33022 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Parts 1112, 1130, and 1236 

[CPSC Docket No. 2017–0020] 

Safety Standard for Infant Sleep 

Products 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: Pursuant to the Consumer 

Product Safety Improvement Act of 

2008 (CPSIA), the U.S. Consumer 

Product Safety Commission (CPSC) is 

issuing this final rule establishing a 

safety standard for infant sleep 

products, which are products marketed 

or intended to provide a sleeping 

accommodation for an infant up to 5 

months of age, and that are not subject 

to any of CPSC’s mandatory standards 

for infant sleep. CPSC is also finalizing 

an amendment to its regulations 

regarding third party conformity 

assessment bodies, to include the safety 

standard for infant sleep products in the 

list of notices of requirements (NORs) 

and an amendment to the consumer 

registration rule, to identify infant sleep 

products as a durable infant or toddler 

product subject to consumer registration 

requirements, as a subcategory of 

bassinets and cradles. 

DATES: This rule is effective June 23, 

2022. The incorporation by reference of 

the publication listed in this rule is 

approved by the Director of the Federal 

Register as of June 23, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Keysha Walker, Compliance Officer, 

U.S. Consumer Product Safety 

Commission, 4330 East-West Highway, 

Bethesda, MD 20814; telephone: 301– 

504–6820; email: kwalker@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Statutory Authority and Background 

A. Statutory Authority 

Section 104(b) of the CPSIA, 15 U.S.C. 

2056a(b), requires the Commission to: 

(1) Consult with representatives of 

consumer groups, juvenile product 

manufacturers, and independent child 

product engineers and experts, to 

examine and assess the effectiveness of 

any voluntary consumer product safety 

standards for durable infant or toddler 

products (15 U.S.C. 2056a(b)(1)(A)); and 

(2) promulgate, in accordance with 5 

U.S.C. 553, consumer product safety 

standards that are substantially the same 

as such voluntary standards, or are more 

stringent than such voluntary standards 

if the Commission determines that more 

stringent standards would further 

reduce the risk of injury associated with 

such products. 15 U.S.C. 2056a(b)(1)(B). 

Additionally, section 104(b)(2) of the 

CPSIA directs the Commission to 

periodically review and revise the 

standards set forth under this 

subsection, to ensure that such 

standards provide the highest level of 

safety for such products that is feasible. 

Section 104(d) of the CPSIA requires 

manufacturers of durable infant or 

toddler products to establish consumer 

registration card programs that comply 

with CPSC’s implementing rule, 16 CFR 

part 1130. Additionally, under section 

14 of the CPSA, children’s products 

(such as durable infant or toddler 

products) must comply with testing and 

certification requirements that CPSC 

implemented through 16 CFR parts 

1107, 1109, and 1110. Section 104(f)(1) 

of the CPSIA states that a ‘‘durable 

infant or toddler product’’ is a ‘‘durable 

product intended for use, or that may be 

reasonably expected to be used, by 

children under the age of 5 years.’’ Id. 

2056a(f)(1). Section 104(f)(2) of the 

CPSIA provides a non-exhaustive list of 

categories of products that are durable 

infant or toddler products, such as cribs, 

toddler beds, and bassinets and cradles. 

Id. 2056a(f)(2). The Commission’s 

consumer registration rule at 16 CFR 

1130.2(a) defines a ‘‘durable infant or 

toddler product’’ as: 

DEFINITION OF DURABLE INFANT OR 

TODDLER PRODUCT means the following 

products intended for use, or that may be 

reasonably expected to be used, by children 

under the age of 5 years. The listed product 

categories are further defined in the 

applicable standards that the Commission 

issues under section 104(b) of the Consumer 

Product Safety Improvement Act of 2008, and 

include products that are combinations of [17 

listed] product categories. . . . 

B. Infant Sleep Products Are Durable 

Infant or Toddler Products 

This rule establishes a category of 

products called ‘‘infant sleep products,’’ 

which are all products marketed or 

intended to provide a sleeping 

accommodation for an infant up to 5 

months of age, and that are not already 

subject to a mandatory CPSC sleep 

standard. The product category ‘‘infant 

sleep products’’ is not included in the 

statutory list of products in section 

104(f)(2) of the CPSIA. However, similar 

sleep products, such as bassinets and 

cradles, and cribs, are listed in the 

statute; and the Commission has the 

authority to add product categories to 

the statutory list. The Commission adds 

product categories to the list of ‘‘durable 

infant or toddler products’’ through a 

rulemaking to amend 16 CFR 1130.2, 

the Commission’s rule requiring durable 

infant or toddler products to meet 

consumer registration rule 

requirements. All durable infant or 

toddler products identified in § 1130.2 

must meet the product registration card 

requirement; and because rules issued 

under section 104 of the CPSIA are 

children’s product safety rules, these 

products must also meet the third-party 

testing and certification requirements in 

section 14 of the CPSA, and 

implemented by the Commission in 16 

CFR parts 1107, 1109, and 1110. 

CPSC issued a notice of proposed 

rulemaking in 2017 (the 2017 NPR), 

proposing to categorize infant inclined 

sleep products as a ‘‘durable infant or 

toddler product’’ under section 104 of 

the CPSIA, as a subset of the bassinet 

and cradle category. 82 FR 16963, 

16969–70 (Apr. 7, 2017). In 2019, CPSC 

issued a supplemental notice of 

proposed rulemaking (the 2019 SNPR), 

proposing to identify an ‘‘infant sleep 

product,’’ a broader category of infant 

sleep, as a durable infant or toddler 

product under section 104(f) of the 

CPSIA, also as a subcategory of 

bassinets and cradles. 84 FR 60949, 

60957 (Nov. 12, 2019). The 2019 SNPR 

proposed to remove the term ‘‘inclined’’ 

from the proposed mandatory standard, 

which included removing the term 

‘‘inclined’’ from the title, scope, 

introduction, and definitions of ASTM 

F3118–17a, and to include within the 

rule, instead: ‘‘any infant sleep product 

not currently covered by another 

mandatory rule for infant sleep 

products: Bassinets/cradles, cribs (fullsize and non-full-size), play yards, and 

bedside sleepers.’’ 84 FR at 60951. 

Accordingly, the 2019 SNPR proposed 

that the scope of the rule include two 

types of sleep products that are 

currently unregulated by CPSC under 

any mandatory standard, including 

inclined sleep products, meaning infant 

sleep products with a sleep surface 

angle greater than 10 degrees from 

horizontal, and flat (non-inclined) sleep 

products, meaning infant sleep products 

with a sleep surface angle equal to or 

less than 10 degrees. 

For this final rule, CPSC will finalize 

the definition of an ‘‘infant sleep 

product’’ as a durable infant or toddler 

product, a category of products that is 

a subset of the bassinet and cradle 

standard, consistent with the 2019 

SNPR. The final rule defines an ‘‘infant 

sleep product’’ as ‘‘a product marketed 

or intended to provide a sleeping 

accommodation for an infant up to 5 

months of age,’’ and that is not already 

subject to one of CPSC’s mandatory 

standards for infant sleep: 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 33023 

1ASTM International website: www.astm.org, 

‘‘About ASTM International.’’ 

• 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

• 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

• 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs 

• 16 CFR part 1221—Safety Standard 

for Play Yards, or 

• 16 CFR part 1222—Safety Standard 

for Bedside Sleepers. 

As defined in the final rule, an ‘‘infant 

sleep product’’ meets the definition of a 

‘‘durable infant or toddler product’’ 

because the products are intended for 

infants up to 5 months old, and the 

products are ‘‘intended for use,’’ and 

‘‘reasonably expected to be used,’’ by 

children under 5 years old. Moreover, 

products marketed or intended as a 

sleeping accommodation for an infant 

are similar to the products for infant 

sleep that are already included in the 

statutory list of durable infant or toddler 

products, such as cribs and bassinets 

and cradles. We also note that ‘‘infant 

sleep products’’ are further defined in 

the final rule, as provided in part 1130. 

Accordingly, adding ‘‘infant sleep 

products’’ as a durable infant or toddler 

product is consistent with the 

Commission’s approach of adding a 

durable infant or toddler product 

category that has a mandatory standard 

to the list of products in part 1130, to 

clarify that these products must meet 

the consumer registration rule, and the 

third-party testing and certification 

requirements for children’s product 

safety rules. 

C. Consultation Regarding the 

Effectiveness of the Voluntary Standard 

To meet the first requirement in 

section 104(b) of the CPSIA that the 

Commission consult with 

representatives of consumer groups, 

juvenile product manufacturers, and 

independent child product engineers 

and experts to examine and assess the 

effectiveness of the relevant voluntary 

standards, CPSC staff regularly 

participates in the juvenile products 

subcommittee meetings of ASTM 

International (ASTM). Staff’s 

participation in ASTM’s voluntary 

standards process includes providing 

anonymized incident data, participating 

in meetings to assess the ability of a 

voluntary standard to address the 

incident data, and working through the 

ASTM process to develop performance 

and labeling requirements to address 

identified hazards. Staff also comments 

or votes on certain ASTM ballots to 

revise voluntary standards. ASTM 

subcommittees consist of members who 

represent producers, users, consumers, 

government, and academia.1

In 2011, ASTM began work on a new 

standard for infant inclined sleep 

products. Development of this new 

ASTM standard for infant inclined sleep 

products, F3118, arose from efforts to 

update the voluntary standard for 

bassinets and cradles. Accordingly, 

staff’s consultation process for the 

inclined sleep product rulemaking 

commenced in approximately 2011, 

when ASTM, with CPSC’s concurrence, 

decided to separate hammocks and 

other inclined sleep products from the 

development of the bassinet standard, 

ASTM F2194, to develop a new 

voluntary standard that would 

specifically address the characteristics 

of inclined sleep products. For example, 

the bassinet standard requires a sleep 

surface angle of 10 degrees or less, and 

inclined products have a sleep angle 

greater than 10 degrees. Since then, staff 

has been actively participating in 

developing the voluntary standard for 

infant inclined sleep products. 

In addition to working on ASTM’s 

inclined sleep standard, staff also has 

been working with the ASTM 

subcommittee developing the bassinet 

standard since before 2011, and to this 

day, continues to provide incident data 

and participate in task group and 

subcommittee meetings, including 

meetings and ASTM ballots involving 

the currently unregulated flat sleep 

products within the scope of this final 

rule. 

Sections V.A.3 and V.B.2 of this 

preamble contain additional 

information about CPSC staff’s work on 

the products within the scope of the 

final rule, both inclined and flat sleep 

products, through the ASTM standards 

development process for the bassinet 

and cradle standard, the infant inclined 

sleep standard, and a new, unpublished 

standard for in-bed sleepers. 

D. 2017 NPR and 2019 Termination 

Notice 

When staff began working on the 

mandatory standard for bassinets and 

cradles, and participating with the 

ASTM standards development 

subcommittee, staff considered whether 

infant hammocks and other inclined 

sleep products should fall within the 

scope of the bassinet and cradle 

standard. Because the bassinets and 

cradles voluntary standard did not 

address products on the market that had 

a sleep incline greater than 10 degrees, 

the Commission directed staff to initiate 

a separate rulemaking effort for infant 

hammocks and other inclined sleep 

products, to address the characteristics 

of inclined products. Accordingly, the 

infant inclined sleep products safety 

standard was an outgrowth of the 

bassinet and cradle standard, intended 

to address products with an incline 

greater than 10 degrees from horizontal. 

In approximately 2011, at the time 

CPSC separated infant inclined sleep 

products from the bassinets and cradles 

standard, ASTM simultaneously began 

work on developing a voluntary 

standard for infant inclined sleep 

products. ASTM published the resulting 

infant inclined sleep products standard 

in May 2015, and updated the standard 

twice in 2016, and twice in 2017. 

ASTM’s latest standard for this product 

category is designated, ASTM F3118– 

17a, Standard Consumer Safety 

Specification for Infant Inclined Sleep 

Products (ASTM F3118–17a). 

CPSC’s 2017 NPR proposed a 

mandatory standard for infant inclined 

sleep products, incorporating by 

reference the then-current voluntary 

standard, ASTM F3118–17, with a 

modification to the standard’s definition 

of ‘‘accessory.’’ 82 FR 16964 (April 7, 

2017). The 2017 NPR for infant inclined 

sleep products, which included 

hammocks, discussed 14 fatal incidents 

related to infant inclined sleep 

products, which were reported to have 

occurred between January 1, 2005 and 

September 30, 2016. The 2017 NPR 

indicated that ASTM F3118–17 

addressed the primary hazard patterns 

CPSC identified in the 657 incidents 

(including 14 deaths), except for the 

definition of ‘‘accessory,’’ which was 

defined too narrowly to address 

potential hazards. Specifically, the 2017 

NPR proposed that CPSC’s standard 

would not include the term ‘‘rigid 

frame’’ in the definition of ‘‘accessory 

inclined sleep product’’ in section 3.1.1 

of ASTM F3118–17, broadening the 

definition to encompass a new product 

that did not have a rigid frame. Id. at 

16968–69, and 16975. The Commission 

concluded that for the mandatory 

standard, more stringent requirements 

were necessary to further reduce the risk 

of injury associated with infant inclined 

sleep products relating to the use of an 

inclined sleep product accessory. Id. at 

16967. 

As the 2017 NPR explained, durable 

infant or toddler products are children’s 

products that must be certified as 

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

2063(a); 82 FR at 16969. Certification 

must be based on testing conducted by 

a CPSC-accepted third party conformity 

assessment body (test laboratory). 15 

U.S.C. 2063(a)(2). CPSC must publish an 


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33024 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

2The October 16, 2019, Staff Briefing Package: 

Draft Supplemental Notice of Proposed Rulemaking 

for Infant Sleep Products under the Danny Keysar 

Child Product Safety Notification Act (Staff’s SNPR 

Briefing Package) is available at: https://

www.cpsc.gov/s3fs-public/SupplementalNoticeof

ProposedRulemakingforInfantSleepProducts_10_

16_2019.pdf?TPVAJZEQcz9x9sKeEGlt

m4LskkonxUWv. 

NOR for the accreditation of test 

laboratories to assess a product’s 

conformity with a children’s product 

safety rule. The 2017 NPR proposed that 

if issued as a final rule, the new Safety 

Standard for Infant Inclined Sleep 

Products, to be codified at 16 CFR part 

1236, would be added to the list of 

NORs for children’s product safety rules 

in 16 CFR part 1112, so that test 

laboratories applying for CPSC 

acceptance could seek accreditation to 

test inclined sleep products. 82 FR at 

16969. The 2017 NPR also proposed to 

amend 16 CFR part 1130, the 

Commission’s requirements for 

consumer registration for durable infant 

or toddler products, to amend the 

definition of ‘‘durable infant or toddler 

product’’ to clarify that infant inclined 

sleep products fall within the term, and 

are subject to the consumer registration 

card requirements. Id. at 16969–70. 

On June 12, 2019, CPSC staff 

submitted a briefing package and a draft 

Federal Register notice to the 

Commission, recommending that the 

Commission terminate the 2017 NPR. 

Staff recommended terminating the 

2017 NPR because, since issuing the 

2017 NPR, CPSC had received reports of 

42 additional fatalities associated with 

rocker-like inclined sleep products, and 

because the Commission had issued 

additional safety alerts and recalls 

involving infant inclined sleep 

products. To date, the Commission has 

not voted on the notice to terminate the 

2017 NPR. 

E. 2019 SNPR 

On October 16, 2019, staff provided 

the Commission with a briefing package 

recommending that instead of 

terminating the 2017 NPR, the 

Commission issue an SNPR. During the 

development of Staff’s 2019 SNPR 

Briefing Package, staff received reports 

of 451 new incidents; 59 were deaths 

that occurred in infant inclined sleep 

products. Commission staff contracted 

with Dr. Erin Mannen, Ph.D., a 

mechanical engineer with a 

biomechanics specialization, to conduct 

infant testing to evaluate the design of 

inclined sleep products. Tab B of the 

Staff’s 2019 SNPR Briefing Package 

contains Dr. Mannen’s study, 

Biomechanical Analysis of Inclined 

Sleep (Mannen Study).2

The Commission published an SNPR 

on November 12, 2019. 84 FR 60949. 

The 2019 SNPR proposed to issue a 

standard for ‘‘infant sleep products,’’ 

meaning products that (1) provide 

sleeping accommodations for infants 

and (2) are not currently subject to a 

CPSC mandatory standard for infant 

sleep: Bassinets/cradles, cribs (full-size 

and non-full size), play yards, and 

bedside sleepers (collectively, CPSC 

sleep standards). The 2019 SNPR 

proposed to incorporate by reference 

ASTM F 3118–17a, with modifications 

to require that for each infant sleep 

product: (1) The seat back angle 

intended for sleep must be equal to or 

less than 10 degrees from horizontal, 

and (2) must meet the requirements for 

a bassinet and cradle in the standard at 

16 CFR part 1218. 84 FR at 60956. The 

Commission also proposed to amend the 

consumer registration rule to identify 

‘‘infant sleep products’’ as a category of 

durable infant or toddler products under 

section 104(f) of the CPSIA, and 

proposed to amend the regulation at 16 

CFR part 1112, to add infant sleep 

products to the list of products that 

require third-party testing. Id. at 60957. 

F. Overview of the Final Rule 

For the final rule, the Commission is 

finalizing the requirements largely as 

proposed in the 2019 SNPR. The final 

rule incorporates by reference the 

voluntary standard, ASTM F3118–17a, 

Standard Consumer Safety 

Specification for Infant Inclined Sleep 

Products, with modifications to the 

introduction, scope, performance, and 

testing requirements, to further reduce 

the risk of injury associated with infant 

sleep products, both flat and inclined. 

The final rule requires that ‘‘infant sleep 

products,’’ defined as products 

marketed or intended to provide a 

sleeping accommodation for an infant 

up to 5 months of age, and that are not 

covered by a CPSC sleep standard, be 

tested to confirm the seat back/sleep 

surface angle is 10 degrees or less from 

horizontal, and meet the requirements 

of 16 CFR part 1218, Safety Standard for 

Bassinets and Cradles, including 

conforming to the definition of a 

‘‘bassinet/cradle.’’ The scope of the final 

rule is also consistent with this 

definition of an ‘‘infant sleep product.’’ 

The final rule specifies CPSC’s sleep 

standards as: 

• 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

• 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

• 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs 

• 16 CFR part 1221—Safety Standard 

for Play Yards, or 

• 16 CFR part 1222—Safety Standard 

for Bedside Sleepers. 

Products intended for sleep that already 

conform to a CPSC sleep standard in 

this list are not within the scope of the 

final rule. 

The scope of the final rule, and the 

definition of ‘‘infant sleep product,’’ are 

purposely broader than the scope of the 

bassinet and cradle standard, and the 

definition of a ‘‘bassinet/cradle,’’ to 

capture within the scope of the final 

rule all products marketed for infant 

sleep for infants up to 5 months old that 

are not covered by a CPSC sleep 

standard; those that are currently on the 

market, and any future products 

developed for this age group. CPSC’s 

intent is to set a baseline of safety for 

infant sleep products so that all of these 

products must, at a minimum, meet the 

performance and labeling requirements 

in 16 CFR part 1218, including 

conforming to the definition of a 

‘‘bassinet/cradle,’’ and being tested and 

certified as meeting these requirements. 

Based on the Commission’s review of 

inclined and flat sleep product incident 

data, and consideration of the comments 

on the 2017 NPR and the 2019 SNPR, 

the Commission is finalizing the 

requirements as proposed in the 2019 

SNPR, with the following clarifications 

in the: 

1. Scope of the final rule, 16 CFR 

1236.1, by removing the examples of 

infant inclined sleep products, and 

aligning the scope of the rule to be 

consistent with the definition of ‘‘infant 

sleep product,’’ to avoid confusion 

about the scope of the rule, which 

includes inclined and flat products; 

2. Introduction of ASTM F3118–17a, 

by explaining more clearly that both 

inclined and flat sleep products fall 

within the definition of an ‘‘infant sleep 

product,’’ and that the purpose of the 

rule is to reduce deaths associated with 

known infant sleep hazards, including, 

but not limited to, seat back or sleep 

surface angles that are greater than 10 

degrees from horizontal; 

3. Scope of ASTM F3118–17a, by 

revising section 1.3 to explain more 

clearly that inclined and flat products 

fall within the scope of the rule, and 

that products subject to the rule are 

infant sleep products that do not already 

meet a mandatory standard for a 

product intended for infant sleep. 

Consistent with the 2019 SNPR, revised 

section 1.3 lists existing infant sleep 

standards, but the final rule lists the five 

CPSC sleep standards with a reference 

to the ASTM standard incorporated by 

reference in each mandatory standard; 

4. Scope of ASTM F3118–17a, by 

adding a new section 1.3.2 stating that 


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3Note that in the 2019 SNPR the Commission 

proposed to revise these terms by removing the 

word ‘‘inclined.’’ 

crib mattresses that meet the voluntary 

standard for crib mattresses, ASTM 

F2933, are not included within the 

scope of the rule. The final rule does not 

cover a crib mattress because a crib 

mattress is not used by itself, and 

instead, is used as the sleep surface in 

a crib, a product that already must 

conform to a CPSC sleep standard; 

5. Referenced documents in ASTM 

F3118–17a, by revising section 2.1 to 

add the voluntary standard for crib 

mattresses, ASTM F2933; 

6. Definition of ‘‘infant sleep product’’ 

in ASTM F3118–17a, by revising section 

3.1.7 to remove the phrases 

‘‘freestanding’’ and ‘‘generally 

supported by a stationary or rocker 

base’’ from the definition, to not 

inadvertently exclude certain infant 

sleep products from the scope of the 

rule, such as those that may not initially 

have a base, or may be sold as an 

attachment to another product. 

Additionally, we revised the age limit in 

this definition from ‘‘approximately 5 

months of age’’ by removing the term 

‘‘approximately.’’ This revision is 

intended to reduce confusion about 

which products fall within the scope of 

the rule, and to clarify that any infant 

sleep product marketed or intended for 

an infant up to 5 months of age, and that 

is not already covered by a CPSC sleep 

standard, falls within the scope of the 

final rule; 

7. Definitions in ASTM F3118–17a, by 

revising section 3.1 to remove the 

definitions for ‘‘accessory inclined sleep 

product,’’ ‘‘compact inclined sleep 

product,’’ and ‘‘newborn inclined sleep 

product,’’ to simplify the regulation text, 

because these definitions are 

unnecessary based on the other 

modifications made to ASTM F3118– 

17a in the final rule, and because these 

products are subsumed within the 

definition of an ‘‘infant sleep product,’’ 

and the final rule does not contain any 

unique requirements for these 

products; 3

8. Requirements in ASTM F3118–17a, 

by revising section 6.9 to remove 

separate ‘‘Maximum Seat Back Angle’’ 

tests for three product types (accessory, 

compact, and newborn), and leaving 

only the test for ‘‘infant sleep products,’’ 

because all products fall within the 

definition of an ‘‘infant sleep product’’ 

in the final rule, and because this test 

is the same for all products; 

9. Requirements in ASTM F3118–17a, 

by revising section 6.9 and 6.9.1 to more 

accurately describe the name of the test 

by clarifying that the seat back angle 

also refers to a ‘‘sleep surface angle.’’ 

This revision is intended to reduce 

confusion, because flat sleep surfaces do 

not have a seat back; and 

10. Requirements in ASTM F3118– 

17a, by revising section 6.9.3 to remove 

the references to accessory, compact, 

and newborn sleep products, and to 

state that infant sleep products must 

meet the requirements of 16 CFR part 

1218, Safety Standard for Bassinets and 

Cradles, including conforming to the 

definition of a bassinet/cradle. This 

revision is intended to streamline the 

regulation text to reduce confusion, and 

to add a specific requirement to meet 

the definition of a bassinet, which 

clarifies that infant sleep products must 

have a stand to meet the performance 

and labeling requirements in part 1218. 

The Commission is also finalizing the 

amendment to part 1112, to include 

‘‘infant sleep products’’ in the list of 

children’s product safety rules for 

which CPSC has issued NORs, as well 

as the amendment to part 1130, to 

identify ‘‘infant sleep products’’ 

specifically as a subcategory of bassinets 

and cradles. 

This final rule is based on information 

and analysis provided in Staff’s Final 

Rule Briefing Package, submitted to the 

Commission on May 12, 2021, which 

can be found on the Commission’s 

website at: https://www.cpsc.gov/s3fspublic/FinalRuleSafetyStandardfor

InfantSleepProducts.pdf

?7s3LjLlkZ4Vm_0GWP2.vstoEzBylG8xg. 

II. Product Description 

A. Scope of Products Within the Final 

Rule 

The scope of products covered by the 

2017 NPR tracked the scope of ASTM 

F3118–17, covering ‘‘a free standing 

product with an inclined sleep surface 

primarily intended and marketed to 

provide sleeping accommodations for an 

infant up to 5 months old or when the 

infant begins to roll over or pull up on 

sides, whichever comes first.’’ The 

scope of products covered by the 2019 

SNPR broadened from the 2017 NPR, 

proposing to incorporate by reference 

ASTM F3118–17a with substantial 

modifications, including revisions in 

the scope of the standard, section 1.3, to 

remove the term ‘‘inclined,’’ and to 

include any infant sleep product not 

currently covered by another CPSC 

mandatory rule for a product intended 

for infant sleep: Bassinets/cradles, cribs 

(full-size and non-full-size), play yards, 

and bedside sleepers. 84 FR at 60951. 

For the final rule, the scope of 

products that fall within the rule is 

consistent with the 2019 SNPR, and 

includes all of the inclined sleep 

products in the 2017 NPR, plus 

additional products marketed or 

intended to provide a sleeping 

accommodation for an infant up to 5 

months of age, and that are not currently 

covered by any of the five CPSC sleep 

standards. Accordingly, as proposed in 

the 2019 SNPR, the final rule includes 

the currently unregulated inclined sleep 

products, such as frame-type inclined 

sleep products, hammocks, compact 

inclined sleep products, and accessory 

inclined sleep products (collectively, 

inclined sleep products). The final rule 

also includes the currently unregulated 

non-inclined, flat, infant sleep products, 

which means products with a seat back 

or sleep surface angle that is already 10 

degrees or less from horizontal (i.e., 

baby boxes, in-bed sleepers, baby nests 

and pods, rigid-sided and rigid-framed 

compact bassinets without a stand or 

legs, various designs of ‘‘travel 

bassinets’’ with soft padded or mesh 

sides, and baby tents (collectively, flat 

sleep products)). 84 FR at 60951. Tabs 

C and E of Staff’s Final Rule Briefing 

Package contain additional information 

and characteristics, as well as pictures 

of the infant sleep products subject to 

the final rule. 

B. Products Excluded From the Scope of 

the Final Rule 

Consistent with the 2019 SNPR, for 

the final rule, products with inclined or 

adjustable seat back positions that are 

covered by other CPSC standards, such 

as infant bouncer seats, strollers, handheld carriers, frame carriers, and infant 

swings, are excluded from the scope of 

the ASTM infant inclined sleeper 

standard, and they are also excluded 

from the scope of the final rule, unless 

the product is specifically marketed for 

infant sleep for an infant up to 5 months 

of age. Id. at 60951–52. If a product’s 

packaging, marketing materials, inserts, 

or instructions indicate that the product 

is for sleep, or includes pictures of 

sleeping infants, then CPSC will 

consider the product to be marketed for 

sleep. 

Products that are already compliant 

with another CPSC sleep standard, such 

as the bassinet standard (16 CFR part 

1218), or the crib standard (16 CFR part 

1219), are excluded from the scope of 

the final rule. Sleep wedge pillows and 

sleep positioners are out of scope for the 

final rule, and may be covered by Food 

and Drug Administration (FDA) 

regulations as medical devices, if they 

are marketed to treat a medical 

condition, such as acid reflux. Infant 

pillows are also out of scope for the 

final rule, and these products are subject 

to 16 CFR § 1500.18, ‘‘Banned toys and 

other banned articles intended for use 


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4Tab E of Staff’s Final Rule Briefing Package 

contains CPSC staff’s analysis of the market for 

infant sleep products. 

5Tab D of Staff’s Final Rule Briefing Package 

contains CPSC staff’s analysis of the hazards 

associated with bed-sharing. 

6The recalled inclined products alone had sales 

of nearly 6.5 million from May 2010 to August 

2019. Assuming that the recalled products 

represented most of the market, 6.5 million divided 

by 9 years is 722,000. 

7https://www.cdc.gov/nchs/nvss/births.htm. 

8https://travel.state.gov/content/travel/en/ 

Intercountry-Adoption/adopt_ref/adoptionstatistics-esri.html. 

by children.’’ Hammocks intended as 

photo props are out of scope for the 

final rule. Hammock accessories 

intended for shopping carts are also not 

in scope, as those products are not 

intended for infant sleep. Bath chairs 

with inclined backs are out of scope, as 

they are covered by another standard 

and are not intended for infant sleep. 

Pet beds, toy hammocks, and play tents 

labeled for children over 5 months are 

out of scope of the final rule. Loungers, 

floor chairs, and rockers are out of scope 

of the final rule, unless they are 

marketed for infant sleep on the product 

itself or its packaging, marketing 

materials, inserts, or instructions, or the 

product is advertised with pictures of 

sleeping infants. 

Finally, in response to a comment on 

the 2019 SNPR, the Commission 

specifically is excluding from the scope 

of the final rule crib mattresses that fall 

within the scope of the voluntary 

standard for crib mattresses, ASTM 

F2933. A crib mattress, alone, does not 

meet the definition of an ‘‘infant sleep 

product,’’ and is always used in 

conjunction with a sleep product, such 

as a crib or play yard, that falls within 

one of CPSC’s sleep standards. The 

Commission issued a notice of proposed 

rulemaking for crib mattresses in 2020, 

and intends to finalize a separate rule 

later this fiscal year, providing 

performance and labeling requirements 

for crib mattresses, based on ASTM 

F2933. 

