Rule2024-24403
Safety Standard for Nursing Pillows
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 25, 2024
Effective
April 23, 2025
Issuing agencies
Consumer Product Safety Commission
Abstract
Pursuant to the Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), the U.S. Consumer Product Safety Commission (Commission or CPSC) is issuing this final rule establishing a consumer product safety standard for nursing pillows. CPSC is also amending its regulations regarding third party conformity assessment bodies, to include the safety standard for nursing pillows in the list of notices of requirements (NORs), along with identifying nursing pillows as a durable infant or toddler product subject to consumer registration requirements.
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<title>Federal Register, Volume 89 Issue 207 (Friday, October 25, 2024)</title>
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[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Rules and Regulations]
[Pages 85388-85420]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24403]
[[Page 85387]]
Vol. 89
Friday,
No. 207
October 25, 2024
Part IV
Consumer Product Safety Commission
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16 CFR Parts 1112, 1130, and 1242
Safety Standard for Nursing Pillows; Final Rule
Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 /
Rules and Regulations
[[Page 85388]]
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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: Final rule.
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SUMMARY: Pursuant to the Danny Keysar Child Product Safety Notification
Act, section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA), the U.S. Consumer Product Safety Commission (Commission or
CPSC) is issuing this final rule establishing a consumer product safety
standard for nursing pillows. CPSC is also amending its regulations
regarding third party conformity assessment bodies, to include the
safety standard for nursing pillows in the list of notices of
requirements (NORs), along with identifying nursing pillows as a
durable infant or toddler product subject to consumer registration
requirements.
DATES: This rule will become effective April 23, 2025. The
incorporation by reference of certain material listed in this rule is
approved by the Director of the Federal Register as of April 23, 2025.
FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety Commission, 4330 East-West Highway,
Bethesda, MD 20814; email: <a href="/cdn-cgi/l/email-protection#2350414c63405350400d444c55"><span class="__cf_email__" data-cfemail="0d7e6f624d6e7d7e6e236a627b">[email protected]</span></a>; telephone: (301) 504-7945 or
(888) 531-9070.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
A. Background
Although nursing pillows are primarily intended to support an
infant during breast or bottle feeding, they are sometimes used to
support infants for sleep or lounging. These sleep and lounging uses
have led to infant deaths and serious injuries from suffocation,
entrapment, or falls.
In 1992, under the Federal Hazardous Substances Act (FHSA), 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. This ban is codified at 16 CFR 1500.18(a)(16) (Infant
Pillow Ban). 57 FR 27912 (June 23, 1992). Certain nursing pillows are
exempt from the Infant Pillow Ban, while others, such as pillows with a
non-granular fill, do not fall within its scope. 16 CFR 1500.86(a)(9).
Many products are currently marketed for both nursing and ``lounging,''
despite the suffocation hazard posed by propping up very young infants
with these products.
On September 26, 2023, the Commission issued a notice of proposed
rulemaking (NPR) under section 104 of the CPSIA that proposed a
mandatory consumer product safety standard for nursing pillows, to
address risks of death and injury associated with these products. 88 FR
65865. The proposed safety standard for nursing pillows addressed the
suffocation, entrapment, and fall hazards associated with infants in
nursing pillows by including performance requirements, labeling and
instructional literature requirements, and a prohibition on the use of
infant restraints.
On April 23, 2024, CPSC published a notice of availability (NOA)
with a 30-day comment period that closed on May 23, 2024. 89 FR 30294.
The NOA announced the availability of, and sought comments from the
public on, the incident data relied upon for the NPR. The NOA also
sought public comments on how the final rule for nursing pillows should
address removable nursing pillow covers, or slipcovers.
On September 10, 2024, after the NPR was published, ASTM
International (ASTM) published a voluntary standard, ASTM F3669--24,
Standard Consumer Safety Specification for Nursing Pillows. A detailed
discussion of the voluntary standard can be found in section IV of this
preamble. The Commission is finalizing this rule to establish mandatory
performance and labeling requirements for nursing pillows based on the
proposal in the NPR, public comments on both the NPR and the NOA, and
staff's assessment of the recent ASTM voluntary standard for nursing
pillows, discussed below in sections VI and VII.
In particular, while a number of provisions of ASTM's voluntary
standard are substantially similar to provisions of the NPR and the
final rule, the Commission determines that more stringent standards set
forth in the final rule would further reduce the risk of injury
associated with these products.\1\
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\1\ On September 18, 2024, the Commission voted (5-0) to publish
this final rule as drafted. Chair Hoehn-Saric and Commissioners
Trumka and Boyle issued statements in connection with their vote,
available at: <a href="https://www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Statement-of-Chair-Alexander-Hoehn-Saric-on-Commission-Approval-of-a-Final-Rule-Establishing-a-Safety-Standard-for-Nursing-Pillows">https://www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Statement-of-Chair-Alexander-Hoehn-Saric-on-Commission-Approval-of-a-Final-Rule-Establishing-a-Safety-Standard-for-Nursing-Pillows</a>; <a href="https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Commissioner-Trumka-Safety-Changes-for-Nursing-Pillows-Will-Save-Babies%E2%80%99-Lives">https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Commissioner-Trumka-Safety-Changes-for-Nursing-Pillows-Will-Save-Babies%E2%80%99-Lives</a>; and <a href="https://www.cpsc.gov/About-CPSC/Commissioner/Mary-T-Boyle/Statement/Commissioner-Mary-T-Boyle-Statement-on-Vote-to-Issue-Final-Rule-on-Nursing-Pillows">https://www.cpsc.gov/About-CPSC/Commissioner/Mary-T-Boyle/Statement/Commissioner-Mary-T-Boyle-Statement-on-Vote-to-Issue-Final-Rule-on-Nursing-Pillows</a>.
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B. 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). Standards issued under section 104 are
to be ``substantially the same as'' the applicable voluntary standards,
or more stringent than the voluntary standard, if the Commission
determines that more stringent requirements would further reduce the
risk of injury associated with the product. Id. at 2056a(b)(1)(B).
The Commission has examined and assessed the effectiveness of the
ASTM voluntary consumer product safety standard for nursing pillows,
ASTM F3669--24, Standard Consumer Safety Specification for Nursing
Pillows. Regarding the consultation requirement in section 104(b)(1) of
the CPSIA, CPSC staff regularly participates in the juvenile products
subcommittee meetings of ASTM International (ASTM). ASTM subcommittees
consist of members who represent producers, users, consumers,
government, and academia.\2\ CPSC 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 with 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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\2\ ASTM International website: <a href="http://www.astm.org">www.astm.org</a>, About ASTM
International.
\3\ <a href="https://www.cpsc.gov/s3fs-public/Nursing-and-Support-Pillow-VS-request.pdf">https://www.cpsc.gov/s3fs-public/Nursing-and-Support-Pillow-VS-request.pdf</a>.
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<bullet> F15.16 Nursing Pillows subcommittee,\4\ intended to
develop a standard for nursing pillows; and
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\4\ Since the subcommittee's formation, the name of the
subcommittee has evolved and gone through the following variants:
Feeding and Infant Support Products subcommittee, Infant Feeding
Support Products subcommittee, and Infant Feeding Supports
subcommittee.
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<bullet> F15.21 Infant Loungers subcommittee, with a remit
including
[[Page 85389]]
nursing pillows that are also intended for lounging.
CPSC staff actively participated in the ASTM's F15.16 Nursing
Pillows subcommittee to develop ASTM F3669--24 with requirements that
address the hazards associated with these products.\5\
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\5\ The docket for this rulemaking on <a href="http://Regulations.gov">Regulations.gov</a> (CPSC-
2023-0037) contains meeting logs for all CPSC staff-attended ASTM
meetings related to the nursing pillow voluntary standard that
occurred between issuance of the NPR and completing this final rule.
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Consistent with CPSC staff's assessment of the voluntary standard,
the Commission determines that the more stringent requirements included
in this final rule would further reduce the risk of injury associated
with nursing pillows. In part, the mandatory consumer product safety
standard for nursing pillows is ``substantially the same as'' ASTM
F3669--24 because it includes similar performance and labeling/
instructional material requirements. However, portions of the CPSC
mandatory standard are more stringent than the ASTM voluntary standard,
as these requirements would further reduce the risk of injury
associated with the use of nursing pillows. For example, the definition
of a ``nursing pillow'' in the final rule states that these products
include removable covers, or slipcovers, that are sold on or together
with the nursing pillow. The ASTM standard does not contain any safety
requirements for the cover element of nursing pillows. In addition, the
product warning in the final rule includes a statement to instruct
consumers to move the baby to an infant sleep product if the baby falls
asleep or if the caregiver feels drowsy. This scenario is associated
with three infant fatalities known to CPSC. Yet the warnings specified
in the ASTM standard do not specifically address it. 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
implementing rule, 16 CFR part 1130. Any product defined as a ``durable
infant or toddler product'' in part 1130 must comply with the product
registration requirements, as well as testing and certification
requirements for children's products, as codified in 16 CFR parts 1107
and 1109. Section 104(f)(1) of the CPSIA defines a ``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 includes
a non-exhaustive list of categories of products that are durable infant
or toddler products, including products used for feeding support, such
as high chairs, booster chairs, and hook-on chairs. Id. 2056a(f)(2)(C);
See Requirements for Consumer Registration of Durable Infant or Toddler
Products, 74 FR. 68668-68669 (Dec. 29, 2009).
This final rule amends part 1130 to include ``nursing pillow'' as a
durable infant or toddler product, as proposed in the NPR, because they
are: (1) intended for use, and may be reasonably expected to be used,
by children under the age of 5 years; (2) similar to other feeding
support products listed in section 104(f)(2) of the CPSIA, such as high
chairs, booster chairs, and hook-on chairs; and (3) commonly available
for resale or ``handed down'' for use by other children over a period
of years.
Lastly, products subject to a consumer product safety rule under
the Consumer Product Safety Act (CPSA) must be certified as complying
with all applicable CPSC-enforced requirements, based on testing
conducted by a CPSC-accepted third party conformity assessment body. 15
U.S.C. 2063(a). 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. Id. 2063(a)(3). Accordingly, we now finalize an
amendment to part 1112, as proposed in the NPR, to add the new Safety
Standard for Nursing Pillows, 16 CFR part 1242, to the list of NORs for
children's product safety rules. The amendment allows test laboratories
applying for CPSC acceptance to seek accreditation to test nursing
pillows within the scope of the rule.
C. NPR
The scope of the NPR included all ``nursing pillows,'' defined 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 NPR proposed exemptions
for (1) maternity pillows, as defined in 16 CFR 1242.2, because they
are not intended primarily for nursing and are intended to support the
body of a pregnant adult, and (2) sling carriers, as defined in 16 CFR
part 1228, because they are subject to the Safety Standard for Sling
Carriers. 16 CFR part 1228.
The proposed nursing pillow safety standard included performance
requirements and labeling and instructional literature requirements to
address the following hazards associated with an infant's use of a
nursing pillow:
(1) suffocation hazards from the product conforming to an infant's
face and occluding the infant's airways;
(2) entrapment hazards posed when the product restricts an infant's
head movements;
(3) suffocation and fall risks resulting from the presence of
infant restraints that could suggest that infants can safely be left
unattended in the product; and
(4) suffocation, entrapment, or fall risks when an infant is left
unattended in the product.
In the NPR, the Commission also proposed to amend the consumer
registration rule, 16 CFR part 1130, to identify ``nursing pillows'' as
a category of ``durable infant or toddler products'' subject to the
consumer registration rule and testing and certification as a
children's product. Finally, the Commission proposed to amend its
regulation at 16 CFR part 1112 to add ``nursing pillows'' to the list
of products that require third party testing as a basis for
certification.
D. Overview of the Final Rule
Pursuant to section 104 of the CPSIA, the Commission is issuing a
mandatory standard for nursing pillows. 15 U.S.C. 2056a. However, based
on comments on the NPR and staff's assessment of the draft and
published ASTM voluntary standard for nursing pillows in section IV,
the final rule contains the following clarifications and changes from
the NPR:
<bullet> The scope has been clarified to explain that slipcovers
sold on or together with a nursing pillow are considered part of the
nursing pillow, as defined in 16 CFR 1242.2, within the scope of the
rule. Accordingly, the definition of ``nursing pillow'' has been
amended to clarify that nursing pillows include any removable covers,
or slipcovers, sold on or together with the product.
<bullet> Soft infant and toddler carriers, as defined in 16 CFR
part 1226, have been added to the list of products outside the scope of
the rule.
<bullet> The definition of ``caregiver attachment'' has been
revised to clarify that a caregiver attachment is not an infant support
surface.
<bullet> The definition of ``conspicuous'' has been revised to mean
visible to the caregiver while placing the nursing pillow on or against
the caregiver's body.
<bullet> The Small Parts requirement language has been revised to
clarify that the cited small parts regulation does not specifically
``define'' a small part, but rather determines whether an item is a
[[Page 85390]]
small part. The language for the Hazardous Sharp Edges or Points
requirement has been clarified similarly.
<bullet> The Permanency of Labels and Warnings requirement has been
corrected by changing a reference from ``infant feeding supports'' to
``nursing pillows.''
<bullet> The figure illustrating the firmness test probe, Figure 1,
has been revised for clarity.
<bullet> The Infant Support Surface Firmness test method has been
revised to specify that, when selecting test locations, the edge of the
test probe shall not extend beyond the edge of the nursing pillow.
However, if the design or size of the product is such that the edge of
the probe must extend beyond the product, then the probe must be
centered over as much of the test surface as possible. The test method
also has been revised to specify that the final force measurement at
each location is taken only after the force has stabilized, meaning
that it has not changed more than 0.1 Newtons (N) over 30 seconds.
<bullet> The Infant Containment test method has been reordered, so
products with a caregiver attachment are tested first without the
caregiver attachment secured, and then again with the caregiver
attachment secured. This test method also revises references from
``inner surfaces'' of the nursing pillow to ``inner wall,'' for
clarity, and revises the referenced figure, Figure 4, to clarify the
test method and to show additional examples of passing and failing
tests.
<bullet> The Caregiver Attachment Strength test method has been
revised to clarify that the requirement applies to all fastening
methods, not just buckles and clasps. The section name has also been
corrected to add the term ``Strength.''
<bullet> The figure showing the example product warning, Figure 7,
has been revised to reflect changes in warning content in response to
public comments. These changes include revising the initial sentence to
state that ``BABIES HAVE DIED USING NURSING PILLOWS FOR SLEEP OR
LOUNGING,'' stating explicitly that nursing pillows are for feeding
only, revising and deleting some of the statements to reduce length,
and adding a line or border to separate the sleep and suffocation-
related warning content from the fall-related warning content.
Section VII of this preamble describes the final rule in more
detail.
II. The Product Category
A. Scope of Products Within the Final Rule
The scope of the final rule includes all nursing pillows, as
defined in 16 CFR 1242.2. 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- 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.
The Commission considers removable nursing pillow covers, or
slipcovers, that are sold on or together with the nursing pillow, to be
a part of the nursing pillow and are therefore within the scope of the
final rule. This comports with the broad definition of a ``consumer
product'' in the CPSA as including any ``component part'' of a product.
15 U.S.C. 2052(a)(5). Slipcovers that are sold separately from a
nursing pillow, not installed on the pillow or included in the price of
the nursing pillow, are not within the scope of the final rule because
they are not considered to be intended, marketed or designed as part of
the product. Accordingly, the Commission is finalizing the definition
of nursing pillow to include this clarification: ``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, including any removable covers, or slipcovers, sold on or
together with such a product. These products rest upon, wrap around, or
are worn by a caregiver in a seated or reclined position.'' (Emphasis
added.) ASTM F3669 defines a nursing pillow using similar language
about support while feeding but does not explicitly address slipcovers.
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 (i.e., a caregiver attachment), 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.\6\
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\6\ See Staff Briefing Package: Staff's Draft Proposed Rule for
Nursing Pillows (Aug. 23, 2023) (Staff's NPR Briefing Package) at 5,
figures 1 and 2, for examples of nursing pillow designs, available
at: <a href="https://www.cpsc.gov/content/Commission-Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Nursing-Pillows">https://www.cpsc.gov/content/Commission-Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Nursing-Pillows</a>.
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B. Market Description
As discussed in the NPR, 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. The number of infants who feed with
a nursing pillow is greater than this, however. Some parents 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, 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 swapped
for other colors, styles or designs.
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
Unlike the Infant Pillow Ban, this final 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 final rule is based in part on data concerning incidents that
occurred between January 2010 through December 2022, many of which were
fatal. The final rule does not alter either the Infant Pillow Ban at 16
CFR 1500.18(a)(16) or the exemption
[[Page 85391]]
codified at 16 CFR 1500.86(a)(9), both of which remain in place. Thus,
products that are not banned under the Infant Pillow Ban but that meet
this rule's definition of a nursing pillow need to comply with the
final rule.
