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Proposed Rule2023-20156

Safety Standard for Nursing Pillows

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Published

September 26, 2023

Issuing agencies

Consumer Product Safety Commission

Abstract

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. The Commission is proposing a safety standard for nursing pillows. The Commission is also proposing to amend CPSC's consumer registration requirements to identify nursing pillows as durable infant or toddler products and proposing to amend CPSC's list of notice of requirements (NORs) to include such nursing pillows. This proposed rule would help ensure that consumers continue to have access to nursing pillows for feeding while reducing hazards that have been identified for this product category.

Full Text

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<title>Federal Register, Volume 88 Issue 185 (Tuesday, September 26, 2023)</title>
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[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Proposed Rules]
[Pages 65865-65887]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20156]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130 and 1242

[CPSC Docket No. 2023-0037]

Safety Standard for Nursing Pillows

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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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. The Commission is proposing a
safety standard for nursing pillows. The Commission is also proposing
to amend CPSC's consumer registration requirements to identify

[[Page 65866]]

nursing pillows as durable infant or toddler products and proposing to
amend CPSC's list of notice of requirements (NORs) to include such
nursing pillows. This proposed rule would help ensure that consumers
continue to have access to nursing pillows for feeding while reducing
hazards that have been identified for this product category.

DATES: Submit comments by November 27, 2023.

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 <a href="/cdn-cgi/l/email-protection#fc93958e9da38f899e91958f8f959392bc93919ed299938cd29b938a">[email&#160;protected]</a>.
Other comments, identified by Docket No. CPSC-2023-0037, may be
submitted electronically or in writing, as follows:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
instructions for submitting comments. CPSC typically does not accept
comments submitted by email, except as described below. CPSC encourages
you to submit electronic comments by using the Federal eRulemaking
Portal, as described above.
Mail/Hand Delivery/Courier Written Submissions: Submit comments by
mail/hand delivery/courier to: Office of the Secretary, Consumer
Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479. If you wish to submit confidential business
information, trade secret information, or other sensitive or protected
information that you do not want to be available to the public, you may
submit such comments by mail, hand delivery, or courier, or you may
email them to: <a href="/cdn-cgi/l/email-protection#b7d4c7c4d49ad8c4f7d4c7c4d499d0d8c1">[email&#160;protected]</a>.
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:
<a href="http://www.regulations.gov">www.regulations.gov</a>. Do not submit electronically any confidential
business information, trade secret information, or other sensitive or
protected information that you do not want to be available to the
public. If you wish to submit such information, please submit it
according to the instructions for mail/hand delivery/courier written
submissions.
Docket: For access to the docket to read background documents or
comments received, go to: <a href="https://www.regulations.gov">https://www.regulations.gov</a>, insert the
docket number, CPSC-2023-0037, into the ``Search'' box, and follow the
prompts.

FOR FURTHER INFORMATION CONTACT: Timothy Smith, Project Manager,
Directorate for Engineering Sciences, U.S. Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; email:
<a href="/cdn-cgi/l/email-protection#592d2a34302d31193a292a3a773e362f">[email&#160;protected]</a>; telephone: (301) 987-2557.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

Section 104(b) of the CPSIA, part of the Danny Keysar Child Product
Safety Notification Act, 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 nursing pillows to
further implement section 104 of the CPSIA.\1\ The briefing package
prepared by Commission staff defines ``nursing pillows'' as ``any
product intended, marketed, or designed to position and support an
infant close to a caregiver's body while breastfeeding or bottle
feeding. These products rest upon, wrap around, or are worn by a
caregiver in a seated or reclined position.'' \2\ Nursing pillows
provide support to caregivers by raising infants to the desired height
for feeding, thereby reducing muscular strain and abdominal pressure on
the caregiver and providing a buffering surface between the infant and
the caregiver. When infants fall asleep or are left unattended on
nursing pillows, however, they are at risk for death or serious injury
by suffocation.
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\1\ On September 8, 2023, the Commission voted (4-0) to publish
this notice of proposed rulemaking. Chair Hoehn-Saric and
Commissioners Trumka and Boyle issued statements in connection with
their votes, available at: <a href="https://www.cpsc.gov/s3fs-public/RCANoticeofProposedRulemakingSafetyStandardforNursingPillows.pdf?VersionId=wCUsHNj0AhXxb3KM2A.kxMawNVGbS6oE">https://www.cpsc.gov/s3fs-public/RCANoticeofProposedRulemakingSafetyStandardforNursingPillows.pdf?VersionId=wCUsHNj0AhXxb3KM2A.kxMawNVGbS6oE</a>.
\2\ Staff Briefing Package: Staff's Draft Proposed Rule for
Nursing Pillows (Aug. 23, 2023) (Staff's NPR Briefing Package),
available at: <a href="https://www.cpsc.gov/content/Commission-Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Nursing-Pillows">https://www.cpsc.gov/content/Commission-Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Nursing-Pillows</a>.
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As required by 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. 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.\3\ CPSC staff
provided ASTM incident data associated with both nursing pillows and
infant support cushions. In response, ASTM formed the following
subcommittees to develop two separate voluntary standards:
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\3\ <a href="https://www.cpsc.gov/s3fs-public/Nursing-and-Support-Pillow-VS-request.pdf">https://www.cpsc.gov/s3fs-public/Nursing-and-Support-Pillow-VS-request.pdf</a>.
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<bullet> the F15.16 Infant Feeding Supports subcommittee,\4\
intended to develop a standard for nursing pillows, which the
subcommittee refers to as infant feeding supports; and
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\4\ The ASTM F15.16 Infant Feeding Supports subcommittee was
initially called the Feeding and Infant Support Products
subcommittee.
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<bullet> the F15.21 Infant Loungers subcommittee, with a remit
including nursing pillows that are also intended for lounging.
CPSC staff has been actively participating in both ASTM
subcommittees to develop voluntary standards that address hazards
associated with these products.
Currently, no voluntary or mandatory safety standard for nursing
pillows exists to address the hazards of infants sleeping on or in
these products. Pursuant to section 104 of the CPSIA, 15 U.S.C. 2056a,
the Commission proposes to issue a mandatory standard for nursing
pillows. Nursing pillows are sometimes used on elevated surfaces or
inside an infant sleep product, which can lead to death or serious
injury by suffocation, entrapment, or falls. CPSC staff identified 154
infant fatalities and 88 nonfatal incidents from January 1, 2010, to
December 31, 2022, involving nursing pillows. Of the 154 fatalities, an
infant was sleeping in or on the nursing pillow in 142 cases. In 1992,
CPSC adopted a ban on certain types of hazardous ``infant pillows''
that contain loosely filled granular materials that conform to an
infant's face or body, codified at 16 CFR 1500.18(a)(16) (Infant

[[Page 65867]]

Pillow Ban). Certain nursing pillows are exempt from the Infant Pillow
Ban while others do not fall within its scope, such as pillows with a
non-granular fill. Many products are currently marketed for both
nursing and ``lounging,'' despite the suffocation hazard posed of by
propping up very young infants. In 2020, the most recent year for which
CPSC has complete data, nursing pillows are associated with 38
fatalities and 14 injuries.
To address the risk of death and injury associated with nursing
pillows, and as required in section 104 of the CPSIA, the Commission is
issuing this proposed rule to establish mandatory performance and
labeling requirements for nursing pillows. The proposed rule is
intended to address the hazards associated with infants in nursing
pillows. Accordingly, the proposed rule addresses:
(1) suffocation hazards associated with nursing pillows, by
requiring nursing pillows to be sufficiently firm that the product is
unlikely to conform to an infant's face and occlude its airways;
(2) entrapment hazards posed when the product restricts an infant's
head movements, via performance standards requiring testing to assess
this hazard;
(3) suffocation and fall risks due to infant restraints that could
suggest to consumers that infants can safely be left unattended in or
on the product; and
(4) the risks of suffocation, entrapment, or fall when an infant is
left unattended in the product by requiring labeling and instructional
literature to better communicate risks.
Section VI of this preamble, and Tabs B and C in Staff's NPR
Briefing Package, provide a detailed explanation of proposed
performance and labeling requirements.
Nursing pillows 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
nursing pillows are not specifically listed in section 104(f)(2), they
are ``durable infant or toddler products'' because (as explained in
Part VIII below) they are durable products reasonably expected to be
used by infants under the age of 5 years for support while they are
being fed.
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. Any product defined in part 1130 as a ``durable infant or toddler
product'' must comply with the product registration requirements, as
well as testing and certification requirements for children's products,
that are codified in 16 CFR parts 1107 and 1109. Because nursing
pillows are durable infant products that will be subject to the
proposed consumer product safety standard, the Commission proposes to
amend part 1130 to include nursing pillows in the list of durable
infant or toddler products that must comply with these product
registration requirements. See 16 CFR 1130.2(a).
The testing and certification requirements of section 14(a) of the
Consumer Product Safety Act (CPSA), 15 U.S.C. 2063(a), apply to
standards promulgated under section 104 of the CPSIA. Section 14(a)(3)
of the 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 the issuance of a
NOR.

