[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 [www.gpo.gov]
[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"><span class="__cf_email__" data-cfemail="b5dadcc7d4eac6c0d7d8dcc6c6dcdadbf5dad8d79bd0dac59bd2dac3">[email protected]</span></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: https://www.regulations.gov. 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"><span class="__cf_email__" data-cfemail="2c4f5c5f4f01435f6c4f5c5f4f024b435a">[email protected]</span></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: 
www.regulations.gov. 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: https://www.regulations.gov, 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"><span class="__cf_email__" data-cfemail="5024233d39243810332023337e373f26">[email protected]</span></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: https://www.cpsc.gov/s3fs-public/RCANoticeofProposedRulemakingSafetyStandardforNursingPillows.pdf?VersionId=wCUsHNj0AhXxb3KM2A.kxMawNVGbS6oE.
    \2\ Staff Briefing Package: Staff's Draft Proposed Rule for 
Nursing Pillows (Aug. 23, 2023) (Staff's NPR Briefing Package), 
available at: https://www.cpsc.gov/content/Commission-Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Nursing-Pillows.
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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\ https://www.cpsc.gov/s3fs-public/Nursing-and-Support-Pillow-VS-request.pdf.
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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 https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data.
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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
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                      Year                          Fatalities       Injuries        No injury         Total
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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
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                       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
                                                 ---------------------------------------------------------------
    Total.......................................             154              64              24             242
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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
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             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 <SUP>10</SUP>
---------------------------------------------------------------------------

    \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: https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
---------------------------------------------------------------------------

    <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 <SUP>13</SUP>
---------------------------------------------------------------------------

    \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 
<SUP>15</SUP>
---------------------------------------------------------------------------

    \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: www.cpsc.gov/labsearch.

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: https://www.surveymonkey.com/r/DQVJYMK. To download or print the standard, 
interested persons may purchase a copy of ANSI Z535.4-2011 from ANSI 
via its website, https://www.ansi.org, or by mail from ANSI, 25 West 
43rd Street, 4th Floor, New York, NY 10036, 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"><span class="__cf_email__" data-cfemail="dcbfacafbff1b3af9cbfacafbff2bbb3aa">[email protected]</span></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: https://www.bls.gov/news.release/archives/ecec_06162023.pdf). 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"><span class="__cf_email__" data-cfemail="20435053430d4f5360435053430e474f56">[email protected]</span></a>. For information on 
the availability of this material at NARA, email 
<a href="/cdn-cgi/l/email-protection#5b3d29753235282b3e382f3234351b353a293a753c342d"><span class="__cf_email__" data-cfemail="f39581dd9a9d80839690879a9c9db39d928192dd949c85">[email protected]</span></a>, or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. A free, read-only copy of the standard is 
available for viewing on the ANSI website at https://ibr.ansi.org/Standards/nema.aspx. 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, www.ansi.org.

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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