. With other products, infants
may move, roll, or be placed in various
positions on the product. To address
known hazard patterns, the rule
appropriately includes a maximum 10degree incline angle requirement that
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applies to any foreseeable use position
on the infant support cushion’s
occupant support surface or sidewall
that supports the head for reclining, to
mitigate suffocation and fall hazards.
The maximum incline angle
requirement applies to all
manufacturer’s recommended use
positions, as well as to all other infant
support cushion surfaces that can
feasibly support an infant’s head
(occupant support surface-head). This
includes the angle from the sidewall (if
present) to the occupant support surface
or from the occupant support surfacehead to the floor when no elevated
sidewall is present or from sidewall to
floor when an elevated sidewall is
present.
Comment: Heroes Technology notes
that an example of a ‘‘feasible location’’
is provided in the proposed rule, but the
term is not defined. The comment also
notes that a ‘‘location likely to fail’’ is
also not defined in the rule, nor is any
guidance provided as to how such a
location should be determined.
Response: A ‘‘feasible location’’ is
language commonly used in ASTM
standards and is typically followed by
an example of such a location in the
requirement. Section 1243.5(d)(8) is the
only place in the rule where the term
feasible location is used. This section
represents the intent for a feasible
location by providing an explicit
example ‘‘such as perpendicular to the
recommended use location(s)’’ without
limiting the potential to test any area
that is applicable with a discrete
definition.
The language a ‘‘location likely to
fail’’ is language commonly used in
ASTM standards and longstanding
CPSC safety standards that incorporate
these ASTM standards. While a location
most likely to fail cannot be determined
by the use of a single test, not all
locations on the product need to be
evaluated. For example, with respect to
the maximum incline angle
requirement, any extremity with respect
to the overall height of the sidewall or
occupant support surface should be
considered areas likely to fail.
Therefore, we disagree that ‘‘feasible
location’’ or ‘‘location most likely to
fail’’ needs to be defined in the rule.
Comment: Graco argues that it is
unclear if a two-inch height would
prevent infants from rolling out of a
product into a dangerous environment.
Dony Ly suggests CPSC should
recommend a side height that will best
mitigate falls, while accounting for the
wide range of infant age and ability but
did not provide any recommendation as
to that height. Julian Dreest proposes
revising the sidewall height limitation
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to a minimum of four inches to mitigate
the risk of falls; he also asks if there has
been a risk assessment analysis
comparing the incidence of falls from
products with different sidewall
heights, while also taking into account
the age of the infant. Heroes Technology
asserts that CPSC failed to consider that
a shorter sidewall height will increase
the fall hazard.
Response: As seen in the incident
data and proposed in the NPR, a
maximum incline angle requirement of
10 degrees or less mathematically limits
the side height of the product to less
than 2 inches to address potential
asphyxiation hazards. The incident data
also indicated that caregivers placed
infant support cushions into infant
sleep settings for unsupervised sleep or
on elevated surfaces. Higher sidewall
heights give the false perception to the
caregiver that the product will safely
contain their infant. At the same time,
the incident data show that higher
sidewall heights do not adequately
contain infants or prevent falls and that
infants roll out from and fall out of
products with a side height of 4 inches
or higher. The incident data also
indicates that infants can turn over or
roll without warning and are at risk of
falling when infant support cushions are
placed on an elevated surface.
In contrast to products with higher
side heights, products with side heights
of approximately 2 inches or less are
less likely to give the false perception to
the caregiver that the product will safely
contain their infant. Therefore,
caregivers are less likely to leave infants
unattended in a product with a less than
2-inch side height or to place the
product on an elevated surface. When
the side height is limited to less than 2
inches it provides a visual cue to
caregivers that the product will NOT
safely contain their infant which
encourages caregivers to place the
product on the floor, thus mitigating the
fall hazard posed to infants from
products placed on elevated surfaces.
Furthermore, there is no evidence that
a maximum sidewall height of about 2
inches would increase the risk of injury
from a fall or lead to different
consequences than a higher sidewall
because, as reflected in the incident
data, infant support cushions with
higher side heights do not safely contain
infants and infants already roll out of
these products. Additionally, products
with side heights of more than 2 inches
would exceed the maximum incline
angle requirement in the final rule and
poses a suffocation or positional
asphyxiation hazard. Also, the
commenter’s proposal to require 4-inchhigh sidewalls would not allow for
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products such as flat playmats or other
infant support cushion products that do
not contain sidewalls. Staff’s analysis of
incident data did not identify the need
for a sidewall requirement and thus the
final rule has no requirements for a
minimum side height. Therefore, the
Commission is not adopting the
commenters’ recommendations to
require higher sidewalls because higher
sidewalls encourage unsafe placement
of infants on elevated surfaces, while
also failing to adequately contain infants
or prevent falls. Finally, staff is unaware
of a risk assessment analysis specifically
comparing the incidence of falls from
infant support cushions of different
product heights, while also taking into
account the age of the infant.
Comment: Heroes Technology asserts
that CPSC failed to consider that with
reduced side heights consumers will use
blankets and towels to create a bumper.
Response: Although this rule only
regulates infant support cushions, it
does contain specific warnings about
the serious risks posed by soft bedding
and other soft items in and around
infant support cushions. Regardless of
the side height of a product, some
caregivers may use other products such
as blankets and pillows to create a
barrier around an infant, whether the
infant is on an infant support cushion
or not. CPSC will continue providing
information and education campaigns
for safe infant care regarding the hazards
associated with soft bedding and soft
items in sleep settings.
3. Firmness
Comment: Boppy argues that the test
requirements and procedures in the
proposed rule do not consider products
that do not have a sidewall. The
performance requirements do not
specify if the sidewall firmness and
angle requirements only apply to
products with a sidewall, and the
testing procedures for sidewalls do not
include language such as ‘‘if applicable’’
or ‘‘for products with a sidewall.’’
Response: We agree that the rule
should clarify whether the performance
requirements and test methods apply to
products that do not contain a sidewall.
Therefore, the final rule adds ‘‘For
products with a sidewall’’ to the
beginning of the sentence regarding the
performance requirements in
§ 1243.4(e)(2) and (3) and (f) and also
adds ‘‘For products with a sidewall’’ to
the beginning of the sentence before
‘‘perform’’ in the test methods in
§§ 1243.5(g) and 1243.4(h) and (i).
Comment: Boppy notes that the rule
does not specify how testing is to be
performed on products with an
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occupant support surface of one inch or
less.
Response: We agree that clarification
on how testing is to be performed on
products with an occupant support
surface of one inch or less is necessary
in the final rule. Therefore, § 1243.5(f) of
the final rule adds the language ‘‘All
products, including products one inch
or less in thickness, are required to be
tested’’ to clarify how testing is to be
performed on products with an
occupant support surface of one inch or
less. The rule requires all in-scope
products, including those with an
occupant support surface of one inch or
less, to be tested to all of the
performance requirements to ensure that
they meet the standard. As discussed
above, no exception is provided for
products of one inch or less in
thickness.
Comment: Safe Infant Sleep proposes
that CPSC should consider a
requirement that would not allow
covers to have extra padding or
cushioning, since such extra padding or
cushioning may introduce an additional
suffocation hazard.
Response: The Commission agrees
that slipcovers with extra padding or
cushioning may introduce a suffocation
hazard that would not be addressed by
testing only the firmness of the infant
support cushion without the slipcover
installed on the product during testing.
The Commission also agrees that testing
should be performed with slipcovers
installed as part of the as assembled
product and the product and slipcover,
if sold on or together with the product,
must meet the test requirements because
extra padding or cushioning on a
slipcover may introduce an additional
suffocation hazard that is not addressed
if the product is tested without the
slipcover installed. In order to make
clear that infant support cushions sold
with a slipcover, on or together with the
product, are subject to the rule and must
be tested as assembled, the definition of
infant support cushion in § 1243.2 has
been revised to add a new sentence at
the end of the definition stating ‘‘This
definition includes any removable
covers, or slipcovers, sold on or together
with an infant support cushion.’’
However, aftermarket slipcovers not
sold with the product do not meet the
definition of an infant support cushion
and thus would not be within scope of
this rule. Finally, § 1243.5(f) adds the
language ‘‘for products sold with a
slipcover on or together with the
product, products shall be tested as
assembled with the slipcover on the
product’’ to the final rule to clarify that
slipcovers, sold on or together with the
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product, need to be installed on the
product during testing.
Comment: Graco argues that infant
support cushions should not be tested
on a solid or firm testing surface.
Response: We disagree. Infant support
cushions should be tested on a solid or
firm testing surface as the product relies
on the underlying surface it is placed
upon for support and shape. In order to
accurately measure the firmness of the
foam, filling, padding, or supporting
material in an infant support cushion,
the testing surface cannot move in
response to the applied force (i.e.,
displace, shift, bend, deviate, compress,
deflect, translate or otherwise), because
any movement of the testing surface in
response to the applied load would
contribute to an under-measured value
for the firmness measurement and thus
would not provide repeatable results.
Comment: Graco argues that the
minimum value for acceptable firmness
for the firmness test cannot be directly
correlated to the firmness values used in
other safety standards for children’s
products. Graco recommends that all
data underlying the performance
requirements be published to permit an
independent assessment. Graco also
argues that the performance
requirements are not substantiated by
reliable test results.
Response: The Commission
considered the recommendations of the
BSU Final Report when developing the
proposed requirements in the rule.29
Additionally, the requirements in the
rule reflect staff’s testing of a variety of
infant support cushions, as well as an
analysis of hazard patterns obtained
from incident data associated with
infant support cushions. The
Commission made this incident data
available for public review and
comment as described in the NOA. This
information was used to develop the
specific performance requirements, and
labeling and instructional literature
requirements that address the
suffocation and fall hazards associated
with infant support cushions. The
development of the firmness test
method and test results are discussed in
further detail in Tab C of the Staff’s NPR
Briefing Package.30
Comment: Heroes Technology argues
that the firmness testing described in
29 Erin M. Mannen et al; Consumer Prod. Safety
Comm’n. Pillows Product Characterization and
Testing (2022). www.cpsc.gov/content/PillowsProduct-Characterization-and-Testing.
30 Staff’s NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
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the rule regarding the intersection of the
occupant support surface and sidewalls
is ambiguous and that the term
‘‘location most likely to fail’’ is similarly
vague.
Response: The firmness test for the
intersection of the sidewall and
occupant support surface is intended to
address suffocation hazards from infant
support cushion products due to the
presence of a sidewall adjacent to an
occupant support surface. The rule
provides instructions and guidance to
measure firmness at the intersection of
the sidewall and occupant support
surface. Specifically, firmness is
measured at the intersection of sidewall
and occupant support surface as the
force to deflect the surface 1.0 in (2.54
cm) using the 3-inch hemispherical
probe oriented at an angle, determined
according to the test method in
§ 1243.5(h), Intersection of sidewall and
occupant support surface firmness.
Section 1243.5(h) requires a force
greater than 10.0 N (2.24 lbs) to address
the suffocation hazard due to soft
surfaces. The terms ‘‘most likely to fail’’
or ‘‘likely to fail’’ are standard language
commonly used in ASTM standards and
longstanding CPSC rules that
incorporate these ASTM standards.
However, areas where the sidewall
appears to be vertical or slanted inward
immediately over top of the occupant
support surface, even while satisfying
the angle requirement for the side as a
whole, would be considered areas
‘‘likely to fail.’’ Therefore, the
Commission disagrees that ‘‘location
most likely to fail’’ needs to be defined
in the rule.
4. Sidewall Angle
Comment: Heroes Technology argues
that the proposed sidewall angle
requirement cannot be conducted
effectively on the firm’s Snuggle Me
infant lounger due to the lounger’s
unique design features.
Response: The sidewall angle
requirement is intended to address the
risk of entrapment between the sidewall
and the occupant support surface that is
not fully addressed by the firmness
requirements alone. While the Snuggle
Me infant lounger may possess unique
design features, such as an unpadded
occupant support surface, the product
can still be evaluated to the sidewall
angle requirement in the rule. The
unpadded surface, and the firm flat
surface the rule requires the units be
tested on, would be considered the
occupant support surface for the
evaluation and the sidewall angle
should be taken with respect to that
surface.
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Comment: Heroes Technology argues
that the rule provides no instructions or
guidance to locate the intersection of the
sidewall and occupant support surface.
Response: In § 1243.5(i), Sidewall
angle determination, the rule provides
instructions and guidance regarding the
test procedure to locate the intersection
of the sidewall and occupant support
surface.
H. Marking and Labeling
Comment: Boppy, AAP, BPQ, the
Joint Consumer Advocate Commenters,
Safe Infant Sleep, and JPMA all
recommend an additional warning for
the tummy time infant support cushion
subcategory to provide clarity and
resolve confusion surrounding the
warning ‘‘use only on floor, with baby
face up on back’’ when it is used on a
product that is also a tummy time
pillow.
Response: We agree that some infant
support cushion products, such as
tummy time pillows, may have features
that require the infant to be on their
stomach while using the product and
that different statements are appropriate
for products designed for tummy time.
Because prone positioning is a risk
factor for infants that can lead to
suffocation when the mouth and nose
are occluded, the final rule adds a new
figure 3 in § 1243.6 to accommodate
products with multi-use positions.
Specifically, the following statement
‘‘Put baby on back after Tummy Time’’
has been added to the warning label
after the phrase ‘‘use only on the floor
with baby on back, face up’’ in new
figure 3. Figure 3 is only required for
products that have a tummy time feature
because only products that have a
tummy time feature should allow prone
positioning. Tummy time pillow
manufacturers may also omit the word
‘‘only’’ from the statement ‘‘use only on
floor with baby on back, face up’’ to
accommodate the multi-use positioning
of the product which is indicated in
new figure 3. This entire warning
statement bullet point was also moved
up within the warning statement in
figures 2 and 3 to reflect the serious
hazard to infants from prone
positioning. Products without a tummy
time feature are required to use figure 2.
Comment: The Joint Consumer
Advocate Commenters propose
requiring the product warning label on
replacement covers for infant support
cushions.
Response: The Commission agrees
that warning labels should be included
on slipcovers that are sold on or
together with infant support cushions.
As discussed above regarding slipcovers
sold on or together with the product that
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must be tested with the slipcover
installed on the product, the definition
of infant support cushion in § 1243.2
has been revised to add a new sentence
at the end of the definition, ‘‘This
definition includes any removable
covers, or slipcovers, sold on or together
with an infant support cushion,’’ to
make clear that slipcovers sold on or
together with the product are subject to
the requirements of the rule. However,
aftermarket slipcovers or third-party
covers are considered accessories that
are not part of the product and thus not
subject to the rule. Finally, in response
to this comment, § 1243.6(e) of the final
rule has been revised to require warning
labels on slipcovers that are sold on or
together with an infant support cushion.
Comment: Safe Infant Sleep
recommends laundering/cleaning
instructions to mitigate a mold hazard.
Response: Incident data do not
indicate there is a mold hazard that
would require infant support cushions
to have laundering/cleaning instructions
as part of this rulemaking. Therefore,
the Commission assesses at this time no
requirement is needed to address
laundering/cleaning. However, if this
information is provided, it should not
be placed on a warning label because
warning labels that have too much
information that is not urgent for the
user of the product dilute all messages
on the label.
Comment: The Joint Consumer
Advocate Commenters suggest that
CPSC should consider more ways to
clearly emphasize in the warning label
that infant support cushions should not
be used for sleep.
Response: The Commission assesses
that no change to the rule is needed to
clearly emphasize the warning against
using infant support cushions for sleep
because this message is already strongly
communicated through the initial
sentence of the warning about the
deadly consequences of using the
product for sleep or naps.
Comment: Safe Infant Sleep objects to
using the statement ‘‘using this product
for sleep or naps can kill’’ because this
statement implies that naps are different
than sleep and this can be damaging to
safe sleep education. The commenter
instead recommends ‘‘using this
product for ANY duration of sleep, even
when supervised can kill.’’
Response: Consumers have indicated
that ‘‘sleep’’ and ‘‘naps’’ may mean
different things for infants and have
indicated that infants ‘‘nap’’ anywhere
but should be in a specific sleep product
when they are put to ‘‘sleep.’’ 31
31 Fors Marsh Group’s, 2022 ‘‘Consumer Product
Safety Commission (CPSC): Sleep Warnings Final
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Therefore, the rule retains the
requirement for the warning label to
contain the statement ‘‘using this
product for sleep or naps can kill’’ to
reinforce that the products are unsafe
for all types of sleep. However, the final
rule revises the warning labels in figure
2 and new figure 3 of § 1243.6 by
separating ‘‘stay near and watch baby
during use’’ from ‘‘if a baby falls asleep,
move baby to infant sleep product, such
as a crib or bassinet.’’ These changes,
which provide clearer instruction on
what a caregiver should do if their baby
falls asleep, have been made to figure 2
and new figure 3 of § 1243.6.
Comment: Graco notes that the
warning ‘‘use only with an awake baby’’
is a new type of warning and it is not
clear if parents understand what level of
awake their baby should be.
Response: The Commission agrees
that the phrase ‘‘use only with an awake
baby’’ from the warning statement
should be removed because the safety
messaging to not use infant support
cushions with sleeping infants or in an
infant sleep setting is already strongly
communicated through the initial
sentence of the warning about the
deadly consequences of using the
product for sleep or lounging. Therefore,
the final rule removes ‘‘use only with an
awake baby’’ from the warning labels in
figure 2 and new figure 3 of § 1243.6.
Comment: Heroes Technology
recommends changing the proposed
warning ‘‘USING THIS PRODUCT FOR
SLEEP OR NAPS CAN KILL’’ to ‘‘USING
THIS PRODUCT FOR INFANT SLEEP
OR NAPS CAN LEAD TO SERIOUS
INJURIES OR DEATH.’’
Response: We disagree with the
commenter’s recommended change to
the warning label. First, the warning
label statement ‘‘can kill’’ is an accurate
and concise statement of the
consequences of infants sleeping or
napping on infant support cushions.
Warning messages on many infant
products are often too long, resulting in
consumers not reading and heeding the
messages. The commenter’s
recommended statement ‘‘can lead to
serious injuries or death’’ is much less
impactful than ‘‘can kill’’ and thus
would not be as effective in warning
caregivers about the serious suffocation
hazard to infants from using these
products for sleep or naps.
Comment: Heroes Technology
suggests stronger warning language
surrounding the use of soft bedding in
and around infant support cushions.
Report’’, available at: www.cpsc.gov/s3fs-public/
Consumer-Product-Safety-Commission%E2%80%
93Sleep-Warnings-Final-Report.pdf?
VersionId=MfJcAAip4YNWVf.RllvXQtwNN7chjHyt.
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87479
Response: Incident data indicate that
infant deaths occurred when soft
bedding was placed in an infant support
cushion. Infant deaths also occurred
when the product was used on soft
bedding and the infant rolled out of the
product into a hazardous setting
containing soft bedding around the
product. The Commission accordingly
agrees that the rule should have stronger
warning language regarding the use of
soft bedding in and around infant
support cushions. Therefore, the
warning labels in figure 2 and new
figure 3 of § 1243.6 have been revised to
add ‘‘Do not use on soft surfaces or in
sleep products like cribs or bassinets.
Keep blankets and other soft items out
of and away from product.’’ to warn
against the hazard presented by soft
bedding in and around infant support
cushions. Additionally, this revision to
figure 2 and new figure 3 of § 1243.6 in
the final rule separates this warning
statement into a separate bullet point to
emphasize the risk to infants from soft
bedding.
Comment: Heroes Technology
suggests stronger and more impactful
language surrounding the fall risk from
placing the product on elevated
surfaces, and warning consumers that
infants may roll unexpectedly.
Response: We disagree that the
warning label in the rule requires
stronger and more impactful language
regarding the fall risk from placing
infant support cushions on elevated
surfaces and warning consumers that
their infants may roll unexpectedly is
necessary. These messages are already
presented concisely on the warning
labels in figure 2 and new figure 3 of
§ 1243.6.
Comment: Graco states that the
warning statements were not provided
in the proposed regulatory text and were
only provided in figure 2 of the NPR.
Response: The proposed rule
characterized the warning label in figure
2 as an example. Thus, it was unclear
if the exact content and format for the
warning label depicted in proposed
figure 2 in § 1243.6(d)(7) is required.
The final rule clarifies that the required
content and format of the warning labels
in figure 2 and new figure 3 are to be
used exactly as written, as applicable.
Additionally, in § 1243.6(d)(7), the word
example was removed from the figure 2
and new figure 3 captions.
Comment: Graco recommends adding
the following statement to the warning
label of the infant support cushion rule:
‘‘For babies with medical conditions,
developmental delay, or complications
relating to premature birth, consult a
doctor before use.’’
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Response: The Commission disagrees
with requiring this information to be
placed on the warning label because not
all helpful information needs to be
included on the warning label in the
rule. The warning label in § 1243.6 of
the rule includes messaging focused on
the serious suffocation and fall hazards
posed by infant support cushions.
I. Comparative Analysis
Comment: JPMA argues that CPSC has
not provided a risk/benefit analysis,
risk/hazard analysis, or a consumer
choice analysis regarding the proposed
rule.
Response: The types of analysis
described by the commenter that would
quantify the hazard reduction benefits
versus the costs of compliance are not
required by section 104 of the CPSIA. A
consumer choice model would require
detailed consumer demand data that
commenters did not provide and would
involve quantifying consumer demand
for theoretical product alternatives not
specified by the commenter and not
required by section 104 of the CPSIA.
The Initial Regulatory Flexibility
Analysis (IRFA) 32 did provide a specific
numerical estimate of the cost of
compliance, and the staff analysis of
incidents found multiple deaths each
year associated with these products—17
deaths per year in 2021 and at least 17
in 2022.33
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J. Effective Date
Comments: Boppy, Heroes
Technology, and JPMA contend that a
180-day effective date is insufficient for
compliance and argue that a one-year
effective date would be appropriate to
limit the burdens on manufacturers.
Response: While the commenters
assert that 180 days is insufficient time
to comply with the rule without
burdening manufacturers, they do not
provide any specific data or information
showing that the level of effort to
redesign and distribute an infant
support cushion would require a oneyear compliance period. Furthermore,
JPMA typically allows 180 days for
products in their certification program
to implement a new voluntary standard
such that juvenile product
manufacturers are accustomed to
32 See Tab E of Staff’s NPR Briefing Package,
available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
EvV00xeX75dsFc.
33 See Tab A of Staff’s NPR Briefing Package,
available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_
EvV00xeX75dsFc.
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Jkt 265001
adjusting to new standards within this
time frame. Therefore, the rule provides
a reasonable effective date that takes
into consideration manufacturers
burdens and the risk of continued infant
injuries and deaths. Based on the
urgency of addressing the hazards
associated with infant support cushions,
the 180-day effective date proposed in
the NPR is appropriate and is being
finalized as proposed.
K. Stockpiling
Comments: AAP and the Joint
Consumer Advocate Commenters
request that CPSC take action to prevent
manufacturers from increasing
production of, or stockpiling,
noncompliant infant support cushions
and to prevent sellers from putting on
the market large quantities of products
that are noncompliant.
Response: The Commission notes the
commenters’ recommendations to
include a stockpiling provision in the
final rule. Commenters provided no
evidence that manufacturers or
importers are likely to increase
significantly their manufacture or
importation of infant support cushions
before the rule’s effective date. In
addition, the 180-day effective date
should serve to limit the stockpiling of
noncompliant products so as to prevent
such manufacturers from circumventing
the purpose of the rule. Therefore, the
final rule does not include a stockpiling
provision.
L. Regulatory Procedure
Comment: BPQ requests that CPSC
revise the NPR and reissue it for public
comment to reflect recent revisions to
ASTM’s draft infant lounger voluntary
standard.
Response: As of the date of the
publication of the final rule, there is no
voluntary standard addressing the
suffocation and fall hazards of infant
support cushions on which a mandatory
rule could be based. Additionally, the
draft ASTM standard is in draft form
and subject to change as part of the
consensus process. Section 104 of the
CPSIA does not require an existing
voluntary standard in order for the
Commission to promulgate a safety
standard for a durable infant or toddler
product. See 15 U.S.C. 2056a(b)(2);
Finnbin, LLC v. Consumer Prod. Safety
Comm’n, 45 F.4th 127, 134 (D.C. Cir.
2022).
Comment: Boppy and Heroes
Technology argue that this rule cannot
be promulgated under section 104 of the
CPSIA without a preexisting voluntary
standard for infant support cushions.
Response: Section 104 of the CPSIA
does not require an existing voluntary
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standard in order for the Commission to
promulgate a safety standard for a
durable infant or toddler product. See
15 U.S.C. 2056a(b)(2); Finnbin, LLC v.
CPSC, 45 F.4th 127, 134 (D.C. Cir. 2022).
In Finnbin, the court explained that
CPSC has an express statutory command
to regulate all categories of durable
infant or toddler products and must do
so for products not covered by voluntary
standards. Furthermore, by the terms of
15 U.S.C. 2056a(b)(1), the requirement
to examine and assess the effectiveness
of any voluntary standards only applies
if a voluntary standard exists. Because
no voluntary standards currently
address the suffocation and fall hazards
posed by infant support cushions, the
procedural requirements in section
104(b) of the CPSIA, to develop a rule
with reference to an existing standard,
do not apply to this rule.
Comment: Boppy argues that infant
support cushions are not durable
nursery products because infant support
cushions are ‘‘pillow-like’’ and pillows
are soft, textile products that are in no
way comparable to cribs, strollers,
bathtubs, or bed rails. Boppy
additionally argues that there are no
products in either the original twelve, or
additional six product categories of
durable goods that can be rationally
compared to ‘‘pillows.’’
Response: Infant support cushions
meet the statutory requirement for
durable infant or toddler products in
section 104(f)(1) of the CPSIA because
they are intended for use, and may be
reasonably expected to be used, by
children under the age of 5 years and
routinely have a life span of several
years. They are not disposable; have a
useful life of up to several years and are
often used by multiple children in
succession; are similar to other soft
durable infant and children’s products
such as crib mattresses and sling
carriers (which the Commission has
issued rules for under section 104); are
resold and widely available on
secondary marketplaces; and are
primarily intended to be used by
children five years old or younger.
Therefore, although infant support
cushions are not specifically listed in
section 104(f)(2) of the CPSIA, the
Commission may reasonably treat them
as ‘‘durable infant or toddler products.’’
The Commission has previously
added to the statutory list of durable
infant or toddler products by including
other products for young infants, such
as changing products and infant
bouncers, that also have a market for
secondary use. As the Commission
explained in 2009, ‘‘[b]ecause the
statute has a broad definition of a
durable infant or toddler product but
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also includes 12 specific product
categories, additional items can and
should be included in the definition.’’
Requirements for Consumer Registration
of Durable Infant or Toddler Products,
74 FR 68668, 68669 (December 29,
2009).
Comments: Boppy contends the
proposed rule is unconstitutional
because it violates the non-delegation
doctrine and the Separation of Powers
and Appointments Clause of the U.S.
Constitution.
Response: The rule is being
promulgated under the Danny Keysar
Child Product Safety Notification Act,
section 104 of the CPSIA, which directs
the Commission to promulgate
consumer product safety standards for
durable infant or toddler products.
CPSC is an independent agency and the
Commissioners do not exercise
Executive power, consistent with the
Supreme Court’s holding in Humphrey’s
Executor v. United States, 295 U.S. 602
(1935). Several Federal Courts of
Appeals have recently rejected similar
Constitutional arguments about CPSC.
Consumers’ Rsch. v. CPSC, 91 F.4th 342
(2024), petition for cert. filed,
(Consumers’ Rsch. v. CPSC, No. 23–
1323 (petition for cert. filed on July 18,
2024)), and Leachco, Inc. v. CPSC, 103
F4th 748 (10th Cir. 2024), petition for
cert. pending, No. 22–7060 (filed Aug. 9,
2024)).
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VII. Description of the Final Rule for
Infant Support Cushions
As section 104 of the CPSIA requires,
to address the risks of death and injury
associated with infant suffocations,
entrapments, and falls, the Commission
is issuing this rule to establish
mandatory performance and labeling
requirements for infant support
cushions. The requirements of the rule
are based on an evaluation of incident
data and the hazard patterns associated
with infant support cushions, and the
recommendations of the BSU Final
Report. The final rule is summarized
below, and the rule is being finalized as
proposed in the NPR except as noted.