II. The Product Category

A. Definition of Nursing Pillows

Nursing pillows are infant products intended to position and
support an infant during breastfeeding--also referred to as nursing--or
bottle feeding. These products generally rest upon or are ``worn'' by
the caregiver while seated or partially reclined. Nursing pillows are
most commonly C-, U-, or crescent- (or horseshoe-) shaped--to fit
closely around the caregiver's torso. However, other designs exist,
including a V-shaped or boomerang-shaped product, a round pod with a
recessed center to support the infant, a stack of multiple petal-shaped
pillows attached to a central tubular pillow, and E-shaped products for
twins. Most nursing pillows are filled with synthetic batting or foam,
but products filled with cotton, wool, or dried grains are available.
See Tab E of Staff's NPR Briefing Package.
In addition to providing a support surface for infants, nursing
pillows raise the infant to the desired height for feeding, thereby
reducing muscular strain on the caregiver, and provide a buffering
surface between the infant and the caregiver, reducing pressure on the
caregiver's abdomen. This latter function is especially helpful where
the caregiver has abdominal stitches from a caesarean section. Some
products include a strap or belt, sometimes with a buckle, to secure
the product to the caregiver's body, and a few have restraints that
attach the infant to the product. Many products come with removable
fabric covers, and some products have small infant head support
bolsters or fabric toys attached.\5\
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\5\ See Staff NPR Briefing Package at 5, figures 1 and 2, for
examples of nursing pillow designs.
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Nursing pillows are not covered by an existing voluntary safety
standard. However, CPSC staff has been working with ASTM's F15.16
Infant Feeding Supports subcommittee to develop requirements intended
to address the primary hazards associated with nursing pillows. On
March 20, 2023, ASTM's F15.16 subcommittee issued a preliminary draft
of the ASTM Infant Feeding Supports voluntary standard (ASTM draft
standard).\6\ The ASTM draft standard (which is not an approved
standard and remains subject to change) defines an infant feeding
support as a ``product that is intended to position and support an
infant (the occupant) close to a caregiver's body, and to reduce strain
and pressure on the caregiver's body, while breastfeeding or bottle
feeding.'' Although not part of the formal definition, the ASTM draft
standard includes clarifying text that states: ``These products are
commonly U-shaped in appearance, and generally rest upon, wrap around,
or are worn by a caregiver in a seated or reclined position. These
products are commonly known as nursing pillows.'' Thus, the ASTM draft
standard for infant feeding supports would include nursing pillows
within the scope of covered products.
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\6\ See Staff NPR Briefing Package at 12-17 and Engineering,
Human Factors, and Health Sciences assessments, Tabs B, C, and D.
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B. Market Description

As discussed in Staff's NPR Briefing Package at Tab E, CPSC
estimates that annual sales of new nursing pillows likely total
approximately $67 million. New nursing pillows range in price from $15
to $100, with most products in the $25 to $65 range. The more expensive
models tend to have removable covers. The Commission's estimate of $67
million per year in sales of new nursing pillows assumes an average
price of approximately $50 and annual sales of 1.34 million units. Some
parents, however, may already own a pillow that was purchased for an
older child, make a pillow, or buy a used pillow to use for nursing.
Used nursing pillows and replacement covers for nursing pillows are
commonly available from secondary marketplaces such as eBay and
Mercari,

[[Page 65868]]

where prices are observed to range from less than $7 to more than $120.
The widespread availability of replacement covers extends the useful
life and durability of nursing pillows, allowing covers to be cleaned
or replaced as needed.
Although more than a thousand businesses sell nursing pillows and
nursing pillow covers online, just nine companies supply the models
commonly sold in brick-and-mortar stores. Individual stores typically
have fewer than four models of nursing pillows in stock, which limits
consumers' ability to assess the safety-related characteristics of the
products and to make selections on that basis.

C. Infant Cushion/Pillow Ban and Nursing Pillow Exemption

In 1992, pursuant to the Commission's authority under the Federal
Hazardous Substances Act (FHSA), the Commission issued its Infant
Pillow Ban. 57 FR 27912 (June 23, 1992). The Infant Pillow Ban bans
``infant cushions,'' ``infant pillows,'' and similar articles that are:
<bullet> loosely filled with granular material, including but not
limited to, polystyrene beads or pellets;
<bullet> easily flattened;
<bullet> capable of conforming to the body or face of an infant;
and
<bullet> intended or promoted for use by children under 1 year of
age.
This proposed rule for nursing pillows does not change the FHSA
ban. That ban was limited to infant cushions and infant pillows defined
in the Infant Pillow Ban and the specific hazard presented by products
with loosely filled granular material such as polystyrene beads or
pellets.
In 2008, the Commission approved an exemption to the Infant Pillow
Ban. 73 FR 77493 (Dec. 19, 2008). The exemption 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). Examples of products that fall within this
exemption include nursing pillows that are tubular in form, C- or
crescent-shaped to fit around a caregiver's waist, round in
circumference, and filled with granular material. The exemption applies
only to the Infant Pillow Ban and is not applicable to this proposed
rule. In approving the exemption, the Commission assessed the utility
of nursing pillows and the risk of harm based on data from January 1992
to May 2008. The Commission found that the data available at that time
did not support a ban on the sale of all nursing pillows under the
FHSA. Termination of Rulemaking Other Than With Respect to Boston
Billow Nursing Pillow and Substantially Similar Nursing Pillows, 73 FR
51386, 51387 (Sept. 3, 2008).
Unlike the Infant Pillow Ban, this proposed rule sets a performance
standard pursuant to the CPSIA that allows for the sale of nursing
pillows that meet the requirements in the standard. As described below,
this proposed rule is based in part on new data concerning incidents
that occurred between January 2010 through December 2022, many of which
were fatal. The proposed rule does not alter either the Infant Pillow
Ban at 16 CFR 1500.18(a)(16) or the exemption codified at 16 CFR
1500.86(a)(9), both of which would remain in place. Thus, products that
are not banned under the Infant Pillow Ban but that meet this proposed
rule's definition of a nursing pillow would need to comply with the
proposed rule.

III. Incident Data and Hazard Patterns

CPSC staff searched the Consumer Product Safety Risk Management
System (CPSRMS) \7\ and National Electronic Injury Surveillance System
(NEISS) \8\ databases for fatalities, incidents, and concerns
associated with nursing pillows and involving infants up to 12 months
old, reported to have occurred between January 1, 2010, and December
31, 2022. Commission staff identified 154 fatal incidents and 88
nonfatal incidents and consumer concerns reported to CPSC during this
time. Because reporting is ongoing, the number of reported fatalities
and nonfatal incidents during this period may increase, especially for
years 2021 and 2022. Tab A of Staff's NPR Briefing Package describes
the incident and hazard patterns associated with nursing pillows.
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\7\ 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.
\8\ 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 <a href="https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data">https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data</a>.
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A. Incident Severity

The Commission is aware of 242 incident reports associated with
nursing pillows. Table 1 groups the reported cases by severity. Of the
242 reports, 154 (64 percent) involved a fatality.\9\ Of the 88
nonfatal incidents, 64 (73 percent) resulted in an injury, and 24 (27
percent) reported no injury. Among the reported incidents without
injury, some included concerns such as product integrity or the smell
of the nursing pillow that are unrelated to the hazards this proposed
rule is intended to address. Table 1 provides the distribution of
incidents by year.
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\9\ More than half of the fatalities of which CPSC staff is
aware were reported to have occurred since 2019. Staff's NPR
Briefing Package at Tab A. However, staff has noted that because the
reported data are anecdotal, fluctuations in the numbers of reported
incidents could simply reflect changes in reporting rather than an
actual change in incident frequency. Id.

Table 1--Reported Incidents and Injury Severity by Year, January 1, 2010-December 31, 2022
----------------------------------------------------------------------------------------------------------------
Year Fatalities Injuries No injury Total
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2010............................................ 7 3 2 12
2011............................................ 5 0 1 6
2012............................................ 7 1 1 9
2013............................................ 5 0 6 11
2014............................................ 4 2 3 9
2015............................................ 10 3 0 13
2016............................................ 6 3 1 10
2017............................................ 10 5 0 15
2018............................................ 16 2 0 18
2019............................................ 17 5 0 22

[[Page 65869]]

2020............................................ 38 14 2 54
2021 *.......................................... 21 14 1 36
2022 *.......................................... 8 12 7 27
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Total....................................... 154 64 24 242
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Source: CPSRMS and NEISS.
Reporting is ongoing; 2021-2022 are incomplete.

As reflected in Table 2, nearly all (144 of the 154, or 94 percent)
of the reported fatalities associated with nursing pillows involved
infants 6 months old and younger, and most (110 out of 154, or 71
percent) were deaths of infants 3 months old or younger. For more than
two-thirds of the nonfatal incidents and nearly all the incidents
without injury, however, the victim's age is not available.

Table 2--Reported Incidents and Injury Severity by Age, January 1, 2010-December 31, 2022
----------------------------------------------------------------------------------------------------------------
Age Fatalities Injuries No injury Total
----------------------------------------------------------------------------------------------------------------
1 month......................................... 44 7 0 51
2 months........................................ 36 4 0 40
3 months........................................ 30 5 0 35
4 months........................................ 15 4 1 20
5 months........................................ 10 4 0 14
6 months........................................ 9 1 0 10
7 months........................................ 6 1 0 7
8 months........................................ 2 1 0 3
9 months........................................ 1 1 0 2
Unknown......................................... 1 36 23 60
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Total....................................... 154 64 24 242
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS.
Reporting is ongoing. 2021-2022 are considered incomplete.

