85388 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

1On 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: https://www.cpsc.gov/About-CPSC/ 

Chairman/Alexander-Hoehn-Saric/Statement/ 

Statement-of-Chair-Alexander-Hoehn-Saric-onCommission-Approval-of-a-Final-Rule-Establishinga-Safety-Standard-for-Nursing-Pillows; https://

www.cpsc.gov/About-CPSC/Commissioner/RichardTrumka/Statement/Commissioner-Trumka-SafetyChanges-for-Nursing-Pillows-Will-SaveBabies%E2%80%99-Lives; and https://

www.cpsc.gov/About-CPSC/Commissioner/Mary-TBoyle/Statement/Commissioner-Mary-T-BoyleStatement-on-Vote-to-Issue-Final-Rule-on-NursingPillows. 

2ASTM International website: www.astm.org, 

About ASTM International. 

3https://www.cpsc.gov/s3fs-public/Nursing-andSupport-Pillow-VS-request.pdf. 

4Since 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. 

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. 

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: sbo@

cpsc.gov; 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

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: 

• F15.16 Nursing Pillows 

subcommittee,4 intended to develop a 

standard for nursing pillows; and 

• F15.21 Infant Loungers 

subcommittee, with a remit including 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85389 

5The docket for this rulemaking on 

Regulations.gov (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. 

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

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 nonexhaustive 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 CPSCaccepted 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: 

• 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. 

• 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. 

• The definition of ‘‘caregiver 

attachment’’ has been revised to clarify 

that a caregiver attachment is not an 

infant support surface. 

• 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. 

• 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 


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85390 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

6See 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: 

https://www.cpsc.gov/content/CommissionBriefing-Package-Notice-of-Proposed-RulemakingSafety-Standard-for-Nursing-Pillows. 

small part. The language for the 

Hazardous Sharp Edges or Points 

requirement has been clarified similarly. 

• The Permanency of Labels and 

Warnings requirement has been 

corrected by changing a reference from 

‘‘infant feeding supports’’ to ‘‘nursing 

pillows.’’ 

• The figure illustrating the firmness 

test probe, Figure 1, has been revised for 

clarity. 

• 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. 

• 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. 

• 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.’’ 

• 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 Eshaped 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

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 safetyrelated 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 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85391 

7CPSRMS 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. 

8NEISS is a statistically valid surveillance system 

for collecting injury data. NEISS is based on a 

nationally representative probability sample of 

hospitals in the U.S. and its territories. Each 

participating NEISS hospital reports patient 

information for every emergency department visit 

associated with a consumer product or a poisoning 

to a child younger than five years of age. The total 

number of product-related hospital emergency 

department visits nationwide can be estimated from 

the sample of cases reported in the NEISS. See 

https://www.cpsc.gov/Research--Statistics/NEISSInjury-Data. 

9More 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. 

10Among 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. 

11This 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. 

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

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. 

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 


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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 (§ 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: 

• 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 (§ 1242.4(c)). 

• 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 

(§ 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. 

• 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 


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12The rulemaking docket for the Safety Standard 

for Nursing Pillows (CPSC–2023–0037, https://

www.regulations.gov/document/CPSC-2023-0037- 

0002) includes nearly 850 emails received prior to 

the comment period that are essentially identical to 

these 53 public comments. 

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 (§ 1242.4(b)). 

• 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 (§ 1242.4(d)). 

• 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 (§ 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 (§ 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 

(§ 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 

(§ 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. 

You can access comments by 

searching for docket number CPSC– 

2020–0023 at http://

www.regulations.gov. 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., 


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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: 

• 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. 

• 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. 

• 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. 


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13Analysis 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 Amazon.com and sells more than 

18,000 units per month on Amazon alone. 

14One 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.). 

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

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 rulecompliant 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 


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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 fallrelated 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. 


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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. 

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: 

• Adopting the recommended test 

method for firmness that was being 

developed by the ASTM Infant Bedding 

subcommittee at the time of the 

comment period; 

• 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; 

• Using the probe figure from the 

firmness test method being developed 

by the ASTM Infant Bedding 

subcommittee; and 

• 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

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 


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16See Staff’s NPR Briefing Package, 62–63. 

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 smallestwaisted 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. 

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. 


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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 nonEnglish 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 


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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: 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85401 

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 https://cdn.ymaws.com/www.jpma.org/ 

resource/collection/DAD0B69F-A001-4829-931E1131DAF39D79/Warning%20Labels%20Final.pdf. 