A. Section 1243.1 Scope, Purpose,
Applications, and Exemptions
Section 1243.1 explains that the rule
applies to infant support cushions,
including infant positioners, nursing
pillows with a dual use for lounging,
infant loungers, infant props, or
cushions used to support an infant for
activities such as tummy time, and other
infant pillow-like products. It excludes
products already regulated by other
Commission mandatory standards for
durable infant products, which are
listed in 16 CFR 1130.2(a). The rule
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applies to all infant support cushions
manufactured after the effective date of
the rule. Section 1243.1 is being
finalized without changes as proposed
in the NPR.
B. Section 1243.2
Definitions
Section 1243.2 provides definitions
for the following terms used in the rule:
conspicuous, infant lounger, infant
positioner, infant support cushion,
occupant support surface, seat bight
line, and sidewall. The definitions in
§ 1243.2 are being finalized as proposed
in the NPR except as discussed below.
In response to a comment from Graco
and for clarity, the definition of infant
lounger has been revised to change the
proposed words ‘‘infant product’’ to
‘‘infant support cushion’’ in the final
rule. Also, in response to comments
from Safe Infant Sleep and The Joint
Consumer Advocate Commenters, the
definition of infant support cushion has
been revised to add a new sentence at
the end of the definition ‘‘This
definition includes any removable
covers, or slipcovers, sold on or together
with an infant support cushion’’.
Finally, in response to a comment from
Boppy, a new definition for the term
‘‘sidewall,’’ which is defined as ‘‘any
wall at the edge of the occupant support
surface’’, has been added to the final
rule to provide clarity regarding the
meaning of that term.
C. Section 1243.3
Requirements
General
Section 1243.3 provides general
requirements for infant support
cushions, including requirements
addressing hazardous sharp edges or
points (§ 1243.3(a)), small parts
(§ 1243.3(b), lead in paints (§ 1243.3(c)),
toys (§ 1243.3(d)), the removal of
components (§ 1243.3(e)), the
permanency of labels and warnings
(§ 1243.3(f)), and convertible products
(§ 1243.3(g)). Section 1243.3 is being
finalized as proposed in the NPR except
that the reference to ‘‘infant pillow’’ in
§ 1243.3(d) has been changed in the
final rule to ‘‘infant support cushion’’
for accuracy and consistency based on
a comment from TA. The final rule also
removes proposed § 1243.3(e) regarding
side height. Measuring the height of the
product is unnecessary and thus
duplicative because the maximum
incline angle test in § 1243.5(d)(7)
already accounts for the height of the
product remaining under 2 inches. The
final rule renumbers the paragraphs
following § 1243.3(d) to reflect this
change.
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D. Section 1243.4
Requirements
87481
Performance
Section 1243.4 provides performance
requirements for infant support
cushions for restraints (§ 1243.4(a)),
seam strength (§ 1243.4(b)), bounded
openings (§ 1243.4(c)), maximum
incline angle (§ 1243.4(d)), firmness
(§ 1243.4(e)), and sidewall angle
(§ 1243.4(f)). Section 1243.4 is being
finalized as proposed in the NPR except
as discussed below. In response to a
comment from Boppy, two changes have
been made in paragraph (e) of § 1243.4
that establishes requirements for
firmness. In § 1243.4(e)(2) and (3), ‘‘For
products with a sidewall’’ has been
added to the beginning of the sentence
because the proposed rule did not make
clear whether the performance
requirements are applicable to products
without sidewalls. Additionally, in
response to a comment from Boppy, the
same change has been made to
§ 1243.4(f) that establishes requirements
for side angles because the proposed
rule did not clarify the applicability of
performance requirements for products
without sidewalls.
E. Section 1243.5
Test Methods
Section 1243.5 provides the test
methods to be used to test for
compliance with the requirements of the
rule. Section 1243.5 includes test
methods for test conditions
(§ 1243.5(a)), test for permanence of
labeling and markings (§ 1243.5(b)),
head entrapment test (§ 1243.5(c)),
maximum incline test (§ 1243.5(d)),
firmness test setup (§ 1243.5(e),
occupant support surface firmness test
method (§ 1243.5(f)), sidewall firmness
test method (§ 1243.5(g)), test method
for the intersection of sidewall and
occupant support surface firmness
(§ 1243.5(h)), test method for sidewall
angle determination (§ 1243.5(i)), seam
strength test method (§ 1243.5(j)), and
removal of components test method
(§ 1243.5(k)). Section 1243.5 is being
finalized as proposed in the NPR except
as discussed below.
For the same reason discussed above
for the removal of proposed § 1243.3(e)
regarding side height, the final rule
removes the corresponding test in
§ 1243.5(d)(8) for consistency. To reflect
this change, all numbers after
§ 1243.5(d)(7) have been renumbered.
In response to a comment from Safe
Infant Sleep, the following language has
been added after the first sentence of
§ 1243.5(f): ‘‘For products sold with a
slipcover on or together with the
product, products shall be tested as
assembled with the slipcover on the
product.’’ This language has been added
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to the final rule because slipcovers with
extra padding or cushioning may
introduce suffocation hazards that
would not be addressed if slipcovers
sold on or together with an infant
support cushion were not required to be
tested as assembled with the slipcover
on the product. In response to a
comment from Boppy, right after the
new sentence added above, the
following language has been added to
§ 1243.5(f) of the final rule: ‘‘All
products, including products one inch
or less in thickness, are required to be
tested.’’ This language has been added
to the final rule because a product could
either vary in thickness or be so close
to 1 inch in thickness that it would be
difficult to determine thickness without
testing. In response to another comment
from Boppy, § 1243.5(g) of the final rule
adds in the first sentence ‘‘products
with a sidewall’’ between ‘‘For’’ and
‘‘perform’’ because the proposed rule
did not specifically clarify the
applicability of test methods for
products without sidewalls. The Boppy
comment also resulted in changes to
§ 1243.5(h) and (i) at the beginning of
the first sentence, adding ‘‘For products
with a sidewall,’’ before ‘‘perform,’’ to
state directly that products with
sidewalls must be tested according to
the test methods.
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F. Section 1243.6 Marking and
Labeling
Section 1243.6 provides the marking
and labeling requirements for infant
support cushions, including general
markings (§ 1243.6(a)), permanency
(§ 1243.6(b)), upholstery labeling
(§ 1243.6(c)), warning design for product
(§ 1243.6(d)), and warning statements
(§ 1243.6(e)). Section 1243.6 is being
finalized as proposed in the NPR except
as discussed below.
Several changes have been made to
figure 2 in § 1243.6(d)(7) as described
below. We also add a new figure 3,
Warning for Tummy Time Product, in
§ 1243.6(d)(7), as described below.
• In response to a comment from
Graco, the phrase ‘‘use only with an
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awake baby’’ has been removed from the
warning label in figure 2 and new figure
3 because the safety messaging to not
use infant support cushions with
sleeping infants or in an infant sleep
setting is already strongly
communicated through the initial
sentence of the warning about the
deadly consequences of using the
product for sleep or naps, and limiting
the amount of text on warning labels
makes the material being presented
more prominent.
• The rule clarifies that figure 2 in
§ 1243.6(d)(7) is required for all infant
support cushions that do not have a
tummy time feature.
• In response to comments from
Boppy, AAP, BPQ, the Joint Consumer
Advocate Commenters, Safe Infant
Sleep, and JPMA, the Commission is
adding a new figure 3 in § 1243.6(d)(7)
for products with a tummy time feature.
The statement bullet point was also
moved up within the warning statement
to reflect the serious hazard to infants
presented by prone positioning. In new
figure 3, the statement ‘‘Put baby on
back after Tummy Time’’ is added to the
warning label after the phrase ‘‘Use only
on the floor with baby on back, face
up,’’ to accommodate multi-use
positions of some infant support
cushion products, such as tummy time
pillows that may have features that
require the infant to be on their stomach
while using the product. Figure 3
additionally omits the word ‘‘only’’
from ‘‘use only on the floor with baby
on back, face up’’. Figure 3 is required
only for products that have a tummy
time feature because only those
products that have a tummy time feature
should allow for prone positioning.
• In response to a comment from Safe
Infant Sleep the warning labels have
been revised with more concise wording
and clarity to provide instruction for
what a caregiver should do if their baby
falls asleep by separating ‘‘stay near and
watch baby during use’’ from ‘‘if a baby
falls asleep, move baby to infant sleep
product, such as a crib or bassinet’’.
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• In response to a comment from
Heroes Technology, the warning labels
for figure 2 and new figure 3 now
includes the statement ‘‘Do not use on
soft surfaces or in sleep products like
cribs or bassinets. Keep blankets and
other soft items out of and away from
product’’ to discourage soft bedding use
in and around the product. This
revision also separates these warning
statements into a separate bullet point to
emphasize the risk to infants from soft
bedding placed both in and around the
product.
• In response to a comment from
Graco, the word ‘‘example’’ was
removed from the captions on figure 2
and new figure 3 because it was unclear
if the exact content and format for the
warning labels in § 1243.6(d)(7) is
required as depicted in proposed figure
2 and new figure 3. Additionally, the
final rule clarifies in § 1243.6(d)(7) that
the content and format as depicted in
figure 2 and new figure 3 as applicable,
are required.
• Note 4 to proposed § 1243.6(e) has
been removed from the rule as
unnecessary because the final rule
clarifies that the required content and
format of the warning labels in figure 2
and new figure 3, as applicable, are to
be used as written.
• A new note 4 to § 1243.6(d)(6) has
been added below figure 1 for paragraph
(d)(6), which was originally the
language above figure 1 for paragraph
(d)(6), with the new note 4 providing
the original text indicating that the
depicted warnings are filler text, known
as lorem ipsum, commonly used to
demonstrate graphic elements.
• In figure 2 and new figure 3, a black
line has been inserted between the
suffocation warnings and the fall
warnings to distinguish between the
messages.
The changes described above are
depicted below in the revised figure 2,
Warning for Product Without Tummy
Time, and new figure 3, Warning for
Tummy Time Product, from § 1243.6 of
the final rule.
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Warning for Product Without Tummy Time
USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL.
Babies can turn over or roll out without warning and CAN
SUFFOCATE in only a few minutes.
•
•
•
•
Only use on the floor with baby on back, face-up.
Stay near and watch baby during use.
Do not use on soft surfaces or in sleep products like cribs
or bassinets. Keep blankets and other soft items out of and
away from product.
If baby falls asleep, move baby to infant sleep product, such
as a crib or bassinet.
Babies have been injured from FALLS.
•
•
Do not use on beds, sofas, or other raised surfaces.
Never carry or move product with baby in it.
Warning for Tummy Time Product
USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL.
Babies can turn over or roll out without warning and CAN
SUFFOCATE in only a few minutes.
•
•
•
•
Use on the floor with baby on back, face-up. Put baby on
back after Tummy Time.
Stay near and watch baby during use.
Do not use on soft surfaces or in sleep products like cribs
or bassinets. Keep blankets and other soft items out of and
away from product.
If baby falls asleep, move baby to infant sleep product, such
as a crib or bassinet.
Babies have been injured from FALLS.
Additionally, in response to a
comment from the Joint Consumer
Advocate Commenters, the final rule
adds language at the end of § 1243.6(e)
stating that slipcovers, sold on or
together with the product, are required
to contain a warning with the content
and format depicted in figure 2 or 3, as
applicable, to paragraph (d)(7). This
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language is being added because when
an infant support cushion is sold with
a slipcover, it is expected that slipcover
will hide the warning label that should
be visible to a caregiver while placing
an infant onto or into the product, when
the product is in the manufacturer’s
recommended use position. Therefore,
the warning label should be
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conspicuously located on the slipcover
as is required for an infant support
cushion that does not come with a
slipcover.
G. Section 1243.7
Literature
Instructional
Section 1243.7 provides requirements
for instructional literature for infant
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ER04NO24.002
Do not use on beds, sofas, or other raised surfaces.
Never carry or move product with baby in it.
ER04NO24.001
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•
•
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support cushions, including requiring
instructional literature be provided with
the product, as well as requirements as
to what such information must include.
Section 1243.7 also requires that
instructional literature meet the
requirements of the National Electrical
Manufacturers Association’s (NEMA’s)
ANSI Z535.4–2011(R2017), American
National Standard for Product Safety
Signs and Labels (ANSI Z535.4–2011).
The final rule specifically requires the
warning format requirements in sections
6.1–6.4, 7.2–7.6.3, and 8.1 of ANSI
Z535.4–2011(R20217). Finally, under
§ 1243.7 any instructions provided in
addition to those required by § 1243.7
shall not contradict or confuse the
meaning of the required information or
be otherwise misleading to the
consumer. Section 1243.7 is being
finalized as proposed in the NPR.
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H. Section 1243.8 Incorporation by
Reference
Section 1243.8 incorporates by
reference ANSI Z535.4–2011(R20217),
American National Standard for
Product Safety Signs and Labels, and
ASTM D3359–23, Standard Test
Methods for Rating Adhesion by Tape
Test, and provides information on
where those standards are available.
ANSI Z535.4–2011 includes
requirements related to safety alert
symbol use; signal word selection;
warning panel format, arrangement, and
shape; color requirements for each
panel; letter style; to identify and warn
against specific hazards; and to provide
information to avoid personal injury.
ASTM D3359–23 covers procedures for
assessing the adhesion of relatively
ductile coating films to metallic
substrates by applying and removing
pressure-sensitive tape over cuts made
in the film.
VIII. Amendment to 16 CFR Part 1112
To Include NOR for Infant Support
Cushions
Products subject to a consumer
product safety rule under the CPSA, or
to a similar rule, ban, standard, or
regulation under any other act enforced
by the Commission, must be certified as
complying with all applicable CPSCenforced requirements. 15 U.S.C.
2063(a). Certification of children’s
products subject to a children’s product
safety rule must be based on testing
conducted by a CPSC-accepted thirdparty conformity assessment body. 15
U.S.C. 2063(a)(2). The Commission must
publish an NOR for the accreditation of
testing laboratories as third party
conformity assessment bodies to assess
conformity with a children’s product
safety rule. 15 U.S.C. 2063(a)(3). The
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infant support cushions rule is a
children’s product safety rule that
requires the issuance of an NOR.
The Commission’s rules, at 16 CFR
part 1112, establish requirements for
accreditation of third party conformity
assessment bodies to test for
conformance with a children’s product
safety rule in accordance with section
14(a)(2) of the CPSA. Part 1112 also lists
the NORs that the CPSC has published.
In the NPR the Commission proposed to
amend part 1112 to include the Safety
Standard for Infant Support Cushions in
the list of children’s product safety rules
for which the CPSC has issued NORs.
Section 1112.15(a)(57) is being finalized
as proposed in the NPR.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new Safety Standard for Infant
Support Cushions standard are required
to meet the third party conformity
assessment body accreditation
requirements in part 1112. When a
laboratory meets the requirements as a
CPSC-accepted third party conformity
assessment body, the laboratory can
apply to the CPSC to have the Safety
Standard for Infant Support Cushions
included in its scope of accreditation as
reflected on the CPSC website at
www.cpsc.gov/labsearch.
IX. Amendment to 16 CFR Part 1130 To
Include Infant Support Cushions
Infant support cushions are a category
of ‘‘durable infant or toddler product’’
for purposes of CPSIA section 104
because they: are intended for use, and
may be reasonably expected to be used,
by children under the age of five years;
are products similar to other products
listed in section 104(f)(2), such as crib
mattresses, and sling carriers; and are
commonly resold or ‘‘handed down’’ for
use by other children over a period of
years. In the NPR, the Commission
proposed to amend 16 CFR part 1130 to
include Infant Support Cushions as
durable infant or toddler products.
Section 1130.2(a)(20) is being finalized
as proposed in the NPR.
X. Incorporation by Reference
The rule incorporates by reference
ANSI Z535.4–2011(R2017), American
National Standard for Product Safety
Signs and Labels, and ASTM D3359–23,
Standard Test Methods for Rating
Adhesion by Tape Test. In accordance
with the regulations of the Office of the
Federal Register, 1 CFR part 51, section
VII.H of this preamble summarizes the
requirements of the ANSI Z535.4–
2011(R2017) and ASTM D3359–23.
Both standards are reasonably
available to interested parties in several
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ways. Interested persons may purchase
a copy of ANSI Z535.4–2011(R2017)
from the National Electrical
Manufacturers Association (NEMA),
1300 17th St. N, Arlington, VA 22209;
phone: (703) 841–3200; website:
www.nema.org. This standard is also
available from ANSI via its website,
www.ansi.org, or by mail from ANSI, 25
West 43rd Street, 4th Floor, New York,
NY 10036, telephone: (212)–642–4900.
Once the rule takes effect, a read-only
copy of ANSI Z535.4–2011(R2017) will
be available for viewing, at no cost, on
the ANSI website at: https://ibr.ansi.org/
Standards/nema.aspx. Interested
individuals may purchase a copy of
ASTM D3359–23 from ASTM, through
its website, www.astm.org, or by mail
from ASTM International, 100 Barr
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428–2959. Once
the rule takes effect, a read-only copy of
the standard will be available for
viewing, at no cost, on the ASTM
website at: www.astm.org/
READINGLIBRARY/. Alternatively,
interested parties may inspect a copy of
the standards at CPSC’s Office of the
Secretary by contacting Alberta E. Mills,
Commission Secretary, U.S. Consumer
Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814;
phone: (301) 504–7479; email: cpsc-os@
cpsc.gov.
XI. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). In the NPR the
Commission proposed an effective date
of 180 days after publication of the final
rule in the Federal Register. This
amount of time is typical for rules
issued under section 104 of the CPSIA.
We note that the 180-day effective date
is the same amount of time that JPMA
typically allows for products in their
certification program to shift to a new
standard once that standard is
published. Therefore, juvenile product
manufacturers are accustomed to
adjusting to new standards within this
time frame. We noted in the NPR that
a 180-day effective date should also be
sufficient for manufacturers to comply
with this rule because the proposed
requirements do not demand significant
preparation by testing laboratories. For
example, no new complex testing
instruments or devices would be
required to test infant support cushions
for compliance with this rule. Based on
the urgency of addressing the hazards
associated with infant support cushions,
the 180-day effective date proposed in
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the NPR is appropriate and is being
finalized as proposed.
B. Comments and Responses
Concerning Impact on Small Entities
XII. Regulatory Flexibility Act
Comment: Boppy and Heroes
Technology state that the maximum
incline angle requirement, which limits
product height to approximately 1.9
inches, would eliminate most products
subject to this rule from the market,
resulting in a significant loss of utility
to consumers for compliant products,
far in excess of CPSC’s estimates.
Response: The IRFA stated that
consumers might not purchase the
redesigned compliant products and
estimated a significant impact on a
substantial number of small businesses.
The commenters did not provide any
data on their assertion that consumers
might not want to buy products with a
shorter side height. Given the number of
playmats and similar items with no
sides or short sides on the market, there
is ample evidence that consumers are
willing to purchase such items. The
Commission has considered the
significant impact on small entities in
the IRFA, and it is discussed in the
possible alternatives analysis in this
FRFA and thus has taken this impact
into account as required by the RFA.
Comment: JPMA states that this rule
would require significant costly changes
to make products compliant.
Response: JPMA did not provide
quantitative estimates of supplier costs
or consumer utility impacts to support
a change in the burden estimates. The
IRFA provided specific estimates of
labor and materials costs for redesign.
The scope of staff’s analysis of burden,
as required by 5 U.S.C. 603, was the
impact on small U.S. businesses, and
none of the comments provided
information to support changing the
estimates of impact on small U.S.
businesses. The Commission has,
however, considered the significant
impact on small entities in finalizing
this rule.
When an agency is required to
publish a notice of proposed
rulemaking, the Regulatory Flexibility
Act (5 U.S.C. 601–612) generally
requires that the agency prepare an
IRFA for the NPR and a final regulatory
flexibility analysis (FRFA) for the final
rule. 5 U.S.C. 603, 604. These analyses
must describe the impact that the rule
would have on small businesses and
other entities. The FRFA must contain:
(1) a statement of the need for and
objectives of the rule;
(2) significant issues raised by
commenters on the IRFA, the agency’s
assessment of those issues, and changes
made to the result as a result of the
comments;
(3) a response to any comments filed
by the Chief Counsel for Advocacy of
the U.S. Small Business Administration
(Advocacy), and changes made as a
result of those comments;
(4) a description and estimate of the
number of small entities to which the
rule will apply;
(5) a description of the projected
reporting, recordkeeping, and other
compliance requirements of the rule,
including an estimate of the classes of
small entities which will be subject to
the requirement and the type of
professional skills necessary for
preparation of the report or record; and
(6) steps the agency has taken to
minimize the significant economic
impact on small entities, consistent with
the objective of the applicable statute,
including the factual, policy, and legal
reasons for selecting the alternative in
the final rule and why other alternatives
were rejected.
Staff prepared an IRFA for this
rulemaking that was summarized in the
NPR and provided in full Tab E of the
Staff’s NPR Briefing Package. The FRFA
is provided below.
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A. Need for and Objectives of This Rule
Section I of this preamble describes
the reasons and legal basis for this final
rule. As discussed in sections VI and VII
of this preamble, the rule sets
mandatory requirements for infant
support cushions to address the
suffocation, entrapment, and fall
hazards associated with these products;
adds infant support cushions to the list
of products for which a registration card
is required; and adds infant support
cushions to the list of durable infant
products for which an NOR is required.
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C. Issues Raised by the Small Business
Administration
The Small Business Administration
(SBA) did not submit a comment on the
proposed rule.
D. Small Entities to Which the Rule
Would Apply
The SBA sets size standards for what
constitutes a U.S. small business for the
purpose of various Federal Government
programs,34 750 employees for
manufacturers (NAICS code 314120)
and 100 to 150 employees for
wholesalers (NAICS codes 424350,
34 The size standards are in listed in the Code of
Federal Regulations. See 13 CFR part 121.
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87485
423990, and 424990).35 Based on staff’s
assessment of prominent online and
brick-and-mortar retail sources for
infant support cushions in the Spring of
2023, there appear to be more than
2,000 suppliers of infant support
cushions to the U.S. market, including
small U.S. crafters, small importers,
small manufacturers, and direct foreign
shippers. Staff estimates that a
significant number of these firms are
small U.S. businesses based on the SBA
thresholds cited above.
E. Compliance, Reporting, Paperwork,
and Recordkeeping Requirements of the
Rule
Suppliers will be required to comply
with the performance requirements of
the rule; provide a warning label, a
consumer registration card, and user
instructions; and conduct third-party
testing to demonstrate compliance.
Suppliers must demonstrate that they
meet the performance requirements of
the rule by providing certificates of
compliance. As specified in 16 CFR part
1109, suppliers who are not the original
manufacturer, such as importers,
wholesalers, and retailers may rely on a
certificate of conformity provided by
their suppliers. Suppliers must also
provide product registration cards.
Recordkeeping and compliance
documentation do not require
specialized expertise. CPSC’s public
website provides instructions and
examples for how to develop the
certificates of compliance and product
registration cards.36 Similarly, because
the final rule provides the text and
graphics for the required labels and
instructions, specialized graphics design
expertise will not be required to develop
the warnings and instructions.
F. Impact of the Rule on Small Entities
The rule will likely have a significant
impact on a substantial number of U.S.
small entities, based on the estimated
costs of modifying the product to
achieve compliance, and the ongoing
cost of testing to demonstrate
compliance. Staff considers one percent
of annual revenue to be a ‘‘significant’’
35 The North American Industry Classification
System (NAICS) is the standard used by Federal
statistical agencies in classifying business
establishments for the purpose of collecting,
analyzing, and publishing statistical data related to
the U.S. business economy. For more information,
see www.census.gov/naics/. Some programs use 6digit NAICS codes, which provide more specific
information than programs that use more general 3
or 4-digit NAICS codes.
36 See for example: www.cpsc.gov/Business—
Manufacturing/Testing-Certification/ChildrensProduct-Certificate; and www.cpsc.gov/Business—
Manufacturing/Business-Education/Durable-Infantor-Toddler-Products/FAQs-Durable-Infant-orToddler-Product-Consumer-Registration.
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economic impact on a company,
consistent with economic analysis from
other Federal Government agencies.
Nearly all of the more than 2,000
suppliers of infant support cushions to
the U.S. are small entities, although
their products often are not
manufactured in United States.
Most products on the market will
require redesign to meet the
requirements in the rule and no
products on the market currently have
the specific labels, customer registration
forms, warnings, and third-party testing
required by the rule. The effort required
for a one-time redesign of a product is
estimated to be 200 hours of
professional staff time per model,
including in-house testing of the
prototypes and development of labels,
customer registration forms, and
instruction materials. Using the Bureau
of Labor Statistics Employer Costs of
Employee Compensation as of March
2024 37 the estimated cost per model is
$13,648, at a current cost for
professional labor of $68.24 per hour,
rounded for the purpose of analysis to
$14,000 per model. Materials costs for
prototyping are estimated to be
minimal, likely under $1,000, given that
pillows are typically made of fabric and
stuffing materials. Third-party testing
for infant support cushions will be an
additional cost for all suppliers and is
estimated to be between $600 and
$1,100 per model, per year, depending
on where the testing takes place and
whether manufacturers’ associations or
groups add infant support cushions to
their certification programs to receive
volume discounts for third-party testing.
The total first year costs of redesign are
estimated to be approximately $16,000
per model ($14,000 for labor, $1,000 for
materials, and $1,000 for third-party
testing).
Staff considers one percent of annual
revenue to be a ‘‘significant’’ economic
impact on a small business. Applying
the one percent threshold to the
estimated redesign and testing costs
from this rule, the threshold for a small
business that would incur a significant
impact are those small firms with less
than $1.6 million in revenue ($16,000
costs ÷ 1 percent of revenue), assuming
they only sell one product model. This
cost estimate will scale with the number
of different models each firm
manufactures. With an estimated 2,000
models from firms that sell to the U.S.
needing to be redesigned, the total cost
for the entire industry could be as high
as $32 million for redesign in the first
year after the rule is published.38
As suppliers will need to redesign
their products to comply with this rule,
both small and large companies may
raise prices to cover costs. Given this
uniformity, these costs would not
necessarily place small businesses at a
competitive disadvantage. JPMA,
Boppy, and Heroes Technology
questioned whether a small retail price
increase would be acceptable to
consumers, or could cover compliance
costs, but these commenters did not
provide an alternative quantitative
estimate of compliance costs or probable
retail price increases.
In summary, given that all U.S.
suppliers will have to redesign products
to comply with this rule, and that these
costs will likely be significant to many
small businesses, this FRFA finds that
this final rule will have a significant
impact on a substantial number of U.S.
small businesses.
37 www.bls.gov/news.release/ecec.t02.htm. The
estimated costs in the link reflect the employers’
cost for salaries, wages, and benefits for civilian
workers.
38 As noted earlier, this estimate is slightly higher
than the estimate in the IRFA, because the relevant
labor rate as reported by the Bureau of Labor
Statistics has risen since the NPR was published.
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G. Other Federal Rules That May
Duplicate, Overlap, or Conflict With the
Final Rule
CPSC has not identified any other
Federal rules that duplicate, overlap, or
conflict with the final rule.
H. Alternatives Considered To Reduce
the Impact on Small Entities
The Commission considered
alternatives to the final rule to reduce
the impact on small businesses. The
Commission considered using a public
education campaign that would result in
no regulatory impact on small
businesses. However, given the
education campaigns on safe sleep
practices that CPSC and others have
been undertaking for years, this
approach would likely result in little to
no mitigation of the current rates of
deaths and injuries from infant support
cushions. The Commission also
considered allowing the voluntary
standards process additional time to
develop a voluntary standard to address
the hazards posed by infant support
cushions. However, there is no certainty
that such a voluntary standard would be
adopted, and a potential voluntary
standard, if published, may not
adequately address the identified
hazards to infants. For example, the
current ASTM draft voluntary standard
for infant loungers would only cover
infant loungers whereas the
Commission’s rule covers all infant
support cushions and has more
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stringent performance requirements and
warnings.
XIII. Paperwork Reduction Act
This rule contains information
collection requirements that are subject
to public comment and review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA; 44 U.S.C. 3501–3521).
The preamble to the NPR discussed the
information collection burden of the
proposed rule and specifically requested
comments on the accuracy of CPSC’s
estimates. 89 FR 2530 (January 16,
2024). The NPR described the
provisions of the proposed rule and
provided an estimate of the annual
reporting burden for the rule under the
PRA. See 89 FR 2542. The estimated
burden of this collection of information
is unchanged from the NPR. CPSC did
not receive any comments regarding the
information collection burden in the
NPR through OMB. OMB has assigned
control number 3041–0202 to this
information collection.