III. Incident Data and Hazard Patterns
As described in the NPR, CPSC staff's search of the Consumer
Product Safety Risk Management System (CPSRMS) \7\ and National
Electronic Injury Surveillance System (NEISS) \8\ databases identified
154 fatal incidents and 88 nonfatal incidents and consumer concerns
associated with nursing pillows, involving infants up to 12 months old,
and reported to have occurred between January 1, 2010, and December 31,
2022. Accordingly, for the final rule, the Commission is aware of 242
incident reports associated with nursing pillows. Sixty-four percent of
the incidents reported in the NPR involved a fatality.\9\ 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. Of the nonfatal incidents, 73 percent resulted in an
injury and 27 percent reported no injury.\10\
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\7\ CPSRMS is the epidemiological database that houses all
anecdotal reports of incidents received by CPSC, ``external cause''-
1based death certificates purchased by CPSC, all in-depth
investigations of these anecdotal reports, as well as investigations
of select NEISS injuries. CPSRMS documents include hotline reports,
online reports, news reports, medical examiner's reports, death
certificates, retailer/manufacturer reports, and documents sent by
state and local authorities, among others.
\8\ NEISS is a statistically valid surveillance system for
collecting injury data. NEISS is based on a nationally
representative probability sample of hospitals in the U.S. and its
territories. Each participating NEISS hospital reports patient
information for every emergency department visit associated with a
consumer product or a poisoning to a child younger than five years
of age. The total number of product-related hospital emergency
department visits nationwide can be estimated from the sample of
cases reported in the NEISS. See <a href="https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data">https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data</a>.
\9\ More than half of the fatalities of which CPSC is aware were
reported to have occurred since 2019. Staff's NPR Briefing Package
at Tab A. However, staff 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.
\10\ 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.
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A. Fatalities and Associated Hazard Patterns
The Commission is aware of 142 fatalities that involved use of the
nursing pillow for sleep; 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. As described in the NPR, nursing pillows are intended to be
used for feeding when both the infant and caregiver are awake, and the
caregiver can ensure that the infant's airways are not covered by the
pillow. However, consumers often placed infants on or in nursing
pillows for sleep.
In addition, because infants frequently fall asleep during or after
feeding and because nursing pillows appear to be comfortable sleeping
environments and are small enough to fit within other sleep products
such as a crib or bassinet, nursing pillows are foreseeably used 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, no witnesses observed the fatal incidents, and
60 of the 154 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. These positions include the following: face
into product, face into other object/bedding outside product, face down
in opening, neck extension/flexion, bedding over face, face into
product or bedding (unknown),\11\ entrapment/overlay while nursing, and
overlay.
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\11\ This hazard pattern includes cases where the infant was
found with their face into either the nursing pillow or other
bedding, but the specific product is unknown.
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One hundred twenty-four fatalities (81 percent) involved the
nursing pillow being used in or on a sleep product. Specifically, 62
fatalities (40 percent) involved the nursing pillow product being used
in an 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.
B. Nonfatal Incidents
CPSC is aware of 88 nonfatal incidents associated with nursing
pillows in which 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,
and all 19 involved the infant falling or rolling off, or out, of the
nursing pillow. An additional three 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. In 66 percent (42 of 64) of the nonfatal
injuries, the location was unknown, but the most common locations among
the remaining incidents were couches and beds. The Commission is aware
of following hazard patterns for the nursing pillow-related nonfatal
incidents: skin allergy/irritation; fall/rollout from an elevated
surface, from the same or unknown level, and while carrying the infant
in the product; filling coming out/choking hazard; product integrity;
and strong smell, among others.
IV. ASTM's Voluntary Standard for Nursing Pillows
On September 10, 2024, ASTM published a new voluntary standard for
nursing pillows, ASTM F3669--24, Standard Consumer Safety Specification
for Nursing Pillows. This section examines and assesses the ASTM
standard.
A. Terminology
As noted in section II.A., the voluntary standard defines a nursing
pillow similarly to the definition of ``nursing pillow'' in the final
rule; however, the voluntary standard's definition does not include
language clarifying that nursing pillows include slipcovers that are
sold on or together with the product. By expressly including such
slipcovers in the
[[Page 85392]]
definition, the final rule is more stringent than the ASTM standard and
further reduces the risk of injury and death relative to the voluntary
standard, as explained in section II.A.
The ASTM voluntary standard's definition of ``caregiver
attachment'' is similar to the definition in the final rule but appears
less protective by referring to the caregiver attachment as a ``device
or other mechanism,'' whereas the rule describes a ``caregiver
attachment'' more broadly as a ``portion of the product.'' Unlike the
voluntary standard, the final rule also clarifies that portions of the
product that function as an infant support surface are not considered
caregiver attachments.
The ASTM voluntary standard defines ``caregiver opening''
differently than the final rule and adds a new definition for ``inner
wall,'' which is not included in the final rule. The voluntary
standard's definition of inner wall implies that it includes any
surface of the nursing pillow intended to fit against the caregiver's
torso during use, even if that surface is part of a caregiver
attachment. This contradicts the final rule's definition of ``caregiver
opening,'' which excludes caregiver attachments.
The voluntary standard defines ``infant support surface''
differently than the final rule. The ASTM standard differs functionally
from the definition in the final rule by specifying that the infant
support surface is necessarily horizontal. The Commission is aware of
some nursing pillows where the infant support surface is not strictly
horizontal during use or where only a portion of the full infant
support surface is horizontal. Because the ASTM standard is more
restrictive in what it considers to be an infant support surface that
is subject to performance requirements, the definition used in the
final rule results in a more stringent standard that further reduces
the risk of injury associated with nursing pillows, relative to the
voluntary standard.
The ASTM voluntary standard does not include definitions for
``maternity pillow'' or ``safety alert symbol,'' both of which are
included in the final rule. Maternity pillows are defined in the rule
because they are included among the exemptions; however, the voluntary
standard does not exempt these products.
The ASTM voluntary standard does not define ``safety alert symbol''
because this is one of the formatting elements for product warnings,
and the product warning requirements refer the reader to the
requirements of ANSI Z535.4, Product Safety Signs and Labels (ANSI
Z535.4-11), which already defines this term. Thus, the omission of this
definition in the ASTM voluntary standard is inconsequential. The
voluntary standard includes other definitions not included in the final
rule, specifically for ``fabric,'' ``manufacturer's recommended use
position,'' ``non-paper label,'' ``paper label,'' and ``seam.'' These
definitions are generally consistent with definitions included in other
mandatory and voluntary juvenile product safety standards, and thus not
essential for inclusion in this rule.
B. General Requirements
ASTM F3669--24 includes general requirements typically found in
other ASTM juvenile product standards, such as requirements limiting
lead in paints; prohibitions against small parts, hazardous sharp edges
or points, and removable components that are accessible to the infant;
requirements for toy accessories that are attached to, removable from,
or sold with the products; and permanency requirements for product
labels and warnings. The voluntary standard's requirements for Lead in
Paints, Small Parts, Hazardous Sharp Edges or Points, Removal of
Components, and Permanency of Labels and Warnings, and the associated
test methods for those requirements, match the same requirements and
test methods in the final rule (Sec. 1242.3(a)-(e)), with one
exception: the voluntary standard's Tension Test (section 7.7.4) in the
Removal of Components test method does not specify the tension test
adapter clamp that may be used if the gap between the back of the
component and the base material is 0.04 inches or more. Although the
use of such a clamp is optional, the rule's provision of this
information is helpful to testers.
ASTM F3669--24 adds a requirement for toy accessories that are
attached to, removable from, or sold with a nursing pillow. This
requirement is not in the final rule, but CPSC is not aware of any
incidents involving toys connected to these products. In addition, the
ASTM voluntary standard includes a general requirement that nursing
pillows that can be converted into another product or that has features
for which a consumer safety specification exists must comply with the
applicable requirements of all applicable standards.
C. Performance Requirements
ASTM F3669--24 includes five performance requirements intended to
address safety hazards specifically associated with nursing pillows:
<bullet> Infant Restraints: This requirement prohibits nursing
pillows from including an infant restraint system, which could entangle
an infant and could suggest to caregivers that it is acceptable to
leave an infant unattended on the nursing pillow. Aside from editorial
differences, the requirement matches the same requirement in the final
rule (Sec. 1242.4(c)).
<bullet> Firmness: This requirement limits the amount by which
certain portions of the product can deflect, or displace, when a 3-inch
diameter hemispheric probe is applied with a certain force. Testing is
performed at three locations at least 3 inches apart on each of two
surfaces: the infant support surface and the inner wall of the
caregiver opening (i.e., the surface of the nursing pillow intended to
fit against the caregiver's torso during use). After the product is
cleaned according to the manufacturer's instructions, the tests are
repeated. Although written in the ASTM standard as a three-part
requirement (i.e., infant support surface firmness, inner wall
firmness, and product conditioning firmness), rather than a single
requirement that refers to three separate test methods as in the final
rule (Sec. 1242.4(a)), this requirement is functionally equivalent to
the firmness requirement and associated test methods in the final rule,
with one exception: the ASTM firmness test method specifies that if the
design of the product does not allow for testing three locations that
are 3 inches apart, then firmness testing is performed on three
separate available locations. The firmness test method in the final
rule does not specifically address products that might not allow for
testing three locations that are 3 inches apart. The ASTM voluntary
standard and the final rule also differ in specific procedure to arrive
at the final, stabilized firmness measurement for each location, but
the two procedures are functionally equivalent.
<bullet> Infant Containment: This requirement is intended to reduce
the potential for an infant's head to become entrapped within the
caregiver opening, and 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 requirement applies a 9-inch diameter head probe to the
caregiver opening of a nursing pillow. No contact is permitted between
the outer half of the probe and the inner wall of the caregiver
opening, and the probe must extend beyond the caregiver opening. When
the probe is moved laterally out of the caregiver opening, the outer
half of the probe must, again, not contact the inner wall of the
product. If the product includes a
[[Page 85393]]
caregiver attachment, which is intended to secure the product to the
caregiver, the test is performed twice: once with the caregiver
attachment unsecured, and again with the caregiver attachment secured
and adjusted to its minimum length. Aside from editorial differences
and additional figures that illustrate the various elements of the test
method, the ASTM requirement and associated test method are
functionally equivalent to those in the final rule (Sec. 1242.4(b)).
<bullet> Seam Strength: This requirement is intended to address
product integrity issues, such as seam failures and material breakage,
by applying a specified pull test along each seam and attachment point.
Other than editorial differences, this requirement and its associated
test method match those in the final rule (Sec. 1242.4(d)).
<bullet> Caregiver Attachment Strength: This requirement is
intended to address possible failures of the caregiver attachment by
requiring each element of the caregiver attachment system (e.g., strap,
buckle) to withstand a static load of 20 pounds. Other than editorial
differences, this requirement and its associated test method match
those in the final rule (Sec. 1242.4(e)).
D. Marking, Labeling, and Instructional Requirements
ASTM F3669--24 includes marking, labeling, and instructional
literature requirements, which include requirements for warnings that
must appear on nursing pillows covered by the standard.
The warning label in ASTM F3669--24 is nearly identical to the
warning in the final rule (Sec. 1242.6), which was amended based on
public comments on the NPR, as discussed in detail in section V and
section VI.E. However, the final rule includes an additional warning
statement: ``Move baby to an infant sleep product, like a crib or
bassinet, if baby falls asleep or if you feel drowsy.'' This statement
reinforces the safe-sleep message that consumers should move the baby
to a product intended for infant, like a crib or bassinet, if the baby
falls asleep during or after feeding, and reminds consumers to stop
using the product if the consumer feels themselves falling asleep,
which is a scenario associated with three infant fatalities.
ASTM F3669--24 requires the warnings to be permanent and
``conspicuous,'' which the voluntary standard defines as ``visible to
the caregiver when the product is being placed onto their body in the
manufacturer's use position.'' Other than editorial differences, the
definition of ``conspicuous'' is equivalent to the definition included
in the final rule, which was amended based on public comments on the
NPR, as discussed in section V and section VI.E.
The voluntary standard also includes requirements for the product
package to include 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. These requirements
match the requirements in the final rule (Sec. 1242.6(f)).
Lastly, ASTM F3669--24 includes requirements for instructional
literature to be provided with products covered by the standard. In
addition to repeating the warnings on the product, the instructions
must warn 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. These requirements match the
requirements in the final rule (Sec. 1242.7).
Staff assesses that ASTM F3669--24 largely aligns with the final
rule, with the primary exceptions being related to scope--with the
final rule defining nursing pillows to include slipcovers sold on or
together with the nursing pillow, while the ASTM voluntary standard
does not mention slipcovers--and the product warning--with the final
rule including an additional warning statement instructing the consumer
to move the baby to an infant sleep product if the baby falls asleep or
if the caregiver feels drowsy. In all, the final rule is more stringent
and protective of infants than the ASTM voluntary standard.
Although, as explained, there are many similarities between the
ASTM voluntary standard and the Commission's rule, we choose not to
incorporate portions of the ASTM standard into our rule at this time,
for two reasons. First, the Administrative Procedure Act (APA) prevents
incorporation by reference of a number of the ASTM provisions that
differ from the NPR's provisions absent an additional notice and
comment period. Such a process would delay unnecessarily adoption of
this rule, and the Commission declines to do so. See 5 U.S.C. 553.
Second, the CPSC rule contains a number of provisions that are more
stringent than the ASTM standard. Adoption of a piecemeal rule, even
after an additional notice and comment period, containing some elements
of the ASTM standard along with the more stringent requirements of the
Commission rule would risk needless complexity and industry confusion.
To the extent changes are made to the voluntary standard in the future
such that it conforms to the final rule, the Commission may consider
incorporating the standard by reference at that time.
V. Response to Comments
The Commission received 129 comments on the NPR before the comment
period closed on November 27, 2023.\12\ The Commission also received
three public comments on the NOA before its comment period closed on
May 23, 2024.
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\12\ The rulemaking docket for the Safety Standard for Nursing
Pillows (CPSC-2023-0037, <a href="https://www.regulations.gov/document/CPSC-2023-0037-0002">https://www.regulations.gov/document/CPSC-2023-0037-0002</a>) includes nearly 850 emails received prior to the
comment period that are essentially identical to these 53 public
comments.
---------------------------------------------------------------------------
You can access comments by searching for docket number CPSC-2020-
0023 at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. The topics addressed in these
comments fell into several broad categories: (1) scope of the rule; (2)
performance requirements; (3) marking and labeling requirements; (4)
effective date; (5) small business issues; and (6) procedure. Below we
summarize and respond to the comments by topic. Public comments related
to the effective date and small business issues are discussed in their
respective sections, X and XI.
A. Scope of the Rule
1. Slipcovers
Comments: First Candle, the Boppy Company, the Juvenile Products
Manufacturers Association (JPMA) and the Breastfeeding Infant
Development Support Alliance (BFIDSA) requested, in response to the
NPR, clarification whether removable nursing pillow covers, or
slipcovers, are included within the scope of the rule. The Boppy
Company, JPMA, and a consumer commented, in response to the NOA, on
whether nursing pillow covers, or slipcovers, should be subject to the
requirements of the rule. The consumer comment stated that nursing
pillow covers, or slipcovers, and anything else that is sold as part of
the product (e.g.,
[[Page 85394]]
buttons, zippers) should be included within the nursing pillow
definition and subject to the requirements of the rule. The Boppy
Company and JPMA stated that slipcovers should not be subject to the
requirements of the rule and the Commission should instead work with
ASTM to create a relevant slipcover rule through the Infant Bedding
subcommittee. The asserted bases for these two comments include the
following:
<bullet> Slipcovers are nondurable accessories to nursing pillows,
and regulating these accessories under the proposed rule is an
overreach of the Commission's legal authority. The comments state that
slipcovers sold with nursing pillows should be excluded from the
definition of nursing pillows, with one of the comments stating that
even slipcovers that are sold pre-installed on the nursing pillow are
not subject to CPSIA section 104 regulation, as accessories.
<bullet> Regulating slipcovers under the proposed rule for nursing
pillows contradicts the precedent set for crib mattresses, which
similarly must have a permanent warning, and crib sheets, which are
sometimes sold with crib mattresses and would cover up such a warning.
Moreover, one of the comments asserts that crib mattresses are even
more likely to be used with a sheet than a nursing pillow is to be used
with a slipcover.
<bullet> Regulating slipcover manufacturers who also manufacture
nursing pillows while excluding aftermarket slipcover manufacturers is
improper, arbitrary, and capricious. Because most aftermarket slipcover
manufacturers are based in China and do not manufacture nursing
pillows, commenters state that such action is discriminatory towards
U.S. small businesses.
JPMA stated that data do not support that slipcovers present a
distinct hazard that should be regulated.