B. Fatalities and Associated Hazard Patterns

The official cause of death reported by the medical examiner in
nearly all of the 154 reported fatalities was asphyxia, suffocation,
overlay, sudden unexpected infant death (SUID), sudden infant death
syndrome (SIDS; a sub-type of SUID), or a similar cause. Nearly all
reported fatalities (142 of the 154) involved use of the nursing pillow
for sleep, and these cases often involved additional unsafe sleep
conditions including sleep-surface sharing--also known as co-sleeping--
or the presence of other soft bedding such as pillows or blankets.
Nursing pillows are intended to be used for feeding when both
infant and caregiver are awake, and the caregiver is able to ensure
that the infant's airways are not covered by the pillow. However,
because infants frequently fall asleep during or after feeding, nursing
pillows are foreseeably misused for infant sleep, which creates a
potential hazard for the infant. For example, if a sleeping infant
rolls over so their face is pressed against the nursing pillow, the
infant's airways may be blocked, causing suffocation. Similarly, if an
infant falls into the opening where the caregiver is positioned during
feeding, the infant can land face-down with the pillow surrounding
their head, causing entrapment against the surface on which the pillow
rests. Even if the infant remains with their back against the top of
the nursing pillow, if the infant's position shifts so that their head
falls against their chest or tilts backwards over the top of the
pillow, the hyperextension or hyperflexion of the infant's neck can
prevent breathing.
For the most part, there was no witness observing the fatal
incidents, and 60 of the fatal cases (39 percent) had insufficient
details to enable CPSC staff to determine the hazard pattern or
scenario. However, CPSC staff classified the remaining 94 reported
fatalities by hazard patterns, based on the best available information
about the position in which the victim was found. Table 3 shows the
distribution of the 154 reported fatalities by hazard scenario.

Table 3--Reported Fatalities by Hazard Scenario, January 1, 2010-
December 31, 2022
------------------------------------------------------------------------
Hazard scenario Fatalities Percent *
------------------------------------------------------------------------
Face into product....................... 32 21
Face into other object/bedding outside 21 14
product................................
Face down in opening.................... 14 9
Neck extension/flexion.................. 13 8
Bedding over face....................... 4 3
Face into product or bedding (unknown).. 4 3
Entrapment/overlay while nursing........ 3 2
Overlay................................. 3 2
Unknown................................. 60 39
-------------------------------

[[Page 65870]]

Total............................... 154 100
------------------------------------------------------------------------
Source: CPSRMS.
Reporting is ongoing, especially for 2021-2022.
* Percentages may not sum to 100 due to rounding.

Sixty-two fatalities (40 percent) involved the nursing pillow
product being used in another infant sleep product, such as a crib,
portable playpen, or bassinet; 61 fatalities (40 percent) involved use
of the product on an adult bed or mattress; and one fatality involved a
mattress of unknown size. Eighteen reported fatalities (12 percent)
involved the product being used on a couch, sofa, or loveseat; one
fatality involved the product being used on the caregiver's lap in a
recliner chair; and the use location for 11 fatalities is unknown.
Table 4 displays fatal incidents by the location where the nursing
pillow and infant were placed.

Table 4--Reported Fatalities by Pillow/Infant Placement, January 1, 2010-
December 31, 2022
------------------------------------------------------------------------
Pillow/infant placement Fatalities Percent *
------------------------------------------------------------------------
Infant sleep product.................... 62 40
Bassinet............................ 29 19
Crib................................ 20 13
Portable playpen/crib............... 13 8
Adult sleep product..................... 61 40
Adult bed........................... 58 38
Adult mattress...................... 3 2
Couch................................... 18 12
Recliner chair.......................... 1 1
Unknown size mattress................... 1 1
Unknown................................. 11 7
-------------------------------
Total........................... 154 100
------------------------------------------------------------------------
Source: CPSRMS.
Reporting is ongoing, especially for 2021-2022.
* Percentages may not sum to 100 due to rounding.

C. Nonfatal Incidents

Of the 88 nonfatal incidents associated with nursing pillows, 64
resulted in an injury to the infant and 24 did not lead to a reported
injury. Of the 64 injury victims, 19 infants were known to have been
treated and released from the emergency department. All 19 of these
injuries involved the infant falling or rolling off, or out, of the
nursing pillow. An additional 3 injuries, one involving a burn, one due
to a fall, and one due to cardiopulmonary arrest after the infant was
laying on the nursing pillow, resulted in hospital admission. The
remaining 42 injuries where the level of care was not known included
falls, near suffocation, near strangulation, choking, and skin
irritation or allergy. Table 5 summarizes the hazard patterns for the
nursing pillow-related nonfatal incidents.

Table 5--Reported Nonfatal Incidents by Hazard Pattern, January 1, 2010-
December 31, 2022
------------------------------------------------------------------------
Nonfatal
Hazard incidents Percent *
------------------------------------------------------------------------
Skin allergy/irritation................. 29 33
Fall/roll out........................... 23 26
Elevated surface.................... 19 22
Carrying in product................. 2 2
Same level.......................... 1 1
Unknown level....................... 1 1
Filling coming out/choking hazard....... 6 7
Product integrity....................... 5 6
Strong smell............................ 5 6
Other................................... 20 23
-------------------------------
Total............................... 88 100
------------------------------------------------------------------------
Source: CPSRMS and NEISS.
Reporting is ongoing for these databases, especially for 2021-2022.
* Percentages may not sum to 100 due to rounding.

Table 6 displays nonfatal injuries by the location in which the
nursing pillow and infant were placed. In 66 percent (42 of 64) of the
nonfatal injuries, the location was unknown, but the most

[[Page 65871]]

common locations among the remaining incidents were couches and beds.

Table 6--Reported Nonfatal Injuries by Pillow/Infant Placement, January
1, 2010-December 31, 2022
------------------------------------------------------------------------
Pillow/infant placement Injuries Percent *
------------------------------------------------------------------------
Couch................................... 8 13
Adult bed [supcaret].................... 5 8
Bed, unknown type....................... 3 5
Infant being carried in product......... 2 3
Table................................... 2 3
Bathroom counter........................ 1 2
Rocking Chair **........................ 1 2
Unknown................................. 42 66
-------------------------------
Total............................... 64 100
------------------------------------------------------------------------
Source: CPSRMS and NEISS.
Reporting is ongoing for these databases, especially for 2021-2022.
* Percentages may not sum to 100 due to rounding.
[supcaret] In one incident, the caregiver was breastfeeding while in an
adult bed.
** Infant was placed on the caregiver's lap while in the rocking chair.

IV. The BSU Final Report 10
---------------------------------------------------------------------------

\10\ See Staff's NPR Briefing Package, Tab B.
---------------------------------------------------------------------------

CPSC awarded a contract to Boise State University (BSU) for infant
biomechanics and suffocation research and consultancy services. One
task under this contract was for research on pillows intended for
infant care and use, and an analysis of the risk of injury or death to
infants associated with the use of infant pillows marketed as aiding
infants during activities such as feeding, nursing, sleeping, propping,
and lounging; that is, nursing pillows and infant support cushions.
BSU delivered its final report on June 30, 2022 (the BSU Final
Report).\11\ The BSU Final Report provides recommendations and
conclusions related to the performance and design of nursing pillows,
including:
---------------------------------------------------------------------------

\11\ 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: <a href="https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing">https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing</a>.
---------------------------------------------------------------------------

<bullet> Firmness Testing. The BSU Final Report recommends that all
nursing pillows be required to undergo firmness testing, because
products that lack firmness are more likely to conform around an
infant's nose and mouth and to present a suffocation hazard. The report
recommends testing using a 3-inch diameter, anthropometry-based
hemispheric probe that is geometrically similar to, and sized to
represent the breadth of, an infant's face. The report suggests that
this probe should be applied to the product at three locations: the
location of maximum thickness, the location of minimum thickness, and a
third location that seems particularly soft or is otherwise most likely
to result in failure. The force required to displace the probe 1 inch
into the product at each location must exceed 10 Newtons (N). Passing
this requirement would mean that the product has firmness comparable to
crib mattresses, which are generally considered the safest place for an
infant to sleep.
<bullet> 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 believe would mitigate the suffocation hazard.
However, the report also recommends that airflow testing is not
required for products that pass their proposed firmness testing,
because a firm product is unlikely to form a seal around an infant's
nose and mouth.
<bullet> Sagittal-Plane Testing. BSU developed prototype sagittal-
plane testing devices to allow for more comprehensive assessments of
infant positioning in and on nursing pillows and infant support
cushions.\12\ The BSU Final report emphasizes that further research is
needed to determine appropriate worst-case positions for testing and to
set threshold values for acceptable body positions that would not
negatively impact infant breathing.
---------------------------------------------------------------------------

\12\ 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.
---------------------------------------------------------------------------

<bullet> Nursing Pillow Shape. The BSU Final Report advises that
nursing pillows that are firm and feature sharper corners, rather than
cylindrical sides, are likely the safest option for infants, because
there would be no reasonable way for consumers to use such a product
for lounging, thereby limiting the hazards associated with sagittal-
plane positioning in a nursing pillow.
CPSC considered the BSU Final Report and its recommendations when
developing this proposed rule for nursing pillows. Tab B of Staff's NPR
Briefing Package contains CPSC staff's assessment of how the proposed
rule reflects the report's conclusions and recommendations.