C. Market Description 4

Infant sleep products covered by this 

rule may be purchased at general 

retailers, online retailers, mattress and 

bedding stores, and baby specialty 

stores. At least 60 small U.S.-based 

manufacturers and importers are in this 

market, as well as five large domestic 

companies, and dozens of foreign 

companies, some that ship these items 

directly to customers in the United 

States via online marketplaces. More 

than a thousand home-based 

manufacturers, hundreds based in the 

United States, sell soft-sided baby nests 

and pods, in-bed sleepers, and infant 

hammocks directly to consumers via 

online marketplaces and as third-party 

sellers via major retailers’ websites. We 

estimate total sales in this market at 

more than $125 million per year, to at 

least a third of U.S. households with 

newborns. 

Products within the scope of the final 

rule compete with products for infant 

sleep that are compliant with one of 

CPSC’s sleep standards and with other 

small, portable products that are not 

marketed for sleep. One goal of the final 

rule is to make it clearer to consumers 

which products are certified as 

compliant with a CPSC sleep standard, 

regardless of the product name or 

advertising. 

The proliferation of physically 

different products with similar names 

(particularly ‘‘bassinets’’), the many 

suppliers in the market, and new 

product types each season, reflect a 

competitive market for innovative sleep 

products. New sleep products are 

marketed as filling a need for a small, 

portable sleeping or napping space. 

Many items are also marketed 

specifically to facilitate bed-sharing.5 In 

addition to the marketing as secondary 

sleeping options, some of these compact 

and relatively inexpensive sleep 

products are also marketed as primary 

sleep spaces for families with limited 

living space and budget. Baby boxes, inbed sleepers, and hammocks, in 

particular, are marketed as primary 

sleep spaces for babies. 

CPSC did not find any evidence that 

consumer demand for compact, 

inexpensive, and portable sleep spaces 

cannot be met by products compliant 

with an existing CPSC sleep standard. 

Many small bassinets that are compliant 

with CPSC’s bassinet standard sell for 

$50 to $75 and have a footprint similar 

to the flat sleep products covered by this 

rule. As for bed-sharing, bedside 

sleepers retail for as little as $100. 

Cradles compliant with the bassinet and 

cradle standard have a swinging 

function similar to a hammock with a 

frame, often at a lower retail price. 

Innovative products compliant with the 

existing CPSC sleep standards have 

been introduced in recent years, 

including small, foldable play yards, 

oval cribs and bassinets, bassinets that 

are attached to an adult chair, bassinets 

with rocking functions, and bedside 

sleepers with a rocking base. 

1. Inclined Sleep Products 

The 2019 SNPR described four types 

of inclined sleep products within the 

scope of the rule: Frame-type inclined 

sleep products, hammocks, compact 

inclined sleep products, and accessory 

inclined sleep products. 84 FR at 60951. 

We update the market for these products 

below, grouping frame-type, compact, 

and accessory inclined products into 

one category, and hammocks into 

another category. 

(a) Hard-Frame Inclined Sleepers, 

Compact Foam Inclined Sleepers, and 

Play Yard Accessories 

Freestanding, inclined hard-frame 

sleepers retail for $40 to $120, 

depending on brand and features, such 

as attached toys, fabric coverings, 

battery-operated sounds, and adjustable 

positions. Compact foam inclined 

sleepers retail for about $100. Hardframe inclined play yard accessories are 

not sold separately; they are included in 

the price of the play yard. 

In recent years, sales of inclined 

sleepers have totaled at least 722,000 

units per year.6 The sales of these 

products alone total nearly a quarter of 

all households with newborn infants, 

given that just under 3.8 million live 

births occurred in the United States in 

2018.7 Additionally, more than 4,000 

adoptions from foreign countries 

occurred, but most of those infants were 

at least 1-year-olds by the time the 

adoption was finalized.8 We assume 

that some of the market for inclined 

sleepers has shifted to other flat sleep 

product categories covered by this rule, 

or shifted to small portable sleep 

products compliant with existing CPSC 

sleep standards. Since the CPSC 

published the NPR in 2017, some 

inclined sleep products have been 

recalled or otherwise removed from the 

market. However, although reselling 

recalled products is prohibited, 

discontinued items sold on the 

secondary market that have not been 

recalled, as well as non-recalled 

physically similar products sold by 

small companies, are still available. 

(b) Baby Hammocks 

Hammocks range in price from about 

$50 for a simple fabric hammock 

without a frame, to more than $300 for 

a hammock with a wooden or metal 

stand. Crib hammocks, which are 

intended to attach to cribs or play yards 

of any brand, retail for about $50 to 

$100. 

Baby hammocks are widely available 

from small domestic companies, 

importers, and home-based sellers. The 

websites of several major general 

retailers sell these items from thirdparty sellers. Hammocks are made of a 

variety of fabrics and may include 

padded sides or bottoms. They may 

come without a frame, or with a wooden 


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9This number is approximate, as the proliferation 

of internet retailing allows importers to enter and 

exit the market quickly, and to switch their product 

line based on demand. 

10A public comment on the SNPR estimated the 

annual sales of ‘‘in-bed sleep products’’ at 500,000 

to 1.5 million units, which is consistent with the 

estimates in the DNPES and from CDC on 

prevalence of bed-sharing. 

11Bombard JM, Kortsmit K, Warner L, et al., Vital 

Signs: Trends and Disparities in Infant Safe Sleep 

Practices—United States, 2009–2015. MMWR Morb 

Mortal Wkly Rep 2018;67:39–46. DOI: http://

dx.doi.org/10.15585/mmwr.mm6701e1. 

or metal stand. Some items are solid 

fabric, while others are mesh or crochet. 

The market is fragmented, and all of the 

sellers in the United States are small 

companies, although some sellers are 

importers of items made by large foreign 

companies. The large number of sellers, 

including at least one company that 

sells only baby hammocks, and dozens 

of home-based sellers, suggests that 

thousands of baby hammocks are sold 

each year. 

2. Flat Sleep Products 

(a) Flat Sleep Surface, Soft-Sided 

Products 

The flat sleep surface, soft-sided 

products that are not covered by a CPSC 

sleep standard include baby pods or 

baby nests, which are marketed for use 

on a hard surface or as in-bed sleepers, 

and soft-sided ‘‘bassinets.’’ Some softsided products are marketed for use 

inside a crib or bassinet. Some sleep 

products are marketed as portable or 

travel infant beds. The flat infant sleep 

products currently not covered by any 

voluntary or mandatory sleep standard, 

but would be regulated under the final 

rule, include: 

• Baby pods and baby nests—These 

products have a soft floor, usually 

padded in some way, with low soft 

fabric or mesh sides, resembling a 

small pet bed. They can be 

rectangular, oval, or figure 8-shaped. 

Some come with a wedge pillow. 

They are sometimes marketed as 

suitable for use inside a crib or play 

yard. 

• Soft-sided ‘‘travel bassinets’’ or 

‘‘travel beds’’—These products can 

have either a soft or semi-rigid floor. 

Some products come with straps and 

zippers so that they can be rolled up 

and carried like a backpack when not 

in use. Some are marketed as ‘‘3-in-1’’ 

products that can also be used as a 

changing mat and include pockets for 

diapers. Some products have a 

‘‘cocoon’’ design, with a soft padded 

top, intended to cover the body of the 

occupant. 

• Hand-held carriers marketed for 

sleep—These products are marketed 

as both a hand-held carrier and a 

(soft) bassinet, suitable for napping or 

sleeping. 

• In-bed sleepers—These products have 

low, soft sides and a soft floor, 

specifically intended and marketed 

for bed-sharing. 

Play yard accessories have mesh or 

fabric sides that attach to the rails of the 

play yard and are marketed for infant 

sleep, including ‘‘napping’’; and they 

would not fall within the scope of the 

rule if they are already compliant with 

the bassinet standard. Items marketed as 

changing pads are not considered to be 

infant sleep products. 

The prices for baby nests, baby pods, 

and in-bed sleepers range from about 

$40 to $200, with the lower-priced items 

tending to come from home-based 

manufacturers and foreign direct 

shippers, and the more expensive items 

coming from larger U.S. companies. 

Smaller products intended only for 

infants up to 5 months of age also tend 

to be cheaper than larger products 

intended for children up to 2 years old. 

The various soft-sided travel bassinets 

and ‘‘travel beds,’’ some that fold up 

into a backpack, have a similar price 

range. At least 30 small businesses, 

mostly importers, sell the soft-sided flat 

sleep surface products.9 Dozens of 

foreign companies ship these sleep 

products directly to U.S. customers via 

U.S. Internet retailers, and there are 

more than 1,000 home-based sellers of 

baby pods and baby nests. 

The estimated annual sales of in-bed 

sleepers alone are 1 million units,10

based on public comment and staff 

analysis. The Durable Nursery Products 

Exposure survey (DNPES) indicated that 

38 percent of parents slept with their 

child under 1 year of age at least once 

a week, with 18 percent indicating they 

sleep with their child under 1 year of 

age every night. The CDC similarly 

found 11 that 24.4 percent of parents 

bed-shared with their infant ‘‘often or 

always’’ and 37 percent indicated they 

bed-shared ‘‘rarely or sometimes.’’ If 

parents who regularly sleep with their 

infants commonly purchase or make a 

soft-sided baby nest or other type of inbed sleeper, then these products could 

be owned by 25 percent of households 

with newborns, representing about 1 

million units sold per year, which is 

consistent with the estimate from a 

public comment on the 2019 SNPR. 

(b) Flat Sleep Surface, Rigid-Sided and 

Rigid-Framed Compact Bassinets, Travel 

Bassinets, and Similar Products 

This infant sleep product category 

includes flat sleep surface, free-standing 

products that resemble a bassinet 

without a stand or legs. Baby boxes and 

other rigid-sided products without a 

stand are marketed for infant sleep, 

sometimes as ‘‘compact’’ or ‘‘travel’’ 

bassinets. Some compact bassinets have 

mesh sides with a rigid metal or plastic 

frame. Larger rigid-sided items that 

comply with the play yard standard, 

and play yard accessories that are 

compliant with the bassinet standard, 

are out of scope for the final rule. Most 

flat sleep surface, rigid-sided products 

are rectangular, but oval and round ones 

are also available. As noted, some flat, 

soft-sided items are also marketed as 

‘‘travel’’ bassinets. The term ‘‘bassinet’’ 

is used in product names for rigid-sided 

items with a stand that meet CPSC’s 

bassinet standard, but the term is also 

used in product names of flat and 

inclined items without a stand, some 

with low and soft padded sides, which 

do not meet the bassinet standard. The 

final rule addresses this issue, and, in 

part, is intended to make it clearer to 

consumers which products are safe for 

infant sleep, regardless of the product 

name. 

Rigid-sided and rigid-framed compact 

bassinets and travel bassinets typically 

sell for about $50 to $150, which is 

comparable to the lower end of the price 

range of bassinets that comply with the 

bassinet standard. Retail prices for baby 

boxes start at about $50 to $75, 

depending on the brand and decorative 

design, although some are sold only as 

part of a $300, or more, bundle with 

clothes, diapers, and other baby items. 

Baby boxes were given away for free by 

some state governments and hospitals, 

so the cost to the consumer was $0, 

although those organizations purchased 

them from a small domestic company 

that is no longer offering them. Play 

yard accessories are not priced or sold 

separately; rather, they are included in 

the price of the play yard. 

Products in this category have a 

variety of names. Several small 

domestic manufacturers and small 

importers, as well as large domestic and 

foreign companies, sell small, rigidsided or rigid-framed products that 

resemble a bassinet without a stand as 

‘‘compact,’’ ‘‘portable,’’ or ‘‘travel’’ 

bassinets, or as infant ‘‘travel beds.’’ 

About a dozen sellers ship these 

products from the United States, and a 

few foreign companies sell through 

internet marketplaces. The presence of 

several large domestic and foreign 

companies in this market, as well as 

introductions of innovative products 

each year, indicate that a strong 

consumer demand for these products. 

CPSC believes it likely that some of the 

demand for inclined rigid-sided 

products has shifted to this market 

sector. Unlike the soft-sided products, 


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12A public comment estimated 2018 sales from 

two of the three U.S. baby box companies at more 

than 10,000. 13Similar programs now offer free cribs or play 

yards. 

this sector does not have many homebased businesses or foreign direct 

shippers. 

Baby boxes are a sub-type of compact 

bassinet that are made of cardboard. 

They are sold in the United States by 

two small domestic companies and one 

foreign company and can also be 

purchased directly from several foreign 

companies. The sales are relatively 

small; estimated at under 20,000 per 

year.12 This means that less than 1 

percent of households with newborns 

purchase these items. Baby boxes are 

sometimes marketed as ‘‘Finnish’’ baby 

boxes, because the government of 

Finland provides new parents with a 

baby box or cash equivalent. As noted, 

in the past, some state and local 

hospitals gave away baby boxes to new 

parents or made them widely available 

through social service agencies.13 Like 

other compact bassinets, baby boxes are 

marketed as a primary sleep 

environment for newborns. 

(c) Baby Tents 

Baby tents, which are a small mesh or 

solid fabric products with a fabric floor 

are marketed for sun protection, play, 

and baby sleep. They are sometimes 

marketed as a combination of tent and 

‘‘travel bed’’ or ‘‘travel bassinet.’’ Some 

baby tents come with flaps, covers, or 

shades so that the baby can sleep in 

darkness. Some products come with 

poles or stakes to fasten the tent to the 

ground or in the sand at the beach. 

Some tents have a shallow fillable pool/ 

sandbox in the bottom, which indicates 

they are not intended primarily for 

sleep, but rather, for play. 

Baby tents retail for about $20 to $75; 

larger and more expensive tents are 

available, but they are marketed for 

older children. Baby tents are offered for 

sale on major internet general retailer 

websites and in general retail stores by 

about a dozen small importers and a few 

large companies. Dozens of foreign 

companies ship these baby tents directly 

to U.S. customers via U.S. Internet 

retailers; the majority of suppliers in 

this category are foreign direct shippers. 

Baby tents are marketed as a specialty 

item for outdoor use, particularly beach 

trips or camping, to shade the baby from 

sun and provide a place for playing and 

sleeping. Indoor ‘‘play’’ tents are also 

marketed for sleep, but those products 

are mostly marketed for children over 3 

years of age. Indoor play yards with 

tent-like covers are in the scope of the 

play yard standard. Although baby tents 

are a relatively niche product, compared 

to some of the other types of sleepers, 

there appears to be sufficient demand 

for baby tents to support the market 

presence of dozens of companies, 

including a few large companies selling 

a variety of other baby products. 

III. Incident Data and Hazard Patterns 

A. Inclined Sleep Products 

1. Incident Data 

The 2017 NPR discussed 14 fatal 

incidents related to inclined sleep 

products, which were reported to have 

occurred between January 1, 2005 and 

September 30, 2016. Eight of the 14 

deaths involved rocker-like inclined 

sleep products; in three cases, the 

unstrapped decedent was found to have 

rolled over into a facedown position. 

Two additional cases also reported a 

rollover into a facedown position, but 

the reports did not include any 

information about the use of a restraint. 

CPSC had little information about the 

cause or manner of the three remaining 

deaths. The 2017 NPR recognized that 

reporting was ongoing and that the 

number of reported fatalities could 

change. 82 FR at 16965–66. 

The 2019 SNPR updated fatal and 

nonfatal incident reports associated 

with the use of an inclined sleep 

product. At the time of the 2019 SNPR, 

CPSC was aware of 451 incidents (59 

fatal and 392 nonfatal) related to 

inclined sleep products that occurred 

from January 1, 2005 through June 30, 

2019, and reported between October 1, 

2016 and June 30, 2019. This count 

included incidents reported after the 

reporting end date stated in the 2017 

NPR. Forty-three percent of the incident 

reports (196 out of 451) were based 

solely on information from 

manufacturers/retailers. Various 

sources, such as hotlines, internet 

reports, newspaper clippings, medical 

examiners, and other state/local 

authorities provided the remaining 

incident reports to CPSC. 84 FR at 

60952–53. Tab A of the October 16, 

2019 Staff SNPR Briefing Package 

describes the incident data and the 

hazard patterns associated with infant 

inclined sleep products at the time of 

the SNPR. 

For the final rule, the Directorate for 

Epidemiology staff, Tab B of Staff’s 

Final Rule Briefing Package, describes 

71 new incident reports associated with 

inclined sleep products since the 2019 

SNPR. Of the 71 new reported incidents, 

10 are fatalities; among the remaining 61 

nonfatal incidents, 17 reported an 

injury. Reporting is ongoing, and 

therefore, the number of reported 

fatalities, nonfatal injuries, and noninjury incidents may change in the 

future. 

(a) Fatalities 

Since the 2019 SNPR, the 

Commission is aware of 10 fatalities 

associated with the use of an inclined 

sleep product that reportedly occurred 

during the period from January 1, 2019 

through December 31, 2020. 

• Three of the 10 fatal reports 

describe infants placed supine (on their 

back) in a rocker-like sleeper product, 

but who ended up rolling over, fully or 

partially, resulting in suffocations or 

positional asphyxiations. Staff does not 

know whether a restraint was used in 

any of these cases. All three decedents 

were 3- or 4-month-old infants. 

• One report describes a fatality 

involving a foam-type reclined infant 

seat. The seat was placed on an adult 

bed, where the parents were also asleep. 

The seat was found tipped over on the 

floor, with the 4-month-old decedent 

found underneath the seat. 

• One incident reports a fatality of a 

3-month-old infant, found supine in an 

infant rocker-like product (in the same 

position as originally placed) with a 

blanket covering the infant’s face. 

• Five remaining fatality reports 

provide very little information on the 

incidents. Lack of any information on 

the circumstances leading up to the 

death does not allow CPSC staff to 

classify these deaths. Of the known 

ages, the decedents ranged in age from 

1 to 6 months old. 

(b) Nonfatal Incidents 

Since the 2019 SNPR, the 

Commission has received reports of 61 

nonfatal incidents associated with the 

use of an inclined sleep product that 

occurred between January 1, 2019 and 

December 31, 2020. Among these 61 

reports, 17 reports involved an injury. 

We describe the severity of the 17 

injuries below: 

• Four infants required hospital 

admission. Three of the hospitalizations 

were for respiratory problems due to 

mold on the sleep product, and one was 

for treatment of injuries from a fall 

when an accessory-type product 

collapsed. 

• Three infants were treated and 

released from emergency departments. 

Those infants were treated for 

respiratory problems from exposure to 

mold or for fall injuries. 

• Ten infants required other medical 

care, mostly for plagiocephaly (flat head 

syndrome), torticollis (twisted neck 

syndrome), or both conditions, which 

were associated with prolonged use of 

inclined sleep products; two of the 10 


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infants suffered minor bumps/bruises 

due to falls or near falls. 

The remaining 44 incidents reported 

no injuries, or provided no information 

about any injury. However, many of the 

descriptions indicated the potential for 

a serious injury, or even death. Thirtyfour percent of the incidents involved 

infants 0 to 5 months of age, and 9 

percent involved infants 6 months to 12 

months of age. CPSC does not know the 

infant’s age in 58 percent of the 

incidents. 

2. Hazard Patterns 

The 2017 NPR identified nine hazard 

patterns among the 657 reported 

incidents associated with inclined sleep 

products. These hazard patterns 

included: Design issues, lack of 

structural integrity, inadequate 

restraints, electrical issues, nonproduct-related or unknown issues, 

difficulty with correct positioning, 

miscellaneous product-related issues, 

unspecified falls, and consumer 

comments. 82 FR at 16965–66. 

For the 2019 SNPR, CPSC staff 

considered all 451 reported incidents 

(59 fatal and 392 nonfatal) to identify 

hazard patterns associated with inclined 

sleep products; and staff described the 

variety of sleep products considered, 

such as: Hammocks, which are 

suspended in air, seat-like products 

meant to be placed on a floor level (yet 

incident reports indicate these products 

often were not placed on floor level), 

and products that sit on top of larger 

nursery products as attachments. CPSC 

staff identified eight hazard patterns 

among 451 reported incidents in the 

2019 SNPR, which differed, depending 

on which product was involved, and 

how the product was being used: Design 

issues, electrical issues, consumer 

comments, undetermined issues (due to 

confounding information), structural 

integrity issues, other product-related 

issues, infant placement issues, and 

insufficient information. Staff’s 

identified hazard pattern categories 

were very similar between the 2017 NPR 

and the 2019 SNPR. 84 FR at 60952–53. 

For the final rule, staff again reports 

that the staff-identified hazard 

categories for inclined sleep products 

are very similar to those identified in 

the 2019 SNPR. Following a CPSCissued safety recall on inclined sleep 

products in April 2019, staff observed a 

surge of reports related to the recall; 

these reports are combined with other 

consumer comments in the hazard 

categories. Staff identified the following 

hazard patterns among the 71 reported 

incidents (10 fatal and 61 nonfatal) 

associated with the use of infant 

inclined sleep products. The categories 

are presented in descending order of 

frequency: 

(a) Consumer comments: Thirty-one 

of the 71 reported incidents (44 percent) 

fall into this category. The reports 

consist of consumer comments/ 

observations of perceived safety 

hazards, complaints about unauthorized 

sale of infant inclined sleep products, or 

inquiries regarding the April 2019 safety 

recall on inclined sleep products. 

Although one complaint describes a 

minor injury incident, none of the 

remaining reports indicate that an 

incident actually occurred. 

(b) Design of the inclined sleep 

product: Twenty-four of the 71 reported 

incidents (34 percent) fall into this 

category. 

(i) Ten incidents report that infants 

rolled over—fully or partially—from 

their original supine (on their back) 

position. Although a few of the infants 

were strapped into the product, for 

others, whether a restraint was used is 

unreported. Reports describe infants as 

young as 1 month of age rolling over. 

Some parents/caregivers, who witnessed 

and reported some of the nonfatal 

incidents, were able to rescue distressed 

infants quickly; some of the other 

infants died due to suffocation or 

asphyxiation. 

(ii) One infant stopped breathing 

temporarily, due to difficulty 

positioning his head correctly. 

(iii) Eight incidents report that infants 

developed physical deformations, such 

as plagiocephaly (flat head syndrome) 

and/or torticollis (twisted neck 

syndrome), from extended product use. 

(iv) According to five reported 

incidents, infants developed respiratory 

ailments due to the growth of mold on 

the product. 

The design category includes three 

deaths, three hospitalizations, one ED 

visit, and eight non-hospitalized, nonED injuries. 

(c) Other product-related issues: Four 

of the 71 incidents (6 percent) report 

other product-related issues, such as 

instability (posed by products that have 

completely or nearly flipped over) or 

lock/latch problem (i.e., the sleep 

surface failed to remain in position 

during use). One of the three instability 

incidents was a fatality that occurred 

when a foam-type reclined seat tipped 

over and fell from the adult bed to the 

floor, trapping the decedent underneath. 

No injury is reported in this category. 

(d) Lack of structural integrity: Three 

of the 71 incidents (4 percent) report 

components breaking, such as the rail, 

hardware, or other unspecified part. 

This category includes one 

hospitalization and one non-ED-treated 

injury due to a fall. 

(e) Electrical issue: One of the 71 

incidents (1 percent) describes an odor 

emanating from the product after a short 

period of use indicative of overheating; 

further investigation revealed molten 

plastic inside. No injury is reported. 

(f) Non-product-related issues: One of 

the 71 incidents (1 percent) reports a 

fatality in an unsafe sleep environment. 

A 3-month-old was placed supine (on 

their back) in an infant rocker-like 

product with a blanket covering the 

face; the decedent was found in the 

same position, with the blanket still 

covering the face. 

(g) Insufficient information: Seven of 

the 71 incident reports (10 percent) 

contain insufficient information for staff 

to categorize them accurately. For five 

deaths, staff has no information on the 

circumstances of the deaths. Reports for 

two injuries in this category describe 

unspecified falls treated in hospital EDs, 

with no information on restraint usage. 

Table 1 presents the distribution of 

the 71 reported incidents by hazard 

patterns and severity of incidents. 

TABLE 1—HAZARD PATTERNS AND INCIDENT SEVERITY ASSOCIATED WITH INFANT INCLINED PRODUCTS 2019–2020 

INCIDENTS

[Reported since 2019 SNPR] 

Issues 

Total incidents Deaths Injuries 

Count Percentage Count Percentage Count Percentage 

Product-Related ...................................... 63 89 4 40 15 88 

Comments/Concerns ....................... 31 44 ........................ ........................ 1 6 

Design .............................................. 24 34 3 30 12 71 

Other Product-Related ..................... 4 6 1 10 ........................ ........................

Structural Integrity ........................... 3 4 ........................ ........................ 2 12 


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14According to the NEISS publication criteria, an 

estimate must be 1,200 or greater, the sample size 

must be 20 or greater, and the coefficient of 

variation must be 33 percent or smaller. 

15 In the reports received by CPSC, consumers 

referred to flat sleep products as ‘‘cribs,’’ 

‘‘bassinets,’’ ‘‘cosleepers,’’ ‘‘cribettes,’’ ‘‘nests,’’ 

‘‘pads,’’ or ‘‘positioners.’’ Because of the variety of 

terms used by consumers to describe these 

products—often unfamiliar to CPSC staff—staff’s 

data search for this analysis was challenging, and 

staff believes it is possible that some relevant 

reports may have been missed. 

TABLE 1—HAZARD PATTERNS AND INCIDENT SEVERITY ASSOCIATED WITH INFANT INCLINED PRODUCTS 2019–2020 

INCIDENTS—Continued 

[Reported since 2019 SNPR] 

Issues 

Total incidents Deaths Injuries 

Count Percentage Count Percentage Count Percentage 

Electrical .......................................... 1 1 ........................ ........................ ........................ ........................

Non-Product-Related .............................. 1 1 1 10 ........................ ........................

Unsafe Sleep Environment .............. 1 1 1 10 ........................ ........................

Insufficient Information ............................ 7 10 5 50 2 12 

Total .......................................... 71 100 10 100 17 100 

Source: CPSC epidemiological databases CPSRMS and NEISS. Percentages may not add to sub-totals and totals due to rounding. 

B. Flat Sleep Products 

In response to the 2019 SNPR, the 

Commission received public comments 

regarding the safety of non-inclined 

sleep products, or flat sleep products, 

that do not fall within an existing CPSC 

sleep standard or a voluntary standard 

that are available in the marketplace. 

Staff completed a review of CPSC’s 

epidemiological databases, CPSRMS 

and NEISS, to respond to these 

comments and concerns. 

Flat sleep products include: In-bed 

sleepers, baskets (that can function as 

hand-held carriers as well), baby boxes, 

compact bassinets (most of which are 

portable for travel), and baby tents. 

Based on the descriptions in the 

incident reports received, some have 

soft, puffy sides along the sleep area 

perimeter; others have semi-rigid sides, 

with mesh or soft-padded sidewalls 

held in place by tubular structures along 

the perimeter. Baby boxes have 

cardboard walls, while baby tents have 

flexible wires which provide structural 

support for fabric/mesh tent walls. All 

of these non-inclined sleep products are 

flat and come with mattress pads. Some 

products have short legs; many can sit 

on the floor or can be used on a bed or 

a couch. The data show that some 

products were placed inside a standardsized crib, play yard, or bassinet. 

For the final rule, we characterize the 

number of deaths and injuries and the 

types of hazards related to flat sleep 

products. CPSC’s characterizations are 

based on anecdotal incident reports 

received by the Commission. The 

number of emergency department (ED)- 

treated injuries associated with flat 

sleep products, for the covered time 

frame, is insufficient to derive any 

reportable national estimates.14

Accordingly, we do not present injury 

estimates here, but include ED-treated 

injuries in the total count of reported 

incidents. Moreover, reporting is 

ongoing and staff considers 2019–2020 

data incomplete, so the number of 

reported fatalities, nonfatal injuries, and 

non-injury incidents reported here may 

change in the future.15

1. Incident Data 

CPSC staff received a total of 183 

incident reports related to flat sleep 

products available in the marketplace. 

These incidents reported a date of 

occurrence between January 1, 2019 and 

December 31, 2020. Manufacturer and 

retailer reports submitted through 

CPSC’s ‘‘Retailer Reporting Program’’ 

serve as the only source of information 

for 73 percent (133 out of 183) of the 

incidents. Of the 183 reported incidents, 

11 are fatalities. Among the remaining 

172 nonfatal incidents, 16 reported an 

injury. Additionally, staff’s flat sleep 

product data search was limited to 

children age 12 months or under, 

because that is typically the 

manufacturer-recommended use age for 

these products. One hundred and fifteen 

incident reports provided the victim’s 

age; among them, 24 involved a fatality 

or injury. Table 2 provides the age 

breakdown among the 183 incident 

reports. 

TABLE 2—AGE DISTRIBUTION IN FLAT SLEEP PRODUCTS-RELATED INCIDENTS IN 2019–2020 

Age of child 

All incidents Injuries and fatalities 

Frequency Percentage Frequency Percentage 

Unreported * .................................................................................................... 68 37 3 11 

One–Five Months ............................................................................................ 89 49 19 70 

Six–Eight Months ............................................................................................ 18 10 4 15 

Nine–Twelve Months ....................................................................................... 8 4 1 4 

Total ......................................................................................................... 183 100 27 100 

Source: CPSC epidemiological databases CPSRMS and NEISS. 

* Age may be ‘‘unreported’’ under two circumstances: age was unknown, or age was not reported, because the incident involved no injury. 

(a) Fatalities 

The Commission is aware of 11 

fatalities associated with the use of a flat 

sleep product, meaning flat sleep 

surface products marketed for infant 

sleep that are not currently within the 

scope of an existing CPSC sleep 

standard or a voluntary standard, 

reported to have occurred during the 

period of January 1, 2019 through 

December 31, 2020. Seven of the 11 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 33031 

fatality reports describe a suffocation 

death, as follows: 

• A 1-month-old was found partially 

rolled over onto their side in a softsided compact bassinet/travel bed. 

• A 2-month-old infant was found 

completely rolled over the edge of an inbed sleeper. 

• A 2-month-old was placed in an inbed sleeper, in a prone position, 

stomach down, with his face turned to 

one side; he was discovered with part of 

his body outside the sleeper, face down 

into a blanket. 

