Safety Standard for Infant Support Cushions, 2530-2554 [2023-27324]
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Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
Commissioner advisor shall be subject
to the following treatment. Written
communications and summaries or
transcripts of oral communications shall
be placed on the rulemaking record if
the communication is received before
the end of the comment period. They
shall be placed on the public record if
the communication is received later.
Unless the outside party making an oral
communication is a member of
Congress, such communications are
permitted only if advance notice is
published in the Weekly Calendar and
Notice of ‘‘Sunshine’’ Meetings.27
By direction of the Commission.
Joel Christie,
Acting Secretary.
[FR Doc. 2024–00678 Filed 1–12–24; 8:45 am]
BILLING CODE 6750–01–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: Notice of proposed rulemaking.
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
direction, the Commission is proposing
a safety standard for infant support
cushions. The Commission is also
proposing to amend CPSC’s consumer
registration requirements to identify
infant support cushions as durable
infant or toddler products and
proposing to amend CPSC’s list of
notices of requirements (NORs) to
include infant support cushions.
DATES: Submit comments by March 18,
2024.
ADDRESSES: Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature requirements of the proposed
rule should be directed to the Office of
Information and Regulatory Affairs,
Office of Management and Budget, Attn:
CPSC Desk Officer, FAX: 202–395–6974,
or emailed to oira_submission@
omb.eop.gov.
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SUMMARY:
27 See
15 U.S.C. 57a(i)(2)(A); 16 CFR 1.18(c).
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Other comments, identified by Docket
No. CPSC–2023–0047, may be
submitted electronically or in writing,
as follows:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Do not submit through this website:
confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public. CPSC
typically does not accept comments
submitted by email, except as described
below.
Mail/Hand Delivery/Courier/
Confidential Written Submissions: CPSC
encourages you to submit electronic
comments by using the Federal
eRulemaking Portal. You may, however,
submit comments by mail, hand
delivery, or courier to: Office of the
Secretary, Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone: (301)
504–7479.
Instructions: All submissions received
must include the agency name and
docket number for this proposed
rulemaking. CPSC may post all
comments without change, including
any personal identifiers, contact
information, or other personal
information provided, to:
www.regulations.gov. If you wish to
submit confidential business
information, trade secret information, or
other sensitive or protected information
that you do not want to be available to
the public, you may submit such
comments by mail, hand delivery, or
courier, or you may email them to: cpscos@cpsc.gov.
Docket: For access to the docket to
read background documents or
comments received, go to: https://
www.regulations.gov, insert the docket
number, CPSC–2023–0047, into the
‘‘Search’’ box, and follow the prompts.
FOR FURTHER INFORMATION CONTACT:
Stefanie Marques, Ph.D., Project
Manager, Directorate for Health
Sciences, U.S. Consumer Product Safety
Commission, 5 Research Place,
Rockville, MD 20850; email: smarques@
cpsc.gov; telephone: (301) 987–2581.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
Section 104(b) 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
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manufacturers, and independent child
product engineers and experts and (2)
promulgate consumer product safety
standards for durable infant and toddler
products. 15 U.S.C. 2056a(b)(1). 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.’’ 15 U.S.C. 2056a(b)(2).
The Commission is issuing this notice
of proposed rulemaking (NPR) to
establish a consumer product safety rule
for infant support cushions to further
implement section 104 of the CPSIA.1
The proposed 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 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.
CPSC staff identified at least 79
reported fatalities involving infant
support cushions from January 1, 2010,
through December 31, 2022, as well as
125 nonfatal incidents or reports
involving these products within the
same time period. There were 17 deaths
in 2020, and at least 17 more in the
potentially incomplete data from 2021.
More than 80 percent of the fatalities
associated with these products involved
infants three months old and younger.
In more than 60 percent of the fatalities,
the official cause of death was either
asphyxia or probable asphyxia, and
these incidents typically involved 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 a on a 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 the threat of
asphyxia or entrapment.
This proposed rule addresses the risk
of death and injury associated with
1 On November 29, 2023, the Commission voted
(4–0) to publish this notice of proposed rulemaking,
with an amendment proposed by Commissioner
Trumka. Commissioners Trumka and Boyle issued
statements in connection with their votes, available
at: https://www.cpsc.gov/s3fs-public/2023-11-29Commission-Meeting-Minutes-Infant-SupportCushions-NPR-Decisional.pdf?
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infant support cushions primarily due
to suffocation, entrapment, and fall
hazards. The proposed rule would
address 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, 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 proposed
rule would set 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
unattended infants. The proposed rule
also requires a strongly worded,
conspicuous, and permanent on-product
warning.
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.2 Currently, however, no
voluntary or mandatory safety standard
for infant support cushions exists to
address the hazards posed by these
products.
Infant support cushions are a durable
infant or toddler product 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.’’ 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 and often are used by
multiple children successively; are
2 CPSC formally began the consultation process
for this rulemaking in December 2021, via a letter
from CPSC 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. CPSC staff has been
actively participating in both ASTM subcommittees
to develop voluntary standards that address hazards
associated with these products.
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similar to other durable infant and
children’s products such as crib
mattresses and sling carriers; 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
Commission proposes to amend 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
also must comply with product
registration requirements, as well as
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 proposed rule would be
a children’s product safety rule that
requires issuance of an NOR.
II. The Product Category
A. Infant Support Cushions
Infant support cushions include
products that support an infant for
lounging, meaning reclining or lying in
a supine, prone, or recumbent position.
Infant products within this category
may or may not contain infants with
perimeter walls. Most infant support
cushions on the market today 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 others, 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.
Illustrative pictures of infant support
cushions can be found in Tab C of staff’s
briefing package for this proposed rule.3
A non-exhaustive list of examples of
infant support cushions includes:
• head positioner pillows;
• flat baby loungers;
• crib pillows;
3 Staff Briefing Package: Staff’s Draft Proposed
Rule for Infant Support Cushions (November 8,
2023) (Staff’s NPR Briefing Package), available at:
https://www.cpsc.gov/s3fs-public/Briefing-PackageNotice-of-Proposed-Rulemaking-Safety-Standardfor-Infant-Support-Cushions.pdf?VersionId=
rA60lesWHddS1.wrk_EvV00xeX75dsFc.
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• wedge pillows for infants;
• infant sleep positioners, unless
regulated by the Food and Drug
Administration (FDA) as medical
devices;
• 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 would be
required to meet the performance
standards of this rule. To avoid
potentially duplicative or conflicting
obligations, however, the scope of
products that would be subject to this
proposed 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).
Illustratively, the following products
are not infant support cushions within
the scope of this proposed rule:
• Pillows not marketed or intended
for use by infants, such as adult bed and
throw pillows;
• nursing pillows if subject to
Commission’s proposed nursing pillow
rule 88 FR 65865 (Sept. 26, 2023) if that
rule is finalized, unless they are also
marketed for lounging;
• crib and play yard mattresses that
are in scope of the play yard and crib
mattress standard in 16 CFR part 1241;
• purely decorative nursery pillows,
such as those personalized with a baby’s
name and birthdate, that are not for
infant use;
• stuffed toys (unless they meet the
definition of an infant support cushion
in this proposed 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; and
• sleeping accommodations, which
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
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general online retailers, online sites for
‘‘big box’’ stores, online baby products
sites, and online marketplaces for handcrafted items. A few types of infant
support cushions, however, are also
available from brick-and-mortar baby
specialty stores and general retail stores,
particularly crib pillows and baby
loungers. 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 sleep. Several thousand
manufacturers and importers, including
hundreds of handcrafters and direct
foreign shippers, supply infant support
cushions to the U.S. market. See Staff’s
NPR Briefing Package, Tab E.
Infant support cushions may be reused for multiple children or sold for
use after an infant outgrows the product.
Commission staff observed that used
infant support cushions are widely
available on secondary marketplaces
such as eBay and Mercari. In June 2023,
for example, 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.
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C. Infant Cushion/Pillow Ban
In 1992, pursuant to the
Commission’s authority under the
Federal Hazardous Substances Act
(FHSA), 15 U.S.C. 1261–1278, the
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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.
16 CFR 1500.18(a)(16). This proposed
rule for infant support cushions does
not change the 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 proposed rule and would be
required to comply with the
performance requirements of this
proposed rule.4
III. Incident Data and Hazard Patterns
CPSC staff searched the Consumer
Product Safety Risk Management
4 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 proposed rule or to the proposed standard
for nursing pillows.
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System (CPSRMS) 5 and National
Electronic Injury Surveillance System
(NEISS) 6 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. Tab A of Staff’s
NPR Briefing Package describes the
incident and hazard patterns associated
with infant support cushions.
Commission staff identified 79 fatal
incidents and 125 nonfatal incidents
and consumer concerns reported to
CPSC from 2010–2022. Of the 125 nonfatal reports. 22 consisted of emergencydepartment-treated injuries, three
involved hospital admissions, 46 reports
involved no injury, and for 52 reports
the disposition was either unknown or
unspecified. Table 1 provides the
distribution of fatal incidents by year.
5 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.
6 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
https://www.cpsc.gov/Research-Statistics/NEISSInjury-Data.
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Table 1: Infant Support Cushion-Related Fatalities Reported by Year for Children 12 Months of
Age or Younger: 2010-2022
18
16
14
(I)
12
(I)
:i:: 10
iii
1u 8
LL
6
4
-
2
0
2010 2011
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021· 2022*
Year
1111 Infant Support Cushion-Related Fatalities
Source: CPSRMS and NEISS databases.
Asterisks(*) indicate that reporting is ongoing for CPSRMS; the years 2021-2022 are considered incomplete.
Table 2 summarizes the number of
reported fatalities related to infant
support cushions for victims 12 months
and younger by age in months and by
gender. As reflected in Table 2, 80
percent of the fatalities with a known
age were infants in the zero to three
month age range. Among the 76
fatalities for which the sex is known,
half were male and half were female.
TABLE 2—INFANT SUPPORT CUSHION-RELATED FATALITIES FOR VICTIMS AGES 12 MONTHS AND YOUNGER AND SEX:
2010–2022
Age
(In months)
Total
(% of total)
Total .................................................................................................................
1 .......................................................................................................................
2 .......................................................................................................................
3 .......................................................................................................................
4 .......................................................................................................................
5 .......................................................................................................................
6 .......................................................................................................................
7 .......................................................................................................................
8 .......................................................................................................................
9 .......................................................................................................................
10 .....................................................................................................................
11 .....................................................................................................................
12 .....................................................................................................................
Unknown ..........................................................................................................
79 (100%)
26 (33%)
19 (24%)
18 (23%)
7 (9%)
3 (4%)
1 (1%)
2 (3%)
0
0
1 (1%)
1 (1%)
0
1 (1%)
Male
(% of total)
38 (48%)
12 (15%)
10 (13%)
8 (10%)
4 (5%)
1 (1%)
0
1 (1%)
0
0
1 (1%)
1 (1%)
0
0
Female
(% of total)
38 (48%)
14 (18%)
9 (11%)
10 (13%)
3 (4%)
0
1 (1%)
1 (1%)
0
0
0
0
0
0
Unknown
(% of total)
3 (4%)
0
0
0
0
2 (3%)
0
0
0
0
0
0
0
1 (1%)
The official cause of death reported by
the medical examiner in the majority of
the 79 reported fatalities 49 (62 percent)
was asphyxia or probable asphyxia; 13
(17 percent) were determined to be due
to sudden unexpected infant death
(SUID) events; 12 (15 percent) had an
undetermined cause of death; and for
five (six percent), no medical examiner’s
report was available. Nearly all reported
fatalities (75 of 79) involved placement
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of the infant support cushion on another
sleep-related consumer product. For the
remaining four fatalities, the placement
of the infant support cushion was either
undetermined or unknown.
In the 125 nonfatal incidents
associated with infant support cushions
that involved children ages 12 months
and younger and occurred between
January 1, 2010, and December 31, 2022,
three infants were admitted to the
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hospital and 22 infants were reported to
have been treated and released from an
emergency department. In 52 of these
nonfatal incidents, the severity of the
injury was unspecified or unknown, and
in 46 of the incidents no injury was
reported. Table 3 summarizes the
disposition of the nonfatal incident
reports associated with infant support
cushions and victims ages 12 months
and younger.
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and threatened asphyxia as the two
major nonfatal hazard patterns
associated with infant support cushions.
In the case of falls, the reports revealed
that in most incidents infant support
cushions had been placed on elevated
Total
reports
Severity
surfaces including adult beds and
(% of total)
couches. The injuries associated with
Total Non-Fatal Reports .......
125 (100%) falls include concussions, facial
Hospital Admissions .............
3 (2%) injuries, and scalp injuries.
Emergency Department
In the case of threatened asphyxia, the
Treated ..............................
22 (18%) narratives described scenarios of infants
Left without being seen ........
1 (1%)
being rescued after being found hanging
Seen by a Medical Professional .................................
1 (1%) partially or completely off of the infant
Unspecified/Unknown ...........
52 (42%) support cushion with their mouths and
No Injury Reported ...............
46 (37%) noses obstructed, with their heads
wedged between sleep positioner side
Source: CPSRMS and NEISS databases. cushions, or having rolled to a facePercentages may not add to 100 due to
rounding; the years 2021–2022 are consid- down position that put them at risk of
an obstructed airway.
ered incomplete.
TABLE 3—INFANT SUPPORT CUSHIONRELATED NONFATAL REPORTS BY
SEVERITY FOR VICTIMS AGES 12
MONTHS AND YOUNGER: 2010–2022
For the 46 reports for which no injury
was reported, many of the descriptions
in the incident reports indicated the
potential for serious injury or death.
Staff’s analysis of the narratives
associated with these incident reports
indicated that in 29 reports (23 percent)
of the incidents, an infant support
cushion occupied by an infant had been
place on an elevated surface (such as an
adult bed or couch) and the infant had
fallen off; 27 (22 percent) specified
threatened asphyxia; and 17 incidents
(14 percent) involved various types of
rashes caused by the product. Table 4
summarizes the hazard patterns for
infant support cushion-related nonfatal
incidents.
TABLE 4—INFANT SUPPORT CUSHIONRELATED NON-FATAL REPORTS BY
HAZARD PATTERN FOR VICTIMS
AGES 12 MONTHS AND YOUNGER:
2010–2022
Number of
non-fatal
reports
(% of total)
Event
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Children
(0 to 12 months)
Fall ....................................
Threatened Asphyxia ........
Rash .................................
Limb Entrapment ..............
Mold ..................................
Choking .............................
Near Strangulation ............
Vomiting ............................
Consumer Complaints ......