Response: Although not all nursing pillows include slipcovers, some
nursing pillows are marketed and sold with slipcovers and these covers,
though removable (e.g., for washing), are intended, marketed and
designed as part of the product to position and support an infant close
to a caregiver's body while breastfeeding or bottle feeding, as defined
in 16 CFR 1242.2. For example, some products are sold with a slipcover
that directly encases the filling material of the product; that is, the
slipcover does not cover another exterior fabric cover or casing that
itself contains filling material. In such cases, the nursing pillow is
not intended to be used without a slipcover.
Staff also found that for nursing pillows with both slipcovers and
caregiver attachments, the caregiver attachment is typically sewn onto,
or otherwise a part of, the slipcover. Thus, the caregiver attachment,
which allows the nursing pillow to perform its intended function by
ensuring the product can rest upon, wrap around, or can be worn by a
caregiver in a seated or reclined position, as defined in 16 CFR
1242.2, cannot be used without the slipcover being installed on the
product.
Lastly, there are nursing pillows that can be used without a
slipcover but are sold with a slipcover on or accompanying the nursing
pillow. This indicates that these nursing pillows are intended,
marketed, or designed to be used with the slipcover that is provided
with the product. Such slipcovers are also considered to be part of the
nursing pillow as defined in 16 CFR 1242.2.
Considering these findings, the Commission clarifies that nursing
pillow slipcovers installed on a pillow, or sold together with a pillow
for a single price, are considered a part of the nursing pillow
product, and therefore are within the scope of the final rule. The
Commission has authority to regulate consumer products under the CPSA,
which defines consumer products to include their component parts. 15
U.S.C. 2052(a)(5). Accordingly, the Commission is finalizing the
definition of ``nursing pillow'' to include any removable covers, or
slipcovers, sold on or together with the product. The Commission also
clarifies that slipcovers that are sold separately, not on or together
with a pillow, are not within the scope of the final rule because they
are not component parts intended, marketed or designed as part of the
product.
In response to the commenters' suggestion that a slipcover cannot
be regulated because it is an accessory, there are no exemptions in the
CPSA for ``accessories'' nor is the term ``accessories'' included in
the definition of a ``consumer product.'' Regardless, the Commission
does not consider a slipcover sold on or together with a nursing pillow
to be an accessory, but rather to be a component part of the consumer
product subject to this final rule, the nursing pillow.
Comments asserting that the Safety Standard for Crib Mattresses, 16
CFR part 1241, which excluded crib sheets, sets a precedent
contradicting this regulation are not persuasive. The decision to
exclude crib sheets from the crib mattress mandatory standard was based
on the nature and use of the product with other products. 87 FR 8640
(Feb. 15, 2022). Unlike crib sheets, which are frequently
interchangeable and, as commenters describe, are sometimes used by
consumers for other products such as playpens, play yards, and
bassinets, a slipcover provided with a nursing pillow can only be used
for, and is intended to be used as part of, a nursing pillow. In
addition, unlike cribs, nursing pillows are sold in a variety of shapes
and sizes, and therefore slipcovers are designed to fit a specific
brand and model of nursing pillow.
The comment stating that slipcovers do not pose a distinct hazard
does not recognize the concern that these parts would cover the
permanent warning on rule-compliant nursing pillows. Nursing pillow
slipcovers that lack the final rule's required product warnings
therefore could reduce consumer awareness of the hazards associated
with nursing pillows. For this reason, the Commission urges ASTM to
address hazards associated with slipcovers that are sold separately. In
the meantime, the Commission encourages all manufacturers of out-of-
scope slipcovers to protect infants against death and injury by
ensuring that their products are consistent with the marking and
labeling and other requirements of this safety standard.
Regarding the comment that the rule is discriminatory against U.S.
small businesses because it does not include aftermarket or third-party
manufacturers of slipcovers that are described as being produced mostly
outside of the U.S, the final rule applies uniformly to all products
within the scope of the rule, as well as all products outside its
scope, independently of where they are manufactured.
2. Exemptions
Comments: The ERGO Baby Carrier, Inc. stated that, in addition to
sling carriers, the final rule should exempt soft infant and toddler
carriers, hip seat carriers, and products that are unable to rest flat
on horizontal surfaces. The commenter stated that soft infant and
toddler carriers are regulated under 16 CFR part 1226; that ``hip
seats,'' or ``hip seat carriers,'' do not have a standard but are often
used with an infant partially supported by the caregiver and product,
and could foreseeably be viewed as having a slightly u-shaped base that
slightly conforms to the caregiver's body and brings the product within
the definition of a nursing pillow; and that products that are unable
to rest flat on a horizontal surface in its intended use position are
unlikely to be used as an infant support product.
[[Page 85395]]
Response: The Commission recognizes that, like nursing pillows,
soft infant and toddler carriers position and support an infant close
to a caregiver's body and could possibly be used for nursing or bottle
feeding. However, unlike nursing pillows, soft infant and toddler
carriers are intended primarily for carrying the infant or child and
are unlikely to be used for independent infant propping, lounging, or
sleep. In addition, as noted in one of the public comments, these
products are already regulated under 16 CFR part 1226. Therefore, the
Commission is exempting soft infant and toddler carriers from the final
rule for nursing pillows.
Although the ``hip seats'' described in the comment are similar to
soft infant and toddler carriers, in that they are intended primarily
for carrying the infant or child and are unlikely to be used for
independent infant propping, lounging, or sleep, a mandatory standard
for these products does not yet exist. Thus, the Commission concludes
that an exemption for hip seats from the final rule is not appropriate,
and that hip seats intended, designed, or marketed for breastfeeding or
bottle feeding, and that otherwise meet the definition of a nursing
pillow, will be considered a nursing pillow under the final rule.
The Commission disagrees with the suggestion to exempt products
that are unable to rest flat on a horizontal surface in their intended
use position because there may be nursing pillows with an uneven bottom
surface that still lend themselves to infant propping or lounging.
Therefore, the Commission concludes that all nursing pillows,
regardless of shape, are subject to the requirements of the final rule.
3. Use of Substitute Products
Comments: Seven consumers, five anonymous individuals, a product
safety consultant, Perspective Enterprises, the Boppy Company, and
BFIDSA, claimed that consumers may use substitute products such as bed
pillows or throw pillows, or may obtain noncompliant products from the
secondhand market, instead of using nursing pillows that comply with
the final rule. Most of these comments asserted that the use of
substitute products instead of compliant nursing pillows will be due to
the rule's firmness requirement (specifically, mattress-like firmness),
the infant containment requirement, or both. Commenters attribute the
reason for consumers using substitute products to comfort levels for
the infant, caregiver, or both; difficulty of use; heavier weight and
transport difficulty; laundering issues; and reduced amount of support
surface for one or more infants. One consumer suggested that CPSC
consult an expert on nursing products and user experience and design
the products to adequately address those concerns. Kids in Danger
expressed support for the requirements in the NPR, stating that they
will lead to safer products without a negative impact on the use of the
product as a nursing pillow.
Response: CPSC acknowledges that some consumers already choose to
use products other than nursing pillows, such as bed pillows or rolled
up towels, to support infants during breastfeeding. In fact, some
websites that promote breastfeeding indicate that consumers often
already use these other products, rather than dedicated nursing
pillows, for breastfeeding and find nursing pillows to be unnecessary.
The CPSIA requires CPSC to promulgate safety standards for all
categories of durable infant and toddler products, even if consumers
also use alternatives to those products. Ensuring that nursing pillows
prevent hazards that could result in serious injury or death to
infants, however, both complies with this Congressional directive and
is likely to encourage safety-conscious caregivers to use nursing
pillows that meet a mandatory safety standard instead of unregulated
alternatives that may pose hazards for infants.
The incident data show that the primary hazard associated with
nursing pillows is the use of these products for lounging and sleeping,
not breastfeeding, and the design of most nursing pillows on the market
lends themselves to lounging and sleeping. Nursing pillows that are
soft and can envelop and support an infant for lounging are likely to
continue to be used in this way if the Commission does not finalize
this safety standard. The CPSIA requires that the Commission act to
prevent these hazards.
Regarding the firmness and infant containment requirements, some
nursing pillows on the market already have firmness and caregiver
opening dimensions that would meet the requirements of the rule, and
consumers have purchased and successfully used these products.\13\
Staff is not aware of widespread reports or complaints of these
products being less comfortable or more difficult to use in comparison
to other products without these features. Moreover, contrary to
comments arguing that the firmness requirements will result in heavier
products that are more difficult to transport, one of the nursing
pillows on the market that meets the final rule's firmness requirement
is one of the lightest nursing pillows examined by staff.\14\
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\13\ Analysis by staff of CPSC's Directorate for Economic
Analysis (EC) finds that one of the nursing pillows currently on the
market that meets the final rule's firmness requirement is a Top 10
bestseller on <a href="http://Amazon.com">Amazon.com</a> and sells more than 18,000 units per month
on Amazon alone.
\14\ One nursing pillow that Boise State University (Mannen et
al., 2022) found to meet the firmness requirement weighed 0.48 kg
(1.06 lb.). This was the lightest of all examined nursing pillows,
which weighed up to 1.84 kg. Even the next lightest nursing pillow
was nearly twice the weight, at 0.88 kg (1.94 lb.).
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Further, while the infant containment provision would reduce the
amount of the nursing pillow that wraps around the caregiver for some
existing products and could reduce the overall available infant support
surface, infants generally do not take up the entire infant support
surface of existing nursing pillows during use, and as noted above,
consumers are successfully using products that already would meet the
infant containment provision.
4. Impact on Breastfeeding
Comments: Many commenters, including 71 consumers, one anonymous
individual, Perspectives Enterprises, the Boppy Company, a Boppy
consultant, and BFIDSA, discussed the possible impact of the rule's
requirements on breastfeeding. Most of these comments assert that the
NPR failed to consider data around the safety, utility, and intended
purpose of nursing pillows, and the required changes to nursing pillows
will reduce the availability of nursing pillows and have a negative
effect on breastfeeding and its associated benefits. One of the
commenters, a Congressional representative, asserted that these
requirements fundamentally alter the function of the product and
effectively prohibit the use of nursing supports for breastfeeding
mothers. Commenters reasoned that this is due to reduced comfort for
the infant, caregiver, or both; reduced ease of use; increased weight
and difficulty in transporting; and difficulty laundering the product.
Some comments from consumers also expressed concerns about rule-
compliant nursing pillows having to use crib mattress material or being
less adjustable to the caregiver's body shape.
Response: None of the comments provide data to support the claim
that the requirements in the proposed rule would adversely affect the
effectiveness or prevalence of breastfeeding. To the contrary, ensuring
that nursing pillows are compliant with a safety standard that prevents
known hazards resulting in injury or death could encourage
[[Page 85396]]
caregivers to use compliant nursing pillows, due to concerns for infant
safety. According to CPSC staff's testing, some nursing pillows on the
market already have infant support surfaces with a level of firmness
that is consistent with the level specified in the proposed rule and
have caregiver openings that would meet the proposed infant containment
provision. These findings indicate that such requirements are unlikely
to decrease the utility of nursing pillows for breastfeeding,
particularly because nursing pillows with these already-compliant
features tend to be single-function products that are designed
specifically for this activity. Furthermore, nursing pillows that do
not comply with the rule's infant containment provision are less likely
to fit a caregiver to enable nursing; their small openings generally
appear designed and intended to fit and support a small infant for
lounging.
The rule does not require nursing pillow manufacturers to use crib
mattress material. The rule establishes a firmness standard but does
not dictate the product's material or construction. The Commission is
also not aware of widespread reports or complaints of existing nursing
products that have increased firmness and are less capable of
containing an infant being less adjustable or fitting poorly in
comparison to other nursing pillows.
5. Product Misuse and Education
Comments: CPSC received comments from 20 consumers, 13 anonymous
individuals, Perspective Enterprises, Kids In Danger, a product safety
consultant, and JPMA, expressing concerns with consumers' alleged
misuse of nursing pillows, disregard for warnings, or allegedly
inattentive/neglectful/irresponsible parenting. Many of these
commenters suggested increased and consistent education, educational
campaigns, or safety alert/guidelines about safe sleep, appropriate
nursing pillow use, and similar topics, and either implied or
explicitly stated that changes to the products are not needed. Several
commenters, however, pointed out that nursing pillows already have
warnings that directly address sleep and other misuse patterns. A
childbirth and nursing educator commented that while education is
important, it is not enough to address the hazards. One commenter, Kids
in Danger, recommended that more education should be combined with
adoption of the requirements in the NPR.
Response: The Commission agrees that using nursing pillows for
sleep or naps is hazardous and that education about safe sleep and the
safe use of nursing pillows is important and useful. However, the
Commission also agrees with the comment that states that education
alone is not enough to address the hazards associated with nursing
pillows. As noted in the comments, virtually all nursing pillows on the
market already warn against using the products for sleep, which is a
foreseeable use pattern given that infants are likely to fall asleep or
to be put to sleep on products intended for lounging or rest, and many
nursing pillows either are or have been marketed for infant lounging.
The improved product warnings and instructional requirements in the
final rule should increase the likelihood that affected consumers will
be better informed about the dangers of using nursing pillows for sleep
and may reduce unsafe use of nursing pillows. However, providing
warnings and instructions about hazards is less effective at
eliminating or reducing exposure to hazards than either designing a
hazard out of a product or guarding the consumer from a hazard. Indeed,
the commenters' recognition that consumers are disregarding existing
warnings confirms the limited effectiveness of warnings in addressing
this issue and supports the need for performance requirements.
Educational campaigns or programs might offer more opportunities to
present hazard information in varied ways and in greater detail than
traditional warnings, but these programs suffer from similar
limitations and cannot be expected to eliminate hazardous use.
B. Performance Requirements
1. Small Parts Requirement
Comment: An anonymous commenter stated that the rule should specify
that the foam cores of nursing pillows must pass small parts testing,
because they are accessible on some products currently on the market,
once the zipper is opened.
Response: All nursing pillows are subject to the small parts
testing, 16 CFR 1242.3(b), which requires that there shall be no small
parts before testing or liberated as a result of testing. The
Commission agrees that products filled with foam and a covering secured
with a zipper would allow access to the foam filling, if the zipper
were opened, and CPSC staff is aware of nonfatal choking incidents
involving infants placing accessible filling into their mouths. This
potential hazard is addressed by the rule's tension test requirement
for nursing pillow components that are accessible to an infant, which
includes a zipper pull. Any part, including filling, that is liberated
thereafter is subject to the small parts requirement. The rule also
includes a firmness test procedure that requires the product to be
laundered according to the manufacturer's instruction. Any part,
including filling, that is liberated as a result of this test will also
be subject to the small parts testing requirement.
CSPC, however, is not aware of any incident reports where an infant
has accessed a foam core of a nursing pillow by opening the zipper.
Thus, adding a specific requirement to address the scenario described
by the commenter is not supported by the data at this time. CPSC will
continue to monitor incidents after the rule becomes effective.
2. Infant Restraint Prohibition
Comments: Comments from three consumers, a Boppy consultant, the
American Academy of Pediatrics (AAP), Kids in Danger, a product safety
consultant, Consumer Reports, the Consumer Federation of America and
the National Center for Health Research (CFA/NCHR), and Safe Kids
Worldwide agreed that infant restraints and harnesses should not be
permitted. In contrast, a comment from China's WTO/TBT National
Notification & Enquiry Center and China's National Center of Standards
Evaluation, Notification and Comment Center on TBT of the State
Administration for Market Regulation (collectively, SAMR) expressed
support for infant restraints and stated that these features are
intended to fasten infants in a position to facilitate breastfeeding
and to reduce the risks of suffocation and falls, among other risks.
This commenter further added that products with infant restraints
include warnings against leaving a child unattended during use. This
comment also included a recommendation to further research the risk of
falls for nursing pillows with restraints compared to those without
restraints.
Response: The Commission will retain the prohibition against infant
restraints in the final rule. There is no evidence provided to support
that breastfeeding caregivers require such features for support of the
infant. Caregivers actively hold and position infants while
breastfeeding, and fall-related incidents of which the Commission is
aware tend to involve unattended infants who were left propped or
lounging in the product. Consumers may interpret the presence of an
infant restraint to imply that such unattended use is acceptable.
[[Page 85397]]
3. Seam Strength Requirement
Comments: Commenters from the AAP, a Boppy consultant, and a
product safety consultant generally supported the seam strength
requirement. One consumer, a lactation consultant, commented that she
is not aware of any problems with seams.
Response: Reported incident data include infants gaining access to
the filling within nursing pillow products because of seam openings.
Therefore, the Commission is finalizing the proposed seam strength
requirement in this rule.
4. Caregiver Attachment Strength Requirement
Comment: Public comments from the AAP and Consumer Reports
generally supported the requirement for caregiver attachment strength.
Consumer Reports, however, stated that it was unclear how buckle- or
clasp-free attachments--for example, those that rely on ties--would be
assessed or if those attachment methods are prohibited.
Response: The caregiver attachment strength requirement was not
intended to be applied only to buckles and clasps. The definition
``caregiver attachment'' states that it ``may comprise components
including, but not limited to, straps, buckles, or latches.''