V. ASTM's Draft Standard 13
---------------------------------------------------------------------------

\13\ See Staff's NPR Briefing Package, Tab B.
---------------------------------------------------------------------------

There are no published U.S. voluntary standards for nursing
pillows. However, on March 20, 2023, ASTM issued ballot F15.16 (23-01),
which included the ASTM draft standard. The ballot closed on April 20,
2023, and received 11 negative votes with comments and 6 other
comments. Although not adopted, the ASTM draft standard reflects the
types of performance requirements that are under consideration by
industry, with input from CPSC staff.\14\ It includes general
requirements typically found in other ASTM juvenile product standards,
such as requirements for lead, including lead in paints; prohibitions
against small parts, hazardous sharp edges or points, and removable
protective components; requirements to prevent injury from scissoring,
shearing, and pinching; requirements for toy accessories that are
attached to, removable from, or sold with the products; and permanency
requirements for labels and warnings.
---------------------------------------------------------------------------

\14\ On August 21, 2023, ASTM issued ballot F15 (23-12), which
included a revised draft of the ASTM Infant Feeding Supports
voluntary standard. This new ballot is scheduled to close on
September 21, 2023. Staff is currently reviewing the ballot
---------------------------------------------------------------------------

The ASTM draft standard also includes four performance requirements

[[Page 65872]]

intended to address safety hazards specifically associated with nursing
pillows:
<bullet> Infant Restraints: This requirement prohibits infant
feeding supports from including an infant restraint system, which may
entangle an infant and could invite misuse by suggesting to caregivers
that it is acceptable to leave an infant unattended on the nursing
pillow.
<bullet> Fabric/Mesh Integrity: This requirement is intended to
address product integrity issues such as seam failures and material
breakage.
<bullet> Firmness: This requirement places limits on the extent to
which certain portions of the product can deflect when a 3-inch
diameter hemispheric probe is applied to the product with a certain
force. The proposed requirement and test method address the suffocation
hazard when a nursing pillow conforms to an infant's face, and are
based on the firmness recommendations in the BSU Final Report.\11\
However, the BSU researchers' recommended requirements were applied not
only to the top infant support surface, but also to the inner wall of
the crescent-like opening of these products. Testing is performed at
three locations on each of these two surfaces.
<bullet> Occupant Containment: This requirement applies a 9-inch
diameter head probe to the opening of an infant feeding support; when
moved laterally through this opening, the probe must not contact the
side walls of the product. The requirement is intended to reduce the
potential for an infant's head to become entrapped within this opening.
This requirement also is intended to reduce the extent to which these
products are used for infant propping or lounging, by limiting the
amount of lateral support available to young infants if they were
placed within the opening.
The ASTM draft standard also includes marking, labeling, and
instructional literature requirements. These include requirements for
warnings that must appear on nursing pillows and other infant feeding
supports covered by the standard. Figure 1 illustrates the ASTM draft
standard's required warning statements that must appear on all nursing
pillows:
[GRAPHIC] [TIFF OMITTED] TP26SE23.013

The ASTM draft standard requires the warnings to be ``permanent''
and ``conspicuous,'' which the draft standard defines as a ``label that
is visible, when the infant feeding support is in a manufacturer's
recommended use position, to a person sitting near the infant feeding
support at any position around the infant feeding support.''
The draft voluntary standard also includes requirements for package
warnings against using nursing pillows for sleep or in sleep products,
and to state the manufacturer's recommended weight, height, age,
developmental level, or combination thereof, of the infant. In
addition, the package cannot include warnings, statements, or graphics
that indicate or imply that the infant may be left in the product
without an adult caregiver in attendance.
Lastly, ASTM's draft voluntary standard includes requirements for
instructional literature to accompany products covered by the standard.
In addition to the warnings on the product, there must be instructions
to consumers to: (1) read all instructions before using the product;
(2) keep the instructions for future use; and (3) not use the product
if it is damaged or broken. The instructions also must indicate the
manufacturer's recommended maximum weight, height, age, developmental
level, or combination thereof, of the infant. If the product is not
intended for use by a child for a specific reason (e.g., a disability
that would prevent safe use of the product), the instructions must
state this limitation.

VI. Description of the Proposed Mandatory Standard for Nursing Pillows
15
---------------------------------------------------------------------------

\15\ See Staff's NPR Briefing Package, Tab B.
---------------------------------------------------------------------------

To address established risks of death and injury associated with
infant suffocations, entrapments, and falls, and as required in section
104 of the CPSIA, the Commission is issuing this proposed rule to
establish mandatory performance

[[Page 65873]]

and labeling requirements for nursing pillows. The proposed rule
addresses:
(1) suffocation hazards associated with nursing pillows, by
requiring nursing pillows to be sufficiently firm so that the product
is unlikely to conform to an infant's face and occlude its airways;
(2) entrapment hazards posed when the product restricts an infant's
head movements, via performance standards requiring testing to assess
this hazard;
(3) suffocation and fall risks due to infant restraints that could
suggest that infants can safely be left unattended in the product; and
(4) the risks of suffocation, entrapment, or fall when an infant is
left unattended in the product by requiring labeling and instructional
literature to better communicate risks.
The text of the proposed rule is based on an evaluation of the
nursing pillow market, the existing Infant Pillow Ban and its
associated exemption, the ASTM draft standard for infant feeding
supports that is under development, and the recommendations of the BSU
Final Report. The proposed rule would apply to all nursing pillows, as
defined below. The proposed rule is summarized below and explained in
more detail in Tabs B and C of Staff's NPR Briefing Package.

A. Scope

Section 1242.2 of the proposed rule defines ``nursing pillow'' as:
Any product intended, marketed, or designed to position and support
an infant close to a caregiver's body while breastfeeding or bottle
feeding. These products rest upon, wrap around, or are worn by a
caregiver in a seated or reclined position.
The definition of ``nursing pillow'' excludes maternity pillows,
also known as pregnancy pillows, which staff defines as ``a large body
pillow intended, marketed, and designed to provide support to a
pregnant adult's body during sleep or while lying down,'' and sling
carriers, as defined in 16 CFR part 1228, which are already required to
meet CPSC's sling carrier safety standard.
This definition is intended to encompass all nursing pillows on the
market and within the available incident data, while excluding products
that are not intended primarily for nursing (maternity pillows) or that
might be used for nursing but whose hazards are already addressed by
another standard (sling carriers). This definition is similar to the
definition developed by the ASTM infant feeding supports subcommittee
for the ASTM draft standard. The proposed rule, however, does not
include additional language used in the ASTM draft standard's
definition of ``infant feeding support,'' which states that these
products are commonly U-Shaped in appearance. That language is not
needed because all products that meet the definition in the proposed
rule are subject to the same hazards and should be considered within
the scope of the proposed rule regardless of the details of their
shape.

B. General Requirements

The proposed rule includes many of the general requirements
included in the ASTM draft standard for infant feeding supports to
address the potential hazards associated with lead in paints; small
parts; sharp edges or points; toy accessories that are attached to,
removable from, or sold with the nursing pillow; and the removal of
protective components. However, the requirement in the ASTM draft
standard to prevent the removal of protective components has been
augmented in the proposed rule to include other possibly detachable
components that are present, such as zipper pulls and buttons. If
detached, these components can expose the infant to hazards such as
sharp points, sharp edges, and choking hazards.
The proposed rule also includes the warning permanency requirements
in the ASTM draft standard, with an additional permanency requirement
for ``free-hanging'' labels that attach to the product at only one end
and are particularly susceptible to attempts at removal or alteration
by consumers. Section 1242.3(e)(4) of the proposed rule includes the
following warning permanency requirement:
Warning labels that are attached to the fabric of nursing pillows
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, when tested in accordance with [reference to
existing test method for assessing permanency of warning labels
attached with seams].