• A 2-month-old infant was put into 

a compact bassinet/travel bed placed on 

top of an adult bed, with one side of the 

compact bassinet/travel bed leaning 

against the wall. According to the 

official report, the combination of the 

travel bed’s non-reinforced flexible 

bottom, along with the soft surface of 

the adult bed, allowed the infant to sink; 

he was found trapped between the bed 

and the wall. 

• A 3-month-old, in a handheld 

basket that was placed on an adult bed, 

was found completely rolled over from 

her original supine position. 

• A 4-month-old was placed on his 

back in an in-bed sleeper that was 

placed inside a standard bassinet; the 

infant was discovered in a prone 

position deceased. 

• A 7-month-old was wrapped in a 

blanket and placed supine in an in-bed 

sleeper. The infant was found deceased, 

having rolled over into a prone position. 

The remaining four fatalities are as 

follows: 

• A 1-month-old was placed in an inbed sleeper inside a play yard. The 

official reports describe the decedent as 

having suffocated on the puffy sides of 

the sleeper or becoming entrapped 

somehow, suffering positional asphyxia. 

• A 7-month-old was placed in an inbed sleeper for a nap. According to 

official reports, at some point, the infant 

got to the edge of the adult bed and 

became entrapped between the 

footboard and the mattress of the adult 

bed and died of positional asphyxia. 

• Official reports deemed the cause 

and manner of death for two additional 

fatalities as undetermined. Both 

decedents were 1-month-olds, one 

placed in a basket, while the other was 

in an in-bed sleeper. 

(b) Nonfatalities 

From among the 172 nonfatal reports, 

CPSC identified 16 injury reports 

associated with the use of flat sleep 

products that occurred between January 

1, 2019 and December 31, 2020. We 

describe the severity of the injury type 

among the 16 injuries below: 

• Two infants required hospital 

admission. An 8-day-old infant suffered 

unspecified breathing difficulties; 

another 2-month-old infant fell out of an 

in-bed sleeper and suffered head 

injuries when a sibling jumped onto the 

couch where the in-bed sleeper was 

situated. 

• Ten infants, ranging in age from 1 

month to 9 months, required emergency 

department (ED) visits after falling out 

of the sleeper product. For most cases, 

the sequence of events leading to each 

fall was unreported. In two cases, the 

infant fell while being transported in the 

sleeper; and in another case, the sleeper 

slipped off of the adult bed on which it 

was placed. The injuries included head 

injuries, such as a skull fracture, closedhead injury, and head contusion, or 

other injuries, such as face abrasion and 

knee contusion. 

• Four other injury incidents reported 

an allergic reaction; a mold-related 

breathing difficulty episode; laceration 

of the nose on the rough mesh wall 

surface on the sleeper; and a fall when 

a sibling pulled on the sleeper, causing 

it to flip over. One of these infants 

required repeated visits to a medical 

professional, but the level of care the 

other infants received was unspecified. 

The remaining 156 incidents reported 

no injuries, or provided no information 

about any injury. However, many of the 

descriptions were similar to incidents in 

which a serious injury or death 

occurred. Therefore, CPSC staff 

indicated the potential for a serious 

injury or even death. Forty-nine percent 

of the incidents involved infants 0 to 5 

months of age, and 4 percent involved 

infants 6 to 12 months of age. The age 

was unknown in 37 percent of the 

incidents. 

2. Hazard Patterns 

Similar to the inclined sleep products, 

the hazard patterns reported for the flat 

sleep products varied according to the 

type and usage pattern of the product. 

Many of the products are new in the 

marketplace, and consumers and safety 

advocates expressed concern about their 

safety. Staff identified the hazard 

patterns among the 183 reported 

incidents (11 fatal and 172 nonfatal) 

associated with the use of these flat 

sleep products. We present the staffidentified hazard patterns below in 

descending order of frequency among 

the reports. 

(a) Lock/Latch problems: One 

hundred and fifteen of the 183 reports 

(63 percent) fall in this category. All but 

one of these reports pertain to different 

models of a particular stand-alone 

compact bassinet. The locking/latching 

mechanism that controls the opening/ 

closing of the cover on the product 

failed. Some reports describe that the 

inability of the cover to open completely 

results in the product not lying flat. The 

single report about a different product 

describes a foldable sleeper not 

remaining flat; the unit reportedly folds 

up while the baby is in the product. 

None of the reports mention any 

injuries. 

(b) Comments/Concerns: Twenty-nine 

of the 183 reports (16 percent) expressed 

consumers’ or safety advocates’ 

concerns about the perceived safety 

hazard of a product, non-compliance 

with the relevant standard(s) for which 

a product is being labeled, and/or 

misleading marketing statements about 

a product. None of the reports indicate 

that an incident actually occurred. 

(c) Falls/Containment issues: Twelve 

of the 183 incidents (7 percent) report 

an infant falling out of the product or an 

infant not being kept contained within 

the product. Examples include infants 

rolling out of a sleeper onto an adult bed 

and then onto floor; an infant falling out 

of a sleeper when a sibling jumped onto 

the couch containing the sleeper; an 

infant crawling/rolling (unwitnessed) 

out of a sleeper and getting entrapped 

between an adult bed frame and 

mattress. This category includes one 

death, one hospital admission, and nine 

ED visits. 

(d) Instability issues: Twelve of the 

183 reported incidents (7 percent) 

describe problems with the product not 

remaining stable. The incident reports 

describe some products with legs lifting 

up higher or leaning on one side; other 

products have slipped off or flipped 

over from the adult beds/couches on 

which they were resting. This category 

includes two reported injuries, one 

involving an ED visit. 

(e) Asphyxiation/Suffocation hazard: 

Nine of the 183 indents (5 percent) fall 

into this category. The products were 

compact bassinets/travel beds, baskets, 

as well as in-bed sleepers, one being 

used inside a standard bassinet and 

another, inside a play yard. All but one 

of the infants had rolled over from their 

initial position—either fully or partially; 

positional information is not available 

for one infant. Eight of the incidents 

were fatalities due to suffocation or 

positional asphyxia; one was a nearsuffocation episode, with a parent 

nearby to rescue the infant. 

(f) Miscellaneous product-related 

issues: Three of the 183 incident reports 

(2 percent) are about mold or quality of 

the product material. Two of the three 

products were in-bed sleepers, and the 

third was a compact bassinet/travel bed. 

All three report an injury. 


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33032 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

16https://www.cpsc.gov/content/cpsc-consumeralert-caregivers-urged-to-use-restraints-withinclined-sleep-products. 17https://www.cpsc.gov/Newsroom/NewsReleases/2019/CPSC-ALERT-CPSC-and-FisherPrice-Warn-Consumers-About-Fisher-Price-Rock-NPlay-Due-to-Reports-of-Death-When-Infants-RollOver-in-the-Product. 18https://www.cpsc.gov/Newsroom/NewsReleases/2020/CPSC-Warns-Consumers-to-StopUsing-Summer-Infant-USA-Inc-s-SwaddleMe-ByYour-Bed-Sleeper. 19https://www.cpsc.gov/Newsroom/NewsReleases/2020/CPSC-Cautions-Consumers-Not-toUse-Inclined-Infant-Sleep-Products. 

20Tab E of Staff’s Final Rule Briefing Package 

contains a description of each CPSC sleep standard 

and the associated voluntary standard the rule is 

based upon. 

21Under section 104(b)(4)(B) of the CPSIA, the 

organization must notify the Commission of a 

revised voluntary standard, and the revised 

standard becomes a consumer product safety 

standard issued by the Commission unless within 

90 days after notification, the Commission 

determines that the revised standard does not 

improve the safety of the consumer product covered 

by the standard, and the Commission is retaining 

the existing consumer product safety standard. The 

revised voluntary standard will become the 

mandatory standard, effective 180 days after the 

Commission received notification of the revision (or 

a later date specified by the Commission in the 

Federal Register). 15 U.S.C. 2056a(b)(4)(B). 

(g) Undetermined issues: In three of 

the 183 incident reports (2 percent), 

staff could not definitively identify the 

issue involved. Two of the incidents 

were fatalities; in both cases, CPSC 

Field investigation reports indicate that 

the cause of death is undetermined. The 

third incident resulted in a 

hospitalization due to unspecified 

breathing difficulties suffered by the 

infant. 

C. Safety Alerts, Press Releases, and 

Product Recalls 

The Commission issued two safety 

alerts involving infant inclined sleep 

products. A May 31, 2018 safety alert 16

advised of infant rollover deaths in 

inclined sleep products, and reminded 

caregivers to always use restraints and 

to stop using the product as soon as an 

infant can roll over. An April 5, 2019 

safety alert 17 advised consumers to stop 

using the inclined sleep product when 

an infant reaches 3 months of age, or as 

soon as an infant exhibits rollover 

capabilities. Since issuing the 2019 

SNPR, the Commission issued two press 

releases regarding infant inclined sleep 

products. A January 16, 2020 press 

release warned the public about the risk 

of suffocation associated with the 

Summer Infant SwaddleMe By Your 

Bed Sleeper, an infant inclined sleeper. 

The release advised consumers to stop 

using the product immediately.18 An 

October 31, 2020 press release warned 

consumers that infant inclined sleep 

products were not safe for infant sleep 

based on the results of the Mannen 

Study, and advised caregivers to stop 

using infant sleep products with an 

inclined seat back of more than 10 

degrees.19

The Commission also conducted 

numerous recalls involving infant 

inclined sleep products. The 2019 SNPR 

stated that from May 10, 2000 to August 

20, 2019, CPSC conducted 13 consumerlevel recalls involving infant inclined 

sleep products. 84 FR at 60953–54. 

CPSC conducted recalls in response to 

hazards involving strangulation, 

suffocation, falls, structural stability, 

entrapment, exposure to mold, and 

death. Six recalls involved infant 

hammocks, six recalls involved infant 

inclined sleep products, and one recall 

involved an infant inclined sleep 

accessory included with a play yard. Id. 

Tab G in the October 2019 Staff SNPR 

Briefing Package contains a detailed 

chart outlining recalls involving infant 

inclined sleep products up through 

August 20, 2019. 

Since the issuance of the 2019 SNPR, 

CPSC conducted six additional recalls 

for a suffocation hazard involving infant 

inclined sleep products. These six 

recalls affected approximately 268,300 

units. Tab F of Staff’s Final Rule 

Briefing Package contains a chart 

outlining these recalls. CPSC did not 

conduct any recalls for flat sleep 

products from August 2019 through 

January 2021. 

IV. Overview of CPSC Sleep Standards 

The final rule would require that any 

‘‘infant sleep product,’’ defined as a 

product marketed or intended to 

provide a sleeping accommodation for 

an infant up to 5 months old, and that 

is not already subject to one of CPSC’s 

mandatory standards for infant sleep, 

must meet the requirements of the 

mandatory standard for bassinets and 

cradles, 16 CFR part 1218, Safety 

Standard for Bassinets and Cradles, 

including conforming to the definition 

of a ‘‘bassinet/cradle.’’ Currently, the 

five mandatory CPSC sleep standards 

are: 20

• 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

• 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

• 16 CFR part 1220—Safety Standards 

for Non-Full-Size Baby Cribs 

• 16 CFR part 1221—Safety Standards 

for Play Yards, and 

• 16 CFR part 1222—Safety Standard 

for Bedside Sleepers. 

The Commission considers products 

that fall within the scope of a CPSC 

sleep standard to generally follow safe 

sleep principles. Additionally, 

caregivers can expect that regulated 

products intended for infant sleep are 

tested for compliance to the applicable 

standard, as well as to any other 

applicable CPSC rule, such as lead in 

paint and lead content. Pursuant to 

section 14 of the CPSA, products within 

the scope of a children’s product safety 

rule, which includes all of CPSC’s sleep 

standards, must be tested for 

compliance to the standard by a CPSCaccepted third party laboratory, and 

such compliance must be certified by 

the manufacturer or importer of the 

product. Staff regularly participates in 

ASTM subcommittees for these 

products, and routinely updates 

incident data associated with regulated 

products, to address identified hazards 

through the ASTM process. If a 

voluntary standard that has been 

adopted by the Commission is revised to 

address identified hazards, section 

104(b)(4)(B) of the CPSIA provides an 

update process, whereby the revised 

voluntary standard becomes the new 

mandatory standard.21 Additionally, 

section 104(b)(2) of the CPSIA requires 

the Commission to periodically review 

and revise rules issued under section 

104, to ensure that such rules provide 

the highest level of safety for such 

products that is feasible. Table 3 

summarizes CPSC sleep standards 

applicable to regulated infant sleep 

products. 


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22CPSC’s mandatory standard, 16 CFR part 1218, 

Safety Standard for Bassinets and Cradles, 

incorporates by reference ASTM F2194–13, 

Standard Consumer Safety Specification for 

Bassinets and Cradles, with modifications to make 

the standard more stringent. In 2016, ASTM revised 

the voluntary standard to include the modifications 

set forth in the mandatory standard. Accordingly, 

ASTM F2194–16e1 is substantially similar to the 

mandatory standard, and we assess this version of 

the voluntary standard in this preamble, to simplify 

our analysis. 

23Meeting logs detailing CPSC’s work with ASTM 

on the infant inclined sleep product voluntary 

standard can be found here: https://www.cpsc.gov/ 

Newsroom/FOIA/ReportList?field_nfr_date_value

%5Bvalue%5D%5Bmonth%5D=&field_nfr_date_

value_1%5Bvalue%5D%5Byear%5D=&field_nfr_

type_value=meeting&title=incline&=Apply. 

24CPSC staff’s correspondence with ASTM since 

issuing the 2017 NPR regarding these products can 

be found on www.regulations.gov under supporting 

materials: https://www.regulations.gov/docket/ 

CPSC-2017-0020/document?documentTypes=

Supporting%20%26%20Related%20Material. 

TABLE 3—REGULATED INFANT SLEEP PRODUCTS AND APPLICABLE STANDARDS

Product Voluntary standard Mandatory standard 

Bassinet/Cradle ................................................................................................................................ ASTM F2194–16e1 22 16 CFR 1218. 

Full-Size Crib ................................................................................................................................... ASTM F1169–19 ....... 16 CFR 1219. 

Non-Full-Size Crib ........................................................................................................................... ASTM F406–19 ......... 16 CFR 1220. 

Play Yard ......................................................................................................................................... ASTM F406–19 ......... 16 CFR 1221. 

Bedside Sleeper .............................................................................................................................. ASTM F2906–13 ....... 16 CFR 1222. 

Some products currently marketed or 

intended for infant sleep are not 

regulated by one of the five existing 

CPSC sleep standards. Additionally, 

new products continue to enter the 

market for infant sleep, but some are 

also not within the scope of an existing 

CPSC sleep standard. Such products 

may not follow safe sleep principles, 

and are not tested for compliance to a 

CPSC sleep standard. These unregulated 

sleep products collectively include 

products such as: Infant inclined sleep 

products, in-bed sleepers, baby boxes, 

compact/travel bassinets without 

handles or handholds, and infant travel 

tents. Hand-held bassinet/cradles are 

regulated as part of 16 CFR part 1225, 

Safety Standard for Hand-Held Infant 

Carriers, but part 1225 does not address 

hazards associated with infant sleep. 

Accordingly, hand-held carriers are 

unregulated if marketed or intended for 

infant sleep. 

The final rule seeks to address 

hazards associated with infant sleep 

products, both inclined and flat. 

Products that already meet a CPSC sleep 

standard are, by definition, outside the 

scope of the rule. The final rule 

addresses hazards associated with infant 

sleep products by requiring them to 

meet the requirements of the bassinet 

and cradle standard, 16 CFR part 1218, 

including conforming to the definition 

of a ‘‘bassinet/cradle.’’ 

V. Voluntary Standards Overview— 

ASTM F3118 and ASTM F2194 

A. Infant Inclined Sleep Products— 

ASTM F3118 

1. History 

As a result of incidents associated 

with the use of inclined sleep products, 

the Commission directed CPSC staff to 

work with ASTM to develop voluntary 

requirements to address the hazard 

patterns related to the use of inclined 

sleep products. ASTM first approved 

ASTM F3118 on April 1, 2015, and 

published it in May 2015. Through the 

ASTM process, CPSC staff consulted 

with manufacturers, retailers, trade 

organizations, laboratories, consumer 

advocacy groups, consultants, and 

members of the public. The current 

standard, ASTM F3118–17a, was 

approved on September 1, 2017, and 

published in October 2017. This is the 

fourth revision of the standard since it 

was first published in May 2015. ASTM 

F3118–17a states that it is intended to 

address hazards from falls, positional 

asphyxiation, and obstruction of nose 

and mouth by bedding. 

2. Description 

The 2017 NPR described the key 

provisions of ASTM F3118–17, 

including: Scope, terminology, general 

requirements, performance 

requirements, test methods, marking 

and labeling, and instructional 

literature. 82 FR at 16967. The 2019 

SNPR proposed to incorporate by 

reference the most recent version of the 

voluntary standard, ASTM F3118–17a, 

which is substantially the same as 

ASTM F3118–17, except that the 

‘‘accessory’’ definition was updated to 

match the modification recommended 

in the 2017 NPR. Like the previous 

version, ASTM F3118–17a describes the 

scope of the voluntary standard, defines 

terms for various types of infant 

inclined sleep products, and sets out 

requirements for performance (such as 

for structural integrity and stability) and 

for warnings and instructions. As 

discussed elsewhere in this preamble, 

CPSC’s final rule makes substantial 

modifications to ASTM F3118–17a. 

3. CPSC Staff’s Work Within the ASTM 

Process 

CPSC staff’s work on the infant 

inclined sleep product voluntary 

standard arose from staff’s work through 

the ASTM process on the voluntary 

standard for bassinets and cradles in 

approximately 2011, in preparation for 

a proposed rule on bassinets and 

cradles. ASTM began developing the 

infant inclined sleep products voluntary 

standard to address hammocks and 

inclined sleep products, whose product 

characteristics at that time did not 

appear to align with bassinets, because 

the bassinets standard requires a sleep 

surface of 10 degrees or less, while the 

inclined product category at that time 

included products with an incline of 10 

to 30 degrees. Staff has been actively 

participating in the development of the 

voluntary standard for inclined sleep 

products since then. 

CPSC staff participated in the ASTM 

process by attending meetings,23

working on task groups, commenting on 

ballots,24 and providing incident data. 

CPSC staff provided incident data and 

hazard pattern analysis associated with 

inclined sleep products for the 2017 

NPR and the 2019 SNPR, and updated 

this information in this final rule 

preamble. Additionally, staff last 

provided ASTM with incident data 

associated with inclined sleep products 

in May 2018. 

Since the SNPR published on 

November 12, 2019, ASTM has not 

updated ASTM F3118–17a to address 

hazards associated with inclined 

products. Staff’s SNPR Briefing Package 

was posted on the Commission’s 

website on October 16, 2019, before 

ASTM held fall meetings on voluntary 

standards for juvenile products, and 

before the Commission voted on the 

SNPR, so that ASTM members and other 

stakeholders could review the package, 

including the Mannen Study, before the 

ASTM meetings, and so that staff could 

discuss the package and the Mannen 

Study with ASTM members. The ASTM 

Agenda for Infant Inclined Sleep 

Products meeting that occurred on 

October 21, 2019, included a link to 

Staff’s SNPR Briefing Package. CPSC 

staff discussed the 2019 SNPR Briefing 


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25Available at: https://www.cpsc.gov/s3fs-public/ 

IISPLettertoASTM-07162020.pdf?6ntZUkyau.r2mlr

QnM31s0B3g1EkUg.9. 

26The ASTM task group approach is different 

than CPSC’s approach in this final rule, because 

ASTM is attempting to put safe sleep requirements 

in ASTM F3118, rather than rely on the 

performance and labeling requirements in the 

bassinets and cradles standard. The Commission 

determines in this final rule that the performance 

and labeling requirements in the bassinet standard 

are the minimum safe sleep requirements for infant 

sleep products. Thus, it remains unclear whether 

ASTM’s approach can be successful. However, if 

the ASTM committee revises ASTM F3118–17a and 

notifies the Commission, the staff will evaluate the 

revised voluntary standard at that time. 

Package at the ASTM meetings in 

October 2019, including the ASTM 

subcommittees for infant inclined sleep 

products, in-bed sleepers, and bassinets, 

discussing the Mannen Study findings, 

as well as addressing the fact that flat 

sleep products were covered by the 

SNPR. Dr. Mannen attended the 

subcommittee meeting for infant 

inclined sleep products via telephone, 

to discuss the Mannen Study and to 

answer questions. 

After the SNPR published in the 

Federal Register on November 12, 2019, 

CPSC staff urged the ASTM 

subcommittee for ASTM F3118 to meet 

and discuss how to address issues 

presented in the 2019 SNPR. However, 

the F3118 subcommittee did not meet 

again until August 26, 2020, following 

a July 16, 2020 letter from CPSC staff.25

After staff’s letter, the ASTM F3118 

subcommittee established a task group 

to revise the infant inclined sleep 

standard’s title, introduction, and scope, 

to be more in line with the proposal in 

the 2019 SNPR. In December 2020, the 

ASTM subcommittee introduced ballot 

F15–18 (20–1) to change the standard’s 

title, introduction, and scope to include 

all infant sleep products (and not just 

inclined sleep products). The ballot 

sought to: 

• Remove the word ‘‘inclined’’ 

throughout the standard. 

• Include in the scope, products 

intended for infants up to 12 months 

old. 

• Include in the scope, products 

marketed or intended to provide 

sleeping accommodations. 

• Change the scope to include all infant 

sleep products that do not fall within 

the scope of an existing infant sleep 

product standard: 

D Full-Sized Cribs (F1169) 

D Bassinets (F2194) 

D Bedside Sleepers (F2906) 

D Non-Full-Size Cribs/Play Yards 

(F406) 

• Exempt crib mattresses from the scope 

of the standard. 

• Limit the sleep surface in all positions 

to be 10 degrees or less. 

However, in January 2021, the ballot did 

not pass due to six negative votes. The 

negative votes objected to a variety of 

different aspects of the ballot, including 

four broad categories: 

1. That the proposal would discourage 

innovation and be too broad; 

2. That the ballot appeared to allow 

products that fall under other sleep 

standards to opt to meet ASTM F3118 

instead; 

3. That the voter could not support 

changing the title, introduction, and 

scope without seeing the underlying 

requirements; and 

4. Editorial comments. 

The ASTM F3118 subcommittee 

discussed the ballot results at a meeting 

on January 27, 2021. During this 

meeting, ASTM members disagreed on 

the intent and consequences of changes 

to the voluntary standard, and the 

meeting ended without a consensus on 

a path forward. However, CPSC staff 

participates on an ASTM task group to 

review safe sleep requirements across 

infant sleep product standards (the 

comparison task group), and reports that 

this task group has met at least four 

times since the January 27, 2021 

meeting. Based on the ballot results and 

the discussions in these ASTM 

meetings, staff advises that it is unlikely 

that ASTM will be able to move forward 

with changes to ASTM F3118 that 

address safe sleep requirements in the 

near term.26

Recently, on April 22, 2021, at an 

ASTM task group meeting on the title, 

introduction, and scope of the voluntary 

standard, task group members discussed 

balloting the proposed regulatory text in 

the 2019 SNPR for the voluntary 

standard, to prevent the sale of infant 

inclined sleep products that purport to 

certify to ASTM F3118–17a, meaning 

products with an incline above 10 

degrees, while ASTM works to revise 

the voluntary standard to be more in 

line with the 2019 SNPR. However, the 

task group does not plan to ballot the 

2019 SNPR requirement that infant 

sleep products meet the requirements of 

the bassinet standard, because ASTM is 

working to create minimum safe sleep 

requirements in a revised ASTM F3118 

standard. Staff is participating in this 

effort as well, but staff has advised the 

task group that staff’s expertise does not 

suggest that requirements that are 

different and less stringent than the 

requirements in the bassinet standard 

will adequately address the risk of 

injury associated with infant sleep 

products. Additionally, staff’s 

conclusion that the Safety Standard for 

Bassinets and Cradles contains the 

minimum safe sleep requirements for 

these products is supported by the 

assessment presented in Staff’s Final 

Rule Briefing Package and in this final 

rule. 

B. Bassinets and Cradles—ASTM F3194 

1. History and Description 

The voluntary standard for bassinets 

and cradles, ASTM F2194, was first 

approved and published by ASTM in 

2002, as ASTM 2194, Standard 

Consumer Safety Specification for 

Bassinets and Cradles. The voluntary 

standard was revised several times 

between 2002 and CPSC’s promulgation 

of a mandatory standard for bassinets in 

2013. CPSC’s mandatory standard for 

bassinets and cradles, codified at 16 

CFR part 1218, incorporates by 

reference ASTM F2194–13, with the 

following modifications to the voluntary 

standard: 

1. Clarify the scope of the standard to 

include multi-mode products in which 

a mode meets the definition of a 

‘‘bassinet/cradle’’ (seat incline is 10 

degrees or less from horizontal) 

2. Modify the stability test procedure 

to require the use of a newborn CAMI 

dummy, rather than an infant CAMI 

dummy. 

3. Add stability requirements for 

removable bassinet beds. 

4. Add more stringent mattress 

flatness performance requirements to 

limit measured angle to 10 degrees 

(versus 14 degrees allowed in ASTM 

F2194–13). 

5. Exempt bassinets that are less than 

15 inches across from the mattress 

flatness requirement. 

In 2016, ASTM approved and 

published the most recent version of the 

standard, ASTM F2194–16e1, with new 

requirements to bring the voluntary 

ASTM standard in line with the 

mandatory standard for bassinets in 16 

CFR part 1218. In developing ASTM 

F2194–16e1, ASTM harmonized the 

voluntary standard with all 

modifications specified in part 1218. In 

addition to including all modifications 

contained in part 1218, ASTM added: 

1. Additional clarification that 

strollers with a removable bassinet must 

be tested to the bassinet standard, 

2. Minor formatting and editorial 

changes, and 

3. An additional warning statement to 

be applied to bassinet bed products that 

are removable from the base/stand 

without the use of tools and that contain 

a lock/latch mechanism that secures the 

bassinet bed to the base/stand. 

Staff assessed the additional changes to 

the voluntary standard, beyond 

harmonization with 16 CFR part 1218, 


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27CPSC meeting logs associated with staff’s work 

with ASTM can be found here: https://

www.cpsc.gov/Newsroom/FOIA/ReportList?field_

nfr_date_value%5Bvalue%5D%5Bmonth%5D=&

field_nfr_date_value_1%5Bvalue%5D%5Byear

%5D=&field_nfr_type_value=meeting&title=

bassinet&=Apply. 

28CPSC correspondence with the ASTM 

Subcommittee for Bassinets and Cradles can be 

found here: https://cpsc.gov/s3fs-public/Vote

CommentToASTMBassinet_10162020.pdf

?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI. 

29Available at: https://www.cpsc.gov/s3fs-public/ 

LetterToASTMBassinet_IISP_121219.pdf?uMq_

ImMYhtrDmFkoDH9I6vdwNI0hsm00. 

30Available at: https://www.cpsc.gov/s3fs-public/ 

VoteCommentToASTMBassinet_10162020.pdf

?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI. CPSC’s 

website, at https://www.cpsc.gov/Regulations-Laws- 

-Standards/Voluntary-Standards, contains 

information on staff activities as well as 

correspondence with voluntary standards 

organizations. 

31Meeting logs describing ASTM meetings are 

available on CPSC’ website: https://www.cpsc.gov/ 

Newsroom/FOIA/ReportList?field_nfr_date_value

%5Bvalue%5D%5Bmonth%5D=&field_nfr_date_

value_1%5Bvalue%5D%5Byear%5D=&field_nfr_

type_value=meeting&title=in-bed&=Apply. 

and advises that the changes are either 

non-substantive, or an improvement in 

safety. We evaluate and discuss ASTM 

F2194–16e1 in this preamble to the final 

rule, and CPSC will update the 

reference in part 1218 to ASTM F2194– 

16e1 as soon as feasible. 

The more significant requirements of 

ASTM F2194 include: 

• Scope—describes the types of 

products intended to be covered under 

the standard. 

• Spacing of rigid-side components— 

is intended to prevent child entrapment 

between both uniformly and nonuniformly spaced components, such as 

slats. 

• Openings for mesh/fabric—is 

intended to prevent the entrapment of 

children’s fingers and toes, as well as 

button ensnarement. 

• Static load test—is intended to 

ensure structural integrity even when a 

child three times the recommended (or 

95th percentile) weight uses the 

product. 

• Stability requirements—is intended 

to ensure that the product does not tip 

over when pulled on by a 2-year-old 

male. 

• Sleeping pad thickness and 

dimensions—is intended to minimize 

gaps and the possibility of suffocation 

due to excessive padding. 

• Tests of locking and latching 

mechanisms—is intended to prevent 

unintentional folding while in use. 

• Suffocation warning label—is 

intended to help prevent soft bedding 

incidents. 

• Fabric-sided openings test—is 

intended to prevent entrapments. 

• Rock/swing angle requirement—is 

intended to address suffocation hazards 

that can occur when latch/lock 

problems and excessive rocking or 

swinging angles press children into the 

side of the bassinet/cradle. 

• Occupant restraints—is intended to 

prevent incidents where unused 

restraints have entrapped and strangled 

children. 

• Side height requirement—is 

intended to prevent falls. 

• Segmented mattress flatness—is 

intended to address suffocation hazards 

associated with ‘‘V’’ shapes that can be 

created by the segmented mattress folds. 

The voluntary standard also includes: 

(1) Torque and tension tests to prevent 

components from being removed; (2) 

requirements for several bassinet/cradle 

features to prevent entrapment and cuts 

(minimum and maximum opening size, 

small parts, hazardous sharp edges or 

points, and edges that can scissor, shear, 

or pinch); (3) requirements for the 

permanency and adhesion of labels; (4) 

requirements for instructional literature; 

and (5) corner post extension 

requirements intended to prevent 

pacifier cords, ribbons, necklaces, or 

clothing that a child may be wearing 

from catching on a projection. 78 FR 

63019, 63020–21 (Oct. 23, 2013). 