Therefore, ties are included among the components that comprise a
caregiver attachment. However, to clarify that fasteners of all types
are subject to the caregiver attachment strength requirement, the
Commission is revising the Caregiver Attachment Strength Test Method to
add ``other fastener,'' in addition to buckle and clasps, to better
describe the range of possible elements of a caregiver attachment.
5. Firmness Requirement
Comments: Nine consumers, one anonymous individual, a Congressional
representative, and Perspectives Enterprises commented that the
firmness requirement, alone or possibly when combined with the infant
containment requirement, will reduce or eliminate the effectiveness of
the product for breastfeeding and will possibly discourage caregivers
from using compliant products. Perspectives Enterprises claimed that
firm nursing pillows are not as popular as softer ones. Comments from
three consumers and a product safety consultant stated that the changes
will drive consumers to substitute products, such as adult pillows, or
to the secondhand market, possibly increasing the risks to infants. One
comment from an anonymous individual questioned whether there is any
research on the negative effects of a firmer surface and whether it is
possible that current products have made breastfeeding safer overall.
Comments from 13 consumers, one anonymous individual, a product
safety consultant, and Perspectives Enterprises stated that greater
firmness will reduce the comfort of nursing pillows for the infant,
caregiver, or both. Nine consumers, a product safety consultant, and
Perspectives Enterprises expressed concerns about mattress-like
firmness, with some comments stating that nursing pillows need to have
pillow-like softness or that they should be soft enough to accommodate
and adjust to different caregiver body sizes and shapes.
The AAP, Kids in Danger, Consumer Reports, CFA/NCHR, Perspectives
Enterprises, and a consumer supported the proposed rule's requirement
for mattress-like firmness, primarily because the requirement will
effectively eliminate or reduce the likelihood of an infant's face
conforming to the product's surface and, when combined with the infant
containment requirement, will lessen the likelihood the product will be
used as a lounger or sleep surface.
Comments from a testing lab representative, a safety engineer,
JPMA, the Boppy Company, the ERGO Baby Carrier, Inc., and BFIDSA
recommended revisions to the firmness test method, including:
<bullet> Adopting the recommended test method for firmness that was
being developed by the ASTM Infant Bedding subcommittee at the time of
the comment period;
<bullet> Changing the firmness probe figure to address missing
information on the probe diameter, the type of material, and
dimensional units, and to remove the term ``recommended'' from the
specified probe length; this comment recommends changing the figure to
mirror Figure 11 in ASTM F833--21;
<bullet> Using the probe figure from the firmness test method being
developed by the ASTM Infant Bedding subcommittee; and
<bullet> Specifying that the final firmness measurement should be
taken after the measured force stabilizes, which should be defined as
when the force does not change by 0.1 N in 30 seconds, and that
multiple firmness measurements should be taken at each test location.
Comments from a safety engineer, JPMA, the Boppy Company, the ERGO
Baby Carrier, Inc., and BFIDSA expressed concerns about the accuracy of
the firmness test method and the test locations proposed in the NPR,
with most recommending that the rule should specify that when choosing
a test location, the edge of the test probe shall not extend beyond the
edge of the product. The ERGO Baby Carrier, Inc. further recommended
that the test method should specify the most pertinent parts of concern
for the nursing pillow, as there may be some areas where the product
tapers to a smaller dimension that is not firm but nevertheless does
not present a suffocation risk.
Response: Comments regarding the impact of the firmness requirement
on breastfeeding and use of substitute products are addressed earlier,
in sections V.A.3 and 4. Regarding comments about the relative
popularity of softer nursing pillows, soft bedding poses a known
suffocation risk to infants while firmer products consistent with the
rule do not have suffocation incidents. Therefore, the argument for
softer products is contradictory to the rule's intent to reduce such
hazards for infants.\15\
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\15\ In addition, many comments express general concern about
nursing pillows having to be as ``hard'' as crib mattresses. Yet,
the final rule's firmness requirement, which requires that the force
to displace the test probe 1 inch be greater than 10 N, represents
the low end of crib mattress firmness. The overall average of all
tested crib mattresses during the development of this requirement
was greater than 15 N.
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Regarding the recommendation to adopt the firmness test method
being developed by the ASTM Subcommittee F15.19 on Infant Bedding, the
ASTM draft test method has not yet been finalized or published and it
is unclear whether and when publication will occur. Staff, however, has
participated in the development of this test method and continues to
participate in related ASTM task group meetings.
Regarding the recommendation to reference Figure 11 of ASTM F833 in
the final rule, this figure is not appropriate for the firmness test
method in the final rule because it is associated with an occupant
retention requirement, not a firmness requirement.
The specific recommended changes to the firmness probe figure, to
add units of measure, set an overall length, and specify probe material
composition and surface finish, are warranted and will improve the
consistency of probe construction among testing laboratories.
Accordingly, the Commission is revising the figure in the final rule as
suggested by commenters. These changes will not affect the substantive
outcome of firmness testing.
The comments recommending changes to the firmness test method to
take the final firmness measurement only after the force has stabilized
would result in an improvement to the
[[Page 85398]]
reliability and repeatability of the test. Accordingly, the Commission
is revising the firmness requirement test method by adding language to
specify that the final force is based on the measurement not changing
more than 0.1 N in successive 30 second periods.
It does not follow, however, that performing multiple firmness
tests at the same locations, as suggested by some comments, would be
beneficial. If a firmness test is repeated at the same specified
location, the product surface will be compressed, and the forces
required to reach the 1.00 in (25.4 cm) deflection in the subsequent
tests will likely result in different, most likely higher, forces. The
commenter who recommended this change, a safety engineer, does not
describe how multiple results in a single location will be used to
determine compliance. As proposed in the NPR, the final rule requires
that the test locations are placed 3 inches apart to reduce the effect
of previous tests.
The Commission agrees with the comments expressing concern about
the accuracy of the test method and the testing locations where the
edge of the test probe extends beyond the edge of the product. Testing
with a probe that extends beyond the edge of the product would be
analogous to an infant's face being only partially in contact with the
product surface. Such a scenario is unlikely to result in the infant's
face being enveloped by the product, and therefore is unlikely to
represent a suffocation scenario. In addition, testing at an
unsupported edge could result in a (false) test failure due to the
deflection measurement including the edge bending away. Therefore, the
final rule limits test locations to those in which the profile of the
head probe is fully within the confines of the product surface.
However, it is possible that some nursing pillows could be of a size or
shape that would require the edge of the probe to extend beyond the
edge of the product to perform firmness testing. Thus, the final rule
specifies that if the design or size of the product is such that the
edge of the probe must extend beyond the product, then the probe must
be centered over as much of the test surface as possible. Additionally,
the proposed rule did not explicitly state to zero the force gauge
before the probe is advanced onto the product. This step is good
laboratory practice to follow and is implied by the low force needed
when setting the deflection to 0.0 inches. However, to ensure the
accuracy of the test results as the probe is moved from location to
location, the final rule now explicitly states to zero the force gauge
after the probe has been oriented and before the probe is advanced onto
the product.
6. Infant Containment Provision
Comments: Comments from the AAP, Kids In Danger, Consumer Reports,
CFA/NCHR, and Safe Kids Worldwide supported the infant containment
requirements, stating that the changes based on this requirement will
discourage the use of these products for non-nursing purposes such as
lounging or sleeping.
Three consumers, a product safety consultant, and Perspective
Enterprises stated that the infant containment requirements will
negatively impact the effectiveness of breastfeeding and deter the
product's use for nursing, driving consumers to use substitute
products.
Comments from two consumers, a product safety consultant, the Boppy
Company, and BFIDSA expressed concerns about the reduced lateral
support resulting from the infant containment requirement, including
claims that it will reduce the product's ability to support multiple
infants, that the requirement is not supported by data, and that the
requirement was not included among the recommendations in the Boise
State University (BSU) report to CPSC on infant pillows (Mannen et al.,
2022).
Two consumers and Perspective Enterprises expressed concerns about
the infant containment provision's effect on caregiver fit,
particularly for larger caregivers.
A consumer and the ERGO Baby Carrier, Inc. sought clarifications
for the infant containment requirements, including distinguishing
between a caregiver opening and a caregiver attachment in products
where the transition between the two might be ambiguous, and
identifying the recovery time between testing a product with a
caregiver attachment secured and unsecured. Lastly, the ERGO Baby
Carrier, Inc. commented that the minimum-length setting requirement for
the caregiver attachment is not supported by incident data and that if
the caregiver attachment is removable, the test should be performed
without it.
Response: The Commission agrees with commenters who support an
infant containment provision that will discourage the use of nursing
pillows for sleep and lounging. Comments regarding the impact of the
infant containment provision on breastfeeding and use of substitute
products were addressed earlier, in sections V.A.3 and 4.
Regarding concerns about reduced lateral support making nursing
pillows unable to accommodate multiple infants for simultaneous
breastfeeding, just as with solo infants, the potential loss of this
feature is outweighed by the safety benefits of not providing lateral
support that would enable young infants to be propped up in these
products for lounging or sleep. Moreover, to CPSC staff's knowledge,
all nursing pillows currently on the market that are designed solely
for nursing or feeding would meet the infant containment provision in
the final rule. The fact that the BSU report did not specifically
consider a requirement for reduced lateral support for infants, and
therefore did not include such a requirement among its recommendations,
is not a valid reason to refrain from making this safety improvement.
The Commission disagrees with comments expressing concern about the
infant containment provision's effect on caregiver fit, particularly
for larger mothers. As noted in the staff briefing package supporting
the NPR,\16\ many nursing pillows currently on the market have openings
whose size and shape seem designed with the specific intention of
supporting a small infant, not primarily to fit a caregiver's body,
with opening sizes smaller than the waist size of even the likely
smallest-waisted adult user of these products. The infant containment
provision would require caregiver opening sizes that more closely match
the expected shape and size of a caregiver's body. Moreover, as that
briefing package also noted, adult anthropometric data demonstrate that
a nursing pillow that meets the infant containment provision would
still allow the sides, or ``arms,'' of the worn product to extend more
than half of the caregiver's full abdominal depth, even among
caregivers with the largest abdominal depths.
---------------------------------------------------------------------------
\16\ See Staff's NPR Briefing Package, 62-63.
---------------------------------------------------------------------------
Regarding the test method for assessing infant containment, the
Commission agrees that for certain products that have a more gradual
transition between the infant support surface and the caregiver
attachment, as described by the commenter, there could be confusion
about what qualifies as part of the caregiver attachment. Accordingly,
the Commission is amending the definition of ``caregiver attachment''
in the final rule to mean, ``a portion of the product that is not an
infant support surface and is intended to secure the nursing pillow to
the caregiver. A caregiver attachment may comprise components
including, but not limited to, straps, buckles, or latches.'' This
revised definition explicitly excludes any part of the product that
functions as an infant support surface.
[[Page 85399]]
The Commission is retaining the rule provision that provides for
testing for infant containment with the caregiver attachment adjusted
to its minimum length. Assessing infant containment after adjusting the
caregiver attachment to its minimum length determines whether a nursing
pillow with a caregiver attachment would allow the caregiver opening to
be adjusted to an opening size that is useful to prop an infant who is
not feeding. The requirement is intended to prevent this known
hazardous use of nursing pillows.
The Commission agrees with the comment stating that the infant
containment test method should require a recovery time between the
steps where the caregiver attachment is secured at the minimum
allowable length and tested with the 9-inch probe, and where the
attachment is then unsecured and the test repeated. Securing a
caregiver attachment typically draws together the sides of the
caregiver opening, which may leave the opening temporarily deformed
after the caregiver attachment is released, resulting in a caregiver
opening that is temporarily smaller. To address this, the final rule
reverses the order of the steps in the Infant Containment test method,
so the product is tested first with the caregiver attachment unsecured,
and then with the caregiver attachment secured at its minimum length.
By applying this revised sequence to the test method, a waiting period
is not needed between the two tests, because the unsecured test does
not affect the secured test. The Commission also revised the
accompanying figure to account for the revised sequence and to more
clearly illustrate passing and failing nursing pillows, both with and
without caregiver attachments.
7. Air Flow Requirement
Comment: A product safety consultant, the AAP, Consumer Reports,
and Safe Kids Worldwide provided comments that addressed the airflow
requirement that the Commission considered, but did not include, in the
proposed rule. All of these commenters, except for Safe Kids Worldwide,
agreed with the Commission's decision not to include an airflow
requirement, stating that such a requirement is unnecessary or
inappropriate. Safe Kids Worldwide appeared to believe that such an
airflow requirement was included in the proposed rule. The AAP
recommended that the Commission continue to monitor incidents and to
consider adding an airflow requirement in the future, if necessary.
Response: Consistent with the NPR and the comments, the Commission
does not include an airflow requirement in the final rule.
8. Angular Requirement
Comments: Comments from a product safety consultant, the Boppy
Company, and BFIDSA agreed with the Commission's decision not to
include an angular requirement (i.e., requiring nursing pillows to have
sharper edges or corners, rather than cylindrical sides) in the
proposed rule. These commenters stated that an angular requirement
would make nursing pillows uncomfortable for nursing, that it is
unclear what would be an appropriate test method to assess the hazard
and to determine compliance with such a requirement, and that the
requirement is unnecessary and redundant for safety, as the suffocation
risk is addressed by the other performance requirements in the rule.
Kids in Danger recommended that the Commission consider adding an
angular requirement in the future if propping or similar lounging-
related uses continue.
Two commenters, AAP and Consumer Reports, stated that an angular
requirement should be added to the rule because it is necessary to
convey to caregivers that the products are not suitable for uses other
than nursing or feeding. CFA/NCHR also recommended adding an angular
requirement, stating that the requirement will ensure there is no
reasonable way to prop up or lounge a baby on the product.
Response: CPSC continues to have concerns about appropriate pass-
fail criteria for an angular requirement and the potential risks
associated with such a requirement, which include the risk of
positional asphyxia by neck hyperflexion or hyperextension if the
nursing pillow is used as a support cushion for lounging, particularly
because many nursing pillows on the market that are intended solely for
nursing, which have not been involved in fatalities, are not
``angular.'' In addition, the final rule's infant containment provision
is likely to achieve the goal of discouraging infant lounging by
limiting the amount of lateral support these products provide to an
infant. Thus, the Commission agrees with the comments supporting the
NPR's proposal not to include such a requirement at this time.
C. Marking and Labeling Requirements
1. General
Comments: Eight comments, from three consumers, the AAP, Kids in
Danger, Consumer Reports, CFA/NCHR, and Safe Kids Worldwide, generally
support the product warning and labeling requirements in the proposed
rule, with three specifically supporting the warning permanence
requirement intended to prevent free-hanging labels. A consumer and
SBA's Office of Advocacy took the view that warning requirements alone
are sufficient to address the hazards and performance requirements are
not necessary.
Response: Providing warnings and instructions about hazards is less
effective at eliminating or reducing exposure to hazards than either
designing the hazard out of a product or guarding the consumer from the
hazard. Virtually all nursing pillows on the market already warn
against using the products for sleep, yet consumers continue to use the
products in this way. Thus, although improved warnings can help, the
Commission disagrees with the comments stating that warnings alone
should be sufficient to address nursing pillow hazards.
2. Warning Content
Comments: Perspective Enterprises and BFIDSA objected to the
proposed warning's initial sentence about sleep and naps, stating that
the sentence is unnecessarily alarming, with BFIDSA stating that the
sentence should be changed to be consistent with other juvenile product
standards that typically describe a hazard causing ``serious injury or
death.'' This latter comment also disagreed with use of the terms
``turn'' and ``scoot'' in the warning, stating that they are
unnecessary, and stated that nursing pillows can be used safely for
naps in the lap of a caregiver, under direct supervision and supported
by the caregiver's arms. A product safety consultant and a consumer
suggested an alternative, briefer warning to improve the likelihood
that it will capture attention and will be read by consumers. These two
comments recommend limiting the text of the warning, after ``WARNING,''
to the following: ``Do not use for infant sleep. Baby can move during
sleep and suffocate against nursing pillow.'' The consumer stated that
the smaller size of the resulting warning would allow it to fit
entirely in a conspicuous location and stated that the warning could
include a reference for additional guidance, if needed. Lastly, CFA/
NCHR recommended the addition of non-English language warnings and
instructions, as well as diagrams that can be easily understood,
regardless of language.
Response: The Commission disagrees with the comments claiming that
the
[[Page 85400]]
proposed rule's initial warning statement, ``USING THIS PRODUCT FOR
INFANT SLEEP OR NAPS CAN KILL,'' is unnecessarily alarming. The use of
nursing pillows for sleep is the most common fatal hazard pattern for
these products, even though warnings about the potential for death by
suffocation if the products are used for sleep are prevalent on nursing
pillows. The continued use of these products for sleep despite these
warnings indicates that current messaging is not sufficient. The
comments' primary concern with the initial warning statement appears to
be the use of the phrase, ``CAN KILL,'' and the ASTM Nursing Pillows
subcommittee received similar comments from ASTM F15 members, with some
claiming that ``kill'' implies intentional violence and is not
appropriate for a juvenile product. The Commission does not agree with
these claims. However, in the final rule, the Commission is replacing
``CAN KILL'' because consumers may interpret this language as
referencing something hypothetical that may not happen to their child.