18See Staff’s NPR Briefing Package, 72–73. 

19The 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). 

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

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. 

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 


ddrumheller on DSK120RN23PROD with RULES4ER25OC24.000</GPH>

BABIES HAVE DIED USING NURSING PILLOWS FOR SLEEP OR LOUNGING 

Babies can move without waming and CAN SUFFOCA 1E within minutes if their 

airway is blocked. 

• Only use this product to fNcl baby. Move baby to an infant sleep product. 

like a aib or bassinet, if baby falls asleep or if you feel drowsy. 

• Never leave or prop up baby alone on this product 

• Never place this product where baby sleeps. 

Babies have been injured from FALLS. 

• Do not use to prop up baby on beds, sofas, or other raised surfaces. 

• Do not use to cany baby. 
85402 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

21https://www.cpsc.gov/s3fs-public/ASTMF1516-Infant-Feeding-Supports-SubcommitteeMeeting-Log.pdf. 

22For 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. 

23https://www.cpsc.gov/s3fs-public/2024-03-19- 

ASTMF15-16Infant-Feeding-Supports-Scope-TaskGroup-Meeting-Log.pdf. 

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

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.’’ 

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 


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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 indepth 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. Indepth 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 


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85404 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

24 Incorporated by reference in 16 CFR part 1250, 

Safety Standard Mandating ASTM F963 for Toys. 

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 nonmandatory ‘‘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 § 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. 

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 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 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. 


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85406 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

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: 

• 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.’’ 

• Stating explicitly that nursing 

pillows should be used for feeding only. 

• 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.’’ 

• 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: 


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PASS, WITH NO CAREGIVER ATTACHMENT FAil, WITH NO CAREGNERATTACHMENT 

NO PROBE CONTACT AI.L0WEO CONTACT 

PASS, WITH CAREGNERATTACHMENT SECURED FAil, WITH CAREGIVER ATTACHMENT SECURED 

Figure 3: Illustration of nursing pillows with and without a caregiver attachment that pass 

(left) and fail (right) CPSC's infant containment provision. 
Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85407 

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 


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BABIES HAVE DIED USING NURSING PILLOWS FOR SLEEP OR LOUNGING 

Babies can move without warning and CAN SUFFOCA 1E within minutes if their 

airway is blocked. 

• Only use this product to feed baby. Move baby to an infant sleep product. 

like a aib or bassinet, if baby falls asleep or if you feel drowsy. 

• Never leave or prop up baby alone on this product 

• Never place this product where baby sleeps. 

Babies have been injured from FALLS. 

• Do not use to prop up baby on beds, sofas, or other raised surfaces. 

• Do not use to cany baby. 

Figure 5: Warning Statement Required on All Nursing Pillows 
85408 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

safety rule under the CPSA, or to a 

similar rule, ban, standard, or regulation 

under any other act enforced by the 

Commission, must be certified as 

complying with all applicable CPSCenforced requirements. 15 U.S.C. 

2063(a). Certification of children’s 

products subject to a children’s product 

safety rule must be based on testing 

conducted by a CPSC-accepted 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: www.cpsc.gov/labsearch. 

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 postagepaid consumer registration form with 

each product; keep records of 

consumers who register their products 

with the manufacturer; and permanently 

place the manufacturer’s name and 

certain other identifying information on 

the product. 

When issuing the consumer 

registration rule, the Commission 

identified six additional products as 

durable infant or toddler products: 

children’s folding chairs; changing 

tables; infant bouncers; infant bathtubs; 

bed rails; and infant slings. 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: 

• https://ibr.ansi.org/Standards/ 

nema.aspx for ANSI Z535.4–2011, 

and 

• https://astm-my.sharepoint.com/:w:/ 

g/personal/mpezzella_astm_org/ 

ES8zruHHM5tJmEuwfwlzj3IBLRg

SRMUlwHQTnt2Eg-f__Q?rtime=

sUx8dRbu3Eg for ASTM D3359–23. 

Once the rule becomes effective, the 

standards can be viewed free of charge 

as a read-only document at: 

• https://ibr.ansi.org/Standards/ 

nema.aspx for ANSI Z535.4–2011, 

and 

• https://www.astm.org/productsservices/reading-room.html for ASTM 

D3359–23. 