29 (23%)
27 (22%)
17 (14%)
1 (1%)
1 (1%)
1 (1%)
1 (1%)
1 (1%)
47 (38%)
Total Non-Fatal Reports ...
125 (100%)
Source: CPSRMS and NEISS databases.
Percentages may not add to 100 due to
rounding; the years 2021–2022 are considered incomplete.
Staff, based on review of nonfatal
incident and report data, identified falls
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IV. International Standards for Infant
Support Cushions
The Commission is aware of two
international standards, both British,
that contain performance requirements
that address 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. 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. Staff assesses
that the proportional approach used in
this standard allows thicker pillows to
have a greater displacement than
thinner pillows, which does not
sufficiently protect against the
suffocation and asphyxia hazards
associated with infant support cushions
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because that greater displacement could
allow the product to obstruct the
infant’s airways.
V. Boise State University Contractor
Report
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. See Staff’s NPR Briefing
Package, Tab C.
BSU delivered its final report on June
30, 2022 (the BSU Final Report).7 The
BSU Final Report provides
recommendations and conclusions
related to the performance and design of
infant support cushions, including the
following.
Firmness Testing. The BSU Final
Report recommends that all infant
support cushions be required to undergo
firmness testing because products that
lack firmness are more likely to conform
around an infant’s nose and mouth and
present a suffocation hazard. The report
recommended testing all infant pillows
for firmness using a three-inch diameter,
anthropometry-based hemispheric probe
that is geometrically similar to, and
sized to represent the breadth of, an
infant’s face. The report recommends
that the probe should be applied to the
product at three locations: the location
of maximum thickness, the location of
minimum thickness, and a subjective
location of interest (i.e., another soft
location most likely to result in failure).
The force required to displace the probe
one inch into the product at each
location must exceed 10 N. Meeting this
requirement would mean that the
product has firmness comparable to crib
mattresses.
Airflow Testing. The BSU Final
Report recommends that products that
do not pass firmness testing be required
to pass an airflow test. Passing the
airflow test would mean that the
product has airflow characteristics
comparable to current mesh crib liners,
which the BSU researchers concluded
would mitigate the suffocation hazard.
However, the report recommends
against requiring that airflow testing for
products that pass the BSU Final
7 Mannen, E.M., Davis, W., Goldrod, S., Lujan, T.,
Siddicky, S.F., Whitaker, B., & Carroll, J. (2022).
Pillows Product Characterization and Testing.
Prepared for the U.S. Consumer Product Safety
Commission under contract no. 61320620D0002,
task order no. 61320621F1015. Available at: https://
www.cpsc.gov/content/Pillows-ProductCharacterization-and-Testing.
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Report’s proposed firmness testing,
because a firm product is unlikely to
form a seal around an infant’s nose and
mouth.
Sagittal-Plane Testing. BSU
developed prototype sagittal-plane
testing devices to allow for more
comprehensive assessments of infant
positioning in and on infant support
cushions.8 The BSU Final Report
recommends further research to
determine appropriate worst-case
positions for testing and to set threshold
values for acceptable body positions
that would not negatively impact infant
breathing.
Tab C of Staff’s NPR Briefing Package
contains staff’s summary of how the
Commission’s proposed rule reflects the
conclusions and recommendations of
the BSU Final Report.
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VI. ASTM’s Working Draft Standard
There are no published U.S. voluntary
standards for infant support cushions.
ASTM is working toward a voluntary
standard for infant loungers under
Subcommittee F15.21 on Infant Carriers,
Bouncers, and Baby Swings.9 In the
draft voluntary standard, an ‘‘infant
lounger’’ is a product ‘‘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.’’ That draft definition would
govern only a subset of the products
covered by this proposed rule, which
includes infant positioners, nursing
products with dual use for lounging,
infant cushions, and other infant pillowlike products, as well as the infant
loungers being considered by ASTM.
Staff has been working with ASTM to
develop performance requirements
intended to address the primary hazards
associated with infant loungers, but to
date ASTM has not issued a ballot on
a standard for infant loungers.
ASTM’s draft voluntary standard
includes general requirements typically
found in other ASTM juvenile product
standards, such as requirements
addressing lead content, small parts,
hazardous sharp edges or points, and
toy accessories that are attached to,
removable from, or sold with the
products. The ASTM draft also specifies
that if the lounger can be converted to
another product it shall comply with the
8 The sagittal plane is an anatomical plane that
runs vertically through the human body, dividing
it into left and right sections. It can be thought of
as viewing the human body in profile.
9 See Staff’s NPR Briefing Package, Tab B. This
ASTM standard is still in draft form and has not
completed the full consensus process to be an
approved standard and the draft language is subject
to change.
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applicable requirements of that
product’s standard. The general
requirements of the draft infant lounger
standard also state that the sidewall
height of the product shall be less than
four inches when measured according to
the sidewall height measurement test
method specified in the draft standard.
The draft voluntary standard further
includes the following performance
requirements:
• Stability: The product shall not tip
over and shall retain the CAMI
dummy 10 when tested in all
manufacturers’ use positions.
• Infant Restraints: The product shall
not have a restraint system.
• Fabric/Mesh Integrity: This
requirement is intended to address
product integrity issues such as seam
failures and material breakage.
• Bounded Openings: This
requirement is intended to address
potential entrapment hazards associated
with openings in the product.
• Occupant Support Surface: This
requirement is intended to address the
thickness of, dimensions of, and
potential gaps in the occupant support
surface.
• Occupant Support Surface
Firmness: This requirement uses an
eight-inch diameter, disc-shaped
‘‘firmometer’’ probe and requires that
there shall be no point where the feeler
arm of the device, which hangs over the
edge of a disc, comes in contact with the
occupant support surface.
• Sidewall Firmness: The top of the
sides of the product cannot be displaced
more than one inch when a three-inch
diameter hemispheric probe is applied
to the product with 10 N of force.
• Side Angle and Deflection: To
address potential entrapment hazards at
the intersection of the side wall and
occupant support surface, the angle
between the sidewall and the occupant
support surface of the infant support
cushion shall be greater than 90 degrees.
The draft voluntary standard also
includes marking, labeling, and
instructional literature requirements,
such as warning the consumer on the
product 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. The draft standard
requires the warnings to be
‘‘permanent’’ and ‘‘conspicuous.’’
10 CAMI (Civil Aeromedical Institute) dummies,
which are designated ASTM test devices, are based
on child anthropometric data and come in multiple
sizes. ASTM’s working draft references the sixmonth-old size.
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2535
The product’s instructions must,
among other requirements, indicate the
manufacturer’s recommended maximum
weight, height, age, developmental
level, or combination of these attributes
for any infant using the product, as well
as any limitation on use of the product
by a child for any specific unintended
use.
VII. Description of the Proposed
Mandatory Standard for Infant Support
Cushions 11
To address established risks of death
and injury associated with infant
suffocations, asphyxiations,
entrapments, and falls, and as section
104 of the CPSIA requires, the
Commission is issuing this proposed
rule to establish mandatory performance
and labeling requirements for infant
support cushions.
The text of the proposed rule is based
on an evaluation of incident data
associated with infant support cushions,
the ASTM working draft standard for
infant loungers that is under
development, and the recommendations
of the BSU Final Report. The proposed
rule is summarized below and
explained in more detail in Tabs C and
F of Staff’s NPR Briefing Package.
A. Scope and Definitions
Section 1243.1 of the proposed rule
explains that the rule would apply to
infant support cushions, including
infant positioners, nursing products
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 would exclude,
however, products already regulated by
other Commission mandatory standards
for durable infant products, which are
listed in 16 CFR 1130.2(a). The
proposed rule would apply to all infant
support cushions manufactured after the
effective date of the rule.
Section 1243.2 of the proposed rule
defines ‘‘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.’’
The scope of ‘‘infant support
cushions’’ is intended to encompass the
products described in Part II above.
As noted previously, this proposed
definition of ‘‘infant support cushions’’
includes, but is not limited to, the infant
11 See
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loungers that would be subject to
ASTM’s draft voluntary standard. The
proposed rule would define ‘‘infant
lounger’’ as ‘‘an infant product 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.’’ Because, however,
incident data show that the suffocation,
asphyxiation, and fall hazards this rule
seeks to address are posed by other
infant pillow-like products, in addition
to those with a raised perimeter or
recess, the proposed broader definition
more effectively addresses the hazards
posed by these products. For example,
the proposed rule would apply to
‘‘infant positioners,’’ defined as a
product intended to help keep an infant
in a particular position while supine or
prone.
As discussed above, ASTM is working
concurrently on developing voluntary
standards for both ‘‘infant feeding
supports’’ and ‘‘infant loungers.’’ The
draft ASTM standards address hazards
posed by ‘‘dual use’’ products intended
to be used both to feed an infant and to
support a lounging infant by requiring
such products to comply with both
standards. Adopting ASTM’s approach,
the proposed rule would apply to
nursing pillows with a dual use for
lounging, while excluding those nursing
pillows that are solely intended to be
used for nursing or feeding, along with
other products already regulated by
other Commission mandatory standards
for durable infant products.
The Commission invites public
comment on the scope of the proposed
rule, including whether it addresses all
products that pose the identified
hazards and whether it is sufficiently
clear and administrable. For example,
the Commission invites public comment
on whether it is appropriate to subject
‘‘dual use’’ products to both the
proposed nursing pillow rule and the
proposed infant support cushion rule
(assuming that both are finalized), and
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what nursing products should be
considered ‘‘dual use.’’
intersection of the occupant support
surface with the sidewall, as follows:
B. General Requirements
The proposed rule includes many of
the general requirements included in
the ASTM draft standard for infant
loungers to address sharp edges or
points, small parts, and lead in paints.
It also requires that toy accessories that
are attached to, removable from, or sold
with the products comply with 16 CFR
part 1250, which establishes a
mandatory safety standard for toys, as
well as requirements for the
permanency of labels and warnings.
However, while ASTM’s draft standard
for infant loungers would allow a
maximum sidewall height of four
inches, the Commission is concerned
that this height may give consumers the
mistaken impression that an infant can
safely be left unattended in or on the
product. For that reason, the proposed
rule addresses the positional asphyxia
hazard with a maximum incline
requirement that effectively sets a lower
limit on sidewall height, rather than the
maximum side height requirement
currently favored by ASTM. The
Commission invites public comment on
side height limit and incline angle
requirements.
a. Occupant Support Surface (OSS)
Firmness
C. Proposed Performance Requirements
1. Firmness
The Commission’s proposed firmness
requirements and associated test
methods are consistent with those
applicable to crib mattresses and more
stringent than those currently included
in ASTM’s draft standard for infant
loungers. As explained in Tab C of
Staff’s NPR Briefing Package, based
upon the findings and recommendations
in the BSU Final Report as well as staff’s
analysis of the incidents and hazard
patterns associated with facial occlusion
into infant support cushions, the
proposed rule requires firmness testing
at three locations: the occupant support
surface, the sidewall, and the
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The proposed rule includes a firmness
test for the occupant support surface 12
that is based on the BSU Final Report,
with modifications to improve the test
methodology. The firmness test is
intended to reduce the likelihood that
the OSS can conform to an infant’s face
and cause suffocation. The proposed
rule requires that OSS firmness be
tested using the three-inch diameter
hemispheric probe developed by BSU,
rather than the eight-inch firmometer
probe in the ASTM draft standard. The
three-inch probe is more consistent, in
both size and shape, with the size and
dimensions of an infant’s head, enabling
it to more accurately detect any material
deformations and surface features that
an infant’s face may come in contact
with on an infant support cushion. In
addition, staff’s testing showed that an
eight-inch disc probe may not be as
accurate as a three-inch hemispheric
probe when used on certain models of
infant support cushions with smaller
dimensions or an OSS surface that is not
completely flat, so that the eight-inch
firmometer cannot fit well enough in the
product to provide accurate
measurement.
To meet the proposed rule’s firmness
requirement, the force required to
displace the probe one inch into the
OSS test location (as well as the two
other test locations) must exceed 10 N
(about 2.25 pounds), which indicates
product firmness that is at least
comparable to a crib mattress. Figure 1,
below, illustrates the firmness test being
applied to the OSS of an infant support
cushion.
BILLING CODE 6355–01–P
12 The proposed rule uses ASTM’s draft definition
of an infant support cushion’s ‘‘occupant support
surface’’ or OSS as ‘‘the area that holds up and
bears the infant or any portion of the infant.’’
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2537
Figure 1: Firmness Test Applied to OSS or Sidewall
lON
3-IN HEMISPHERICAL
TEST PROBE
OCCUPANT SUPPORT SURFACE
. - - - 3 - f f l HfMJSPtlEIOCAL
TESf PROIIE
oss
.._______ TEST~
"-----lNTERSEC"l10N
Because an infant’s head or face may
rest on the sidewall of a product, as well
as on the product’s OSS, the proposed
rule includes firmness requirements for
any product sidewall. While the ASTM
working draft also requires firmness
testing of sidewalls, the proposed rule
requires testing a minimum of four
sidewall locations, including the
location of maximum sidewall height,
and requires that the test locations
include at least one location most likely
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to fail, rather than requiring that
sidewalls be tested in six-inch
increments around the product as stated
in ASTM’s draft. The differences from
ASTM in testing protocol are intended
to provide more accurate testing for both
smaller head pillows and larger lounger
products.
b. Intersection of OSS With Sidewall
To address the hazard of suffocation
when an infant’s face is surrounded on
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two sides by the OSS and a sidewall, the
proposed rule includes firmness
requirements based on testing the angle
at which the two surfaces intersect, to
ensure sufficient firmness to prevent the
product from conforming to the infant’s
mouth or face and obstructing airways.
It requires testing of firmness with the
three-inch hemispherical probe
positioned to bisect the angle formed
where the two surfaces intersect, as
shown in Figure 2.
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BILLING CODE 6355–01–C
EP16JA24.014</GPH>
SIDEWAli/OSS
2538
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
Figure 2: Test Configuration for Intersection of Sidewall and
Occupant Support Surface Firmness
- - - - - 4 - 3 - I H HEMlSfflERICAL
TEST~
--oss
----TEST BASE
------INTERSeCTteN
SIDEWAU,/OSS
2. Sidewall Angle
ddrumheller on DSK120RN23PROD with PROPOSALS1
The proposed rule, like ASTM’s draft,
requires that the angle formed between
the product’s OSS and any sidewall be
greater than 90 degrees to reduce
potential entrapment hazards between
the sidewall and the occupant support
surfaces. The proposed rule requires a
slightly different methodology for
measuring this angle than does ASTM’s
draft. While ASTM’s draft requires that
this angle be measured with a protractor
or similar tool at four-inch intervals
along the product’s interior, the
proposed rule specifies assessing this
angle with the cylindrical side of the
three-inch probe, with a 10 N force
applied to the probe. The probe, which
is designed to simulate the size and
shape of an infant’s head, is used to
determine whether there is any contact
between the sidewall and the probe’s
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side when the ‘‘face’’ of the probe is
pressed against the OSS/sidewall
intersection. If there is such contact,
indicating an entrapment risk, that
indicates that the angle is less than 90
degrees and the product would fail.