Instead, the Commission is finalizing the following statement that more
concretely states the hazard: ``BABIES HAVE DIED USING NURSING PILLOWS
FOR SLEEP OR LOUNGING.''
Like the original initial statement, this revised statement
immediately communicates to consumers the actual and potential deadly
consequences of using nursing pillows for sleep, which is the primary
use pattern that has resulted in fatalities with these products.
However, the revised wording also identifies the dangers of using the
product for lounging and places emphasis on the fact that deaths have
occurred when the product is used for sleeping and lounging, and thus
communicates that the stated hazard is not merely hypothetical.
Mentioning actual deaths should increase the perceived threat or
hazardousness of the situation, which has been shown to motivate
precautionary intent and behavior (Riley, 2006; Tannenbaum et al.,
2015).
The Commission disagrees with the comment suggesting that the
statement be reworded to say that using the product for sleep can cause
``serious injury or death.'' Although use of this phrase would be
consistent with other juvenile product standards, the common use of
this phrase elsewhere is likely to undercut its effectiveness in
capturing attention and motivating warning compliance, compared to the
language in the NPR and the final rule.
The Commission disagrees with the comments proposing very brief
warning content that only tells consumers not to use the product for
infant sleep and that the baby can move during sleep and suffocate
against the nursing pillows. This omits important hazard information
about, for example, consumers leaving the infant unattended in the
product for reasons other than sleep (e.g., lounging, propping);
consumers using the product where the infant sleeps (e.g., cribs,
bassinets); and falls from elevated surfaces.
Nevertheless, the Commission does concur that revisions to the
warning content could eliminate redundancy and potentially unnecessary
information, thereby reducing the overall length of the warning without
reducing the warning's effectiveness. The warning language in the final
rule replaces ``turn, scoot, or roll over'' with ``move'' and ``in only
a few minutes'' with ``within minutes.'' The Commission also revises
the warning label to better reflect that nursing pillows are intended
solely for feeding. Specifically, in the final rule the warning
statement ``Use only with an awake baby'' will be revised to ``Only use
this product to feed baby.''
To be more clear and actionable, the Commission also changes
subsequent warning statements from ``a firm, flat sleep surface'' to
``an infant sleep product,'' and from ``Never use in sleep products
like cribs, bassinets or play yards,'' to ``Never place this product
where baby sleeps.'' Furthermore, the Commission is removing warning
statements that communicate redundant messages, which include: ``Use
only with an awake baby''; ``KEEP baby in arm's reach during use''; and
``Stop using if you feel yourself falling asleep.'' Lastly, for brevity
and to emphasize a specific use that has led to falls, the Commission
is revising ``Never carry or move product with baby in it,'' to ``Do
not use to carry baby.''
In addition to the changes outlined above, the final rule provides
for the addition of a border, or line, to separate the sleep- and
suffocation-related warning language from the fall-related language.
Grouping the warning text into separate, conceptually related sections
in this way will allow consumers to more easily differentiate between
the two distinct hazards, facilitating the search and acquisition of
information (Tullis, 1997 as cited in Wogalter & Vigilante, 2006). In
addition, this change visually communicates to consumers the limited
information that must be processed on each topic, so consumers are not
overwhelmed by a single mass of text that might otherwise dissuade them
from reading.
Thus, the Commission is adopting the following warning for the
final rule:
[[Page 85401]]
[GRAPHIC] [TIFF OMITTED] TR25OC24.000
The Commission recognizes the potential usefulness of providing
warnings and instructions in multiple languages, and many nursing
pillow manufacturers already do so. At this time, the Commission will
not impose a mandatory requirement that departs from the traditional
approach of only English-language warnings; however, manufacturers may
add additional languages on the warnings to best reach their customers.
In addition, the Commission is not aware of any pictograms or similar
graphics that would effectively communicate the primary hazard or the
appropriate avoidance behaviors to most consumers. Some graphics
thought to be obvious are poorly understood and even can give rise to
interpretations that are opposite of the intended meaning (cf. Johnson,
2006; Wogalter, Silver, Leonard, & Zaikina, 2006).
3. Warning Format
Comments: CPSC received comments from a product safety consultant
and a consumer discussing the warning format. Both commenters recommend
replacing the orange-and-black ``WARNING'' signal word panel with the
word ``STOP!'' The product safety consultant suggested that this will
address consumer habituation to warnings that have become nearly
identical in appearance and format.
Response: The warning format requirements in the proposed rule are
based in part on the recommendations of the ASTM Ad Hoc Language task
group (Ad Hoc TG), which developed its warning format recommendations
specifically to address concerns raised by ASTM F15 members about the
lack of consistency in warning requirements across ASTM juvenile
product standards.\17\ Ad Hoc TG's recommended requirements are further
based on the requirements of ANSI Z535.4-11 which are the benchmark
against which warning labels are evaluated for adequacy. Research
generally shows that the individual elements or components of the ANSI
Z535 format (e.g., signal word, color) can be effective in improving
noticeability, perceived hazard, and intended compliance.\18\
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\17\ In 2015, more than 30 ASTM members--representatives that
included juvenile product manufacturers, independent consultants who
participate in ASTM, consumer groups, and other supply-chain
stakeholders--sent a letter to CPSC's then-Chairman Kaye, expressing
concern with inconsistent warning formats across the standards and
seeking consensus-based, consistent warnings. See <a href="https://cdn.ymaws.com/www.jpma.org/resource/collection/DAD0B69F-A001-4829-931E-1131DAF39D79/Warning%20Labels%20Final.pdf">https://cdn.ymaws.com/www.jpma.org/resource/collection/DAD0B69F-A001-4829-931E-1131DAF39D79/Warning%20Labels%20Final.pdf</a>.
\18\ See Staff's NPR Briefing Package, 72-73.
---------------------------------------------------------------------------
Changing the appearance of a warning can be helpful in reducing the
potential for habituation, and the specific revisions proposed in the
comments might accomplish this goal during initial exposures to the
warning while conveying a similar level of hazardousness as the warning
format specified in the proposed rule.\19\ However, CPSC is unaware of
any nursing pillows with prominent warnings affixed to the product in a
conspicuous location similar to what the final rule requires; rather,
most product warnings on these products appear to be on free-hanging,
easily removable tags. Even if consumers generally are habituating to
the appearance of ANSI Z535-style warnings, caregivers are unlikely to
be dismissive of brief, conspicuous warnings on products intended for
infants and are likely to read and process at least the initial
sentence of the warning, ``BABIES HAVE DIED USING NURSING PILLOWS FOR
SLEEP OR LOUNGING,'' which immediately communicates to consumers the
deadly consequences of using nursing pillows for sleep and is likely to
motivate further reading by the caregiver.\20\ The reduced length of
the warnings required by the final rule, compared to the NPR, further
increases the likelihood that consumers will read the warning. The
Commission thus will not change the format requirements of the warning
for the final rule.
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\19\ The alternative signal word proposed by the comment,
``STOP,'' has been studied and the perceived hazardousness of this
term compared to ``WARNING'' is mixed; the perceived hazard levels
of these two terms generally appear to be similar (Wogalter &
Silver, 1995). It conceivable, though, that using ``STOP,''
particularly if printed in red, could be at least as effective as an
ANSI Z535-style ``WARNING'' signal word panel in communicating the
hazardousness of the scenario described in the nursing pillow
warning.
\20\ In their discussion of warning research related to
attention capture and maintenance, Wogalter and Vigilante (2006)
acknowledge the potential for standardized warning formats to lead
to habituation but still recommend maximizing attention to visual
warnings by, among other things, including ``features that add
prominence such as a signal word panel containing a signal word,
color, and an alert symbol'' (p. 261).
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4. Warning Placement
Comments: The AAP, Perspective Enterprises, a product safety
consultant, Consumer Reports, and CFA/NCHR discussed issues related to
the placement of the warning on the product. The AAP, Consumer Reports,
and CFA/NCHR support the proposed rule's ``conspicuous'' requirement
and definition. Perspective Enterprises stated that based on the
proposed ``conspicuous'' definition, there will have to be multiple
warning labels on products that can be used in various positions. A
product safety consultant
[[Page 85402]]
recommended that the warning be positioned in the ``crook'' or the
center of the nursing pillow, where the caregiver is inclined to prop
up the infant, as this will be visible regardless of the pillow
position at the time of the critical decision of where to place the
infant.
CPSC also received comments from two anonymous individuals, Kids In
Danger, a product safety consultant, and a consumer discussing the
placement of warnings or other markings on nursing pillow slipcovers.
The comments indicated: warnings already exist on nursing pillows and
their covers; covers could have printed instructions and diagrams;
warnings should be included on any slipcovers for the product, whether
sold with the product or separate, and in particular aftermarket
slipcover manufacturers should be required to label just like nursing
pillow manufacturers; warnings are needed on slipcovers because
slipcovers can block the visibility of the warning on the nursing
pillow itself; and a smaller warning label could fit entirely in
conspicuous locations on both the pillow product and any covers. The
Boppy Company and BFIDSA noted that a slipcover could obscure a
permanent warning on the pillow, but did not explicitly state that a
warning should be required on slipcovers.
Response: The Commission agrees that a revised definition of
``conspicuous'' is appropriate for the final rule. The proposed rule
defined this term 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.'' Staff worked with the ASTM
Nursing Pillows subcommittee to develop this definition; however, since
then, the subcommittee has expressed concerns about the definition,
similar to those in the public comments. See staff's log of the
February 1, 2024, meeting of the F15.16 Infant Feeding Supports
subcommittee.\21\ The definition used in the proposed rule could
require multiple warning labels on certain products; for example,
products with multiple infant support surfaces would likely require
multiple, identical warnings.\22\
---------------------------------------------------------------------------
\21\ <a href="https://www.cpsc.gov/s3fs-public/ASTM-F1516-Infant-Feeding-Supports-Subcommittee-Meeting-Log.pdf">https://www.cpsc.gov/s3fs-public/ASTM-F1516-Infant-Feeding-Supports-Subcommittee-Meeting-Log.pdf</a>.
\22\ For example, CPSC is aware of a nursing pillow consisting
of a stack of multiple petal-shaped pillows attached to a central
tubular pillow. Based on the ``conspicuous'' definition in the
proposed rule, such a product would likely require a warning on
nearly every adjustable pillow.
---------------------------------------------------------------------------
The primary messages in the product warning relate to use of the
product for sleep or lounging, and incidents involving the use of
nursing pillows in these ways consistently involve consumers propping
or placing the infant in the caregiver opening. Thus, requiring the
warning to be visible when the consumer is facing, or placing an infant
into, the caregiver opening places the warning where the consumer is
likely to be looking while placing an infant into or onto the product
for lounging. However, some products that fall under the scope of the
final rule might not have a caregiver opening, and the ASTM Infant
Feeding Supports Scope task group shared the same concern. (See staff's
log of the March 19, 2024, meeting of the F15.16 Infant Feeding
Supports Scope task group.) \23\ Based on these considerations, the
Commission concludes that a preferred approach would be to require the
warning to be visible to the caregiver while placing the nursing pillow
onto themselves. This would mean the warning would be in a readily
visible location and would allow products with a caregiver opening to
have a single warning in this location, even if there are multiple
infant support surfaces. Accordingly, the Commission is revising the
definition of conspicuous to be the following: ``visible to the
caregiver while placing the product in the manufacturer's recommended
use position on or against the caregiver's body.''
---------------------------------------------------------------------------
\23\ <a href="https://www.cpsc.gov/s3fs-public/2024-03-19-ASTMF15-16Infant-Feeding-Supports-Scope-Task-Group-Meeting-Log.pdf">https://www.cpsc.gov/s3fs-public/2024-03-19-ASTMF15-16Infant-Feeding-Supports-Scope-Task-Group-Meeting-Log.pdf</a>.
---------------------------------------------------------------------------
Regarding the placement of warnings or other markings on nursing
pillow slipcovers, slipcovers sold on or together with the nursing
pillow are within the scope of the rule. The Commission shares
commenters' concerns about slipcovers that are sold separately from the
nursing pillow covering the otherwise conspicuous warnings on rule-
compliant nursing pillows and encourages slipcover makers to adopt the
rule's warning label for their products even if not legally required,
and ASTM to form a working group to develop a voluntary standard for
slipcovers that are sold separately.
5. Additional Warnings
Comment: One commenter, Kids in Danger, suggested that the
Commission also consider an additional, removable warning with strong
messaging about safe sleep and the danger posed by leaving a child in
the product unattended or sleeping, that consumers must handle (i.e.,
remove) to use the product. This message could be repeated on the
product itself for future users.
Response: Considering that the final rule already includes a
requirement for a permanent, prominent, strongly worded warning that
will be visible to both new and future product users, the Commission
concludes that a removable warning or label about safety sleep and the
use of nursing pillows for sleep, as recommended by this commenter, is
not warranted at this time.
D. Stockpiling Concern
Comment: Comments from the AAP and CFA/NCHR advised CPSC to take
measures to avoid a sell-off of inventory for products that would be
noncompliant after the effective date.
Response: Commenters who expressed a concern about potential
selling off of inventory did not provide specific information as to
actual stockpiling of nursing pillows that will be noncompliant under
the final rule. Pursuant to 15 U.S.C. 2058(g)(1), the rule requires all
products manufactured after the effective date to comply with the
standard.
E. Procedure and Constitutional Issues
1. Statutory Authority
Comments: The Boppy Company, JPMA, and BFIDSA commented that the
Commission is required to examine and assess the effectiveness of
voluntary standards, and the Boppy Company and BFIDSA stated that the
Commission can only promulgate a section 104 rule where a voluntary
standard already exists.
Response: Under section 104 of the CPSIA, there is no statutory
prerequisite requiring an existing voluntary standard in order for the
Commission to promulgate a safety standard for a durable infant or
toddler product. 15 U.S.C. 2056a(b)(2); Finnbin, LLC v. Consumer Prod.
Safety Comm'n, 45 F.4th 127, 134 (D.C. Cir. 2022). In this instance,
however, CPSC examined and assessed the effectiveness of the voluntary
standard, ASTM F3669, as discussed in section IV of this preamble.
2. Regulatory Procedure
Comments: CPSC received three comments from JPMA, the Boppy
Company, and BFIDSA that disagreed that nursing pillows are durable
infant products subject to section 104 of the CPSIA. The comments
argued that the product is primarily intended to support adult
caregivers and is not for use by infants, whose contact is incidental.
Commenters also asserted that nursing pillows are soft textile products
that are used for a year or less. Lastly, the Boppy
[[Page 85403]]
Company and BFIDSA stated that nursing pillows are unlike other feeding
support items and products under the original list of durable infant or
toddler products in section 104 because they are soft, textile
products, rather than hard, rigid, plastic, or wooden products. They
also contended that while nursing pillows may be resold or ``handed
down,'' the same can be true of nondurable goods like infant clothing.
Response: Nursing pillows meet the statutory requirement for
``durable infant or toddler products'' in section 104(f)(1) of the
CPSIA because they are intended for use, and may be reasonably expected
to be used, by children under the age of 5 years and routinely have a
life span of several years with multiple children. Specifically, CPSC
staff's assessment indicates that nursing pillows are commonly
purchased in ``used'' condition on marketplaces such as eBay, often at
prices approaching half their original sale price, in addition to
commonly being used by the original owner to nurse or feed additional
siblings after being used for the first infant. Replacement covers are
available for nursing pillows, which further confirms the extended
service life of the pillow and differentiates nursing pillows from non-
durable items such as infant clothing.
The Commission has previously added to the statutory list of
durable infant or toddler products by including other products for
young infants, such as changing products and infant bouncers, that also
have a market for secondary use. As the Commission explained in 2009,
``[b]ecause the statute has a broad definition of a durable infant or
toddler product but also includes 12 specific product categories,
additional items can and should be included in the definition.''
Requirements for Consumer Registration of Durable Infant or Toddler
Products, 74 FR 68668, 68669 (Dec. 29, 2009). Nursing pillows are
intended for use by very young breast-fed and bottle-fed infants. The
product is primarily designed to be used by infants to allow them to be
nursed or fed successfully and comfortably by a caregiver. Contrary to
commenters' suggestion, the fact that caregivers also interact with
nursing pillows and find the products useful does not negate their use
by and benefit for the infant. Infant carriers, for example, are worn
by caregivers and have utility for them, but are on the statutory list
of durable infant products. 15 U.S.C. 2056a(f)(2)(H).
3. Data
Comments: In response to the NPR, JPMA, the Boppy Company, and
BFIDSA expressed concerns about the availability of incident data
supporting the rule.