To download or print the standard, 

interested persons may purchase a copy 

of the standards from: 

• ASTM International (ASTM), 100 

Barr Harbor Drive, P.O. Box CB700, 

West Conshohocken, Pennsylvania 

19428–2959; phone: (800) 262–1373; 

website: www.astm.org for ASTM 

D3359–23 Standard Test Methods for 

Rating Adhesion by Tape Test, 

approved February 1, 2023, 

• National Electrical Manufacturers 

Association (NEMA), 1300 17th St. N, 

Arlington, VA 22209; phone: (703) 841– 

3200; website: www.nema.org 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, 

https://www.ansi.org, or by mail from 

ANSI, 25 West 43rd Street, 4th Floor, 

New York, NY 10036, USA, telephone: 

(212) 642–4900. 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85409 

25See Staff’s NPR Briefing Package at Tab B. 26See Staff’s NPR Briefing Package at Tab E. 

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: cpsc-os@cpsc.gov. 

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. 

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. 

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. 


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27CPSC received comments from SBA’s Office of 

Advocacy via email; they are included on the 

public docket for the NPR: https://

www.regulations.gov/comment/CPSC-2023-0037- 

0428. 

28The 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 https://www.census.gov/naics/. 

Some programs use 6-digit NAICS codes, which 

provide more specific information than programs 

that use more general 3- or 4-digit NAICS codes. 

29Based on staff’s assessment of prominent online 

and brick and mortar retail stores for nursing 

pillows in the Spring of 2023. 

30See, 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. 

31https://www.bls.gov/news.release/archives/ 

ecec_06182024.htm. Table 2. Total Compensation 

for ‘‘Professional and related.’’ These costs reflect 

the employers’ cost for salaries, wages, and benefits 

for civilian workers. 

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. 

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. 

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. 

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). 

Although some manufacturers may 

offer a wide selection of fabric 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85411 

32See the following: The Pros and Cons of 

Outsourcing: A Look at American Clothing 

Manufacturers | by clothing manufacturers | 

Medium; Outsourcing Manufacturing in the 

Fashion Industry: Pros & Cons for Small 

Businesses—ApparelMagic; Outsourcing Clothing 

Manufacturing: Challenges and Solutions Strategy— 

Uphance, available at: https://

usaclothingmanufacturers.medium.com/the-prosand-cons-of-outsourcing-a-look-at-americanclothing-manufacturers-8a772b00302c and https://

www.uphance.com/blog/outsourcing-fashionmanufacturing/. 

33For instance, see: https://www.cpsc.gov/ 

Business--Manufacturing/Small-BusinessResources. 

34For instance, see: https://www.cpsc.gov/ 

Business--Manufacturing/Testing-Certification/ 

Childrens-Product-Certificate and https://

www.cpsc.gov/Business--Manufacturing/BusinessEducation/Durable-Infant-or-Toddler-Products/ 

FAQs-Durable-Infant-or-Toddler-ProductConsumer-Registration. 

35Several 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. 

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. 

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 perunit 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

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

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

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 


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36See Staff’s NPR Briefing Package at Tab C. 

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 bestselling 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. 

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: 

• Title for the collection of 

information; 

• Summary of the collection of 

information; 


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37Although 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. 

38U.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: 

https://www.bls.gov/news.release/archives/ecec_

06182024.htm. 

• Brief description of the need for the 

information and the proposed use of the 

information; 

• Description of the likely 

respondents and proposed frequency of 

response to the collection of 

information; 

• Estimate of the burden that shall 

result from the collection of 

information; and 

• 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

Burden 

type 

Number of 

respondents 

Frequency 

of responses 

Total 

annual 

responses 

Hours per 

response 

Total 

burden 

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 × 1 response per year × 

2 hours per response = 1,688 hours 

annually. 

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 × 

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. 

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: https://www.cpsc.gov/ 

content/Pillows-ProductCharacterization-and-Testing. 

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). 


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85414 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

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 

■ 1. The authority citation for part 1112 

continues to read as follows: 

Authority: 15 U.S.C. 2063. 

■ 2. Amend § 1112.15 by adding 

paragraph (b)(56) to read as follows: 

§ 1112.15 When can a third party 

conformity assessment body apply for 

CPSC acceptance for a particular CPSC rule 

and/or test method? 