C. Proposed Performance Requirements

1. Infant Restraints
To address a potential entanglement hazard, the proposed rule
prohibits nursing pillows from including an infant restraint system.
The draft ASTM voluntary standard for infant feeding supports includes
a similar requirement. Proper use of a nursing pillow involves actively
attending to the infant during use, and the presence of restraints
could suggest to consumers that infants properly can be left unattended
on the product.
2. Seam Strength
Under the proposed rule nursing pillow seams would be subject to a
tension test similar to that applied to toys intended for children up
to 18 months old under ASTM F963, Standard Consumer Safety
Specification for Toy Safety (the toy standard),\16\ but tested at a
higher tension force of 15 pounds rather than 10 pounds, because
nursing pillows may be used for multiple children or passed on to other
caregivers, meaning these products would be subject to stress over a
usable life that can span more than a single infant's use. CPSC is
aware of one injury associated with seam failures, where an infant
reportedly choked on filling that came out of the product, and has
received additional reports of nonfatal incidents involving product
integrity issues such as seam failures See Staff's NPR Briefing Package
at Tab A. The seam strength requirement and test method in the proposed
rule would address such incidents.
---------------------------------------------------------------------------

\16\ Incorporated by reference in 16 CFR part 1250, Safety
Standard Mandating ASTM F963 for Toys.
---------------------------------------------------------------------------

3. Caregiver Attachments
To address the potential for infant falls if the buckled belts,
straps, or other features intended to secure the product to the
caregiver fails, the proposed rule includes a requirement and test
method for the strength of caregiver attachments. Specifically, the
proposed rule would require that each element of the caregiver
attachment system (e.g., strap or buckle) that is included on nursing
pillows be required to withstand a static load equal to the recommended
weight limit of the product, or 20 pounds, whichever is greater.
4. Firmness
The proposed rule includes a firmness requirement that applies to
each nursing pillow's infant support surface, as well as the inner wall
of the nursing pillow opening (e.g., within the crescent-like opening).
As explained in Tab B of Staff's NPR Package, the proposed firmness
requirement and test method is based on the recommendations of the BSU
Final Report, with modifications including the addition of a
requirement to test the inner wall of the opening. The test applies a
3-inch diameter hemispheric probe, which is similar in size and shape
to an infant's face, to three test locations on each surface. To meet
the firmness requirement, the force

[[Page 65874]]

required to displace the probe 1 inch into each test location must
exceed 10 N (about 2.25 pounds), which results in product firmness that
is comparable to crib mattresses. The diagrams in Figure 2, below,
illustrate the firmness test being applied to the two surfaces of a
nursing pillow. This requirement is intended to reduce the likelihood
that the infant support surface or the interior opening of the nursing
pillow can conform to an infant's face and suffocate the child.
[GRAPHIC] [TIFF OMITTED] TP26SE23.024

ASTM's draft voluntary standard includes a firmness requirement
similar to the firmness requirement in the proposed rule, including for
the inner wall of the nursing pillow opening.
5. Infant Containment
The proposed rule requires nursing pillow openings to be of a size
that is more appropriate for an adult user, rather than an infant, and
limits the amount of lateral support for young infants who might be
placed within the nursing pillow opening. This requirement also reduces
the potential for an infant's head to become entrapped in the nursing
pillow's opening or for the product to restrict a young infant's head
movements, should the infant find themselves in the opening.
As shown in Figure 3, a 9-inch probe is used to ensure that the
product opening is wider than the probe and that the probe can be moved
outward from inside the nursing pillow without contacting its surface.
[GRAPHIC] [TIFF OMITTED] TP26SE23.014

[[Page 65875]]

Tab B in Staff's NPR Briefing Package contains a detailed
description of this proposed testing method. The requirement in the
proposed rule is similar to the requirement that appears in the ASTM
draft standard for infant feeding supports. The proposed rule, however,
includes an additional requirement that the nursing pillow cannot
extend beyond the opposite end of the probe, and also requires testing
to be performed both with and without any caregiver attachments
secured, as shown in Figure 4, below.
[GRAPHIC] [TIFF OMITTED] TP26SE23.015

D. Performance Requirements Considered But Not Proposed

1. Airflow Requirement
The BSU Final Report recommends that nursing pillows that do not
pass firmness testing be required to pass an airflow test that would
demonstrate the product has airflow characteristics comparable to mesh
crib liners, which the authors concluded would mitigate the suffocation
hazard. However, the report also stated that airflow testing is not
needed for a product that passes the proposed firmness testing, because
a firm product is unlikely to form a seal around an infant's nose and
mouth. BSU Final Report at 49-63. Because the proposed rule would
require that all nursing pillows meet firmness testing that is at least
as stringent as that recommended in the BSU Final Report, an airflow
requirement for nursing pillows is unnecessary.
2. Angular Requirement
The BSU Final Report assessed that nursing pillows that are firm
and feature sharper corners, rather than cylindrical sides, might be
safer for infants because there would be no reasonable way for
consumers to use such a product as an infant support cushion. The
proposed rule does not include an angular requirement, however, because
of uncertainties surrounding what would be appropriate pass-fail
criteria and the potential for such a requirement to increase the risk
of positional asphyxia by neck hyperflexion or hyperextension if the
nursing pillow is used as a support cushion for lounging. See Staff NPR
Briefing Package at 21-22 and Tab C at 66-67.
The Commission invites public comments on this issue. Specifically,
the Commission is interested in information on the potential
effectiveness of an angular requirement, including what pass-fail
criteria would effectively discourage use of a nursing pillow for
infant lounging; the potential risks associated with such a
requirement; and whether an alternative requirement could better
discourage consumers from using nursing pillows for infant lounging
without concurrently increasing risks if the product is used in that
manner.

E. Warning and Instructional Requirements

Compared to the performance requirements described above, warnings
are likely to be less effective in eliminating or adequately reducing
exposure to nursing pillow hazards. Nevertheless, prominent and well-
designed warnings can be a secondary safety mechanism that provides
consumers 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 nursing pillows, with
particular emphasis on the potentially deadly consequences of using
these products for naps or sleep.
The proposed rule includes warning content and format requirements
that are similar to those in the ASTM draft standard, with minor
changes for clarity and internal consistency. Figure 5 shows the
warning statements and format that would be required on all nursing
pillows:

[[Page 65876]]

[GRAPHIC] [TIFF OMITTED] TP26SE23.016

The ASTM draft standard requires the warning to be ``conspicuous,''
which the ASTM draft standard defines as a ``label that is visible,
when the infant feeding support is in a manufacturer's recommended use
position, to a person sitting near the infant feeding support at any
position around the infant feeding support.'' The proposed rule does
not rely on this definition, because it would allow the warning to be
placed on a side of the product that is not visible to the caregiver
who is using the product (e.g., the side opposite the crescent-like
opening). Instead, the proposed rule defines ``conspicuous'' as
``visible, when the nursing pillow is in each manufacturer's
recommended use position, to a person while placing an infant into or
onto the nursing pillow.''
More specifically, the proposed rule incorporates by reference the
following provisions of the ANSI warning format requirements published
in ANSI Z535.4, Product Safety Signs and Labels (ANSI Z535.4): sections
6.1-6.4, which include requirements related to safety alert symbol use,
signal word selection, and warning panel format, arrangement, and
shape; sections 7.2-7.6.3, which include color requirements for each
panel; and section 8.1, which addresses letter style. See Staff's NPR
Briefing Package, 72-73.
The ASTM draft standard also requires the warnings to be
``permanent'' and includes warning permanence requirements among the
General Requirements for infant feeding supports. As discussed in Part
VI.B. above, the proposed rule includes an additional permanence
requirement to further reduce the potential for the warnings to be
torn, ripped, or cut off.
In addition to on-product warnings, the ASTM draft standard
includes basic warning requirements for the packaging that accompanies
nursing pillows, largely based on the ASTM Ad Hoc Language task group's
recommended requirements for package warnings. The requirements in the
ASTM draft standard include warning statements about not using the
product for sleep or in sleep products such as cribs, bassinets, or
play yards; information about the manufacturer's recommended weight,
height, age, or developmental stage; and a prohibition against other
warnings, statements, or graphics that indicate or imply that an infant
can be left in the product without an adult caregiver present. The
package warnings also are required to have formatting similar to the
on-product warnings. The proposed rule includes these requirements. The
ASTM draft standard for infant feeding supports includes requirements
for instructional literature to accompany nursing pillows, including
requirements for the instructions to include all on-product warnings
and to instruct consumers to read all instructions before using the
product, to keep the instructions for future use, and not to use the
product if it is damaged or broken. Like the package requirements, the
instructions must provide information about the manufacturer's
recommended weight, height, age, or developmental stage, at a minimum.
These requirements are based on meetings of the ASTM Infant Feeding
Supports Warnings task group and on the recommended requirements for
instructional literature by the ASTM Ad Hoc Language task group. The
proposed rule includes these instructional literature requirements.

VII. Proposed Amendment to 16 CFR Part 1112 To Include NOR for Nursing
Pillows

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 third party conformity assessment bodies
to assess conformity with a children's product safety rule to which a
children's product is subject. 15 U.S.C. 2063(a)(3). The proposed
standard for nursing pillows would be a children's product safety rule
that requires the issuance of an NOR.
The Commission published a final rule, Requirements Pertaining to
Third Party Conformity Assessment Bodies, 78 FR 15836, which is
codified at 16 CFR part 1112. Part 1112 became effective on June 10,
2013, and establishes requirements for accreditation of third-

[[Page 65877]]

party conformity assessment bodies (or laboratories) 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. Accordingly, the Commission proposes to amend part
1112 to include the Safety Standard for Nursing Pillows in the list of
other 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 Nursing Pillows
included in its scope of accreditation as reflected on the CPSC website
at: <a href="http://www.cpsc.gov/labsearch">www.cpsc.gov/labsearch</a>.

VIII. 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 also
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 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. Nursing pillows 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 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. Id. at 68669. The
Commission explained that the specified statutory categories were 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
``Nursing pillows,'' as defined, as durable infant or toddler products.
The Commission tentatively finds that nursing pillows 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 5 years; (2) are products
similar to the other feeding support products listed in section
104(f)(2), such as high chairs, booster chairs, and hook-on chairs; and
(3) are commonly available for resale or ``handed down'' for use by
other children over a period of years.