In response to the NOA, after CPSC made the data available, JPMA
and the Boppy Company commented that the data was not causative and
that incidents involved misuse of the product in unsafe environments
despite warnings. JPMA specifically commented that focus should be on
increasing consumer awareness of safe sleep and the safe use of nursing
pillows, rather than re-engineering and reducing the utility of nursing
pillows.
Also, the Boppy Company objected to references within the incident
reports to the nursing pillow being the ``first product'' associated
with these incidents.
One consumer commenting on the NOA stated that the incident data
demonstrated the need for adopting the proposed safety standard to
reduce the identified risks.
Response: In the NOA, CPSC announced the availability of incident
data relied upon for the NPR. The data made available to the public for
their review and comments included in-depth investigations (IDIs) and
incident reports providing materials such as death certificates and
information from medical examiners, consumers, and manufacturers. CPSC
also released a list of NEISS data that included incidents and injuries
treated in U.S. hospital emergency departments.
The Commission disagrees with the suggestion that the proposed rule
is not based on causative data. As noted in staff's NPR briefing
package, at least 32 of the 154 fatalities associated with nursing
pillows during the timeframe examined involved an infant who was found
with their face into the nursing pillow, and an additional 13
fatalities involved an infant found in contact with the nursing pillow,
with their neck hyper-flexed and the head pressed against their chest
or the neck hyperextended and the head tilted backward over the top of
the product. Unsafe uses for lounging or sleep are foreseeable,
regardless of the presence of warnings against using these products for
sleep, given that many of these products previously were marketed and
seemingly intended for infant propping and lounging, and infants who
are lounging or resting on the product are likely to fall asleep. The
final rule's primary performance requirements are intended to address
these known hazard patterns; for example, and as discussed in the NPR,
firmness reduces the potential for the product to conform to an
infant's face, which addresses incidents of infants being found
deceased with their face into the nursing pillow, while the infant
containment provision reduces the likelihood that consumer can and will
use the product for infant lounging or sleep. There are nursing pillows
currently on the market that are intended solely for nursing that meet
these requirements, and CPSC is not aware of any fatalities associated
with these single-function, nursing-only products.
The Commission's response to public comments stating that the focus
should be on increasing consumer awareness of safe sleep and the safe
use of nursing pillows, rather than re-engineering nursing pillows, is
provided above.
Lastly, in response to the comment about references within the
incident reports to the nursing pillow being the ``first product''
associated with these incidents, the commenter is misinterpreting the
use of this term. In-depth investigation reports list the products that
are associated with the incident, and these products may be identified
as the ``first product'' and ``second product.'' Investigators
generally give priority to products that were involved in the incident
for which CPSC has manufacturer information, as opposed to products for
which CPSC does not have such information, particularly if the
manufacturer has a U.S. presence. The terms ``first product'' and
``second product'' do not necessarily communicate the degree to which
the product in question is the cause of the incident.
3. Constitutional Issues
Comments: CPSC received comments from the Boppy Company and BFIDSA
that contended the proposed rule is unconstitutional because it
violates the non-delegation doctrine and the Separation of Powers and
Appointments Clause of the U.S. Constitution.
Response: The final rule is promulgated under the Danny Keysar
Child Product Safety Notification Act, section 104 of CPSIA, which
directs the Commission to promulgate consumer product safety standards
for durable infant or toddler products. CPSC is finalizing a safety
standard for nursing pillows pursuant to this detailed statutory
instruction.
CPSC is an independent agency and its Commissioners do not exercise
Executive power, consistent with the Supreme Court's holding in
Humphrey's Executor v. United States, 295 U.S. 602 (1935). Federal
Courts of Appeals have recently rejected Constitutional arguments like
the ones made by the commenters here. Consumers' Rsch. v. Consumer
Prod. Safety Comm'n, 91
[[Page 85404]]
F.4th 342 (5th Cir. 2024), petition for cert. filed, (Consumers' Rsch.
v. Consumer Prod. Safety Comm'n, No. 23-1323 (petition for cert. filed
on July 18, 2024)), and Leachco, Inc. v. Consumer Prod. Safety Comm'n,
103 F4th 748 (10th Cir. 2024), petition for cert. filed, (Leachco, Inc.
v. Consumer Prod. Safety Comm'n, No. 22-7060 (petition for cert. filed
on Aug. 9, 2024)).
VI. Mandatory Standard for Nursing Pillows
As required in section 104 of the CPSIA, the final safety standard
for nursing pillows establishes mandatory performance and labeling
requirements for nursing pillows to address the risks of death and
injury associated with infant suffocations, entrapments, and falls.
Below we summarize the requirements in the final safety standard,
including changes from the NPR.
A. Scope
The final 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, including any
removable covers, or slipcovers, sold on or together with such a
product. These products rest upon, wrap around, or are worn by a
caregiver in a seated or reclined position. As explained in section
V.A.1, in response to public comments, the Commission is clarifying
that slipcovers sold on or together with a nursing pillow are a part of
a nursing pillow, as defined, and are therefore included within the
scope of the rule. The Commission, therefore, is amending the nursing
pillow definition to include clarifying language. Expressly including
slipcovers within the definition and scope of the final rule further
reduces the risk of injury associated with nursing pillows by requiring
slipcovers that are part of the nursing pillow to include the
conspicuous product warning that will inform consumers about the
primary hazards with nursing pillows. The definition of ``nursing
pillow'' is similar to the definition in ASTM F3669--24. However, as
discussed in section IV, the ASTM voluntary standard does not
specifically address slipcovers in its definition. The Commission
encourages all slipcover manufacturers to ensure that their products
align with the requirements of this safety standard to further reduce
the risk of death and injury associated with nursing pillows and
encourages ASTM to form a working group to develop a voluntary standard
for slipcovers.
The final rule does not include the additional language used in the
non-mandatory ``Discussion'' portion of the ASTM voluntary standard's
definition of ``nursing pillow,'' which states that the products are
``typically stuffed, filled or molded foam.'' That language is intended
to exclude sling carriers from the definition's scope without
explicitly exempting these products and is unnecessary given the
specific exclusions discussed below.
In the NPR, the definition of ``nursing pillow'' excluded maternity
pillows, as defined in Sec. 1242.2, and sling carriers, as defined in
16 CFR part 1228. In the final rule, in response to public comments
discussed in section V, CPSC is retaining these exclusions and also
adding an exclusion for soft infant and toddler carriers, as defined in
16 CFR part 1226, because there is an existing mandatory rule that
addresses the hazards associated with those products. As discussed in
section IV, ASTM F3669--24 does not define or exempt maternity pillows.
B. General Requirements
The final safety standard for nursing pillows includes many of the
general requirements included in ASTM F3669--24 to address the
potential hazards associated with lead in paints; small parts; sharp
edges or points; and the removal of components that are accessible to
infants; however, as discussed in section IV, the voluntary standard's
Tension Test (7.7.4) in the Removal of Components test method does not
specify the tension test adapter clamp that may be used if the gap
between the back of the component and the base material is 0.04 inches
or more, as is done in the final rule. Although the use of such a clamp
is optional, providing this information is helpful to the tester. Like
ASTM F3669--24, the final rule also includes requirements that assess
the permanence of warning labels, whether paper, non-paper, or applied
directly to the surface of the product, and require warning labels that
are attached with seams to remain in contact with the fabric around the
entire perimeter of the label when the product is in all manufacturer-
recommended use positions. Thus, the final rule includes general
requirements that are substantially the same as those in the ASTM
voluntary standard.
The final rule, however, does not include the ASTM voluntary
standard's general requirements for toy accessories that are attached
to, removable from, or sold with a nursing pillow, and for nursing
pillows that can be converted into another product or that have
features for which a consumer safety specification exists to comply
with the applicable requirements of all applicable standards. The
Commission did not propose these two additional general requirements at
the NPR stage, and therefore, these requirements were not subject to
public notice and comment procedures of the APA. As a result,
consistent with procedural requirements for rulemaking, the final rule
does not include these provisions at this time.
C. Performance Requirements
1. Infant Restraint Prohibition
To address a potential entanglement hazard, the final rule
prohibits nursing pillows from including an infant restraint system.
This requirement is substantially the same as Infant Restraint
requirement (section 6.1) in ASTM F3669--24. Proper use of a nursing
pillow involves actively attending to the infant during use for
feeding, and the presence of restraints could suggest to consumers that
infants properly can be left unattended on the product.
2. Seam Strength
The seams of the nursing pillows secure the filling material that,
if released, can be swallowed by the infant. The Commission is aware of
incidents involving seams opening and incidents in which infants
accessed, and in one case choked on, filling materials. To address
potential injuries associated with seam failures, the final rule adopts
the NPR's requirement that nursing pillows not fail at any seams or
points of attachment when subjected to a seam strength test similar to
the tension test applied to toys intended for children up to 18 months
old under ASTM F963, Standard Consumer Safety Specification for Toy
Safety (the toy standard),\24\ but tested at a higher tension force of
15 pounds rather than 10 pounds. However the final rule corrects a unit
conversion error in the proposed rule, which incorrectly identified 0.5
pounds as equivalent to 1.1 N, rather than 2.2 N. The corrected
requirement of the rule is substantially the same as the Seam Strength
requirement (section 6.6) in ASTM F3669--24.
---------------------------------------------------------------------------
\24\ Incorporated by reference in 16 CFR part 1250, Safety
Standard Mandating ASTM F963 for Toys.
---------------------------------------------------------------------------
3. Caregiver Attachment Strength
To address the potential for infant falls if the buckled belts,
straps, or other features intended to secure the product to the
caregiver fail, the final rule includes a requirement and test method
for the strength of caregiver
[[Page 85405]]
attachments. Specifically, the final rule requires that each element of
the caregiver attachment system (e.g., strap, buckle) that is included
on nursing pillows be required to withstand a static load of 20 pounds.
The test method also has been revised slightly for the final rule to
clarify that the requirements apply to all fasteners, not just buckles
or clasps. This requirement is substantially the same as the Caregiver
Attachment Strength requirement (section 6.7) in ASTM F3669--24;
however, the definition of ``caregiver attachment'' in the voluntary
standard is more limited in scope by referring to the caregiver
attachment as a ``device or other mechanism'' rather than more broadly
as a ``portion of the product.'' Thus, the definition included in the
final rule is more stringent than the voluntary standard and further
reduce the risk of injury associated with the use of nursing pillows.
4. Firmness
To reduce the likelihood that the nursing pillow will conform to an
infant's face and suffocate the child, the final 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's
caregiver opening (e.g., the wall within the crescent-like opening).
The firmness requirement and test method are based on the
recommendations of the BSU Final Report, with modifications including 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: one at
the location of maximum thickness and two others at locations most
likely to fail. To avoid passing pillows with soft areas, and to
minimize any influence that conducting the test can have on the
firmness of foam near the test location, these test locations must be
at least 3 inches apart. In addition, addressing public comments, the
final rule specifies that the locations must be selected so the edge of
the probe does not extend beyond the edge of the product--unless the
design or size of the product is such that the edge of the probe must
extend beyond the product, in which case, the probe must be centered
over as much of the test surface as possible--and the force gauge must
be set to zero before the probe is advanced onto the test surface on
the product.
To meet the firmness requirement, the force 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 the
minimum firmness of crib mattresses. In response to public comments,
the final rule revises the test method to specify that the final force
measurement at each test location is taken only after the force
measurement has stabilized, meaning that it has not changed more than
0.1 N over 30 seconds. After laundering the product according to the
manufacturer's instructions, the infant support surface and inner wall
firmness tests are repeated. The final rule requirement is
substantially the same as the three firmness requirements in ASTM
F3669--24 (section 6.2 Infant Support Surface Firmness, 6.3 Inner Wall
Firmness, and 6.4 Product Conditioning Firmness). However, as discussed
in section IV, the ASTM firmness test method specifies that if the
design of the product does not allow for testing three locations that
are 3 inches apart, then firmness testing is performed on three
separate available locations. The firmness test method in ASTM 3669--24
also includes additional figures not included in the proposed rule to
illustrate the firmness probe and relevant aspects of the test method.
Although not within the scope of the current proceeding as defined by
the NPR, the Commission could assess the potential safety implications
of these differences in a future proceeding to consider incorporating
the ASTM voluntary standard by reference.
As discussed in section IV, the voluntary standard also defines
certain terms that are used in the Firmness test method differently
than the final rule. For example, ASTM F3669--24 defines ``infant
support surface'' in a more limited way, by specifying that the infant
support surface is necessarily ``horizontal.'' Thus, the definition
included in the final rule is more stringent than the voluntary
standard and further reduces the risk of injury associated with nursing
pillows. The voluntary standard also defines ``caregiver opening''
differently than the proposed rule and adds a new definition for
``inner wall,'' which is not included in the final rule. The voluntary
standard's definition of inner wall implies that it includes any
surface of the nursing pillow intended to fit against the caregiver's
torso during use, even if that surface is part of a caregiver
attachment. This contradicts the final rule's definition of caregiver
opening, which excludes caregiver attachments.
5. Infant Containment
To reduce the hazards associated with a nursing pillow opening that
could be used for lounging or sleeping, the final rule requires nursing
pillow openings to be of a size that is more appropriate for an adult
user, rather than an infant, and limiting the amount of lateral support
for young infants who might be placed within the nursing pillow
opening. In case the infant is placed in the opening, this requirement
will reduce 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.
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.
[[Page 85406]]
[GRAPHIC] [TIFF OMITTED] TR25OC24.001
If the nursing pillow has a caregiver attachment, during testing
the attachment is unlatched, or otherwise unsecured, and moved away
from the caregiver opening. To perform the test, the 9-inch probe is
placed against the innermost surface of the caregiver opening. The
inner wall of the caregiver opening cannot contact the outer half of
the probe and the probe must extend beyond a line projected across the
outside limits of the caregiver opening. The probe is then slid
horizontally out of the caregiver opening, and the outer half of the
probe cannot contact the inner wall of the caregiver opening. Contact
with a caregiver attachment is not included in these assessments. Then,
if the nursing pillow has a caregiver attachment, the caregiver
attachment is adjusted to its minimum length and secured, and the same
tests are repeated. In the NPR, testing would initially be performed
with the caregiver attachment secured and then repeated with the
attachment unsecured. However, to allow the product to return to its
original shape, as recommended in public comments, the order of testing
is reversed for the final rule. The final rule also includes a revised
figure--the one shown in Figure 3--to clarify some of the pass-fail
criteria for different nursing pillows. The requirement in the final
rule is substantially the same as the Infant Containment requirement
(section 6.5) in ASTM F3669--24, although the illustrative figures
differ.
E. Warning and Instructional Requirements
As a secondary safety mechanism that provides consumers important
information about the hazards associated with nursing pillows and
appropriate behaviors to avoid those hazards, the final rule includes
requirements for on-product warnings that address the primary hazards
associated with nursing pillows, with revisions to address public
comments related to warning content and length. The changes include the
following:
<bullet> Revising the initial sentence from, ``USING THIS PRODUCT
FOR INFANT SLEEP OR NAPS CAN KILL,'' to, ``BABIES HAVE DIED USING
NURSING PILLOWS FOR SLEEP OR LOUNGING.''
<bullet> Stating explicitly that nursing pillows should be used for
feeding only.
<bullet> Revising some language for brevity; for example, changing
``turn, scoot, or roll over'' to ``move;'' changing ``in only a few
minutes'' to ``within minutes;'' and changing ``Never carry or move
product with baby in it'' to ``Do not use to carry baby.''
<bullet> Deleting some statements that communicate redundant
messages, for example removing the statements ``Use only with an awake
baby,'' ``Keep baby in arm's reach during use,'' and ``Keep baby's face
visible and airway clear.''
In addition, the example warning has been reformatted to include a
line, or border, to separate the sleep/suffocation-related warning
content from the fall-related content.
Figure 5 shows the warning statements and format that would be
required on all nursing pillows:
[[Page 85407]]
[GRAPHIC] [TIFF OMITTED] TR25OC24.002
The warning content and format requirements in the final rule are
nearly identical to those in section 8 of ASTM F3669--24. The key
difference is that the warning in the final rule includes the
statement, ``Move baby to an infant sleep product, like a crib or
bassinet, if baby falls asleep or if you feel drowsy,'' at the end of
the first bullet. This statement, which is similar to content in the
NPR's proposed rule warning, is needed (1) to reinforce the safe-sleep
message that consumers should move the baby to a product intended for
infant, like a crib or bassinet, if the baby falls asleep during or
after feeding, and (2) to remind consumers to stop using the product if
the consumer feels themselves falling asleep, which is a scenario
associated with three infant fatalities. Thus, the warning required in
the final rule is more stringent than the voluntary standard and will
further reduce the risk of injury associated with the use of nursing
pillows.
The final rule also includes a revision to the definition of
``conspicuous'' to address public comments expressing concerns that the
original definition used in the NPR, ``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,'' would require
multiple identical warning labels on products with multiple infant
support surfaces. The final rule defines ``conspicuous'' to mean
``visible to the caregiver while placing the product in the
manufacturer's recommended use position on or against the caregiver's
body.'' This definition is substantially the same as the definition
included in ASTM F3669--24.