Conversely, if there is no contact
between the sidewall and the side of the
probe, the angle is greater than 90
degrees and the product meets this
requirement.
3. Maximum Incline Angle
The proposed rule, like ASTM’s draft,
requires that any incline of the OSS of
an infant support cushion not exceed 10
degrees. This requirement is consistent
with incline test of CPSC’s Safety
Standard for Infant Sleep Products, 16
CFR part 1236, and the ban of inclined
sleepers for infants in the Safe Sleep for
Babies Act, 15 U.S.C. 2057d, and
similarly it addresses the hazards
associated with inclined sleep products.
The proposed rule, however, differs
from ASTM’s maximum incline angle
requirements and test procedures in
order to improve test consistency across
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all infant support cushion products and
to address additional locations of
potential inclined lounging, reclining,
and sleep. The three ways in which the
proposed rule modifies ASTM’s
proposed testing protocol are: (1) setting
a maximum incline angle that applies
not only to all of a manufacturer’s
recommended use positions, but also to
all other infant cushion surfaces that
can feasibly support an infant’s head,
including, for example, the angle from
any sidewall to the OSS or from the
sidewall to the floor; (2) use of a
newborn hinged weight gauge, rather
than an infant gauge; and (3) positioning
the gauge differently throughout testing.
Figure 3 below, shows the use of a
hinged weight gauge to measure the
incline on an infant support cushion
with a sidewall. The proposed rule
requires use of a newborn hinged weight
gauge, rather than the heavier infant
gauge specified in the ASTM draft,
because infant support cushions are
commonly used for newborns, who are
at higher risk of suffocation.
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The proposed rule’s firmness
requirements for the OSS/Sidewall
intersection are similar to those in
ASTM’s draft standard.
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
2539
Figure 3: Test Fixture Configuration to Measure Incline Angle
on an Infant Lounger
HINGED
WEIGHT GAUGE
-NEWBORN
SEAT BIGHT
LINE
oss----SIOEWALL
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The proposed rule limits the height of
any sidewall of an infant support
cushion, as does ASTM’s draft.
However, the proposed rule addresses
the hazards associated with relatively
high sidewalls in a manner that is more
closely tailored to the hazards, and
applies to all of the products that fall
within the scope of the proposed rule.
These hazards are that caregivers may
judge that an infant support cushion
with relatively high sidewalls can safely
contain an infant without supervision
and is suitable for use on top of an adult
bed or in a crib notwithstanding any
contrary warnings, and that high
sidewalls can cause hazardous
positioning of the infant’s neck when an
infant’s head is placed on top of the
sidewall while their body is on a lower
surface either inside or outside of the
product. See Staff’s NPR Briefing
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Package, Tabs B and C. While ASTM’s
draft sets a four-inch limit on sidewall
height, the proposed rule addresses
these hazards by limiting the maximum
incline angle and provides testing
protocols based on the type of product
(for example, lounger-type products or
head cushions). Using the test
methodology prescribed in the proposed
rule, sidewall heights, for products that
have sidewalls, would be limited to
approximately 1.9 inches.
The Commission invites public
comments on the proposed rule’s
method for addressing hazards posed by
sidewall heights via measurement of
maximum incline angle and what
methodology would most effectively
address the identified fall and positional
asphyxia hazards.
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D. Warning and Instructional
Requirements
Compared to the performance
requirements described above, warnings
are less effective in eliminating or
adequately reducing exposure to
hazards associated with infant support
cushions. Nevertheless, prominent and
well-designed warnings can provide
consumers with important information
about the hazards associated with these
products and appropriate behaviors to
avoid the hazards. Thus, the proposed
rule includes requirements for onproduct warnings that address the
primary hazards associated with infant
support cushions.
The proposed rule includes warning
content and format requirements similar
to those in the ASTM draft standard.
Figure 4 shows the warning statements
and format that would be required on
infant support cushions:
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4. Sidewall Height
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Figure 4: Example of Infant Support Cushion Warning
USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL.
Babies can tum ov,er or rol out without warning and CAN
SUFFOCATE in only a few minutes.
• Use only with an AWAKE baby.
•
Stay near and watch baby during use. ff baby falls asleep,
remove baby as soon as possible and place baby on a firm,
flat sleep surface such as a crib or bassinet.
• Use only on floor, with baby face-up on back. Do not use on
soft surfaces or in sleep products like cribs or bassinets.
• Keep blankets and other soft bedding or items out of product.
Babies have been injured from FALLS.
• Do not use on beds, sofas, or other raised surfaces.
The proposed rule, like ASTM’s draft,
requires on-product warning labels to be
‘‘conspicuous,’’ defined as ‘‘visible,
when the product is in each
manufacturer’s recommended use
position, to a person while placing an
infant into or onto the product.’’ Also,
like ASTM’s draft, the proposed rule
requires such warning labels to be
‘‘permanent,’’ with permanence
requirements based on ASTM’s draft but
better addressing the potential for
consumers to attempt to remove onproduct warning labels. The draft ASTM
warning label for infant loungers
indicates that the product should only
be used on the floor, ‘‘with baby faceup on back.’’ This proposed rule would
adopt ASTM’s draft language. However,
this proposed rule for infant support
cushions includes products that can be
used for ‘‘tummy time,’’ for which
infants are on their stomach. The
Commission invites public comments in
answer to the following questions:
Should manufacturers have flexibility to
remove or change the ‘‘with baby faceup on back’’ language in the warning
label? If so, in what circumstances?
The proposed rule incorporates by
reference American National Standards
Institute (ANSI) ANSI Z535.4, Product
Safety Signs and Labels, which includes
requirements related to safety alert
symbol use; signal word selection;
warning panel format, arrangement, and
shape; color requirements for each
panel; and letter style. The Commission
specifically references the warning
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format requirements published in
sections 6.1–6.4, 7.2–7.6.3, and 8.1. See
Staff’s NPR Briefing Package, Tab D, 80–
81.
In addition to on-product warnings,
the ASTM draft standard includes basic
warning requirements for instructional
literature that are the same as those in
ASTM’s draft.
VIII. Proposed 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
proposed standard for infant support
cushions would be 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
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safety rule in accordance with section
14(a)(2) of the CPSA. Part 1112 also lists
the NORs that the CPSC has published.
The Commission proposes 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.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new 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. Product Registration Rule
Amendment
In addition to requiring the
Commission to issue safety standards
for durable infant or toddler products,
section 104 of the CPSIA directed the
Commission to issue a rule requiring
that manufacturers of durable infant or
toddler products establish a program for
consumer registration of those products.
15 U.S.C. 2056a(d). Section 104(f) of the
CPSIA 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,’’ and
lists 12 distinct product categories. 15
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U.S.C. 2056a(f). The product categories
listed in section 104(f)(2) of the CPSIA
represent a non-exhaustive list of
durable infant or toddler product
categories. Infant support cushions are
not included in the statutory list of
durable infant or toddler products.
In 2009, the Commission issued a rule
implementing the consumer registration
requirement. 74 FR 68668 (Dec. 29,
2009) (establishing 16 CFR part 1130).
As section 104(d) of the CPSIA directs,
the consumer registration rule requires
each manufacturer of a durable infant or
toddler product to provide a postagepaid consumer registration form with
each product; keep records of
consumers who register their products
with the manufacturer; and permanently
place the manufacturer’s name and
certain other identifying information on
the product.
When issuing the consumer
registration rule, the Commission
identified six additional products as
durable infant or toddler products:
children’s folding chairs; changing
tables; infant bouncers; infant bathtubs;
bed rails; and infant slings. 74 FR
68669. The Commission explained that
the specified statutory categories are not
exclusive, and that the Commission is
charged with identifying the product
categories that are covered. ‘‘Because
the statute has a broad definition of a
durable infant or toddler product but
also includes 12 specific product
categories,’’ the Commission noted,
‘‘additional items can and should be
included in the definition, but should
also be specifically listed in the rule.’’
Id. at 68670.
The Commission proposes in this
NPR to amend part 1130 to include
‘‘Infant Support Cushions’’ as durable
infant or toddler products. Infant
support cushions are a category of
‘‘durable infant or toddler product’’ for
purposes of CPSIA section 104 because
they: (1) are intended for use, and may
be reasonably expected to be used, by
children under the age of five years; (2)
are products similar to other products
listed in section 104(f)(2), such as crib
mattresses and sling carriers; and (3) are
commonly resold or ‘‘handed down’’ for
use by other children over a period of
years.
X. Incorporation by Reference
The proposed rule incorporates by
reference ANSI Z535.4–2011, American
National Standard for Product Safety
Signs and Labels and ASTM D3359,
Standard Test Methods for Rating
Adhesion by Tape Test. In accordance
with regulations of the Office of the
Federal Register (OFR), 1 CFR part 51,
Part VII.D of this preamble summarizes
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ANSI Z535.4–2011. ASTM D3359
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.
Both standards are reasonably
available to interested parties in several
ways. By permission of ANSI, the ANSI
standard can be viewed as a read-only
document during the comment period
on this NPR, at: https://www.survey
monkey.com/r/DQVJYMK. To download
or print the standard, interested persons
may purchase a copy of ANSI Z535.4–
2011 from ANSI via its website, https://
www.ansi.org, or by mail from ANSI, 25
West 43rd Street, 4th Floor, New York,
NY 10036, telephone: (212)–642–4900.
By permission of ASTM, this ASTM
standard can be viewed as a read-only
document during the comment period
on this NPR, at: https://www.astm.org/
cpsc.htm. To download or print the
standard, interested persons may
purchase a copy of ASTM D3359 from
ASTM, through its website, https://
www.astm.org, or by mail from ASTM
International, 100 Barr Harbor Drive,
P.O. Box 0700, West Conshohocken, PA
19428–2959. 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 EastWest Highway, Bethesda, MD 20814;
telephone: (301) 504–7479; email: cpscos@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). The Commission
proposes an effective date of 180 days
after publication of the final rule in the
Federal Register, such that the
requirements of the rule would apply to
all infant support cushions
manufactured after that date. This
amount of time is typical for rules
issued under section 104 of the CPSIA.
It is also the period that the Juvenile
Products Manufacturers Association
(JPMA) typically allows for products in
their certification program to shift to a
new standard once that new standard is
published. Therefore, juvenile product
manufacturers are accustomed to
adjusting to new standards within this
time. 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
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2541
would be required to test infant support
cushions for compliance with the
proposed rule. The Commission invites
comments, particularly from small
businesses, that provide specific data
addressing whether the proposed 180day effective date period is appropriate.
XII. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA;
5 U.S.C. 601–612) requires that agencies
review a proposed rule’s potential
economic impact on U.S. small entities,
including small businesses. Section 603
of the RFA generally requires that
agencies make an initial regulatory
flexibility analysis (IRFA) available to
the public for comment when the NPR
is published. The IRFA must describe
the impact of the proposed rule on small
entities and identify significant
alternatives that accomplish the
statutory objectives and minimize any
significant economic impact of the
proposed rule on small entities. Staff
prepared an IRFA for this rulemaking
that appears at Tab E of the Staff’s NPR
Briefing Package. We summarize the
IRFA below.
A. Reasons and Legal Basis for the NPR
Part I of this preamble describes the
reasons and legal basis for this NPR. As
discussed in Parts VII–IX of this
preamble, and detailed in Tab B of
Staff’s NPR Briefing Package, the
proposed rule sets out 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. Small Entities to Which the Proposed
Rule Would Apply
As explained in Tab E to Staff’s NPR
Briefing Package, Commission staff has
identified more than 2,000 suppliers of
infant support cushions to the U.S.
market, including manufacturers,
importers, and foreign direct shippers.
The majority of these suppliers are
small businesses.
C. Impact of the Proposed Rule on Small
Manufacturers and Importers
Most in-scope products on the market
will require redesign to meet the
requirements in the proposed rule, and
redesign costs would be potentially
significant for a substantial number of
small firms, particularly small-volume
home crafters, for the first year that a
rule is effective. Staff considers a
‘‘significant’’ impact to be at least one
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percent of annual revenue, which is
consistent with the regulatory flexibility
analyses of other federal agencies. With
an estimated 2,000 models to be
redesigned, the total cost of redesign to
the industry in the first year could be up
to $27 million. However, as discussed in
Tab E of Staff’s Briefing Package,
suppliers may be able to cover these
costs by implementing modest retail
price increases which would reduce the
rule’s impact on individual small
entities. For example, a firm supplying
5,000 infant support cushions per year
could cover the entire cost of redesign
by raising the retail price by $2.70.
If issued, a final rule would require all
manufacturers and importers of infant
support cushions to meet additional
third party testing requirements under
section 14 of the CPSA. As specified in
16 CFR part 1109, entities that are not
manufacturers of children’s products,
such as importers and wholesalers, may
rely on the certificates of compliance
provided by others. However,
manufacturers could pass on at least
some of the cost of testing for
compliance to U.S. importers and
wholesalers.
Third party testing costs for infant
support cushions are estimated to be
$500 to $1,000 per model. The annual
cost of samples for testing is estimated
at around $100, bringing the overall
annual testing cost to an estimated $600
to $1,100 per model. The costs of testing
per model would be similar for
suppliers of all sizes, although larger
firms may be more likely to qualify for
volume discounts. As with redesign
costs, these testing costs could largely
be covered by modest retail price
increases.
The hand crafters of infant support
cushions with the smallest sales
volumes may not have sufficient sales
volume to cover these costs and may
exit the market. However, consumers
would likely not experience a
significant loss of utility as there are
many different products available from
different suppliers.
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D. Other Federal Rules That May
Duplicate, Overlap, or Conflict With the
Proposed Rule
The Commission has not identified
any federal rules that duplicate, overlap
with, or conflict with the proposed rule.
E. Alternatives Considered To Reduce
the Impact on Small Entities
The Commission considered the
following alternatives to the proposed
rule to reduce the impact on small
businesses. The Commission requests
comments on these alternatives and
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other alternatives that could reduce the
potential burden on U.S. small entities.
1. Not Establishing a Safety Standard
The Commission considered not
establishing a safety standard for infant
support cushions. While this alternative
would result in no regulatory impact on
small entities, deaths and injuries from
the use of infant support cushions
would likely continue to occur at
similar rates as those observed during
the period from 2010 through 2022. In
2020 alone, there were 17 fatalities
involving infant support cushions.