IX. Incorporation by Reference

Section 1242.8 of the proposed rule incorporates by reference
American National Standards Institute (ANSI) Z535.4-2011, American
National Standard for Product Safety Signs and Labels, sections 6.1-
6.4, 7.2-7.6.3, and 8.1, with modifications to further reduce the risk
of injury associated with nursing pillows. In accordance with
regulations of the Office of the Federal Register (OFR), 1 CFR part 51,
section VI.E of this preamble summarizes the provisions of ANSI Z535.4-
2011 that the Commission proposes to incorporate by reference. The ANSI
standard is reasonably available to interested parties in several ways.
By permission of ANSI, the standard can be viewed as a read-only
document during the comment period on this NPR, at: <a href="https://www.surveymonkey.com/r/DQVJYMK">https://www.surveymonkey.com/r/DQVJYMK</a>. To download or print the standard,
interested persons may purchase a copy of ANSI Z535.4-2011 from ANSI
via its website, <a href="https://www.ansi.org">https://www.ansi.org</a>, or by mail from ANSI, 25 West
43rd Street, 4th Floor, New York, NY 10036, USA, telephone: (212) 642-
4900. Alternatively, interested parties may inspect a copy of the
standard 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: <a href="/cdn-cgi/l/email-protection#385b484b5b15574b785b484b5b165f574e">[email&#160;protected]</a>.

X. 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
nursing pillows manufactured after that date. This amount of time is
typical for rules issued under section 104 of the CPSIA. Six months is
also the period that 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 nursing
pillows for compliance to 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.

XI. 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
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. CPSC 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

Section I of this preamble describes the reasons and legal basis
for this NPR. As discussed in sections VI-VIII of this preamble, and
detailed in Tab B of Staff's NPR Briefing Package, the proposed rule
sets out mandatory requirements for nursing pillows to

[[Page 65878]]

address the suffocation, entrapment, fall, and other hazards associated
with these products, adds nursing pillows to the list of products for
which a registration card is required, and adds nursing pillows 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 22 small U.S. manufacturers, 6 small U.S.
importers, and more than 500 U.S. non-employer businesses that would be
impacted by the proposed NPR in the United States. The majority of
nursing pillow suppliers to the U.S. market are small U.S.
manufacturers, importers, or non-employee businesses.

C. Impact of the Proposed Rule on Small Manufacturers and Importers

This proposed rule would likely have a significant impact on a
substantial number of these small entities, based on the estimated
costs of modifying nursing pillows to achieve compliance, and the
ongoing cost of testing to demonstrate compliance. The Commission
considers one percent of annual revenue to be a ``significant''
economic impact on a company, consistent with regulatory flexibility
analyses used by other federal government agencies.
1. Costs Associated With Modifying Products
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 for the
first year that a rule is effective. With an estimated 1,000 models to
be redesigned, the total cost of redesign to the industry in the first
year could be as high as $13.5 million. The cost of redesign is likely
to be significant for a substantial number of small U.S. firms,
particularly small home crafters.
2. Third Party Testing Costs
If issued, a final rule would require all manufacturers and
importers of nursing pillows to meet additional third-party testing
requirements under section 14 of the CPSA. As specified in 16 CFR part
1109, though, entities that are not manufacturers of children's
products, such as importers and wholesalers, may rely on the
certificate of compliance provided by others. Further, manufacturers
would pass on at least some of the cost of testing for compliance to
importers and wholesalers.
Third party testing costs for nursing pillows under the proposed
rule are estimated at $500 to $1,000 per model. The annual cost of
samples for testing is estimated at around $150, bringing the overall
annual cost to an estimated $650 to $1,150 per model. However, some
small volume suppliers would likely be able to raise retail prices to
cover at least some of their testing costs. For example, a hand crafter
selling 200 nursing pillows a year could cover the entire testing cost
by raising the price by $3.25, while a smaller supplier could cover at
least some of their costs with a modest price increase.
3. Summary of Impacts
The best-selling nursing pillows are from companies that have
sufficient sales volume to spread the cost of compliance over thousands
of units and are unlikely to exit the market. It is likely that the
products currently in stores, and the best-selling online-only
products, would still be available, with modest redesigns. However,
there may be some loss in sales of specific products if the redesigned
products are less appealing to consumers.
The redesign could increase wholesale or retail prices by a few
dollars, but likely not a significant amount, given that the materials
and production methods are likely to remain roughly similar. Warning
labels, registration forms, and instruction manuals could add up to $1
to the cost of the product. If companies decide to pass the ongoing
cost of testing onto consumers, the additional retail price increase of
perhaps $1, added to the additional $1 cost of the warning labels and
instruction manuals, would total $2, or 4 percent of the price of a $50
item.

D. Other Federal Rules That May Duplicate, Overlap, or Conflict With
the Proposed Rule

CPSC has not identified any other federal rules that duplicate,
overlap, 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 or other alternatives that
could reduce the potential burden on small entities.
1. Not Establishing a Safety Standard
The Commission considered not establishing a safety standard for
nursing pillows. While this alternative would result in no regulatory
impact on small businesses, deaths and injuries from the use of nursing
pillows would likely continue to occur at similar rates as those
observed during the 2010-2022 time period. As discussed earlier, CPSC
observed 88 nonfatal incidents and 154 fatalities during this time
period. In 2020 alone--the most recent year for which there is complete
data--there were 38 fatalities and 14 injuries from nursing pillows.
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 or adequately address the identified
hazards.
3. ``Angular'' Performance Requirement
The Commission considered including in the proposed safety standard
an ``angular'' performance requirement based upon the BSU Final
Report's suggestion that nursing pillows that are firm and feature
sharper corners are likely safer for babies because there is no
reasonable way to use these products for lounging. However, as the BSU
Final Report notes, its recommendation on that point is preliminary and
the Commission is seeking comment from the public on this point.
4. Earlier Effective Date
The Commission is proposing an effective date 180 days after
publication of the final rule in the Federal Register. 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.
The Commission considered adopting an earlier effective date to
achieve the safety benefits of the rule more quickly, but a shorter
period would 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

[[Page 65879]]

of nursing pillows due to a lack of availability of testing laboratory
resources.

F. Impact on Testing Labs

Section 14 of the CPSC requires that all products that are subject
to a children's product safety rule must be tested by a third party
conformity assessment body that has been accredited by CPSC. One of the
roles of these third party conformity assessment bodies is to test
products for compliance with applicable children's product safety
rules. Testing laboratories that want to conduct testing must meet the
NOR for third-party conformity testing. See 16 CFR part 1112.
The Commission does not expect a significant adverse impact on any
testing laboratories as a result of this rule. Laboratories will not
need to acquire complex or costly testing instruments or devices to
test nursing pillows for compliance, and laboratories will decide for
themselves whether to offer testing services for nursing pillow
compliance.

XII. 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 nursing pillows falls within the categorical
exclusion.

XIII. Paperwork Reduction Act

This proposed rule for nursing pillows 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:
<bullet> a title for the collection of information;
<bullet> a summary of the collection of information;
<bullet> a brief description of the need for the information and
the proposed use of the information;
<bullet> a description of the likely respondents and proposed
frequency of response to the collection of information;
<bullet> an estimate of the burden that shall result from the
collection of information; and
<bullet> notice that comments may be submitted to the OMB.
Title: Safety Standard for Nursing Pillows.
Description: The proposed rule would require each nursing pillow
within the scope of the rule to meet the rule's new 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
nursing pillows.
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 responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling and instructions.......................................... 844 1 844 2 1,688
--------------------------------------------------------------------------------------------------------------------------------------------------------

While some products currently have labels, all 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 844 entities that would respond to this
collection annually.\17\ We estimate that the time required to create
and modify labeling and instructions is about 2 hours per response.
Therefore, the estimated burden associated with this collection is 844
responses x 1 response per year x 2 hours per response = 1,688 hours
annually.
---------------------------------------------------------------------------

\17\ Although Commission staff estimate the total number of
nursing pillow suppliers to the United States to be more than 1,000,
staff anticipates that only a portion of those suppliers will
respond to the collection each year based on when they introduce new
product models or redesign previous models.
---------------------------------------------------------------------------

We estimate the hourly compensation for the time required to
respond to the collection is $37.41 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' March 2023, Table 4,
total compensation for all sales and office workers in goods-producing
private industries: <a href="https://www.bls.gov/news.release/archives/ecec_06162023.pdf">https://www.bls.gov/news.release/archives/ecec_06162023.pdf</a>). Therefore, the estimated annual labor cost of the
collection is $63,148 ($37.41 per hour x 1,688 hours = $63,148.08).
Based on this analysis, the proposed standard for nursing pillows
would impose an additional burden to industry of 1,688 hours at a cost
of $63,148.
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:
[ssquf] whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
[ssquf] the accuracy of the CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
[ssquf] ways to enhance the quality, utility, and clarity of the
information to be collected;
[ssquf] 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
[ssquf] the estimated burden hours associated with label
modification, including any alternative estimates.

XIV. Preemption

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a standard

[[Page 65880]]

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
nursing pillows.

XV. Request for Comments

The Commission seeks public comment on all aspects of the proposed
rule. In particular, however, the Commission seeks comment on the
potential effectiveness of an angular requirement not included in the
proposed rule; including what pass-fail criteria would effectively
discourage the use of nursing pillows for lounging, the potential risks
associated with such a requirement, and whether an alternative
requirement could assist in discouraging consumers from using nursing
pillows for infant lounging without increasing risks to those infants
whose caregivers still choose to use the product this way. The
Commission also specifically requests comments on the proposed
effective date and the costs of compliance with, and testing to, the
proposed Safety Standard for Nursing Pillows.
Comments should be submitted in accordance with the instructions in
the ADDRESSES section at the beginning of this notice.