The final rule incorporates by reference the National Electrical
Manufacturers Association's (NEMA's) ANSI Z535.4-2011(R2017), American
National Standard for Product Safety Signs and Labels (ANSI Z535.4-
2011), which is the primary U.S. voluntary standard pertaining to the
design, application, use, and placement of product safety signs and
labels. ANSI Z535.4-2011 includes the following warning format
requirements: 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.
The final rule also incorporates ASTM D3359-23, Standard Test
Methods for Rating Adhesion by Tape Test, which covers procedures for
assessing the adhesion of relatively ductile coating films to metallic
substrates by applying and removing pressure-sensitive tape over cuts
made in the film. Many ASTM juvenile product standards use one of the
procedures in this standard to assess the permanency of warnings that
are applied directly to the surface of a product.
In addition to on-product warnings, the final rule 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 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. Section 8.6 of ASTM
F3669--24 includes the same requirements.
The final rule also includes requirements for the instructional
literature 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. Section 9 of ASTM
F3669--24 also includes these instructional literature requirements.
F. Severability
If any requirements in the final rule are stayed or determined to
be invalid by a court, the Commission intends that the remaining
requirements in the rule will continue in effect and finds that the
individual requirements in the rule each independently promote the
safety of infants. This applies to all provisions adopted as part of
the safety standard for nursing pillows under section 104 of the CPSIA,
to reflect the Commission's intent that part 1242 be given its greatest
effect.
VII. Amendment to 16 CFR Part 1112 To Include NOR for Nursing Pillows
The CPSA establishes requirements for product certification and
testing. Products subject to a consumer product
[[Page 85408]]
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. Id. 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. Id.
2063(a)(3). The final rule establishing the Safety Standard for Nursing
Pillows, to be codified as 16 CFR part 1242, is 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 (March 12, 2013),
which is codified at 16 CFR part 1112. Part 1112 became effective on
June 10, 2013, and establishes requirements for accreditation of third-
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. 16 CFR 1112.15. All new NORs for new children's
product safety rules, such as the nursing pillow standard, require an
amendment to part 1112. Accordingly, in the NPR, the Commission
proposed to amend part 1112 to add part 1242, Safety Standard for
Nursing Pillows, in the list of NORs.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new standard for nursing
pillows 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 16 CFR part 1242, Safety
Standard for Nursing Pillows, included in the laboratory's scope of
accreditation of CPSC safety rules listed on the CPSC website at:
<a href="http://www.cpsc.gov/labsearch">www.cpsc.gov/labsearch</a>.
VIII. Amendment to Definitions in Product Registration Rule
The statutory definition of ``durable infant or toddler product''
in section 104(f) applies to all of section 104 of the CPSIA. 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).
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. See 16 CFR
1130.2. 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 68669.
In the NPR, the Commission proposed to amend part 1130 to include
``Nursing pillows,'' as defined, as durable infant or toddler products.
The Commission proposed to include nursing pillows as 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. 88 FR 65865, 65877. The
Commission received comments on this proposal, which are addressed in
section V of this preamble. After considering the comments, the
Commission now finalizes the amendment to part 1130 to add ``Nursing
pillows'' to the list of durable infant or toddler products.
IX. Incorporation by Reference
Sections 1242.6(d)(4) and 1242.7(d) of the final rule provide that
each nursing pillow must comply with applicable provisions of ANSI
Z535.4-11. The Office of the Federal Register (OFR) has regulations
concerning incorporation by reference. 1 CFR part 51. For a final rule,
agencies must discuss in the preamble to the rule the way in which
materials that the agency incorporates by reference are reasonably
available to interested persons, and how interested parties can obtain
the materials. Additionally, the preamble to the rule must summarize
the material. 1 CFR 51.5(b).
In accordance with regulations of the OFR's requirements, section
VI of this preamble summarizes ANSI Z535.4-2011 and ASTM D3359-23,
which the Commission is incorporating by reference. ANSI Z535.4-2011
and ASTM D3359-23 are copyrighted. Before the effective date of this
rule, you can view a copy of these standards at:
<bullet> <a href="https://ibr.ansi.org/Standards/nema.aspx">https://ibr.ansi.org/Standards/nema.aspx</a> for ANSI Z535.4-2011,
and
<bullet> <a href="https://astm-my.sharepoint.com/:w:/g/personal/mpezzella_astm_org/ES8zruHHM5tJmEuwfwlzj3IBLRgSRMUlwHQTnt2Eg-f__Q?rtime=sUx8dRbu3Eg">https://astm-my.sharepoint.com/:w:/g/personal/mpezzella_astm_org/ES8zruHHM5tJmEuwfwlzj3IBLRgSRMUlwHQTnt2Eg-f__Q?rtime=sUx8dRbu3Eg</a> for ASTM D3359-23.
Once the rule becomes effective, the standards can be viewed free
of charge as a read-only document at:
<bullet> <a href="https://ibr.ansi.org/Standards/nema.aspx">https://ibr.ansi.org/Standards/nema.aspx</a> for ANSI Z535.4-2011,
and
<bullet> <a href="https://www.astm.org/products-services/reading-room.html">https://www.astm.org/products-services/reading-room.html</a> for
ASTM D3359-23.
To download or print the standard, interested persons may purchase
a copy of the standards from:
<bullet> ASTM International (ASTM), 100 Barr Harbor Drive, P.O. Box
CB700, West Conshohocken, Pennsylvania 19428-2959; phone: (800) 262-
1373; website: <a href="http://www.astm.org">www.astm.org</a> for ASTM D3359-23 Standard Test Methods for
Rating Adhesion by Tape Test, approved February 1, 2023,
<bullet> National Electrical Manufacturers Association (NEMA), 1300
17th St. N, Arlington, VA 22209; phone: (703) 841-3200; website:
<a href="http://www.nema.org">www.nema.org</a> for ANSI Z535.4-2011(R2017), American National Standard
for Product Safety Signs and Labels, ANSI-approved October 20, 2017.
This standard is also available from ANSI via its website, <a href="https://www.ansi.org">https://www.ansi.org</a>, or by mail from ANSI, 25 West 43rd Street, 4th Floor, New
York, NY 10036, USA, telephone: (212) 642-4900.
[[Page 85409]]
Alternatively, interested parties can 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#9af9eae9f9b7f5e9daf9eae9f9b4fdf5ec"><span class="__cf_email__" data-cfemail="cfacbfbcace2a0bc8facbfbcace1a8a0b9">[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 proposed an effective date
of 180 days after publication of the final rule. Commenters both
supported and opposed the 180-day effective date. The AAP, Consumer
Reports, and CFA/NCHR supported the 180-day effective date, with two
commenters who recommended that CPSC adopt the rule expeditiously, or
as early as feasible.
Four comments, from PM&J, LLC; JPMA; the Boppy Company; and BFIDSA,
recommend a later effective date of 1 year. The commenters stated that
as a result of the rule nursing pillows will need extensive product
redesign and will need to meet registration card requirements. They
suggested that the additional time is needed to review, understand, and
apply the requirements, to design the product to meet the requirements,
to perform prototyping and sampling, to perform preproduction testing
to ensure compliance, and to perform final random inspections and lab
testing, and a shorter timeframe could result in a gap in product
availability in the market that would result in people using substitute
products.
SAMR noted that Section 1242.1 of the proposed rule specifies an
effective date of March 25, 2024, and suggests that CPSC specify at
least 6 months after publication of the final rule, rather than a
specific date.
The Commission agrees with the comments in support of the 180 day
or 6-month effective date to urgently address the hazards associated
with nursing pillows. The request to delay the effective date to one
year is not supported by any specific information as to why the
redesign and testing process for a nursing pillow would require 1 year
rather than 6 months. Instead, the justification for 1 year is based on
the precedent of the registration card rule published in 2009. Some
products on the market already meet most of the requirements in the
final rule, as discussed in the NPR briefing package,\25\ and the
testing process is relatively simple and can be completed using minimal
equipment by the testing labs. The commenter who stated that
manufacturers need ``additional time'' to develop compliant products
did not provide any details as to why 6 months would not be sufficient.
That commenter specifically mentions that it could take a full month
for final product inspections and testing to the new rule, but that
does not explain why 6 months is not sufficient to comply.
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\25\ See Staff's NPR Briefing Package at Tab B.
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The comments also do not provide any specifics as to the extent to
which the effort required is more or less than the 200 hours of labor
estimated in the NPR. For one person working alone, 200 hours
represents 5 weeks of full-time effort. Comments do not provide any
specific data as to why the level of effort to redesign and distribute
a nursing pillow would require 1 year to complete. Delaying the rule by
an additional 6 months would delay the benefits of hazard reduction by
6 months, therefore, the Commission does not adopt a later effective
date.
The portion of the proposed rule stating that the effective date of
the rule is March 25, 2024, was in error. The commenter expressing
concern about this date is correct that the final rule should specify
an effective date of 6 months after publication of the final rule,
rather than a date before the final rule is even published.
After considering the comments, the Commission now finalizes the
rule with a 180-day effective date, because this amount of time is
typical for rules issued under section 104 of the CPSIA and commenters
have not justified a different period. 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
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 with
the final rule.
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 U.S. entities, including small businesses. Section 604 of the RFA
generally requires that agencies make a final regulatory flexibility
analysis (FRFA) available when a final rule is published. A FRFA must
describe the impact of the 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. It must also describe issues raised by public comments, and
by the U.S. Small Business Administration's Office of Advocacy (SBA's
Office of Advocacy) on the Initial Regulatory Flexibility Analysis
(IRFA) that was prepared for the proposed rule and any changes to the
final rule made in response to those comments. CPSC staff prepared an
IRFA for this rulemaking that was included in the NPR and the staff's
briefing package to the Commission for the NPR.\26\ For the final rule,
an FRFA is provided below.
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\26\ See Staff's NPR Briefing Package at Tab E.
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A. Need for and Objectives of This Rule
The objective of the final rule is to reduce the risk of injury and
death associated with nursing pillows. A detailed analysis of the
objectives and statutory basis for the rule is set forth in section I
of the preamble. As discussed in sections VI, VII, and VIII of this
preamble, the rule sets mandatory requirements for nursing pillows to
address the suffocation, entrapment, and fall 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 a NOR is required.
B. Issues Raised by Public Comments Concerning Impact on Small
Entities; Changes in Response to Those Comments
Comments from the SBA's Office of Advocacy and Unrattled, LLC
addressed small business impacts. A small business, Unrattled, LLC,
commented that the amount of time and money associated with
redesigning, remanufacturing, and relaunching could cause them to go
out of business. The commenter did not provide any data to support this
assertion. The comment requested a ``6 months or more'' timeframe for
compliance. The NPR included and the final rule provides 180 days or 6
months for compliance. The other comment was from the SBA's Office of
Advocacy and this comment is addressed below. There were no other
public comments in response to the IRFA.
[[Page 85410]]
C. Issues Raised by the Staff of the Small Business Administration's
Chief Counsel for the Office of Advocacy; Changes in Response to Those
Comments
The SBA's Office of Advocacy did not file public comments but
shared small business concerns with CPSC that the safety standard will
drastically increase the cost of labor, materials, and testing
associated with nursing pillows.\27\ This is consistent with the
analysis in the IRFA that the burden would be significant for a
substantial number of small entities. SBA's Office of Advocacy provided
specific estimates that the use of firmer pillow filling would cost 22
to 30 percent more than a baseline, and that newly designed products
would require 38 percent more fabric. SBA's Office of Advocacy also
estimated that sewing the new designs would be more difficult,
increasing labor costs by 10 to 15 percent. The Commission is not
making any changes to burden estimates based on this input because SBA
Advocacy did not provide data for their specific estimates, denying
CPSC the opportunity to validate these claims. The final rule is a
performance-based standard, not a design standard. Moreover, SBA's
Office of Advocacy did not provide a source for their estimates, did
not include a specific amount of estimated burden, and did not include
a baseline for their estimates of increased percentages.
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\27\ CPSC received comments from SBA's Office of Advocacy via
email; they are included on the public docket for the NPR: <a href="https://www.regulations.gov/comment/CPSC-2023-0037-0428">https://www.regulations.gov/comment/CPSC-2023-0037-0428</a>.
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SBA's Office of Advocacy also commented that the cost of the rule
should be annualized over a ten-year period that is discounted at 7
percent. CPSC, however, is not obligated by the RFA to provide such a
calculation for the cost of a rule, and does not do so for this rule,
where, consistent with SBA Office of Advocacy's fundamental position,
CPSC has independently concluded that this rule would have a
significant impact to a substantial number of small businesses.
In addition, SBA's Office of Advocacy suggested the regulatory
alternatives of requiring only a warning label with no performance
requirements and delaying implementation of the final rule to reduce
the burden on small entities. The IRFA for the NPR discussed delaying
implementation to wait for the ASTM standard. The specific alternatives
recommended by SBA's Office of Advocacy are considered below, in
section XII, G.
D. Small Entities To Which the Rule Would Apply
Small entities subject to this rule include small businesses that
supply nursing pillows to the U.S. market, which includes manufacturers
and importers. The SBA size standard for what constitutes a ``small''
business is typically 500 to 750 employees, depending on the North
American Industry Classification Series (NAICS) category.\28\
Manufacturers and importers of nursing pillows may fall into a diverse
range of NAICS categories, depending on their primary line of business,
which is typically in a broader category of children's products or
other consumer goods.
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\28\ The size standards are based on the number of employees or
the annual revenue of the firm, and there is a specific size
standard for each 6-digit North American Industry Classification
Series (NAICS) category. The North American Industry Classification
System (NAICS) is the standard used by Federal statistical agencies
in classifying business establishments for the purpose of
collecting, analyzing, and publishing statistical data related to
the U.S. business economy. For more information, see <a href="https://www.census.gov/naics/">https://www.census.gov/naics/</a>. Some programs use 6-digit NAICS codes, which
provide more specific information than programs that use more
general 3- or 4-digit NAICS codes.
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CPSC staff identified 22 small U.S. manufacturers that design
nursing pillows in the U.S. and ship from a U.S. address, although
production may be in a foreign country.\29\ In addition, staff
identified six small U.S. importers \30\ that do not appear to have
U.S. design staff but do ship from a U.S. address. Staff also
identified more than 500 U.S. small crafters that ship from the United
States.
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\29\ Based on staff's assessment of prominent online and brick
and mortar retail stores for nursing pillows in the Spring of 2023.
\30\ See, in 13 CFR 121.103, SBA's regulations for considering
foreign and domestic affiliated companies in determining the size
standard that applies to a particular company. The determinations
differ by program and corporate structure.
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The final rule clarifies that slipcovers sold on or together with
the nursing pillow are subject to the requirements of the safety
standard. Manufacturers of nursing pillows and the nursing pillow
covers they sell with their nursing pillows are the same entities that
were included in the IRFA of the NPR and are included in this FRFA for
the final rule.
The final rule does not apply to manufacturers or suppliers of
aftermarket nursing pillow covers by a third-party manufacturer (i.e.,
not the nursing pillow manufacturer). There could be an indirect impact
on these companies if nursing pillow manufacturers change the size or
shape of nursing pillows to comply with the rule and thereby require
changes to aftermarket slipcover designs. There are hundreds of these
suppliers, the majority of which are small businesses.
The final rule also does not apply to any small U.S. retailers. As
specified in 16 CFR part 1109, retailers may rely on a certificate of
compliance provided by their suppliers.
E. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of
the Rule
Suppliers will be required to meet the performance, warning label,
consumer registration card, and user instruction requirements of the
rule, and conduct third-party testing to demonstrate compliance. A
detailed discussion of mandatory requirements is set forth in section
VII of the preamble. Section III of this preamble describes the
products subject to this final rule.
1. Costs Associated With Modifying Products
Most of the nursing pillows on the market will require
modification, which will result in most of the costs to be incurred in
the first year as a result of redesigning the product to meet the
requirements in the final rule. With an estimated 1,000 models to be
redesigned across all firms who sell to the U.S., the total cost of
redesign to the industry in the first year could be as high as $15
million. This cost is slightly higher than the estimate in the IRFA
because the labor rates have been updated to reflect the most current
Bureau of Labor Statistics (BLS) data.
The effort required for a one-time redesign is estimated to require
200 hours of professional staff (i.e., designers and testers) time per
model, including in-house testing of the prototypes and development of
labels, customer registration forms, and instruction materials. Using
the BLS Employer Costs of Employee Compensation as of March 2024,\31\
the estimated cost per model is $13,648, at a current cost for
professional labor of $68.24 per hour, rounded for the purpose of
analysis to $14,000 per model. Materials costs for prototyping are
estimated to be minimal, likely under $1,000, given that nursing
pillows typically are made of fabric and stuffing materials. Therefore,
the total cost of redesign, including redesigning slipcovers, is
approximately $15,000 per model ($14,000 for labor and $1,000 for
materials).