* * * * * 

(b) * * * 

(56) 16 CFR part 1242, Safety 

Standard for Nursing Pillows. 

* * * * * 

PART 1130—REQUIREMENTS FOR 

CONSUMER REGISTRATION OF 

DURABLE INFANT OR TODDLER 

PRODUCTS 

■ 3. The authority citation for part 1130 

continues to read as follows: 

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

■ 4. Amend § 1130.2 by: 

■ a. Removing the semicolons at the 

ends of paragraphs (a)(1) through (16) 

and adding periods in their place; 

■ b. Removing ‘‘; and’’ at the end of 

paragraph (a)(17) and adding a period in 

its place; and 

■ c. Adding paragraph (a)(19). 

The addition reads as follows: 

§ 1130.2 Definitions. 

* * * * * 

(a) * * * 

(19) Nursing pillows. 

* * * * * 

■ 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 

§ 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 § 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 

§ 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. 

§ 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. 

§ 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 § 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 

§ 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 

§ 1242.5(c)(4). 

(3) Non-paper labels shall not liberate 

small parts when tested in accordance 

with § 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 manufacturerrecommended use positions, when 

tested in accordance with § 1242.5(c)(3). 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85415 

§ 1242.4 Performance requirements. 

(a) Firmness. When tested in 

accordance with § 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 

(b) Infant containment. When tested 

in accordance with § 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 § 1242.5(g)(6), the 

probe must extend past the caregiver 

opening. 

Figure 2 to Paragraph (b)—9-in. Head 

Probe 


ddrumheller on DSK120RN23PROD with RULES4ER25OC24.003</GPH> ER25OC24.004</GPH>

l--2.so inch length--t 

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(DO-) 
85416 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

(c) Infant restraints. Nursing pillows 

shall not include any infant restraint 

system. 

(d) Seam strength. When tested in 

accordance with § 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 § 1242.3(b) and (c). 

(e) Caregiver attachment strength. 

When tested in accordance with 

§ 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 

§ 1242.3(b) and (c). 

§ 1242.5 Test methods. 

(a) Test conditions. (1) Condition the 

product for 48 hours at 23 °C +/¥2 °C 

(73.4 °F +/¥3.6 °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 § 1242.4(a)) does not deflect 

more than 0.01 in. (0.025 cm) under a 

10 N (2.2 lb) load applied in each 

orientation required in the test methods. 

(b) Removal of components test 

method—(1) Equipment. For torque and 

tension tests, any suitable device may be 

used to grasp the component, provided 

that it does not interfere with the 

attachment elements that are stressed 

during the tests. 

(2) Torque test. Gradually apply a 4 

lb-in. (0.4 N-m) torque over 5 seconds 

(s.) in a clockwise rotation to 180 

degrees or until 4 lb-in. has been 

reached. Maintain for 10 s. Release and 

allow component to return to relaxed 

state. Repeat the torque test in a 

counterclockwise rotation. 

(3) Tension test. For components that 

can reasonably be grasped between 

thumb and forefinger, or teeth, apply a 

15 lb (67 N) force over 5 s., in a 

direction to remove the component. 

Maintain for 10 s. A clamp such as 

shown in figure 1 to this paragraph 

(b)(3) may be used if the gap between 

the back of the component and the base 

material is 0.04 in. (0.1 cm) or more. 

Figure 1 to Paragraph (b)(3)—Tension 

Test Adapter Clamp 

(c)Permanency of labels and 

warnings. (1) A paper label (excluding 

labels attached by a seam) shall be 

considered permanent if, during an 

attempt to remove it without the aid of 

tools or solvents, it cannot be removed, 

it tears into pieces upon removal, or 

such action damages the surface to 

which it is attached. 

(2) A non-paper label (excluding 

labels attached by a seam) shall be 

considered permanent if, during an 

attempt to remove it without the aid of 

tools or solvents, it cannot be removed 

or such action damages the surface to 

which it is attached. 

(3) A warning label attached by a 

seam shall be considered permanent if 

it does not detach when subjected to a 

15-lbf (67–N) pull force applied in the 

direction most likely to cause failure 

using a 3⁄4-in. (1.9 cm) diameter clamp 

surface. Gradually apply the force 

within a period of 5 s. and maintain for 

an additional 10 s. 

(4) Adhesion Test for Warnings 

Applied Directly onto the Surface of the 

Product: 

(i) Apply the tape test defined in Test 

Method B of ASTM D3359–23 

(incorporated by reference, see 

§ 1242.8), eliminating parallel cuts. 