Another 17 fatalities have been recorded
in the potentially incomplete data for
2021. See Staff NPR Briefing Package,
Tab A.
2. Delay To Await Publication of a
Voluntary Standard
The Commission considered delaying
the draft proposed rule to allow possible
publication of a voluntary standard.
Although this alternative would delay
any impact on small businesses, it
would also allow the hazard to continue
indefinitely, as there is no clear date at
which ASTM or any other voluntary
standards organization will adopt a
relevant standard, nor any assurance
that a voluntary standard, if published,
would be complied with by industry or
adequately address the identified
hazards.
3. Earlier or Later Effective Date
The Commission is proposing an
effective date 180 days after publication
of the final rule in the Federal Register.
An earlier effective date would achieve
the safety benefits of the rule more
quickly, but it would also increase the
burden on small businesses to quickly
redesign and test their products. In
addition, a significantly earlier effective
date could result in temporary shortages
of infant support cushions due to a
potential lack of availability of testing
laboratory resources.
The Commission is not proposing a
later effective date, which would
somewhat reduce burdens on small
suppliers, because 180 days has
generally been sufficient time for
suppliers to come into compliance with
durable infant or toddler product rules.
Additionally, six months from the
change in a voluntary standard is the
period that JPMA uses for its
certification program, so compliant
manufacturers are used to this time
frame to comply with a modified
standard. Testing laboratories should
have no difficulty preparing to test to
the proposed new mandatory standards
within a 180-day period.
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F. Impact on Testing Labs
The proposed rule should not have a
significant adverse impact on testing
laboratories. Laboratories will not need
to acquire complex or costly testing
instruments or devices to test infant
support cushions for compliance, and
laboratories will decide for themselves,
based on expected demand for their
testing services, whether to offer testing
services for infant support cushion
compliance.
XIII. 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 proposed rule for
infant support cushions falls within the
categorical exclusion.
XIV. Paperwork Reduction Act
This proposed 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). In this document, pursuant
to 44 U.S.C. 3507(a)(1)(D), we set forth:
• a title for the collection of
information;
• a summary of the collection of
information;
• a brief description of the need for
the information and the proposed use of
the information;
• a description of the likely
respondents and proposed frequency of
response to the collection of
information;
• an estimate of the burden that shall
result from the collection of
information; and
• notice that comments may be
submitted to the OMB.
Title: Safety Standard for Infant
Support Cushions.
Description: The proposed rule would
require each infant support cushion
within the scope of the rule to meet the
rule’s performance and labeling
requirements. It would require suppliers
to conduct third party testing to
demonstrate compliance and provide
the specified warning label and
instructions. These requirements fall
within the definition of a ‘‘collection of
information,’’ as defined in 44 U.S.C.
3502(3).
Description of Respondents: Persons
who manufacture or import infant
support cushions.
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2543
Estimated Burden: We estimate the
burden of this collection of information
as follows:
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TABLE 7—ESTIMATED ANNUAL REPORTING BURDEN
Burden type
Number of
respondents
Frequency of
response
Total annual
responses
Hours per
response
Total burden
hours
Labeling and instructions .....................................................
2,000
1
2,000
2
4,000
While some infant support cushion
products currently have labels, all of
these products would have to meet the
specific labeling requirements and
instructions specified in the proposed
rule, which provides the text and
graphics for the required labels and
instructions. Specialized expertise in
graphics design would not be required
to develop the warnings and
instructions. Most reporting and
recordkeeping requirements in this
proposed rule would be new for all
suppliers.
CPSC estimates there are 2,000
entities that would respond to this
collection annually, the majority of
which would be small entities. We
estimate that the time required to create
and/or modify labeling and instructions
is about two hours per response.
Therefore, the estimated burden
associated with this collection is 2,000
responses × one response per year × two
hours per response = 4,000 hours
annually.
We estimate the hourly compensation
for the time required to respond to the
collection is $37.88 (U.S. Bureau of
Labor Statistics, ‘‘Employer Costs for
Employee Compensation,’’ June 2023,
Table 4, total compensation for all sales
and office workers in goods-producing
private industries: https://www.bls.gov/
news.release/archives/ecec_
09122023.pdf. Therefore, the estimated
annual cost of the collection is $151,520
($37.88 per hour × 4,000 hours =
$151,520).
Based on this analysis, the proposed
standard for infant support cushions
would impose a burden to industry of
4,000 hours at a cost of $151,520.
Comments. CPSC has submitted the
information collection requirements of
this proposed rule to OMB for review in
accordance with PRA requirements. 44
U.S.C. 3507(d). CPSC requests that
interested parties submit comments
regarding information collection to the
Office of Information and Regulatory
Affairs, OMB (see the ADDRESSES section
at the beginning of this NPR). Pursuant
to 44 U.S.C. 3506(c)(2)(A), the
Commission invites comments on:
• whether the collection of
information is necessary for the proper
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performance of CPSC’s functions,
including whether the information will
have practical utility;
• the accuracy of CPSC’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
• ways to enhance the quality, utility,
and clarity of the information to be
collected;
• ways to reduce the burden of the
collection of information on
respondents, including the use of
automated collection techniques when
appropriate and other forms of
information technology; and
• the estimated burden hours
associated with label modification,
including any alternative estimates.
XV. 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, if
finalized, the preemption provision of
section 26(a) of the CPSA would apply
to this rule for infant support cushions.
XVI. Request for Comments
The Commission seeks public
comment on all aspects of the proposed
rule. In particular, the Commission
seeks comments on the scope of the
proposed rule, with respect to both in
scope and out of scope products,
including comments on whether the
proposed definition of ‘‘infant support
cushion’’ is sufficient to include all
infant support cushions that are not
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subject to the FHSA infant pillow ban,
16 CFR 1500.18(a)(16). The Commission
would also welcome comments on the
wording of proposed warning label as
well as on whether the on-product
warning label requirement included in
the proposed rule should be applied to
replacement covers for infant support
cushions in addition to the cushions
themselves. In addition, the
Commission invites public comment on
the proposed limit on sidewall height
and whether the proposed rule’s incline
angle requirements provide appropriate
protection against positional
asphyxiation. The Commission also
seeks comment on whether an antistockpiling provision should be
included and, if so, whether the
Commission should include an antistockpiling provision comparable to the
one proposed in the recent SNPR for
portable generators at 88 FR 24346,
24372 (Apr. 20, 2023). Finally, the
Commission requests comments on the
proposed effective date and the costs of
compliance with, and testing to, the
proposed rule.
Submit comments in accordance with
the instructions in the ADDRESSES
section at the beginning of this NPR.
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 proposes to
amend chapter II of title 16 of the Code
of Federal Regulations as follows:
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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: Pub. L. 110–314, section 3, 122
Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend § 1112.15, as proposed to be
amended at 88 FR 65865 (Sept. 26,
2023), by:
■ a. Removing the semicolons at the
ends of paragraphs (b)(1) through (9)
and (11) through (27), (b)(28)(v),
(b)(29)(iv), (b)(30)(iv), and (b)(31)(ii) and
adding periods in their place;
■ b. Adding periods at the ends of
paragraphs (b)(32)(ii)(A) through (KK);
and
■ c. Adding paragraph (b)(57).
The addition reads as follows:
■
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/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
3. The authority citation for 16 CFR
part 1130 continues to read as follows:
Authority: 15 U.S.C. 2056a, 2065(b).
4. Amend § 1130.2, as proposed to be
amended at 88 FR 65865 (Sept. 26,
2023) and 88 FR 73551 (Oct. 26, 2023),
by:
■ a. Removing the semicolons at the
ends of paragraphs (a)(1) through (16)
and adding periods in their place;
■ b. Removing ‘‘; and’’ at the end of
paragraph (a)(17) and adding a period in
its place; and
■ c. Adding paragraph (a)(21).
The addition reads as follows:
■
Definitions.
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*
*
*
*
*
(a) * * *
(21) 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.
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Test methods.
Marking and labeling.
Instructional literature.
Incorporation by reference.
Authority: 15 U.S.C. 2056a.
§ 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 § 1243.2. This includes but
is not limited to infant positioners,
nursing products 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 [effective
date of the final rule], 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, however,
are not exempt from this part.
§ 1243.2
■
§ 1130.2
1243.5
1243.6
1243.7
1243.8
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
product 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.
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.
§ 1243.3
General requirements.
(a) Hazardous sharp edges or points.
There shall be no hazardous sharp
points or edges as defined in 16 CFR
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1500.48 and 1500.49 before or after the
product has been tested.
(b) Small parts. There shall be no
small parts as defined in 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
pillow, as well as their means of
attachment, shall comply with the
applicable requirements of 16 CFR part
1250.
(e) Side height. The maximum side
height for the product, measured from
the OSS-body or test base, as
appropriate, to the top of the sidewall,
shall not exceed the maximum of the
side heights determined in
§ 1243.5(d)(8).
(f) 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.
(g) 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).
(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).
(h) 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).
E:\FR\FM\16JAP1.SGM
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Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
(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 three-inch
2545
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 N.
3-in. Hemispherical
Surface.,
Smooth Rnish
1-2 in.
R.eoommended Length
§ 1243.5
Test methods.
ddrumheller on DSK120RN23PROD with PROPOSALS1
(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%.
(b) Permanence of labels and
warnings. (1) A paper label (excluding
labels attached by a seam) shall be
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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.
(ii) Perform this test once in each
different location where warnings are
applied.
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(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 2 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
3 to this paragraph (c)) can be freely
inserted through the opening.
E:\FR\FM\16JAP1.SGM
16JAP1
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(2) Sidewall firmness. When the threeinch diameter hemispherical head probe
is applied according to the test method
for sidewall firmness, § 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.
When the three-inch diameter
hemispherical head probe is applied
according to the test method for
firmness at the intersection of sidewall
and occupant support surface,
§ 1243.5(h), the force required for a oneinch displacement shall be greater than
10 N.
(f) Sidewall angle. Sidewall angle
shall be greater than 90 degrees when
determined according to the sidewall
angle determination, § 1243.5(i).
2546
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
Figure 2 to Paragraph (c)—Small Head
Probe
Figure 3 to Paragraph (c)—Large Head
Probe
f rl _-___.l
-_LL_-__-:]l:~
4.11.ltl,
(11111 mm}
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i::
I• -::..--:-._--
(i) Digital protractor with accuracy +/
¥ 1 degree;
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(ii) Hinged weight gauge-newborn,
requirements for part masses and
E:\FR\FM\16JAP1.SGM
16JAP1
EP16JA24.020</GPH>
(d) Maximum incline test. (1)
Equipment shall include:
--
EP16JA24.019</GPH>
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L
~f
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
assembly (figure 4 to this paragraph
(d)(1)(ii));
2547
Figure 4 to Paragraph (d)(ii)—Hinged
Weight Gauge-Newborn, Requirements
for Part Masses and Assembly
BILLING CODE 6355–01–P
ITEM
Assembly
3.378 ± .02 kg (7.447 ± .05 lb)
1
Upper Plate
2.275 kg
(5.816 lb)
289.8 cmA3
(17.68 jnA3)
2
Lower Plate
1.079 kg
(2.379 lb)
137.4 cmA3
(8385 cmA3)
3
Pin
8.824 kg
(8.053 lb)
3.03 cmAJ
{0,185 jnA3)
Note 1. Part mass is calculated as Volume divided by the density for
mild steel of 7.85 g/cmA3 (0.283 lbs/inA3).
1------(279.4 [11.00 i n ] ) - - -
- - - - - - - - - ( 4 6 2 . 0 [18.19 i n ] ) - - -
(iii) Hinged weight gauge-newborn,
requirements for part dimensions (figure
5 to this paragraph (d)(1)(iii)); and
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ddrumheller on DSK120RN23PROD with PROPOSALS1
□
2548
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
Figure 5 to Paragraph (d)(1)(iii)—
Hinged Weight Gauge–Newborn,
Requirements for Part Dimensions
tU[.ta in] Brealt·Eiml!S---------.
All Around
2
3
103,6 [4.08 in]
R3.2[R.13ln1
-tfltC
R15J) [R.59 inJ
-2 PLC
id(S.Js PresS Fit • •
n.10 r.soo 1111
~---t!
[,$]\IL,;:.;._·.- - - - . ; . . _ ..;.._-·.;.._·.;.._-.;.._---,- ..;.._-.;.._-.;.._.;.._-.;.._·.;.._I
l
0.8 {.03 in] Break Edges
6;35 (;250 ~]
I
i.86 [;270111]
213.9 [8.42 in]
279.4 [U.,(!)t lh]
All Arouno
1
9SJ}[3.18m]
61.0 [2.40 in] .~
63.5[ .SO In]
note 1
56.0 [2.2(;) in]
ill
~--------1
' - ' - - - - - - - - - ( 2 8 5 . 8 [11.25 I n } ) - - - - - - - - ,
(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
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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
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portion of the gauge, depending on the
product design, allowed to lay freely on
the product or on the test base (figure 6
to this paragraph (d)(4)).
Figure 6 to Paragraph (d)(4)—Test
Fixture Configuration To Measure
Incline Angle on an Infant Support
Cushion Product
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ddrumheller on DSK120RN23PROD with PROPOSALS1
BILLING CODE 6355–01–C
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
2549
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) Remove the newborn gauge and
determine the side height at the incline
angle location, measured from the OSSbody or test base, as appropriate, to the
top of the OSS-head.
(9) 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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(10) 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 three-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. See
figure 7 to this paragraph (f).
(1) Orient the axis of the three-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.
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(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
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.
E:\FR\FM\16JAP1.SGM
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ddrumheller on DSK120RN23PROD with PROPOSALS1
SIDEWALL
2550
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
Figure 7 to Paragraph (f)—Test
Configuration for Occupant Support
Surface Firmness Test
10N
3•lN HEMISPHERICAL
TEST PROBE
OCCUPANT SUPPORT SURFACE
TEST BASE
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(h) Intersection of sidewall and
occupant support surface firmness.
Perform the following steps to
determine the intersection firmness of
the product as received from the
manufacturer (figure 8 to this paragraph
(h)).
(1) Orient the axis of the three-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.
Figure 8 to Paragraph (h)—Test
Configuration for Intersection of
Sidewall and Occupant Support
Surface Firmness
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ddrumheller on DSK120RN23PROD with PROPOSALS1
(g) Sidewall firmness test method. For
sidewalls, 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 six 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.
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
2551
- - - - - - + - : M N HEMISF'HERICAI.
TI::ST PROBE
OSIS
----TEST BASE
'------INTERSECTION
SIDEWAlL/OSS
(i) Sidewall angle determination.