XIV. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that when a consumer
product safety standard is in effect and
applies to a product, no state or political
subdivision of a state may either
establish or continue in effect a standard
or regulation that prescribes
requirements for the performance,
composition, contents, design, finish,
construction, packaging, or labeling of
such product dealing with the same risk
of injury unless the state requirement is
identical to the Federal standard.
Section 26(c) of the CPSA also provides
that states or political subdivisions of
states may apply to the Commission for
an exemption from this preemption
under certain circumstances. Section
104(b) of the CPSIA refers to the rules
to be issued under that section as
consumer product safety rules.
Therefore, the preemption provision of
section 26(a) of the CPSA apply to this
final rule for infant support cushions.
XV. Environmental Considerations
Certain categories of CPSC actions
normally have ‘‘little or no potential for
affecting the human environment’’ and
therefore do not require an
environmental assessment or an
environmental impact statement. Safety
standards providing requirements for
consumer products come under this
categorical exclusion. 16 CFR
1021.5(c)(1). The final rule for infant
support cushions falls within the
categorical exclusion.
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Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
XVI. Congressional Review Act
The Congressional Review Act (CRA;
5 U.S.C. 801–808) states that before a
rule may take effect, the agency issuing
the rule must submit the rule, and
certain related information, to each
House of Congress and the Comptroller
General. 5 U.S.C. 801(a)(1). The CRA
submission must indicate whether the
rule is a major rule. The CRA states that
the Office of Information and Regulatory
Affairs determines whether a rule
qualifies as a major rule.
Pursuant to the CRA, OMB’s Office of
Information and Regulatory Affairs has
determined that this rule does not
qualify as a major rule, as defined in 5
U.S.C. 804(2). To comply with the CRA,
CPSC will submit the required
information to each House of Congress
and the Comptroller General.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1243
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
Pillows, Toys.
For the reasons discussed in the
preamble, the Commission amends
chapter II of title 16 of the Code of
Federal Regulations as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for 16 CFR
part 1112 continues to read as follows:
■
Authority: 15 U.S.C. 2063.
2. Amend § 1112.15 by adding
paragraph (b)(57) to read as follows:
■
lotter on DSK11XQN23PROD with RULES1
Authority: 15 U.S.C. 2056a, 2065(b).
4. Amend § 1130.2 by adding
paragraph (a)(20) to read as follows:
■
§ 1130.2
Definitions.
*
*
*
*
*
(a) * * *
(20) Infant support cushions.
*
*
*
*
*
■
5. Add part 1243 to read as follows:
PART 1243—SAFETY STANDARD FOR
INFANT SUPPORT CUSHIONS
Sec.
1243.1 Scope, purpose, application, and
exemptions.
1243.2 Definitions.
1243.3 General requirements.
1243.4 Performance requirements.
1243.5 Test methods.
1243.6 Marking and labeling.
1243.7 Instructional literature.
1243.8 Incorporation by reference.
§ 1243.1 Scope, purpose, application, and
exemptions.
Administrative practice and
procedure, Business and industry,
Consumer protection, Reporting and
recordkeeping requirements.
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
or test method?
*
*
*
*
*
(b) * * *
(57) 16 CFR part 1243, Safety
Standard for Infant Support Cushions.
*
*
*
*
*
15:57 Nov 01, 2024
3. The authority citation for 16 CFR
part 1130 continues to read as follows:
■
Authority: 15 U.S.C. 2056a.
16 CFR Part 1130
VerDate Sep<11>2014
PART 1130—REQUIREMENTS FOR
CONSUMER REGISTRATION OF
DURABLE INFANT OR TODDLER
PRODUCTS
Jkt 265001
(a) Scope and purpose. The consumer
product safety standard in this part
prescribes requirements to reduce the
risk of death and injury from hazards
associated with infant support cushions,
as defined in § 1243.2. This includes but
is not limited to infant positioners,
nursing pillows with a dual use for
lounging, infant loungers, and infant
props or cushions used to support an
infant. All infant support cushions must
be tested according to the requirements
of § 1243.5 and comply with all
requirements of this part.
(b) Application. All infant support
cushions manufactured after May 5,
2025, are subject to the requirements of
this part.
(c) Exemptions. Products subject to
another standard listed in 16 CFR
1130.2(a) are exempt from this part.
Nursing pillows that also meet the
definition of infant lounger in § 1243.2,
however, are not exempt from this part.
§ 1243.2
Definitions.
Conspicuous means visible, when the
product is in each manufacturer’s
recommended use position, to a person
while placing an infant into or onto the
product.
Infant lounger means an infant
support cushion with a raised
perimeter, a recess, or other area that
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87487
provides a place for an infant to recline
or to be in a supine, prone, or
recumbent position.
Infant positioner means a product
intended to help keep an infant in a
particular position while supine or
prone.
Infant support cushion means 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. This definition
includes any removable covers, or
slipcovers, sold on or together with an
infant support cushion.
Occupant support surface (OSS)
means the area that holds up and bears
the infant or any portion of the infant.
Seat bight line means the intersection
of the seat back surface with the seat
bottom surface.
Sidewall means any wall at the edge
of the occupant support surface.
§ 1243.3
General requirements.
(a) Hazardous sharp edges or points.
There shall be no hazardous sharp
points or edges as determined by 16
CFR 1500.48 and 1500.49 before or after
the product has been tested.
(b) Small parts. There shall be no
small parts as determined by 16 CFR
part 1501 before testing or presented as
a result of testing.
(c) Lead in paints. All paint and
surface coatings on the product shall
comply with the requirements of 16 CFR
part 1303.
(d) Toys. Toy accessories attached to,
removable from, or sold with an infant
support cushion, as well as their means
of attachment, shall comply with the
applicable requirements of 16 CFR part
1250.
(e) Removal of components. When
tested in accordance with § 1243.5(k),
any removal of components that are
accessible to an infant while in the
product or from any position around the
product shall not present a small part,
sharp point, or sharp edge as required
in paragraphs (a) and (b) of this section.
(f) Permanency of labeling and
warnings. (1) Warning labels, whether
paper or non-paper, shall be permanent
when tested in accordance with
§ 1243.5(b)(1) through (3).
(2) Warning statements applied
directly onto the surface of the product
by hot stamping, heat transfer, printing,
wood burning, or any other method
shall be permanent when tested in
accordance with § 1243.5(b)(4).
E:\FR\FM\04NOR1.SGM
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87488
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
(3) Non-paper labels shall not liberate
small parts when tested in accordance
with § 1243.5(b)(5).
(4) Warning labels that are attached to
the fabric of the product with seams
shall remain in contact with the fabric
around the entire perimeter of the label
when the product is in all manufacturerrecommended use positions and when
tested in accordance with § 1243.5(b)(3).
(g) Convertible products. If the infant
support cushion can be converted into
another product for which a consumer
product safety standard exists, the
product also shall comply with the
applicable requirements of that
standard.
§ 1243.4
Performance requirements.
(a) Restraint. The product shall not
include a restraint system.
(b) Seam strength. When tested in
accordance with § 1243.5(j), fabric/mesh
seams and points of attachment shall
not fail such that a small part, sharp
point, or sharp edge is presented, as
required in § 1243.3(a) and (b).
(c) Bounded openings. When tested to
§ 1243.5(c), all completely bounded
openings that exist in the front, sides, or
back of the occupant lounging area, or
that are created when an accessory is
attached to the product, shall not allow
complete passage of the small head
probe unless it allows the complete
passage of the large head probe.
(d) Maximum incline angle. The
maximum incline angle shall not exceed
10 degrees when tested in accordance
with § 1243.5(d).
(e) Firmness—(1) Occupant support
surface firmness. When the 3-inch
diameter (figure 1 to this paragraph
(e)(1)) hemispherical head probe is
applied according to the test method for
occupant support surface firmness,
§ 1243.5(f), the force required for a oneinch displacement shall be greater than
10 Newtons (N).
Figure 1 to paragraph (e)(1)—3-inch
Head Probe
3-in. Hemispherical
Surface,
L
J
(2) Sidewall firmness. For products
with a sidewall, when the 3-inch
diameter hemispherical head probe is
applied according to the test method for
sidewall firmness in § 1243.5(g), the
force required for a one-inch
displacement shall be greater than 10 N.
(3) Firmness at intersection of
sidewall and occupant support surface.
For products with a sidewall, when the
3-inch diameter hemispherical head
probe is applied according to the test
method for firmness at the intersection
of sidewall and occupant support
surface in § 1243.5(h), the force required
for a one-inch displacement shall be
greater than 10 N.
(f) Sidewall angle. For products with
a sidewall, the sidewall angle shall be
greater than 90 degrees when
determined according to the sidewall
angle determination in § 1243.5(i).
§ 1243.5
Test methods.
(a) Test conditions. Condition the
product for 48 hours at 23 °C +/¥ 2 °C
(73.4 °F +/¥ 3.6 °F) and a relative
humidity of 50% +/¥ 5%.
VerDate Sep<11>2014
15:57 Nov 01, 2024
Jkt 265001
(b) Permanence of labels and
warnings. (1) A paper label (excluding
labels attached by a seam) shall be
considered permanent if, during an
attempt to remove it without the aid of
tools or solvents, it cannot be removed,
it tears into pieces upon removal, or
such action damages the surface to
which it is attached.
(2) A non-paper label (excluding
labels attached by a seam) shall be
considered permanent if, during an
attempt to remove it without the aid of
tools or solvents, it cannot be removed
or such action damages the surface to
which it is attached.
(3) A warning label attached by a
seam shall be considered permanent if
it does not detach when subjected to a
15-lbs (67–N) pull force applied in any
direction using a 3⁄4-inch diameter
clamp surface.
(4) Adhesion test for warnings applied
directly onto the surface of the product.
(i) Apply the tape test defined in Test
Method B, Cross-Cut Tape Test of
ASTM D3359 (incorporated by
reference, see § 1243.8), eliminating
parallel cuts.
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(ii) Perform this test once in each
different location where warnings are
applied.
(iii) The warning statements will be
considered permanent if the printing in
the area tested is still legible and
attached after being subjected to this
test.
(5) A non-paper label, during an
attempt to remove it without the aid of
tools or solvents, shall not be removed
or shall not fit entirely within the small
parts cylinder defined in 16 CFR part
1501 if it can be removed.
(c) Head entrapment test. For all
applicable openings, rotate the small
head probe (figure 1 to this paragraph
(c)) to the orientation most likely to fail
and gradually apply an outward force
from the occupant lounging area of 25
lbs (111 N). Apply the force to the probe
in the direction most likely to fail
within a period of 5 seconds and
maintain it for an additional 10 seconds.
If the small head probe can pass entirely
through the opening in any orientation,
determine if the large head probe (figure
2 to this paragraph (c)) can be freely
inserted through the opening.
E:\FR\FM\04NOR1.SGM
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1-2in.
Recommended L.'.ength
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
87489
Figure 1 to paragraph (c)—Small Head
Probe
4.31n.
(109mm)
- - - 5.71n. (14Smm)---
5.2 In.
(132mm)
l
Base of Probe
Handle
Figure 2 to paragraph (c)—Large Head
Probe
_.,_
.
.
.
.
.
--.
.
.
-dfN.
r ,-----.
------------f1i-->
--
----uaDJA---....
(3110nmi)
1-4-----um.-.,----tH
VerDate Sep<11>2014
15:57 Nov 01, 2024
Jkt 265001
(ii) Hinged weight gauge—newborn,
requirements for part masses and
assembly (figure 3 to this paragraph
(d)(1)(ii));
BILLING CODE 6355–01–P
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ER04NO24.005
(d) Maximum incline test. (1)
Equipment shall include:
(i) Digital protractor with accuracy
+/¥1 degree;
ER04NO24.004
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(230mm)
87490
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
Figure 3 to paragraph (d)(1)(ii)—Hinged
Weight Gauge—Newborn,
Requirements for Part Masses and
Assembly
3.378 ± .02 kg (7.447 ± .05 lb.)
1
Upper Plate
2.275 kg
(5.116 lb)
289.8 cmA3
(17.68 jnA3)
2
Lewer Plate
1.u, kg
(2.379 lb)
137.4 cmA3
(8.385 cmA3)
3
Pin
tU)24 kg
(0.153 Ill>)
3.03 cmA3
(D.185 inA3)
Note 1. Part mass is calculated as Volume divided by the density for
mild steel of 7.85 g/cmA3 (0.283 lbs/inA3).
,___--(27!>.4 [1U)O in])-----
. . - - - - - - - - - - - ( 4 ( ; 2 . 0 [18.19 i n ] ) - - ~
(iii) Hinged weight gauge-newborn,
requirements for part dimensions (figure
4 to this paragraph (d)(1)(iii)); and
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□
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
87491
Figure 4 to paragraph (d)(1)(iii)—
Hinged Weight Gauge—Newborn,
Requirements for Part Dimensions
12.79 [.510 In]
I
:I
✓ ~.35 Slip Flt
[.250}
I
0.8 [.83 In] Break Edges
AIIAreuna
182.6 [7.19 In]
6.36 [.251\l in]
I
7.il,[.JH in]
(22.9 [.91\l inJ}
1,
.6.351 [.251\l]
25.S[UUin]
149.4 [ .Nin]
2
.8 [.83.in]
X45°CH
60.H [2.362 in]
3
-
---- --------
183.6 [4.08 in)
R12.7 [R.59 in]
R3.2 [R.13 ln]
·2PLC
R15.D [R.59 in]
-2 PLC
17
i]nlo]
i------(189.9 [7.44 in]1------1
f!ii.35 Press F i t ~
[.251] 1.,1.
_ _ _ _ _ _ _-_--_--_-_--_--_
12.70 [.508 In]
-_--_--,---t-f
c-=-==-=-::=--..:._____________
_,___~
I
6.35 [.251 ill]
I
r
u
[.83 in] Break Eages
All Around
213.9 [8.42 in]
279.4 [11.H in]
~1.J__I. L , _ _ _ _ _ ~ : : - - - - ~ - - - - - r
1
95.9 [3.78 in]
63.5 [2.58 In]
nete 1
56.8 [2.20 in]
-------1
l - ' . - - - - - - - - - t 2 8 5 . 8 [11.25 i n ] ) - - - - - - - - - - i
(iv) A test base that is horizontal, flat,
firm, and smooth.
(2) If applicable, place the product in
the manufacturer’s recommended
highest seat back angle position
intended for lounging.
(3) If applicable, place the hinged
weight gauge—newborn in the product
VerDate Sep<11>2014
15:57 Nov 01, 2024
Jkt 265001
and position the gauge with the hinge
centered over the seat bight line and the
upper plate of the gauge back. Place a
digital protractor on the upper torso/
head area lengthwise and measure the
incline angle.
(4) Place the head/torso portion of the
newborn hinged weight gauge on the
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product according to the manufacturer’s
recommended use position with the seat
portion of the gauge, depending on the
product design, allowed to lay freely on
the product or on the test base (figure 5
to this paragraph (d)(4)).
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BILLING CODE 6355–01–C
87492
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
Figure 5 to paragraph (d)(4)—Test
Fixture Configuration to Measure
Incline Angle on an Infant Support
Cushion Product
ASTM HINGED
WEIGHT GAUGE
-NEWBORN
SEAT BIGHT
LINE
oss------
(5) Move and rotate the newborn
hinged weight gauge the minimum
amount necessary such that the head/
torso portion rests on an OSS that could
foreseeably support an infant’s head,
and place the head/torso portion of the
gauge according to all situations that
apply:
(i) In tests on products with an OSS
for the infant’s body, align the top edge
of the head/torso portion of the gauge to
coincide with a plumb line to the
outermost edge of the OSS-head.
(ii) In all tests, place the seat portion
of the gauge on the test base, adjust the
newborn gauge to the greatest incline
angle in which the top edge of the gauge
maintains contact with the top surface
of the product.
(6) If a product’s seating bight area
prevents reasonable positioning of the
head/torso portion to the outermost
edge, then position the seat portion of
the newborn hinged weight gauge as far
forward as possible towards the
outermost edge and allow the head/
torso portion of the gauge to rest on the
product.
(7) Place a digital protractor
lengthwise on the head/torso portion of
the gauge and measure the incline angle.
(8) Measure the incline angle at the
manufacturer’s recommended use
location(s), at feasible locations such as
perpendicular to the recommended use
location(s), and at least one location
likely to fail in which the newborn
gauge seat is supported on the test
surface.
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Jkt 265001
(9) Determine the maximum incline
angle from the incline angle
measurements.
(e) Firmness test setup. (1) Equipment
shall include:
(i) Force gauge with accuracy +/¥
0.05 N (0.01 lbs).
(ii) Distance gauge with accuracy +/¥
0.01 inches (0.03 cm).
(2) Align the axis of the 3-inch head
probe (figure 1 to paragraph (e)(1) of
§ 1243.4) with a force gauge and parallel
to a distance measurement device or
gauge.
(3) Use a lead screw or similar device
to control movement along a single
direction.
(4) Support the firmness fixture to a
test base such that the head probe does
not deflect more than 0.01 inches (0.025
cm) under a 10.0 N (2.24 lbs) load
applied in each orientation required in
the test methods.
(f) Occupant support surface firmness
test method. Perform the following steps
to determine the occupant support
surface firmness of the product as
received from the manufacturer. For
products sold with a slipcover on or
together with the product, products
shall be tested as assembled with the
slipcover on the product. All products,
including products one inch or less in
thickness, are required to be tested. See
figure 6 to this paragraph (f).
(1) Orient the axis of the 3-inch head
probe perpendicular to the surface of
the product at each test location that is
oriented greater than five degrees
relative to the test base or align the axis
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of the probe perpendicular to the test
base (vertically) at each test location
that is oriented equal to or less than five
degrees to the test base.
(2) The first test location shall be at
the location of maximum thickness of
the surface being tested, perpendicular
to the test base.
(3) Lay the product, with the occupant
support surface facing up, on a test base
that is horizontal, flat, firm, and smooth.
(4) Prevent movement of the product
in a manner that does not affect the
force or deflection measurement of the
product surface under test. Provide no
additional support beneath the product.
(5) Advance the probe into the
product and set the deflection to 0.0
inches when a force of 0.1 N (0.02 lbs)
force is reached.
(6) Continue to advance the head
probe into the product at a rate not to
exceed 0.1 inch per second and pause
when the force exceeds 10.0 N (2.24
lbs), or the deflection is equal to 1.00
inches (2.54 cm).
(7) Wait 30 seconds. If the deflection
is less than 1.00 inches and the force is
10.0 N or less, repeat the steps in
paragraphs (f)(6) and (7) of this section.
(8) Record the final force and
deflection when the deflection has
reached 1.00 inches or when the force
has exceeded 10.0 N.
(9) If the maximum thickness of the
OSS is greater than 1.0 inches (2.54 cm),
perform additional tests, space
permitting, at the geometric center of
the OSS, at four locations along the
product’s longitudinal and lateral axes
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SIDEWALL
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
therefrom, 1.5 inches (3.8 cm) towards
center from the intersection of the
sidewall and OSS, and at one location
most likely to fail.
(10) Repeat the occupant support
surface firmness tests on any other
occupant support surface and in all
intended and feasible configurations
that could affect an occupant support
87493
surface, such as the folding or layering
of parts of the product.
Figure 6 to paragraph (f)—Test
Configuration for Occupant Support
Surface Firmness Test
lON
3-lN HEMISPHERICAL
TEST PROBE
OCCUPANT SUPPORT SURFACE
TEST BASE
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Jkt 265001
(h) Intersection of sidewall and
occupant support surface firmness. For
products with a sidewall, perform the
following steps to determine the
intersection firmness of the product as
received from the manufacturer (figure 7
to this paragraph (h)).
(1) Orient the axis of the 3-inch head
probe perpendicular to the sidewall
perimeter at an angle from horizontal
that bisects the angle determined in
sidewall angle determination with the
axis directed at the intersection of the
occupant support surface and the
sidewall.
(2) The first test location shall be at
the location of maximum product
thickness parallel to the test base.
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(3) Perform the steps in paragraphs
(f)(3) through (8) of this section.
(4) Perform a minimum of four
additional tests, located at intervals not
to exceed six inches along the entire
inside perimeter of the intersection of
the sidewall and OSS, and at one
additional location most likely to fail.
(5) Repeat the intersection of sidewall
and occupant support surface firmness
test in all the intended or feasible
configurations that could affect the
intersection firmness, such as the
folding or layering of parts of the
product.
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(g) Sidewall firmness test method. For
products with a sidewall, perform the
steps in paragraphs (f)(1) through (8) of
this section to determine the sidewall
firmness of the product as received from
the manufacturer and then perform the
following:
(1) Perform a minimum of four
additional tests, located at intervals not
to exceed 6 inches along the entire top
perimeter of the sidewall, starting from
the maximum side height location, and
at one additional location most likely to
fail.
(2) Repeat the sidewall firmness test
in all the intended or feasible
configurations that could affect the
sidewall firmness, such as the folding or
layering of parts of the product.
87494
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
Figure 7 to paragraph (h)—Test
Configuration for Intersection of
Sidewall and Occupant Support
Surface Firmness
- - - - - - ' r - 3 - I N HEMISPHERICAL
TEST PRCIBE
Q5l5
~ - - - T E T BASE
~-----INTERSECTION
SIIDEWALL/1:JSS
(i) Sidewall angle determination. For
products with a sidewall, perform the
following steps to determine if the angle
between the sidewall and OSS is 90
degrees or less, or to measure the angle
above 90 degrees. See figure 8 to this
paragraph (i).
(1) Orient the 3-inch (7.62 cm)
diameter hemispherical head probe
vertically and place it over the OSS with
the cylindrical surface of the probe
tangent to the intersection of the
sidewall and the OSS. Advance the
probe into the product until a
downward force of 10 N (2.2 lbs) force
is reached.
(2) After 30 seconds, determine
whether the sidewall is in contact with
the cylindrical side of the 3-inch head
probe. If the sidewall contacts the
cylindrical part of the probe, the
sidewall angle is equal to or less than 90
degrees.
(3) For sidewall angles greater than 90
degrees, calculate the sidewall angle as
90 degrees plus the measured angle
between the cylindrical side of the 3inch head probe and the sidewall.
(4) Determine a minimum of four
sidewall angles at locations not to
exceed 6-inch (15.2 cm) intervals along
the intersection of the sidewall and
OSS.
(5) Measure the angle with a
protractor or gauge placed to the depth
of and in contact with the cylindrical
side of the 3-inch probe side and the
sidewall.
Figure 8 to paragraph (i)—Test Fixture
Configuration for Sidewall Angle
Measurement
-
-----3-IN HEMJSPffERJQL
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SIDEWAU/GS'S
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87495
(j) Seam strength test method. (1)
Equipment shall include:
(i) Clamps with 0.75 inches (1.9 cm)
diameter clamping surfaces capable of
holding fabric and with a means to
attach a force gauge. See figure 9 to this
paragraph (j)(1), or equivalent.
(ii) A force gauge, accuracy +/¥ 0.5
lbs (1.1 N).
Figure 9 to paragraph (j)(1)—Seam
Clamp
(2) Clamp the fabric of the infant
support cushion on each side of the
seam under test with the 0.75 inches
clamping surfaces placed not less than
0.5 inches (1.2 cm) from the seam.
(3) Apply a tension of 15 lbs (67 N)
evenly over 5 seconds and maintain for
an additional 10 seconds.
(4) Repeat the test on every distinct
seam and every 12 inches (15 cm) along
each seam.
(k) Removal of components test
method—(1) Suitable devices. For
torque and tension tests, any suitable
device may be used to grasp the
component that does not interfere with
the attachment elements that are
stressed during the tests.
(2) Torque test. Gradually apply a 4
lbs-in (0.4 N–m) torque over 5 seconds
in a clockwise rotation to 180 degrees or
until 4 lbs-in has been reached.
Maintain for 10 seconds. Release and
allow component to return to relaxed
state. Repeat the torque test in a
counterclockwise rotation.
(3) Tension test. For components that
can reasonably be grasped between
thumb and forefinger, or teeth, apply a
15 lbs (67 N) force over 5 seconds, in a
direction to remove the component.
Maintain for 10 seconds. A clamp such
as shown in figure 10 to this paragraph
(k)(3) may be used if the gap between
the back of the component and the base
material is 0.04 inches (0.1 cm) or more.
Figure 10 to paragraph (k)(3)—Tension
Test Adapter Clamp
Marking and labeling.
(a) General markings. Each product
and its retail package shall be marked or
labeled clearly and legibly to indicate
the following:
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15:57 Nov 01, 2024
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(1) The name, place of business (city,
state, and mailing address, including zip
code), and telephone number of the
manufacturer, distributor, or seller.
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(2) A code mark or other means that
identifies the date (month and year as a
minimum) of manufacture.
(3) The marking or labeling in
paragraphs (a)(1) and (2) of this section
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§ 1243.6
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are not required on the retail package if
they are on the product and are visible
in their entirety through the retail
package. When no retail packaging is
used to enclose the product, the
information provided on the product
shall be used for determining
compliance with paragraphs (a)(1) and
(2) of this section. Cartons and other
materials used exclusively for shipping
the product are not considered retail
packaging.
(b) Permanency. The marking and
labeling on the product shall be
permanent.
(c) Upholstery labeling. Any
upholstery labeling required by law
shall not be used to meet the
requirements of this section.
(d) Warning design for product. (1)
The warnings shall be easy to read and
understand and be in the English
language at a minimum.
(2) Any marking or labeling provided
in addition to those required by this
section shall not contradict or confuse
the meaning of the required information
or be otherwise misleading to the
consumer.
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Note 4 to figure 1 to paragraph (d)(6): The
text shown for the warnings in figure 1 to this
paragraph (d)(6) is filler text, known as lorem
ipsum, commonly used to demonstrate
graphic elements.
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15:57 Nov 01, 2024
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(3) The warnings shall be conspicuous
and permanent.
(4) The warnings shall conform to
ANSI Z535.4–2011(R2017)
(incorporated by reference, see § 1243.8)
sections 6.1–6.4, 7.2–7.6.3, and 8.1, with
the following changes.
(i) In sections 6.2.2, 7.3, 7.5, and 8.1.2,
replace ‘‘should’’ with ‘‘shall.’’
(ii) In section 7.6.3, replace ‘‘should
(when feasible)’’ with ‘‘shall.’’
(iii) Strike the word ‘‘safety’’ when
used immediately before a color (for
example, replace ‘‘safety white’’ with
‘‘white’’).
Note 1 to paragraph (d)(4)(iii): For
reference, ANSI Z535.1, American National
Standard for Safety Colors, provides a system
for specifying safety colors. See note 1 to
§ 1243.8(a) for ANSI contact information.
(5) The safety alert symbol and the
signal word ‘‘WARNING’’ shall be at
least 0.2 inches (5 mm) high. The
remainder of the text shall be in
characters whose upper case shall be at
least 0.1 inches (2.5 mm), except where
otherwise specified.
(7) All infant support cushions are
required to contain a warning with the
content and format depicted in this
section as figure 2 (for products without
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Note 2 to paragraph (d)(5): For improved
warning readability, typefaces with large
height-to- width ratios, which are commonly
identified as ‘‘condensed,’’ ‘‘compressed,’’
‘‘narrow,’’ or similar, should be avoided.
(6) The message panel shall have the
following text layout requirements:
(i) The text shall be left-aligned,
ragged-right for all but one-line text
messages, which can be left-aligned or
centered. See figure 1 to this paragraph
(d)(6) for examples of left-aligned text.
Note 3 to paragraph (d)(6)(i): Left-aligned
means that the text is aligned along the left
margin, and in the case of multiple columns
of text, along the left side of each individual
column.
(ii) The text in each column should be
arranged in list or outline format, with
precautionary (hazard avoidance)
statements preceded by bullet points.
Multiple precautionary statements shall
be separated by bullet points if
paragraph formatting is used.
Figure 1 to paragraph (d)(6)—Examples
of Left-Aligned Text
tummy time) or figure 3 (if the product
has a tummy time feature) to this
paragraph (d)(7).
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Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
87497
Figure 2 to paragraph (d)(7)—Warning
for Product Without Tummy Time
USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL.
Babies can turn over or roll out without warning and CAN
SUFFOCATE in only a few minutes.
•
•
•
•
Only use on the floor with baby on back, face-up.
Stay near and watch baby during use.
Do not use on soft surfaces or in sleep products like cribs
or bassinets. Keep blankets and other soft items out of and
away from product.
If baby falls asleep, move baby to infant sleep product, such
as a crib or bassinet.
Babies have been injured from FALLS.
•
•
Do not use on beds, sofas, or other raised surfaces.
Never carry or move product with baby in it.
Figure 3 to paragraph (d)(7)—Warning
for Tummy Time Product
USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL.