(ii) Perform this test once in each 

different location where warnings are 

applied. 

(iii) The warning statements will be 

considered permanent if the printing in 

the area tested is still legible and 

attached after being subjected to this 

test. 

(5) A non-paper label, during an 

attempt to remove it without the aid of 

tools or solvents, shall not fit entirely 

within the small parts cylinder defined 

in 16 CFR part 1501 if it can be 

removed. 

(d) Infant support surface firmness 

test method. Perform the following steps 

to determine the infant support surface 

firmness of the product as received from 

the manufacturer. 

(1) Conduct tests at three locations on 

the surface to be tested, with 3 in. (7.62 

cm) or more separation: maximum 

thickness perpendicular to the test 

surface and two other locations most 

likely to fail. When selecting these 

locations, the edge of the probe shall not 

extend beyond the edge of the product. 

If the design or size of the product is 

such that the edge of the probe must 

extend beyond the edge of the product, 

the probe shall be centered over as 

much of the test surface as possible. 

(2) Lay the product, with the infant 

support surface facing up, on a test base 

that is horizontal, flat, firm, and smooth. 

(3) Prevent movement of the product 

in a manner that does not affect the 

force or deflection measurement of the 

product surface under test. Provide no 

additional support beneath the product. 

(4) Orient the axis of the 3-in. head 

probe (figure 1 to § 1242.4(a)) 

perpendicular to the test surface and 

aligned with a force gauge and parallel 

to a distance measurement device or 

gauge. Zero the force gauge. 

(5) Using a lead screw or similar 

device to control movement along a 

single direction, advance the probe onto 

the product and set the deflection to 0.0 

in. when a force of 0.1 N (0.02 lb) is 

reached. 

(6) Continue to advance the head 

probe into the product at a rate not to 

exceed 0.1 inch per second and pause 

when the force exceeds 10.0 N (2.24 lb), 

or the deflection is equal to 1.00 in. 

(2.54 cm). 

(7) Monitor the force and wait for it 

to stabilize, meaning the force has not 

changed more than 0.1 N (0.02 lb) for at 

least 30 s. If, after the force stabilizes, 

the deflection is less than 1.00 in. and 

the force is 10.0 N or less, repeat 

paragraphs (d)(6) and (7) of this section. 

(8) Record the final force and 

deflection amounts. 

(9) Repeat the infant support surface 

firmness tests on any other infant 

support surface and in all manufacturerintended configurations that could 

affect the infant support surface, such as 

the folding or layering of parts of the 

product. 

(e) Inner wall firmness test method. 

For nursing pillows with a caregiver 

opening, perform the steps in 

paragraphs (d)(1) through (8) of this 

section on the inner wall of the 

caregiver opening, and perform the 

following, to determine the inner wall 


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0 
Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85417 

firmness as received from the 

manufacturer. Repeat the inner wall 

firmness tests in all manufacturerintended configurations that could 

affect the inner wall firmness. 

(f) Product conditioning firmness test 

method. Following the firmness testing 

in paragraphs (d) and (e) of this section, 

perform the following steps to 

determine the product firmness after 

conditioning. 

(1) Launder and dry the product 

according to the manufacturer’s 

instructions. 

(2) Repeat paragraph (d) of this 

section. 

(3) Repeat paragraph (e) of this 

section. 

(g) Infant containment test method. 

(1) Lay the product, with the infant 

support surface facing up, on a test base 

that is horizontal, flat, firm, and smooth. 

(2) For nursing pillows with a 

caregiver attachment, unsecure and 

move the caregiver attachment away 

from the caregiver opening. 

(3) Place the 9-in. head probe (figure 

2 to § 1242.4(b)) inside the caregiver 

opening such that the flat bottom of the 

probe rests on the test surface and the 

probe’s perimeter contacts the 

innermost surface of the caregiver 

opening. 

(4) If the inner wall of the caregiver 

opening contacts the outwardly facing 

portions of the probe, or the inner wall 

interferes with placing the probe down, 

the caregiver opening is considered to 

constrain the probe. See figure 2 to this 

paragraph (g)(4). Do not include in the 

assessment any contact with a caregiver 

attachment. 