2. CPSC Staff’s Work Within the ASTM 

Process 

CPSC has been working with ASTM 

on the voluntary standard for bassinets 

and cradles since before publication of 

the original voluntary standard in 2002. 

CPSC began rulemaking under section 

104 of the CPSIA, to create a mandatory 

standard for bassinet and cradles based 

on the voluntary standard, in 

approximately 2009, following passage 

of the CPSIA. CPSC issued a notice of 

proposed rulemaking in 2010 (75 FR 

22303 (Apr. 28, 2010)), a supplemental 

notice of proposed rulemaking in 2012 

(77 FR 64055 (Oct. 18, 2012)), and a 

final rule in 2013 (78 FR 63019 (Oct. 28, 

2013)). The final rule is codified at 16 

CFR part 1218, Safety Standard for 

Bassinets and Cradles. The final rule 

incorporated by reference the thencurrent voluntary standard, ASTM 

F2194–13, with modifications to make 

the standard more stringent. 

CPSC staff has continually 

participated in the ASTM process, 

including attending subcommittee 

meetings,27 participating in task 

groups,27 commenting and voting on 

ballots to revise the voluntary 

standard,28 and providing incident data, 

when requested. This has included 

ASTM’s recent efforts to address 

hazards associated with currently 

unregulated flat sleep products, such as 

compact bassinets, baby boxes, and inbed sleepers, since approximately 2015. 

ASTM has not yet been successful in 

adding any of these flat sleep products 

to the bassinet standard. 

CPSC staff’s correspondence with 

ASTM states that staff is opposed to 

removing or reducing the requirements 

of the bassinet and cradle voluntary 

standard to create new requirements 

specifically for these products, when 

such requirements are inconsistent with 

safe sleep principles already required in 

the bassinet standard. Accordingly, for 

example, in a December 12, 2019 letter 

to both the inclined sleep and bassinet 

subcommittees, CPSC staff reiterated 

concerns with weakening the safe sleep 

requirements in the voluntary standard 

for bassinets and cradles in order to 

accommodate unregulated products, 

such as in-bed sleepers, compact 

bassinets, and baby boxes.29

Additionally, on October 16, 2020, staff 

voted negatively on an ASTM ballot to 

modify the bassinet standard to include 

less stringent stability and side height 

requirements for compact bassinets, 

versus traditional bassinets.30 To ensure 

safe sleep, staff’s negative ballot vote 

urged ASTM to maintain the same side 

height and stability requirements for 

compact bassinets that are required of 

bassinets. 

In June 2019, ASTM began to develop 

a separate in-bed sleeper voluntary 

standard. Staff provided data to ASTM 

regarding in-bed sleepers in 2017, and 

has participated in ASTM meetings for 

in-bed sleepers since June 2019, as well 

as working with performance and 

labeling task groups.31 Task groups 

working on the in-bed sleeper standard 

have been unable to reach consensus on 

performance requirements for in-bed 

sleepers, and have been focusing on 

developing warning labels for these 

products. CPSC staff continues to 

participate in all of these ASTM efforts, 

and to urge ASTM members to retain 

safe sleep principles in standards 

development. For example, in a July 8, 

2020 letter to the Subcommittee 

Chairman for ASTM’s in-bed sleeper 

committee, CPSC staff stated: 

We would like to be clear that based on our 

evaluation of incident data related to in-bed 

sleepers, we have great concerns regarding 

the safety of in-bed sleepers and the 

feasibility of developing any safety standard 

that fully addresses potential hazards. Based 

on the 12 deaths discussed with the In-bed 

Sleeper Data Task Group members, CPSC 

staff cannot foresee how these products can 

be designed and regulated to ensure safe use 

for infants. Staff is not confident that an inbed sleeper voluntary standard that differs 


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33036 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

32See July 8, 2020 Letter from C. Kish to ASTM 

Subcommittee for In-bed Sleepers, available at: 

https://www.cpsc.gov/s3fs-public/InbedSleepers_

07082020ASTM%20Letter.pdf?3SpzS3cG3zv

PjCLFamcCz.9FxNjpUu2s. 

from the current bassinet standard will result 

in a safe sleep product.32

VI. Assessment of the Voluntary 

Standards To Address Identified 

Hazard Patterns Associated With Infant 

Sleep Products 

A. Inclined Sleep Products 

The 2019 SNPR assessed the 

adequacy of ASTM F3118–17a to 

address the risk of injury associated 

with inclined sleep products. 84 FR 

60955–56. The assessment relied, in 

part, on the Mannen Study regarding the 

safety of inclined sleep surfaces for 

infant sleep, attached as Tab B to Staff’s 

SNPR Briefing Package, and also 

summarized in the 2019 SNPR. Id. at 

60954. Based on the Mannen Study, 

CPSC staff advised that a flat sleep 

surface, meaning one that does not 

exceed 10 degrees from the horizontal, 

is the safest sleep surface for infants. Id. 

Accordingly, the Commission proposed 

in the 2019 SNPR to remove the term 

‘‘inclined’’ in CPSC’s mandatory 

standard, and to require that all sleep 

products not otherwise subject to a 

CPSC sleep standard (full-size cribs, 

non-full-size cribs, play yards, bedside 

sleepers, and bassinets and cradles), 

meet the requirements of 16 CFR part 

1218, Safety Standard for Bassinets and 

Cradles, which, among other 

requirements, mandates a seat back/ 

sleep surface angle intended for sleep to 

be 10 degrees or less from horizontal. Id. 

Here, we summarize the results of the 

Mannen Study again, summarize the 

assessment of ASTM F3118–17a in the 

2019 SNPR, and update our assessment 

to determine whether the voluntary 

standards, ASTM F3118–17a, or ASTM 

F2194–16e1, are adequate to address the 

incidents associated with inclined sleep 

products, including the 71 new 

incidents reported since the 2019 SNPR. 

Based on the following analysis, the 

Commission determines that ASTM 

F3118–17a is inadequate to address the 

risk of injury associated with inclined 

sleep products, and that more stringent 

requirements are necessary in the final 

rule to further reduce the risk of injury 

associated with infant inclined sleep 

products. Specifically, the Commission 

determines that the performance 

requirements in the mandatory 

standard, 16 CFR part 1218, Safety 

Standard for Bassinets and Cradles, 

would adequately address the risk of 

injury associated with these products. 

1. Mannen Study Summary 

During the development of the 2019 

SNPR, staff reviewed 450 incidents, 59 

were deaths that occurred while in 

infant inclined sleep products. 

Commission staff contracted with Dr. 

Erin Mannen, Ph.D., a mechanical 

engineer with a biomechanics 

specialization, to conduct infant testing 

to evaluate the design of inclined sleep 

products. The Mannen Study examined 

how the degree of a seatback angle 

affects an infant’s ability to move within 

the products and whether those designs 

directly impact safety or present a risk 

factor that could contribute to the 

suffocation of an infant. The testing 

compared infants’ muscle movement 

and oxygen saturation on a flat crib 

mattress at 0 degrees, 10 degrees, and 20 

degrees, versus seven different inclined 

sleep products. The Mannen Study 

concluded that none of the inclined 

sleep products tested were safe for 

infant sleep. Id. 

The Mannen Study concluded that 

muscle activity for infants who rolled 

over in inclined sleep products with a 

20-degree incline sleep surface was 

significantly different than in products 

with a zero-degree incline surface. The 

increased demand on the abdominal 

muscles could lead to increased fatigue 

and suffocation if an infant is unable to 

reposition themselves after rolling from 

a supine to prone position. The Mannen 

Study also concluded that inclined 

sleep products with a 10-degree or less 

sleep surface incline do not significantly 

impact infant motion or muscle activity. 

Based on the Mannen Study, staff 

recommended that 10 degrees is the 

maximum sleep surface angle that 

should be allowed for any product 

intended for infant sleep, similar to the 

requirements found in the EN 1130:2019 

children’s cribs, EN 1466:2014 carry 

cots, and the AS/NZS 4385:96 infant 

rocking cradles international standards. 

Id. 

2. Hazard Pattern Categories 

In the 2019 SNPR, CPSC reviewed 451 

reported incidents involving inclined 

sleep products, which included 59 

fatalities and 96 injuries. CPSC 

identified seven hazards that involved 

deaths and injuries (for this analysis, we 

did not consider patterns, such as 

consumer comments, that did not 

involve injuries or deaths): 

• Design issues (31 percent). This 

hazard involved 19 deaths, 17 resulting 

from infants rolling over into a prone 

(face down) position. An additional 71 

injuries were reported in this category, 

including five hospitalizations and four 

emergency department visits. Thirtythree percent of the reported incidents 

involved infants rolling from their 

original supine (on their back) position. 

• Electrical issues (28 percent). This 

hazard involved no deaths and two 

reports of injuries. 

• Undetermined (8 percent). This 

hazard involved 28 deaths and six 

injuries. Among the 28 deaths, staff was 

unable to determine the product’s role, 

but often unsafe sleep environment was 

cited as a co-contributing condition to 

sudden infant death syndrome (SIDS). 

• Structural Integrity (6 percent). This 

hazard involved no deaths and two 

injuries. 

• Insufficient information (4 percent). 

This hazard involved eight deaths and 

six injuries. The reports did not provide 

information on the circumstances of 

deaths and injuries involved 

unspecified falls. 

• Other Product-Related Issues (3 

percent). This hazard involved no 

deaths and nine injuries. The category 

includes reports of instability (product 

tipping over) and inadequacy of 

restraints, and most of the injuries 

involved falls. 

• Infant placement issues (1 percent). 

This hazard involved four deaths and no 

injuries. Three of the four deaths 

involved infants placed in a prone 

position. 

Id. at 60952–53. 

Since the 2019 SNPR, CPSC received 

a total of 71 new incident reports related 

to inclined sleep products. While the 

distribution of the data in this update 

varies somewhat, staff advises that the 

broader hazard categories are very 

similar. The 71 new reports included 10 

fatalities and 17 injuries. Of the 10 

fatalities, three deaths involved an 

infant who rolled from a supine 

position, one death involved an 

overturned sleeper, one death involved 

an infant placed with a blanket, and five 

deaths without reports containing 

information on the circumstances of the 

death. Of the 17 injuries 12 involved 

design issues, two involved structural 

integrity, and two involved unspecified 

falls. 

3. Assessment of ASTM Standards in 

Addressing Hazards 

Below we summarize the hazard 

patterns associated with deaths and 

injuries from all 522 incident reports 

related to inclined sleep products CPSC 

received and reviewed since the 2017 

NPR. CPSC did not consider patterns, 

such as consumer comments, that did 

not involve injuries or deaths. The 522 

incidents involved 69 deaths and 113 

injuries. We assesses the adequacy of 

the voluntary standard for infant 


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33Beal SM, Moore L, Collett M, Montgomery B, 

Sprod C, Beal A. The danger of freely rocking 

cradles. J Paediatr Child Health. 1995 Feb;31(1):38– 

40. doi: 10.1111/j.1440–1754.1995.tb02910.x. PMID: 

7748688. 

34 In the final rule for bassinets, the Commission 

stated they intended to limit the scope of the 

bassinet standard to exclude all inclined products 

‘‘when the incline is more than 10 degrees from 

horizontal.’’ 78 FR 63,021. 

inclined sleep products (ASTM F3118) 

and the adequacy of the voluntary 

standard for bassinets (ASTM F2194) in 

addressing hazards associated with 

injuries and deaths. 

In the 2019 SNPR, CPSC determined 

that the voluntary standard for infant 

inclined sleep products, ASTM F3118– 

17a, is inadequate to address the risk of 

injury associated with the incline of 

sleep products, because the standard 

allows for products with a seatback 

angle greater than 10 degrees. Id. at 

60955–56. The majority of deaths (in 

which the circumstances were known) 

were due to suffocation after the infant 

rolled over in the product, and the same 

hazard pattern was reported in nonfatal 

incidents. For the mandatory standard, 

CPSC proposed to modify ASTM 

F3118–17a to limit the seatback angle 

for all infant sleep products to 10 

degrees or less, and to replace the 

performance requirements with the 

performance requirements in 16 CFR 

part 1218, Safety Standard for Bassinets 

and Cradles, which incorporates by 

reference ASTM F2194–13 Standard 

Consumer Safety Specification for 

Bassinets and Cradles, with 

modifications. With the modifications 

in the mandatory standard, the standard 

is substantially similar to ASTM F2194– 

16e1, which we use for the assessment 

here. 

(a) Hazard: Design Issues 

When combining the data from the 

2019 SNPR with new incident data 

received since the SNPR, the ‘‘design 

issues’’ hazard is associated with 22 

deaths and 83 injuries. At least 20 

deaths involved infants rolling into a 

prone position (face down) and 

suffocating. More than one-third of the 

incidents also reported that infants 

rolled over—fully or partially—from 

their original supine (on their back) 

position. 

In the 2019 SNPR, we concluded that 

a flat sleeping surface that does not 

exceed 10 degrees from horizontal offers 

infants the safest sleep environment. 

This conclusion was based on findings 

from the Mannen Study. 84 FR at 

60955–56. Although some comments to 

the 2019 SNPR stated that more testing 

should be done to determine if the 

maximum angle for safe sleep may be 

between 10 degrees to 20 degrees, the 

Mannen Study suggested if future work 

were done on safe sleep angles, one area 

of study would be additional 

biomechanical testing to determine 

‘‘which, if any, angles between 10- and 

20-degrees may be safe for infant sleep.’’ 

The Mannen Study recommendations 

do not imply that an incline angle 

between 10 and 20 degrees may be safe 

for infant sleep, merely that if higher 

angles are considered, additional 

biomechanical testing is required. The 

Mannen Study also stated that its testing 

of awake infants was a limitation 

because ‘‘while the muscle use and 

motion may be similar, it is likely that 

infants who find themselves in a 

compromised position in an inclined 

sleep product during a nap or overnight 

sleep may not have enough energy or 

alertness to achieve self-correction and 

may succumb to suffocation earlier or 

more easily than infants who are fully 

awake.’’ 

Given the vulnerability of newborn 

infants and infant fatalities who were 

most likely asleep at the time of 

incidents in inclined products, we 

conclude that additional research of 

inclines above 10 degrees is 

unnecessary for the final rule. Based on 

the biomechanical results of the 

Mannen Study, and its conclusion that 

10 degrees is likely a safe incline for 

infant sleep, which supports the 10 

degrees stated in the scope of ASTM 

F2194–16e1, the Commission concludes 

that 10 degrees is the maximum sleep 

surface angle that should be allowed for 

any product intended for infant sleep 

for young infants up to 5 months old. 

Additionally, other research 33 has 

demonstrated a discernable difference 

in infant ability between 5, 7, and 10 

degrees in a side-to-side tilt, which 

formed the basis of the 7-degree 

maximum sleep surface angle in Health 

Canada’s regulations. Staff advises that 

additional research at angles higher than 

10 degrees is unlikely to alter their 

assessment that 10 degrees is the 

maximum safe incline for infant sleep. 

The current voluntary standard for 

infant inclined sleep products, ASTM 

F3118–17a, defines an ‘‘inclined sleep 

product,’’ in part, as having a seatback 

angle greater than 10 degrees and not 

exceeding 30 degrees. Based on the 

Mannen Study and the other factors 

discussed above, we conclude that 

ASTM F3118–17a does not adequately 

address the risk of injury related to a 

sleep surface incline greater than 10 

degrees, because the voluntary standard 

does not limit the sleep surface to a safe 

incline angle. In comparison, the 

voluntary standard for bassinets, ASTM 

F2194–16e1, defines a sleep surface as 

being less than or equal to 10 degrees, 

and includes performance requirements 

for mattress flatness that limit measured 

angles to 10 degrees or less.34 Therefore, 

for the mandatory standard specified in 

this final rule, with respect to sleep 

surfaces, all infant sleep products, 

including inclined sleep products, must 

meet the more stringent sleep surface 

angle requirement of the voluntary 

standard for bassinets, ASTM F2194– 

16e1, as codified in 16 CFR part 1218, 

to further reduce the risk of death from 

suffocation. 

(b) Hazard: Undetermined Product Issue 

This hazard category is associated 

with 28 deaths and six injuries. Among 

the 28 deaths and six injuries, staff was 

unable to determine the product’s role. 

Without information on the product’s 

role in deaths or injuries, we are unable 

to assess whether the voluntary 

standard for infant inclined sleep, 

ASTM F3118–17a, or the voluntary 

standard for bassinets, ASTM F2194– 

16e1, would adequately address the 

hazards in this category. 

(c) Hazard: Insufficient Information 

This hazard category is associated 

with 13 deaths and eight injuries. The 

reports did not provide information on 

the circumstances of deaths and injury 

reports involving unspecified falls. 

Without information on the 

circumstances of deaths or injuries, staff 

is unable to assess if the voluntary 

standard for infant inclined sleep, 

ASTM F3118–17a, or the voluntary 

standard for bassinets, ASTM F2194– 

16e1, would adequately address the 

hazards in this category. Falls are 

discussed in more detail in ‘‘Other 

Product-Related Issues,’’ below. 

(d) Hazard: Infant Placement 

This hazard category is associated 

with five deaths and no injuries. Three 

of the deaths involved infants placed in 

a prone position, and one death 

involved an infant placed in a supine 

position with a blanket covering the 

face. Based on the Mannen study, sleep 

surfaces with a 20-degree incline 

significantly increased the demand on 

abdominal muscles and could lead to 

increased fatigue and suffocation if an 

infant is unable to reposition themselves 

after rolling from a supine to prone 

position. In three of the deaths in this 

hazard category, the infant was placed 

in the prone position and the inclined 

sleep surface may have contributed to 

suffocation if the angle of the sleep 

surface led to fatigue that prevented the 

infant from rolling to a supine position. 


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While infants can die in flat products 

when placed to sleep in the prone 

position, based on the Mannen Study, 

an inclined surface could further 

contribute to deaths in the prone 

position. A sleep surface limited to a 10- 

degree or less incline, as required in the 

bassinet standard (ASTM F2194–16e1), 

could reduce the risk of injury 

associated with the prone position, 

when compared to an inclined sleep 

product. Therefore, with respect to sleep 

surfaces, for the mandatory rule, all 

infant sleep products, including 

inclined sleep products, must meet the 

more stringent sleep surface angle 

requirement of the voluntary standard 

for bassinets, ASTM F2194–16e1, as set 

forth in 16 CFR part 1218, to further 

reduce the risk of death from 

suffocation. 

(e) Hazard: Other Product-Related Issues 

(Instability, Restraints, etc.) 

This hazard category includes reports 

of instability (product tipping over) and 

containment; the category is associated 

with one death and nine injuries. One 

death occurred when a foam-type 

reclined product tipped over and fell 

from the adult bed to the floor, trapping 

the infant underneath. Most of the 

injuries involved falls and at least 10 

reports (with no injury reported) related 

to nearly or completely flipped over 

products. 

The death, and most likely the 

injuries, relate to the stability of the 

product and how easy it is to tip the 

product over into a hazardous situation. 

The voluntary standard for infant 

inclined sleep products, ASTM F3118– 

17a, includes two stability performance 

requirements that apply to ‘‘Compact 

Inclined Sleep Products’’ and ‘‘Infant or 

Newborn Inclined Sleep Products.’’ For 

the ‘‘Compact Inclined Sleep Products,’’ 

the product must remain upright when 

placed on a 20-degree inclined test 

platform. For the ‘‘Infant or Newborn 

Inclined Sleep Products,’’ a 23-lb. 

vertical force and 5-lb. horizontal force 

are applied to the product’s side with a 

newborn CAMI dummy occupant to 

simulate an older sibling pulling up on 

the side to view the infant in the 

bassinet, and the product must remain 

upright containing the CAMI dummy. 

The ‘‘Compact Inclined Sleep Products’’ 

are exempt from the 23- and 5-pound 

force requirements, with the rationale 

that the compact products are intended 

to sit on a floor and are unlikely to have 

an older sibling attempt to pull up to see 

the infant inside. 

The current voluntary standard for 

bassinets, ASTM F2194–16e1, includes 

an identical stability requirement that 

applies a 23-lb. vertical force and a 5- 

lb. horizontal force to the product with 

a newborn CAMI dummy occupant, and 

this requirement applies to all products; 

it does not provide exemptions for 

‘‘Compact Inclined Sleep Products’’ to 

meet only the less stringent 20-degree 

inclined test platform test. The rationale 

in ASTM F2194 states the dual 

application of forces simulates a 2-yearold male pulling on the side of the 

product; staff advises that sibling 

interaction is a reasonable scenario 

which may cause the product to tip 

over. Due to the portability of some of 

the unregulated compact sleep products, 

incident data confirm that the products 

are used on raised surfaces from which 

infants and product may fall. Therefore, 

regarding the product’s stability, in the 

final rule, all infant sleep products, 

including inclined products, must meet 

the more stringent stability requirement 

of the voluntary standard for bassinets, 

ASTM F2194–16e1, as codified in 16 

CFR part 1218, to further reduce the risk 

of injury from tip over of the product. 

(f) Hazard: Structural Integrity 

This hazard category includes reports 

of some component failures on the 

product such as buckles/straps, 

hardware coming loose, hub/rail/leg 

coming loose, or other unspecified 

components breaking. This hazard 

category involved no deaths and four 

injuries. All injuries were related to 

falls, and include one hospitalization 

and three emergency department visits. 

The voluntary standard for infant 

inclined sleep products, ASTM F3118– 

17a, includes performance requirements 

to assess the integrity of inclined sleep 

products. The requirements specify a 

dynamic test in which an 18-lb. load, 

consisting of a 6- to 8-inch steel shot 

bag, is dropped 50 times from a height 

of 1.0 inch onto the seat surface. The 

requirements also specify a static test in 

which a 50-lb. load or three times the 

product’s maximum recommended 

weight, whichever is greater, is 

gradually applied through a 6-inch 

square wooden block to the seat surface 

for 60 seconds. The current voluntary 

standard for bassinets, ASTM F2194– 

16e1, has a performance requirement to 

address structural integrity that 

specifies a static load test that applies a 

54-lb. load or three times the 

manufacturer’s recommended weight, 

whichever is greater, through a 6-inch 

aluminum block to the sleep surface for 

60 seconds. The rationale in ASTM 

F2194 states 54 lbs. is three times the 

weight of the 95th percentile of a 3- to 

5-month-old infant. 

Although the voluntary standard for 

infant inclined sleep products, ASTM 

F3118–17a, requires a dynamic test for 

structural integrity, its effectiveness in 

evaluating the product’s strength is 

minimal, compared to the static test. 

The load in the dynamic test being onethird of the static load, the low drop 

height, short test timeframe, and 

presence of energy-absorbing material 

(shot bag and flexible product material), 

combine to minimize the effect of this 

test on the product’s structural integrity. 

In contrast, the static test applies a 

much larger load, three times the 

heaviest infant in the product, with a 

rigid applicator applied continuously 

for 60 seconds. Therefore, staff advises 

that the static test is the more stringent 

evaluator of product integrity than the 

dynamic test. 

The static load in ASTM F2194–16e1 

is 54 lbs., which is a more stringent load 

compared to the static load of 50 lbs. in 

ASTM F3118–17a. Therefore, to further 

reduce the risk of injury associated with 

structural defects, for the final rule, the 

Commission concludes that the static 

load test in ASTM F2194 is adequate to 

assess structural integrity of infant sleep 

products, and is more stringent than the 

static load test in ASTM F3118–17a. 

The final rule requires that all infant 

sleep products, including inclined sleep 

products, meet the more stringent 

structural integrity requirement of the 

voluntary standard for bassinets, ASTM 

F2194–16e1, as codified in 16 CFR part 

1218. 

(g) Hazard: Electrical Issues 

This hazard category involved no 

deaths and two reports of injuries 

related to electric shock. Non-injury 

incidents reported overheating/melting 

of components and issues with batteries. 

As noted in the 2019 SNPR, the infant 

inclined sleep products standard, ASTM 

F3118–17a, does not include any 

performance requirements for electrical 

components. 84 FR at 60956. The 

voluntary standard for bassinets, ASTM 

F2194–16e1, also does not address 

electrical hazards. However, CPSC staff 

advises that they raised this issue with 

ASTM, and that the ASTM Ad Hoc task 

group is developing performance 

requirements to address electrical 

hazards across juvenile products. As 

these electrical requirements are added 

during the ASTM voluntary standard 

updates, CPSC can review the updated 

voluntary standard pursuant to the 

update provision in Public Law 112–28, 

and determine whether to revise the 

mandatory standard based on a revised 

voluntary standard. 


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4. Assessment of International 

Standards 

(a) EN1466:2014 Carry Cots 

The BS EN 1466:2014 Child use and 

care articles—Carry cots and stands— 

Safety requirements and test methods 

European standard applies to products 

intended for carrying a child in a lying 

position using a handle or stand. This 

standard applies to children who cannot 

sit unaided or roll over or push up on 

their hands and knees and is a 

maximum weight of 19.84 pounds. 

i. Side Height 

For cots on a stand, EN 1466:2014 

standard requires an internal height of 

at least 7.87 inches (200 mm) from the 

top of a mattress, compressed by a 

19.84-pound (9kg) steel plate, to the 

lowest point of the upper edge of the 

sides. For carry cots not on a stand, the 

standard requires an internal height 5.9 

inches (150mm) to 7.09 inches 

(180mm), depending on the length of 

the cot, using the same test method. 

This requirement measures the internal 

side height when an occupant of the 

maximum weight compresses the 

mattress. This standard has a side height 

requirement similar to the ASTM 

F2194–16e1 bassinet standard, which 

requires a minimum side height of 7.5 

inches from an uncompressed mattress. 

For bassinets on a stand, if the mattress 

compresses more than 3⁄8 of an inch, 

ASTM F2194–16e1 requires a higher 

side. For bassinets not on a stand, 

ASTM F2194–16e1 has a higher side 

height of 7.5 inches from an 

uncompressed mattress, compared to 

the EN 1466:2014 requirement, which is 

7.09 inches from a compressed mattress. 

Additionally, ASTM F2194–16e1 

requires a consistent side height no 

matter the configuration. 

ii. Sleep Surface Angle 

The EN 1466:2014 standard requires a 

maximum sleep surface angle of 10 

degrees. This requirement is similar to 

the ASTM F2194–16e1 bassinet 

standard, which requires a maximum 

sleep surface angle of 10 degrees. 

iii. Latching Requirements 

The EN 1466:2014 standard requires 

products with a folding stand 

mechanism not to collapse after the 

latch is operated (closed and opened) 

300 times, and after a 44.96 pound-force 

(200N) is applied in the area of the 

stand most likely to cause the product 

to fold. The EN 1466:2014 standard’s 

latching requirement only simulates the 

action of unintentionally folding the 

stand without the carry cot or box 

assembled on the stand. In contrast, the 

ASTM F2194–16e1 bassinet standard 

tests both the stand and the bassinet as 

a fully assembled product. 

The ASTM F2194–16e1 bassinet 

standard requires products without a 

latching or locking device not to fold 

when a 20 pound-force is applied to the 

top edge of the bassinet in the direction 

most likely to cause it to fold. The 

ASTM F2194–16e1 bassinet standard 

requires a lower force than the EN 

standard, but the force is applied at a 

higher location (top side of the bassinet) 

than the EN standard (force applied to 

the stand). The higher location of the 

force can create a higher torque at the 

latch due to the longer lever arm. For 

bassinets with a locking hinge or latch, 

the locking mechanism must withstand 

a 10-pound force in the direction most 

likely to release it. Determining which 

latching requirement is more stringent is 

difficult because the test parameters are 

not directly comparable. Staff assesses 

that testing the product fully assembled, 

as required by ASTM, is a better test 

because it simulates realistic use of the 

product. 

The ASTM standard also includes a 

Removable Bassinet Bed Attachment to 

Base/Stand requirement and testing to 

address latching and locking devices 

intended to secure removable bassinet 

beds to the base/stand. These 

requirements and test are unique 

because they address known incidents 

of false latching of a removable bassinet 

bed. By considering the latching, 

unintentional folding, and bassinet bed 

attachments to the stand requirements 

in total, staff assesses that the ASTM 

F2194–16e1 bassinet standard’s latching 

requirements are adequate. 

iv. Stability Requirements 

The EN1466:2014 standard requires 

products with an occupant test mass of 

15.43 pounds not to tip over when 

placed on a 20-degree surface. 

EN1466:2014 rationalizes this test by 

stating: ‘‘Carry cots shall be designed so 

that they do not tip over when they are 

placed on slightly sloping ground or 

when the child leans against one side of 

the carry cot.’’ This is different 

compared to the ASTM F2194–16e1 

bassinet standard that requires the 

product (with simulated newborn 

occupant) to withstand a 23-lb. vertical 

force and 5-lb. horizontal force along its 

side, without tipping. The rationale in 

ASTM F2194 states the dual application 

of forces simulates a 2-year-old male 

pulling on the side of the product; staff 

advises that this is a reasonable scenario 

in which the product may tip over. 

Determining which stability 

requirement is more stringent is 

difficult, because both standards’ torque 

arms depend upon the product’s 

geometry. Using a 10-inch wide by 10- 

inch tall sidewall box on a 10-inch 

stand as a reference product for 

comparison, staff determined the 

reference product would fail the ASTM 

F2194 bassinet standard’s test and pass 

the EN 1466 standard’s test. Therefore, 

staff assesses that the ASTM 2194–16e1 

bassinet standard’s stability requirement 

is more stringent for this reference 

product. 

v. EN1466:2014 Summary 

The EN 1466:2014 carry cots standard 

has a side height and sleep surface angle 

requirement similar to ASTM F2194– 

16e1’s bassinet standard. However, the 

ASTM F2194–16e1 standard has a 

potentially more stringent stability 

requirement. 

(b) EN 1130:2019 Children’s Cribs and 

Cradles 

The European Standard, EN 1130–1: 

2019 ‘‘Furniture—Cribs and Cradles for 

Domestic Use’’ has several requirements 

not found in ASTM F2194–16e1. Most 

of these additional requirements address 

hazards associated with cribs intended 

for use with older children (in excess of 

the 5-month recommended maximum 

age for bassinets); and thus, these 

requirements are not applicable to 

bassinets. 

i. Side Height 

The EN 1130:2019 standard requires a 

side height of at least 7.87 inches (200 

mm) when a 19.84-pound (9kg) steel 

plate is placed on the compressed 

mattress. This measures the crib’s 

internal side height with a 19.84-pound 

occupant is compressing the mattress. 