Babies can turn over or roll out without warning and CAN
SUFFOCATE in only a few minutes.
•
•
•
•
Use on the floor with baby on back, face-up. Put baby on
back after Tummy Time.
Stay near and watch baby during use.
Do not use on soft surfaces or in sleep products like cribs
or bassinets. Keep blankets and other soft items out of and
away from product.
If baby falls asleep, move baby to infant sleep product, such
as a crib or bassinet.
Babies have been injured from FALLS.
Do not use on beds, sofas, or other raised surfaces.
Never carry or move product with baby in it.
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Slipcovers sold on, or together with the
product, shall contain the warning
statement shown on figure 2 or 3 to
paragraph (d)(7) of this section, as
applicable.
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§ 1243.7
Instructional literature.
(a) Instructions shall be provided with
the product and shall be easy to read
and understand and shall be in the
English language at a minimum. These
instructions shall include information
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ER04NO24.016
(e) Warning statements. Each product
shall contain the warning statements
shown on figure 2 (for products without
tummy time) or figure 3 (if the product
has a tummy time feature) to paragraph
(d)(7) of this section, at a minimum.
ER04NO24.015
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•
•
87498
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations
on assembly, maintenance, cleaning,
and use, where applicable.
(b) The instructions shall address the
following additional warnings:
(1) Read all instructions before using
this product.
(2) Keep instructions for future use.
(3) Do not use this product if it is
damaged or broken.
(4) Instructions shall indicate the
manufacturer’s recommended maximum
weight, height, age, developmental
level, or combination thereof, of the
occupant for which the infant support
cushion is intended. If this product is
not intended for use by a child for a
specific reason, the instructions shall
state this limitation.
(c) The cautions and warnings in the
instructions shall meet the requirements
specified in § 1243.6(d)(4) though (6),
except that section 6.4 and sections 7.2–
7.6.3 of ANSI Z535.4–2011(R2017)
(incorporated by reference, see § 1243.8)
need not be applied. However, the
signal word and safety alert symbol
shall contrast with the background of
the signal word panel, and the cautions
and warnings shall contrast with the
background of the instructional
literature.
Note 1 to paragraph (c): For example, the
signal word, safety alert symbol, and the
warnings may be black letters on a white
background, white letters on a black
background, navy blue letters on an off-white
background, or some other high-contrast
combination.
(d) Any instructions provided in
addition to those required by this
section shall not contradict or confuse
the meaning of the required information
or be otherwise misleading to the
consumer.
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§ 1243.8
Incorporation by reference.
15:57 Nov 01, 2024
Jkt 265001
Note 1 to paragraph (a): NEMA standards
are also available from the American
National Standards Institute (ANSI), which
provides a free, read-only copy of the
standard at https://ibr.ansi.org/Standards/
nema.aspx. Contact ANSI by mail at
American National Standards Institute, 25
West 43rd Street, 4th Floor, New York, NY
10036, USA; phone: (212) 642–4900; website:
www.ansi.org.
(b) ASTM International (ASTM), 100
Barr Harbor Drive, P.O. Box CB700,
West Conshohocken, Pennsylvania
19428–2959; phone: (800) 262–1373;
website: www.astm.org.
(1) ASTM D3359–23, Standard Test
Methods for Rating Adhesion by Tape
Test, approved February 1, 2023;
approved for § 1243.5.
(2) [Reserved]
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2024–25181 Filed 11–1–24; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2024–0745]
RIN 1625–AA09
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register under 5 U.S.C. 552(a) and 1
CFR part 51. All approved incorporation
by reference (IBR) material is available
for inspection at the U.S. Consumer
Product Safety Commission and at the
National Archives and Records
Administration (NARA). Contact the
U.S. Consumer Product Safety
Commission at: the Office of the
Secretary, U.S. Consumer Product
Safety Commission, 4330 East West
Highway, Bethesda, MD 20814; phone
(301) 504–7479; email: cpsc-os@
cpsc.gov. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations or email fr.inspection@
nara.gov. The material may be obtained
from the following sources:
VerDate Sep<11>2014
(a) National Electrical Manufacturers
Association (NEMA), 1300 17th St. N,
Arlington, VA 22209; phone: (703) 841–
3200; website: www.nema.org.
(1) ANSI Z535.4–2011(R2017),
American National Standard for
Product Safety Signs and Labels,
approved October 20, 2017; approved
for §§ 1243.6 and 1243.7.
(2) [Reserved]
Drawbridge Operation Regulation;
Sacramento River, Rio Vista, CA
Coast Guard, DHS.
Temporary interim rule with
request for comments.
AGENCY:
ACTION:
The Coast Guard is
temporarily modifying the operating
schedule that governs the draw of the
California Department of Transportation
Rio Vista (State Route 12) highway
bridge across the Sacramento River,
mile 12.8, at Rio Vista, CA. This action
is necessary to allow the bridge owner
to complete rehabilitation of the bridge.
DATES: This temporary interim rule is
effective from November 4, 2024
through 5 p.m. on August 29, 2025.
Comments and related material must
reach the Coast Guard on or before
December 4, 2024.
SUMMARY:
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To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov. Type the docket
number (USCG–2024–0745) in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’. In
the Document Type column, select
‘‘Supporting & Related Material’’.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
interim rule, call or email Carl Hausner,
Chief, Bridge Section, Eleventh Coast
Guard District; telephone 510–219–
4366, email D11Bridges@uscg.mil.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Table of Abbreviations
Caltrans California Department of
Transportation
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
MHW Mean High Water
NOTD Notice of Temporary Deviation
NPRM Notice of proposed rulemaking
Pub. L. Public Law
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary interim rule without prior
notice and opportunity to comment
pursuant to authority under the
authority in 5 U.S.C. 553(b)(B). This
provision authorizes an agency to issue
a rule without prior notice and
opportunity to comment when the
agency for good cause finds that those
procedures are ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ The Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because it is
impracticable and contrary to the public
interest due to Caltrans Headquarters
continuing to add projects to the
ongoing rehabilitation project, which
will require extending the length of time
for advance notice for opening the span.
The current NOTD expires November 1,
2024 and the Coast Guard cannot add
additional dates to that NOTD because
it will extend the NOTD beyond the
allowed 180 days. The continuation of
the temporary deviation is necessary for
the safety of the work crews on the
bridge.
Also, under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists
for making this rule effective less than
30 days after publication in the Federal
Register. Delaying the effective date of
this rule would be impracticable and
contrary to the public interest because
Caltrans has allocated funds for
additional rehabilitation work on the
E:\FR\FM\04NOR1.SGM
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Agencies
[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Rules and Regulations]
[Pages 87467-87498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25181]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112, 1130, and 1243
[CPSC Docket No. 2023-0047]
Safety Standard for Infant Support Cushions
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA), requires the U.S. Consumer Product Safety Commission
(Commission or CPSC) to promulgate consumer product safety standards
for durable infant or toddler products. Under this statutory authority,
the Commission is issuing a safety standard for infant support
cushions. The Commission is also amending CPSC's consumer registration
requirements to identify infant support cushions as durable infant or
toddler products and amending CPSC's list of notices of requirements
(NORs) to include infant support cushions.
DATES: The rule is effective on May 5, 2025. The incorporation by
reference of the publication listed in this rule is approved by the
Director of the Federal Register as of May 5, 2025.
FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7945 or (888) 531-9070; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
A. Background
Infant support cushions are filled with or comprised of resilient
material such as foam, fibrous batting, or granular material or with a
gel, liquid, or gas, and are 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. CPSC is aware of at least 79
reported fatalities involving infant support cushions from January 1,
2010, through December 31, 2022, as well as 124 nonfatal incidents or
reports involving these products within the same time period. There
were 17 deaths in 2020, and a minimum of 17 more in 2021.\1\ More than
80 percent of the known fatalities associated with these products
involve infants three months old or younger. In more than 60 percent of
the fatalities, the official cause of death was asphyxia or probable
asphyxia. These incidents typically involved the use of an infant
support cushion placed in or on a sleep-related consumer product such
as an adult bed, futon, crib, bassinet, play yard, or couch. For the
nonfatal incidents, the most common circumstances involved an infant
falling from an infant support cushion placed on a raised surface such
as a bed or a sofa, or a threat of asphyxia or entrapment.
---------------------------------------------------------------------------
\1\ Due to reporting delays, fatality data reported to the CPSC
is not considered complete until three years later; thus, the 2021
fatality data were not yet considered complete when the analysis was
conducted in 2023.
---------------------------------------------------------------------------
In 1992, pursuant to authority under the Federal Hazardous
Substances Act (FHSA), 15 U.S.C. 1261-1278, the Commission issued a ban
on certain infant cushions and pillows filled with foam, plastic beads,
or other granular material. 57 FR 27912 (June 23, 1992). That ban
prohibits infant cushions, infant pillows, and similar articles that
are:
made with a flexible fabric covering;
loosely filled with granular material, including, but not
limited to, polystyrene beads or pellets;
easily flattened;
capable of conforming to the body or face of an infant;
and
intended or promoted for use by children under one year of
age.
See 16 CFR 1500.18(a)(16). This final rule for infant support cushions
does not change the existing FHSA ban. That ban was limited to products
with the specific hazard presented by loosely filled granular material
such as polystyrene beads or pellets, and those products will continue
to be banned under the FHSA. Infant support cushions that are not
subject to the ban are within the scope of this rule and are required
to comply with the performance and labeling requirements of this
rule.\2\
---------------------------------------------------------------------------
\2\ An exemption to the infant pillow ban applies to Boston
Billow nursing pillows and substantially similar nursing pillows
that are designed to be used only as nursing aids for breastfeeding
mothers. 16 CFR 1500.86(a)(9). The exemption applies specifically to
the FHSA ban and is not applicable to this rule or to the final rule
for nursing pillows. 89 FR 85388 (October 25, 2024).
---------------------------------------------------------------------------
B. Statutory Authority
Section 104(b)(1)(A) of the CPSIA requires the Commission to (1)
examine and assess the effectiveness of voluntary consumer product
safety standards for durable infant or toddler products, in
consultation with representatives of consumer groups, juvenile product
manufacturers, and independent child product engineers and experts and
(2) promulgate consumer product safety standards for durable infant and
toddler products. See 15 U.S.C. 2056a(b)(1)(A). The Commission must
continue to promulgate standards for all categories of durable infant
or toddler products until the Commission has promulgated standards for
all such product categories. See 15 U.S.C. 2056a(b)(2).
Consistent with section 104(b)(1)(A) of the CPSIA, CPSC consulted
with manufacturers, retailers, trade organizations, laboratories,
consumer advocacy groups, consultants, and the public to develop this
rule, including through participation in the juvenile products
subcommittee meetings of ASTM.\3\ However, currently no voluntary or
mandatory safety standard for infant support cushions exists to
[[Page 87468]]
address the hazards posed by these products.
---------------------------------------------------------------------------
\3\ CPSC formally began the consultation process for this
rulemaking in December 2021, via a letter from staff requesting that
ASTM form a working group to develop a voluntary standard to reduce
the risk of death and injury from hazards associated with infant
pillow products, including nursing pillows. In response, ASTM formed
two subcommittees intended to develop two separate voluntary
standards: the F15.16 Infant Feeding Supports subcommittee, intended
to develop a standard for nursing pillows; and the F15.21 Infant
Loungers subcommittee. Staff has been actively participating in both
ASTM subcommittees to develop voluntary standards that address
hazards associated with these products.
---------------------------------------------------------------------------
Infant support cushions are durable infant or toddler products
under section 104(f) of the CPSIA. Section 104(f)(1) defines the term
durable infant or toddler product as a durable product intended for
use, or that may be reasonably expected to be used, by children under
the age of 5 years. See 15 U.S.C. 2056a(f)(1). Section 104(f)(2) of the
CPSIA provides a non-exhaustive list of product categories within the
definition of durable infant or toddler products. Although infant
support cushions are not specifically listed in section 104(f)(2), they
are durable infant or toddler products because (as explained in Part
II, below) they: are not disposable; have a useful life of up to
several years during which they are often used by multiple children
successively; are similar to other soft durable infant and children's
products such as crib mattresses and sling carriers (which the
Commission has issued rules for under section 104); are resold and
widely available on secondary marketplaces; and are primarily intended
to be used by children five years old or younger.
Section 104(d) of the CPSIA requires manufacturers of durable
infant or toddler products to establish a product registration program
and comply with CPSC's rule for product registration cards, 16 CFR part
1130. The final rule amends part 1130 to include infant support
cushions in the list of durable infant or toddler products that must
comply with these product registration requirements. See 16 CFR
1130.2(a).
Manufacturers of children's products must also comply with the
testing and certification requirements for children's products that are
codified in 16 CFR parts 1107 and 1109. Section 14(a)(3) of the
Consumer Product Safety Act (CPSA) requires the Commission to publish
an NOR for the accreditation of third party conformity assessment
bodies (test laboratories) to assess conformity with a children's
product safety rule to which a children's product is subject. The final
rule is a children's product safety rule that requires issuance of an
NOR.
C. Notice of Proposed Rulemaking (NPR)
On January 16, 2024, the Commission published an NPR under section
104 of the CPSIA that proposed a mandatory consumer product safety
standard for infant support cushions to address the risk of death and
injury associated with these products. 89 FR 2530. The proposed rule
addressed the suffocation, entrapment, and fall hazards associated with
infant support cushions by including performance, testing, labeling,
and instructional literature requirements. The proposed requirements in
the NPR were based on staff's analysis of the hazards presented by
infant support cushions as well as incident, injury and fatality data.
The proposed requirements also considered the recommendations in the
June 30, 2022, Pillows Product Characterization and Testing, Boise
State University Report (BSU Final Report).\4\ CPSC awarded a contract
to Boise State University (BSU) for infant biomechanics and suffocation
research and consultancy services. This research included an analysis
of the risk of injury or death to infants associated with the use of
nursing pillows and infant support cushions during activities such as
feeding, nursing, sleeping, propping, and lounging. The BSU Final
Report provided recommendations and conclusions related to the
performance and design of infant support cushions, including
recommendations regarding firmness testing, airflow testing, and
sagittal-plane testing. Tab C of Staff's NPR Briefing Package
summarizes how the requirements of the NPR relate to the conclusions
and recommendations of the BSU Final Report. The Commission received 18
comments in response to the NPR.
---------------------------------------------------------------------------
\4\ Erin M. Mannen et al; Consumer Prod. Safety Comm'n. Pillows
Product Characterization and Testing (2022). www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
---------------------------------------------------------------------------
On April 23, 2024, CPSC published a notice of availability (NOA) in
the Federal Register that announced the availability of the incident
data relied upon for the infant support cushions NPR and sought
comments from the public. 89 FR 30295. The Commission received one
comment in response to the NOA.
D. Final Rule Overview
Pursuant to section 104 of the CPSIA, 15 U.S.C. 2056a, the
Commission is issuing a mandatory standard for infant support cushions
based on the proposed requirements in the NPR, with certain
modifications in response to public comments, which are discussed in
detail in Sections VI and VII of the preamble.\5\ The final rule
defines an infant support cushion 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. This definition includes any removable covers, or
slipcovers, sold on or together with an infant support cushion. This
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. The
final rule addresses the risk of death and injury associated with
infant support cushions primarily due to suffocation, entrapment, and
fall hazards. It addresses positional asphyxiation hazards by requiring
that all surfaces be sufficiently firm that they are unlikely to
conform to an infant's face and occlude the airways,\6\ and by setting
a maximum incline angle that would prevent hazardous positioning of an
infant's head and neck along the surfaces of the product. The final
rule sets a side angle requirement that addresses the risk of
entrapment between the sidewall and the occupant support surface. It
addresses fall hazards by effectively limiting sidewall height to
discourage caregivers from mistakenly believing these products to be
safe for unsupervised infants. Finally, the final rule requires a
strongly worded, conspicuous, and permanent on-product warning label.
---------------------------------------------------------------------------
\5\ On October 16, 2024, the Commission voted (5-0) to publish
this final rule with changes. Chair Hoehn-Saric issued a statement
in connection with his vote, available at: www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Statement-of-Chair-Alexander-Hoehn-Saric-on-Commission-Approval-of-a-Final-Rule-Establishing-a-Safety-Standard-for-Infant-Support-Cushions.
\6\ Airways occlusion means to block the passage of air from the
nose and mouth into the lungs, so that inhaled air cannot reach the
lungs. In this case, the airway occlusion is caused by a soft
product that covers the nose and mouth. Once an infant's airflow is
compromised, decreased levels of oxygen in the blood can further
impair the ability of the infant to respond to the situation. If an
infant cannot respond, a feedback loop of decreased heart and
respiration rate develops that can eventually lead to cessation of
breathing and may become fatal if uninterrupted.
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Based on comments received on the NPR, the following changes have
been made in the final rule:
For clarity, the definition of infant lounger in Sec.
1243.2 has been revised to change the term infant product to infant
support cushion.
For clarity, the definition of infant support cushion in
Sec. 1243.2. has been revised to add the sentence ``This definition
includes any removable covers, or slipcovers, sold on or together with
an infant support cushion'' at the end of the definition.
To avoid ambiguity, a new definition of the term sidewall
has been added in Sec. 1243.2 which is defined as any wall at the edge
of the occupant support surface.
[[Page 87469]]
For accuracy and consistency, a reference to infant pillow
in Sec. 1243.3(d) has been changed to infant support cushion.
The final rule removes proposed Sec. 1243.3(e) regarding
side height as this requirement is redundant with the maximum incline
angle limits in the rule. The final rule renumbers the paragraphs
following proposed Sec. 1243.3(e) to reflect this change. The rule
also removes the corresponding test in Sec. 1243.5(d)(8) for
consistency. To reflect this change, all numbers after Sec.
1243.5(d)(7) have been renumbered in the final rule.
The performance requirements in Sec. 1243.4(e)(2) and (3)
and (f) as well as the corresponding test methods in Sec. Sec.
1243.5(g) and 1243.4(h) and (i) have been revised to clarify that the
performance requirements and test methods apply only to products that
contain a sidewall with language stating, for products with a sidewall.
The test method in Sec. 1243.5(f) has been clarified to
explain that products sold with a slipcover on or together with the
product are to be tested as assembled, with the slipcover on the
product. The test method in Sec. 1243.5(f) has also been clarified to
explain that all products, including products one inch or less in
thickness, shall be tested.
Figure 2 (for products without a tummy time feature) to
paragraph (d)(7) in Sec. 1243.6 has been revised and a new figure 3
(for products with a tummy time feature) has been added to reflect
changes in warning content made in response to public comments. These
changes include adding a statement to address prone use during tummy
time, removing references to ``an awake baby,'' separating the sleep
and suffocating-relating warning content to provide clarity, adding a
warning to address soft bedding both in and outside of the product, and
deleting some of the statements to reduce length and increase clarity.
Additionally, Sec. 1243.6(d)(7) clarifies that all infant support
cushions are required to contain a warning with the content and format
depicted in this section as figure 2 (for products without tummy time)
or figure 3 (if the product has a tummy time feature) to paragraph
(d)(7), as applicable.
Section 1243.6(e) has been revised to clarify that
slipcovers sold on or together with the product shall contain the
warning statement shown in figures 2 and 3 to paragraph (d)(7), as
applicable.
II. The Product Category
A. Infant Support Cushions
Infant support cushions are products that support an infant for
lounging, meaning reclining in a supine, prone, or recumbent position.
Infant products within this category may or may not have perimeter
sidewalls. Most infant support cushions currently on the market are
filled with cushy foam or soft fibrous batting, covered by flexible
fabric. Some infant support cushions are marketed for use in a crib or
other infant sleep product, notwithstanding warnings from the
Commission and other institutions, including the American Academy of
Pediatrics (AAP), that soft objects, such as pillows and excess
bedding, should not be placed in an infant's sleep environment.\7\
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\7\ Rachel Y. Moon, Rebecca F. Carlin, Ivan Hand, The Task Force
On Sudden Infant Death Syndrome And The Committee On Fetus And
Newborn, 150(1) American Academy of Pediatrics: Evidence Base for
2022 Updated Recommendations for a Safe Infant Sleeping Environment
to Reduce the Risk of Sleep-Related Infant Deaths (2022).
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Illustrative pictures of infant support cushions can be found in
Tab C of Staff's NPR Briefing Package.\8\ A non-exhaustive list of
examples of infant support cushions includes:
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\8\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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head positioner pillows;
flat baby loungers;
crib pillows;
wedge pillows for infants;
infant sleep positioners, unless regulated as medical
devices by the Food and Drug Administration (FDA);
stuffed toys marketed for use as an infant support
cushion;
infant tummy time or lounging pillows, whether flat or
inclined;
multi-purpose pillows marketed for both nursing and
lounging;
anti-rollover pillows with or without straps that fasten
the pillow to the infant;
infant self-feeding pillows that hold a bottle in front of
the face of a reclining or lying infant;
pads and mats; and
accessory pillows and other padded accessories, often
marketed for use with an infant car seat, stroller, or bouncer, but not
sold with that product and therefore not included in the mandatory
safety standard for those products.
These in-scope products must meet the requirements of the rule.
However, to avoid potentially duplicative or conflicting obligations,
the scope of products that would be subject to this rule does not
include durable infant products that are already regulated by the
Commission and included in the list of products at 16 CFR 1130.2(a).
The following products are NOT infant support cushions within the
scope of this rule:
pillows not marketed, designed, or intended for use by
infants, such as adult bed and throw pillows;
nursing pillows if subject to the Commission's final rule
for nursing pillows (89 FR 85388 (October 25, 2024)), unless they are
also marketed for lounging;
crib and play yard mattresses that are regulated under the
play yard standard (16 CFR part 1221) and crib mattress standard (16
CFR part 1241);
purely decorative nursery pillows, such as those
personalized with a baby's name and birthdate, that are not marketed,
designed, or intended for infant use;
stuffed toys (unless they meet the definition of an infant
support cushion in this rule);
padded seat liners that are sold with a rocker, stroller,
car seat, infant carrier, swing, highchair, or bouncer that are
specifically designed to fit that product;
padded seat liners and inserts for a rocker, stroller, car
seat, infant carrier, swing, highchair, or bouncer that are sold
separately by the manufacturer as a replacement part and specifically
designed to fit that product; and
sleeping accommodations that are regulated under the
Commission's infant sleep product rule at 16 CFR part 1236.
B. Market Description
Most types of new infant support cushions are sold online,
including from general online retailers, online sites for ``big box''
stores, online baby products sites, and online marketplaces for hand-
crafted items. Some types of infant support cushions, particularly crib
pillows and baby loungers, are also available from brick-and-mortar
baby specialty stores and general retail stores. Prices for new infant
support cushions average roughly $30 and range from less than $15 for a
simple head positioner pillow or crib pillow to more than $250 for a
lounger with a removable cover or a large stuffed toy marketed for use
while an infant sleeps. Several thousand manufacturers and importers,
including hundreds of handcrafters and direct foreign shippers, supply
infant support cushions to the U.S. market. See Tab E of Staff's NPR
Briefing Package.\9\
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\9\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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[[Page 87470]]
Infant support cushions may be re-used for multiple children or
resold for use after an infant outgrows the product. For example, in
June 2023, staff found listings on Mercari for used changing pads,
large stuffed toys marketed for infant sleep, crib wedge pillows, baby
neck pillows, baby sleep positioners, baby loungers, baby sleep mats,
baby pillow chairs, infant self-feeding pillows, baby/toddler bean bag
chairs, and crib pillows. Similar listings were identified on eBay.
III. Incident Data and Hazard Patterns
Staff searched the Consumer Product Safety Risk Management System
(CPSRMS) \10\ and National Electronic Injury Surveillance System
(NEISS) \11\ 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. Staff identified 79 fatal incidents and 124 nonfatal
incidents and consumer concerns reported to CPSC from 2010-2022. Of the
124 \12\ non-fatal reports, 22 consisted of emergency-department-
treated injuries, three involved hospital admissions, 45 involved no
injury, and for 54 the disposition was either unknown or unspecified.
The incident data and hazard patterns cited in support of the NPR
support this final rule and are unchanged from the NPR. For further
discussion of the incident data and hazard patterns, see the NPR and
Tab A of Staff's NPR Briefing Package, which describe the incident and
hazard patterns associated with infant support cushions,\13\ and the
NOA, which describes the incident data and hazard patterns relied on
for the rulemaking.\14\
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\10\ CPSRMS is the epidemiological database that houses all
anecdotal reports of incidents received by CPSC, ``external cause''-
based death certificates purchased by CPSC, all in-depth
investigations of these anecdotal reports, as well as investigations
of select NEISS injuries. CPSRMS documents include hotline reports,
online reports, news reports, medical examiner's reports, death
certificates, retailer/manufacturer reports, and documents sent by
state and local authorities, among others.
\11\ NEISS is a statistically valid surveillance system for
collecting injury data. NEISS is based on a nationally
representative probability sample of hospitals in the U.S. and its
territories. Each participating NEISS hospital reports patient
information for every emergency department visit associated with a
consumer product or a poisoning to a child younger than five years
of age. The total number of product-related hospital emergency
department visits nationwide can be estimated from the sample of
cases reported in the NEISS. See www.cpsc.gov/Research--Statistics/
NEISS-Injury-Data.
\12\ The NPR listed 125 nonfatal incidents, but one of those
incidents was a duplicate.
\13\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
\14\ Notice of Availability and Request for Comment: Data
Regarding Incidents Associated With Infant Support Cushions, 89 FR
30295 (April 23, 2024), available at: www.federalregister.gov/d/2024-08605.
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IV. International and Voluntary Standards for Infant Support Cushions
A. International Standards for Infant Support Cushions
The Commission is aware of two British standards that contain
performance requirements addressing suffocation and asphyxiation
hazards associated with infant pillows: BS 1877-8:1974, Specification
for Domestic bedding--Part 8: Pillows and bolsters for domestic use
(excluding cellular rubber pillows and bolsters) (BS 1877-8:1974) and
BS 4578:1970, Specification for Methods of test for hardness of, and
for air flow through, infants' pillows (BS 4578:1970). The scope of BS
1877-8:1974 includes both adult and cot pillows (infant pillows) and
recommends that cot pillows be filled firmly enough to prevent infants'
heads from sinking into the products and that the pillow covering not
be loose enough to be drawn into an infant's mouth. BS 1877-8:1974 has
requirements for cot pillow size, filling, and covering. Under that
standard, cot pillows must be 58 x 38 cm (23 x 15 inches) and their
covering must be of open construction to allow air permeability. Both
the filling and covering must meet performance requirements described
in BS 4578:1970 for hardness (i.e., firmness) and air permeability.
The hardness test in BS 4578:1970 requires that a 100 mm diameter
probe be placed in the center of the product with 10 newtons (N) of
force for one minute. BS 1877-8:1974 requires that displacement of the
pillow when the force is applied shall not exceed 25 percent of the
thickness. The proportional approach used in this standard allows
thicker pillows to have a greater displacement than thinner pillows,
which staff assesses does not sufficiently protect against the
suffocation and asphyxia hazards associated with infant support
cushions because that greater displacement could allow the product to
obstruct the infant's airway.
B. ASTM Voluntary Standards Work
Currently, there are no published U.S. voluntary standards for
infant support cushions. ASTM is working on a voluntary standard for
infant loungers under the Subcommittee F15.21 on Infant Carriers,
Bouncers, and Baby Swings.\15\ On March 25, 2024, ASTM issued ballot
F15.21 (24-01), which included the latest draft of the infant lounger's
voluntary standard. The ballot closed on April 29, 2024, and received
eight negative votes and other comments including a comment from
staff.\16\ On September 16, 2024, ASTM issued ballot F15 (24-18), Item
#1 which addressed the negative comments and other comments on the
draft standard for infant loungers included in ballot F15 (24-01). That
ballot closed on October 16, 2024.\17\
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\15\ See Tab B of Staff's NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc. This ASTM
standard is still in draft form and has not completed the full
consensus process to become an approved standard, and thus the draft
standard is subject to change.
\16\ CPSC Staff Comment to Ballot ASTM F15.21 on Infant
Loungers, available at: www.cpsc.gov/s3fs-public/CPSCStaffCommenttoBallotASTMF1521onInfantLoungers.pdf?VersionId=tGM05rvyA6WCUzQxHFCDkVHVxRLbtQLv.
\17\ CPSC Staff Comment to Ballot ASTM F15.21 on Infant
Loungers, available at: www.cpsc.gov/s3fs-public/staff-comment-to-ballot-ASTM-F15-21-on-infant-loungers.pdf?VersionId=oMjqKOhKBI0lEWiQliiCJ3u3OP2XcB7n.