Figure 2 to Paragraph (g)(4)—Infant 

Containment, Example 

(5) With the probe at the position 

contacting the innermost surface within 

the caregiver opening, determine if any 

portion of the probe extends beyond a 

line projected across the outside limits 

of the caregiver opening. 

(6) Slide the probe horizontally out of 

the caregiver opening to the outside of 

the nursing pillow. Determine if the 

probe is constrained by the inner wall 

of the caregiver opening contacting the 

outwardly facing portions of the probe. 

See figure 2 to paragraph (g)(4) of this 

section. Do not include in the 

assessment any contact with a caregiver 

attachment. 

(7) For nursing pillows with a 

caregiver attachment, adjust and secure 

the caregiver attachment to the 

minimum length allowed by the product 

and repeat paragraphs (g)(3) through 

(g)(5). 

(h) Seam strength test method. (1) 

Equipment shall include clamps with 

0.75 in. (1.9 cm) diameter clamping 

surfaces capable of holding fabric and 

with a means to attach a force gauge. 

Figure 3 to this paragraph (h)(1), or 

equivalent. The force gauge must have 

an accuracy of +/¥0.5 lb (2.2 N). 


ddrumheller on DSK120RN23PROD with RULES4ER25OC24.006</GPH>

PASS, WITH NO CAREGIVER ATTACHMENT 

NO PROSE CONTACT Al.LOWED 

IHNERWAU. 

0-INHE'AD 

PROBE 

FAIL, WITH NO CAREGIVER ATTACHMENT 

PASS, WITH CAREGIVER ATTACHMENT SECURED FAIL, WITH CAREGIVER ATTACHMENT SECURED 
85418 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

Figure 3 to Paragraph (h)(1)—Seam 

Clamp 

(2) Clamp the fabric of the nursing 

pillow on each side of the seam under 

test with the 0.75 in. clamping surfaces 

placed not less than 0.5 in. (1.2 cm) 

from the seam. 

(3) Apply a tension of 15 lb (67 N) 

evenly over 5 s. and maintain for an 

additional 10 s. 

(4) Repeat the test on every distinct 

seam and every 6 in. (15 cm) along each 

seam. 

(i) Caregiver attachment strength test 

method. (1) Any suitable clamping 

devices with means to attach a force 

gauge with accuracy of 0.5 lb (1.2 N) 

may be used. The clamping surfaces 

shall grasp across the entire width of the 

strap or attachment element. 

(2) Support the nursing pillow to 

resist the pull forces and release the 

buckle, clasp, or other fastener of the 

caregiver attachment. 

(3) Clamp one side of the attachment 

or strap of the nursing pillow not less 

than 0.5 in. (1.2 cm) from the 

attachment to the nursing pillow. 

(4) Apply a tension of 20 lb (89 N) 

evenly over 5 s. and maintain for an 

additional 10 s. 

(5) Repeat the test on the other side 

of the attachment or strap. 

(6) Join the buckle, clasp, or other 

fastener of the attachment or straps. 

(7) Clamp both sides of the 

attachment or straps across the buckle, 

clasp, or other fastener, one on each side 

and not less than 0.5 in. (1.2 cm) from 

the fastener. 

(8) Apply a tension of 20 lb (89 N) 

evenly over 5 s. and maintain for an 

additional 10 s. 

§ 1242.6 Marking and labeling. 

(a) Each product and its retail package 

shall be marked or labeled clearly and 

legibly to indicate the following: 

(1) The name, place of business (city, 

state, and mailing address, including zip 

code), and telephone number of the 

manufacturer, distributor, or seller. 

(2) A code mark or other means that 

identifies the date (month and year as a 

minimum) of manufacture. 

(3) The marking or labeling in 

paragraphs (a)(1) and (2) of this section 

are not required on the retail package if 

they are on the product and are visible 

in their entirety through the retail 

package. When no retail packaging is 

used to enclose the product, the 

information provided on the product 

shall be used for determining 

compliance paragraphs (a)(1) and (2). 

Cartons and other materials used 

exclusively for shipping the product are 

not considered retail packaging. 

(b) The marking and labeling on the 

product shall be permanent. 

(c) Any upholstery labeling required 

by law shall not be used to meet the 

requirements of this section. 

(d) Warning design for product: 

(1) The warnings shall be easy to read 

and understand and be in the English 

language at a minimum. 

(2) Any marking or labeling provided 

in addition to those required by this 

section shall not contradict or confuse 

the meaning of the required information 

or be otherwise misleading to the 

consumer. 