This standard has a side height 

requirement similar to the ASTM 

F2194–16e1 bassinet standard, which 

requires a minimum side height of 7.5 

inches from an uncompressed mattress. 

If the mattress compresses more than 3⁄8

of an inch, ASTM F2194–16e1 requires 

a higher side. 

ii. Sleep Surface Angle 

The EN 1130:2019 standard requires a 

maximum sleep surface angle of 10 

degrees. This standard has a sleep 

surface angle requirement similar to the 

ASTM F2194–16e1 bassinet standard, 

which requires a maximum sleep 

surface angle of 10 degrees. 

iii. Latching Requirements 

The EN 1130:2019 standard requires 

folding products to contain a dualaction locking mechanism, and to 

unlock with a tool, and to fold only 

when the crib is lifted, or not collapse 

after the latch is operated (closed and 


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opened) 300 times, and at least an 

11.24-pound force (50N) is required to 

unlock it. The EN 1130:2019 standard’s 

latching requirement only simulates the 

action of unintentionally folding the 

product’s folding or adjustable legs, 

while the ASTM F2194–16e1 bassinet 

standard tests both the standard and the 

bassinet as a fully assembled product. 

The ASTM F2194–16e1 bassinet 

standard requires products without a 

locking mechanism to withstand a 20- 

pound force applied to the top edge of 

the bassinet in the direction most likely 

to cause it to fold. For products with a 

locking hinge or latch, the locking 

mechanism must withstand a 10-pound 

force in the direction most likely to 

release it. Staff’s assessment is that 

testing the product fully assembled, as 

required by ASTM, is a better test 

because it simulates realistic use of the 

product. 

The ASTM standard also includes a 

Removable Bassinet Bed Attachment to 

Base/Stand requirement and testing to 

address latching and locking devices 

intended to secure removable bassinet 

beds to the base/stand. These 

requirements and the test are unique 

because they address known incidents 

of false latching of a removable bassinet 

bed. By considering the latching, 

unintentional folding, and bassinet bed 

attachments to the stand requirements 

in total, staff assesses that the ASTM 

F2194–16e1 bassinet standard’s latching 

requirements are adequate. 

iv. Stability Requirements 

The EN1330:2019 standard requires 

products not to tip over when a 19.87- 

pound weight is placed on one side of 

the crib, while on the opposite side’s 

top rail, a 6.74 pound-force is 

horizontally applied towards the 

weight. This test is similar to the ASTM 

F2194–16e1 bassinet standard with 

reasonably similar forces. EN1330:2019 

rationalizes the test, stating the product 

‘‘should remain stable when the child 

moves in the crib or when the crib 

swings along the amplitude permitted 

by the suspension device.’’ ASTM 

F2194–16e1 is based on U.S. incident 

data of a 2-year-old sibling pulling over 

a bassinet, which is a more severe 

condition than an infant moving within 

the product. Therefore, staff concludes 

the ASTM F2194–16e1 bassinet 

standard’s stability requirements are 

adequate. 

v. EN 1130:2019 Summary 

The EN 1130:2019 children’s cribs 

and cradle standard has side height, 

sleep surface angle, and stability 

requirements similar to the ASTM 

F2194–16e1 bassinet standard; however, 

the ASTM F2194–16e1 standard has a 

more extensive and stringent latching 

requirement. 

(c) AS/NZS 4385:1996 Infant’s Rocking 

Cradles 

The Australian/New Zealand standard 

(AS/NZS 4385:1996) contains 

requirements for rocking and swinging 

angles used to develop some of the 

ASTM F2194–12 requirements. The 

ASTM rock/swing rest angle 

performance requirement is more 

stringent because the occupant 

surrogate, a CAMI dummy, is placed 

against the sidewall, resulting in higher 

rest angles. 

i. Side Height 

The AS/NZS 4385:1996 standard 

requires a minimum side height of 11.81 

inches (300 mm) between the top of the 

mattress support to the top edge of the 

lowest rocking cradle’s side. The 

maximum mattress thickness the AS/ 

NZS standard permits is 2.95 inches 

(75mm). Therefore, the minimum side 

height between the top of the mattress 

and the top edge of the lowest side is 

8.85 inches. This is similar to the ASTM 

F2194–16e1 bassinet standard, which 

requires a minimum side height of 7.5 

inches between the top of the mattress 

and the top of the lowest sidewall. 

ii. Sleep Surface Angle 

The AS/NZS 4385:1996 standard 

requires the mattress angle on rocking 

cradles without a self-leveling device 

not to exceed 5 degrees and 10 degrees 

on rocking cradles with a self-leveling 

device. This is similar to the ASTM 

F2194–16e1 bassinet standard, which 

requires a maximum sleep surface angle 

of 10 degrees. 

iii. Latching Requirements 

The AS/NZS 4385:1996 standard does 

not contain any latching requirements to 

address the unintentional folding 

hazard. The ASTM F2194–16e1 bassinet 

standard is more stringent because it 

requires products without a locking 

mechanism to withstand a 20-pound 

force without folding, or a 10-pound 

force for hinges with locking 

mechanisms. The ASTM F2194–16e1 

also addresses the false latching of a 

removable bassinet bed with 

requirements including an automatic 

locking latch or a false latch indicator. 

iv. Stability Requirements 

The AS/NZS 4385:1996 standard 

requires a product not to tip over when 

a 19.84-pound (9 kg) weight is on the 

mattress and a 4.49-pound force (20N) is 

applied horizontally to the uppermost 

rail. This test is similar to the ASTM 

F2194–16e1 bassinet standard, which 

requires the product (with simulated 

newborn occupant) to withstand a 23- 

pound vertical force and 5-lb. horizontal 

force along its side, without tipping. 

The rationale in ASTM F2194 states the 

dual application of forces simulates a 2- 

year-old male pulling on the side of the 

product; staff concludes that this is a 

reasonable scenario in which the 

product may tip over. 

v. AS/NZS 4385:1996 Summary 

The AS/NZS 4385:1996 infant’s 

rocking cradle standard has a side 

height, sleep surface angle, and stability 

requirement similar to the ASTM 

F2194–16e1 bassinet standard. 

However, the ASTM F2194–16e1 

bassinet standard has a more stringent 

latching requirement. 

(d) Canadian Standard (SOR/2016–152) 

Cribs, Cradles, and Bassinets 

The Canadian standard (SOR/2016– 

152) includes requirements for cribs, 

cradles, and bassinets. Staff focused 

their analysis on the requirements for 

‘‘bassinets,’’ which are defined as 

providing sleeping accommodations for 

a child with sides to confine the child, 

and a sleep surface area less than or 

equal to 4000 cm2 (620 in2). 

i. Side Height 

The Canadian standard requires a 

minimum side height of 230 mm (9.05 

inches), measured from the mattress 

support. Because ASTM F2194–16e1 

allows a bassinet mattress of 1.5 inches, 

measuring from the upper surface of the 

mattress support to the upper surface of 

the side would be 1.5 inches greater 

than measuring from the upper surface 

of an uncompressed mattress. Therefore, 

staff advises that the 7.5-inch side 

height, from the upper surface of an 

uncompressed mattress, is functionally 

equivalent to the 9-inch side height, 

measured from the upper surface of the 

mattress support in the Canadian 

standard. 

ii. Sleep Surface Angle 

The Canadian standard requires the 

sleep surface angle not to exceed 7 

degrees, which is based on a 1995 study 

that demonstrated a discernable 

difference in infant ability between 5, 7, 

and 10 degrees in a side-to-side tilt. 

Staff advises they understand that 

Health Canada selected 7 degrees and 

applied it to all sides of the product, 

regardless of head-to-toe or side-to-side 

tilt. The ASTM F2194–16e1 bassinets 

standard allows for a side-to-side resting 

angle of 7 degrees for rocking cradles, 

and limits head-to-toe angle to 10 

degrees. As discussed in section 


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35Tab C of Staff’s Final Rule Briefing Package 

contains CPSC staff’s assessment of the adequacy of 

ASTM F2194–16e1 to address incidents associated 

with flat sleep products. 

VI.A.3(a) of this preamble, based on the 

Mannen Study and other factors, the 

Commission concludes that a flat 

sleeping surface that does not exceed 10 

degrees from horizontal offers infants 

the safest sleep environment. 

iii. Latching Requirements 

The Canadian standard requires 

folding products to contain an autolocking mechanism that requires a dualsimultaneous action to disengage and 

that does not fold when a 52.91-pound 

(24kg) load is applied on any area most 

likely to damage the mattress support. 

While the Canadian standard requires 

an auto-locking mechanism that 

requires a dual-simultaneous action to 

disengage, it also tests the latching 

strength by loading the mattress 

support. The ASTM F2194–16e1 

bassinet standard requires that products 

without a latching or locking device not 

fold when a 20-pound force is applied 

to the top edge of the bassinet in the 

direction most likely to cause it to fold. 

The ASTM F2194–16e1 bassinet 

standard requires a lower force than the 

Canadian standard, but the force is 

applied at a higher location (top side of 

the bassinet) than the Canadian 

standard (force applied to the mattress 

support). The higher location of the 

force could create a greater torque at the 

latch, due to the longer lever arm. For 

bassinets with a locking hinge or latch, 

the locking mechanism must withstand 

a 10-pound force in the direction most 

likely to release it. Determining which 

latching requirement is more stringent is 

difficult because the test parameters are 

not directly comparable. 

The ASTM standard also includes a 

Removable Bassinet Bed Attachment to 

Base/Stand requirement and testing to 

address latching and locking devices 

intended to secure removable bassinet 

beds to the base/stand. These 

requirements and test are unique 

because they address known incidents 

of false latching of a removable bassinet 

bed. By considering the latching, 

unintentional folding, and bassinet bed 

attachments to the stand requirements 

in total, staff assesses that the ASTM 

F2194–16e1 bassinet standard’s latching 

requirements are adequate. 

iv. Stability Requirements 

The Canadian requirement in 

Schedule 11, Test for Stability of 

Cradles, Bassinets, and Stands, of their 

regulation is substantially equivalent to 

the requirement in ASTM F2194–16e1. 

The requirement specifies that the 

product (with a simulated newborn 

occupant) must withstand a 10-kg 

(approximately 22 pounds) static 

vertical load over a period of 5 seconds 

and a 22 N (approximately 4.9 pounds) 

horizontal force, without tipping. Staff 

advises that this test evaluates the same 

stability hazard and is substantially 

equivalent to the ASTM F2194–16e1 

bassinets standard, differing slightly 

due to conversions to metric. 

v. SOR/2016–152 Summary 

The Canadian standard has a side 

height and stability requirement similar 

to the ASTM F2194–16e1 bassinet 

standard. While the Canadian standard 

has a more stringent sleep surface angle 

requirement, the ASTM F2194–16e1 

bassinet standard has a more extensive 

latching requirement. Staff concludes 

that the requirements in the ASTM 

standard are adequate to address the 

risk of injury demonstrated in the 

incident data. 

B. Flat Sleep Products 35

CPSC received public comments on 

the 2019 SNPR regarding the safety of 

currently unregulated flat infant sleep 

products available in the marketplace. 

In response, for the final rule CPSC staff 

completed a review of CPSC’s 

epidemiological databases, CPSRMS 

and NEISS. CPSC received a total of 183 

incident reports from January 1, 2019 

through December 30, 2020, related to 

flat sleep products available in the 

marketplace that are currently not under 

the purview of any mandatory or 

voluntary standard that addresses sleep 

hazards. These flat sleep products 

include: In-bed sleepers, baskets (that 

can function as hand-held carriers as 

well), baby boxes, compact bassinets, 

most of which are portable for travel, 

and travel tents. All of these 

unregulated sleep products are flat 

(sleep surface has no incline) and most 

come with mattress pads (with the 

exception of some baby travel tents). 

Based on the following analysis, the 

Commission determines that the 

performance and labeling requirements 

of the voluntary standard for bassinets 

and cradles, ASTM F2194–16e1, as 

codified in 16 CFR part 1218, Safety 

Standard for Bassinets and Cradles, are 

adequate to address the risk of injury 

associated with flat infant sleep 

products, and furthermore, finds that 

requiring flat products to conform to 

these requirements would also further 

reduce the risk of injury associated with 

flat sleep products. 

1. Hazard Pattern Categories 

Of the 183 reported incidents, 11 are 

fatalities; among the remaining 172 

nonfatal incidents, 16 reported an 

injury. Seven of the 11 fatalities 

involved suffocation. We identified six 

hazards related to the risk of injury or 

death (we did not consider patterns that 

did not relate to injuries or deaths, such 

as consumer comments). The hazard 

patterns identified among the 183 

incidents are: Lock/latch problems, 

falls/containment issues, instability, 

asphyxiation/suffocation, productrelated issues, and undetermined 

causes. 

Engineering staff analyzed whether 

the voluntary standard for bassinets, 

ASTM F2194–16e1, would address the 

identified hazards for flat sleep 

products. The voluntary standard for 

bassinets, ASTM F2194–16e1, is more 

applicable to these flat products than 

ASTM F3118–17a, because these 

products have a sleep surface less than 

10 degrees, and because, as set forth 

below, the standard addresses the 

identified hazards associated with these 

products. The current voluntary 

standard for infant inclined sleep 

products, ASTM F3118–17a, is not 

applicable to these flat sleep surface 

products, and it does not address 

hazards associated with flat sleep 

surfaces. 

In the 2019 SNPR, the Commission 

proposed expanding the scope of ASTM 

F3118–17a for the mandatory rule, to 

include all infant sleep products 

(inclined and flat) that are not covered 

by another CPSC sleep standard, 

including the bassinets, cribs (full-size 

and non-full size), play yards, or 

bedside sleepers standards. The 2019 

SNPR proposed to require that all 

products marketed or intended for 

infant sleep have a seatback angle of 10 

degrees or less, and meet 16 CFR part 

1218, Safety Standard for Bassinets and 

Cradles, which includes the 

performance requirements of ASTM 

F2194–16e1 bassinets. The following are 

the identified hazards for flat sleep 

products are discussed below. 

(a) Hazard: Lock/Latch Issue 

One hundred fifteen of the 183 

incidents, and no deaths, were related to 

latches that control the opening/closing 

of the cover on the product failed. 

Although these latch incidents did not 

relate to a product folding or collapsing, 

they illustrate, nevertheless, that these 

products have latch failures. From 

analyses on other products, staff is 

aware that failure of a product’s latch 

can cause the product to fold or collapse 

unintentionally and pose a suffocation 

hazard to the infant. The ASTM F2194– 

16e1 bassinets standard addresses 

hazards posed by a lock/latch failure 

with an unintentional folding 


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36 78 FR 63,109 (Oct. 23, 2013). 

requirement. The requirement specifies 

that if a folding product does not have 

a latching or locking device, then it 

shall not fold when a 20-lb. force is 

applied in the direction most likely to 

fold the product (with simulated infant 

occupant). The requirement also 

specifies if a folding product does have 

a single-action latch, then it shall not 

fold when a 10-lb. force is applied in the 

direction most likely to fold the 

product. Staff assesses that this 

requirement adequately simulates the 

action of unintentionally folding the 

product, and therefore, to address this 

risk of injury, we conclude that all flat 

sleep products with a lock or latch 

should at least meet the ASTM F2194– 

16e1 bassinets standard’s unintentional 

folding requirement. 

The ASTM F2194–16e1 bassinets 

standard also includes a ‘‘Removable 

Bassinet Bed Attachment to Base/ 

Stand’’ performance requirement. A 

removable bassinet bed attaches to the 

bassinet stand and is secured with a 

latch/lock. This requirement states a 

removable bassinet bed shall: 

• Not be supported by the bassinet 

stand in an unlocked/latched 

configuration; 

• automatically lock to the bassinet 

stand and can’t be placed in an 

unlocked position on the bassinet 

stand; 

• clearly and obviously be unstable 

when the product is unlocked/latched 

by placing the sleeping surface at a 

20-degree incline; 

• have a false latch/lock visual 

indicator designed to visually alert 

caregivers when the bed is not 

properly locked to the stand; or 

• have a lock/latch mechanism that is 

not needed to pass the stability 

requirement. 

The purpose of this requirement is to 

ensure that bassinets that can be 

removed from their stand are securely 

latched to the stand when in use. Staff 

assesses that the ASTM F2194–16e1 

bassinets standard’s requirement 

adequately simulates the action of a 

bassinet unintentionally unlatching 

from its stand. Staff also assesses that 

the ASTM F2194–16e1 bassinets 

standard’s requirement is more stringent 

compared to the ASTM F3118–17a 

infant inclined sleep products standard, 

which lacks a requirement for products 

that can be removed from a stand. 

Therefore, the final rule requires that 

flat sleep products meet the ASTM 

F2194–16e1 bassinets standard’s 

‘‘unintentional folding requirement’’ 

and the ‘‘Removable Bassinet Bed 

Attachment to Base/Stand 

requirement,’’ if applicable, to address 

the risk of injury associated with locks 

and latching features on these products. 

(b) Hazard: Falls/Containment Issue 

Twelve of the 183 incidents were 

related to falls or an infant otherwise 

not being kept contained within the 

product. Of the 12 incidents, one 

resulted in a death, one required 

hospital admission, and nine required 

ED visits. Failure to contain occupants 

in an infant sleep product can lead to 

infants falling or climbing out of the 

infant sleep product into a hazardous 

area. 

Typically, regulated sleep products do 

not allow an active occupant restraint 

system for occupant containment. 

Active restraint systems are only 

effective when the caregiver actively 

uses them and adjusts them correctly; 

however, in a sleep environment, active 

restraints can create an entanglement 

and asphyxiation hazard. 

The ASTM F2194–16e1 bassinets 

standard does not allow the use of 

restraints, and instead addresses 

containment-related hazards posed with 

a side height requirement, a passive 

safety feature. The requirement specifies 

that the product’s interior side height 

with an uncompressed mattress shall be 

at least 7.5 inches. 

In 2012, the ASTM F2194–12 

bassinets standard first required a 

minimum 7.5-inch side height based on 

the Canadian standard.36 The side 

height is measured from the upper 

surface of the uncompressed mattress to 

the upper surface of the lowest side. 

This requirement remains in effect in 

the most recent version of the bassinets 

standard, ASTM F2194–16e1. Canada 

requires a side height of 230 mm (9 

inches), measured from the mattress 

support. Because ASTM F2194–16e1 

allows a bassinet mattress of 1.5 inches, 

measuring from the upper surface of the 

mattress support, which is underneath 

the mattress, to the upper surface of the 

side would be 1.5 inches greater than 

measuring from the upper surface of an 

uncompressed mattress. Therefore, staff 

assesses that the 7.5-inch side height, 

from the upper surface of an 

uncompressed mattress is functionally 

equivalent to the 9-inch side height, 

measured from the upper surface of the 

mattress support in Canada. 

Products that CPSC staff identified as 

flat sleep products are not currently 

subject to a voluntary or mandatory 

standard that specifies a minimum side 

height. Flat sleep products that are 

considered hand-held carriers under 16 

CFR part 1225, Safety Standard for 

Hand-Held Infant Carriers, and ASTM 

F2050–19, Standard Consumer Safety 

SpeciÉcation for Hand-Held Infant 

Carriers, can be defined as a ‘‘hand-held 

bassinet/cradle’’ product intended for 

sleep, but ‘‘hand-held bassinet/cradles’’ 

are not subject to a side height 

requirement in the mandatory or 

voluntary standard. Products without a 

minimum side height could fail to 

contain occupants, which can lead to 

infants falling or climbing out of the 

product into a hazardous area. 

Table 4 shows the side height 

requirements for each sleep product 

standard. Sleep products that have a 

minimum side height requirement range 

from 2-inches for the voluntary standard 

for infant inclined sleep products, to 9- 

inches for cribs. Bassinets, bedside 

sleepers, and infant inclined sleep 

products are intended for infants from 

birth to 5-months old. Cribs are 

intended for newborns up to children 

35-inches tall, which is equivalent to a 

95th percentile in stature 21-month-old. 

TABLE 4—SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTS

Standard Side height requirement Age range 

16 CFR 1218—Safety Standard for Bassinets and Cradles ..................

ASTM F2194–16e1, Standard Consumer Safety Specification for Bassinets and Cradles. 

7.5 inches ...................................... 0–5 months, or sit up. 

16 CFR 1219—Safety Standard for Full-Size Baby Cribs ......................

ASTM F1169–19, Standard Consumer Safety Specification for FullSize Baby Cribs. 

9 inches ......................................... 0–35 inches tall (95th percentile 

21-month old). 


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TABLE 4—SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTS—Continued 

Standard Side height requirement Age range 

16 CFR 1220—Safety Standards for Non-Full-Size Baby Cribs ............

16 CFR 1221—Safety Standards for Play Yards. 

ASTM F 406–19, Standard Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards. 

9 inches ......................................... 0–35 inches tall (95th percentile 

21-month old). 

16 CFR 1222—Safety Standard for Bedside Sleepers ..........................

ASTM F2906–13, Standard Consumer Safety Specification for Bedside Sleepers. 

4 inches on side next to adult bed. 

7.5 inches for other 3 sides.

0–5 months, or sit up. 

ASTM F3118–17a, Standard Consumer Safety Specification for Infant 

Inclined Sleep Products.

3 inches .........................................

2 inches .........................................

0–5 months, or sit up. 

0–3 months. 

16 CFR part 1225 Safety Standard for Hand-Held Infant Carrier ..........

ASTM F2050–19 Standard Consumer Safety Specification for HandHeld Infant Carrier. 

No requirements.

Inclined sleep products covered in 

ASTM F3118–17a can meet the standard 

with a minimum side height of 3-inches, 

for products intended for newborns, to 

5-month of age and a minimum side 

height of 2-inches, for products 

intended for newborns up to 3-months 

old. 

Upon review of applicable standards, 

CPSC staff determined that the ASTM 

F2194–16e1 bassinets standard’s 7.5- 

inch side height requirement provided 

the greatest safety for the intended use 

for newborns to 5-months of age. Staff 

assesses that the minimum side height 

requirement of 2-inches and 3-inches in 

ASTM F3118–17a is inadequate to 

address the incidents of infants failing 

to be contained in low-sided products, 

and the 3-inch side height is lower than 

the center of gravity of a 5-month-old 

infant on its side. Staff determined that 

because most flat sleep products are 

intended for infants under 5 months, 

who cannot sit upright unassisted, the 

side height requirement in ASTM 

F2194–16e1 is adequate to address 

containment incidents. Based on staff’s 

analysis, the Commission determines 

that flat sleep products with no side 

height requirements pose a potential fall 

hazard, as reflected in the incident data. 

Staff’s analysis demonstrates that the 

ASTM F2194–16e1 bassinets standard’s 

7.5-inch side height requirement is 

appropriate and would adequately 

address the falls/containment hazard in 

flat sleep products for infants up to 5 

months old or who cannot sit up 

unassisted. Therefore, consistent with 

the 2019 SNPR, the final rule requires 

that all infant sleep products, inclined 

and flat, meet the side height 

requirement of the ASTM F2194–16e1 

bassinets standard, as provided in 16 

CFR part 1218, to address fall/ 

containment hazards. 

(c) Hazard: Instability 

Twelve of the 183 incidents were 

related to the instability of the product. 

An unstable product can lead to tip-over 

incidents. Of the 12 incidents, two 

resulted in injuries, one involved an ED 

visit. The data summarized in Tab B of 

the Staff’s Final Rule Briefing Package 

includes at least one incident in a small, 

portable infant sleep product involving 

a sibling interaction resulting in a fall. 

Specifically, the NEISS report states: 

‘‘7WKOF WITH HEAD INJURY, FELL 

FROM PORTABLE BASSINET THAT 

WAS ON COUCH, APPROX 1.5FT, 

YOUNGER BROTHER PULLED THE 

BASSINET AND IT FLIPPED ONTO 

THE PLAYMAT, PT LANDED ON RT 

SIDE OF HEAD.’’ This sibling 

interaction-type incident is addressed 

by the bassinet standard, as discussed 

below. 

Unregulated flat sleep products are 

not required to have a stand. Therefore, 

these products can be placed directly on 

the floor or on potentially hazardous or 

unstable elevated surfaces, such as 

tables, countertops, soft mattresses, or 

couches. The ASTM F2194–16e1 

bassinets standard addresses this hazard 

scenario by requiring bassinets to have 

a stand/base/frame. ASTM F2194–16e1 

defines a ‘‘bassinet’’ as a small bed 

‘‘supported by free standing legs, a 

stationary frame/stand, a wheeled base, 

a rocking base, or which can swing 

relative to a stationary base.’’ This 

requirement to have a stand, and be 

raised off the floor, increases the 

stability of a portable product by 

discouraging or preventing use of the 

product on other, less stable, surfaces, 

such as elevated surfaces or soft surfaces 

(couches and adult beds). Therefore, 

with respect to this hazard scenario, and 

as proposed in the 2019 SNPR, the final 

rule requires that all infant sleep 

products, flat and inclined, meet the 

ASTM F2194–16e1 bassinets standard’s 

requirements, including requiring 

products to have a stand, to further 

reduce the risk of injury from a product 

placed on a hazardous elevated surface 

or an unstable surface, such as a couch 

or adult bed. This requirement in the 

final rule is codified by requiring 

products to meet the definitional 

requirement of a ‘‘bassinet/cradle.’’ 

Additionally, the ASTM F2194–16e1 

bassinets standard addresses hazards 

posed by the product’s instability with 

a stability requirement. The requirement 

specifies that the product (with 

simulated newborn occupant) withstand 

a 23-lb. vertical force and 5-lb. 

horizontal force along its side, without 

tipping. The rationale in ASTM F2194 

states the dual application of forces 

simulates a 2-year-old male pulling on 

the side of the product; staff assesses 

that this is a reasonable scenario in 

which the product may tip over. 

Incident data also demonstrate that 

these compact products are used on 

elevated surfaces, such as beds and 

couches, from which the infant and 

product fell. Therefore, with respect to 

the product’s stability, the final rule 

requires that all infant sleep products 

meet the stability requirement of the 

voluntary standard for bassinets, ASTM 

F2194–16e1, as provided in 16 CFR part 

1218, to further reduce the risk of injury 

associated with product tip-over. 

The Canadian requirement in 

Schedule 11, Test for Stability of 

Cradles, Bassinets and Stands, of their 

regulation is substantially equivalent to 

the requirement in ASTM F2194–16e1. 

The requirement specifies that the 

product (with a simulated newborn 

occupant) withstand a 10-kg 

(approximately 22 pounds) static 

vertical load over a period of 5 seconds 

and a 22 newton (approximately 4.9 

pounds) horizontal force without 

tipping. Staff advises that this test is 

substantially equivalent to the ASTM 

test, differing slightly due to 

conversions to metric. 

(d) Hazard: Asphyxiation/Suffocation 

Nine of the 183 incidents were related 

to infants that partially or fully rolled 

over from their initial position in infant 

sleep products. Of the nine incidents, 

eight resulted in a death, and one 


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resulted in a near-suffocation prevented 

by a nearby parent. 

The voluntary standard for bassinets, 

ASTM F2194–16e1, addresses the 

asphyxiation/suffocation hazard with 

the following general/performance 

requirements: 

• 5.10 Corner Posts: This 

requirement addresses corner post 

extensions that can entangle ribbons, 

pacifier cords, necklaces, or occupant 

clothing. Entanglement of any of these 

items could lead to the asphyxiation of 

the occupant. This requirement limits 

the extension of a bassinet’s corner post 

from extending more than .06 inches 

above the upper edge of an end or side 

panel. Corner posts that extend at least 

16 inches above the top of a side rail are 

exempt because they are deemed 

inaccessible to the occupant. These are 

the same requirements found in the 

regulated ASTM F406–19 (non-fullsized cribs) and ASTM F1169–19 (fullsized cribs) standards that CPSC staff 

previously concluded adequately 

address the corner post entanglement 

hazard. 

• 6.1 Spacing of Rigid-Sided 

Bassinet/Cradle Components. This 

requirement limits the distance between 

slats to less than 23⁄8 inches to mitigate 

the suffocation hazard from feet-first 

head entrapment. 

• 6.2 Openings for Mesh/FabricSided Bassinets/Cradle. This 

requirement tests openings in the 

bassinet’s mesh for entrapment of 

fingers, toes, and snaring buttons, often 

used on infant clothing. The snaring of 

a button entraps the button and could 

lead to asphyxiation as the infant 

becomes entangled and entrapped. In 

this performance requirement, the 

mesh-sided bassinet’s openings cannot 

allow a 1⁄4-inch rod to fit through. 

• 6.5.3 Pad Dimensions. This 

requirement mitigates the hazard of 

suffocating when entrapped in the space 

between the edge of the mattress and the 

bassinet’s sidewall, by limiting the 

available space to less than 1 inch. 

• 6.7 Bassinets with Segmented 

Mattress: Flatness Test. This 

requirement limits sleep surface 

variability of a segmented or folding 

mattress to 10 degrees or less. This angle 

was determined to reduce the likelihood 

of an infant’s face becoming engulfed by 

a small ‘‘V’’ shape formed by the creases 

in a folded mattress, potentially present 

in a bassinet that uses a folding play 

yard mattress as the bassinet mattress. 

• 6.8 Fabric-Sided Enclosed 

Openings. This requirement addresses 

the hazard of a feet-first head 

entrapment through the openings of 

fabric-sided bassinets. This requirement 

limits the openings in a fabric-sided 

bassinet to prevent the 5th percentile 0 

to 2-year-old torso probe from passing 

through. This requirement prevents a 

child’s torso from fitting through any 

openings in the fabric sidewalls; 

therefore, staff concludes this 

requirement would prevent a feet-first 

head entrapment. 