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In the ASTM draft voluntary standard, infant loungers would be
products with a raised perimeter, a recess, or other area that is
intended to be placed on the floor and to provide a place for an infant
to sit, lie, recline, or rest, while supervised by an adult, but are
not intended or marketed for sleep. The draft definition would apply to
only a subset of the products covered by this rule, which includes
infant positioners, nursing pillows with dual use for lounging, infant
cushions, and other infant pillow-like products, as well as the infant
loungers being considered by the ASTM draft standard. ASTM's draft
voluntary standard for infant loungers includes general requirements
typically found in other ASTM juvenile product standards, such as
requirements addressing lead content, small parts, hazardous sharp
edges or points, resistance to collapse and disassembly, openings,
protective components, permanency of labels and warnings, and toy
accessories that are attached to, removable from, or sold with the
products. The ASTM draft standard also specifies that if the lounger
can be converted to another product, it shall comply with the
applicable requirements of the converted product's standard. The
general requirements of the ASTM draft infant lounger standard also
state that the sidewall height of the
[[Page 87471]]
product shall be less than two inches on both the interior and exterior
sides of the sidewall when measured according to the sidewall height
measurement test method specified in the draft standard. The ASTM draft
voluntary standard includes performance requirements that address
stability, restraints, occupant support surface angle, fabric/mesh
integrity, bounded openings, occupant support surface firmness,
sidewall firmness, side angle measurements, and deflection at the
occupant support surface and sidewall intersection. Finally, the ASTM
draft voluntary standard for loungers also includes marking, labeling,
and instructional literature requirements, such as warning the consumer
about not using the product for sleep or naps, only using the product
when the occupant baby is supervised, only using the product on the
floor, keeping soft bedding out of the product, not using the product
on raised surfaces, and not using the product to carry or move an
infant.
As previously noted, the ASTM draft standard for infant loungers
primarily differs from the final rule regarding the scope of products
subject to the standard. Specifically, the final rule includes all
types of infant support cushions such as infant positioners, infant
loungers, and other types of infant mats and pads, while the scope of
the ASTM draft standard would apply only to infant loungers. Given that
the ASTM draft standard for loungers has not been finalized and
published and would not cover the same scope of products as the final
rule, the Commission finds that no voluntary standard currently exists
or will likely exist in the foreseeable future that would adequately
address the hazards presented by infant support cushions. This rule is
required under section 104 of the CPSIA to address the identified
hazards presented by infant support cushions. 15 U.S.C. 2056a.
VI. Response to Public Comments
CPSC received 18 public comments during the NPR comment period, and
one comment during the NOA comment period. The comments are available
on: www.regulations.gov, by searching under docket number CPSC-2023-
0047. This section describes the significant issues raised in the
comments and CPSC's responses to them.
A. Scope of the Final Rule
Comment: The Boppy Company, LLC (Boppy), Best Practice Quality LLC
(BPQ), Heroes Technology (US) LLC d/b/a Snuggle Me Organic (Heroes
Technology), and Juvenile Products Manufacturers Association (JPMA)
object to the broad scope of the proposed rule and argue that the
proposed rule does not take into consideration that it is difficult to
develop specific standards because of the wide range of infant support
cushion designs.
Response: We disagree that performance requirements and warning and
labeling requirements for a wide range of infant support cushions
cannot be comprehensively developed to mitigate the hazards posed to
infants from infant support cushions. Although infant support cushions
include many different types of products, incident data relied upon to
support the rule indicate that infants are at risk from falls and
suffocations, and that the hazard patterns are similar for all types of
infant support cushions. As indicated in the incident data, caregivers
use infant support cushions, which are not intended for sleep, in
infant sleep settings and infants tend to fall asleep in these
products. Thus, it is reasonably foreseeable that caregivers will use
infant support cushions in infant sleep settings, which poses a
suffocation hazard. Therefore, the performance requirements and
warnings in the rule are designed to reduce the fall and suffocation
hazards that these products pose.
Comment: JPMA argues that a rule for infant support cushions is
unnecessary because CPSC has a safety standard for infant sleep
products, codified at 16 CFR part 1236, addressing infant support
cushions that are primarily intended or marketed for sleep.
Response: The scope of this rule includes products that are not
subject to the infant sleep products rule, but that still present a
risk of injury or death to infants. Infant support cushions do not meet
the definition of infant sleep products because they are not marketed
or intended to provide sleeping accommodations. Therefore, this rule is
necessary to addresses the hazards posed by infant support cushions
because the infant sleep products rule does not apply to infant support
cushions.
1. Scope Age
Comment: BPQ asserts that the in-scope age range in the rule should
be changed to align with the ASTM Lounger standard in development,
which BPQ states covers infants 0-6 months.
Response: Since publication of the NPR, the ASTM F15.21 Infant
Loungers Scope Task Group changed the scope of its draft safety
standard to include infants up to 12 months of age.\18\ Incident data,
as outlined in the incident data and hazard pattern section of the NPR
and Tab A of Staff's NPR Briefing Package,\19\ indicate that incidents
associated with infant support cushions occur with infants up to 12
months old (i.e., 365 days). Based on the incident data and hazard
pattern analysis, the performance requirements and warnings were
developed to mitigate the hazards associated with infant support
cushions for infants up to 12 months old. The Commission declines to
limit the scope of the final rule with a specific age limitation. The
Commission's approach mitigates the hazards associated with infant
support cushions for all infants, regardless of age, and discourages
manufacturers from making age-based marketing claims specifically to
attempt to remove their products from being subject to the rule.
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\18\ ASTM F15.21 Infant Loungers Scope Task Group--MeetingLog,
available at: www.cpsc.gov/content/ASTM-F1521-Infant-Loungers-Scope-Task-Group-Meeting%E2%80%AFLog-1.
\19\ Staff's NPR Briefing Package available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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2. Tummy Time Pillows
Comment: BPQ, the Toy Association (TA), Boppy, and Graco Children's
Products Inc (Graco) argue that the rule should exempt tummy time
pillows.
Response: We disagree that tummy time pillows should be exempted
from the rule. Tummy time pillows, which are pillow products on which
infants may be propped, present the same suffocation and fall hazards
as other types of infant support cushions, as indicated in the incident
data discussed above. Infants can suffocate when tummy time pillows
conform to an infant's face and occlude the airways; further, infants
can roll from a tummy time pillow, creating a fall risk if the tummy
time pillow is placed on an elevated surface. Therefore, tummy time
pillows are subject to the requirements of the rule because allowing an
exemption for tummy time pillows would allow those products to present
the same suffocation and fall hazards to infants that this rule is
intended to address. We note that AAP and National Institute of Child
Health and Human Development (NICHD), while endorsing tummy time, do
not specifically
[[Page 87472]]
recommend tummy time pillows for that activity.20 21
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\20\ Benefits of Tummy Time [verbar] Safe to Sleep[supreg]
(nih.gov), available at: https://safetosleep.nichd.nih.gov/reduce-
risk/tummy-
time#:~:text=Babies%20benefit%20from%20having%20two,of%20total%20tumm
y%20time%20daily .
\21\ American Academy of Pediatrics (2017). Back to sleep, tummy
to play. Retrieved August 28, 2018, from www.healthychildren.org/English/ages-stages/baby/sleep/Pages/Back-to-Sleep-Tummy-to-Play.aspx.
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3. Dual Use Products
Comment: AAP supports the scope of the proposed rule and
specifically asserts that dual use products marketed for both nursing
and lounging should be within the scope of the rule. BPQ and Boppy
state that the rule should exempt dual use products. Boppy asserts that
there are distinct differences between nursing pillows and infant
support cushions; it further states that the intent of the nursing
pillows rule is to limit nursing pillow use to solely breast feeding
and bottle feeding, obviating the need to cover nursing pillows of any
type, including dual use, in this rule. BPQ further argues that because
the draft ASTM nursing pillows standard, at the time of the comment,
specifically states that nursing pillows may not be marketed for
multipurpose use, nursing pillows should be exempt from this rule even
if they otherwise would meet the definition of an infant lounger.
Response: We disagree that the rule should exempt dual use products
marketed for both nursing and lounging. A nursing pillow that is also
marketed for lounging is an infant support cushion subject to this
rule. The new nursing pillow standard, ASTM F3669-24, published on
September 10, 2024, specifies that if a nursing pillow can be converted
into another product or has use features for which a consumer safety
specification exists, the product shall comply with the requirements of
all applicable voluntary standards. On October 25, 2024, the Commission
final rule for nursing pillows published (89 FR 85388), which does not
have a requirement for convertible products. Nursing pillows that meet
the definition of infant lounger in Sec. 1243.2 must also meet the
requirements of this rule because the two rules are intended to address
different hazard patterns. While the nursing pillow performance
requirements and warnings discourage lounging, the infant support
cushion rule requirements are intended to mitigate suffocation hazard
while lounging. It is common for multiple CPSC mandatory safety
regulations to apply to a single children's product, such as the
existing regulations for small parts, phthalates, and lead content.
Comment: BPQ recommends the following statement should be added to
the rule: If the infant lounger can be converted into another product
for which a consumer safety specification exists, the product shall
comply with the applicable requirements of that standard.
Response: The commenter's requested statement is unnecessary
because Sec. 1243.3(g) of the rule regarding convertible products
already states that if the infant support cushion can be converted into
another product for which a consumer product safety standard exists,
the product also shall comply with the applicable requirements of that
standard.
4. Playmats
Comments: Bureau Veritas (BV) requests clarification regarding
whether playmats are intended to be classified as infant support
cushions. Dorel Juvenile Group, Inc. asserts that playmat products
subject to the requirements for toys in ASTM F963 and 16 CFR part 1250
and whose base ``pad or mat'' is a flat layer no greater than one inch
in thickness should be exempt from the rule. TA and Graco also assert
that playmats that are subject to ASTM F963 and 16 CFR part 1250 should
be exempt from the rule.
Response: We disagree that the rule should exempt playmats. While
playmats must meet the requirements of ASTM F963 and 16 CFR part 1250,
those requirements do not address the infant suffocation hazards
presented by playmats. Additionally, a playmat could have a flat layer
no greater than one inch in thickness but still have greater than 1-
inch sides or borders presenting a potential suffocation hazard.
Finally, not providing the requested exemption is consistent with the
ASTM draft voluntary standard for infant loungers, which currently also
does not contain an exemption for playmats.
5. Accessory Pillows and Other Padded Accessories
Comment: BV requests clarification on the scope of the final rule
regarding accessory pillows and other padded accessories sold with a
juvenile product, or accessories sold separately from a juvenile
product but intended to be used on a juvenile product. Boppy and Graco
assert that the rule should exempt accessory pillows and other padded
accessories for durable nursery products that are sold separately.
Boppy additionally states that infants are seated while in contact with
these pillows and padded accessories, so they do not meet the
definition of an infant support cushion. Dorel Juvenile Group argues
that the rule should exempt padded seat liners and inserts included
with a car seat. BPQ argues that products that are used to keep an
infant's head positioned in an infant carrier should be out of scope of
this rule.
Response: Padded seat liners that are sold with a rocker, stroller,
car seat, infant carrier, swing, highchair, or bouncer and are
specifically designed to fit that product are not subject to the rule.
However, we agree with BV, Boppy, Graco, and Dorel Juvenile Group that
replacement padded seat liners and inserts for these products that are
sold separately by the manufacturer as a replacement part and
specifically designed to fit a rocker, stroller, car seat, infant
carrier, swing, highchair, or bouncer would meet the rule's definition
of an infant support cushion, even though they would be subject to the
rules for those specific products as well. To avoid this unintended
result, we have added these products to the list of products not within
the scope of the rule because they are subject to the specific safety
standard for those products discussed in section II.A of the preamble.
Under Sec. 1243.1, products subject to another standard listed in 16
CFR 1130.2(a) are exempt from the rule.
Aftermarket accessory pillows and other padded accessories, often
marketed for use with a rocker, stroller, infant car seat, infant
carrier, swing, highchair, or bouncer, but not sold with that specific
product or as a replacement part, are subject to this rule, and thus
must meet the requirements of the rule. This can include products that
are used to keep an infant's head positioned in an infant carrier,
unless they are sold with that product or as a manufacturer's
replacement part. Such portable products can be used for purposes other
than their intended use, including as an infant sleep product.
Therefore, we disagree with BPQ that products that are used to keep an
infant's head positioned in an infant carrier should be outside the
scope of this rule. We also disagree with Boppy that accessory pillows
and other padded accessories, used with seated products, should be
excluded from the scope of the rule. These accessories present a
suffocation hazard to infants because they are highly portable, and
therefore can be used not only in the product for which they were
intended but also in a variety of other products in which infants
sleep, such as cribs, bassinets, and play yards. Because infants sleep
for a majority of the day and tend to fall asleep in products intended
for lounging, it is reasonably
[[Page 87473]]
foreseeable that caregivers will use these accessory products in an
infant sleep environment or that infants will fall asleep on them.
Therefore, the rule has requirements and warnings to reduce the
suffocation hazard presented by infant support cushions.
6. Infant Sleep Positioners, Anti-Rollover Pillows, and Wedge Pillows
for Infants
Comment: BPQ and Boppy argue that the rule should exempt infant
sleep positioners and anti-rollover pillows. Boppy states that the rule
should exempt wedge pillows for infants. Boppy and Graco additionally
state infant wedge pillows, infant sleep positioners, and anti-rollover
pillows are all sleep products and thus should be subject to the infant
sleep products rule, not this rule. BPQ additionally states that there
is precedent to have discrete standards for each product category.
Response: We disagree with the commenters' assertion that infant
wedge pillows, infant sleep positioners, and anti-rollover pillows
should be outside the scope of the rule because all of these products
are sleep products.\22\ Infant wedge pillows, infant sleep positioners,
and anti-rollover pillows do not meet the definition of infant sleep
products in 16 CFR part 1236 because they are not marketed or intended
to provide sleeping accommodations. Nevertheless, it is reasonably
foreseeable that caregivers will use these products in an infant sleep
environment. CPSC and FDA have warned against using infant positioning
products in an infant sleep environment because they pose suffocation
hazards.23 24 The incident data, which includes both fatal
and nonfatal incidents, show that infants can suffocate when wedges,
sleep positioners, and anti-rollover pillows conform to an infant's
face. Therefore, the performance requirements and warnings of the rule
are intended to mitigate the suffocation hazard posed by these
products. Because the incident data hazard patterns associated with
these products are the same and show that all infant support cushions
are used for lounging, we disagree that it is necessary to develop
separate standards specifically for these products.
---------------------------------------------------------------------------
\22\ See Safety Standard for Infant Sleep Products, 86 FR 33022
(June 23, 2021), available at: www.federalregister.gov/d/2021-12723.
\23\ Recommendations for Parents/Caregivers About the Use of
Baby Products [verbar] FDA, available at: www.fda.gov/medical-devices/baby-products-sids-prevention-claims/recommendations-parentscaregivers-about-use-baby-products.
\24\ Deaths prompt CPSC, FDA warning on infant sleep positioners
[verbar] CPSC.gov, available at: www.cpsc.gov/Newsroom/News-Releases/2010/Deaths-prompt-CPSC-FDA-warning-on-infant-sleep-positioners.
---------------------------------------------------------------------------
7. Pads and Mats
Comments: An anonymous commenter requests clarification on the type
of pads and mats subject to the rule because they assert that the term
is generic and could apply to products beyond those on which a child
could sleep.
Response: Pads and mats that are 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 are subject to the rule.
These pads and mats pose a suffocation hazard because they can be used
in a variety of products in which infants sleep such as cribs,
bassinets, and play yards. In addition, because infants sleep for a
majority of the day and tend to fall asleep in products intended for
lounging, it is reasonably foreseeable that infants will fall asleep on
pads and mats. Pads and mats are associated with both fatal and
nonfatal incidents in the incident data, and the performance
requirements of the final rule are intended to mitigate the suffocation
hazard to infants from these products.
8. Framed Seating Products
Comment: Graco argues that framed seating products should be exempt
from the rule because these types of framed products do not present the
same hazards as soft cushioned infant pillow products and because the
NPR did not specifically address hazards associated with seated infant
products that have rigid frame containment.
Response: We agree with the commenter that framed seating products,
including infant floor seats, rockers, strollers, car seats, infant
carriers, swings, highchairs, bouncers, or other infant products with
rigid components are not infant support cushions as defined in Sec.
1243.2 of the rule. Thus, an exemption is unnecessary because these
products are not subject to the requirements of the final rule.
B. Definitions
Comment: TA requests the term ``infant pillow'' used in Sec.
1243.3(d), but nowhere else in the proposed rule, be amended to
reference the defined term of infant support cushion for consistency.
Alternatively, TA argues that ``infant pillow'' could be included as a
discrete term in Sec. 1243.2.
Response: For consistency and clarity, the reference to infant
pillow in Sec. 1243.3(d) of the proposed rule has been changed to
infant support cushion in the final rule.
Comment: Graco requests that the definition of infant lounger be
modified by to substitute the term infant support cushion for infant
product. Graco also requests that the phrase ``infant loungers do not
include seated infant products with a rigid frame used as containment''
be added to the definition of an infant lounger.
Response: We agree with the commenter's recommended change to the
definition of infant lounger in Sec. 1243.2 and have replaced the
phrase infant product with infant support cushion in the final rule. We
disagree that it is necessary to specify that infant loungers do not
include seated products with a rigid frame used as containment as these
products are not within the scope of infant support cushions and thus
are not subject to the requirements of the rule.
Comment: JPMA asserts that the definitions used in the rule should
align with the ASTM standard, in development, for infant loungers.
Response: The draft ASTM standard for infant loungers is in draft
form and subject to change as part of the consensus process. Therefore,
we decline to align the definitions in the final rule with the ASTM
standard in development. Additionally, the final rule's definition of
infant support cushion addresses the hazards presented by different
types of infant support cushions, not just the infant loungers under
consideration by the ASTM draft standard.
Comment: Heroes Technology argues that many of the products within
the scope of the rule do not have an occupant support surface and the
rule does not address how to test products without an occupant support
surface.
Response: All infant support cushions contain an occupant support
surface, which is defined in Sec. 1243.2 as the area that holds up and
bears the infant or any portion of the infant to support the infant's
weight or any portion of the infant while reclining or in a supine,
prone, or recumbent position. By definition, every infant support
cushion subject to the rule contains an occupant support surface, and
thus is required to meet the performance requirements of the rule that
involve testing the occupant support surface.
Comment: Boppy notes that the proposed rule does not define the
term sidewall.
Response: The Commission agrees that a definition of the term
sidewall is needed for clarity. Thus, a new definition for sidewall,
which means any wall at the edge of the occupant support surface, has
been added to Sec. 1243.2 of the final rule.
[[Page 87474]]
C. Use of Substitute Products
Comment: Boppy, Heroes Technology and JPMA raised a concern about
the potential for consumers to use substitute products such as adult
pillows or blankets, instead of infant support cushions. The commenters
note that such products would fall outside the scope of the rule but
could pose similar suffocation and fall hazards to infants.
Response: None of the commenters provide data to support the claim
that the requirements in the proposed rule would lead consumers to use
substitute products. The rule is intended to ensure that consumers have
access to infant support cushions that do not present the same risks of
death or injury as some current products, and this rule should not
cause consumers to seek out alternative products. The rule also
contains warnings that explain why soft surfaces, blankets, and other
soft items present a hazard when placed in and around the product,
which can further educate consumers on the risks posed by substitute
products with soft surfaces.
Comment: Boppy questions whether the performance requirements in
the proposed rule could negatively impact tummy time rates.
Response: The rule is not likely to reduce beneficial tummy time.
Regarding tummy time, AAP and NICHD, while endorsing tummy time, do not
recommend specifically using tummy time pillows. Additionally, this
rule would allow the manufacture and sale of tummy time products as
long as those products meet the requirements of the rule. Therefore,
tummy time guidance is not likely to change based on this rule.
D. Product Misuse and Education
Comment: BPQ recommends CPSC develop educational campaigns to
address the unsafe sleep settings and misuse of products not intended
for infant sleep exhibited in the incident data. Commenter Julian
Dreest asks what strategies are currently in place to educate consumers
about the proper use of infant support cushions.
Response: The use of infant support cushions for sleep, or in an
infant sleep setting, is not appropriate. Consumer education campaigns
about safe sleep and the safe use of infant support cushions are useful
and necessary to assist new parents and older generations of caregivers
about safe sleep practices. CPSC actively promotes safe sleep outreach
and education throughout the year to reach parents, grandparents, and
caregivers on our website \25\ and by engaging in targeted safe sleep
messaging during Baby Safety month (September).
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\25\ Safe Sleep--Cribs and Infant Products, available at:
www.cpsc.gov/SafeSleep.
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However, education campaigns alone are not enough to address the
hazards associated with infant support cushions. Data generally
indicate that consumers believe if an infant product is on the market,
it must be safe for use with infants--an assumption that is not always
true. Therefore, this final rule for infant support cushions, paired
with educational campaigns, is needed to better ensure safe uses of
these products.
Comment: Julian Dreest, BPQ, and Heroes Technology assert that
educational strategies should reflect the new requirement for a maximum
incline angle of 10 degrees or less, which limits the side height of
the product to approximately 1.9 inches. The commenters assert this new
requirement will invite some caregivers to improvise or modify the
product to achieve the containment level they desire, increase consumer
complacency, and provide a false sense of security leading to less
supervision. Therefore, they argue, the rule will increase falls from
elevated surfaces and the likelihood of roll-out from the product into
an unsafe setting. AAP and the Joint Consumer Advocate Commenters
strongly support the maximum incline angle requirement of 10 degrees or
less in the proposed rule.
Response: We disagree that limiting the maximum incline angle to 10
degrees or less will lead to increased falls or suffocations due to
decreased supervision. As discussed in Tab D of Staff's NPR Briefing
Package,\26\ a cushioned sidewall with a height of up to four inches
may give caregivers the false perception that the product can safely
contain a child without supervision, regardless of what the product
warnings might say. The presence of a distinct, raised perimeter
surrounding the occupant support surface, as observed in various
products on the market, provides a visual cue to consumers that the
infant is safely contained in the product. Infant support cushions
currently marketed for sale often display images of infants sleeping or
resting in such products, and thus convey the appearance of effective
containment of infants. The incident data shows that parents may
mistakenly believe that products with cushioned sidewalls greater than
two inches surrounding the infant would make them safe on elevated
surfaces, that the infant can be left alone on the product, and that
the product will safety contain their infant. The incident data further
shows that infants suffer falls from products with cushioned sidewalls
that are higher than 2 inches surrounding the occupant. Specifically,
infants roll out of products with cushioned sidewalls greater than two
inches into hazardous settings. With infant support cushions with
cushioned sidewalls less than 2 inches, parents can see their infant is
not secure in the product, that the product does not contain their
infant, and that the infant should not be left alone on the product,
particularly on elevated surfaces. Furthermore, the accompanying
warnings alert users to the risks of leaving infants unattended or
allowing use of the products for sleep or using on elevated surfaces.
We note that AAP and the Joint Consumer Advocate Commenters strongly
support the maximum incline angle requirement of 10 degrees or less in
the proposed rule.
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\26\ See Tab D of Staff's NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------
Comment: Graco states that in addition to the current infant
pillows that are already banned under 16 CFR 1500.18, the CPSC had
considered an ``Infant Pillow Ban'' in former operating plans that
would take these dangerous products off the market, but instead has
pivoted to allow the very same types of products in the NPR, without
sufficient requirements that would address the inherent misuse and
hazards.
Response: The Commission finds that the requirements in this rule
will mitigate the suffocation and fall hazards to infants posed by
infant support cushions. Therefore, the Commission concludes, that this
rule will better address the known hazards posed by infant support
cushions rather than just merely expanding the existing infant pillow
ban, while still providing consumers with the utility of infant support
cushions for supervised infant use.
Comment: JPMA asserts that improper use of infant support cushions
has contributed to the majority of incidents associated with these
products since 2010. JPMA also contends that the majority of the
products in the scope of this rule are not marketed or intended for
sleep and have recognized utility for parents who need a safe product
in which to place their child during awake time interaction, play, and
engagement.
Response: The incident data clearly indicate a pattern of use of
infant support cushions in infant sleep settings and for sleep. The
designs of infant
[[Page 87475]]
support cushions currently on the market encourage the use of these
products for sleep. These products are often used for sleep because of
the false perception that the soft, pillow-like design, with high
borders/sides, are appropriate for infant sleep and will safely contain
an infant, including on elevated surfaces. Further, staff is aware of
infant support cushions that are or have previously been marketed and
promoted as sleep products. Changing only the marketing of the product,
without changing the design of the product, will not adequately
discourage the behavior of caregivers allowing infants to sleep on
infant support cushions unsupervised. We agree that infant support
cushions have utility for parents to place their infant when actively
supervised.
E. Incident Data
Comment: BPQ, Boppy, Heroes Technology, and JPMA state that the
percentages of incidents by product category are not provided in the
NPR and Tab A of Staff's NPR Briefing Package. BPQ also argues that the
two largest nonfatal hazard patterns, falls and threatened asphyxia,
are not broken down by age.
Response: The Commission published an NOA announcing the
availability of incident data relied upon for the NPR and seeking
comment. The data in the NOA released for public comment shows that for
fatal incidents, 63 incidents were associated with loungers, 10
incidents were associated with sleep positioners, four incidents were
associated with pads/mats, one incident was associated with an infant
wedge, and one incident was associated with a tummy time pillow. For
nonfatal incidents, 104 incidents were associated with loungers, 13
incidents were associated with sleep positioners, three incidents were
associated with infant wedges, two incidents were associated with pads/
mats, one incident was associated with a tummy time pillow, and one
incident was associated with a small infant pillow. As described above,
the hazard patterns throughout these incidents are consistent with the
risks of suffocation and falls presented by infant support cushions.
Based on the data made available to commenters in the NOA, for
incidents involving threatened asphyxia, 21 victims were up to 4 months
old, two were 4-6 months old, and in three incidents the age was
unreported. For incidents involving falls, 15 victims were up to 4
months old, nine were 4-6 months old, four were over 6 months old, and
in one incident the age was unreported.
Comment: Boppy argues in a comment on the NPR that CPSC provided
insufficient data to support that all products proposed to be covered
by the rule, and specifically tummy time pillows, need regulation with
a mandatory rule. Boppy also argues in a comment on the NOA that there
are zero reported incidents related to tummy time pillows, so there is
no justification for any inclusion of tummy time pillows within the
scope of this proposed rule.
Response: The Commission disagrees that tummy time pillows should
be excluded from the scope of the rule. Tummy time pillows are products
on which infants may be propped, and therefore they must meet the
requirements of this rule. Tummy time pillows were associated with one
fatal incident and one nonfatal incident as reflected in the incident
data and present the same hazards as other infant support cushions. So,
allowing a tummy time pillow for infants to be exempted from this
regulation is contrary to the regulation's intent and would allow
manufacturers to remarket other types of infant support cushions as
tummy time pillows to avoid regulation. We note AAP and NICHD, while
endorsing tummy time, do not specifically recommend pillows for tummy
time.
F. General Requirements
Comments: Consumer Federation of America, Consumer Reports, Kids In
Danger, National Center for Health Research, Public Citizen, U.S.
Public Interest Research Group (Joint Consumer Advocate Commenters),
and Safe Infant Sleep recommend that the rule prohibit any type of
electronics used inside or attached to an infant support cushion. The
commenters also recommend prohibiting battery powered features,
including vibration and white noise that can encourage sleep or may
overheat presenting a burn risk, or features that contain cords which
present a strangulation risk.
Response: Some vibrations and music/sounds may lull infants to
sleep. However, other music and sounds may engage infants during awake
time. Staff has not identified any products in the incident data where
an electronic component caused an injury or a death through fire, heat,
or otherwise. Because no such products were identified in the incident
data as presenting a hazard, this rule does not include a requirement
related to electronics.
G. Performance Requirements
Comment: Heroes Technology requests that CPSC conduct round robin
studies of the performance requirements and test methods involving
multiple laboratories and multiple exemplar products in each category,
with a view to reproposing and ultimately adopting test methods and
performance requirements.