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 9 to this paragraph
(i).
(1) Orient the three-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 three-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
three-inch head probe and the sidewall.
(4) Determine a minimum of four
sidewall angles at locations not to
exceed six 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 three-inch probe side and the
sidewall.
Figure 9 to Paragraph (i)—Test Fixture
Configuration for Sidewall Angle
Measurement
10 N
.-----3-IN lffHlSl'l1ERlCAL
T!ST PROllf:
SIDEWAU/OSS
(j) Seam strength test method. (1)
Equipment shall include:
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Jkt 262001
(i) Clamps with 0.75 inches (1.9 cm)
diameter clamping surfaces capable of
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holding fabric and with a means to
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------INTERSECTION
EP16JA24.025</GPH>
ddrumheller on DSK120RN23PROD with PROPOSALS1
OS'S
2552
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
attach a force gauge. See figure 10 to this
paragraph (j)(1), or equivalent.
(ii) A force gauge, accuracy +/¥0.5
lbs (1.1 N).
Figure 10 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 five 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) 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) Gradually apply a four lbs-inch
(0.4 N-m) torque over five seconds in a
clockwise rotation to 180 degrees or
until four lbs-inch 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) For components that can
reasonably be grasped between thumb
and forefinger, or teeth, apply a 15 lbs
(67 N) force over five seconds, in a
direction to remove the component.
Maintain for 10 seconds. A clamp such
as shown in figure 11 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 11 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:
(1) The name, place of business (city,
state, and mailing address, including zip
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16:48 Jan 12, 2024
Jkt 262001
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
are not required on the retail package if
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Sfmt 4702
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
E:\FR\FM\16JAP1.SGM
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§ 1243.6
EP16JA24.027</GPH>
ddrumheller on DSK120RN23PROD with PROPOSALS1
0
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
(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 (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’’).
2553
least 0.2 inches (five 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.
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.
(6) The message panel text should
have the following layout:
(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.
(5) The safety alert symbol and the
signal word ‘‘WARNING’’ shall be at
Figure 1 to Paragraph (d)(6)—Examples
of Left-Aligned Text
The text shown for these warnings is filler text, known as lorem ipsum,
commonly used to demonstrate graphic elements .
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....... ........ ... ,-
................ ,......,,.._.......
.... -'<n1clc-,,...
~t...................... ~ ......,..-
• tl ,_. NII •1""-:..,_,,._._," _,..,,.,..._,,.,_,,,_,...,,,,II-..••
~
W,.:11,...lil•. . . . -.(.ll. . . . . . . . .)
.,,......................
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...,,_..... _.,~..,..,.,_.,.n,........,.'W.r_.,.
___...,.,._,_,u~t• ..-.~cw-t•
-~..... ......
---- ..........,........,., ... ""' w,.,1..,.
._..-.l_.......,,,_"°_...,_\
1.,......,.,••
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.... .....
. . . . . . . . .j,...,.,..,.ll'"ll''h
t ........
lttkv.....-wt,~-......~4!.--
. . , .• • . , ..........Ill\ • • • • •, ....... ·•PO."'I
•W.,.,i;_.. . .,llir...... (............i.. 411.it:-•
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- - • - ~ !............
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\-11-•...t.•..:i•-~-~;
................. ,'>t. . . . . . . . . . . . . . . .
...._,_;~~-
, . ...,.,.,..,• .....,."tr. . .l:ll•~
. ....
....,.,,~ .•
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...... ....
. . . . . . . . . . . . . . . . . . . .. . . _ . . . . . . . .I., . .
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. . . . , . , . . . . . . . . . . . . . . . .(l"IJIIIIM.,C ......t ......~
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..'- ... ~•~•-•fll'
....,,. .,,
. . . . . . . . . . . . . wi!)l..ltlM-'Wl,;ill-'o•
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.. o.,.,""""'•~· ................~........._
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margin, and in the case of multiple columns
VerDate Sep<11>2014
16:48 Jan 12, 2024
Jkt 262001
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
PO 00000
Frm 00039
Fmt 4702
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be separated by bullet points if
paragraph formatting is used.
(7) An example warning in the format
described in this section is shown in
figure 2 to this paragraph (d)(7).
Figure 2 to Paragraph (d)(7)—Example
of Warning
E:\FR\FM\16JAP1.SGM
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ddrumheller on DSK120RN23PROD with PROPOSALS1
The text shown for these warnings is
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2554
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Proposed Rules
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ddrumheller on DSK120RN23PROD with PROPOSALS1
§ 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
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 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 sections 6.4 and 7.2–7.6.3 of
ANSI Z535.4—2011 need not be
applied. However, the signal word and
safety alert symbol shall contrast with
the background of the signal word
VerDate Sep<11>2014
16:48 Jan 12, 2024
Jkt 262001
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.
§ 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: 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:
(a) American National Standards
Institute (ANSI), 25 West 43rd Street,
PO 00000
Frm 00040
Fmt 4702
Sfmt 4702
4th Floor, New York, NY 10036, USA;
phone: (212) 642–4900; website:
www.ansi.org (https://ibr.ansi.org/
Standards/nema.aspx).
(1) ANSI Z535.4–2011, American
National Standard for Product Safety
Signs and Labels, approved October 20,
2017; approved for § 1243.6.
(2) [Reserved]
(b) ASTM International, 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 [TBD]; approved for
§ 1243.5.
(2) [Reserved]
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2023–27324 Filed 1–12–24; 8:45 am]
BILLING CODE 6355–01–P
COMMODITY FUTURES TRADING
COMMISSION
17 CFR Part 23
RIN 3038–AF33
Capital and Financial Reporting
Requirements for Swap Dealers and
Major Swap Participants
Commodity Futures Trading
Commission.
ACTION: Proposed rule.
AGENCY:
The Commodity Futures
Trading Commission (‘‘Commission’’ or
SUMMARY:
E:\FR\FM\16JAP1.SGM
16JAP1
EP16JA24.030</GPH>
(e) Warning statements. Each product
shall address the warning statements
shown on figure 13 to paragraph (d)(7)
of this section, at a minimum.
]]>Agencies
[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Proposed Rules]
[Pages 2530-2554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27324]
=======================================================================
-----------------------------------------------------------------------
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: Notice of proposed rulemaking.
-----------------------------------------------------------------------
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 direction,
the Commission is proposing a safety standard for infant support
cushions. The Commission is also proposing to amend CPSC's consumer
registration requirements to identify infant support cushions as
durable infant or toddler products and proposing to amend CPSC's list
of notices of requirements (NORs) to include infant support cushions.
DATES: Submit comments by March 18, 2024.
ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature requirements of the
proposed rule should be directed to the Office of Information and
Regulatory Affairs, Office of Management and Budget, Attn: CPSC Desk
Officer, FAX: 202-395-6974, or emailed to [email protected].
Other comments, identified by Docket No. CPSC-2023-0047, may be
submitted electronically or in writing, as follows:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. Do not submit through this
website: confidential business information, trade secret information,
or other sensitive or protected information that you do not want to be
available to the public. CPSC typically does not accept comments
submitted by email, except as described below.
Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC
encourages you to submit electronic comments by using the Federal
eRulemaking Portal. You may, however, submit comments by mail, hand
delivery, or courier to: Office of the Secretary, Consumer Product
Safety Commission, 4330 East West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479.
Instructions: All submissions received must include the agency name
and docket number for this proposed rulemaking. CPSC may post all
comments without change, including any personal identifiers, contact
information, or other personal information provided, to:
www.regulations.gov. If you wish to submit confidential business
information, trade secret information, or other sensitive or protected
information that you do not want to be available to the public, you may
submit such comments by mail, hand delivery, or courier, or you may
email them to: [email protected].
Docket: For access to the docket to read background documents or
comments received, go to: https://www.regulations.gov, insert the
docket number, CPSC-2023-0047, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Stefanie Marques, Ph.D., Project
Manager, Directorate for Health Sciences, U.S. Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; email:
[email protected]; telephone: (301) 987-2581.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
Section 104(b) 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. 15 U.S.C. 2056a(b)(1). 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.'' 15 U.S.C. 2056a(b)(2).
The Commission is issuing this notice of proposed rulemaking (NPR)
to establish a consumer product safety rule for infant support cushions
to further implement section 104 of the CPSIA.\1\ The proposed 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 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.
---------------------------------------------------------------------------
\1\ On November 29, 2023, the Commission voted (4-0) to publish
this notice of proposed rulemaking, with an amendment proposed by
Commissioner Trumka. Commissioners Trumka and Boyle issued
statements in connection with their votes, available at: https://www.cpsc.gov/s3fs-public/2023-11-29-Commission-Meeting-Minutes-Infant-Support-Cushions-NPR-Decisional.pdf?VersionId=9Y0qjnS2A74SHa932SzV9txWDIaMddXU.
---------------------------------------------------------------------------
CPSC staff identified at least 79 reported fatalities involving
infant support cushions from January 1, 2010, through December 31,
2022, as well as 125 nonfatal incidents or reports involving these
products within the same time period. There were 17 deaths in 2020, and
at least 17 more in the potentially incomplete data from 2021. More
than 80 percent of the fatalities associated with these products
involved infants three months old and younger. In more than 60 percent
of the fatalities, the official cause of death was either asphyxia or
probable asphyxia, and these incidents typically involved 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 a on a
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 the threat of asphyxia or
entrapment.
This proposed rule addresses the risk of death and injury
associated with
[[Page 2531]]
infant support cushions primarily due to suffocation, entrapment, and
fall hazards. The proposed rule would address 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,
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 proposed rule would set 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 unattended infants. The proposed rule
also requires a strongly worded, conspicuous, and permanent on-product
warning.
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.\2\ Currently, however, no voluntary or
mandatory safety standard for infant support cushions exists to address
the hazards posed by these products.
---------------------------------------------------------------------------
\2\ CPSC formally began the consultation process for this
rulemaking in December 2021, via a letter from CPSC 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. CPSC staff has been actively participating in
both ASTM subcommittees to develop voluntary standards that address
hazards associated with these products.
---------------------------------------------------------------------------
Infant support cushions are a durable infant or toddler product
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.'' 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 and often are used by multiple children
successively; are similar to other durable infant and children's
products such as crib mattresses and sling carriers; 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 Commission proposes to amend 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 also must comply with product
registration requirements, as well as 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 proposed rule would be a children's
product safety rule that requires issuance of an NOR.
II. The Product Category
A. Infant Support Cushions
Infant support cushions include products that support an infant for
lounging, meaning reclining or lying in a supine, prone, or recumbent
position. Infant products within this category may or may not contain
infants with perimeter walls. Most infant support cushions on the
market today 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 others, 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.
Illustrative pictures of infant support cushions can be found in
Tab C of staff's briefing package for this proposed rule.\3\ A non-
exhaustive list of examples of infant support cushions includes:
---------------------------------------------------------------------------
\3\ Staff Briefing Package: Staff's Draft Proposed Rule for
Infant Support Cushions (November 8, 2023) (Staff's NPR Briefing
Package), available at: https://www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------
head positioner pillows;
flat baby loungers;
crib pillows;
wedge pillows for infants;
infant sleep positioners, unless regulated by the Food and
Drug Administration (FDA) as medical devices;
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 would be required to meet the performance
standards of this rule. To avoid potentially duplicative or conflicting
obligations, however, the scope of products that would be subject to
this proposed 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).
Illustratively, the following products are not infant support
cushions within the scope of this proposed rule:
Pillows not marketed or intended for use by infants, such
as adult bed and throw pillows;
nursing pillows if subject to Commission's proposed
nursing pillow rule 88 FR 65865 (Sept. 26, 2023) if that rule is
finalized, unless they are also marketed for lounging;
crib and play yard mattresses that are in scope of the
play yard and crib mattress standard in 16 CFR part 1241;
purely decorative nursery pillows, such as those
personalized with a baby's name and birthdate, that are not for infant
use;
stuffed toys (unless they meet the definition of an infant
support cushion in this proposed 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; and
sleeping accommodations, which 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
[[Page 2532]]
general online retailers, online sites for ``big box'' stores, online
baby products sites, and online marketplaces for hand-crafted items. A
few types of infant support cushions, however, are also available from
brick-and-mortar baby specialty stores and general retail stores,
particularly crib pillows and baby loungers. 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
sleep. Several thousand manufacturers and importers, including hundreds
of handcrafters and direct foreign shippers, supply infant support
cushions to the U.S. market. See Staff's NPR Briefing Package, Tab E.
Infant support cushions may be re-used for multiple children or
sold for use after an infant outgrows the product. Commission staff
observed that used infant support cushions are widely available on
secondary marketplaces such as eBay and Mercari. In June 2023, for
example, 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.
C. Infant Cushion/Pillow Ban
In 1992, pursuant to the Commission's 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.
16 CFR 1500.18(a)(16). This proposed rule for infant support cushions
does not change the 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 proposed rule and would be
required to comply with the performance requirements of this proposed
rule.\4\
---------------------------------------------------------------------------
\4\ 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 proposed rule or to the
proposed standard for nursing pillows.
---------------------------------------------------------------------------
III. Incident Data and Hazard Patterns
CPSC staff searched the Consumer Product Safety Risk Management
System (CPSRMS) \5\ and National Electronic Injury Surveillance System
(NEISS) \6\ 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. Tab A of Staff's NPR Briefing Package describes the
incident and hazard patterns associated with infant support cushions.
---------------------------------------------------------------------------
\5\ 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.
\6\ 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 https://www.cpsc.gov/Research-Statistics/NEISS-Injury-Data.
---------------------------------------------------------------------------
Commission staff identified 79 fatal incidents and 125 nonfatal
incidents and consumer concerns reported to CPSC from 2010-2022. Of the
125 non-fatal reports. 22 consisted of emergency-department-treated
injuries, three involved hospital admissions, 46 reports involved no
injury, and for 52 reports the disposition was either unknown or
unspecified. Table 1 provides the distribution of fatal incidents by
year.
[[Page 2533]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.012
Table 2 summarizes the number of reported fatalities related to
infant support cushions for victims 12 months and younger by age in
months and by gender. As reflected in Table 2, 80 percent of the
fatalities with a known age were infants in the zero to three month age
range. Among the 76 fatalities for which the sex is known, half were
male and half were female.