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 1242

Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Nursing, Pillows, and Toys.

For the reasons discussed in the preamble, the Commission proposes
to amend Title 16 of the Code of Federal Regulations as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES

0
1. The authority citation for 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 by adding paragraph (b)(56) to read as follows:

Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
(b) * * *
(56) 16 CFR part 1242, Safety Standard for Nursing Pillows.
* * * * *
0
3. The authority citation for part 1130 continues to read as follows:

Authority: 15 U.S.C. 2056a, 2065(b).

0
4. Amend Sec. 1130.2 by adding paragraph (a)(19) to read as follows:

PART 1130--REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT
OR TODDLER PRODUCTS

Sec. 1130.2 Definitions.

* * * * *
(a) * * *
(19) Nursing pillows.
* * * * *
0
5. Add part 1242 to read as follows:

PART 1242--SAFETY STANDARD FOR NURSING PILLOWS

Sec.
1242.1 Scope, purpose, application, and exemptions.
1242.2 Definitions.
1242.3 General requirements.
1242.4 Performance requirements.
1242.5 Test methods.
1242.6 Marking and labeling.
1242.7 Instructional literature.
1242.8 Incorporation by reference.

Authority: 15 U.S.C. 2056a.

Sec. 1242.1 Scope, purpose, application, and exemptions.

(a) Scope and Purpose. This part 1242, a consumer product safety
standard, prescribes requirements intended to reduce the risk of death
and injury from hazards associated with nursing pillows, as defined in
Sec. 1242.2.
(b) Application. Except as provided in paragraph (c) of this
section, all nursing pillows that are manufactured after March 25,
2024, are subject to the requirements of this part 1242.
(c) Exemptions. The following products are exempt from this part
1242: (1) Maternity pillows, as defined in Sec. 1242.2, and (2) Sling
carriers, as defined in 16 CFR part 1228.

Sec. 1242.2 Definitions.

Caregiver attachment means a portion of the product intended to
secure the nursing pillow to the caregiver and not intended to secure
the infant to the nursing pillow. A caregiver attachment may comprise
components including, but not limited to, straps, buckles, or latches.
Caregiver opening means the surface of the nursing pillow,
excluding the caregiver attachment, intended to fit against the
caregiver's torso during use. This surface is typically, but not
necessarily, crescent-like in shape.
Conspicuous means visible, when the nursing pillow is in each
manufacturer's recommended use position, to a person while placing an
infant into or onto the nursing pillow.
Infant restraint system means a portion of a product intended to
secure or hold an infant in place on the product. These typically take
the form of straps or harnesses that are secured by the caregiver.
Infant support surface means the manufacturer's intended support
surface for the infant during nursing or feeding.
Maternity pillow, also known as a pregnancy pillow, means a large
body pillow intended, marketed, and designed to provide support to a
pregnant adult's body during sleep or while lying down.
Nursing pillow means any product intended, marketed, or designed to
position and support an infant close to a caregiver's body while
breastfeeding or bottle feeding. These products rest upon, wrap around,
or are worn by a caregiver in a seated or reclined position.
Safety alert symbol means a symbol consisting of an exclamation
mark surrounded by an equilateral triangle, or an equilateral triangle
with a contrasting superimposed exclamation mark. The safety alert
symbol precedes the signal word ``WARNING,'' or other signal word, in
the signal word panel of a warning.

Sec. 1242.3 General requirements.

(a) Lead in Paints. All paint and surface coatings on the product
shall comply with the requirements of 16 CFR part 1303.
(b) Small Parts. There shall be no small parts, as defined in 16
CFR part 1501, before testing or liberated as a result of testing.
(c) Hazardous Sharp Edges or Points. There shall be no hazardous
sharp points or edges, as defined in 16 CFR

[[Page 65881]]

1500.48 and 16 CFR 1500.49, before or after testing.
(d) Removal of Components. When tested in accordance with Sec.
1242.5(b), 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 Sec.
1242.3(b) and Sec. 1242.3(c).
(e) Permanency of Labels and Warnings. (1) Warning labels (whether
paper or non-paper) shall be permanent when tested in accordance with
Sec. 1242.5(c)(1) through Sec. 1242.5(c)(3).
(2) Warning statements applied directly onto the surface of the
product by hot stamping, heat transfer, printing, wood burning, etc.
shall be permanent when tested in accordance with Sec. 1242.5(c)(4).
(3) Non-paper labels shall not liberate small parts when tested in
accordance with Sec. 1242.5(c)(5).
(4) Warning labels that are attached to the fabric of infant
feeding supports 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, when tested in accordance with
Sec. 1242.5(c)(3).

Sec. 1242.4 Performance requirements.

(a) Firmness. When tested in accordance with Sec. 1242.5(d), Sec.
1242.5(e) and Sec. 1242.5(f), the force required for a 1.00-in. (2.54
cm) displacement of the 3-inch (76.2 mm) diameter hemispheric probe
(Figure 1 to this paragraph (a)--3-in. head probe) at any measurement
location shall be greater than 10.0 N (2.24 lb).

Figure 1 to Paragraph (a)--3-In Head Probe
[GRAPHIC] [TIFF OMITTED] TP26SE23.017

(b) Infant Containment. When tested in accordance with Sec.
1242.5(g), the surfaces within the caregiver opening of the product
shall not contact the 9-inch (230 mm) diameter head probe (Figure 2 to
this paragraph (b)--9-in. head probe) such that the probe is
constrained within the caregiver opening and, when placed according to
Sec. 1242.5(g)(6), the probe must extend past the caregiver opening.

Figure 2 to Paragraph (b)--9-In. Head Probe

[[Page 65882]]

[GRAPHIC] [TIFF OMITTED] TP26SE23.018

(c) Infant Restraints. Nursing pillows shall not include any infant
restraint system.
(d) Seam Strength. When tested in accordance with Sec. 1242.5(h),
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. 1242.3(b) and Sec. 1242.3(c).
(e) Caregiver Attachment Strength. When tested in accordance with
Sec. 1242.5(i), material seams, points of attachment, and attachment
components shall not fail, and shall create no hazardous conditions,
such as small parts or sharp edges, as required in Sec. 1242.3(b) and
Sec. 1242.3(c).

Sec. 1242.5 Test methods.

(a) Test Conditions. (1) 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%.
(2) Secure the firmness fixture to a test base such that the 3-in.
head probe (Figure 1 to Sec. 1242.4(a)) does not deflect more than
0.01 in. (0.025 cm) under a 10 N (2.2 lb) load applied in each
orientation required in the test methods.
(b) Removal of Components Test Method. (1) For torque and tension
tests, any suitable device may be used to grasp the component, provided
that it does not interfere with the attachment elements that are
stressed during the tests.
(2) Torque Test. Gradually apply a 4 lb-in. (0.4 N-m) torque over 5
seconds (s.) in a clockwise rotation to 180 degrees or until 4 lb-in.
has been reached. Maintain for 10 s. Release and allow component to
return to relaxed state. Repeat the torque test in a counterclockwise
rotation.
(3) Tension Test. For components that can reasonably be grasped
between thumb and forefinger, or teeth, apply a 15 lb (67 N) force over
5 s., in a direction to remove the component. Maintain for 10 s. A
clamp such as shown in Figure 3 to this paragraph (b)(3) may be used if
the gap between the back of the component and the base material is 0.04
in. (0.1 cm) or more.

Figure 3 to Paragraph (b)(3)--Tension Test Adapter Clamp

[[Page 65883]]