• 6.9 Rock/Swing Angle. This 

requirement limits the bassinet’s 

sleeping surface angle to less than 20 

degrees when rocked, and seven degrees 

when the bassinet is at rest. In the 2019 

SNPR, and in this final rule, the 

Commission determined that a flat sleep 

surface that does not exceed 10 degrees 

offers infants the safest sleep 

environment. This conclusion is based 

on the Mannen Study. 

In total, these requirements address 

known suffocation hazards with infant 

sleep and create a minimally safe sleep 

environment. Therefore, for the final 

rule, with respect to the asphyxiation/ 

suffocation hazard, we finalize the 2019 

SNPR proposal, by requiring that all 

infant sleep products meet general and 

performance requirements of the 

voluntary standard for bassinets, ASTM 

F2194–16e1, as provided in 16 CFR part 

1218, to further reduce the risk of death 

from suffocation. 

(e) Hazard: Product-Related Issues 

Three of the 183 incidents were 

related to mold or quality of the product 

material. Two of the three products 

were in-bed sleepers, while the third 

was a compact bassinet/travel bed. All 

three reported an injury. None of the 

voluntary standards currently address 

conditions such as mold that manifest 

due to the conditions under which a 

product is used. A moisture-resistant 

requirement has been discussed in the 

ASTM task group for baby boxes (which 

is under the bassinet subcommittee), but 

the task group has not reached a 

consensus on appropriate performance 

requirements to address mold and 

moisture resistance. CPSC staff will 

continue to work with this task group. 

(f) Hazard: Undetermined Issues 

Three of the 183 incidents did not 

have enough reported information for us 

to determine the issue involved. Two of 

the incidents were fatalities; in both 

cases, CPSC Field investigation reports 

indicate that the cause of death is 

undetermined. The third incident 

resulted in a hospitalization due to 

unspecified breathing difficulties 

suffered by the infant. The reports did 

not provide sufficient information on 

the circumstances of deaths, and injury 

reports involved unspecified falls. 

Without information on the 

circumstances of deaths or injuries, we 

are unable to assess whether the 

voluntary standard for bassinets, ASTM 

F2194–16e1, would adequately address 

the hazards in this category. 

2. Assessment of International 

Standards 

(a) EN12790:2009 Reclined Cradles 

The scope of the European Standard, 

EN 12790–2009 ‘‘Child use and care 

articles—Reclined cradles’’ includes 

inclined bassinets/cradles, car seat 

carriers, hammocks, and bouncers. 

Some of the general requirements could 

apply, but because the scope of the 

products that fall within this standard is 

not the same as the final rule, most of 

the requirements are not applicable to 

infant sleep products. 

i. Side Height 

The EN 12790:2009 standard does not 

have a side height requirement, but it 

includes a three-point restraint to 

address the containment hazard. The 

ASTM F2194–16e1 bassinet standard is 

more stringent by requiring a minimum 

side height of 7.5 inches. Restraints are 

an active safety feature that might not 

always be used, while the side height 

requirement is a passive safety feature. 

ii. Sleep Surface Angle 

The EN 12790:2009 standard requires 

a seatback angle between 10 degrees and 

80 degrees, while the ASTM F2194– 

16e1 bassinet standard is more stringent 

by requiring a maximum sleep surface 

angle of 10 degrees. The EN 12790:2009 

standard was written for products that 

may or may not be intended for sleep, 

such as car seats, a scope that is broader 

than the scope of the ASTM bassinet 

standard. The Mannen Study concluded 

that a seatback angle of 10 degrees or 

less is safe. Accordingly, the sleep 

surface requirement in the final rule 

remains consistent with the Mannen 

Study findings, and as already codified 

in 16 CFR part 1218. 

iii. Latching Requirements 

The EN 12790:2009 standard specifies 

that infant rocking cradles must have at 

least one automatic locking latch 

mechanism, and that the locking 

mechanisms: 

• Require 50N (11.24 pounds-force) to 

unlatch after operating the latch 300 

times; 

• Require a tool to unlatch; 

• Require two consecutive actions to 

unlatch; or 

• Require two independent and 

simultaneous actions to unlatch. 

The EN 12790:2009 standard’s 

latching requirement simulates the 

action of unintentionally folding the 

product. The ASTM F2194–16e1 


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bassinets standard similarly includes 

requirements that address the 

unintentional folding hazard and 

requirements that address the false 

latching of a removable bassinet bed. 

Therefore, staff assesses that the ASTM 

F2194–16e1 bassinets standard’s 

latching requirements are adequate. 

iv. Stability Requirements 

The EN 12790:2009 standard requires 

products with a test mass not to tip over 

when placed on a 15-degree surface. 

The test mass for cradles designed for 

occupants up to 13.22 pounds is 19.84 

pounds. The test mass for cradles 

designed for occupants up to 19.87 

pounds is 33.06 pounds. This standard 

simulates the stability of an occupied 

reclined cradle on an uneven surface. 

This is different compared to the ASTM 

F2194–16e1 bassinets standard, which 

requires the product (with simulated 

newborn occupant) to withstand a 23-lb. 

vertical force and 5-lb. horizontal force 

along its side, without tipping. The 

rationale in ASTM F2194 states the dual 

application of forces simulates a 2-yearold male pulling on the side of the 

product; staff concludes that this is a 

reasonable scenario in which the 

product may tip over. 

v. EN 12790:2009 Summary 

The EN 12790:2009 reclined cradle 

standard is less stringent than the 

ASTM F2194–16e1 bassinets standard 

by not requiring any minimum side 

height for containment and permits a 

more inclined sleep surface angle for 

products that include reclined cradles 

and car seats for children up to 19.84 

pounds. 

C. Applicability of ASTM F2194–16e1 to 

Flat Sleep Product Hazards 

Table 5 summarizes the hazards 

associated with flat sleep products and 

how each hazard category is addressed 

by the voluntary standard for bassinets, 

ASTM F2194–16e1. Table 5 

demonstrates that four hazard categories 

(shaded) are addressed by ASTM 

F2194–16e1: Latching, Falls/ 

Containment, Instability, and 

Asphyxiation/Suffocation. 

TABLE 5—FLAT SLEEP PRODUCT HAZARDS ADDRESSED BY BASSINETS VOLUNTARY STANDARD

Product 

Applicable 

voluntary 

standard 

Infant sleep hazards 

Latching Falls/ 

containment Instability Asphyxiation/ suffocation 

Miscellaneous 

product-related Undetermined 

Flat Sleep Products 

(flat and inclined).

........................... 115 incidents: 

Not currently 

addressed.

12 incidents: 1 

death. Not currently addressed.

12 incidents: 2 

injuries. Not 

currently addressed.

9 incidents: 8 deaths; not 

currently addressed.

3 mold-related 

incidents; not 

currently addressed.

3 incidents: Two 

deaths. Too little information 

to determine 

addressability. 

Bassinet/Cradle ..... ASTM F2194– 

16e1.

Unintentional 

folding requirement.

Side height requirement.Stability requirement.Max sleep surface angle 

defined in definition; 

Restraints not allowed; 

Flatness/hazardous Vs 

identified; Pad dimensions; Corner posts; 

fabric sided enclosed 

openings; Spacing; 

Mesh openings.

Not currently addressed; task 

group work.

Too little information to determine 

addressability. 

Based on this assessment of the 

hazards associated with flat sleep 

products, and consistent with the 2019 

SNPR, the final rule requires that all 

infant sleep products not already 

regulated by a CPSC sleep standard 

meet the requirements in the ASTM 

F2194–16e1 bassinets standard, as 

provided in 16 CFR part 1218, to 

address the risk of injury associated 

with these sleep products. Specifically, 

the final rule requires that infant sleep 

products, meaning products that are 

marketed or intended as a sleeping 

accommodation for an infant up to 5 

months of age, and that are not subject 

to a CPSC sleep standard (bassinets and 

cradles, cribs (full-size and non-fullsize), play yards, or bedside sleepers), 

meet the requirements of 16 CFR part 

1218, including conforming to the 

definition of a ‘‘bassinet/cradle.’’ 

VII. Response to Comments 

The Commission collected comments 

on the 2017 NPR, which proposed to 

incorporate by reference the thencurrent voluntary standard for infant 

inclined sleep products, ASTM F3118– 

17, with a modification to the standard’s 

definition of ‘‘accessory.’’ 82 FR 16964 

(April 7, 2017). The Commission also 

collected comments on the 2019 SNPR, 

which proposed to incorporate by 

reference the current voluntary standard 

for infant inclined sleep products 

(ASTM F3118–17a), with modifications 

to make the standard more stringent, to 

further reduce the risk of injury. 84 FR 

60949 (Nov. 12, 2019). The 2019 SNPR 

proposed to expand the scope of the 

rule to include all unregulated infant 

sleep products, including inclined 

products and non-inclined, flat 

products. The 2019 SNPR invited the 

public to submit written comments 

during a 75-day comment period, 

beginning on the SNPR publication 

date, and ending on January 27, 2020. In 

response to a request for an extension of 

the comment period, the Commission 

extended the comment period by 30 

days, closing on February 26, 2020. 85 

FR 4918 (Jan. 28, 2020). 

Below we consolidate the 

Commission’s responses to comments 

on the 2017 NPR and the 2019 SNPR. 

In response to the 2017 NPR, the 

Commission received seven comments. 

In response to the 2019 SNPR, the 

Commission received 56 comments 

within the comment period. We also 

considered two late-filed documents, 

one received on February 2, 2021, and 

one received on April 30, 2021. We 

organized the comments by rulemaking 

notice (2017 NPR or 2019 SNPR), and 

then by topic. 

Numerous commenters on the 2019 

SNPR, such as the American Academy 

of Pediatrics (AAP), consumer groups, 

and individual parents, supported the 

SNPR, because the products covered in 

the final rule will be required to follow 

the AAP safe sleep guidelines. Based on 

consideration of the comments received, 

for the final rule, the Commission will 

maintain the proposed 12-month 

effective date, and make several 

clarifications, as listed in section I.F of 

this preamble. 

A. Comments on the 2017 NPR 

1. Safety of Inclined Products 

Comment 1: Three commenters 

disagreed with the 2017 NPR, stating 

that infant sleep products with a 30- 

degree seat back angle are not safe and 

contradict the AAP’s safe sleep 


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recommendations. One commenter also 

indicated that the Commission should: 

• Conduct more research on the 30- 

degree seat back angle; 

• Conduct more research on 

developmental implications when an 

infant is restrained while sleeping; 

• Provide performance requirements 

to address product misassembly; 

• Make the side height requirement 

match the 7.5 side height requirement in 

the bassinets and cradles standard; 

• Develop performance or design 

changes for compact units so they 

cannot be placed on a raised surface, in 

crib, or on soft surface; 

• Add seat back height requirement 

for infant products like newborn 

products; 

• Add requirements for hammocks to 

increase stability; 

• Add requirements for flat sleep 

products, so an infant cannot move into 

an unsafe chin to chest position; 

• Add pictograms to warnings like 

slings and hand-held carriers; 

• Include ‘‘marking’’ on products to 

show compliance with new regulations; 

• Conduct market surveillance after a 

regulation becomes effective; and 

• Have a 6-month effective date for 

the final rule. 

Response 1: We agree, based on the 

Mannen Study, that infant sleep 

products, as defined in the final rule, 

should not have a seat back/sleep 

surface angle greater than 10 degrees. 

The Commission proposed to address 

many of the commenter’s in-scope 

recommendations noted above in the 

2019 SNPR, and is now finalizing the 

requirements, by requiring inclined and 

flat sleep products that are marketed or 

intended to provide a sleeping 

accommodation for an infant up to 5 

months old, to meet the bassinet 

standard. Due to the expected 

significant economic impact on some 

manufacturers, the Commission will 

maintain the proposed 12-month 

effective date for the final rule. 

2. Definition of ‘‘Infant Inclined Sleep 

Product’’ 

Comment 2: A commenter stated that 

the phrase, ‘‘primarily intended and 

marketed to provide sleeping 

accommodations,’’ in the proposed 

definition of an ‘‘infant inclined sleep 

product,’’ is not needed, because 

‘‘incorporating a manufacturer’s 

marketing intentions into a definition of 

a product which impacts the safety 

standard of that product opens the door 

to potential conflicts of interests.’’ The 

commenter reasoned that a child’s age 

and the product incline are objective 

factors, while a manufacturer’s intent is 

more subjective, and could allow 

manufacturers to market the product in 

a way to avoid meeting the requirements 

of the rule. 

Response 2: Although the definition 

the commenter refers to in the standard 

no longer includes the term ‘‘inclined,’’ 

we respond here to the concept of 

including the phrase ‘‘marketed or 

intended’’ in the definition of ‘‘infant 

sleep product’’ in the final rule. A 

manufacturer’s intended use of the 

product and marketing guide informs 

caregivers about the product’s safe use. 

Manufacturers of products that are not 

designed or marketed for use as an 

infant sleep product should provide 

caregivers with instructions and 

warnings regarding safe use of the 

product. Including a manufacturer’s 

marketing and intent in the definition 

also assists the Commission to enforce 

the regulation, because it provides 

objective criteria for CPSC staff to apply 

to a product’s name, packaging, 

warnings, labeling, and marketing 

materials about whether the product 

falls within the scope of the rule. CPSC 

staff has experience using marketing 

materials to enforce CPSC’s regulations, 

and CPSC is required to use such 

materials in some cases. For example, 

section 3 of the CPSA provides factors 

for determining whether a product is a 

‘‘children’s product,’’ and includes 

several factors that require reviewing 

labeling, promotion, and advertising, to 

determine whether a product is 

‘‘designed or intended primarily for 

children 12 years of age or younger.’’ 15 

U.S.C. 2052(a)(2). Products that have no 

use other than infant sleep, based on the 

product’s design, cannot be labelled as 

not intended for infant sleep to avoid 

meeting the requirements of the final 

rule. 

3. Comments Superseded by the 2019 

SNPR 

Comment 3: Two commenters agreed 

with the modification of the ‘‘accessory’’ 

definition in the 2017 NPR, and with 

the 12-month effective date. One 

commenter had a specific comment 

related to restraint requirements in the 

NPR. 

Response 3: The 2019 SNPR 

supersedes the 2017 NPR. The proposed 

modification to the definition of 

‘‘accessory’’ is no longer at issue in the 

final rule, because this definition has 

been removed, along with other 

requirements related to inclined sleep 

products. The Commission will 

maintain the 12-month effective date for 

the final rule, to provide manufacturers 

and importers sufficient time to come 

into compliance. Allowance of a 

restraint requirement in an infant sleep 

product was unique to inclined sleep 

products to contain the infant in the 

product. Consistent with the 2019 

SNPR, the Commission removed the 

restraint requirement in the final rule, 

because restraints can create a 

strangulation hazard. The passive 

containment provision in the bassinet 

and cradle standard, which requires a 

product side height of 7.5 inches and a 

flat (below 10 degree) sleep surface, 

follows safe sleep practices for 

containment: A bare, flat, infant sleep 

surface. 

B. Comments on the 2019 SNPR 

1. Scope of the Final Rule 

(a) All Products Marketed, Promoted, or 

Otherwise Indicated for Sleep 

Comment 4: A commenter suggested: 

‘‘[t]he new standard should apply not 

just to those infant products intended by 

the manufacturer for sleep or certified as 

being for sleep, but also any product 

that is marketed, promoted, or otherwise 

indicated—or may be reasonably 

interpreted as indicating—as being for 

any kind of sleep, including products 

described using substitute language for 

sleep, such as ‘nap’ or ‘snooze.’ ’’ 

Several other commenters expressed 

concern that various terms used in the 

2019 SNPR were vague, and 

recommended that more precise 

definitions be provided for ‘‘sleep’’ and 

‘‘sleeping accommodations.’’ In 

addition, commenters requested 

clarification regarding which products 

are included in the definitions. 

Response 4: In response to this 

comment, the preamble and regulation 

text for the final rule: (1) Clarify that the 

scope of the rule includes products with 

inclined and flat sleep surfaces, and (2) 

more precisely explain the definition of 

an ‘‘infant sleep product.’’ For example, 

to clarify that the scope of the rule 

includes inclined and flat sleep 

products, the scope of CPSC’s regulation 

text in § 1236.2, and the scope of the 

revised voluntary standard in section 

1.3, explain that the scope of the infant 

sleep products rule includes products 

with inclined and flat sleep surfaces. 

The final rule also broadens the 

definition of an ‘‘infant sleep product’’ 

to include the term ‘‘marketed’’: Which 

is ‘‘a product marketed or intended to 

provide sleeping accommodations for an 

infant up to 5 months old that is not 

subject to any of the following . . . .’’ 

The definition then lists CPSC’s five 

infant sleep standards, to ensure that all 

infant products marketed or intended 

for infant sleep meet the requirements of 

a CPSC sleep standard, so that all 

products meet minimum safe sleep 

requirements. Staff modified the 

introduction, scope, and definitions in 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 33047 

37https://www.stanfordchildrens.org/en/topic/ 

default?id=infant-sleep-90-P02237. 

the final rule to clarify the applicability 

of the rule to any infant sleep product 

not covered by another CPSC sleep 

standard. 

While newborns can and do fall 

asleep in many products, because young 

infants sleep for extended hours 

throughout the day, certain products are 

designed, marketed, and intended for 

infant sleep. Therefore, ‘‘sleep’’ and 

‘‘sleeping accommodations’’ refer to 

products that are marketed or intended 

for both extended, unattended sleep, 

and also napping, snoozing, and other 

types of sleep in which a parent may or 

may not be present, awake, and 

attentive. Additionally, if a product 

name implies the product is for use as 

an infant sleep product, such as use of 

the terms ‘‘bed,’’ ‘‘bassinet,’’ or ‘‘crib,’’ 

but does not already comply with the 

bassinet or crib regulation, the product 

falls within the scope of the final rule. 

If a product, through marketing, 

pictures, and written description, 

indicates that the product is being sold 

as an infant sleep product for infants up 

to 5 months old, that product will be 

covered by this regulation if it is not 

already subject to a CPSC sleep 

standard. 

The 2019 SNPR included four 

definitions, ‘‘infant sleep products,’’ 

‘‘newborn sleep products,’’ ‘‘compact 

sleep products,’’ and ‘‘accessory sleep 

products.’’ However, this distinction is 

not necessary and creates confusion 

when identifying infant sleep products, 

because there are no unique 

requirements in this rule based on these 

definitions. Accordingly, for the final 

rule, to clarify which infant sleep 

products are subject to the rule, the 

Commission removed the separate 

definitions of ‘‘newborn,’’ ‘‘compact,’’ 

and ‘‘accessory’’ sleep products, and 

will rely solely on the definition of an 

‘‘infant sleep product’’: 

3.1.7 infant sleep product, n—a 

product marketed or intended to 

provide a sleeping accommodation for 

an infant up to 5 months of age, and that 

is not subject to any of the following: 

• 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

• 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

• 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs 

• 16 CFR part 1221—Safety Standard 

for Play Yards 

• 16 CFR part 1222—Safety Standard 

for Bedside Sleepers 

(b) Distinguishing Non-Sleep Products 

Comment 5: A commenter stated that 

infant car seats, swings, and rockers 

typically have seatback angles greater 

than 30 degrees, adding that these 

products have use patterns very similar 

to products that fall within the scope of 

ASTM F3118. The commenter requested 

clarification of the distinguishing 

features or characteristics that 

differentiate these two types of products 

with very similar usage patterns. 

Response 5: The purpose of the final 

rule is to regulate all products marketed 

or intended for infant sleep for infants 

up to 5 months old. Accordingly, the 

products within the scope of the final 

rule are all marketed and intended for 

sleep, and do not include car seats, 

swings, or rockers, unless a product is 

marketed or intended for sleep. 

Newborns can and do fall asleep in 

many products, because young infants 

typically sleep 16 to 17 hours a day, 1 

to 2 hours at a time. By 3 months, 

infants can sleep 4 to 5 hours during the 

day and 9 to 10 hours during the 

night.37 However, products such as car 

seats, swings, and rockers typically are 

not marketed for use as an infant sleep 

product; these products are intended for 

use while the child is awake. Moreover, 

regarding car seats, CPSC has 

jurisdiction only for use outside of an 

automobile, when the product is being 

used as an infant carrier; while the 

National Highway Traffic Safety 

Administration (NHTSA) has 

jurisdiction over car seats being used in 

an automobile, including the car seats’ 

angle and design for safe use in an 

automobile. 

Comment 6: Several commenters 

stated that the scope of the 2019 SNPR 

was too broad, and expressed concerns 

that non-sleep products would be 

included. Some of the comments 

requested specific exclusions or 

inclusions to the scope of the final rule. 

Response 6: The final rule does not 

apply to products that are not marketed 

or intended for infant sleep, such as 

bouncer seats, swings, infant chairs, or 

other similar durable infant or toddler 

products that are marketed for use while 

a child is awake. In addition, the 

Commission is specifically excluding 

crib mattresses that fall within the scope 

of the voluntary standard for crib 

mattresses, ASTM F2933, from the 

scope of the final rule. A crib mattress, 

alone, does not meet the definition of an 

‘‘infant sleep product,’’ and is always 

used in conjunction with a sleep 

product, such as a crib or play yard, 

which are within one of the five existing 

CPSC sleep standards. The Commission 

issued a notice of proposed rulemaking 

for crib mattresses in 2020, and we 

intend to finalize a separate rule on crib 

mattresses this fiscal year. 

The purpose of the rule is to set 

minimum safe sleep requirements for 

products that are marketed or intended 

for infant sleep up to 5 months old. The 

Commission is aware that infant sleep 

products share hazard patterns that can 

be addressed by performance and 

labeling requirements; but currently, a 

gap exists between regulated and 

unregulated products. Therefore, the 

scope of the final rule includes all infant 

sleep products not already covered by a 

mandatory CPSC sleep standard 

(bassinets, full-sized cribs, non-fullsized cribs, play yards, or bedside 

sleepers), and requires the product to be 

tested to the bassinet standard as a 

default, so that all infant sleep products 

follow a mandatory safety standard for 

infant sleep, specifically (and 

minimally) the standard for bassinets 

and cradles. Based on staff’s evaluation, 

following the requirements of the 

bassinet and cradle standard would 

address the hazard patterns found in the 

incident data for unregulated inclined 

and flat sleep products (see section VI 

of this preamble and Tab B and C of 

Staff’s Final Rule Briefing Package). 

The Commission is also concerned 

about new infant sleep products that 

come on the market and that do not 

follow any CPSC sleep standard. The 

concern is that caregivers may view 

these products as safe because they are 

on the market, even though these 

products may not address known infant 

sleep hazards or may not be tested to an 

appropriate standard. Accordingly, the 

final rule requires all products marketed 

or intended for sleep for infants up to 

5 months old to follow core safe sleep 

principles, which the Commission, in 

agreement with AAP, states are: Place 

infants alone, on their back, and on a 

flat, firm surface with no restraints or 

loose fabric nearby. 

Rather than list specific inclusions 

and exclusions, other than excluding 

crib mattresses, the scope and 

definitions in the final rule address 

potential confusion about which infant 

sleep products are covered. For 

example, the definition of an ‘‘infant 

sleep product’’ states: 

3.1.7 infant sleep product, n—a 

product marketed or intended to 

provide a sleeping accommodation for 

an infant up to 5 months of age, and that 

is not subject to any of the following: 

• 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

• 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

• 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs 

• 16 CFR part 1221—Safety Standard 

for Play Yards 


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33048 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

• 16 CFR part 1222—Safety Standard 

for Bedside Sleepers 

Comment 7: Several commenters 

asked for clarification regarding whether 

products, similar in design to inclined 

sleepers but marketed as a ‘‘soother,’’ 

‘‘rocker,’’ or ‘‘lounger,’’ are in-scope for 

the rule, and suggested that such 

products should be in-scope due to the 

potential for consumer confusion as to 

intended uses. We also received a 

comment asking that inclined products 

for activity and transport, such as a 

bouncers, strollers, and swings, be 

excluded from the scope of the rule. 

Response 7: Infant products, inclined 

or flat, do not fall within the scope of 

the final rule as long as they are not 

intended for sleep, and they are 

marketed conspicuously as not for sleep 

by infants up to 5 months old. This 

means that the product packaging, 

marketing materials, inserts, and 

instructions cannot indicate that the 

product is for sleep, or imply through 

pictures of sleeping infants that sleeping 

in the product is acceptable. In addition, 

if ‘‘attended’’ or ‘‘supervised’’ sleep is 

indicated, then the product would be 

considered within the scope of the final 

rule. The product name, description, 

and instructions also cannot include 

references to sleep, snooze, dream, or 

nap. CPSC staff would consider 

decorations on the product that include 

pictures of sleeping animals or sleeping 

cartoon figures to imply the product is 

intended for sleep. Additionally, the 

product must not be described as a bed. 

Some of these products, such as stroller 

accessories, are already required by the 

mandatory standard for that product 

type to meet the bassinet standard when 

the product is in bassinet mode. 

Comment 8: One commenter 

acknowledged that the scope of the rule 

does not include sleep positioners and 

requested ‘‘the CPSC to better enforce 

the ban on sleep positioners.’’ 

Response 8: Neither CPSC, nor FDA, 

has a ‘‘ban on sleep positioners’’; 

however, both agencies advise 

consumers not to use them with infants 

due to the risk of suffocation. Sleep 

positioners are considered accessories, 

and not an ‘‘infant sleep product’’ under 

the definition proposed in the 2019 

SNPR or as clarified in the final rule. 

Similar to crib mattresses, sleep 

positioners are not intended to be used 

as the sole product for sleep; instead, 

they are used in conjunction with a 

sleep product, for example, to hold an 

infant in a position while inside a crib. 

Therefore, sleep positioners do not fall 

within the final rule because they are 

not intended to provide a sleeping 

accommodation for an infant. The 

Commission declines to explicitly 

exclude sleep positioners from the final 

rule at this time. 

(c) Upper Age Limit for Infants Up to 5 

Months Old 

Comment 9: The 2019 SNPR posed a 

question regarding whether the 

Commission should remove the upper 

age limit from the scope of the 

mandatory standard, to accommodate a 

broad scope of infant sleep products. 

Several commenters stated that the final 

rule should remain applicable to 

products intended for infants up to 5 

months old. Otherwise, the commenters 

said new requirements addressing 

containment, stability, and side height 

would need to be added to the bassinet 

standard for products intended for ages 

6 to 12 months, noting that the existing 

bassinet requirements are designed only 

for infants up to 5 months old. 

Response 9: After further 

consideration, the Commission agrees 

that changing the scope of the final rule 

to remove the upper age limit, or to 

include products intended for infants 

up to 12 months old (as suggested at an 

ASTM task group meeting), would 

require new performance, labeling, and 

testing requirements in the bassinet 

standard. As the commenters noted, the 

bassinet standard only applies to infants 

up to 5 months of age. Therefore, a 

number of requirements in the ASTM 

F2194–16e1 bassinet standard, would 

need to be changed to address older, 

larger, and more mobile and active 

infants, including changes to the scope 

in section 1.3, the stability requirement 

in section 6.4, and the side height 

requirement in section 6.5.4. 

Additionally, the final rule focuses on 

hazards to young infants associated with 

infant sleep products because infants 

under 5 months old are the most 

vulnerable, due to their limited mobility 

and young, developing respiratory 

system. Requiring currently unregulated 

inclined and flat sleep products to meet 

the bassinet standard sets minimum 

requirements for safe sleep. Bassinets 

are designed for children who are not 

yet mobile, and the final rule addresses 

the hazards seen in this population. 

Older infants, i.e., 6 to 12 months old, 

have different needs for sleep, and the 

existing standards for this older age 

group are designed to address those 

needs. By 6 months of age, infants have 

developed enough mobility that they 

can perform such actions as rolling back 

and forth and pulling themselves up. 

The Commission agrees with CPSC 

staff’s assessment that it is unsafe for 6 

to 12 month olds to be in a confined 

space, such as a bassinet, for sleeping, 

as they may roll out of the product, or 

pull themselves out of the product. 

The unregulated products on the 

market with which CPSC has concerns, 

e.g., in-bed sleepers, baby boxes, and 

compact bassinets, are intended for this 

younger, more vulnerable population. In 

addition, CPSC data indicate that 34 

percent of the incidents involving 

inclined sleep products and 49 percent 

of the incidents involving unregulated, 

flat, sleep products happened to infants 

0 to 5 months of age. Infants 6 to 12 

months old were involved in 9 percent 

of inclined sleep products and 4 percent 

of unregulated, flat sleep product 

incidents, respectively. Therefore, 

consistent with the 2019 SNPR, the final 

rule limits the scope of the standard to 

infants up to 5 months of age. Due to the 

size and design of these unregulated 

compact/travel products, older infants 

should not be placed to sleep in these 

products, and older infants are not 

included within the scope of the final 

rule. 

(d) Consumer Registration Rule 

Comment 10: A commenter expressed 

no objection to requiring product 

registration cards for products within 

the scope of the rule, but suggested that 

the Commission ‘‘remain open to 

innovation as to the specific methods of 

achieving optimum product traceability, 

particularly now that so many products 

are linked to internet devices.’’ 

Response 10: In the 2009 NPR for the 

consumer registration rule (74 FR 30986 

(June 29, 2009)), the Commission said it: 

‘‘intends to encourage innovation in the 

use of the internet for product 

registration,’’ and the methods of 

registration online are encouraged, 

whether through a website or email. The 

Commission is open to innovation in 

this area, but we note that section 104(e) 

of the CPSIA sets forth a process the 

Commission must follow to allow new 

technology for product registration, in 

lieu of the product registration card 

requirements in part 1130. 

Comment 11: A commenter supported 

the Commission’s amendment of the 

consumer registration rule, 16 CFR part 

1130, to identify infant sleep products 

as durable infant or toddler products 

subject to the product registration 

requirements, so that freestanding sleep 

products without a frame, are included 

within the scope of part 1130. 

Staff Response 11: To avoid 

confusion, and to ensure that all infant 

sleep products fall within the 

requirements of part 1130, the final rule 

updates the list of durable infant or 

toddler products in part 1130 to 

explicitly identify ‘‘infant sleep 

products’’ as durable infant or toddler 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 33049 

38October 2, 2017 email from Hope Nesteruk to 

Lisa Trofe and Meredith Thomas, JPMA contacts for 

ASTM meetings. 