Table 2--Infant Support Cushion-Related Fatalities for Victims Ages 12 Months and Younger and Sex: 2010-2022
----------------------------------------------------------------------------------------------------------------
Total (% of Male (% of Female (% of Unknown (% of
Age (In months) total) total) total) total)
----------------------------------------------------------------------------------------------------------------
Total........................................... 79 (100%) 38 (48%) 38 (48%) 3 (4%)
1............................................... 26 (33%) 12 (15%) 14 (18%) 0
2............................................... 19 (24%) 10 (13%) 9 (11%) 0
3............................................... 18 (23%) 8 (10%) 10 (13%) 0
4............................................... 7 (9%) 4 (5%) 3 (4%) 0
5............................................... 3 (4%) 1 (1%) 0 2 (3%)
6............................................... 1 (1%) 0 1 (1%) 0
7............................................... 2 (3%) 1 (1%) 1 (1%) 0
8............................................... 0 0 0 0
9............................................... 0 0 0 0
10.............................................. 1 (1%) 1 (1%) 0 0
11.............................................. 1 (1%) 1 (1%) 0 0
12.............................................. 0 0 0 0
Unknown......................................... 1 (1%) 0 0 1 (1%)
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Percentages may not add to 100 due to rounding; the years 2021-2022 are
considered incomplete.
The official cause of death reported by the medical examiner in the
majority of the 79 reported fatalities 49 (62 percent) was asphyxia or
probable asphyxia; 13 (17 percent) were determined to be due to sudden
unexpected infant death (SUID) events; 12 (15 percent) had an
undetermined cause of death; and for five (six percent), no medical
examiner's report was available. Nearly all reported fatalities (75 of
79) involved placement of the infant support cushion on another sleep-
related consumer product. For the remaining four fatalities, the
placement of the infant support cushion was either undetermined or
unknown.
In the 125 nonfatal incidents associated with infant support
cushions that involved children ages 12 months and younger and occurred
between January 1, 2010, and December 31, 2022, three infants were
admitted to the hospital and 22 infants were reported to have been
treated and released from an emergency department. In 52 of these
nonfatal incidents, the severity of the injury was unspecified or
unknown, and in 46 of the incidents no injury was reported. Table 3
summarizes the disposition of the nonfatal incident reports associated
with infant support cushions and victims ages 12 months and younger.
[[Page 2534]]
Table 3--Infant Support Cushion-Related Nonfatal Reports by Severity for
Victims Ages 12 Months and Younger: 2010-2022
------------------------------------------------------------------------
Total reports
Severity (% of total)
------------------------------------------------------------------------
Total Non-Fatal Reports................................. 125 (100%)
Hospital Admissions..................................... 3 (2%)
Emergency Department Treated............................ 22 (18%)
Left without being seen................................. 1 (1%)
Seen by a Medical Professional.......................... 1 (1%)
Unspecified/Unknown..................................... 52 (42%)
No Injury Reported...................................... 46 (37%)
------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Percentages may not add to 100 due
to rounding; the years 2021-2022 are considered incomplete.
For the 46 reports for which no injury was reported, many of the
descriptions in the incident reports indicated the potential for
serious injury or death. Staff's analysis of the narratives associated
with these incident reports indicated that in 29 reports (23 percent)
of the incidents, an infant support cushion occupied by an infant had
been place on an elevated surface (such as an adult bed or couch) and
the infant had fallen off; 27 (22 percent) specified threatened
asphyxia; and 17 incidents (14 percent) involved various types of
rashes caused by the product. Table 4 summarizes the hazard patterns
for infant support cushion-related nonfatal incidents.
Table 4--Infant Support Cushion-Related Non-Fatal Reports by Hazard
Pattern for Victims Ages 12 Months and Younger: 2010-2022
------------------------------------------------------------------------
Number of non-
fatal reports (%
of total)
Event -----------------
Children (0 to
12 months)
------------------------------------------------------------------------
Fall.................................................. 29 (23%)
Threatened Asphyxia................................... 27 (22%)
Rash.................................................. 17 (14%)
Limb Entrapment....................................... 1 (1%)
Mold.................................................. 1 (1%)
Choking............................................... 1 (1%)
Near Strangulation.................................... 1 (1%)
Vomiting.............................................. 1 (1%)
Consumer Complaints................................... 47 (38%)
-----------------
Total Non-Fatal Reports............................... 125 (100%)
------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Percentages may not add to 100 due
to rounding; the years 2021-2022 are considered incomplete.
Staff, based on review of nonfatal incident and report data,
identified falls and threatened asphyxia as the two major nonfatal
hazard patterns associated with infant support cushions. In the case of
falls, the reports revealed that in most incidents infant support
cushions had been placed on elevated surfaces including adult beds and
couches. The injuries associated with falls include concussions, facial
injuries, and scalp injuries.
In the case of threatened asphyxia, the narratives described
scenarios of infants being rescued after being found hanging partially
or completely off of the infant support cushion with their mouths and
noses obstructed, with their heads wedged between sleep positioner side
cushions, or having rolled to a face-down position that put them at
risk of an obstructed airway.
IV. International Standards for Infant Support Cushions
The Commission is aware of two international standards, both
British, that contain performance requirements that address 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. 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. Staff assesses that the proportional approach used in this
standard allows thicker pillows to have a greater displacement than
thinner pillows, which 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 airways.
V. Boise State University Contractor Report
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. See Staff's NPR Briefing Package, Tab C.
BSU delivered its final report on June 30, 2022 (the BSU Final
Report).\7\ The BSU Final Report provides recommendations and
conclusions related to the performance and design of infant support
cushions, including the following.
---------------------------------------------------------------------------
\7\ Mannen, E.M., Davis, W., Goldrod, S., Lujan, T., Siddicky,
S.F., Whitaker, B., & Carroll, J. (2022). Pillows Product
Characterization and Testing. Prepared for the U.S. Consumer Product
Safety Commission under contract no. 61320620D0002, task order no.
61320621F1015. Available at: https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
---------------------------------------------------------------------------
Firmness Testing. The BSU Final Report recommends that all infant
support cushions be required to undergo firmness testing because
products that lack firmness are more likely to conform around an
infant's nose and mouth and present a suffocation hazard. The report
recommended testing all infant pillows for firmness using a three-inch
diameter, anthropometry-based hemispheric probe that is geometrically
similar to, and sized to represent the breadth of, an infant's face.
The report recommends that the probe should be applied to the product
at three locations: the location of maximum thickness, the location of
minimum thickness, and a subjective location of interest (i.e., another
soft location most likely to result in failure). The force required to
displace the probe one inch into the product at each location must
exceed 10 N. Meeting this requirement would mean that the product has
firmness comparable to crib mattresses.
Airflow Testing. The BSU Final Report recommends that products that
do not pass firmness testing be required to pass an airflow test.
Passing the airflow test would mean that the product has airflow
characteristics comparable to current mesh crib liners, which the BSU
researchers concluded would mitigate the suffocation hazard. However,
the report recommends against requiring that airflow testing for
products that pass the BSU Final
[[Page 2535]]
Report's proposed firmness testing, because a firm product is unlikely
to form a seal around an infant's nose and mouth.
Sagittal-Plane Testing. BSU developed prototype sagittal-plane
testing devices to allow for more comprehensive assessments of infant
positioning in and on infant support cushions.\8\ The BSU Final Report
recommends further research to determine appropriate worst-case
positions for testing and to set threshold values for acceptable body
positions that would not negatively impact infant breathing.
---------------------------------------------------------------------------
\8\ The sagittal plane is an anatomical plane that runs
vertically through the human body, dividing it into left and right
sections. It can be thought of as viewing the human body in profile.
---------------------------------------------------------------------------
Tab C of Staff's NPR Briefing Package contains staff's summary of
how the Commission's proposed rule reflects the conclusions and
recommendations of the BSU Final Report.
VI. ASTM's Working Draft Standard
There are no published U.S. voluntary standards for infant support
cushions. ASTM is working toward a voluntary standard for infant
loungers under Subcommittee F15.21 on Infant Carriers, Bouncers, and
Baby Swings.\9\ In the draft voluntary standard, an ``infant lounger''
is a product ``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.'' That
draft definition would govern only a subset of the products covered by
this proposed rule, which includes infant positioners, nursing products
with dual use for lounging, infant cushions, and other infant pillow-
like products, as well as the infant loungers being considered by ASTM.
Staff has been working with ASTM to develop performance requirements
intended to address the primary hazards associated with infant
loungers, but to date ASTM has not issued a ballot on a standard for
infant loungers.
---------------------------------------------------------------------------
\9\ See Staff's NPR Briefing Package, Tab B. This ASTM standard
is still in draft form and has not completed the full consensus
process to be an approved standard and the draft language is subject
to change.
---------------------------------------------------------------------------
ASTM's draft voluntary standard includes general requirements
typically found in other ASTM juvenile product standards, such as
requirements addressing lead content, small parts, hazardous sharp
edges or points, and toy accessories that are attached to, removable
from, or sold with the products. The ASTM draft also specifies that if
the lounger can be converted to another product it shall comply with
the applicable requirements of that product's standard. The general
requirements of the draft infant lounger standard also state that the
sidewall height of the product shall be less than four inches when
measured according to the sidewall height measurement test method
specified in the draft standard. The draft voluntary standard further
includes the following performance requirements:
Stability: The product shall not tip over and shall retain
the CAMI dummy \10\ when tested in all manufacturers' use positions.
---------------------------------------------------------------------------
\10\ CAMI (Civil Aeromedical Institute) dummies, which are
designated ASTM test devices, are based on child anthropometric data
and come in multiple sizes. ASTM's working draft references the six-
month-old size.
---------------------------------------------------------------------------
Infant Restraints: The product shall not have a restraint
system.
Fabric/Mesh Integrity: This requirement is intended to
address product integrity issues such as seam failures and material
breakage.
Bounded Openings: This requirement is intended to address
potential entrapment hazards associated with openings in the product.
Occupant Support Surface: This requirement is intended to
address the thickness of, dimensions of, and potential gaps in the
occupant support surface.
Occupant Support Surface Firmness: This requirement uses
an eight-inch diameter, disc-shaped ``firmometer'' probe and requires
that there shall be no point where the feeler arm of the device, which
hangs over the edge of a disc, comes in contact with the occupant
support surface.
Sidewall Firmness: The top of the sides of the product
cannot be displaced more than one inch when a three-inch diameter
hemispheric probe is applied to the product with 10 N of force.
Side Angle and Deflection: To address potential entrapment
hazards at the intersection of the side wall and occupant support
surface, the angle between the sidewall and the occupant support
surface of the infant support cushion shall be greater than 90 degrees.
The draft voluntary standard also includes marking, labeling, and
instructional literature requirements, such as warning the consumer on
the product 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. The draft standard requires the warnings to be
``permanent'' and ``conspicuous.''
The product's instructions must, among other requirements, indicate
the manufacturer's recommended maximum weight, height, age,
developmental level, or combination of these attributes for any infant
using the product, as well as any limitation on use of the product by a
child for any specific unintended use.
VII. Description of the Proposed Mandatory Standard for Infant Support
Cushions \11\
---------------------------------------------------------------------------
\11\ See Staff's NPR Briefing Package, Tab C.
---------------------------------------------------------------------------
To address established risks of death and injury associated with
infant suffocations, asphyxiations, entrapments, and falls, and as
section 104 of the CPSIA requires, the Commission is issuing this
proposed rule to establish mandatory performance and labeling
requirements for infant support cushions.
The text of the proposed rule is based on an evaluation of incident
data associated with infant support cushions, the ASTM working draft
standard for infant loungers that is under development, and the
recommendations of the BSU Final Report. The proposed rule is
summarized below and explained in more detail in Tabs C and F of
Staff's NPR Briefing Package.
A. Scope and Definitions
Section 1243.1 of the proposed rule explains that the rule would
apply to infant support cushions, including infant positioners, nursing
products 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 would exclude,
however, products already regulated by other Commission mandatory
standards for durable infant products, which are listed in 16 CFR
1130.2(a). The proposed rule would apply to all infant support cushions
manufactured after the effective date of the rule.
Section 1243.2 of the proposed rule defines ``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.''
The scope of ``infant support cushions'' is intended to encompass
the products described in Part II above.
As noted previously, this proposed definition of ``infant support
cushions'' includes, but is not limited to, the infant
[[Page 2536]]
loungers that would be subject to ASTM's draft voluntary standard. The
proposed rule would define ``infant lounger'' as ``an infant product
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.'' Because, however, incident data show that the suffocation,
asphyxiation, and fall hazards this rule seeks to address are posed by
other infant pillow-like products, in addition to those with a raised
perimeter or recess, the proposed broader definition more effectively
addresses the hazards posed by these products. For example, the
proposed rule would apply to ``infant positioners,'' defined as a
product intended to help keep an infant in a particular position while
supine or prone.
As discussed above, ASTM is working concurrently on developing
voluntary standards for both ``infant feeding supports'' and ``infant
loungers.'' The draft ASTM standards address hazards posed by ``dual
use'' products intended to be used both to feed an infant and to
support a lounging infant by requiring such products to comply with
both standards. Adopting ASTM's approach, the proposed rule would apply
to nursing pillows with a dual use for lounging, while excluding those
nursing pillows that are solely intended to be used for nursing or
feeding, along with other products already regulated by other
Commission mandatory standards for durable infant products.
The Commission invites public comment on the scope of the proposed
rule, including whether it addresses all products that pose the
identified hazards and whether it is sufficiently clear and
administrable. For example, the Commission invites public comment on
whether it is appropriate to subject ``dual use'' products to both the
proposed nursing pillow rule and the proposed infant support cushion
rule (assuming that both are finalized), and what nursing products
should be considered ``dual use.''
B. General Requirements
The proposed rule includes many of the general requirements
included in the ASTM draft standard for infant loungers to address
sharp edges or points, small parts, and lead in paints. It also
requires that toy accessories that are attached to, removable from, or
sold with the products comply with 16 CFR part 1250, which establishes
a mandatory safety standard for toys, as well as requirements for the
permanency of labels and warnings. However, while ASTM's draft standard
for infant loungers would allow a maximum sidewall height of four
inches, the Commission is concerned that this height may give consumers
the mistaken impression that an infant can safely be left unattended in
or on the product. For that reason, the proposed rule addresses the
positional asphyxia hazard with a maximum incline requirement that
effectively sets a lower limit on sidewall height, rather than the
maximum side height requirement currently favored by ASTM. The
Commission invites public comment on side height limit and incline
angle requirements.