[GRAPHIC] [TIFF OMITTED] TP26SE23.023

(c) Permanency 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-lbf (67-N) pull
force applied in the direction most likely to cause failure using a \3/
4\-in. (1.9 cm) diameter clamp surface. Gradually apply the force
within a period of 5 s. and maintain for an additional 10 s.
(4) Adhesion Test for Warnings Applied Directly onto the Surface of
the Product:
(i) Apply the tape test defined in Test Method B of Test Method
D3359, 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.
(iv) A non-paper label, during an attempt to remove it without the
aid of tools or solvents, shall not fit entirely within the small parts
cylinder defined in 16 CFR part 1501 if it can be removed.
(d) Infant Support Surface Firmness Test Method. Perform the
following steps to determine the infant support surface firmness of the
product as received from the manufacturer.
(1) Conduct tests at three locations on the surface to be tested,
with 3 in. (7.62 cm) or more separation: maximum thickness
perpendicular to the test surface and two other locations most likely
to fail.
(2) Lay the product, with the infant support surface facing up, on
a test base that is horizontal, flat, firm, and smooth.
(3) 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.
(4) Orient the axis of the 3-in. head probe (Figure 1 to Sec.
1242.4(a)) perpendicular to the test surface and aligned with a force
gauge and parallel to a distance measurement device or gauge.
(5) Using a lead screw or similar device to control movement along
a single direction, advance the probe onto the product and set the
deflection to 0.0 in. when a force of 0.1 N (0.02 lb) 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 lb), or the deflection is equal to 1.00 in. (2.54 cm).
(7) Wait 30 s. If the deflection is less than 1.00 in. and the
force is 10.0 N or less, repeat steps Sec. 1242.5(d)(6) and Sec.
1242.5(d)(7)).
(8) Record the final force and deflection amounts.
(9) Repeat the infant support surface firmness tests on any other
infant support surface and in all manufacturer-intended configurations
that could affect the infant support surface, such as the folding or
layering of parts of the product.
(e) Inner Wall Firmness Test Method. For nursing pillows with a
caregiver opening, perform the steps in Sec. 1242.5(d)(1) through
Sec. 1242.5(d)(8) on the inner wall of the caregiver opening, and
perform the following, to determine the inner wall firmness as received
from the manufacturer. Repeat the inner wall firmness tests in all
manufacturer-intended configurations that could affect the inner wall
firmness.
(f) Product Conditioning Firmness Test Method. Following the
firmness testing in Sec. 1242.5(d) and Sec. 1242.5(e), perform the
following steps to determine the product firmness after conditioning.
(1) Launder and dry the product according to the manufacturer's
instructions.
(2) Repeat Sec. 1242.5(d) Infant Support Surface Firmness Test
Method.
(3) Repeat Sec. 1242.5(e) Inner Wall Firmness Test Method.
(g) Infant Containment Test Method. (1) Lay the product, with the
infant support surface facing up, on a test base that is horizontal,
flat, firm, and smooth.
(2) For nursing pillows with a caregiver attachment, adjust and
latch the caregiver attachment to the minimum length allowed by the
product.
(3) Place the 9-in. head probe (Figure 2 to Sec. 1242.4(b)) inside
the caregiver opening such that the flat bottom of the probe rests on
the test surface and the probe's perimeter contacts the innermost
surface of the caregiver opening.

[[Page 65884]]

(4) If any inner surfaces of the caregiver opening contact the
outwardly facing portions of the probe, or the inner surfaces interfere
with placing the probe down, the caregiver opening is considered to
constrain the probe. See Figure 4 to this paragraph (g)(4). Do not
include in the assessment any contact with a caregiver attachment.

Figure 4 to Paragraph (g)(4)--Infant Containment, Example

In Sec. 1242.5(g), the inner walls of the nursing pillow,
excluding the strap, shall not constrain the 9-in. head probe in the
caregiver opening, such that no contact with the outwardly facing
portion (red arc) of the probe is allowed.
[GRAPHIC] [TIFF OMITTED] TP26SE23.019

(5) Unlatch and move any caregiver attachment away from the
caregiver opening. Conduct steps Sec. 1242.5(g)(3) and Sec.
1242.5(g)(4) in the procedure.
(6) With the probe at the position contacting the innermost surface
within the caregiver opening, determine if any portion of the probe
extends beyond a line projected across the outside limits of the
caregiver opening.
(7) Slide the probe horizontally out of the caregiver opening to
the outside of the nursing pillow. Determine if the probe is
constrained by any inner surfaces of the caregiver opening contacting
the outwardly facing portions of the probe. Do not include in the
assessment any contact with a caregiver attachment.
(h) Seam Strength Test Method. (1) Equipment. Clamps with 0.75 in.
(1.9 cm) diameter clamping surfaces capable of holding fabric and with
a means to attach a force gauge. Figure 5 to this paragraph (h)(1), or
equivalent. The force gauge must have an accuracy of <plus-minus>0.5 lb
(1.1 N).

Figure 5 to Paragraph (h)(1)--Seam Clamp
[GRAPHIC] [TIFF OMITTED] TP26SE23.020

[[Page 65885]]

(2) Clamp the fabric of the nursing pillow on each side of the seam
under test with the 0.75 in. clamping surfaces placed not less than 0.5
in. (1.2 cm) from the seam.
(3) Apply a tension of 15 lb (67 N) evenly over 5 s. and maintain
for an additional 10 s.
(4) Repeat the test on every distinct seam and every 6 in. (15 cm)
along each seam.
(i) Caregiver Attachment Test Method. (1) Equipment. Any suitable
clamping devices with means to attach a force gauge with accuracy of
0.5 lb (1.2 N) may be used. The clamping surfaces shall grasp across
the entire width of the strap or attachment element.
(2) Support the nursing pillow to resist the pull forces and
release the buckle or clasp of the caregiver attachment.
(3) Clamp one side of the attachment or strap of the nursing pillow
not less than 0.5 in. (1.2 cm) from the attachment to the nursing
pillow.
(4) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain
for an additional 10 s.
(5) Repeat the test on the other side of the attachment or strap.
(6) Join the buckle or clasp of the attachment or straps.
(7) Clamp both sides of the attachment or straps across the buckle
or clasp, one on each side and not less than 0.5 in. (1.2 cm) from the
buckle or clasp.
(8) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain
for an additional 10 s.

Sec. 1242.6 Marking and labeling.

(a) 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 Sec. 1242.6(a)(1) and Sec.
1242.6(a)(2) 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 Sec. 1242.6(a)(1) and Sec. 1242.6(a)(2). Cartons and
other materials used exclusively for shipping the product are not
considered retail packaging.
(b) The marking and labeling on the product shall be permanent.
(c) 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, American
National Standard for Product Safety Signs and Labels, sections 6.1
through 6.4, 7.2 through 7.6.3, and 8.1 (incorporated by reference, see
Sec. 1242.8), 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)--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 in. (5 mm) high. The remainder of the text shall be in
characters whose upper case shall be at least 0.1 in. (2.5 mm), except
where otherwise specified.

Note 2 to paragraph (d)(5)--For improved warning readability,
avoid typefaces with large height-to-width ratios, which are
commonly identified as ``condensed,'' ``compressed,'' ``narrow,'' or
similar.

(6) Message Panel Text Layout. (i) The text shall be left-aligned,
ragged-right for all but one-line text messages, which can be left-
aligned or centered.

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. See
Figure 6 to this paragraph (d)(6)(i) for examples of left-aligned
text.

Figure 6 to Paragraph (d)(6)(i)--Examples of Left-Aligned Text

The text shown for these warnings is filler text, known as lorem
ipsum, commonly used to demonstrate graphic elements.

[[Page 65886]]

[GRAPHIC] [TIFF OMITTED] TP26SE23.021

(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 7 to this paragraph (d)(7).

Figure 7 to Paragraph (d)(7)--Example of Warning
[GRAPHIC] [TIFF OMITTED] TP26SE23.022

(e) Warning Statements. Each product shall have warning statements.
The text must address the warnings as shown in Figure 7 to paragraph
(d)(7), Example of Warning.

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.

(f) Package Warnings. (1) The warnings and statements are not
required on the retail package if they are on the product and are
visible in their entirety through the retail package. Cartons and other
materials used exclusively for shipping the product are not considered
retail packaging.
(2) Warning Statements. Each product's package shall have warning
statements to address the following, at a minimum, as specified in
Sec. 1242.6(d)(1), Sec. 1242.6(d)(2), Sec. 1242.6(d)(4), Sec.
1242.6(d)(5), and Sec. 1242.6(d)(6):
(i) Do not use for sleep.
(ii) Do not use in sleep products like cribs, bassinets, or play
yards.
(3) Each product's retail package shall address the manufacturer's

[[Page 65887]]

recommended weight, height, age, or developmental stage or combination
thereof of the infant.
(4) Warnings, statements, or graphic pictorials on the product and
package shall not indicate or imply that the infant may be left in the
product without an adult caregiver in attendance.

Sec. 1242.7 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 include all warnings specified in Sec.
1242.6(e).
(c) 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 infant for whom the nursing pillow is intended. If this
product is not intended for use by a child for a specific reason, the
instructions shall so state this limitation.
(d) The cautions and warnings in the instructions shall meet the
requirements specified in Sec. 1242.6(d)(4), Sec. 1242.6(d)(5), and
Sec. 1242.6(d)(6), except that sections 6.4 and 7.2 through 7.6.3 of
ANSI Z535.4--2011, American National Standard for Product Safety Signs
and Labels, 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 5 to paragraph (d)--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.

(e) 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.

Note 6 to paragraph (e)--For additional guidance on the design
of warnings for instructional literature, please refer to ANSI
Z535.6, American National Standard: Product Safety Information in
Product Manuals, Instructions, and Other Collateral Materials.

Sec. 1242.8 Incorporation by Reference

ANSI Z535.4-2011, American National Standard for Product Safety
Signs and Labels, approved October 20, 2017, is incorporated by
reference. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. This 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,
telephone (301) 504-7479, email: <a href="/cdn-cgi/l/email-protection#40233033236d2f3300233033236e272f36">[email&#160;protected]</a>. For information on
the availability of this material at NARA, email
<a href="/cdn-cgi/l/email-protection#5b3d29753235282b3e382f3234351b353a293a753c342d">[email&#160;protected]</a>, or go to: <a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a>. A free, read-only copy of the standard is
available for viewing on the ANSI website at <a href="https://ibr.ansi.org/Standards/nema.aspx">https://ibr.ansi.org/Standards/nema.aspx</a>. You may also obtain a copy from American National
Standards Institute (ANSI), 25 West 43rd Street, 4th Floor, New York,
NY 10036, USA, telephone: (212) 642-4900, <a href="http://www.ansi.org">www.ansi.org</a>.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2023-20156 Filed 9-25-23; 8:45 am]
BILLING CODE 6355-01-P

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