39Email dated June 4, 2019, from Hope Nesteruk 

to Meredith Thomas, JPMA contact for ASTM 

meetings. 

products, as a subcategory of bassinets 

and cradles. 

2. Incident Data 

(a) Inclusion of Flat Sleep Products 

Comment 12: Multiple commenters 

expressed concern about in-bed 

sleepers, baby boxes, and compact 

bassinets being subject to the standard. 

Concerns included: 

• In-bed sleepers, baby boxes, and 

compact bassinets are not identified 

in CPSC data; 

• Bed-sharing is a common practice in 

the United States and abroad; 

• Potential disparity in safety among inbed sleepers versus a potential ban of 

in-bed sleepers; 

• Interest in increased advocacy 

regarding bed-sharing; and 

• Differences among products 

necessitates different requirements 

based on demonstrable hazard data. 

Commenters objected to including noninclined sleep products in this 

rulemaking, including objecting to 

replacing the term ‘‘infant inclined 

sleep products,’’ with the more general 

‘‘infant sleep products.’’ Instead, these 

commenters urged the Commission to 

focus on inclined products for this 

rulemaking and to review requirements 

for non-inclined products in separate 

rulemaking efforts. A commenter stated 

that it is inappropriate to require all 

products not subject to an existing 

standard to comply with the bassinet 

standard. 

Response 12: The Commission 

recognizes that bed-sharing is a common 

practice of parents, both in the United 

States and abroad. However, we cannot 

recommend bed-sharing as a safe sleep 

practice, due to the increased risk of 

SIDS, overlay, and other hazards. AAP 

safe sleep recommendations encourage 

infants to room-share with parents, but 

to provide infants with their own firm, 

flat space, near the parents, but not in 

the same bed. For a more detailed 

discussion on bed-sharing, please see 

CPSC human factor’s staff memorandum 

at Tab D of Staff’s Final Rule Briefing 

Package. 

As discussed in section III of this 

preamble, in response to the comments, 

the Directorate for Epidemiology staff 

identified 183 incident reports related to 

non-inclined, flat products marketed as 

infant sleep products, such as in-bed 

sleepers, and compact bassinets. The 

incident data, reported to have occurred 

during the period from January 1, 2019 

through December 31, 2020, identified 

11 fatalities and 16 injury reports. Seven 

of the 11 fatalities described a 

suffocation death. The other deaths 

involved the infant rolling over to a 

prone position, or rolling out of the 

product and becoming entrapped. The 

final rule identifies the flat sleep 

products that fall within the scope of 

the rule, provides incident data, 

describes hazard patterns, analyzes the 

effectiveness of the bassinet standard to 

address the hazards, and compares the 

performance requirements in 

international standards to demonstrate 

that these products have similar hazard 

patterns that can be addressed by the 

requirements in the bassinet standard. 

Comment 13: Several commenters 

urged the Commission to work with 

ASTM to develop product-specific 

safety standards for each of the 

identified flat products, such as in-bed 

sleepers, baby boxes, and compact 

bassinets, and to do so in a separate 

effort. 

Response 13: The ASTM process for 

developing the voluntary standard for 

infant inclined sleep products took 

close to 5 years before the standard was 

published. The bassinet subcommittee 

also has been working about 5 years to 

add ‘‘compact bassinets’’ to the 

standard, which has not been 

completed. CPSC staff has participated 

in these efforts and provided incident 

data to the ASTM committees and task 

groups. Throughout all this time, 

inclined and compact infant sleep 

products have entered the retail market 

without meeting any safe sleep testing, 

voluntary or mandatory. The incident 

data discussed in section III of this 

preamble (Tab B of Staff’s Final Rule 

Briefing Package), and the engineering 

and human factors analysis in section VI 

of this preamble (Tabs C and D of Staff’s 

Final Rule Briefing Package), 

demonstrate that inclined, compact, and 

in-bed sleep products pose risks to 

infants and therefore, should not be 

allowed to be sold as infant sleep 

products without meeting one of CPSC’s 

mandatory sleep standards. 

Comment 14: A commenter stated that 

no data indicate that overlay injuries or 

fatalities exist while using an infant inbed sleeper. 

Response 14: As part of CPSC staff’s 

participation with ASTM voluntary 

standards groups, in fall 2017 38 and 

summer 2019,39 CPSC staff provided the 

ASTM in-bed sleeper working group 

with incident data that identified fatal 

and nonfatal incidents involving in-bed 

sleepers. This data demonstrated 11 

fatalities and 22 nonfatalities associated 

with in-bed sleepers. The primary 

hazard patterns, consistent with the 

incident data discussed in this final 

rule, involved infants falling out of inbed sleepers, rolling into the side, 

bedsharing, and consumer complaints. 

An overlay hazard typically occurs 

during bed-sharing, when a parent lays 

over their infant, and typically does not 

realize they have done so because they 

are asleep. Accordingly, during task 

group and subcommittee meetings, staff 

expressed additional concerns with low 

side height, soft-sided, in-bed sleepers, 

because use of such products may 

provide parents with a potentially false 

sense of security when bed-sharing. 

Based on this information, and bedsharing concerns generally, CPSC has 

substantial concerns that a low, softsided, in-bed sleeper may not prevent a 

parent from inadvertently laying over an 

infant and suffocating the baby. CPSC 

data for in-bed sleepers is anecdotal in 

nature, and therefore, we may not have 

received overlay incidents that involve 

an in-bed sleeper, but the large number 

of overlay incidents reported to the 

CPSC generally indicate that bedsharing can be hazardous. 

Comment 15: A commenter stated that 

the 2019 SNPR is well-intentioned, but 

that it is premature, and that the scope 

of the rule ultimately may harm 

consumer safety, because consumers 

will use soft bedding and other tools to 

replace an entire category of products 

that effectively are banned under the 

SNPR. The commenter stated that the 

data necessary to support the rule is 

either missing or incorrect. Another 

commenter stated that the data on inbed sleepers, and the existing CPSC 

sleep standards, do not support CPSC’s 

approach in the 2019 SNPR, noting that 

babies die in all types of infant sleep 

products despite having an existing 

standard, citing bassinets, cribs, and 

play yards. Infants die for reasons not 

associated with the product, the 

commenter asserted, adding that CPSC 

has not presented data to warrant all 

infant sleep products without a standard 

to comply with the bassinet standard. 

This commenter maintained that CPSC 

is using a ‘‘back-door method’’ to 

remove infant products from the market 

without the data to support or justify 

this action. The commenter opined that 

CPSC should write safety standards that 

will ensure safe sleep for each product 

type, and not funnel various products 

into one standard, bassinets and cradles, 

which was not intended for these 

products. 

Response 15: In coordination with a 

range of stakeholders, CPSC has 

carefully developed safety regulations 

for five infant sleep products (cribs: fullsize and non-full-size, bassinets, play 


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33050 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

40Read the full report from Dr. Mannen beginning 

on page 91, Tab B, of CPSC Staff’s SNPR Briefing 

Package: https://cpsc.gov/s3fs-public/ 

SupplementalNoticeofProposedRulemaking

forInfantSleepProducts_10_16_2019.pdf. 

41Beal SM, Moore L, Collett M, Montgomery B, 

Sprod C, Beal A. The danger of freely rocking 

cradles. J Paediatr Child Health. 1995 Feb;31(1):38– 

40. doi: 10.1111/j.1440–1754.1995.tb02910.x. PMID: 

7748688. 

yards, and bedside sleepers), and we 

encourage consumers to use these 

products for infant sleep. The 

Commission is aware that deaths occur 

in these products, but as noted, infant 

deaths are not always associated with 

the product. We particularly urge 

consumers to follow the AAP safe sleep 

recommendations when using any 

product intended for infant sleep. CPSC 

data, in section III of this preamble (Tab 

B of Staff’s Final Rule Briefing Package), 

and evaluated in section VI of this 

preamble (Tabs C and D of Staff’s Final 

Rule Briefing Package), show that deaths 

and injuries occur in untested and 

unregulated infant sleep products, 

including inclined and flat sleep 

products, and sometimes these 

incidents involve a use contrary to AAP 

recommendations. However, CPSC’s 

evaluation of the incidents in section VI 

of this preamble demonstrates that 

requiring currently unregulated infant 

sleep products to meet the requirements 

of the bassinet standard will further 

reduce the risk of death and injury 

associated with these products (Tab C of 

Staff’s Final Rule Briefing Package). 

The argument that parents will use 

soft bedding and other tools to replace 

products taken off the market is the 

same argument used in support of 

creating a separate voluntary and 

mandatory standard for infant inclined 

sleep products, and infants died in these 

products that did not meet AAP safe 

sleep guidelines. Accordingly, to further 

reduce the risk of death and injury, the 

final rule requires that all products 

marketed or intended as a sleeping 

accommodation for infants up to 5 

months old be tested and certified to an 

existing CPSC sleep standard, and that 

CPSC, the AAP, and the industry, 

continue to promote and educate 

caregivers about safe sleep practices for 

infants. 

(b) Statistically Significant Data 

Comment 16: One commenter 

questioned whether the data presented 

in the 2019 SNPR are statistically 

significant for inclined sleep products, 

or are the deaths due to SIDS? 

Response 16: The analysis presented 

in the 2019 SNPR and in this final rule 

is based on reported incidents, and 

therefore, anecdotal in nature. This 

means that the data do not constitute a 

statistical sample representing all 

incidents related to inclined and flat 

sleep products; nor do the data 

represent a complete set of incidents 

that may have occurred involving the 

products. As such, no statistical 

inference is possible. However, the data 

do provide at least a minimum count for 

the number of incidents related to each 

type of product reviewed. 

Many of the fatality reports contain 

unclear, conflicting, and/or inconsistent 

information. For example, for some 

deaths, medical examiners may have 

concluded the cause of death to be SIDS 

or Sudden Unexpected Infant Death 

(SUID), but they also may mention cocontributing conditions, such as an 

unsafe sleep environment (e.g., soft 

bedding, inclined sleep surface) or other 

pre-existing medical condition(s). This 

can confound CPSC’s ability to 

determine a predominant factor in the 

fatality. Staff used a consensus-based 

decision-making process to review 

incident data. If an unsafe sleep 

environment or a product design was 

one of the factors, staff classified the 

death under that category. Otherwise, 

staff classified the reported incident 

under the ‘‘undetermined’’ category, 

when no one factor stood out, or staff 

classified the incident under the 

‘‘insufficient information’’ category, 

when staff did not have enough 

information to classify the incident in 

another category to avoid overestimating 

the risk. 

3. Degree of Incline 

(a) Additional Testing for Inclines 

Between 10 and 20 Degrees 

Comment 17: Several commenters 

stated that the Commission should 

conduct additional research on the 

safety of inclines between 10 and 20 

degrees for infant sleep products. A 

commenter stated that CPSC has failed 

to provide relevant data to support the 

2019 SNPR’s approach regarding 

inclined sleep products, to limit the seat 

back angle to 10 degrees or less, and not 

to conduct additional study on the 10 to 

20 degree angle, or to provide 

information or incidents to support this 

decision. 

Response 17: During the development 

of the 2019 SNPR, Commission staff 

contracted with Dr. Erin Mannen to 

examine how the degree of a seat back 

angle affects an infant’s ability to move 

within inclined sleep products, and if 

the incline angle directly impacts safety 

or presents a risk factor that could 

contribute to the suffocation of an 

infant.40 The Mannen Study findings 

showed that infants in products with a 

seat back angle greater than 20 degrees 

exhibit increased demand on their 

abdominal muscles. The Mannen Study 

concluded that this could lead to 

increased fatigue and suffocation, if an 

infant is unable to reposition themselves 

after an accidental roll from supine to 

prone. The Mannen Study concluded 

that a sleep surface that is 10 degrees or 

less, is comparable to a crib mattress 

surface and can be considered a safe 

sleep surface. The Mannen Study 

suggested if future work were done on 

safe sleep angles, one area of study 

would be additional biomechanical 

testing to determine ‘‘which, if any, 

angles between 10- and 20-degrees may 

be safe for infant sleep.’’ 

The Mannen Study recommendations 

do not imply that an incline angle above 

10 degrees may be safe; rather, the 

Mannen Study merely suggests that if 

higher angles are considered, additional 

biomechanical testing is required. We 

are not aware of existing research that 

suggests that an inclined sleep surface 

between 10 and 20 degrees is safe, nor 

is CPSC currently conducting similar 

research. The Mannen Study also stated 

that its testing of awake infants was a 

limitation because ‘‘while the muscle 

use and motion may be similar, it is 

likely that infants who find themselves 

in a compromised position in an 

inclined sleep product during a nap or 

overnight sleep may not have enough 

energy or alertness to achieve selfcorrection and may succumb to 

suffocation earlier or more easily than 

infants who are fully awake.’’ Given the 

vulnerability of newborn infants and the 

precedence of fatalities of infants who 

were most likely asleep in inclined 

products at the time of incidents, 

additional research of inclines above 10 

degrees is unnecessary for the final rule. 

Additionally, other research 41 has 

demonstrated a discernable difference 

in infant ability between 5, 7, and 10 

degrees in a side-to-side tilt, which 

formed the basis of the 7-degree 

maximum sleep surface angle in Health 

Canada’s regulations and the 5-degree 

limit in the Australian requirement. The 

10-degree sleep surface limit in the final 

rule is a slightly higher allowed sleep 

surface angle than other countries. 

Based on the Mannen Study and the 

research that supports sleep surface 

angles in international standards 

reviewed by CPSC staff, staff believes 

that it is unlikely that additional 

research at angles higher than 10 

degrees will demonstrate that an angle 

greater than 10 degrees is safe for infant 

sleep. Accordingly, for the final rule, 

infant sleep products must be tested for 

a seat back or sleep surface angle of 10 


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42https://www.sleepfoundation.org/sleepdeprivation. 

degrees or less from horizontal, and they 

must meet the requirements of the 

bassinet and cradle standard. 

(b) Adopt Canadian Standard of 7 

Degrees 

Comment 18: One commenter stated 

that Canada only allows up to 7-degree 

seat back angle in sleep products, and 

suggested CPSC should consider 

adopting the Canadian standard. 

Another commenter supported the 

SNPR proposal that infant sleep surfaces 

be no more than 10 degrees from 

horizontal. 

Response 18: The Mannen Study 

concluded that a seatback angle of 10 

degrees or less is safe. This seatback 

angle is consistent with CPSC’s Safety 

Standard for Bassinets and Cradles, 

which also requires a 10 degree or less 

incline. We recognize that Health 

Canada is using a 7-degree maximum 

incline; however, that requirement is 

based on a side-to-side tilt study of 

infants in rocking cradles published in 

1995. The 2019 Mannen Study 

compared infant muscle and breathing 

behavior on a flat crib mattress and on 

a crib mattress, head-to-toe 10 degrees 

from horizontal, and determined that 

infant responses were essentially the 

same on both sleep surfaces. 

Accordingly, based on the Mannen 

Study findings, to provide a safe sleep 

surface, the final rule is consistent with 

the current requirement in the bassinet 

and cradle standard, requiring that 

infant sleep products must have a headto-toe incline angle of 10 degrees or less. 

(c) Highest Seat Back Angle Clarification 

Comment 19: A commenter requested 

that CPSC replace the phrase: ‘‘the 

manufacturer’s recommended highest 

seat back angle position intended for 

sleep,’’ with ‘‘the seat back angle 

position that is the highest position 

intended for sleep or that is the highest 

position that a reasonable consumer 

would consider as being for infant sleep, 

whichever is higher.’’ 

Response 19: The commenter’s 

suggestion, by focusing on the ‘‘seat 

back’’ of an infant sleep product, 

illustrates some confusion with 

terminology. The 2019 SNPR applied to 

infant sleep products, and required all 

infant sleep products to be 10 degrees or 

less from horizontal–the same as the 

sleep surface in bassinets. However, the 

safe sleep principle requirement from 

the Mannen Study, and already 

reflected in the bassinet standard, is that 

infants should sleep flat on their backs. 

Accordingly, the SNPR term ‘‘seat back’’ 

created confusion, because the term 

implies that infant sleep products are 

for ‘‘sitting’’ in a device with a ‘‘seat.’’ 

Thus, to reduce this confusion in the 

final rule, we replace the term ‘‘seat 

back’’ with the term ‘‘Seat Back/Sleep 

Surface.’’ 

4. Safe Sleep Principles 

(a) Request to Ban Infant Inclined Sleep 

Products 

Comment 20: Approximately 25 

commenters requested that CPSC ‘‘ban’’ 

or ‘‘remove’’ infant inclined sleep 

products from store shelves. Of those 

commenters, three indicated that their 

child died while sleeping in an inclined 

sleep product. 

Response 20: Many products with an 

incline greater than 10 degrees from 

horizontal have been removed from the 

market through CPSC recalls. To 

address newly manufactured products, 

the final rule does not ‘‘ban’’ all infant 

sleep products with an angle, but 

addresses the hazards associated with 

inclined sleep products by requiring 

that any product marketed or intended 

for sleep for infants up to 5 months old 

must not have a sleep surface angle 

greater than 10 degrees, and that any 

currently unregulated infant sleep 

product meet the bassinet standard. The 

purpose of these requirements is to 

ensure that all infant sleep products 

meet minimum safe-sleep principles, 

including the sleep surface angle, as 

addressed through an existing CPSC 

sleep standard. 

(b) Aligning with AAP Safe Sleep 

Practices 

Comment 21: One commenter 

acknowledged that the 2019 SNPR 

aligns with the AAP’s safe sleep 

recommendations, and encourages 

CPSC to ensure that the proposed rule 

sends a clear message addressing safe 

sleep practices. 

Response 21: The Commission is 

committed to addressing safe sleep 

practices in this rulemaking and 

ensuring that all products marketed, 

intended, promoted, or otherwise 

indicated as being for any kind of infant 

sleep for infants up to 5 months old are 

addressed. Therefore, the final rule 

requires that all infant sleep products, 

including inclined and flat products, be 

subject to 16 CFR part 1218, Safety 

Standard for Bassinets and Cradles, 

because part 1218 includes safe sleep 

requirements. Additionally, CPSC’s 

website provides extensive information 

regarding best practices for safe sleep 

through its CPSC’s Safe Sleep Campaign 

and Baby Safety information at: https:// 

www.cpsc.gov/SafeSleep. 

(c) Use of Unsafe Products by Sleep 

Deprived Parents 

Comment 22: One commenter 

expressed concern that parents, 

particularly those who are sleep 

deprived, cannot reasonably be 

expected to use a product that is unsafe 

by design in a safe manner. 

Response 22: Lack of sleep may have 

a detrimental effect on a parent’s 

judgment when using an infant sleep 

product. Research demonstrates that 

fatigue can negatively affect memory, 

concentration, and decision making.42

The final rule is the most effective 

method of ensuring that infant sleep 

products for infants up to 5 months of 

age are safe for use. 

5. Definitions 

(a) Remove ‘‘Intended’’ From 

Definitions 

Comment 23: A commenter requested 

that the word ‘‘intended’’ be struck from 

the definitions of infant and newborn 

sleep products. 

Response 23: We disagree with the 

request to remove ‘‘intended’’ from the 

definitions. Manufacturer’s intent, 

which can be evaluated through stated 

warning messages, marketing photos, 

product instructions and other factors, 

must remain a factor for staff’s 

consideration. As the commenter noted, 

some products are marketed for 

swinging or bouncing. If infant products 

are not intended for sleep and are not 

marketed in ways that imply they are for 

sleeping or napping, they are not subject 

to the infant sleep product standard. 

CPSC will evaluate a manufacturer’s 

intent using all available materials, 

including marketing. Accordingly, the 

final rule maintains the word 

‘‘intended’’ and also broadens the 

definition of an ‘‘infant sleep product’’ 

to include the word ‘‘marketed.’’ 

(b) Define or Clarify ‘‘Free Standing’’ 

Infant Sleep Products 

Comment 24: One commenter 

contended that ‘‘free standing’’ is an 

ambiguous term. 

Response 24: A ‘‘free-standing’’ infant 

sleep product is a sleep product that can 

be used by itself, without the need of 

another product, such as a portable play 

yard. ASTM F3118—17a contains a 

separate definition for ‘‘accessory 

inclined sleep product,’’ which applies 

to products that are supported by 

another product, such as a play yard. 

The term ‘‘free-standing’’ is used 

without issue in other ASTM and CPSC 

standards. For the final rule, the 


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definition of ‘‘infant sleep product’’ is 

broadened to cover all inclined and flat 

products marketed or intended as a 

sleeping accommodation, regardless of 

whether the product is free-standing or 

attached to another product. 

Accordingly, we removed the term 

‘‘free-standing’’ from the definition of 

‘‘infant sleep product’’ in the final rule, 

to reduce confusion about which infant 

sleep products are subject to the rule. 

6. Warnings and Instructions 

(a) Provide Information About Scoliosis 

and Torticollis 

Comment 25: One commenter 

recommended that information about 

deformities, such as scoliosis and 

torticollis, be included on an insert with 

all infant sleep products. 

Response 25: Providing parents with 

information and resources regarding 

various infant deformities is beneficial, 

and manufacturers are not prevented 

from including this information if they 

desire. However, as indicated in the 

2019 SNPR, increases in the number of 

children with plagiocephaly may 

actually be attributed to the AAP’s 

recommendation to place infants to 

sleep on their backs to decrease the risk 

of SIDS. The final rule does not contain 

any modifications to the voluntary 

standard to address this issue. 

(b) Placement of Warnings 

Comment 26: One commenter 

recommended that warnings should be 

placed on the outside and inside of the 

packaging, as well as on the product. 

The commenter also recommended that 

packaging should be labeled, easily 

visible, and easy to read/understand. 

Response 26: Consistent with the 

2019 SNPR, the final rule requires that 

infant sleep products not already subject 

to a CPSC sleep standard, be subject to 

the warning requirements set forth in 

the bassinet standard, ASTM F2194– 

16e1, which requires that warning labels 

be present on the product and its 

packaging, and that warning 

information be present in the 

instructional literature. ASTM F2194– 

16e1 also requires that the warnings be 

conspicuous, permanent, and easy to 

read/understand. 

7. Economic Analysis 

Comment 27: A commenter suggested 

that CPSC conduct an exposure study to 

research the relative risks of these 

different sleep products. This 

commenter also suggested that CPSC 

perform a full cost-benefit analysis of 

the final rule. 

Response 27: CPSC is continuing 

research topics related to safe sleep, 

which may potentially involve types of 

infant sleep products. Although an 

exposure study is an effective means to 

estimate exposure, we can estimate 

exposure by comparing annual sales of 

products to the number of live births, 

and staff identifies the hazard patterns 

from the incident data. The Commission 

is not required to conduct cost-benefit 

analyses under section 104 of the 

CPSIA, and has not done so for any 

durable infant or toddler rulemaking. 

We are uncertain what the purpose of 

such an analysis would accomplish for 

a rule promulgated under section 104 of 

the CPSIA, where cost/benefit 

considerations are not germane to the 

Commission’s rulemaking authority. 

8. Effective Date 

Comment 28: Commenters both 

supported and opposed the 12-month 

effective date. Some opposing 

commenters supported a 6-month 

effective date instead, because 

additional time for the rule to become 

effective puts infants at risk, while other 

opposing commenters wanted a longer 

effective date, or an indefinite delay 

until ASTM completes additional 

standards for specific products. The 

2019 SNPR proposed that the effective 

date would apply to products 

manufactured or imported after the final 

rule effective date. We received multiple 

comments that the effective date should 

apply to products sold after the final 

rule effective date instead of the ‘‘sold 

by date,’’ to prevent stockpiling and 

remove the hazards as soon as possible. 

Response 28: For the final rule, the 

Commission will maintain the 2019 

SNPR proposed effective date of 12 

months after the date of publication in 

the Federal Register. A 6-month 

effective date may seem reasonable 

because suppliers have had ample lead 

time to prepare for this rule since the 

SNPR was published in 2019, and many 

of the products within the scope of the 

final rule have been withdrawn from the 

market or redesigned, particularly for 

inclined sleep products. However, for 

manufacturers of other unregulated flat 

sleep products that remain in the 

market, there will likely be a significant 

economic impact as a result of this final 

rule. While some suppliers can reduce 

the impact of this rule by relabeling 

their products as not for infant sleep, 

not all manufacturers can simply 

remarket the product if the physical 

form of the product demonstrates that it 

is intended for sleep. For some of these 

products, manufacturers could relabel 

them as intended for infants older than 

five months, or, in some cases, for pets. 

However, the demand for infant sleep 

products for pet use is probably limited. 

The final rule is considered a 

consumer product safety standard 

issued under the Commission’s 

authority in section 104 of the CPSIA. 

Section 104(b)(1)(B). We are unclear 

regarding what the commenters’ ‘‘sold 

by’’ date references. The Consumer 

Product Safety Act (CPSA) sets forth 

requirements for manufacturers and 

importers once a rule becomes effective. 

Section 19(a)(1) of the CPSA states: 

(a) It shall be unlawful for any person 

to— 

(1) sell, offer for sale, manufacture for 

sale, distribute in commerce, or import 

into the United States any consumer 

product, or other product or substance 

that is regulated under this Act or any 

other Act enforced by the Commission, 

that is not in conformity with an 

applicable consumer product safety rule 

under this Act, or any similar rule, 

regulation, standard, or ban under any 

other Act enforced by the Commission; 

15 U.S.C. 2068(a)(1). Accordingly, the 

CPSA provides that, as of the effective 

date of the final rule, it is unlawful to 

‘‘sell, offer for sale, manufacture for sale, 

distribute in commerce, or import into 

the United States,’’ any infant sleep 

product, as defined in the rule, that is 

not in conformity with the final rule. 

9. Procedural Comments 

(a) Products Subject to the Final Rule 

Comment 29: A commenter stated that 

the proposed rule would apply to 

domestic products, and not to products 

made overseas. The commenter stated 

that the rule should apply to products 

made overseas and sold in the United 

States, for ‘‘optimal consumer safety.’’ 

Response 29: The commenter appears 

to misunderstand the scope of products 

subject to the final rule. If finalized, the 

rule would make it unlawful to sell, 

offer for sale, manufacture for sale, 

distribute in commerce, or import into 

the United States, an infant sleep 

product that is not in conformity with 

this rule, regardless of whether the 

product was manufactured in the 

United States or overseas. 

(b) Incorporation by Reference 

Comment 30: A commenter states that 

the Commission should publish the 

legal standard for infant sleep products, 

rather than incorporate the standard by 

reference. The commenter stated: 

• Publishing the legal standard ‘‘will 

advance fundamental principles of 

fair notice and due process by 

ensuring that the public has open and 

unimpeded access to the law.’’ 

• The law belongs to the people, 

regardless of who drafts the law, and 

thus citizens have a fundamental right 

to know what the law contains. 


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• When the public is not informed 

about relevant legal standards, this 

has the potential for arbitrary or 

discriminatory enforcement. 

• People cannot comply with a law if 

they do not know the substance of the 

law. 

Response 30: Section 104 of the 

CPSIA directs the Commission to issue 

standards for durable infant or toddler 

products that are ‘‘substantially the 

same as,’’ or more stringent than, 

applicable voluntary standards. Thus, 

unless the Commission determines that 

more stringent requirements are 

necessary to further reduce the risk of 

injury, the Commission’s rules must be, 

for the most part, the same as the 

applicable voluntary standard. In this 

case, the final rule would incorporate by 

reference ASTM F3118–17a, with 

substantial modifications to make the 

standard more stringent, to further 

reduce the risk of injury associated with 

infant sleep products. This final rule 

would set forth in the Code of Federal 

Regulations (CFR): Definitions, one test 

for the seatback/sleep surface angle of 

an infant sleep product, and otherwise 

require infant sleep products that do not 

already meet a CPSC sleep standard to 

meet the requirements of the bassinet 

standard, to further reduce the risk of 

injury associated with inclined and flat 

infant sleep products. CPSC’s bassinet 

standard, 16 CFR part 1218, currently 

incorporates by reference performance 

and labeling requirements in ASTM 

F2194–13, with modifications set forth 

in the CFR. CPSC’s mandatory standard 

is substantially similar to ASTM F2194– 

16e1. 

ASTM’s voluntary standards are 

protected by copyright, which the 

Commission (and the federal 

government generally) must observe. 

The United States may be held liable for 

copyright infringement. 28 U.S.C. 1498. 

Accordingly, the Commission cannot 

violate copyright law by publishing 

ASTM’s voluntary standards in the CFR. 

The Office of the Federal Register (OFR) 

has established procedures for 

incorporation by reference that seek to 

balance the interests of copyright 

protection and public accessibility of 

material. 1 CFR part 51. OFR’s 

regulations are based on Freedom of 

Information Act provisions that require 

materials to be ‘‘reasonably available’’ 

when incorporated by reference with 

approval of the Director of the Federal 

Register. 5 U.S.C. 552(a)(1). Under the 

OFR’s requirements, an agency may 

incorporate by reference specific 

publications, including standards, if 

they are ‘‘reasonably available to and 

usable by the class of persons affected.’’ 

1 CFR 51.7. To ensure the material is 

‘‘reasonably available,’’ an agency must 

summarize the material it will 

incorporate by reference and discuss 

how that material is available to 

interested parties in the Federal 

Register notice. Id. §§ 51.3(a), 51.5(a). 

Manufacturers and importers of infant 

sleep products represent the class of 

persons affected by the final rule. 

Although any interested person has 

access to the content of CPSC’s 

regulations through Federal Register 

notices of proposed and final rules, the 

CFR, and the content of voluntary 

standards on ASTM’s website, under the 

statutory scheme set forth in the CPSIA, 

it is those manufacturers and importers 

who want to ‘‘sell, offer for sale, 

manufacture for sale, distribute in 

commerce, or import into the United 

States,’’ any durable infant or toddler 

product, that must conduct testing using 

a third party conformity assessment 

body (lab) and certify their product as 

compliant with the applicable consumer 

product safety rule. 15 U.S.C. 

§ 2063(a)(2). 