C. Proposed Performance Requirements
1. Firmness
The Commission's proposed firmness requirements and associated test
methods are consistent with those applicable to crib mattresses and
more stringent than those currently included in ASTM's draft standard
for infant loungers. As explained in Tab C of Staff's NPR Briefing
Package, based upon the findings and recommendations in the BSU Final
Report as well as staff's analysis of the incidents and hazard patterns
associated with facial occlusion into infant support cushions, the
proposed rule requires firmness testing at three locations: the
occupant support surface, the sidewall, and the intersection of the
occupant support surface with the sidewall, as follows:
a. Occupant Support Surface (OSS) Firmness
The proposed rule includes a firmness test for the occupant support
surface \12\ that is based on the BSU Final Report, with modifications
to improve the test methodology. The firmness test is intended to
reduce the likelihood that the OSS can conform to an infant's face and
cause suffocation. The proposed rule requires that OSS firmness be
tested using the three-inch diameter hemispheric probe developed by
BSU, rather than the eight-inch firmometer probe in the ASTM draft
standard. The three-inch probe is more consistent, in both size and
shape, with the size and dimensions of an infant's head, enabling it to
more accurately detect any material deformations and surface features
that an infant's face may come in contact with on an infant support
cushion. In addition, staff's testing showed that an eight-inch disc
probe may not be as accurate as a three-inch hemispheric probe when
used on certain models of infant support cushions with smaller
dimensions or an OSS surface that is not completely flat, so that the
eight-inch firmometer cannot fit well enough in the product to provide
accurate measurement.
---------------------------------------------------------------------------
\12\ The proposed rule uses ASTM's draft definition of an infant
support cushion's ``occupant support surface'' or OSS as ``the area
that holds up and bears the infant or any portion of the infant.''
---------------------------------------------------------------------------
To meet the proposed rule's firmness requirement, the force
required to displace the probe one inch into the OSS test location (as
well as the two other test locations) must exceed 10 N (about 2.25
pounds), which indicates product firmness that is at least comparable
to a crib mattress. Figure 1, below, illustrates the firmness test
being applied to the OSS of an infant support cushion.
BILLING CODE 6355-01-P
[[Page 2537]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.013
[GRAPHIC] [TIFF OMITTED] TP16JA24.014
BILLING CODE 6355-01-C
Because an infant's head or face may rest on the sidewall of a
product, as well as on the product's OSS, the proposed rule includes
firmness requirements for any product sidewall. While the ASTM working
draft also requires firmness testing of sidewalls, the proposed rule
requires testing a minimum of four sidewall locations, including the
location of maximum sidewall height, and requires that the test
locations include at least one location most likely to fail, rather
than requiring that sidewalls be tested in six-inch increments around
the product as stated in ASTM's draft. The differences from ASTM in
testing protocol are intended to provide more accurate testing for both
smaller head pillows and larger lounger products.
b. Intersection of OSS With Sidewall
To address the hazard of suffocation when an infant's face is
surrounded on two sides by the OSS and a sidewall, the proposed rule
includes firmness requirements based on testing the angle at which the
two surfaces intersect, to ensure sufficient firmness to prevent the
product from conforming to the infant's mouth or face and obstructing
airways. It requires testing of firmness with the three-inch
hemispherical probe positioned to bisect the angle formed where the two
surfaces intersect, as shown in Figure 2.
[[Page 2538]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.015
The proposed rule's firmness requirements for the OSS/Sidewall
intersection are similar to those in ASTM's draft standard.
2. Sidewall Angle
The proposed rule, like ASTM's draft, requires that the angle
formed between the product's OSS and any sidewall be greater than 90
degrees to reduce potential entrapment hazards between the sidewall and
the occupant support surfaces. The proposed rule requires a slightly
different methodology for measuring this angle than does ASTM's draft.
While ASTM's draft requires that this angle be measured with a
protractor or similar tool at four-inch intervals along the product's
interior, the proposed rule specifies assessing this angle with the
cylindrical side of the three-inch probe, with a 10 N force applied to
the probe. The probe, which is designed to simulate the size and shape
of an infant's head, is used to determine whether there is any contact
between the sidewall and the probe's side when the ``face'' of the
probe is pressed against the OSS/sidewall intersection. If there is
such contact, indicating an entrapment risk, that indicates that the
angle is less than 90 degrees and the product would fail. Conversely,
if there is no contact between the sidewall and the side of the probe,
the angle is greater than 90 degrees and the product meets this
requirement.
3. Maximum Incline Angle
The proposed rule, like ASTM's draft, requires that any incline of
the OSS of an infant support cushion not exceed 10 degrees. This
requirement is consistent with incline test of CPSC's Safety Standard
for Infant Sleep Products, 16 CFR part 1236, and the ban of inclined
sleepers for infants in the Safe Sleep for Babies Act, 15 U.S.C. 2057d,
and similarly it addresses the hazards associated with inclined sleep
products.
The proposed rule, however, differs from ASTM's maximum incline
angle requirements and test procedures in order to improve test
consistency across all infant support cushion products and to address
additional locations of potential inclined lounging, reclining, and
sleep. The three ways in which the proposed rule modifies ASTM's
proposed testing protocol are: (1) setting a maximum incline angle that
applies not only to all of a manufacturer's recommended use positions,
but also to all other infant cushion surfaces that can feasibly support
an infant's head, including, for example, the angle from any sidewall
to the OSS or from the sidewall to the floor; (2) use of a newborn
hinged weight gauge, rather than an infant gauge; and (3) positioning
the gauge differently throughout testing. Figure 3 below, shows the use
of a hinged weight gauge to measure the incline on an infant support
cushion with a sidewall. The proposed rule requires use of a newborn
hinged weight gauge, rather than the heavier infant gauge specified in
the ASTM draft, because infant support cushions are commonly used for
newborns, who are at higher risk of suffocation.
[[Page 2539]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.016
4. Sidewall Height
The proposed rule limits the height of any sidewall of an infant
support cushion, as does ASTM's draft. However, the proposed rule
addresses the hazards associated with relatively high sidewalls in a
manner that is more closely tailored to the hazards, and applies to all
of the products that fall within the scope of the proposed rule. These
hazards are that caregivers may judge that an infant support cushion
with relatively high sidewalls can safely contain an infant without
supervision and is suitable for use on top of an adult bed or in a crib
notwithstanding any contrary warnings, and that high sidewalls can
cause hazardous positioning of the infant's neck when an infant's head
is placed on top of the sidewall while their body is on a lower surface
either inside or outside of the product. See Staff's NPR Briefing
Package, Tabs B and C. While ASTM's draft sets a four-inch limit on
sidewall height, the proposed rule addresses these hazards by limiting
the maximum incline angle and provides testing protocols based on the
type of product (for example, lounger-type products or head cushions).
Using the test methodology prescribed in the proposed rule, sidewall
heights, for products that have sidewalls, would be limited to
approximately 1.9 inches.
The Commission invites public comments on the proposed rule's
method for addressing hazards posed by sidewall heights via measurement
of maximum incline angle and what methodology would most effectively
address the identified fall and positional asphyxia hazards.
D. Warning and Instructional Requirements
Compared to the performance requirements described above, warnings
are less effective in eliminating or adequately reducing exposure to
hazards associated with infant support cushions. Nevertheless,
prominent and well-designed warnings can provide consumers with
important information about the hazards associated with these products
and appropriate behaviors to avoid the hazards. Thus, the proposed rule
includes requirements for on-product warnings that address the primary
hazards associated with infant support cushions.
The proposed rule includes warning content and format requirements
similar to those in the ASTM draft standard. Figure 4 shows the warning
statements and format that would be required on infant support
cushions:
[[Page 2540]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.017
The proposed rule, like ASTM's draft, requires on-product warning
labels to be ``conspicuous,'' defined as ``visible, when the product is
in each manufacturer's recommended use position, to a person while
placing an infant into or onto the product.'' Also, like ASTM's draft,
the proposed rule requires such warning labels to be ``permanent,''
with permanence requirements based on ASTM's draft but better
addressing the potential for consumers to attempt to remove on-product
warning labels. The draft ASTM warning label for infant loungers
indicates that the product should only be used on the floor, ``with
baby face-up on back.'' This proposed rule would adopt ASTM's draft
language. However, this proposed rule for infant support cushions
includes products that can be used for ``tummy time,'' for which
infants are on their stomach. The Commission invites public comments in
answer to the following questions: Should manufacturers have
flexibility to remove or change the ``with baby face-up on back''
language in the warning label? If so, in what circumstances?
The proposed rule incorporates by reference American National
Standards Institute (ANSI) ANSI Z535.4, Product Safety Signs and
Labels, which includes requirements related to safety alert symbol use;
signal word selection; warning panel format, arrangement, and shape;
color requirements for each panel; and letter style. The Commission
specifically references the warning format requirements published in
sections 6.1-6.4, 7.2-7.6.3, and 8.1. See Staff's NPR Briefing Package,
Tab D, 80-81.
In addition to on-product warnings, the ASTM draft standard
includes basic warning requirements for instructional literature that
are the same as those in ASTM's draft.
VIII. Proposed 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 proposed standard for
infant support cushions would be 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. The Commission proposes 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.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new 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. Product Registration Rule Amendment
In addition to requiring the Commission to issue safety standards
for durable infant or toddler products, section 104 of the CPSIA
directed the Commission to issue a rule requiring that manufacturers of
durable infant or toddler products establish a program for consumer
registration of those products. 15 U.S.C. 2056a(d). Section 104(f) of
the CPSIA 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,'' and lists 12 distinct
product categories. 15
[[Page 2541]]
U.S.C. 2056a(f). The product categories listed in section 104(f)(2) of
the CPSIA represent a non-exhaustive list of durable infant or toddler
product categories. Infant support cushions are not included in the
statutory list of durable infant or toddler products.
In 2009, the Commission issued a rule implementing the consumer
registration requirement. 74 FR 68668 (Dec. 29, 2009) (establishing 16
CFR part 1130). As section 104(d) of the CPSIA directs, the consumer
registration rule requires each manufacturer of a durable infant or
toddler product to provide a postage-paid consumer registration form
with each product; keep records of consumers who register their
products with the manufacturer; and permanently place the
manufacturer's name and certain other identifying information on the
product.
When issuing the consumer registration rule, the Commission
identified six additional products as durable infant or toddler
products: children's folding chairs; changing tables; infant bouncers;
infant bathtubs; bed rails; and infant slings. 74 FR 68669. The
Commission explained that the specified statutory categories are not
exclusive, and that the Commission is charged with identifying the
product categories that are covered. ``Because the statute has a broad
definition of a durable infant or toddler product but also includes 12
specific product categories,'' the Commission noted, ``additional items
can and should be included in the definition, but should also be
specifically listed in the rule.'' Id. at 68670.
The Commission proposes in this NPR to amend part 1130 to include
``Infant Support Cushions'' as durable infant or toddler products.
Infant support cushions are a category of ``durable infant or toddler
product'' for purposes of CPSIA section 104 because they: (1) are
intended for use, and may be reasonably expected to be used, by
children under the age of five years; (2) are products similar to other
products listed in section 104(f)(2), such as crib mattresses and sling
carriers; and (3) are commonly resold or ``handed down'' for use by
other children over a period of years.
X. Incorporation by Reference
The proposed rule incorporates by reference ANSI Z535.4-2011,
American National Standard for Product Safety Signs and Labels and ASTM
D3359, Standard Test Methods for Rating Adhesion by Tape Test. In
accordance with regulations of the Office of the Federal Register
(OFR), 1 CFR part 51, Part VII.D of this preamble summarizes ANSI
Z535.4-2011. ASTM D3359 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.
Both standards are reasonably available to interested parties in
several ways. By permission of ANSI, the ANSI standard can be viewed as
a read-only document during the comment period on this NPR, at: https://www.surveymonkey.com/r/DQVJYMK. To download or print the standard,
interested persons may purchase a copy of ANSI Z535.4-2011 from ANSI
via its website, https://www.ansi.org, or by mail from ANSI, 25 West
43rd Street, 4th Floor, New York, NY 10036, telephone: (212)-642-4900.
By permission of ASTM, this ASTM standard can be viewed as a read-only
document during the comment period on this NPR, at: https://www.astm.org/cpsc.htm. To download or print the standard, interested
persons may purchase a copy of ASTM D3359 from ASTM, through its
website, https://www.astm.org, or by mail from ASTM International, 100
Barr Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428-2959.
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; telephone: (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). The Commission proposes an effective date
of 180 days after publication of the final rule in the Federal
Register, such that the requirements of the rule would apply to all
infant support cushions manufactured after that date. This amount of
time is typical for rules issued under section 104 of the CPSIA. It is
also the period that the Juvenile Products Manufacturers Association
(JPMA) typically allows for products in their certification program to
shift to a new standard once that new standard is published. Therefore,
juvenile product manufacturers are accustomed to adjusting to new
standards within this time. 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 the proposed rule. The Commission invites comments,
particularly from small businesses, that provide specific data
addressing whether the proposed 180-day effective date period is
appropriate.
XII. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) requires
that agencies review a proposed rule's potential economic impact on
U.S. small entities, including small businesses. Section 603 of the RFA
generally requires that agencies make an initial regulatory flexibility
analysis (IRFA) available to the public for comment when the NPR is
published. The IRFA must describe the impact of the proposed rule on
small entities and identify significant alternatives that accomplish
the statutory objectives and minimize any significant economic impact
of the proposed rule on small entities. Staff prepared an IRFA for this
rulemaking that appears at Tab E of the Staff's NPR Briefing Package.
We summarize the IRFA below.
A. Reasons and Legal Basis for the NPR
Part I of this preamble describes the reasons and legal basis for
this NPR. As discussed in Parts VII-IX of this preamble, and detailed
in Tab B of Staff's NPR Briefing Package, the proposed rule sets out
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. Small Entities to Which the Proposed Rule Would Apply
As explained in Tab E to Staff's NPR Briefing Package, Commission
staff has identified more than 2,000 suppliers of infant support
cushions to the U.S. market, including manufacturers, importers, and
foreign direct shippers. The majority of these suppliers are small
businesses.
C. Impact of the Proposed Rule on Small Manufacturers and Importers
Most in-scope products on the market will require redesign to meet
the requirements in the proposed rule, and redesign costs would be
potentially significant for a substantial number of small firms,
particularly small-volume home crafters, for the first year that a rule
is effective. Staff considers a ``significant'' impact to be at least
one
[[Page 2542]]
percent of annual revenue, which is consistent with the regulatory
flexibility analyses of other federal agencies. With an estimated 2,000
models to be redesigned, the total cost of redesign to the industry in
the first year could be up to $27 million. However, as discussed in Tab
E of Staff's Briefing Package, suppliers may be able to cover these
costs by implementing modest retail price increases which would reduce
the rule's impact on individual small entities. For example, a firm
supplying 5,000 infant support cushions per year could cover the entire
cost of redesign by raising the retail price by $2.70.
If issued, a final rule would require all manufacturers and
importers of infant support cushions to meet additional third party
testing requirements under section 14 of the CPSA. As specified in 16
CFR part 1109, entities that are not manufacturers of children's
products, such as importers and wholesalers, may rely on the
certificates of compliance provided by others. However, manufacturers
could pass on at least some of the cost of testing for compliance to
U.S. importers and wholesalers.