(3) The warnings shall be conspicuous 

and permanent. 

(4) The warnings shall conform to 

sections 6.1 through 6.4, 7.2 through 

7.63, and 8.1 of ANSI Z535.4–2011, 

(incorporated by reference, see 

§ 1242.8), with the following changes. 

(i) In sections 6.2.2, 7.3, 7.5, and 8.1.2, 

replace ‘‘should’’ with ‘‘shall.’’ 

(ii) In section 7.6.3, replace ‘‘should 

(when feasible)’’ with ‘‘shall.’’ 

(iii) Strike the word ‘‘safety’’ when 

used immediately before a color (for 

example, replace ‘‘safety white’’ with 

‘‘white’’). 

Note 1 to paragraph (d)(4). For reference, 

ANSI Z535.1, American National Standard 

for Safety Colors, provides a system for 

specifying safety colors. See note 1 to 

§ 1242.8(b) for ANSI contact information. 

(5) The safety alert symbol and the 

signal word ‘‘WARNING’’ shall be at 

least 0.2 in. (5 mm) high. The remainder 

of the text shall be in characters whose 

upper case shall be at least 0.1 in. (2.5 

mm), except where otherwise specified. 

Note 2 to paragraph (d)(5). For improved 

warning readability, avoid typefaces with 

large height-to-width ratios, which are 

commonly identified as ‘‘condensed,’’ 

‘‘compressed,’’ ‘‘narrow,’’ or similar. 

(6) The message panel shall meet the 

following text layout requirements. 

(i) The text shall be left-aligned, 

ragged-right for all but one-line text 

messages, which can be left-aligned or 

centered. 

Note 3 to paragraph (d)(6)(i). Left-aligned 

means that the text is aligned along the left 

margin, and in the case of multiple columns 

of text, along the left side of each individual 

column. See figure 1 to this paragraph 

(d)(6)(i) for examples of left-aligned text. 


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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 85419 

Figure 1 to Paragraph (d)(6)(i)— 

Examples of Left-Aligned Text 

Note 4 to figure 1 to paragraph (d)(6)(i). 

The text shown for these warnings is filler 

text, known as lorem ipsum, commonly used 

to demonstrate graphic elements. 

(ii) The text in each column should be 

arranged in list or outline format, with 

precautionary (hazard avoidance) 

statements preceded by bullet points. 

Multiple precautionary statements shall 

be separated by bullet points if 

paragraph formatting is used. 

(7) An example warning in the format 

described in this section is shown in 

figure 2 to this paragraph (d)(7). 

Figure 2 to Paragraph (d)(7)—Example 

of Warning 

(e) Warning statements. Each product 

shall have warning statements. The text 

must address the warnings as shown in 

figure 2 to paragraph (d)(7) of this 

section. 

Note 5 to paragraph (e). ‘‘Address’’ means 

that verbiage other than what is shown can 

be used as long as the meaning is the same 

or information that is product-specific is 

presented. 

(f) Package warnings. (1) The 

warnings and statements are not 

required on the retail package if they are 

on the product and are visible in their 

entirety through the retail package. 

Cartons and other materials used 

exclusively for shipping the product are 

not considered retail packaging. 

(2) Each product’s package shall have 

warning statements to address the 

following, at a minimum, as specified in 

paragraphs (d)(1) and (2) and (4) 

through (6) of this section: 

(i) Do not use for sleep. 

(ii) Do not use in sleep products like 

cribs, bassinets, or play yards. 

(3) Each product’s retail package shall 

address the manufacturer’s 

recommended weight, height, age, or 


ddrumheller on DSK120RN23PROD with RULES4ER25OC24.008</GPH> ER25OC24.009</GPH>

BABIES HAVE DIED USING NURSING PILLOWS FOR SLEEP OR LOUNGING 

Babies can move without warning and CAN SUFFOCA 1E within minutes if their 

airway is blocked. 

• Only use 1hls product to feed baby. Move baby to an infant sleep product, 

like a aib or bassinet, if baby faRs asleep or if you feel drowsy. 

• Never leave or prop up baby alone on this product 

• Never place this product where baby sleeps. 

Babies have been injured from FALLS. 

• Do not use to prop up baby on beds, sofas, or other raised surfaces. 