Response: The Commission considers the performance requirements and
test methods in this rule to adequately address the hazards associated
with infant support cushions without a need for the type of round robin
process suggested by Heroes Technology, which could take years to
complete while injuries and deaths continue to occur. The Commission
concludes that the urgency of addressing the hazards associated with
infant support cushions, and the requirement in CPSIA section 104 to
promulgate safety standards, supports the Commission's promulgation of
this rule. The factual and scientific basis for the performance
requirements and test methods in the rule are described in Tab C of
Staff's NPR Briefing Package.\27\
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\27\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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1. Restraint
Comments: Graco asserts that the presence of a restraint system on
an infant support cushion or lounger would further deter consumers from
using them for sleep because the safety standards for sleep products do
not allow restraint systems or cords or straps in the occupant area. On
this basis, Graco suggests that the rule's prohibition on restraints
could indicate to caregivers that infant support cushions are intended
for sleep.
Response: The Commission's yearly report of injuries and deaths
associated with nursery products demonstrates that consumers use infant
products, both with and without restraints, for infant sleep.\28\ In
addition, restraints indicate to consumers that the infant is secure in
the product and will not move, and thus the caregiver can leave the
infant unsupervised. Because fall-related incidents have involved
unattended infants who were left propped or lounging in the product,
consumers are likely to interpret the presence of an infant restraint
as meaning that unattended use is acceptable when an infant is
restrained. Additionally, as is the case with several other children's
product areas, loops, cords, or strings
[[Page 87476]]
that enter into the occupant space can create an entanglement hazard,
as seen in the incident data. Infant support cushions should be used
with constant adult supervision, so prohibiting restraints in the rule
is appropriate.
---------------------------------------------------------------------------
\28\ Injuries and Deaths Associated with Nursery Products Among
Children Younger than Age Five, August 2023, available at:
www.cpsc.gov/content/Injuries-and-Deaths-Associated-with-Nursery-Products-Among-Children-Younger-than-Age-Five-12.
---------------------------------------------------------------------------
2. Maximum Incline Angle
Comment: Heroes Technology argues that it is not clear in the rule
what ``approximately 1.9 inches'' means and asserts that this is an
arbitrary value. Graco argues that figure 6 in the text of the proposed
rule alludes to a side height measurement, without criteria stipulated
for the side height.
Response: The rule does not include a side height performance
requirement or a side height test method. Instead, the maximum incline
angle performance requirement of 10 degrees or less in the rule
effectively limits the height of the product to approximately 1.9
inches, which reduces the hazard from falls and suffocation when the
product could otherwise give the false perception of containment to a
caregiver that the product will safely contain the infant. The maximum
incline angle test in the rule, as compared to a side height test, can
more effectively be applied to all the different types of infant
support cushions subject to the rule, which include infant support
cushion products other than loungers and even products without a
sidewall. Some products subject to the rule contain occupant support
surfaces that allow an infant to be placed in various locations on the
product. The maximum incline angle requirement applies to all the
manufacturer's recommended use positions, and also to all other infant
support cushion surfaces that can feasibly support an infant's head
(occupant support surface-head), including the angle from the sidewall
(if present) to the occupant support surface, or from the occupant
support surface-head to the floor when no elevated sidewall is present,
or from the sidewall to the floor when an elevated sidewall is present.
Staff calculated that the side height for very firm products which meet
the 10-degree angle requirements would likely be approximately 1.9
inches (4.8 cm) or less based on the geometry of the newborn hinged
weight gauge. The side height was not recommended arbitrarily, and is
not itself a requirement, but rather describes the geometric
calculations of the likely height of a product just meeting the
required incline angle of 10 degrees.
Comment: BPQ recommends the sidewall height should be set at 2
inches, as in the draft ASTM infant loungers standard, and not 1.9
inches. BPQ contends that if the height of the product is set at 1.9
inches, then there would be no need to measure the incline angle. The
commenter also recommends that the inclined angle of 10 degrees or less
should be applied on the support surface of the base and only if the
side height is greater than 2 inches.
Response: The Commission disagrees that a maximum sidewall height
of 2 inches should be required. The NPR did not propose a maximum side
height requirement but instead proposed a maximum incline angle
performance requirement. As discussed in the response to the previous
comment, the maximum incline angle performance requirement in the rule
is based on the varying designs of products and is expected to
geometrically result in the height of the product being no more than
1.9 inches in order to comply with the incline angle requirement.
Comment: Graco argues that subjecting infant support cushions to a
maximum incline angle requirement for products that are not intended
for sleep would incorrectly result in them sharing a critical
characteristic of infant sleep products, that are also required to have
a sleep surface of 10 degrees or less.
Response: Infant support cushions are not sleep products, but
infants fall asleep in many types of products other than sleep
products, including infant support cushions. The maximum incline angle
requirement in the rule addresses the suffocation hazard that could
result if an infant sleeps in an infant support cushion. Section
1243.5(d) of the rule requires infant support cushions to have an
incline angle of 10 degrees or less in order to reduce the hazard of
suffocation if an infant falls asleep in the product.
Comment: Heroes Technology argues that if there is no incline in
the manufacturer's recommended use location for the product, and other
use locations represent misuse, then the product should not be subject
to a maximum incline angle requirement.
Response: We disagree that products with no incline in the
manufacturer's recommended use location should not be subject to the
maximum incline angle requirement of the rule. Some products subject to
the rule contain occupant support surfaces that allow a variety of use
modes, so the infant may be placed in various locations on the product,
while some products do not have sidewalls. With other products, infants
may move, roll, or be placed in various positions on the product. To
address known hazard patterns, the rule appropriately includes a
maximum 10-degree incline angle requirement that applies to any
foreseeable use position on the infant support cushion's occupant
support surface or sidewall that supports the head for reclining, to
mitigate suffocation and fall hazards. The maximum incline angle
requirement applies to all manufacturer's recommended use positions, as
well as to all other infant support cushion surfaces that can feasibly
support an infant's head (occupant support surface-head). This includes
the angle from the sidewall (if present) to the occupant support
surface or from the occupant support surface-head to the floor when no
elevated sidewall is present or from sidewall to floor when an elevated
sidewall is present.
Comment: Heroes Technology notes that an example of a ``feasible
location'' is provided in the proposed rule, but the term is not
defined. The comment also notes that a ``location likely to fail'' is
also not defined in the rule, nor is any guidance provided as to how
such a location should be determined.
Response: A ``feasible location'' is language commonly used in ASTM
standards and is typically followed by an example of such a location in
the requirement. Section 1243.5(d)(8) is the only place in the rule
where the term feasible location is used. This section represents the
intent for a feasible location by providing an explicit example ``such
as perpendicular to the recommended use location(s)'' without limiting
the potential to test any area that is applicable with a discrete
definition.
The language a ``location likely to fail'' is language commonly
used in ASTM standards and longstanding CPSC safety standards that
incorporate these ASTM standards. While a location most likely to fail
cannot be determined by the use of a single test, not all locations on
the product need to be evaluated. For example, with respect to the
maximum incline angle requirement, any extremity with respect to the
overall height of the sidewall or occupant support surface should be
considered areas likely to fail. Therefore, we disagree that ``feasible
location'' or ``location most likely to fail'' needs to be defined in
the rule.
Comment: Graco argues that it is unclear if a two-inch height would
prevent infants from rolling out of a product into a dangerous
environment. Dony Ly suggests CPSC should recommend a side height that
will best mitigate falls, while accounting for the wide range of infant
age and ability but did not provide any recommendation as to that
height. Julian Dreest proposes revising the sidewall height limitation
[[Page 87477]]
to a minimum of four inches to mitigate the risk of falls; he also asks
if there has been a risk assessment analysis comparing the incidence of
falls from products with different sidewall heights, while also taking
into account the age of the infant. Heroes Technology asserts that CPSC
failed to consider that a shorter sidewall height will increase the
fall hazard.
Response: As seen in the incident data and proposed in the NPR, a
maximum incline angle requirement of 10 degrees or less mathematically
limits the side height of the product to less than 2 inches to address
potential asphyxiation hazards. The incident data also indicated that
caregivers placed infant support cushions into infant sleep settings
for unsupervised sleep or on elevated surfaces. Higher sidewall heights
give the false perception to the caregiver that the product will safely
contain their infant. At the same time, the incident data show that
higher sidewall heights do not adequately contain infants or prevent
falls and that infants roll out from and fall out of products with a
side height of 4 inches or higher. The incident data also indicates
that infants can turn over or roll without warning and are at risk of
falling when infant support cushions are placed on an elevated surface.
In contrast to products with higher side heights, products with
side heights of approximately 2 inches or less are less likely to give
the false perception to the caregiver that the product will safely
contain their infant. Therefore, caregivers are less likely to leave
infants unattended in a product with a less than 2-inch side height or
to place the product on an elevated surface. When the side height is
limited to less than 2 inches it provides a visual cue to caregivers
that the product will NOT safely contain their infant which encourages
caregivers to place the product on the floor, thus mitigating the fall
hazard posed to infants from products placed on elevated surfaces.
Furthermore, there is no evidence that a maximum sidewall height of
about 2 inches would increase the risk of injury from a fall or lead to
different consequences than a higher sidewall because, as reflected in
the incident data, infant support cushions with higher side heights do
not safely contain infants and infants already roll out of these
products. Additionally, products with side heights of more than 2
inches would exceed the maximum incline angle requirement in the final
rule and poses a suffocation or positional asphyxiation hazard. Also,
the commenter's proposal to require 4-inch-high sidewalls would not
allow for products such as flat playmats or other infant support
cushion products that do not contain sidewalls. Staff's analysis of
incident data did not identify the need for a sidewall requirement and
thus the final rule has no requirements for a minimum side height.
Therefore, the Commission is not adopting the commenters'
recommendations to require higher sidewalls because higher sidewalls
encourage unsafe placement of infants on elevated surfaces, while also
failing to adequately contain infants or prevent falls. Finally, staff
is unaware of a risk assessment analysis specifically comparing the
incidence of falls from infant support cushions of different product
heights, while also taking into account the age of the infant.
Comment: Heroes Technology asserts that CPSC failed to consider
that with reduced side heights consumers will use blankets and towels
to create a bumper.
Response: Although this rule only regulates infant support
cushions, it does contain specific warnings about the serious risks
posed by soft bedding and other soft items in and around infant support
cushions. Regardless of the side height of a product, some caregivers
may use other products such as blankets and pillows to create a barrier
around an infant, whether the infant is on an infant support cushion or
not. CPSC will continue providing information and education campaigns
for safe infant care regarding the hazards associated with soft bedding
and soft items in sleep settings.
3. Firmness
Comment: Boppy argues that the test requirements and procedures in
the proposed rule do not consider products that do not have a sidewall.
The performance requirements do not specify if the sidewall firmness
and angle requirements only apply to products with a sidewall, and the
testing procedures for sidewalls do not include language such as ``if
applicable'' or ``for products with a sidewall.''
Response: We agree that the rule should clarify whether the
performance requirements and test methods apply to products that do not
contain a sidewall. Therefore, the final rule adds ``For products with
a sidewall'' to the beginning of the sentence regarding the performance
requirements in Sec. 1243.4(e)(2) and (3) and (f) and also adds ``For
products with a sidewall'' to the beginning of the sentence before
``perform'' in the test methods in Sec. Sec. 1243.5(g) and 1243.4(h)
and (i).
Comment: Boppy notes that the rule does not specify how testing is
to be performed on products with an occupant support surface of one
inch or less.
Response: We agree that clarification on how testing is to be
performed on products with an occupant support surface of one inch or
less is necessary in the final rule. Therefore, Sec. 1243.5(f) of the
final rule adds the language ``All products, including products one
inch or less in thickness, are required to be tested'' to clarify how
testing is to be performed on products with an occupant support surface
of one inch or less. The rule requires all in-scope products, including
those with an occupant support surface of one inch or less, to be
tested to all of the performance requirements to ensure that they meet
the standard. As discussed above, no exception is provided for products
of one inch or less in thickness.
Comment: Safe Infant Sleep proposes that CPSC should consider a
requirement that would not allow covers to have extra padding or
cushioning, since such extra padding or cushioning may introduce an
additional suffocation hazard.
Response: The Commission agrees that slipcovers with extra padding
or cushioning may introduce a suffocation hazard that would not be
addressed by testing only the firmness of the infant support cushion
without the slipcover installed on the product during testing. The
Commission also agrees that testing should be performed with slipcovers
installed as part of the as assembled product and the product and
slipcover, if sold on or together with the product, must meet the test
requirements because extra padding or cushioning on a slipcover may
introduce an additional suffocation hazard that is not addressed if the
product is tested without the slipcover installed. In order to make
clear that infant support cushions sold with a slipcover, on or
together with the product, are subject to the rule and must be tested
as assembled, the definition of infant support cushion in Sec. 1243.2
has been revised to add a new sentence at the end of the definition
stating ``This definition includes any removable covers, or slipcovers,
sold on or together with an infant support cushion.'' However,
aftermarket slipcovers not sold with the product do not meet the
definition of an infant support cushion and thus would not be within
scope of this rule. Finally, Sec. 1243.5(f) adds the language ``for
products sold with a slipcover on or together with the product,
products shall be tested as assembled with the slipcover on the
product'' to the final rule to clarify that slipcovers, sold on or
together with the
[[Page 87478]]
product, need to be installed on the product during testing.
Comment: Graco argues that infant support cushions should not be
tested on a solid or firm testing surface.
Response: We disagree. Infant support cushions should be tested on
a solid or firm testing surface as the product relies on the underlying
surface it is placed upon for support and shape. In order to accurately
measure the firmness of the foam, filling, padding, or supporting
material in an infant support cushion, the testing surface cannot move
in response to the applied force (i.e., displace, shift, bend, deviate,
compress, deflect, translate or otherwise), because any movement of the
testing surface in response to the applied load would contribute to an
under-measured value for the firmness measurement and thus would not
provide repeatable results.
Comment: Graco argues that the minimum value for acceptable
firmness for the firmness test cannot be directly correlated to the
firmness values used in other safety standards for children's products.
Graco recommends that all data underlying the performance requirements
be published to permit an independent assessment. Graco also argues
that the performance requirements are not substantiated by reliable
test results.
Response: The Commission considered the recommendations of the BSU
Final Report when developing the proposed requirements in the rule.\29\
Additionally, the requirements in the rule reflect staff's testing of a
variety of infant support cushions, as well as an analysis of hazard
patterns obtained from incident data associated with infant support
cushions. The Commission made this incident data available for public
review and comment as described in the NOA. This information was used
to develop the specific performance requirements, and labeling and
instructional literature requirements that address the suffocation and
fall hazards associated with infant support cushions. The development
of the firmness test method and test results are discussed in further
detail in Tab C of the Staff's NPR Briefing Package.\30\
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\29\ Erin M. Mannen et al; Consumer Prod. Safety Comm'n. Pillows
Product Characterization and Testing (2022). www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
\30\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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Comment: Heroes Technology argues that the firmness testing
described in the rule regarding the intersection of the occupant
support surface and sidewalls is ambiguous and that the term ``location
most likely to fail'' is similarly vague.
Response: The firmness test for the intersection of the sidewall
and occupant support surface is intended to address suffocation hazards
from infant support cushion products due to the presence of a sidewall
adjacent to an occupant support surface. The rule provides instructions
and guidance to measure firmness at the intersection of the sidewall
and occupant support surface. Specifically, firmness is measured at the
intersection of sidewall and occupant support surface as the force to
deflect the surface 1.0 in (2.54 cm) using the 3-inch hemispherical
probe oriented at an angle, determined according to the test method in
Sec. 1243.5(h), Intersection of sidewall and occupant support surface
firmness. Section 1243.5(h) requires a force greater than 10.0 N (2.24
lbs) to address the suffocation hazard due to soft surfaces. The terms
``most likely to fail'' or ``likely to fail'' are standard language
commonly used in ASTM standards and longstanding CPSC rules that
incorporate these ASTM standards. However, areas where the sidewall
appears to be vertical or slanted inward immediately over top of the
occupant support surface, even while satisfying the angle requirement
for the side as a whole, would be considered areas ``likely to fail.''
Therefore, the Commission disagrees that ``location most likely to
fail'' needs to be defined in the rule.
4. Sidewall Angle
Comment: Heroes Technology argues that the proposed sidewall angle
requirement cannot be conducted effectively on the firm's Snuggle Me
infant lounger due to the lounger's unique design features.
Response: The sidewall angle requirement is intended to address the
risk of entrapment between the sidewall and the occupant support
surface that is not fully addressed by the firmness requirements alone.
While the Snuggle Me infant lounger may possess unique design features,
such as an unpadded occupant support surface, the product can still be
evaluated to the sidewall angle requirement in the rule. The unpadded
surface, and the firm flat surface the rule requires the units be
tested on, would be considered the occupant support surface for the
evaluation and the sidewall angle should be taken with respect to that
surface.
Comment: Heroes Technology argues that the rule provides no
instructions or guidance to locate the intersection of the sidewall and
occupant support surface.
Response: In Sec. 1243.5(i), Sidewall angle determination, the
rule provides instructions and guidance regarding the test procedure to
locate the intersection of the sidewall and occupant support surface.
H. Marking and Labeling
Comment: Boppy, AAP, BPQ, the Joint Consumer Advocate Commenters,
Safe Infant Sleep, and JPMA all recommend an additional warning for the
tummy time infant support cushion subcategory to provide clarity and
resolve confusion surrounding the warning ``use only on floor, with
baby face up on back'' when it is used on a product that is also a
tummy time pillow.
Response: We agree that some infant support cushion products, such
as tummy time pillows, may have features that require the infant to be
on their stomach while using the product and that different statements
are appropriate for products designed for tummy time. Because prone
positioning is a risk factor for infants that can lead to suffocation
when the mouth and nose are occluded, the final rule adds a new figure
3 in Sec. 1243.6 to accommodate products with multi-use positions.
Specifically, the following statement ``Put baby on back after Tummy
Time'' has been added to the warning label after the phrase ``use only
on the floor with baby on back, face up'' in new figure 3. Figure 3 is
only required for products that have a tummy time feature because only
products that have a tummy time feature should allow prone positioning.
Tummy time pillow manufacturers may also omit the word ``only'' from
the statement ``use only on floor with baby on back, face up'' to
accommodate the multi-use positioning of the product which is indicated
in new figure 3. This entire warning statement bullet point was also
moved up within the warning statement in figures 2 and 3 to reflect the
serious hazard to infants from prone positioning. Products without a
tummy time feature are required to use figure 2.
Comment: The Joint Consumer Advocate Commenters propose requiring
the product warning label on replacement covers for infant support
cushions.
Response: The Commission agrees that warning labels should be
included on slipcovers that are sold on or together with infant support
cushions. As discussed above regarding slipcovers sold on or together
with the product that
[[Page 87479]]
must be tested with the slipcover installed on the product, the
definition of infant support cushion in Sec. 1243.2 has been revised
to add a new sentence at the end of the definition, ``This definition
includes any removable covers, or slipcovers, sold on or together with
an infant support cushion,'' to make clear that slipcovers sold on or
together with the product are subject to the requirements of the rule.
However, aftermarket slipcovers or third-party covers are considered
accessories that are not part of the product and thus not subject to
the rule. Finally, in response to this comment, Sec. 1243.6(e) of the
final rule has been revised to require warning labels on slipcovers
that are sold on or together with an infant support cushion.
Comment: Safe Infant Sleep recommends laundering/cleaning
instructions to mitigate a mold hazard.
Response: Incident data do not indicate there is a mold hazard that
would require infant support cushions to have laundering/cleaning
instructions as part of this rulemaking. Therefore, the Commission
assesses at this time no requirement is needed to address laundering/
cleaning. However, if this information is provided, it should not be
placed on a warning label because warning labels that have too much
information that is not urgent for the user of the product dilute all
messages on the label.
Comment: The Joint Consumer Advocate Commenters suggest that CPSC
should consider more ways to clearly emphasize in the warning label
that infant support cushions should not be used for sleep.
Response: The Commission assesses that no change to the rule is
needed to clearly emphasize the warning against using infant support
cushions for sleep because this message is already strongly
communicated through the initial sentence of the warning about the
deadly consequences of using the product for sleep or naps.
Comment: Safe Infant Sleep objects to using the statement ``using
this product for sleep or naps can kill'' because this statement
implies that naps are different than sleep and this can be damaging to
safe sleep education. The commenter instead recommends ``using this
product for ANY duration of sleep, even when supervised can kill.''
Response: Consumers have indicated that ``sleep'' and ``naps'' may
mean different things for infants and have indicated that infants
``nap'' anywhere but should be in a specific sleep product when they
are put to ``sleep.'' \31\ Therefore, the rule retains the requirement
for the warning label to contain the statement ``using this product for
sleep or naps can kill'' to reinforce that the products are unsafe for
all types of sleep. However, the final rule revises the warning labels
in figure 2 and new figure 3 of Sec. 1243.6 by separating ``stay near
and watch baby during use'' from ``if a baby falls asleep, move baby to
infant sleep product, such as a crib or bassinet.'' These changes,
which provide clearer instruction on what a caregiver should do if
their baby falls asleep, have been made to figure 2 and new figure 3 of
Sec. 1243.6.
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\31\ Fors Marsh Group's, 2022 ``Consumer Product Safety
Commission (CPSC): Sleep Warnings Final Report'', available at:
www.cpsc.gov/s3fs-public/Consumer-Product-Safety-Commission%E2%80%93Sleep-Warnings-Final-Report.pdf?VersionId=MfJcAAip4YNWVf.RllvXQtwNN7chjHyt.
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Comment: Graco notes that the warning ``use only with an awake
baby'' is a new type of warning and it is not clear if parents
understand what level of awake their baby should be.
Response: The Commission agrees that the phrase ``use only with an
awake baby'' from the warning statement should be removed because the
safety messaging to not use infant support cushions with sleeping
infants or in an infant sleep setting is already strongly communicated
through the initial sentence of the warning about the deadly
consequences of using the product for sleep or lounging. Therefore, the
final rule removes ``use only with an awake baby'' from the warning
labels in figure 2 and new figure 3 of Sec. 1243.6.
Comment: Heroes Technology recommends changing the proposed warning
``USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL'' to ``USING THIS
PRODUCT FOR INFANT SLEEP OR NAPS CAN LEAD TO SERIOUS INJURIES OR
DEATH.''
Response: We disagree with the commenter's recommended change to
the warning label. First, the warning label statement ``can kill'' is
an accurate and concise statement of the consequences of infants
sleeping or napping on infant support cushions. Warning messages on
many infant products are often too long, resulting in consumers not
reading and heeding the messages. The commenter's recommended statement
``can lead to serious injuries or death'' is much less impactful than
``can kill'' and thus would not be as effective in warning caregivers
about the serious suffocation hazard to infants from using these
products for sleep or naps.
Comment: Heroes Technology suggests stronger warning language
surrounding the use of soft bedding in and around infant support
cushions.
Response: Incident data indicate that infant deaths occurred when
soft bedding was placed in an infant support cushion. Infant deaths
also occurred when the product was used on soft bedding and the infant
rolled out of the product into a hazardous setting containing soft
bedding around the product. The Commission accordingly agrees that the
rule should have stronger warning language regarding the use of soft
bedding in and around infant support cushions. Therefore, the warning
labels in figure 2 and new figure 3 of Sec. 1243.6 have been revised
to add ``Do not use on soft surfaces or in sleep products like cribs or
bassinets. Keep blankets and other soft items out of and away from
product.'' to warn against the hazard presented by soft bedding in and
around infant support cushions. Additionally, this revision to figure 2
and new figure 3 of Sec. 1243.6 in the final rule separates this
warning statement into a separate bullet point to emphasize the risk to
infants from soft bedding.
Comment: Heroes Technology suggests stronger and more impactful
language surrounding the fall risk from placing the product on elevated
surfaces, and warning consumers that infants may roll unexpectedly.
Response: We disagree that the warning label in the rule requires
stronger and more impactful language regarding the fall risk from
placing infant support cushions on elevated surfaces and warning
consumers that their infants may roll unexpectedly is necessary. These
messages are already presented concisely on the warning labels in
figure 2 and new figure 3 of Sec. 1243.6.
Comment: Graco states that the warning statements were not provided
in the proposed regulatory text and were only provided in figure 2 of
the NPR.
Response: The proposed rule characterized the warning label in
figure 2 as an example. Thus, it was unclear if the exact content and
format for the warning label depicted in proposed figure 2 in Sec.
1243.6(d)(7) is required. The final rule clarifies that the required
content and format of the warning labels in figure 2 and new figure 3
are to be used exactly as written, as applicable. Additionally, in
Sec. 1243.6(d)(7), the word example was removed from the figure 2 and
new figure 3 captions.
Comment: Graco recommends adding the following statement to the
warning label of the infant support cushion rule: ``For babies with
medical conditions, developmental delay, or complications relating to
premature birth, consult a doctor before use.''
[[Page 87480]]
Response: The Commission disagrees with requiring this information
to be placed on the warning label because not all helpful information
needs to be included on the warning label in the rule. The warning
label in Sec. 1243.6 of the rule includes messaging focused on the
serious suffocation and fall hazards posed by infant support cushions.
I. Comparative Analysis
Comment: JPMA argues that CPSC has not provided a risk/benefit
analysis, risk/hazard analysis, or a consumer choice analysis regarding
the proposed rule.
Response: The types of analysis described by the commenter that
would quantify the hazard reduction benefits versus the costs of
compliance are not required by section 104 of the CPSIA. A consumer
choice model would require detailed consumer demand data that
commenters did not provide and would involve quantifying consumer
demand for theoretical product alternatives not specified by the
commenter and not required by section 104 of the CPSIA. The Initial
Regulatory Flexibility Analysis (IRFA) \32\ did provide a specific
numerical estimate of the cost of compliance, and the staff analysis of
incidents found multiple deaths each year associated with these
products--17 deaths per year in 2021 and at least 17 in 2022.\33\
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\32\ See Tab E of Staff's NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
\33\ See Tab A of Staff's NPR Briefing Package, available at:
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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J. Effective Date
Comments: Boppy, Heroes Technology, and JPMA contend that a 180-day
effective date is insufficient for compliance and argue that a one-year
effective date would be appropriate to limit the burdens on
manufacturers.
Response: While the commenters assert that 180 days is insufficient
time to comply with the rule without burdening manufacturers, they do
not provide any specific data or information showing that the level of
effort to redesign and distribute an infant support cushion would
require a one-year compliance period. Furthermore, JPMA typically
allows 180 days for products in their certification program to
implement a new voluntary standard such that juvenile product
manufacturers are accustomed to adjusting to new standards within this
time frame. Therefore, the rule provides a reasonable effective date
that takes into consideration manufacturers burdens and the risk of
continued infant injuries and deaths. Based on the urgency of
addressing the hazards associated with infant support cushions, the
180-day effective date proposed in the NPR is appropriate and is being
finalized as proposed.
K. Stockpiling
Comments: AAP and the Joint Consumer Advocate Commenters request
that CPSC take action to prevent manufacturers from increasing
production of, or stockpiling, noncompliant infant support cushions and
to prevent sellers from putting on the market large quantities of
products that are noncompliant.
Response: The Commission notes the commenters' recommendations to
include a stockpiling provision in the final rule. Commenters provided
no evidence that manufacturers or importers are likely to increase
significantly their manufacture or importation of infant support
cushions before the rule's effective date. In addition, the 180-day
effective date should serve to limit the stockpiling of noncompliant
products so as to prevent such manufacturers from circumventing the
purpose of the rule. Therefore, the final rule does not include a
stockpiling provision.
L. Regulatory Procedure
Comment: BPQ requests that CPSC revise the NPR and reissue it for
public comment to reflect recent revisions to ASTM's draft infant
lounger voluntary standard.
Response: As of the date of the publication of the final rule,
there is no voluntary standard addressing the suffocation and fall
hazards of infant support cushions on which a mandatory rule could be
based. Additionally, the draft ASTM standard is in draft form and
subject to change as part of the consensus process. Section 104 of the
CPSIA does not require an existing voluntary standard in order for the
Commission to promulgate a safety standard for a durable infant or
toddler product. See 15 U.S.C. 2056a(b)(2); Finnbin, LLC v. Consumer
Prod. Safety Comm'n, 45 F.4th 127, 134 (D.C. Cir. 2022).
Comment: Boppy and Heroes Technology argue that this rule cannot be
promulgated under section 104 of the CPSIA without a preexisting
voluntary standard for infant support cushions.
Response: Section 104 of the CPSIA does not require an existing
voluntary standard in order for the Commission to promulgate a safety
standard for a durable infant or toddler product. See 15 U.S.C.
2056a(b)(2); Finnbin, LLC v. CPSC, 45 F.4th 127, 134 (D.C. Cir. 2022).