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\31\ <a href="https://www.bls.gov/news.release/archives/ecec_06182024.htm">https://www.bls.gov/news.release/archives/ecec_06182024.htm</a>. Table 2. Total Compensation for ``Professional
and related.'' These costs reflect the employers' cost for salaries,
wages, and benefits for civilian workers.
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Although some manufacturers may offer a wide selection of fabric
[[Page 85411]]
coverings, most manufacturers offer three or fewer physically different
models with different dimensions or features that might impact
compliance. Thus, the high-end cost estimate of redesign per
manufacturer is, based on three different models, $45,000. In most
cases, particularly for small companies, the cost is likely less
because most companies usually have one or at most two physically
distinct models. Manufacturers that sell into the U.S. market have
mostly outsourced production to foreign countries, but generally still
design their products in North America. Therefore, the estimate for the
cost of redesign reflects U.S. labor and materials costs for prototype
designs.\32\ In addition, even though importers do not directly pay for
the cost of redesign, the cost of redesign is likely reflected in the
wholesale price.
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\32\ See the following: The Pros and Cons of Outsourcing: A Look
at American Clothing Manufacturers [bond] by clothing manufacturers
[bond] Medium; Outsourcing Manufacturing in the Fashion Industry:
Pros & Cons for Small Businesses--ApparelMagic; Outsourcing Clothing
Manufacturing: Challenges and Solutions Strategy--Uphance, available
at: <a href="https://usaclothingmanufacturers.medium.com/the-pros-and-cons-of-outsourcing-a-look-at-american-clothing-manufacturers-8a772b00302c">https://usaclothingmanufacturers.medium.com/the-pros-and-cons-of-outsourcing-a-look-at-american-clothing-manufacturers-8a772b00302c</a> and <a href="https://www.uphance.com/blog/outsourcing-fashion-manufacturing/">https://www.uphance.com/blog/outsourcing-fashion-manufacturing/</a>.
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The clarification in the final rule that slipcovers sold on or
together with the nursing pillow are within the scope of the rule does
not change or add to the burden estimate per company or the number of
small entities impacted by the rule, because the impact on these
entities for these requirements, as noted above, was included in the
NPR and the final rule.
Changes to labeling and instructions will be necessary on nursing
pillows, including their slipcovers. Generally, costs associated with
marking and labeling, as well as providing instructional materials, are
low on a per-unit basis. The final rule provides the text and graphics
for the required labels and instructions. Therefore, specialized
expertise in graphic design will not be required to develop the
warnings and instructions.
The reporting and recordkeeping requirements in this rule will be
new for all suppliers. The labeling and instruction requirements
constitute a ``paperwork'' burden under the Paperwork Reduction Act
(PRA). See section XIII for a detailed discussion. The ongoing cost of
the new labels, registration forms, and instruction manuals is
estimated at about $1 per item for materials. The initial cost for
labor of developing the labels and instruction manuals is included in
the cost of redesigning models to comply with this rule. CPSC's Office
of the Small Business Ombudsman provides additional online resources
for small businesses to assist with the recordkeeping requirements.\33\
---------------------------------------------------------------------------
\33\ For instance, see: <a href="https://www.cpsc.gov/Business--Manufacturing/Small-Business-Resources">https://www.cpsc.gov/Business--Manufacturing/Small-Business-Resources</a>.
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Suppliers must also provide product registration cards. CPSC's
public website provides instructions and examples for how to develop
the certificates of compliance and product registration cards.\34\
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\34\ For instance, see: <a href="https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate">https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate</a>
and <a href="https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-Consumer-Registration">https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-Consumer-Registration</a>.
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2. Third-Party Testing Costs
The final rule will 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,
entities that are not manufacturers of children's products, such as
importers and wholesalers, may rely on the certificate of compliance
provided by others. It is reasonable to anticipate that while foreign
manufacturers may bear most of the initial cost of testing, due to the
prevalence of overseas manufacturing for this product sector, those
manufacturers would pass on at least some of the cost of testing for
compliance to U.S.-based importers and wholesalers.
Third-party testing costs for nursing pillows under the final 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 crafter selling
200 nursing pillows a year could cover the entire testing cost by
raising the price by $3.25.
3. Summary of Impacts
Generally, based on SBA's Office of Advocacy's guidelines, CPSC
considers impacts that exceed 1 percent of a firm's revenue to be
potentially significant. Staff determined that an average of $45,000 is
a conservative estimate of the redesign cost per manufacturer.
Therefore, any firms with revenue less than $4.5 million in revenue
(about 90,000 units at an average price of $50 per unit) could incur a
significant impact, because their redesign costs could exceed 1 percent
of their revenue. For small firms with just one product, the redesign
cost would be $15,000, and their revenue threshold would be $1.5
million. Staff estimates that 14 U.S. firms exceed the threshold and
therefore the rule would not have a significant impact: nine of these
firms offer their products in brick and mortar stores, and five sell
their products online only. Of these 14 firms, nine are small U.S.
businesses. There are, however, more than 1,000 suppliers to the U.S.
market--with annual sales for the whole industry estimated at 1.34
million units--nearly all of which fall below the threshold of 90,000
units sold per year. For this reason, the costs of redesign are likely
to be significant for a substantial number of small firms, particularly
small home crafters.\35\
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\35\ Several hundred foreign direct shippers, including small
home crafter businesses, will also likely be impacted, but the RFA
requires analysis of the impact on U.S. small businesses.
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Firms may be able to reduce the impact of the redesign costs by
raising the retail price of nursing pillows by a few dollars, which may
reduce the impact of the rule for small businesses. Since warning
labels, registration forms, and instruction manuals could add up to $1
to the cost of the product, firms may decide to pass this on to the
consumer. In addition, 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. The overall market for nursing pillows is relatively inelastic,
meaning that an increase or decrease in price will not have a
proportional increase or decrease in demand, because many parents
perceive a nursing pillow as a necessity and are therefore likely
willing to pay an increased price.
As noted above, the retail price increase to cover redesign costs
could be relatively minor, even for relatively small-volume suppliers.
For example, a firm supplying 5,000 nursing pillows per year could
cover the entire cost of redesign by raising the price by $3. Small-
volume hand crafters, however, may not have enough sales to cover the
expense of redesign and testing, while small-volume importers may not
be able to find compliant suppliers. But again, even relatively small-
volume suppliers may be able to reduce the impact of the rule by
raising prices to cover costs of testing and redesign. A retail price
increase of less than $5 could cover all the testing costs and a
substantial
[[Page 85412]]
portion of the redesign costs, even for a very small supplier.
Since most nursing pillows will need to be redesigned, as described
above, large businesses may also have to raise their prices to cover
compliance costs, which means that small businesses would not
necessarily be less competitive if they also had to raise their prices
to cover compliance costs. Some public commenters stated that the
current nursing pillow market will not be able to support any retail
price increases; however, the commenters did not provide any data to
support this assertion.
In addition, the best-selling nursing pillows are from companies,
including small U.S. 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.
Consumers may not experience a significant loss of consumer utility
as some small-volume sellers exit online marketplaces, since the
selection in brick-and-mortar stores is already limited to the products
of only nine companies. Also, many of the best-selling products online
are from the same group of firms that sell in stores, which include
small businesses. It is likely that the products currently in stores,
and the best-selling online-only products, will still be available,
with modest redesigns. However, there may be some loss in sales of
specific products because of the requirements of the final rule, if the
redesigned products are less appealing to consumers.
F. Other Federal Rules That May Duplicate, Overlap, or Conflict With
the Final Rule
CPSC has not identified any other federal rules that duplicate,
overlap, or conflict with the final rule.
G. Alternatives Considered To Reduce the Impact on Small Entities
The Commission considered the following alternatives to minimize
the significant economic impact on small businesses.
1. Not Establishing a Safety Standard
The Commission considered not establishing a safety standard for
nursing pillows. Although 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 between 2010 and 2022. Therefore, the Commission is
issuing a final rule to establish a safety standard for nursing pillows
to reduce the likelihood of injuries and deaths from the use of nursing
pillows, as required by CPSIA section 104.
2. Different Effective Date
The Commission is establishing a 180-day effective date after
publication of the final rule in the Federal Register for the reasons
discussed in section X. In the NPR, the Commission rejected adopting an
effective date earlier than 180 days because of concerns that it would
have increased the burden on small businesses and could have resulted
in temporary shortages of nursing pillows due to testing laboratory
capabilities.
Some public comments on the NPR requested a later effective date of
one year to allow suppliers more time to comply, to redesign and to
ship the product. The commenters, however, did not provide any specific
data (such as amount of labor needed for redesign or current shipping
times from foreign manufacturers) on why it would take more than 6
months to redesign and distribute a pillow. Other public comments
received recommended effective dates of 180 days or 6 months as
proposed in the NPR. Therefore, the Commission does not have a basis to
delay implementation of the rule beyond 6 months, especially inasmuch
it could result in additional injuries and deaths.
3. ``Angular'' Performance Requirement
In the NPR, the Commission requested comments on whether to include
an ``angular'' performance requirement in the safety standard for
nursing pillows, discussed above in section V. Some commenters
supported this requirement; however, none provided specific data to
support such a requirement. SBA's Office of Advocacy commented that
this alternative might increase the burden on small businesses, without
effectively reducing the hazard and agreed with the Commission's
preliminary decision to not include the requirement in the NPR. As
discussed above, the Commission is not including such a requirement in
the final rule, thereby eliminating a potential burden on small
businesses.
4. Warning Label Requirement Only
In response to comments by SBA's Office of Advocacy and a consumer,
the Commission considered the impact of only requiring warning labels
in the safety standard of nursing pillows. Warning about hazards is
less effective at eliminating or reducing exposure to hazards than
either designing the hazard out of a product or guarding the consumer
from the hazard; therefore, the use of warnings is lower in the hazard
control hierarchy than the other two approaches.\36\ This alternative
would reduce the burden on small entities. However, because it would
also reduce benefits of the regulation leading to additional deaths of
infants, the Commission is not adopting the alternative to only require
warning labels.
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\36\ See Staff's NPR Briefing Package at Tab C.
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H. Impact on Testing Labs
Section 14 of the CPSA 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 final rule for nursing pillows falls within the categorical
exclusion.
XIII. Paperwork Reduction Act
This final 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> Title for the collection of information;
<bullet> Summary of the collection of information;
[[Page 85413]]
<bullet> Brief description of the need for the information and the
proposed use of the information;
<bullet> Description of the likely respondents and proposed
frequency of response to the collection of information;
<bullet> Estimate of the burden that shall result from the
collection of information; and
<bullet> Notice that comments may be submitted to the OMB.
The preamble to the NPR discussed the information collection burden
of the proposed rule and specifically requested comments on the
accuracy of our estimates. 85 FR 67927-28. The OMB assigned control
number 3041-0197 for this information collection. CPSC did not receive
any comment regarding the information collection burden of the proposal
in the NPR. In accordance with PRA requirements, the Commission
provides the following information:
Title: Safety Standard for Nursing Pillows.
Description: The final rule requires each nursing pillow within the
scope of the rule to meet the rule's new performance and labeling
requirements. It also requires 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
----------------------------------------------------------------------------------------------------------------
Total
Burden type Number of Frequency of Total annual Hours per burden
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 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 rule would be new for
all suppliers.
CPSC estimates there are 844 entities that would respond to this
collection annually.\37\ 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.
---------------------------------------------------------------------------
\37\ Although the total number of nursing pillow suppliers to
the United States is estimated to be more than 1,000, 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 $41.76.\38\ Therefore, the estimated
annual labor cost of the collection is $70,491 ($41.76 per hour x 1,688
hours = $70,490.88). Based on this analysis, the mandatory safety
standard for nursing pillows will impose an additional burden to
industry of 1,688 hours at a total cost of $70,491. In compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), CPSC has
submitted the information collection requirements of this final rule to
the OMB.
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\38\ U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' March 2024, Table 4, total compensation for
all sales and office workers in goods-producing private industries:
<a href="https://www.bls.gov/news.release/archives/ecec_06182024.htm">https://www.bls.gov/news.release/archives/ecec_06182024.htm</a>.
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XIV. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a standard or regulation that prescribes
requirements for the performance, composition, contents, design,
finish, construction, packaging, or labeling of such product dealing
with the same risk of injury unless the state requirement is identical
to the federal standard. Section 26(c) of the CPSA also provides that
states or political subdivisions of states may apply to the Commission
for an exemption from this preemption under certain circumstances.
Section 104(b) of the CPSIA refers to the rules to be issued under that
section as ``consumer product safety standards.'' Therefore, once this
final rule is issued, the rule will preempt state laws in accordance
with section 26(a) of the CPSA.
XV. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that,
before a rule may take effect, the agency issuing the rule must submit
the rule, and certain related information, to each House of Congress
and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must
indicate whether the rule is a ``major rule.'' The CRA states that the
Office of Information and Regulatory Affairs (OIRA) determines whether
a rule qualifies as a ``major rule.'' Pursuant to the CRA, OIRA
designated this rule as not a ``major rule,'' as defined in 5 U.S.C.
804(2). To comply with the CRA, CPSC will submit the required
information to each House of Congress and the Comptroller General.
XVI. References
Daniel A. Johnson, Practical Aspects of Graphics Related to Safety
Instructions and Warnings, in Handbook of Warnings 463-476 (Michael
S. Wogalter ed., 2006).
Michael J. Kalsher et al., Reconsidering the Role of Design
Standards in Developing Effective Safety Labeling: Monolithic
Recipes or Collections of Separable Features?, 61(6) Human Factors,
920-952 (2019).
Kenneth R. Laughery, Sr. & Danielle Paige Smith, Explicit
Information in Warnings, in Handbook of Warnings 419-428 (Michael S.
Wogalter ed., 2006).
Mary F. Lesch. Consumer Product Warnings: Research and
Recommendations, in Handbook of Warnings 137-146 (Michael S.
Wogalter ed., 2006).
Erin M. Mannen, U.S. Consumer Prod. Safety Comm'n, Pillows Product
Characterization and Testing (2022). Available: <a href="https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing">https://www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing</a>.
Donna M. Riley, Beliefs, Attitudes, and Motivation, in Handbook of
warnings 289-300 (Michael S. Wogalter ed., 2006).
Melanie B. Tannenbaum et al., Appealing to Fear: A meta-analysis of
fear appeal effectiveness and theories, 141(6) Psychological
Bulletin, 1178-1204 (2015).
Michael S. Wogalter & N. Clayton Silver, Warning signal words:
Connoted strength and understandability by children, elders, and
non-native English speakers, 38(11) Ergonomics, 2188-2206 (1995).
Michael S. Wogalter et al., Warning Symbols, in Handbook of Warnings
159-176 (Michael S. Wogalter ed., 2006).
[[Page 85414]]
Michael S. Wogalter, Attention Switch and Maintenance, in Handbook
of Warnings 245-265 (Michael S. Wogalter ed., 2006).
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, chapter II, 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: 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 and/or test method?
* * * * *
(b) * * *
(56) 16 CFR part 1242, Safety Standard for Nursing Pillows.
* * * * *
PART 1130--REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT
OR TODDLER PRODUCTS
0
3. The authority citation for part 1130 continues to read as follows:
Authority: 15 U.S.C. 2056a(d), 2065(b).
0
4. Amend Sec. 1130.2 by:
0
a. Removing the semicolons at the ends of paragraphs (a)(1) through
(16) and adding periods in their place;
0
b. Removing ``; and'' at the end of paragraph (a)(17) and adding a
period in its place; and
0
c. Adding paragraph (a)(19).
The addition reads as follows:
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.
1242.9 Severability.
Authority: 15 U.S.C. 2056a
Sec. 1242.1 Scope, purpose, application, and exemptions.
(a) Scope and purpose. This part, 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 April 23,
2025, are subject to the requirements of this part.
(c) Exemptions. The following products are exempt from this part:
(1) Maternity pillows, as defined in Sec. 1242.2,
(2) Sling carriers, as defined in 16 CFR part 1228, and
(3) Soft infant and toddler carriers, as defined in 16 CFR part
1226.
Sec. 1242.2 Definitions.
Caregiver attachment means a portion of the product that is not an
infant support surface and is intended to secure the nursing pillow to
the caregiver. 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 to the caregiver while placing the
product in the manufacturer's recommended use position on or against
the caregiver's body.
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, including any removable covers, or
slipcovers, sold on or together with such a product. 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 determined by 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 determined by 16 CFR 1500.48 and 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
paragraphs (b) and (c) of this section.
(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 (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 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 Sec.
1242.5(c)(3).
[[Page 85415]]
Sec. 1242.4 Performance requirements.
(a) Firmness. When tested in accordance with Sec. 1242.5(d), (e)
and (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] TR25OC24.003
(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
[GRAPHIC] [TIFF OMITTED] TR25OC24.004
[[Page 85416]]
(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 (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
(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
orie
[…truncated; see source link]Indexed from Federal Register on October 25, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.