Third party testing costs for infant support cushions are estimated
to be $500 to $1,000 per model. The annual cost of samples for testing
is estimated at around $100, bringing the overall annual testing cost
to an estimated $600 to $1,100 per model. The costs of testing per
model would be similar for suppliers of all sizes, although larger
firms may be more likely to qualify for volume discounts. As with
redesign costs, these testing costs could largely be covered by modest
retail price increases.
The hand crafters of infant support cushions with the smallest
sales volumes may not have sufficient sales volume to cover these costs
and may exit the market. However, consumers would likely not experience
a significant loss of utility as there are many different products
available from different suppliers.
D. Other Federal Rules That May Duplicate, Overlap, or Conflict With
the Proposed Rule
The Commission has not identified any federal rules that duplicate,
overlap with, or conflict with the proposed rule.
E. Alternatives Considered To Reduce the Impact on Small Entities
The Commission considered the following alternatives to the
proposed rule to reduce the impact on small businesses. The Commission
requests comments on these alternatives and other alternatives that
could reduce the potential burden on U.S. small entities.
1. Not Establishing a Safety Standard
The Commission considered not establishing a safety standard for
infant support cushions. While this alternative would result in no
regulatory impact on small entities, deaths and injuries from the use
of infant support cushions would likely continue to occur at similar
rates as those observed during the period from 2010 through 2022. In
2020 alone, there were 17 fatalities involving infant support cushions.
Another 17 fatalities have been recorded in the potentially incomplete
data for 2021. See Staff NPR Briefing Package, Tab A.
2. Delay To Await Publication of a Voluntary Standard
The Commission considered delaying the draft proposed rule to allow
possible publication of a voluntary standard. Although this alternative
would delay any impact on small businesses, it would also allow the
hazard to continue indefinitely, as there is no clear date at which
ASTM or any other voluntary standards organization will adopt a
relevant standard, nor any assurance that a voluntary standard, if
published, would be complied with by industry or adequately address the
identified hazards.
3. Earlier or Later Effective Date
The Commission is proposing an effective date 180 days after
publication of the final rule in the Federal Register. An earlier
effective date would achieve the safety benefits of the rule more
quickly, but it would also increase the burden on small businesses to
quickly redesign and test their products. In addition, a significantly
earlier effective date could result in temporary shortages of infant
support cushions due to a potential lack of availability of testing
laboratory resources.
The Commission is not proposing a later effective date, which would
somewhat reduce burdens on small suppliers, because 180 days has
generally been sufficient time for suppliers to come into compliance
with durable infant or toddler product rules. Additionally, six months
from the change in a voluntary standard is the period that JPMA uses
for its certification program, so compliant manufacturers are used to
this time frame to comply with a modified standard. Testing
laboratories should have no difficulty preparing to test to the
proposed new mandatory standards within a 180-day period.
F. Impact on Testing Labs
The proposed rule should not have a significant adverse impact on
testing laboratories. Laboratories will not need to acquire complex or
costly testing instruments or devices to test infant support cushions
for compliance, and laboratories will decide for themselves, based on
expected demand for their testing services, whether to offer testing
services for infant support cushion compliance.
XIII. 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 proposed rule for infant support cushions falls within the
categorical exclusion.
XIV. Paperwork Reduction Act
This proposed 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). In this document, pursuant to 44 U.S.C.
3507(a)(1)(D), we set forth:
a title for the collection of information;
a summary of the collection of information;
a brief description of the need for the information and
the proposed use of the information;
a description of the likely respondents and proposed
frequency of response to the collection of information;
an estimate of the burden that shall result from the
collection of information; and
notice that comments may be submitted to the OMB.
Title: Safety Standard for Infant Support Cushions.
Description: The proposed rule would require each infant support
cushion within the scope of the rule to meet the rule's performance and
labeling requirements. It would require suppliers to conduct third
party testing to demonstrate compliance and provide the specified
warning label and instructions. These requirements fall within the
definition of a ``collection of information,'' as defined in 44 U.S.C.
3502(3).
Description of Respondents: Persons who manufacture or import
infant support cushions.
[[Page 2543]]
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 7--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
Burden type respondents response responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling and instructions.......................................... 2,000 1 2,000 2 4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
While some infant support cushion products currently have labels,
all of these products would have to meet the specific labeling
requirements and instructions specified in the proposed rule, which
provides the text and graphics for the required labels and
instructions. Specialized expertise in graphics design would not be
required to develop the warnings and instructions. Most reporting and
recordkeeping requirements in this proposed rule would be new for all
suppliers.
CPSC estimates there are 2,000 entities that would respond to this
collection annually, the majority of which would be small entities. We
estimate that the time required to create and/or modify labeling and
instructions is about two hours per response. Therefore, the estimated
burden associated with this collection is 2,000 responses x one
response per year x two hours per response = 4,000 hours annually.
We estimate the hourly compensation for the time required to
respond to the collection is $37.88 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' June 2023, Table 4, total
compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/news.release/archives/ecec_09122023.pdf. Therefore, the estimated annual cost of the
collection is $151,520 ($37.88 per hour x 4,000 hours = $151,520).
Based on this analysis, the proposed standard for infant support
cushions would impose a burden to industry of 4,000 hours at a cost of
$151,520.
Comments. CPSC has submitted the information collection
requirements of this proposed rule to OMB for review in accordance with
PRA requirements. 44 U.S.C. 3507(d). CPSC requests that interested
parties submit comments regarding information collection to the Office
of Information and Regulatory Affairs, OMB (see the ADDRESSES section
at the beginning of this NPR). Pursuant to 44 U.S.C. 3506(c)(2)(A), the
Commission invites comments on:
whether the collection of information is necessary for the
proper performance of CPSC's functions, including whether the
information will have practical utility;
the accuracy of CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
ways to enhance the quality, utility, and clarity of the
information to be collected;
ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques
when appropriate and other forms of information technology; and
the estimated burden hours associated with label
modification, including any alternative estimates.
XV. 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, if finalized,
the preemption provision of section 26(a) of the CPSA would apply to
this rule for infant support cushions.
XVI. Request for Comments
The Commission seeks public comment on all aspects of the proposed
rule. In particular, the Commission seeks comments on the scope of the
proposed rule, with respect to both in scope and out of scope products,
including comments on whether the proposed definition of ``infant
support cushion'' is sufficient to include all infant support cushions
that are not subject to the FHSA infant pillow ban, 16 CFR
1500.18(a)(16). The Commission would also welcome comments on the
wording of proposed warning label as well as on whether the on-product
warning label requirement included in the proposed rule should be
applied to replacement covers for infant support cushions in addition
to the cushions themselves. In addition, the Commission invites public
comment on the proposed limit on sidewall height and whether the
proposed rule's incline angle requirements provide appropriate
protection against positional asphyxiation. The Commission also seeks
comment on whether an anti-stockpiling provision should be included
and, if so, whether the Commission should include an anti-stockpiling
provision comparable to the one proposed in the recent SNPR for
portable generators at 88 FR 24346, 24372 (Apr. 20, 2023). Finally, the
Commission requests comments on the proposed effective date and the
costs of compliance with, and testing to, the proposed rule.
Submit comments in accordance with the instructions in the
ADDRESSES section at the beginning of this NPR.
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 proposes
to amend chapter II of title 16 of the Code of Federal Regulations as
follows:
[[Page 2544]]
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: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15, as proposed to be amended at 88 FR 65865 (Sept.
26, 2023), by:
0
a. Removing the semicolons at the ends of paragraphs (b)(1) through (9)
and (11) through (27), (b)(28)(v), (b)(29)(iv), (b)(30)(iv), and
(b)(31)(ii) and adding periods in their place;
0
b. Adding periods at the ends of paragraphs (b)(32)(ii)(A) through
(KK); and
0
c. Adding paragraph (b)(57).
The addition reads as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/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, as proposed to be amended at 88 FR 65865 (Sept.
26, 2023) and 88 FR 73551 (Oct. 26, 2023), by:
0
a. Removing the semicolons at the ends of paragraphs (a)(1) through
(16) and adding periods in their place;
0
b. Removing ``; and'' at the end of paragraph (a)(17) and adding a
period in its place; and
0
c. Adding paragraph (a)(21).
The addition reads as follows:
Sec. 1130.2 Definitions.
* * * * *
(a) * * *
(21) 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 products 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
[effective date of the final rule], 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, 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 product 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.
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.
Sec. 1243.3 General requirements.
(a) Hazardous sharp edges or points. There shall be no hazardous
sharp points or edges as defined in 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 defined in 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 pillow, as well as their means of attachment, shall comply
with the applicable requirements of 16 CFR part 1250.
(e) Side height. The maximum side height for the product, measured
from the OSS-body or test base, as appropriate, to the top of the
sidewall, shall not exceed the maximum of the side heights determined
in Sec. 1243.5(d)(8).
(f) 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.
(g) 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).
(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).
(h) 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).
[[Page 2545]]
(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
three-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 N.
[GRAPHIC] [TIFF OMITTED] TP16JA24.018
(2) Sidewall firmness. When the three-inch diameter hemispherical
head probe is applied according to the test method for sidewall
firmness, 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. When the three-inch diameter hemispherical head probe is
applied according to the test method for firmness at the intersection
of sidewall and occupant support surface, Sec. 1243.5(h), the force
required for a one-inch displacement shall be greater than 10 N.
(f) Sidewall angle. Sidewall angle shall be greater than 90 degrees
when determined according to the sidewall angle determination, 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 2 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 3 to this paragraph (c)) can be freely
inserted through the opening.
[[Page 2546]]
Figure 2 to Paragraph (c)--Small Head Probe
[GRAPHIC] [TIFF OMITTED] TP16JA24.019
Figure 3 to Paragraph (c)--Large Head Probe
[GRAPHIC] [TIFF OMITTED] TP16JA24.020
(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
[[Page 2547]]
assembly (figure 4 to this paragraph (d)(1)(ii));
BILLING CODE 6355-01-P
Figure 4 to Paragraph (d)(ii)--Hinged Weight Gauge-Newborn,
Requirements for Part Masses and Assembly
[GRAPHIC] [TIFF OMITTED] TP16JA24.021
(iii) Hinged weight gauge-newborn, requirements for part dimensions
(figure 5 to this paragraph (d)(1)(iii)); and
[[Page 2548]]
Figure 5 to Paragraph (d)(1)(iii)--Hinged Weight Gauge-Newborn,
Requirements for Part Dimensions
[GRAPHIC] [TIFF OMITTED] TP16JA24.022
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 6 to
this paragraph (d)(4)).
Figure 6 to Paragraph (d)(4)--Test Fixture Configuration To Measure
Incline Angle on an Infant Support Cushion Product
[[Page 2549]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.023
(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) Remove the newborn gauge and determine the side height at the
incline angle location, measured from the OSS-body or test base, as
appropriate, to the top of the OSS-head.
(9) 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.
(10) 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 three-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. See figure 7 to this
paragraph (f).
(1) Orient the axis of the three-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 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.
[[Page 2550]]
Figure 7 to Paragraph (f)--Test Configuration for Occupant Support
Surface Firmness Test
[GRAPHIC] [TIFF OMITTED] TP16JA24.024
(g) Sidewall firmness test method. For sidewalls, 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 six 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.
Perform the following steps to determine the intersection firmness of
the product as received from the manufacturer (figure 8 to this
paragraph (h)).
(1) Orient the axis of the three-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.
Figure 8 to Paragraph (h)--Test Configuration for Intersection of
Sidewall and Occupant Support Surface Firmness
[[Page 2551]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.025
(i) Sidewall angle determination. 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 9 to this
paragraph (i).
(1) Orient the three-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 three-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 three-inch head probe and the sidewall.
(4) Determine a minimum of four sidewall angles at locations not to
exceed six 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 three-inch
probe side and the sidewall.
Figure 9 to Paragraph (i)--Test Fixture Configuration for Sidewall
Angle Measurement
[GRAPHIC] [TIFF OMITTED] TP16JA24.026
(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
[[Page 2552]]
attach a force gauge. See figure 10 to this paragraph (j)(1), or
equivalent.
(ii) A force gauge, accuracy +/-0.5 lbs (1.1 N).
Figure 10 to Paragraph (j)(1)--Seam Clamp
[GRAPHIC] [TIFF OMITTED] TP16JA24.027
(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 five 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) 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) Gradually apply a four lbs-inch (0.4 N-m) torque over five
seconds in a clockwise rotation to 180 degrees or until four lbs-inch
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) For components that can reasonably be grasped between thumb and
forefinger, or teeth, apply a 15 lbs (67 N) force over five seconds, in
a direction to remove the component. Maintain for 10 seconds. A clamp
such as shown in figure 11 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 11 to Paragraph (k)(3)--Tension Test Adapter Clamp
[GRAPHIC] [TIFF OMITTED] TP16JA24.028
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 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
[[Page 2553]]
(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 (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.
(5) The safety alert symbol and the signal word ``WARNING'' shall
be at least 0.2 inches (five 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 text should have the following layout:
(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.
Figure 1 to Paragraph (d)(6)--Examples of Left-Aligned Text
[GRAPHIC] [TIFF OMITTED] TP16JA24.029
The text shown for these warnings is filler text, known as lorem
ipsum, commonly used to demonstrate graphic elements.
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.
(7) An example warning in the format described in this section is
shown in figure 2 to this paragraph (d)(7).
Figure 2 to Paragraph (d)(7)--Example of Warning
[[Page 2554]]
[GRAPHIC] [TIFF OMITTED] TP16JA24.030
(e) Warning statements. Each product shall address the warning
statements shown on figure 13 to paragraph (d)(7) of this section, at a
minimum.
Note 4 to paragraph (e): ``Address'' means that verbiage other
than what is shown can be used as long as the meaning is the same or
information that is product-specific is presented.
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 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 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
sections 6.4 and 7.2-7.6.3 of ANSI Z535.4--2011 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) American National Standards Institute (ANSI), 25 West 43rd
Street, 4th Floor, New York, NY 10036, USA; phone: (212) 642-4900;
website: www.ansi.org (https://ibr.ansi.org/Standards/nema.aspx).
(1) ANSI Z535.4-2011, American National Standard for Product Safety
Signs and Labels, approved October 20, 2017; approved for Sec. 1243.6.
(2) [Reserved]
(b) ASTM International, 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 [TBD]; approved for Sec. 1243.5.
(2) [Reserved]
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2023-27324 Filed 1-12-24; 8:45 am]
BILLING CODE 6355-01-P