In Finnbin, the court explained that CPSC has an express statutory
command to regulate all categories of durable infant or toddler
products and must do so for products not covered by voluntary
standards. Furthermore, by the terms of 15 U.S.C. 2056a(b)(1), the
requirement to examine and assess the effectiveness of any voluntary
standards only applies if a voluntary standard exists. Because no
voluntary standards currently address the suffocation and fall hazards
posed by infant support cushions, the procedural requirements in
section 104(b) of the CPSIA, to develop a rule with reference to an
existing standard, do not apply to this rule.
Comment: Boppy argues that infant support cushions are not durable
nursery products because infant support cushions are ``pillow-like''
and pillows are soft, textile products that are in no way comparable to
cribs, strollers, bathtubs, or bed rails. Boppy additionally argues
that there are no products in either the original twelve, or additional
six product categories of durable goods that can be rationally compared
to ``pillows.''
Response: Infant support cushions meet the statutory requirement
for durable infant or toddler products in section 104(f)(1) of the
CPSIA because they are intended for use, and may be reasonably expected
to be used, by children under the age of 5 years and routinely have a
life span of several years. They are not disposable; have a useful life
of up to several years and are often used by multiple children in
succession; are similar to other soft durable infant and children's
products such as crib mattresses and sling carriers (which the
Commission has issued rules for under section 104); are resold and
widely available on secondary marketplaces; and are primarily intended
to be used by children five years old or younger. Therefore, although
infant support cushions are not specifically listed in section
104(f)(2) of the CPSIA, the Commission may reasonably treat them as
``durable infant or toddler products.''
The Commission has previously added to the statutory list of
durable infant or toddler products by including other products for
young infants, such as changing products and infant bouncers, that also
have a market for secondary use. As the Commission explained in 2009,
``[b]ecause the statute has a broad definition of a durable infant or
toddler product but
[[Page 87481]]
also includes 12 specific product categories, additional items can and
should be included in the definition.'' Requirements for Consumer
Registration of Durable Infant or Toddler Products, 74 FR 68668, 68669
(December 29, 2009).
Comments: Boppy contends the proposed rule is unconstitutional
because it violates the non-delegation doctrine and the Separation of
Powers and Appointments Clause of the U.S. Constitution.
Response: The rule is being promulgated under the Danny Keysar
Child Product Safety Notification Act, section 104 of the CPSIA, which
directs the Commission to promulgate consumer product safety standards
for durable infant or toddler products. CPSC is an independent agency
and the Commissioners do not exercise Executive power, consistent with
the Supreme Court's holding in Humphrey's Executor v. United States,
295 U.S. 602 (1935). Several Federal Courts of Appeals have recently
rejected similar Constitutional arguments about CPSC. Consumers' Rsch.
v. CPSC, 91 F.4th 342 (2024), petition for cert. filed, (Consumers'
Rsch. v. CPSC, No. 23-1323 (petition for cert. filed on July 18,
2024)), and Leachco, Inc. v. CPSC, 103 F4th 748 (10th Cir. 2024),
petition for cert. pending, No. 22-7060 (filed Aug. 9, 2024)).
VII. Description of the Final Rule for Infant Support Cushions
As section 104 of the CPSIA requires, to address the risks of death
and injury associated with infant suffocations, entrapments, and falls,
the Commission is issuing this rule to establish mandatory performance
and labeling requirements for infant support cushions. The requirements
of the rule are based on an evaluation of incident data and the hazard
patterns associated with infant support cushions, and the
recommendations of the BSU Final Report. The final rule is summarized
below, and the rule is being finalized as proposed in the NPR except as
noted.
A. Section 1243.1 Scope, Purpose, Applications, and Exemptions
Section 1243.1 explains that the rule applies to infant support
cushions, including infant positioners, nursing pillows with a dual use
for lounging, infant loungers, infant props, or cushions used to
support an infant for activities such as tummy time, and other infant
pillow-like products. It excludes products already regulated by other
Commission mandatory standards for durable infant products, which are
listed in 16 CFR 1130.2(a). The rule applies to all infant support
cushions manufactured after the effective date of the rule. Section
1243.1 is being finalized without changes as proposed in the NPR.
B. Section 1243.2 Definitions
Section 1243.2 provides definitions for the following terms used in
the rule: conspicuous, infant lounger, infant positioner, infant
support cushion, occupant support surface, seat bight line, and
sidewall. The definitions in Sec. 1243.2 are being finalized as
proposed in the NPR except as discussed below. In response to a comment
from Graco and for clarity, the definition of infant lounger has been
revised to change the proposed words ``infant product'' to ``infant
support cushion'' in the final rule. Also, in response to comments from
Safe Infant Sleep and The Joint Consumer Advocate Commenters, the
definition of infant support cushion has been revised to add a new
sentence at the end of the definition ``This definition includes any
removable covers, or slipcovers, sold on or together with an infant
support cushion''. Finally, in response to a comment from Boppy, a new
definition for the term ``sidewall,'' which is defined as ``any wall at
the edge of the occupant support surface'', has been added to the final
rule to provide clarity regarding the meaning of that term.
C. Section 1243.3 General Requirements
Section 1243.3 provides general requirements for infant support
cushions, including requirements addressing hazardous sharp edges or
points (Sec. 1243.3(a)), small parts (Sec. 1243.3(b), lead in paints
(Sec. 1243.3(c)), toys (Sec. 1243.3(d)), the removal of components
(Sec. 1243.3(e)), the permanency of labels and warnings (Sec.
1243.3(f)), and convertible products (Sec. 1243.3(g)). Section 1243.3
is being finalized as proposed in the NPR except that the reference to
``infant pillow'' in Sec. 1243.3(d) has been changed in the final rule
to ``infant support cushion'' for accuracy and consistency based on a
comment from TA. The final rule also removes proposed Sec. 1243.3(e)
regarding side height. Measuring the height of the product is
unnecessary and thus duplicative because the maximum incline angle test
in Sec. 1243.5(d)(7) already accounts for the height of the product
remaining under 2 inches. The final rule renumbers the paragraphs
following Sec. 1243.3(d) to reflect this change.
D. Section 1243.4 Performance Requirements
Section 1243.4 provides performance requirements for infant support
cushions for restraints (Sec. 1243.4(a)), seam strength (Sec.
1243.4(b)), bounded openings (Sec. 1243.4(c)), maximum incline angle
(Sec. 1243.4(d)), firmness (Sec. 1243.4(e)), and sidewall angle
(Sec. 1243.4(f)). Section 1243.4 is being finalized as proposed in the
NPR except as discussed below. In response to a comment from Boppy, two
changes have been made in paragraph (e) of Sec. 1243.4 that
establishes requirements for firmness. In Sec. 1243.4(e)(2) and (3),
``For products with a sidewall'' has been added to the beginning of the
sentence because the proposed rule did not make clear whether the
performance requirements are applicable to products without sidewalls.
Additionally, in response to a comment from Boppy, the same change has
been made to Sec. 1243.4(f) that establishes requirements for side
angles because the proposed rule did not clarify the applicability of
performance requirements for products without sidewalls.
E. Section 1243.5 Test Methods
Section 1243.5 provides the test methods to be used to test for
compliance with the requirements of the rule. Section 1243.5 includes
test methods for test conditions (Sec. 1243.5(a)), test for permanence
of labeling and markings (Sec. 1243.5(b)), head entrapment test (Sec.
1243.5(c)), maximum incline test (Sec. 1243.5(d)), firmness test setup
(Sec. 1243.5(e), occupant support surface firmness test method (Sec.
1243.5(f)), sidewall firmness test method (Sec. 1243.5(g)), test
method for the intersection of sidewall and occupant support surface
firmness (Sec. 1243.5(h)), test method for sidewall angle
determination (Sec. 1243.5(i)), seam strength test method (Sec.
1243.5(j)), and removal of components test method (Sec. 1243.5(k)).
Section 1243.5 is being finalized as proposed in the NPR except as
discussed below.
For the same reason discussed above for the removal of proposed
Sec. 1243.3(e) regarding side height, the final rule removes the
corresponding test in Sec. 1243.5(d)(8) for consistency. To reflect
this change, all numbers after Sec. 1243.5(d)(7) have been renumbered.
In response to a comment from Safe Infant Sleep, the following
language has been added after the first sentence of Sec. 1243.5(f):
``For products sold with a slipcover on or together with the product,
products shall be tested as assembled with the slipcover on the
product.'' This language has been added
[[Page 87482]]
to the final rule because slipcovers with extra padding or cushioning
may introduce suffocation hazards that would not be addressed if
slipcovers sold on or together with an infant support cushion were not
required to be tested as assembled with the slipcover on the product.
In response to a comment from Boppy, right after the new sentence added
above, the following language has been added to Sec. 1243.5(f) of the
final rule: ``All products, including products one inch or less in
thickness, are required to be tested.'' This language has been added to
the final rule because a product could either vary in thickness or be
so close to 1 inch in thickness that it would be difficult to determine
thickness without testing. In response to another comment from Boppy,
Sec. 1243.5(g) of the final rule adds in the first sentence ``products
with a sidewall'' between ``For'' and ``perform'' because the proposed
rule did not specifically clarify the applicability of test methods for
products without sidewalls. The Boppy comment also resulted in changes
to Sec. 1243.5(h) and (i) at the beginning of the first sentence,
adding ``For products with a sidewall,'' before ``perform,'' to state
directly that products with sidewalls must be tested according to the
test methods.
F. Section 1243.6 Marking and Labeling
Section 1243.6 provides the marking and labeling requirements for
infant support cushions, including general markings (Sec. 1243.6(a)),
permanency (Sec. 1243.6(b)), upholstery labeling (Sec. 1243.6(c)),
warning design for product (Sec. 1243.6(d)), and warning statements
(Sec. 1243.6(e)). Section 1243.6 is being finalized as proposed in the
NPR except as discussed below.
Several changes have been made to figure 2 in Sec. 1243.6(d)(7) as
described below. We also add a new figure 3, Warning for Tummy Time
Product, in Sec. 1243.6(d)(7), as described below.
In response to a comment from Graco, the phrase ``use only
with an awake baby'' has been removed from the warning label in figure
2 and new figure 3 because the safety messaging to not use infant
support cushions with sleeping infants or in an infant sleep setting is
already strongly communicated through the initial sentence of the
warning about the deadly consequences of using the product for sleep or
naps, and limiting the amount of text on warning labels makes the
material being presented more prominent.
The rule clarifies that figure 2 in Sec. 1243.6(d)(7) is
required for all infant support cushions that do not have a tummy time
feature.
In response to comments from Boppy, AAP, BPQ, the Joint
Consumer Advocate Commenters, Safe Infant Sleep, and JPMA, the
Commission is adding a new figure 3 in Sec. 1243.6(d)(7) for products
with a tummy time feature. The statement bullet point was also moved up
within the warning statement to reflect the serious hazard to infants
presented by prone positioning. In new figure 3, the statement ``Put
baby on back after Tummy Time'' is added to the warning label after the
phrase ``Use only on the floor with baby on back, face up,'' to
accommodate multi-use positions of some infant support cushion
products, such as tummy time pillows that may have features that
require the infant to be on their stomach while using the product.
Figure 3 additionally omits the word ``only'' from ``use only on the
floor with baby on back, face up''. Figure 3 is required only for
products that have a tummy time feature because only those products
that have a tummy time feature should allow for prone positioning.
In response to a comment from Safe Infant Sleep the
warning labels have been revised with more concise wording and clarity
to provide instruction for what a caregiver should do if their baby
falls asleep by separating ``stay near and watch baby during use'' from
``if a baby falls asleep, move baby to infant sleep product, such as a
crib or bassinet''.
In response to a comment from Heroes Technology, the
warning labels for figure 2 and new figure 3 now includes the statement
``Do not use on soft surfaces or in sleep products like cribs or
bassinets. Keep blankets and other soft items out of and away from
product'' to discourage soft bedding use in and around the product.
This revision also separates these warning statements into a separate
bullet point to emphasize the risk to infants from soft bedding placed
both in and around the product.
In response to a comment from Graco, the word ``example''
was removed from the captions on figure 2 and new figure 3 because it
was unclear if the exact content and format for the warning labels in
Sec. 1243.6(d)(7) is required as depicted in proposed figure 2 and new
figure 3. Additionally, the final rule clarifies in Sec. 1243.6(d)(7)
that the content and format as depicted in figure 2 and new figure 3 as
applicable, are required.
Note 4 to proposed Sec. 1243.6(e) has been removed from
the rule as unnecessary because the final rule clarifies that the
required content and format of the warning labels in figure 2 and new
figure 3, as applicable, are to be used as written.
A new note 4 to Sec. 1243.6(d)(6) has been added below
figure 1 for paragraph (d)(6), which was originally the language above
figure 1 for paragraph (d)(6), with the new note 4 providing the
original text indicating that the depicted warnings are filler text,
known as lorem ipsum, commonly used to demonstrate graphic elements.
In figure 2 and new figure 3, a black line has been
inserted between the suffocation warnings and the fall warnings to
distinguish between the messages.
The changes described above are depicted below in the revised
figure 2, Warning for Product Without Tummy Time, and new figure 3,
Warning for Tummy Time Product, from Sec. 1243.6 of the final rule.
[[Page 87483]]
[GRAPHIC] [TIFF OMITTED] TR04NO24.001
[GRAPHIC] [TIFF OMITTED] TR04NO24.002
Additionally, in response to a comment from the Joint Consumer
Advocate Commenters, the final rule adds language at the end of Sec.
1243.6(e) stating that slipcovers, sold on or together with the
product, are required to contain a warning with the content and format
depicted in figure 2 or 3, as applicable, to paragraph (d)(7). This
language is being added because when an infant support cushion is sold
with a slipcover, it is expected that slipcover will hide the warning
label that should be visible to a caregiver while placing an infant
onto or into the product, when the product is in the manufacturer's
recommended use position. Therefore, the warning label should be
conspicuously located on the slipcover as is required for an infant
support cushion that does not come with a slipcover.
G. Section 1243.7 Instructional Literature
Section 1243.7 provides requirements for instructional literature
for infant
[[Page 87484]]
support cushions, including requiring instructional literature be
provided with the product, as well as requirements as to what such
information must include. Section 1243.7 also requires that
instructional literature meet the requirements of the National
Electrical Manufacturers Association's (NEMA's) ANSI Z535.4-
2011(R2017), American National Standard for Product Safety Signs and
Labels (ANSI Z535.4-2011). The final rule specifically requires the
warning format requirements in sections 6.1-6.4, 7.2-7.6.3, and 8.1 of
ANSI Z535.4-2011(R20217). Finally, under Sec. 1243.7 any instructions
provided in addition to those required by Sec. 1243.7 shall not
contradict or confuse the meaning of the required information or be
otherwise misleading to the consumer. Section 1243.7 is being finalized
as proposed in the NPR.
H. Section 1243.8 Incorporation by Reference
Section 1243.8 incorporates by reference ANSI Z535.4-2011(R20217),
American National Standard for Product Safety Signs and Labels, and
ASTM D3359-23, Standard Test Methods for Rating Adhesion by Tape Test,
and provides information on where those standards are available. ANSI
Z535.4-2011 includes requirements related to safety alert symbol use;
signal word selection; warning panel format, arrangement, and shape;
color requirements for each panel; letter style; to identify and warn
against specific hazards; and to provide information to avoid personal
injury. ASTM D3359-23 covers procedures for assessing the adhesion of
relatively ductile coating films to metallic substrates by applying and
removing pressure-sensitive tape over cuts made in the film.
VIII. Amendment to 16 CFR Part 1112 To Include NOR for Infant Support
Cushions
Products subject to a consumer product safety rule under the CPSA,
or to a similar rule, ban, standard, or regulation under any other act
enforced by the Commission, must be certified as complying with all
applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Certification
of children's products subject to a children's product safety rule must
be based on testing conducted by a CPSC-accepted third-party conformity
assessment body. 15 U.S.C. 2063(a)(2). The Commission must publish an
NOR for the accreditation of testing laboratories as third party
conformity assessment bodies to assess conformity with a children's
product safety rule. 15 U.S.C. 2063(a)(3). The infant support cushions
rule is a children's product safety rule that requires the issuance of
an NOR.
The Commission's rules, at 16 CFR part 1112, establish requirements
for accreditation of third party conformity assessment bodies to test
for conformance with a children's product safety rule in accordance
with section 14(a)(2) of the CPSA. Part 1112 also lists the NORs that
the CPSC has published. In the NPR the Commission proposed to amend
part 1112 to include the Safety Standard for Infant Support Cushions in
the list of children's product safety rules for which the CPSC has
issued NORs. Section 1112.15(a)(57) is being finalized as proposed in
the NPR.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new Safety Standard for
Infant Support Cushions standard are required to meet the third party
conformity assessment body accreditation requirements in part 1112.
When a laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have the Safety Standard for Infant Support Cushions included in its
scope of accreditation as reflected on the CPSC website at
www.cpsc.gov/labsearch.
IX. Amendment to 16 CFR Part 1130 To Include Infant Support Cushions
Infant support cushions are a category of ``durable infant or
toddler product'' for purposes of CPSIA section 104 because they: are
intended for use, and may be reasonably expected to be used, by
children under the age of five years; are products similar to other
products listed in section 104(f)(2), such as crib mattresses, and
sling carriers; and are commonly resold or ``handed down'' for use by
other children over a period of years. In the NPR, the Commission
proposed to amend 16 CFR part 1130 to include Infant Support Cushions
as durable infant or toddler products. Section 1130.2(a)(20) is being
finalized as proposed in the NPR.
X. Incorporation by Reference
The rule incorporates by reference ANSI Z535.4-2011(R2017),
American National Standard for Product Safety Signs and Labels, and
ASTM D3359-23, Standard Test Methods for Rating Adhesion by Tape Test.
In accordance with the regulations of the Office of the Federal
Register, 1 CFR part 51, section VII.H of this preamble summarizes the
requirements of the ANSI Z535.4-2011(R2017) and ASTM D3359-23.
Both standards are reasonably available to interested parties in
several ways. Interested persons may purchase a copy of ANSI Z535.4-
2011(R2017) from the National Electrical Manufacturers Association
(NEMA), 1300 17th St. N, Arlington, VA 22209; phone: (703) 841-3200;
website: www.nema.org. This standard is also available from ANSI via
its website, www.ansi.org, or by mail from ANSI, 25 West 43rd Street,
4th Floor, New York, NY 10036, telephone: (212)-642-4900. Once the rule
takes effect, a read-only copy of ANSI Z535.4-2011(R2017) will be
available for viewing, at no cost, on the ANSI website at: https://ibr.ansi.org/Standards/nema.aspx. Interested individuals may purchase a
copy of ASTM D3359-23 from ASTM, through its website, www.astm.org, or
by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box 0700,
West Conshohocken, PA 19428-2959. Once the rule takes effect, a read-
only copy of the standard will be available for viewing, at no cost, on
the ASTM website at: www.astm.org/READINGLIBRARY/. Alternatively,
interested parties may inspect a copy of the standards at CPSC's Office
of the Secretary by contacting Alberta E. Mills, Commission Secretary,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814; phone: (301) 504-7479; email: [email protected].
XI. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). In the NPR the Commission proposed an
effective date of 180 days after publication of the final rule in the
Federal Register. This amount of time is typical for rules issued under
section 104 of the CPSIA. We note that the 180-day effective date is
the same amount of time that JPMA typically allows for products in
their certification program to shift to a new standard once that
standard is published. Therefore, juvenile product manufacturers are
accustomed to adjusting to new standards within this time frame. We
noted in the NPR that a 180-day effective date should also be
sufficient for manufacturers to comply with this rule because the
proposed requirements do not demand significant preparation by testing
laboratories. For example, no new complex testing instruments or
devices would be required to test infant support cushions for
compliance with this rule. Based on the urgency of addressing the
hazards associated with infant support cushions, the 180-day effective
date proposed in
[[Page 87485]]
the NPR is appropriate and is being finalized as proposed.
XII. Regulatory Flexibility Act
When an agency is required to publish a notice of proposed
rulemaking, the Regulatory Flexibility Act (5 U.S.C. 601-612) generally
requires that the agency prepare an IRFA for the NPR and a final
regulatory flexibility analysis (FRFA) for the final rule. 5 U.S.C.
603, 604. These analyses must describe the impact that the rule would
have on small businesses and other entities. The FRFA must contain:
(1) a statement of the need for and objectives of the rule;
(2) significant issues raised by commenters on the IRFA, the
agency's assessment of those issues, and changes made to the result as
a result of the comments;
(3) a response to any comments filed by the Chief Counsel for
Advocacy of the U.S. Small Business Administration (Advocacy), and
changes made as a result of those comments;
(4) a description and estimate of the number of small entities to
which the rule will apply;
(5) a description of the projected reporting, recordkeeping, and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record; and
(6) steps the agency has taken to minimize the significant economic
impact on small entities, consistent with the objective of the
applicable statute, including the factual, policy, and legal reasons
for selecting the alternative in the final rule and why other
alternatives were rejected.
Staff prepared an IRFA for this rulemaking that was summarized in
the NPR and provided in full Tab E of the Staff's NPR Briefing Package.
The FRFA is provided below.
A. Need for and Objectives of This Rule
Section I of this preamble describes the reasons and legal basis
for this final rule. As discussed in sections VI and VII of this
preamble, the rule sets mandatory requirements for infant support
cushions to address the suffocation, entrapment, and fall hazards
associated with these products; adds infant support cushions to the
list of products for which a registration card is required; and adds
infant support cushions to the list of durable infant products for
which an NOR is required.
B. Comments and Responses Concerning Impact on Small Entities
Comment: Boppy and Heroes Technology state that the maximum incline
angle requirement, which limits product height to approximately 1.9
inches, would eliminate most products subject to this rule from the
market, resulting in a significant loss of utility to consumers for
compliant products, far in excess of CPSC's estimates.
Response: The IRFA stated that consumers might not purchase the
redesigned compliant products and estimated a significant impact on a
substantial number of small businesses. The commenters did not provide
any data on their assertion that consumers might not want to buy
products with a shorter side height. Given the number of playmats and
similar items with no sides or short sides on the market, there is
ample evidence that consumers are willing to purchase such items. The
Commission has considered the significant impact on small entities in
the IRFA, and it is discussed in the possible alternatives analysis in
this FRFA and thus has taken this impact into account as required by
the RFA.
Comment: JPMA states that this rule would require significant
costly changes to make products compliant.
Response: JPMA did not provide quantitative estimates of supplier
costs or consumer utility impacts to support a change in the burden
estimates. The IRFA provided specific estimates of labor and materials
costs for redesign. The scope of staff's analysis of burden, as
required by 5 U.S.C. 603, was the impact on small U.S. businesses, and
none of the comments provided information to support changing the
estimates of impact on small U.S. businesses. The Commission has,
however, considered the significant impact on small entities in
finalizing this rule.
C. Issues Raised by the Small Business Administration
The Small Business Administration (SBA) did not submit a comment on
the proposed rule.
D. Small Entities to Which the Rule Would Apply
The SBA sets size standards for what constitutes a U.S. small
business for the purpose of various Federal Government programs,\34\
750 employees for manufacturers (NAICS code 314120) and 100 to 150
employees for wholesalers (NAICS codes 424350, 423990, and 424990).\35\
Based on staff's assessment of prominent online and brick-and-mortar
retail sources for infant support cushions in the Spring of 2023, there
appear to be more than 2,000 suppliers of infant support cushions to
the U.S. market, including small U.S. crafters, small importers, small
manufacturers, and direct foreign shippers. Staff estimates that a
significant number of these firms are small U.S. businesses based on
the SBA thresholds cited above.
---------------------------------------------------------------------------
\34\ The size standards are in listed in the Code of Federal
Regulations. See 13 CFR part 121.
\35\ The North American Industry Classification System (NAICS)
is the standard used by Federal statistical agencies in classifying
business establishments for the purpose of collecting, analyzing,
and publishing statistical data related to the U.S. business
economy. For more information, see www.census.gov/naics/. Some
programs use 6-digit NAICS codes, which provide more specific
information than programs that use more general 3 or 4-digit NAICS
codes.
---------------------------------------------------------------------------
E. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of
the Rule
Suppliers will be required to comply with the performance
requirements of the rule; provide a warning label, a consumer
registration card, and user instructions; and conduct third-party
testing to demonstrate compliance. Suppliers must demonstrate that they
meet the performance requirements of the rule by providing certificates
of compliance. As specified in 16 CFR part 1109, suppliers who are not
the original manufacturer, such as importers, wholesalers, and
retailers may rely on a certificate of conformity provided by their
suppliers. Suppliers must also provide product registration cards.
Recordkeeping and compliance documentation do not require specialized
expertise. CPSC's public website provides instructions and examples for
how to develop the certificates of compliance and product registration
cards.\36\ Similarly, because the final rule provides the text and
graphics for the required labels and instructions, specialized graphics
design expertise will not be required to develop the warnings and
instructions.
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\36\ See for example: www.cpsc.gov/Business--Manufacturing/
Testing-Certification/Childrens-Product-Certificate; and
www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-
Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-
Consumer-Registration.
---------------------------------------------------------------------------
F. Impact of the Rule on Small Entities
The rule will likely have a significant impact on a substantial
number of U.S. small entities, based on the estimated costs of
modifying the product to achieve compliance, and the ongoing cost of
testing to demonstrate compliance. Staff considers one percent of
annual revenue to be a ``significant''
[[Page 87486]]
economic impact on a company, consistent with economic analysis from
other Federal Government agencies. Nearly all of the more than 2,000
suppliers of infant support cushions to the U.S. are small entities,
although their products often are not manufactured in United States.
Most products on the market will require redesign to meet the
requirements in the rule and no products on the market currently have
the specific labels, customer registration forms, warnings, and third-
party testing required by the rule. The effort required for a one-time
redesign of a product is estimated to be 200 hours of professional
staff time per model, including in-house testing of the prototypes and
development of labels, customer registration forms, and instruction
materials. Using the Bureau of Labor Statistics Employer Costs of
Employee Compensation as of March 2024 \37\ the estimated cost per
model is $13,648, at a current cost for professional labor of $68.24
per hour, rounded for the purpose of analysis to $14,000 per model.
Materials costs for prototyping are estimated to be minimal, likely
under $1,000, given that pillows are typically made of fabric and
stuffing materials. Third-party testing for infant support cushions
will be an additional cost for all suppliers and is estimated to be
between $600 and $1,100 per model, per year, depending on where the
testing takes place and whether manufacturers' associations or groups
add infant support cushions to their certification programs to receive
volume discounts for third-party testing. The total first year costs of
redesign are estimated to be approximately $16,000 per model ($14,000
for labor, $1,000 for materials, and $1,000 for third-party testing).
---------------------------------------------------------------------------
\37\ www.bls.gov/news.release/ecec.t02.htm. The estimated costs
in the link reflect the employers' cost for salaries, wages, and
benefits for civilian workers.
---------------------------------------------------------------------------
Staff considers one percent of annual revenue to be a
``significant'' economic impact on a small business. Applying the one
percent threshold to the estimated redesign and testing costs from this
rule, the threshold for a small business that would incur a significant
impact are those small firms with less than $1.6 million in revenue
($16,000 costs / 1 percent of revenue), assuming they only sell one
product model. This cost estimate will scale with the number of
different models each firm manufactures. With an estimated 2,000 models
from firms that sell to the U.S. needing to be redesigned, the total
cost for the entire industry could be as high as $32 million for
redesign in the first year after the rule is published.\38\
---------------------------------------------------------------------------
\38\ As noted earlier, this estimate is slightly higher than the
estimate in the IRFA, because the relevant labor rate as reported by
the Bureau of Labor Statistics has risen since the NPR was
published.
---------------------------------------------------------------------------
As suppliers will need to redesign their products to comply with
this rule, both small and large companies may raise prices to cover
costs. Given this uniformity, these costs would not necessarily place
small businesses at a competitive disadvantage. JPMA, Boppy, and Heroes
Technology questioned whether a small retail price increase would be
acceptable to consumers, or could cover compliance costs, but these
commenters did not provide an alternative quantitative estimate of
compliance costs or probable retail price increases.
In summary, given that all U.S. suppliers will have to redesign
products to comply with this rule, and that these costs will likely be
significant to many small businesses, this FRFA finds that this final
rule will have a significant impact on a substantial number of U.S.
small businesses.
G. Other Federal Rules That May Duplicate, Overlap, or Conflict With
the Final Rule
CPSC has not identified any other Federal rules that duplicate,
overlap, or conflict with the final rule.