• Do not use to carry baby. 
85420 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Rules and Regulations 

developmental stage or combination 

thereof of the infant. 

(4) Warnings, statements, or graphic 

pictorials on the product and package 

shall not indicate or imply that the 

infant may be left in the product 

without an adult caregiver in 

attendance. 

§ 1242.7 Instructional literature. 

(a) Instructions shall be provided with 

the product and shall be easy to read 

and understand and shall be in the 

English language at a minimum. These 

instructions shall include information 

on assembly, maintenance, cleaning, 

and use, where applicable. 

(b) The instructions shall include all 

warnings specified in § 1242.6(e). 

(c) The instructions shall address the 

following additional warnings: 

(1) Read all instructions before using 

this product. 

(2) Keep instructions for future use. 

(3) Do not use this product if it is 

damaged or broken. 

(4) Instructions shall indicate the 

manufacturer’s recommended maximum 

weight, height, age, developmental 

level, or combination thereof, of the 

infant for whom the nursing pillow is 

intended. If this product is not intended 

for use by a child for a specific reason, 

the instructions shall so state this 

limitation. 

(d) The cautions and warnings in the 

instructions shall meet the requirements 

specified in § 1242.6(d)(4) through (6) of 

this section, except that sections 6.4 and 

7.2 through 7.6.3 of ANSI Z535.4—2011, 

need not be applied. However, the 

signal word and safety alert symbol 

shall contrast with the background of 

the signal word panel, and the cautions 

and warnings shall contrast with the 

background of the instructional 

literature. 

Note 1 to paragraph (d). For example, the 

signal word, safety alert symbol, and the 

warnings may be black letters on a white 

background, white letters on a black 

background, navy blue letters on an off-white 

background, or some other high-contrast 

combination. 

(e) Any instructions provided in 

addition to those required by this 

section shall not contradict or confuse 

the meaning of the required information 

or be otherwise misleading to the 

consumer. 

Note 2 to paragraph (e). For additional 

guidance on the design of warnings for 

instructional literature, please refer to ANSI 

Z535.6, American National Standard: 

Product Safety Information in Product 

Manuals, Instructions, and Other Collateral 

Materials. See note 1 to § 1242.8(b) for ANSI 

contact information. 

§ 1242.8 Incorporation by reference. 

Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. All approved 

incorporation by reference (IBR)material 

is available for inspection at the U.S. 

Consumer Product Safety Commission 

and at the National Archives and 

Records Administration (NARA). 

Contact the U.S. Consumer Product 

Safety Commission at: the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, 4330 East-West 

Highway, Bethesda, MD 20814, phone 

(301) 504–7479, email: cpsc-os@

cpsc.gov. For information on the 

availability of this material at NARA, go 

to: www.archives.gov/federal-register/ 

cfr/ibr-locations. or email fr.inspection@

nara.gov. The material may be obtained 

from the following sources: 

(a) ASTM International (ASTM), 100 

Barr Harbor Drive, P.O. Box CB700, 

West Conshohocken, Pennsylvania 

19428–2959; phone: (800) 262–1373; 

website: www.astm.org. 

(1) ASTM D3359–23 Standard Test 

Methods for Rating Adhesion by Tape 

Test, approved February 1, 2023; 

§ 1242.5(c). 

(2) [Reserved] 

(b) National Electrical Manufacturers 

Association (NEMA), 1300 17th St. N, 

Arlington, VA 22209; phone: (703) 841– 

3200; website: www.nema.org. 

(1) ANSI Z535.4–2011(R2017), 

American National Standard for Product 

Safety Signs and Labels, ANSI-approved 

October 20, 2017 (ANSI Z535.4–2011); 

§§ 1242.6(d). 

(2) [Reserved] 

Note 1 to paragraph (b). NEMA standards 

are also available from ANSI, which provides 

a free, read-only copy of the standard at 

https://ibr.ansi.org/Standards/nema.aspx. 

American National Standards Institute 

(ANSI), 25 West 43rd Street, 4th Floor, New 

York, NY 10036, USA, telephone: (212) 642– 

4900, www.ansi.org. 

§ 1242.9 Severability. 

The provisions of this part are 

separate and severable from one 

another. If any provision is stayed or 

determined to be invalid, it is the 

Commission’s intention that the 

remaining provisions shall continue in 

effect. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2024–24403 Filed 10–24–24; 8:45 am] 

BILLING CODE 6355–01–P 


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