H. Alternatives Considered To Reduce the Impact on Small Entities
The Commission considered alternatives to the final rule to reduce
the impact on small businesses. The Commission considered using a
public education campaign that would result in no regulatory impact on
small businesses. However, given the education campaigns on safe sleep
practices that CPSC and others have been undertaking for years, this
approach would likely result in little to no mitigation of the current
rates of deaths and injuries from infant support cushions. The
Commission also considered allowing the voluntary standards process
additional time to develop a voluntary standard to address the hazards
posed by infant support cushions. However, there is no certainty that
such a voluntary standard would be adopted, and a potential voluntary
standard, if published, may not adequately address the identified
hazards to infants. For example, the current ASTM draft voluntary
standard for infant loungers would only cover infant loungers whereas
the Commission's rule covers all infant support cushions and has more
stringent performance requirements and warnings.
XIII. Paperwork Reduction Act
This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C.
3501-3521). The preamble to the NPR discussed the information
collection burden of the proposed rule and specifically requested
comments on the accuracy of CPSC's estimates. 89 FR 2530 (January 16,
2024). The NPR described the provisions of the proposed rule and
provided an estimate of the annual reporting burden for the rule under
the PRA. See 89 FR 2542. The estimated burden of this collection of
information is unchanged from the NPR. CPSC did not receive any
comments regarding the information collection burden in the NPR through
OMB. OMB has assigned control number 3041-0202 to this information
collection.
XIV. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a standard or regulation that prescribes
requirements for the performance, composition, contents, design,
finish, construction, packaging, or labeling of such product dealing
with the same risk of injury unless the state requirement is identical
to the Federal standard. Section 26(c) of the CPSA also provides that
states or political subdivisions of states may apply to the Commission
for an exemption from this preemption under certain circumstances.
Section 104(b) of the CPSIA refers to the rules to be issued under that
section as consumer product safety rules. Therefore, the preemption
provision of section 26(a) of the CPSA apply to this final rule for
infant support cushions.
XV. Environmental Considerations
Certain categories of CPSC actions normally have ``little or no
potential for affecting the human environment'' and therefore do not
require an environmental assessment or an environmental impact
statement. Safety standards providing requirements for consumer
products come under this categorical exclusion. 16 CFR 1021.5(c)(1).
The final rule for infant support cushions falls within the categorical
exclusion.
[[Page 87487]]
XVI. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that
before a rule may take effect, the agency issuing the rule must submit
the rule, and certain related information, to each House of Congress
and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission
must indicate whether the rule is a major rule. The CRA states that the
Office of Information and Regulatory Affairs determines whether a rule
qualifies as a major rule.
Pursuant to the CRA, OMB's Office of Information and Regulatory
Affairs has determined that this rule does not qualify as a major rule,
as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit
the required information to each House of Congress and the Comptroller
General.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1130
Administrative practice and procedure, Business and industry,
Consumer protection, Reporting and recordkeeping requirements.
16 CFR Part 1243
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Pillows, Toys.
For the reasons discussed in the preamble, the Commission amends
chapter II of title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for 16 CFR part 1112 continues to read as
follows:
Authority: 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(57) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?
* * * * *
(b) * * *
(57) 16 CFR part 1243, Safety Standard for Infant Support Cushions.
* * * * *
PART 1130--REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT
OR TODDLER PRODUCTS
0
3. The authority citation for 16 CFR part 1130 continues to read as
follows:
Authority: 15 U.S.C. 2056a, 2065(b).
0
4. Amend Sec. 1130.2 by adding paragraph (a)(20) to read as follows:
Sec. 1130.2 Definitions.
* * * * *
(a) * * *
(20) Infant support cushions.
* * * * *
0
5. Add part 1243 to read as follows:
PART 1243--SAFETY STANDARD FOR INFANT SUPPORT CUSHIONS
Sec.
1243.1 Scope, purpose, application, and exemptions.
1243.2 Definitions.
1243.3 General requirements.
1243.4 Performance requirements.
1243.5 Test methods.
1243.6 Marking and labeling.
1243.7 Instructional literature.
1243.8 Incorporation by reference.
Authority: 15 U.S.C. 2056a.
Sec. 1243.1 Scope, purpose, application, and exemptions.
(a) Scope and purpose. The consumer product safety standard in this
part prescribes requirements to reduce the risk of death and injury
from hazards associated with infant support cushions, as defined in
Sec. 1243.2. This includes but is not limited to infant positioners,
nursing pillows with a dual use for lounging, infant loungers, and
infant props or cushions used to support an infant. All infant support
cushions must be tested according to the requirements of Sec. 1243.5
and comply with all requirements of this part.
(b) Application. All infant support cushions manufactured after May
5, 2025, are subject to the requirements of this part.
(c) Exemptions. Products subject to another standard listed in 16
CFR 1130.2(a) are exempt from this part. Nursing pillows that also meet
the definition of infant lounger in Sec. 1243.2, however, are not
exempt from this part.
Sec. 1243.2 Definitions.
Conspicuous means visible, when the product is in each
manufacturer's recommended use position, to a person while placing an
infant into or onto the product.
Infant lounger means an infant support cushion with a raised
perimeter, a recess, or other area that provides a place for an infant
to recline or to be in a supine, prone, or recumbent position.
Infant positioner means a product intended to help keep an infant
in a particular position while supine or prone.
Infant support cushion means 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.
This definition includes any removable covers, or slipcovers, sold on
or together with an infant support cushion.
Occupant support surface (OSS) means the area that holds up and
bears the infant or any portion of the infant.
Seat bight line means the intersection of the seat back surface
with the seat bottom surface.
Sidewall means any wall at the edge of the occupant support
surface.
Sec. 1243.3 General requirements.
(a) Hazardous sharp edges or points. There shall be no hazardous
sharp points or edges as determined by 16 CFR 1500.48 and 1500.49
before or after the product has been tested.
(b) Small parts. There shall be no small parts as determined by 16
CFR part 1501 before testing or presented as a result of testing.
(c) Lead in paints. All paint and surface coatings on the product
shall comply with the requirements of 16 CFR part 1303.
(d) Toys. Toy accessories attached to, removable from, or sold with
an infant support cushion, as well as their means of attachment, shall
comply with the applicable requirements of 16 CFR part 1250.
(e) Removal of components. When tested in accordance with Sec.
1243.5(k), any removal of components that are accessible to an infant
while in the product or from any position around the product shall not
present a small part, sharp point, or sharp edge as required in
paragraphs (a) and (b) of this section.
(f) Permanency of labeling and warnings. (1) Warning labels,
whether paper or non-paper, shall be permanent when tested in
accordance with Sec. 1243.5(b)(1) through (3).
(2) Warning statements applied directly onto the surface of the
product by hot stamping, heat transfer, printing, wood burning, or any
other method shall be permanent when tested in accordance with Sec.
1243.5(b)(4).
[[Page 87488]]
(3) Non-paper labels shall not liberate small parts when tested in
accordance with Sec. 1243.5(b)(5).
(4) Warning labels that are attached to the fabric of the product
with seams shall remain in contact with the fabric around the entire
perimeter of the label when the product is in all manufacturer-
recommended use positions and when tested in accordance with Sec.
1243.5(b)(3).
(g) Convertible products. If the infant support cushion can be
converted into another product for which a consumer product safety
standard exists, the product also shall comply with the applicable
requirements of that standard.
Sec. 1243.4 Performance requirements.
(a) Restraint. The product shall not include a restraint system.
(b) Seam strength. When tested in accordance with Sec. 1243.5(j),
fabric/mesh seams and points of attachment shall not fail such that a
small part, sharp point, or sharp edge is presented, as required in
Sec. 1243.3(a) and (b).
(c) Bounded openings. When tested to Sec. 1243.5(c), all
completely bounded openings that exist in the front, sides, or back of
the occupant lounging area, or that are created when an accessory is
attached to the product, shall not allow complete passage of the small
head probe unless it allows the complete passage of the large head
probe.
(d) Maximum incline angle. The maximum incline angle shall not
exceed 10 degrees when tested in accordance with Sec. 1243.5(d).
(e) Firmness--(1) Occupant support surface firmness. When the 3-
inch diameter (figure 1 to this paragraph (e)(1)) hemispherical head
probe is applied according to the test method for occupant support
surface firmness, Sec. 1243.5(f), the force required for a one-inch
displacement shall be greater than 10 Newtons (N).
Figure 1 to paragraph (e)(1)--3-inch Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.003
(2) Sidewall firmness. For products with a sidewall, when the 3-
inch diameter hemispherical head probe is applied according to the test
method for sidewall firmness in Sec. 1243.5(g), the force required for
a one-inch displacement shall be greater than 10 N.
(3) Firmness at intersection of sidewall and occupant support
surface. For products with a sidewall, when the 3-inch diameter
hemispherical head probe is applied according to the test method for
firmness at the intersection of sidewall and occupant support surface
in Sec. 1243.5(h), the force required for a one-inch displacement
shall be greater than 10 N.
(f) Sidewall angle. For products with a sidewall, the sidewall
angle shall be greater than 90 degrees when determined according to the
sidewall angle determination in Sec. 1243.5(i).
Sec. 1243.5 Test methods.
(a) Test conditions. Condition the product for 48 hours at 23
[deg]C +/- 2 [deg]C (73.4 [deg]F +/- 3.6 [deg]F) and a relative
humidity of 50% +/- 5%.
(b) Permanence of labels and warnings. (1) A paper label (excluding
labels attached by a seam) shall be considered permanent if, during an
attempt to remove it without the aid of tools or solvents, it cannot be
removed, it tears into pieces upon removal, or such action damages the
surface to which it is attached.
(2) A non-paper label (excluding labels attached by a seam) shall
be considered permanent if, during an attempt to remove it without the
aid of tools or solvents, it cannot be removed or such action damages
the surface to which it is attached.
(3) A warning label attached by a seam shall be considered
permanent if it does not detach when subjected to a 15-lbs (67-N) pull
force applied in any direction using a \3/4\-inch diameter clamp
surface.
(4) Adhesion test for warnings applied directly onto the surface of
the product.
(i) Apply the tape test defined in Test Method B, Cross-Cut Tape
Test of ASTM D3359 (incorporated by reference, see Sec. 1243.8),
eliminating parallel cuts.
(ii) Perform this test once in each different location where
warnings are applied.
(iii) The warning statements will be considered permanent if the
printing in the area tested is still legible and attached after being
subjected to this test.
(5) A non-paper label, during an attempt to remove it without the
aid of tools or solvents, shall not be removed or shall not fit
entirely within the small parts cylinder defined in 16 CFR part 1501 if
it can be removed.
(c) Head entrapment test. For all applicable openings, rotate the
small head probe (figure 1 to this paragraph (c)) to the orientation
most likely to fail and gradually apply an outward force from the
occupant lounging area of 25 lbs (111 N). Apply the force to the probe
in the direction most likely to fail within a period of 5 seconds and
maintain it for an additional 10 seconds. If the small head probe can
pass entirely through the opening in any orientation, determine if the
large head probe (figure 2 to this paragraph (c)) can be freely
inserted through the opening.
[[Page 87489]]
Figure 1 to paragraph (c)--Small Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.004
Figure 2 to paragraph (c)--Large Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.005
(d) Maximum incline test. (1) Equipment shall include:
(i) Digital protractor with accuracy +/-1 degree;
(ii) Hinged weight gauge--newborn, requirements for part masses and
assembly (figure 3 to this paragraph (d)(1)(ii));
BILLING CODE 6355-01-P
[[Page 87490]]
Figure 3 to paragraph (d)(1)(ii)--Hinged Weight Gauge--Newborn,
Requirements for Part Masses and Assembly
[GRAPHIC] [TIFF OMITTED] TR04NO24.006
(iii) Hinged weight gauge-newborn, requirements for part dimensions
(figure 4 to this paragraph (d)(1)(iii)); and
[[Page 87491]]
Figure 4 to paragraph (d)(1)(iii)--Hinged Weight Gauge--Newborn,
Requirements for Part Dimensions
[GRAPHIC] [TIFF OMITTED] TR04NO24.007
BILLING CODE 6355-01-C
(iv) A test base that is horizontal, flat, firm, and smooth.
(2) If applicable, place the product in the manufacturer's
recommended highest seat back angle position intended for lounging.
(3) If applicable, place the hinged weight gauge--newborn in the
product and position the gauge with the hinge centered over the seat
bight line and the upper plate of the gauge back. Place a digital
protractor on the upper torso/head area lengthwise and measure the
incline angle.
(4) Place the head/torso portion of the newborn hinged weight gauge
on the product according to the manufacturer's recommended use position
with the seat portion of the gauge, depending on the product design,
allowed to lay freely on the product or on the test base (figure 5 to
this paragraph (d)(4)).
[[Page 87492]]
Figure 5 to paragraph (d)(4)--Test Fixture Configuration to Measure
Incline Angle on an Infant Support Cushion Product
[GRAPHIC] [TIFF OMITTED] TR04NO24.008
(5) Move and rotate the newborn hinged weight gauge the minimum
amount necessary such that the head/torso portion rests on an OSS that
could foreseeably support an infant's head, and place the head/torso
portion of the gauge according to all situations that apply:
(i) In tests on products with an OSS for the infant's body, align
the top edge of the head/torso portion of the gauge to coincide with a
plumb line to the outermost edge of the OSS-head.
(ii) In all tests, place the seat portion of the gauge on the test
base, adjust the newborn gauge to the greatest incline angle in which
the top edge of the gauge maintains contact with the top surface of the
product.
(6) If a product's seating bight area prevents reasonable
positioning of the head/torso portion to the outermost edge, then
position the seat portion of the newborn hinged weight gauge as far
forward as possible towards the outermost edge and allow the head/torso
portion of the gauge to rest on the product.
(7) Place a digital protractor lengthwise on the head/torso portion
of the gauge and measure the incline angle.
(8) Measure the incline angle at the manufacturer's recommended use
location(s), at feasible locations such as perpendicular to the
recommended use location(s), and at least one location likely to fail
in which the newborn gauge seat is supported on the test surface.
(9) Determine the maximum incline angle from the incline angle
measurements.
(e) Firmness test setup. (1) Equipment shall include:
(i) Force gauge with accuracy +/- 0.05 N (0.01 lbs).
(ii) Distance gauge with accuracy +/- 0.01 inches (0.03 cm).
(2) Align the axis of the 3-inch head probe (figure 1 to paragraph
(e)(1) of Sec. 1243.4) with a force gauge and parallel to a distance
measurement device or gauge.
(3) Use a lead screw or similar device to control movement along a
single direction.
(4) Support the firmness fixture to a test base such that the head
probe does not deflect more than 0.01 inches (0.025 cm) under a 10.0 N
(2.24 lbs) load applied in each orientation required in the test
methods.
(f) Occupant support surface firmness test method. Perform the
following steps to determine the occupant support surface firmness of
the product as received from the manufacturer. For products sold with a
slipcover on or together with the product, products shall be tested as
assembled with the slipcover on the product. All products, including
products one inch or less in thickness, are required to be tested. See
figure 6 to this paragraph (f).
(1) Orient the axis of the 3-inch head probe perpendicular to the
surface of the product at each test location that is oriented greater
than five degrees relative to the test base or align the axis of the
probe perpendicular to the test base (vertically) at each test location
that is oriented equal to or less than five degrees to the test base.
(2) The first test location shall be at the location of maximum
thickness of the surface being tested, perpendicular to the test base.
(3) Lay the product, with the occupant support surface facing up,
on a test base that is horizontal, flat, firm, and smooth.
(4) Prevent movement of the product in a manner that does not
affect the force or deflection measurement of the product surface under
test. Provide no additional support beneath the product.
(5) Advance the probe into the product and set the deflection to
0.0 inches when a force of 0.1 N (0.02 lbs) force is reached.
(6) Continue to advance the head probe into the product at a rate
not to exceed 0.1 inch per second and pause when the force exceeds 10.0
N (2.24 lbs), or the deflection is equal to 1.00 inches (2.54 cm).
(7) Wait 30 seconds. If the deflection is less than 1.00 inches and
the force is 10.0 N or less, repeat the steps in paragraphs (f)(6) and
(7) of this section.
(8) Record the final force and deflection when the deflection has
reached 1.00 inches or when the force has exceeded 10.0 N.
(9) If the maximum thickness of the OSS is greater than 1.0 inches
(2.54 cm), perform additional tests, space permitting, at the geometric
center of the OSS, at four locations along the product's longitudinal
and lateral axes
[[Page 87493]]
therefrom, 1.5 inches (3.8 cm) towards center from the intersection of
the sidewall and OSS, and at one location most likely to fail.
(10) Repeat the occupant support surface firmness tests on any
other occupant support surface and in all intended and feasible
configurations that could affect an occupant support surface, such as
the folding or layering of parts of the product.
Figure 6 to paragraph (f)--Test Configuration for Occupant Support
Surface Firmness Test
[GRAPHIC] [TIFF OMITTED] TR04NO24.009
(g) Sidewall firmness test method. For products with a sidewall,
perform the steps in paragraphs (f)(1) through (8) of this section to
determine the sidewall firmness of the product as received from the
manufacturer and then perform the following:
(1) Perform a minimum of four additional tests, located at
intervals not to exceed 6 inches along the entire top perimeter of the
sidewall, starting from the maximum side height location, and at one
additional location most likely to fail.
(2) Repeat the sidewall firmness test in all the intended or
feasible configurations that could affect the sidewall firmness, such
as the folding or layering of parts of the product.
(h) Intersection of sidewall and occupant support surface firmness.
For products with a sidewall, perform the following steps to determine
the intersection firmness of the product as received from the
manufacturer (figure 7 to this paragraph (h)).
(1) Orient the axis of the 3-inch head probe perpendicular to the
sidewall perimeter at an angle from horizontal that bisects the angle
determined in sidewall angle determination with the axis directed at
the intersection of the occupant support surface and the sidewall.
(2) The first test location shall be at the location of maximum
product thickness parallel to the test base.
(3) Perform the steps in paragraphs (f)(3) through (8) of this
section.
(4) Perform a minimum of four additional tests, located at
intervals not to exceed six inches along the entire inside perimeter of
the intersection of the sidewall and OSS, and at one additional
location most likely to fail.
(5) Repeat the intersection of sidewall and occupant support
surface firmness test in all the intended or feasible configurations
that could affect the intersection firmness, such as the folding or
layering of parts of the product.
[[Page 87494]]
Figure 7 to paragraph (h)--Test Configuration for Intersection of
Sidewall and Occupant Support Surface Firmness
[GRAPHIC] [TIFF OMITTED] TR04NO24.010
(i) Sidewall angle determination. For products with a sidewall,
perform the following steps to determine if the angle between the
sidewall and OSS is 90 degrees or less, or to measure the angle above
90 degrees. See figure 8 to this paragraph (i).
(1) Orient the 3-inch (7.62 cm) diameter hemispherical head probe
vertically and place it over the OSS with the cylindrical surface of
the probe tangent to the intersection of the sidewall and the OSS.
Advance the probe into the product until a downward force of 10 N (2.2
lbs) force is reached.
(2) After 30 seconds, determine whether the sidewall is in contact
with the cylindrical side of the 3-inch head probe. If the sidewall
contacts the cylindrical part of the probe, the sidewall angle is equal
to or less than 90 degrees.
(3) For sidewall angles greater than 90 degrees, calculate the
sidewall angle as 90 degrees plus the measured angle between the
cylindrical side of the 3-inch head probe and the sidewall.
(4) Determine a minimum of four sidewall angles at locations not to
exceed 6-inch (15.2 cm) intervals along the intersection of the
sidewall and OSS.
(5) Measure the angle with a protractor or gauge placed to the
depth of and in contact with the cylindrical side of the 3-inch probe
side and the sidewall.
Figure 8 to paragraph (i)--Test Fixture Configuration for Sidewall
Angle Measurement
[GRAPHIC] [TIFF OMITTED] TR04NO24.011
[[Page 87495]]
(j) Seam strength test method. (1) Equipment shall include:
(i) Clamps with 0.75 inches (1.9 cm) diameter clamping surfaces
capable of holding fabric and with a means to attach a force gauge. See
figure 9 to this paragraph (j)(1), or equivalent.
(ii) A force gauge, accuracy +/- 0.5 lbs (1.1 N).
Figure 9 to paragraph (j)(1)--Seam Clamp
[GRAPHIC] [TIFF OMITTED] TR04NO24.012
(2) Clamp the fabric of the infant support cushion on each side of
the seam under test with the 0.75 inches clamping surfaces placed not
less than 0.5 inches (1.2 cm) from the seam.
(3) Apply a tension of 15 lbs (67 N) evenly over 5 seconds and
maintain for an additional 10 seconds.
(4) Repeat the test on every distinct seam and every 12 inches (15
cm) along each seam.
(k) Removal of components test method--(1) Suitable devices. For
torque and tension tests, any suitable device may be used to grasp the
component that does not interfere with the attachment elements that are
stressed during the tests.
(2) Torque test. Gradually apply a 4 lbs-in (0.4 N-m) torque over 5
seconds in a clockwise rotation to 180 degrees or until 4 lbs-in has
been reached. Maintain for 10 seconds. Release and allow component to
return to relaxed state. Repeat the torque test in a counterclockwise
rotation.
(3) Tension test. For components that can reasonably be grasped
between thumb and forefinger, or teeth, apply a 15 lbs (67 N) force
over 5 seconds, in a direction to remove the component. Maintain for 10
seconds. A clamp such as shown in figure 10 to this paragraph (k)(3)
may be used if the gap between the back of the component and the base
material is 0.04 inches (0.1 cm) or more.
Figure 10 to paragraph (k)(3)--Tension Test Adapter Clamp
[GRAPHIC] [TIFF OMITTED] TR04NO24.013
Sec. 1243.6 Marking and labeling.
(a) General markings. Each product and its retail package shall be
marked or labeled clearly and legibly to indicate the following:
(1) The name, place of business (city, state, and mailing address,
including zip code), and telephone number of the manufacturer,
distributor, or seller.
(2) A code mark or other means that identifies the date (month and
year as a minimum) of manufacture.
(3) The marking or labeling in paragraphs (a)(1) and (2) of this
section
[[Page 87496]]
are not required on the retail package if they are on the product and
are visible in their entirety through the retail package. When no
retail packaging is used to enclose the product, the information
provided on the product shall be used for determining compliance with
paragraphs (a)(1) and (2) of this section. Cartons and other materials
used exclusively for shipping the product are not considered retail
packaging.
(b) Permanency. The marking and labeling on the product shall be
permanent.
(c) Upholstery labeling. Any upholstery labeling required by law
shall not be used to meet the requirements of this section.
(d) Warning design for product. (1) The warnings shall be easy to
read and understand and be in the English language at a minimum.
(2) Any marking or labeling provided in addition to those required
by this section shall not contradict or confuse the meaning of the
required information or be otherwise misleading to the consumer.
(3) The warnings shall be conspicuous and permanent.
(4) The warnings shall conform to ANSI Z535.4-2011(R2017)
(incorporated by reference, see Sec. 1243.8) sections 6.1-6.4, 7.2-
7.6.3, and 8.1, with the following changes.
(i) In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace ``should'' with
``shall.''
(ii) In section 7.6.3, replace ``should (when feasible)'' with
``shall.''
(iii) Strike the word ``safety'' when used immediately before a
color (for example, replace ``safety white'' with ``white'').
Note 1 to paragraph (d)(4)(iii): For reference, ANSI Z535.1,
American National Standard for Safety Colors, provides a system for
specifying safety colors. See note 1 to Sec. 1243.8(a) for ANSI
contact information.
(5) The safety alert symbol and the signal word ``WARNING'' shall
be at least 0.2 inches (5 mm) high. The remainder of the text shall be
in characters whose upper case shall be at least 0.1 inches (2.5 mm),
except where otherwise specified.
Note 2 to paragraph (d)(5): For improved warning readability,
typefaces with large height-to- width ratios, which are commonly
identified as ``condensed,'' ``compressed,'' ``narrow,'' or similar,
should be avoided.
(6) The message panel shall have the following text layout
requirements:
(i) The text shall be left-aligned, ragged-right for all but one-
line text messages, which can be left-aligned or centered. See figure 1
to this paragraph (d)(6) for examples of left-aligned text.
Note 3 to paragraph (d)(6)(i): Left-aligned means that the text
is aligned along the left margin, and in the case of multiple
columns of text, along the left side of each individual column.
(ii) The text in each column should be arranged in list or outline
format, with precautionary (hazard avoidance) statements preceded by
bullet points. Multiple precautionary statements shall be separated by
bullet points if paragraph formatting is used.
Figure 1 to paragraph (d)(6)--Examples of Left-Aligned Text
[GRAPHIC] [TIFF OMITTED] TR04NO24.014
Note 4 to figure 1 to paragraph (d)(6): The text shown for the
warnings in figure 1 to this paragraph (d)(6) is filler text, known
as lorem ipsum, commonly used to demonstrate graphic elements.
(7) All infant support cushions are required to contain a warning
with the content and format depicted in this section as figure 2 (for
products without tummy time) or figure 3 (if the product has a tummy
time feature) to this paragraph (d)(7).
[[Page 87497]]
Figure 2 to paragraph (d)(7)--Warning for Product Without Tummy Time
[GRAPHIC] [TIFF OMITTED] TR04NO24.015
Figure 3 to paragraph (d)(7)--Warning for Tummy Time Product
[GRAPHIC] [TIFF OMITTED] TR04NO24.016
(e) Warning statements. Each product shall contain the warning
statements shown on figure 2 (for products without tummy time) or
figure 3 (if the product has a tummy time feature) to paragraph (d)(7)
of this section, at a minimum. Slipcovers sold on, or together with the
product, shall contain the warning statement shown on figure 2 or 3 to
paragraph (d)(7) of this section, as applicable.
Sec. 1243.7 Instructional literature.
(a) Instructions shall be provided with the product and shall be
easy to read and understand and shall be in the English language at a
minimum. These instructions shall include information
[[Page 87498]]
on assembly, maintenance, cleaning, and use, where applicable.
(b) The instructions shall address the following additional
warnings:
(1) Read all instructions before using this product.
(2) Keep instructions for future use.
(3) Do not use this product if it is damaged or broken.
(4) Instructions shall indicate the manufacturer's recommended
maximum weight, height, age, developmental level, or combination
thereof, of the occupant for which the infant support cushion is
intended. If this product is not intended for use by a child for a
specific reason, the instructions shall state this limitation.
(c) The cautions and warnings in the instructions shall meet the
requirements specified in Sec. 1243.6(d)(4) though (6), except that
section 6.4 and sections 7.2-7.6.3 of ANSI Z535.4-2011(R2017)
(incorporated by reference, see Sec. 1243.8) need not be applied.
However, the signal word and safety alert symbol shall contrast with
the background of the signal word panel, and the cautions and warnings
shall contrast with the background of the instructional literature.
Note 1 to paragraph (c): For example, the signal word, safety
alert symbol, and the warnings may be black letters on a white
background, white letters on a black background, navy blue letters
on an off-white background, or some other high-contrast combination.
(d) Any instructions provided in addition to those required by this
section shall not contradict or confuse the meaning of the required
information or be otherwise misleading to the consumer.
Sec. 1243.8 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register under 5 U.S.C.
552(a) and 1 CFR part 51. All approved incorporation by reference (IBR)
material is available for inspection at the U.S. Consumer Product
Safety Commission and at the National Archives and Records
Administration (NARA). Contact the U.S. Consumer Product Safety
Commission at: the Office of the Secretary, U.S. Consumer Product
Safety Commission, 4330 East West Highway, Bethesda, MD 20814; phone
(301) 504-7479; email: [email protected]. For information on the
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The
material may be obtained from the following sources:
(a) National Electrical Manufacturers Association (NEMA), 1300 17th
St. N, Arlington, VA 22209; phone: (703) 841-3200; website:
www.nema.org.
(1) ANSI Z535.4-2011(R2017), American National Standard for Product
Safety Signs and Labels, approved October 20, 2017; approved for
Sec. Sec. 1243.6 and 1243.7.
(2) [Reserved]
Note 1 to paragraph (a): NEMA standards are also available from
the American National Standards Institute (ANSI), which provides a
free, read-only copy of the standard at https://ibr.ansi.org/Standards/nema.aspx. Contact ANSI by mail at American National
Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY
10036, USA; phone: (212) 642-4900; website: www.ansi.org.
(b) ASTM International (ASTM), 100 Barr Harbor Drive, P.O. Box
CB700, West Conshohocken, Pennsylvania 19428-2959; phone: (800) 262-
1373; website: www.astm.org.
(1) ASTM D3359-23, Standard Test Methods for Rating Adhesion by
Tape Test, approved February 1, 2023; approved for Sec. 1243.5.
(2) [Reserved]
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-25181 Filed 11-1-24; 8:45 am]
BILLING CODE 6355-01-P