The Commission complies with the 

requirement that publications, including 

standards, are ‘‘reasonably available to 

and usable by the class of persons 

affected,’’ whenever incorporating 

material by reference. For example, 

when the Commission proposes a rule 

under section 104 of the CPSIA, the 

Commission describes and summarizes 

the requirements of the rule, including 

the voluntary standard, in the preamble 

of the rule printed in the Federal 

Register, and explains that ASTM’s 

copyrighted voluntary standards are 

available to review online for free 

during the comment period at https://

www.astm.org/CPSC.htm. Once a rule 

becomes effective, ASTM provides a 

read-only copy of the standard for 

review on the ASTM website at: https:// 

www.astm.org/READINGLIBRARY/. As 

always, any person can purchase a 

voluntary standard from ASTM, or may 

schedule a time to review a voluntary 

standard (for free) at the Commission’s 

headquarters in Bethesda, MD, or at the 

National Archives and Records 

Administration (NARA). Accordingly, 

citizens who are interested in the 

content of the law have unimpeded 

access to the regulation, and have 

several avenues for free access to the 

text of voluntary standards incorporated 

by reference into a mandatory CPSC 

standard for a durable infant or toddler 

product. 

Comment 31: A commenter states that 

CPSC’s practice of incorporating 

voluntary standards by reference into 

law forces citizens to either visit the 

agency in person, or pay for access, to 

view the proposed law. The commenter 

contends that CPSC’s actions to allow 

public access to the proposal, including 

summarizing the proposed requirements 

in the preamble to the proposed rule, 

making the voluntary standard available 

for review at CPSC’s offices, or reading 

the standard on ASTM’s website free of 

charge, are all problematic, as the 

regulations are not ‘‘reasonably 

available’’ to the class or persons 

affected. The commenter states that 

ASTM’s restrictions on downloading or 

printing the standard (unless the 

standard is purchased) are an 

impediment to accessing the law, and 

describes the Commission’s access to 

the proposed law as ‘‘limited’’ and 

insufficient to ‘‘ensure robust public 

access to the law.’’ Specifically, the 

commenter notes that without the 

ability to download graphs and charts in 

the ASTM standard, the graphs are 

unreadable in portrait view. The 

commenter states that ‘‘reasonably 

available’’ is not defined in the APA, 

but should be interpreted broadly ‘‘to 

promote fundamental constitutional 

values. . . .’’ 

Response 31: We disagree with the 

commenter that CPSC’s efforts to make 

voluntary standards ‘‘reasonably 

available’’ are ‘‘limited.’’ For rules 

issued under section 104 of the CPSIA, 

stakeholders have several ways to access 

the content of the voluntary standard 

proposed to be incorporated by 

reference, and after the standard is 

incorporated by reference into a 

regulation, including reading a 

summary of the requirements of a 

voluntary standard in a proposed or 

final rule (free), reviewing voluntary 

standards in person at CPSC’s offices 

(free), reviewing read-only copies of the 

voluntary standard on ASTM’s website 

(free), and by purchasing a copy of the 

standard. The OFR’s regulations do not 

require free access to the contents of 

copyrighted materials. In developing a 

regulation, the OFR considered whether 

to require free access to materials that 

are incorporated by reference into 

regulations, and specifically declined to 

do so. 79 FR 66267 (Nov. 7, 2014). The 

OFR found that adopting requirements 

to summarize the content of the material 

incorporated, and explaining to 

stakeholders how to obtain the material, 

was adequate to make the material 

‘‘reasonably available.’’ Id. at 66,270. 

Accordingly, CPSC’s efforts to make 

copyrighted materials reasonably 

available exceed the OFR’s 

requirements. 

Comment 32: A commenter states that 

incorporation by reference, without 

providing free access to the law, 

undermines due process because it may 


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limit public input and exclude 

meaningful participation by some 

stakeholders. The commenter explains, 

for example, that to participate in ASTM 

standards development, one must be an 

ASTM member, which costs $75 per 

year. The commenter notes that the 

regulated community can afford this 

and participate, while members of the 

public cannot meaningfully participate. 

Response 32: Stakeholders have 

several options to review the content of 

a voluntary standard for free, as 

described in response to comments 30 

and 31. ASTM typically seeks a cross 

section of stakeholders to participate in 

standards development. While ASTM 

requires membership to vote on balloted 

items to create or revise a voluntary 

standard, ASTM does not require 

membership to participate in ASTM 

meetings where stakeholders discuss 

standards development for durable 

infant or toddler products. Thus, if a 

consumer wanted to participate in an 

ASTM meeting, they could do so 

without membership. Additionally, if a 

consumer wanted to become an ASTM 

voting member and cannot afford the 

membership fee, that person can contact 

ASTM to learn about additional options 

for membership. For example, students 

can be ASTM members free of charge. 

We further note that CPSC’s 

regulation at 16 CFR part 1031 does not 

allow staff to participate in voluntary 

standards meetings that are not open to 

the public. CPSC staff’s participation in 

ASTM meetings discussing durable 

infant or toddler products are posted on 

CPSC’s calendar (on CPSC’s website) at 

least a week in advance. The meeting 

notice provides the date, time, purpose 

of the meeting, the staff attending, and 

contact information for staff (to obtain 

ASTM login information) so that any 

person who wants to participate in the 

ASTM meeting may do so. Moreover, 

CPSC staff creates a written meeting log 

for each ASTM meeting where staff 

participates, which summarizes the 

meeting content. 

We encourage members of the public 

to meaningfully participate in standards 

development efforts for durable infant 

or toddler products through the ASTM 

process and by commenting on CPSC’s 

proposed rules. 

Comment 33: A commenter describes 

a recent holding by the Eleventh Circuit 

finding that annotations to a Georgia 

statute were ‘‘sufficiently law-like’’ to 

require free public access. The 

commenter also describes two district 

court cases challenging PACER system 

fees, but notes the cases are in the early 

stages of litigation, but ‘‘the underlying 

principles of free public access to the 

law and legal proceedings are directly 

relevant here.’’ 

Response 33: As described in 

response to comments 30 and 31, CPSC 

exceeds the OFR’s regulation requiring 

that voluntary standards that are 

incorporated by reference be made 

reasonably available to the class of 

persons affected, because the voluntary 

standards incorporated by reference by 

CPSC in rules under section 104 of the 

CPSIA are available for review by all 

interested parties. ASTM provides 

access to review voluntary standards 

incorporated by reference before and 

after a rulemaking, free of charge, on 

ASTM’s website. Additionally, any 

person can schedule a time to review a 

voluntary standard (for free) at the 

Commission’s headquarters in Bethesda, 

MD, or at the National Archives and 

Records Administration (NARA). 

(c) Alleged Notice and Comment and 

Section 104 Procedural Defects 

Comment 34: A commenter states that 

the rulemaking process for including 

flat products within the scope of the 

2019 SNPR, such as in-bed sleepers, is 

procedurally deficient and does not 

follow the procedure for rules issued 

under section 104 of the CPSIA, because 

the Commission’s 2019 SNPR did not 

include sufficient data demonstrating 

the need for a rule to cover non-inclined 

sleep products. The commenter states 

that the data set for non-inclined 

products is incomplete and 

insufficiently reviewed, suggesting that 

the Commission did not review incident 

data for non-inclined products with the 

ASTM committee. The commenter 

states that the Commission’s failure to 

publish a revised SNPR to include CPSC 

staff’s concerns with compact bassinets, 

baby boxes, and in-bed sleepers, as 

described in a December 12, 2019 letter 

from staff to several ASTM 

subcommittees, which the commenter 

states did not appear in the 2019 SNPR, 

and to instead provide a 30 day 

extension of the comment period, was 

insufficient notice to all interested 

parties, and may result in a flawed 

standard that is unable to withstand 

judicial scrutiny. 

Response 34: The 2019 SNPR 

provided notice to stakeholders that 

unregulated, non-inclined, flat infant 

sleep products were included in the 

proposal, by proposing to remove the 

term ‘‘inclined’’ from the standard, and 

to include within the scope of the rule 

currently unregulated infant sleep 

products, including inclined and noninclined products. For example, the 

SNPR states: 

• ‘‘CPSC’s proposed standard would 

cover products intended for infant sleep 

that are not already addressed by 

another standard.’’ 84 FR at 60949. 

• ‘‘CPSC proposes to define ‘infant 

sleep products’ as products that provide 

sleeping accommodations for infants 

that are not currently covered by 

bassinets/cradles, cribs (full-size and 

non-full size), play yards, and bedside 

sleepers . . .’’ Id. at 60950. Similar 

statements are also made on pages 

60951 (three times), 60956, and in the 

draft regulatory text (proposed § 1236.1, 

§ 1236.2(b)(4)(D) and § 1236.2(b)(11)(i)) 

at 60962–63). 

• ‘‘The Supplemental NPR proposes 

to incorporate ASTM F3118–17a with 

substantial modifications, including 

revisions in the scope of the standard, 

section 1.3, to remove the term 

‘‘inclined,’’ and to include any infant 

sleep product not currently covered by 

another mandatory rule for infant sleep 

products. . . .’’ 

• The request for comments on page 

60961 asks for comments on noninclined products likely to be impacted 

by the SNPR, including, for example, a 

request for comment on: 

Æ ‘‘. . . any additional types of 

products that commenters believe may 

be impacted by the Supplemental NPR.’’ 

Æ ‘‘. . . products with inclines less 

than or equal to 10 degrees that do not 

already comply with the bassinet 

standard.’’ 

Æ removing the upper age limit of 5 

months because the SNPR ‘‘proposes to 

address ‘infant sleep products’ not 

already covered by traditional sleep 

product [standards].’’ 

• The Staff’s October 16, 2019 SNPR 

Briefing Package, referenced in the 

Federal Register notice, contains similar 

statements about the scope of the rule 

(pages 15, 16, 21, 117, 136), and on page 

133 also specifically states (and on page 

134, Figure 1 provides a picture of an 

unregulated flat sleep product): 

The draft supplemental proposed rule 

would also cover products with inclined 

sleep surfaces greater than 30 degrees 

and less than 10 degrees, if they are 

intended or marketed for children under 

5 months of age for sleep purposes, and 

they are not subject to another sleep 

product standard. For example, the draft 

supplemental proposed rule would 

include the hammock-style crib 

accessory shown in Figure 1. It appears 

to have an incline of 10 degrees or less, 

but does not fall under another sleep 

category. 

CPSC’s description of the scope of the 

rule throughout the 2019 SNPR and the 

Staff’s SNPR Briefing Package, and the 

request for comment on these products, 

were sufficient to inform stakeholders 

that these unregulated flat sleep 


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43https://cpsc.gov/Regulations-Laws--Standards/ 

Voluntary-Standards. 

products were included within the 

scope of the rule. 

In addition, ASTM members had 

actual notice of the contents of the 2019 

SNPR before and after publication. 

Sections V.A.3 and V.B.2 of this 

preamble discuss staff’s work with the 

ASTM subcommittees and task groups. 

Staff’s SNPR Briefing Package was 

posted on the Commission’s website on 

October 16, 2019, before ASTM held fall 

meetings on voluntary standards for 

juvenile products, and before the 

Commission voted on the SNPR, so that 

ASTM members and other stakeholders 

could review the package, including the 

Mannen Study, before the ASTM 

meetings, and so that staff could discuss 

the package and the Mannen Study with 

ASTM members. The ASTM Agenda for 

the Infant Inclined Sleep Products 

meeting that occurred on October 21, 

2019 included a link to Staff’s SNPR 

Briefing Package. CPSC staff discussed 

the 2019 SNPR Briefing Package at the 

ASTM meetings in October 2019, 

including with the ASTM 

subcommittees for infant inclined sleep 

products, in-bed sleepers, and bassinets, 

discussing the Mannen Study findings, 

as well as addressing the fact that flat 

sleep products were covered by the 

SNPR. Dr. Mannen attended the 

subcommittee meeting for infant 

inclined sleep products via telephone, 

to discuss the Mannen Study and to 

answer questions. 

The SNPR published in the Federal 

Register on November 12, 2019. In a 

December 12, 2019 letter to both the 

ASTM inclined sleep and bassinet 

subcommittees, CPSC staff again 

reiterated its concerns with weakening 

the safe sleep requirements in the 

voluntary standard for bassinets and 

cradles to accommodate unregulated 

products, such as in-bed sleepers, 

compact bassinets, and baby boxes. 

Thus, the letter represents an additional 

effort to ensure that the relevant ASTM 

subcommittees (and thus subcommittee 

members) were aware of CPSC staff’s 

concerns with these products, as well as 

the content of the 2019 SNPR, which 

proposed that flat sleep products would 

need to meet the requirements of the 

bassinet standard. Even though this 

letter was in addition to, and not instead 

of, the notice provided in the 2019 

SNPR, the Commission extended the 

comment period for an additional 30 

days, to accommodate any confusion 

among stakeholders. The final rule 

addresses scope and data concerns 

submitted by commenters on the 

inclusion of unregulated flat sleep 

products. 

With regard to in-bed sleepers, baby 

boxes, and compact bassinets 

specifically, ASTM members, which 

include manufacturers of these 

products, have been well aware of CPSC 

staff’s concerns with these products for 

years, based on activity on the bassinet 

subcommittee which has been 

developing requirements for these 

products to include in the bassinet 

standard, but has thus far been 

unsuccessful. With regard to in-bed 

sleepers, ASTM created a separate 

standards development effort for this 

product, which CPSC staff has 

participated in, and provided incident 

data on the products, including notice 

of the injuries and fatalities associated 

with these products. Indeed, through 

staff’s participation in the ASTM 

process, including attending meetings, 

providing incident data, and providing 

comments and votes on ballot efforts, 

staff’s concerns with unregulated flat 

sleep products, and the incident data 

associated with these products, is not 

unknown to stakeholders and these 

commenters. 

Comment 35: A commenter states that 

CPSC statutes require the Commission 

to defer to voluntary standards under 

certain conditions, and that CPSC’s 

website states that CPSC follows OMB 

Circular A–119, but the Commission has 

done neither in this case. Another 

commenter states that the 2019 SNPR 

did not rely on the ASTM consensusdriven process to develop a standard, 

and that CPSC’s data cannot be 

presented belatedly to ASTM 

participants, after or at the same time as 

the SNPR was provided to the 

Commission. This commenter states that 

while CPSC claims the process was a 

collaborative one, for the 2019 SNPR, 

the process was not. 

Response 35: Rulemaking pursuant to 

sections 7 and 9 of the CPSA requires 

the Commission to rely on a voluntary 

standard, rather than promulgate a rule, 

if: (1) The voluntary standard 

adequately addresses the risk of injury 

associated with a product, and (2) there 

is likely to be substantial compliance 

with the voluntary standard. If either of 

these criteria are not met, the 

Commission may proceed with 

rulemaking under sections 7 and 9 of 

the CPSA, if the Commission can make 

the other required findings. Those 

criteria are not relevant under section 

104 of the CPSIA, which requires the 

Commission to consult ‘‘with 

representatives of consumer groups, 

juvenile product manufacturers, and 

independent child product engineers 

and experts, examine and assess the 

effectiveness of any voluntary consumer 

product safety standards for durable 

infant or toddler products,’’ and to 

promulgate rules that are substantially 

the same as the voluntary standards, or 

more stringent than the voluntary 

standards, if the Commission finds that 

more stringent standards would further 

reduce the risk of injury. 

Although CPSC staff’s standards 

development work through the ASTM 

process can colloquially be termed 

‘‘collaborative,’’ nothing in section 104 

of the CPSIA requires ‘‘collaboration’’ 

on a rule outside of the rulemaking 

process. Under section 104, the 

Commission is not required to ‘‘defer’’ 

to the voluntary standard, rather, the 

Commission must promulgate rules, and 

those rules must be substantially the 

same as the voluntary standard, or more 

stringent than the voluntary standard, if 

more stringent requirements would 

further reduce the risk of injury. Section 

104 requires the Commission to consult 

regarding the effectiveness of a 

voluntary standard; the Commission is 

not required to consult on the timing of 

a proposed rule, the Commission’s 

enforcement work, or on the content of 

a proposed rule outside of the 

rulemaking process. In the case of 

bassinets, unregulated flat sleep 

products, and inclined sleep products, 

staff has been consulting on the 

effectiveness of the voluntary standards, 

or lack thereof, for these products for 

many years. 

Generally, CPSC staff’s work through 

the ASTM process has improved the 

safety of durable infant or toddler 

products. However, nothing in section 

104 of the CPSIA requires the 

Commission to delay addressing risks of 

harm to the most vulnerable infants in 

sleep products that parents rely upon as 

a safe place for an infant, until all 

ASTM members have reached a 

consensus on whether and how to create 

or revise a voluntary standard to address 

the risk. The Commission would be 

relinquishing the statutory mandate to 

protect consumers by ceding product 

safety to the very industry Congress 

required the agency to regulate. CPSC 

met the requirement to consult on the 

effectiveness of the voluntary standards. 

The lengthy record of staff’s 

participation with the infant inclined 

sleep committee since the 2017 NPR is 

available on regulations.gov, as well as 

through ASTM records. A similarly 

robust record of staff’s participation on 

the bassinet and cradle committee, 

outside of the rulemaking process, is 

available through ASTM, on CPSC’s 

website, and through CPSC’s Office of 

the Secretariat.43

Finally, as reviewed in response to 

comment 12, the final rule addresses 


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scope and data concerns submitted by 

commenters on the inclusion of 

unregulated flat sleep products, by 

specifically listing the products 

included within the scope of the final 

rule in this preamble, reviewing 

incident data and hazard patterns 

associated with flat products, and by 

demonstrating that the requirements in 

the bassinet standard are adequate to 

address the risk of injury associated 

with flat infant sleep products. CPSC’s 

description of the scope of the rule 

throughout the 2019 SNPR and Staff’s 

SNPR Briefing Package, and the request 

for comment on these products 

(including a 30 day comment 

extension), were sufficient to inform 

stakeholders that these unregulated flat 

sleep products were included within the 

scope of the rule. Moreover, the 

Commission received comments on the 

inclusion of flat sleep products within 

the scope of the rule, demonstrating 

knowledge of their inclusion. 

Comment 36: A commenter states that 

CPSC had been participating 

collaboratively with the ASTM 

committee for ASTM F3118 before the 

summer of 2019, when the commenter 

states the Commission rescinded its 

rulemaking to adopt ASTM F3118 as a 

mandatory standard, and to modify the 

standard through the SNPR. The 

commenter states that the better practice 

would be to issue an advanced notice of 

proposed rulemaking (ANPR) while also 

seeking modifications to ASTM F3118 

through the ASTM process, so that 

stakeholders can ‘‘work with urgency’’ 

toward addressing CPSC incident data 

to develop a performance-based 

standard, versus a design restrictive 

standard. The commenter also 

expressed disappointment that CPSC is 

‘‘subverting’’ the ASTM process, which 

has a proven track record for resolving 

product problems. The commenter 

requests that CPSC ‘‘correct its course’’ 

and provide the relevant data to the 

ASTM committee, so that the committee 

can address the problems associated 

with inclined sleep products through 

the ASTM process. The commenter 

requests that CPSC hold the SNPR in 

abeyance while proceeding as the 

commenter has suggested, with an 

ANPR and working through the ASTM 

process. 

Response 36: Although staff 

submitted an NPR termination package 

for infant inclined sleep products to the 

Commission on June 12, 2019, the 

Commission never voted on the 

termination package. Instead, the 

Commission voted (5–0) on October 25, 

2019 to issue the SNPR for infant sleep 

products. 

Generally, CPSC staff’s work through 

the ASTM process to improve the 

requirements of voluntary standards to 

address hazards associated with durable 

infant or toddler products has improved 

the safety of these products, and CPSC 

will continue its work through the 

ASTM process. Accordingly, CPSC did 

not, and is not, subverting the ASTM 

process to address the hazards 

associated with inclined and flat sleep 

products. CPSC staff has been 

participating in the infant inclined sleep 

product standards development process, 

as well as the bassinet and cradle 

standards development committee, for 

many years, both before and after the 

Commission issued the 2019 SNPR. 

ASTM did not hold subcommittee 

meetings or task group meetings on 

inclined sleep products or the SNPR for 

almost one full year after the October 

2019 ASTM meetings, and did not 

schedule any meetings until after CPSC 

staff sent a letter to the ASTM 

subcommittee for infant inclined sleep 

products on July 16, 2020. After staff’s 

letter, the ASTM F3118 subcommittee 

established a task group to revise the 

infant inclined sleep standard’s title, 

introduction, and scope, to be more in 

line with the proposal in the 2019 

SNPR. In December 2020, the ASTM 

subcommittee introduced ballot F15–18 

(20–1) to change the standard’s title, 

introduction, and scope to include all 

infant sleep products (and not just 

inclined sleep products). A more 

detailed description of this ballot is in 

section V.A.3 of this preamble. 

However, in January 2021, the ballot did 

not pass due to six negative votes. The 

ASTM F3118 subcommittee discussed 

the ballot results at a meeting on 

January 27, 2021. During this meeting, 

ASTM members disagreed on the intent 

and consequences of changes to the 

voluntary standard, and the meeting 

ended without a consensus on a path 

forward. 

Based on the ballot results and the 

discussions in these ASTM meetings, 

staff advises that it is unlikely that 

ASTM will be able to move forward 

with changes to ASTM F3118 that 

address safe sleep requirements in the 

near term. However, we note that a task 

group to review safe sleep requirements 

across infant sleep product standards 

(the comparison task group) has met 

four times since the January 27, 2021 

meeting. CPSC staff has participated in 

all of these ASTM efforts, including 

commenting on ASTM’s ballot. 

The December 2020 ASTM ballot to 

revise the title, introduction, and scope 

of ASTM F3118, and the January 2021 

meeting to discuss the negatives on the 

ballot, demonstrate that ASTM members 

do not have a consensus on moving 

forward to address the hazards 

associated with infant sleep products, 

despite CPSC’s 2019 SNPR and staff’s 

continued participation in the process. 

Although ASTM task groups continue to 

work on revisions to the voluntary 

standard, staff reports that the ASTM 

process is not close to completing their 

work, and staff was not confident that 

ASTM would achieve consensus on 

revisions to the standard in the near 

term. 

In a recent ASTM task group meeting 

on revisions to the title, introduction, 

and scope of the standard (April 22, 

2021), task group members discussed 

balloting the proposed regulatory text in 

the 2019 SNPR to replace ASTM F3118– 

17a, to prevent the sale of infant 

inclined sleep products that purport to 

certify to ASTM F3118–17a, meaning 

products with an incline above 10 

degrees, while ASTM works to revise 

the voluntary standard. However, the 

task group did not plan to ballot the 

requirement that all infant sleep 

products meet the bassinet standard, 

because an ASTM task group is 

attempting to identify minimum safe 

sleep requirements that could apply to 

infant sleep products to include in 

F3118. Staff is participating in this effort 

as well, but, based on the assessment in 

this final rule, does not believe that 

requirements that are different and less 

stringent than the requirements in the 

bassinet standard will adequately 

address the risk of injury associated 

with infant sleep products. 

Section 104 of the CPSIA requires 

CPSC to consult regarding the 

effectiveness of the voluntary standard; 

it does not require CPSC to consult on 

the timing of rulemaking, the content of 

a rule outside the rulemaking process, 

or to delay rulemaking until ASTM 

members achieve consensus. Moreover, 

stakeholders have now had sufficient 

time to consider and comment on the 

Mannen Study, which has been 

available on CPSC’s website as an 

attachment to Staff’s SNPR Briefing 

Package since October 2019, and how to 

address hazards associated with 

products within the scope of the SNPR, 

through the rulemaking and the ASTM 

processes. Despite having a year and a 

half to make progress through the ASTM 

process, stakeholders have not achieved 

consensus on how to move forward. 

When ASTM members do not have, or 

cannot achieve, consensus on whether 

or how a voluntary standard can address 

associated hazards, product safety is not 

improved. 

The Commission’s statutory mandate 

under section 104 of the CPSIA is to 

ensure that durable infant or toddler 


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product standards provide the highest 

level of safety for such products that is 

feasible. Accordingly, CPSC will not 

delay the final rule, and section 104 of 

the CPSIA does not require CPSC to 

delay under the circumstances. 

Comment 37: A commenter states that 

the scope of the 2019 SNPR includes 

many different types of products, with 

different sizes, age capacities, 

breathability, firmness, geometry, 

perceived usage, and different warnings. 

The SNPR did not explain CPSC’s 

rationale to include all of these products 

under ASTM F3118 and to conclude 

that all of these products are unsafe. 

Response 37: The 2019 SNPR stated 

that the rule applied to all infant sleep 

products not subject to a CPSC sleep 

standard, including products with an 

incline less than 10 degrees, as outlined 

in response to comment 34. CPSC staff 

has been participating on the ASTM 

committees for bassinets and infant 

inclined sleep for many years about the 

hazards associated with products that 

would fall within the scope of the final 

rule. The infant inclined sleep product 

standard and the developing in-bed 

sleeper standard both evolved from the 

bassinet standard, and ASTM is 

currently trying to create new 

requirements in the bassinet standard to 

accommodate designs of certain flat 

sleep products. Accordingly, as 

provided in response to comment 36 

regarding staff’s efforts through the 

ASTM process, stakeholders understand 

the scope of products addressed in the 

2019 SNPR and the final rule, ASTM’s 

efforts to modify the bassinet 

requirements to accommodate these 

products, and CPSC staff’s objection to 

modification of the safe sleep 

requirements in the bassinet standard. 

To address comments on the 2019 

SNPR, the final rule includes additional 

incident data and analysis to 

demonstrate that the performance and 

labeling requirements of the bassinet 

standard would address the risk of 

injury associated with currently 

unregulated flat and inclined sleep 

products. 

Comment 38: A commenter states that 

CPSC followed the process set forth in 

section 104 of the CPSIA when it issued 

the 2017 NPR to incorporate by 

reference into a mandatory rule, ASTM 

F3118. The commenter notes that the 

NPR was substantially the same as the 

voluntary standard, and that CPSC staff 

consulted with representatives from 

consumer groups, juvenile product 

manufacturers, and independent child 

product engineers and experts, to 

examine and assess the effectiveness of 

ASTM F3118, as required by section 104 

of the CPSIA. The commenter states, 

however, that the 2019 SNPR for infant 

sleep products did not meet these two 

requirements in the CPSIA. Instead of 

consulting with consumer groups, 

manufacturers, and product safety 

experts through the section 104 process, 

CPSC staff ‘‘informed’’ stakeholders 

about the Commission’s change in 

direction at the October 2019 ASTM 

committee meetings, after the SNPR was 

already issued. Moreover, although 

CPSC staff remains engaged in the 

ASTM F3118 subcommittee, their 

engagement is in support of the SNPR. 

The commenter maintains that the 2019 

SNPR was not a collaborative effort, and 

that CPSC did not consult with 

stakeholders before issuing the SNPR. 

The commenter states: ‘‘The stakeholder 

community, impacted and potentially 

impacted manufacturers, are in the very 

unfortunate position of being subject to 

a mandatory rule that they had no part 

in helping to craft, by way of the ASTM 

development process.’’ The commenter 

also suggests that CPSC staff has acted 

in an ‘‘ultra vires manner to sanitize 

from incline sleep products’’ that are 

otherwise subject to an existing 

standard and to the rulemaking. The 

commenter recommends that the 

Commission issue another SNPR to 

clarify the scope of the rulemaking and 

evaluate and mitigate any unintended 

consequences, and to allow time for 

stakeholders and CPSC staff to work 

through the ASTM process to examine 

the impact of the proposed rule. 

Another commenter similarly urges the 

Commission to proceed in accordance 

with section 104 of the CPSIA by 

working with ASTM to develop a 

standard with a clearly defined scope, 

clear definitions, and creation of 

performance requirements based on 

specific product types within the infant 

sleep product category. This approach 

would require working with ASTM, and 

then reissuing an SNPR, before 

proceeding with a final rule. 

Response 38: Section 104(b)(1) of the 

CPSIA requires the Commission to: ‘‘(A) 

in consultation with representatives of 

consumer groups, juvenile product 

manufacturers, and independent child 

product engineers and experts, examine 

and assess the effectiveness of any 

voluntary consumer product safety 

standards for durable infant or toddler 

products;’’ and (B) in accordance with 

the informal notice and comment 

rulemaking requirements under section 

553 of the Administrative Procedures 

Act (APA), ‘‘promulgate consumer 

product safety standards that—(i) are 

substantially the same as such voluntary 

standards; or (ii) are more stringent than 

such voluntary standards, if the 

Commission determines that more 

stringent standards would further 

reduce the risk of injury associated with 

such products.’’ 

The regulated community participates 

in the rulemaking process by 

commenting on a proposed rule. Neither 

section 104 of the CPSIA nor the APA 

requires that stakeholders craft a CPSC 

mandatory rule. CPSC is required to 

consult regarding the effectiveness of 

the voluntary standard and to 

promulgate rules. As set forth in section 

V.A.3 and V.B.2 of this preamble, CPSC 

staff has been consulting about the 

effectiveness of the voluntary standards 

at issue, infant inclined sleep products 

and bassinets and cradles, for many 

years, through participation with the 

relevant ASTM subcommittees and task 

groups. For example, since ASTM began 

development of an infant inclined sleep 

product standard in or around 2011, 

CPSC has participated in the 

development of the standard. Similarly, 

CPSC staff has participated in the 

development and revisions to the 

bassinet and cradle standard since at 

least 2002. For both standards, CPSC 

staff has provided incident data, 

participated in subcommittee and task 

group meetings, and submitted 

comments and/or votes on ASTM 

ballots. For this final rule, CPSC has 

reviewed the incident data, hazard 

patterns, and the adequacy of the 

voluntary standards to address the risk 

of injury associated with products 

within the scope of the final rule, 

unregulated inclined and flat sleep 

products, and is promulgating a rule 

that is more stringent than the voluntary 

standard, as proposed in the 2019 

SNPR, to further reduce the risk of 

injury associated with infant sleep 

products. 

ASTM members have now had ample 

time to consider the hazards associated 

with infant sleep products, to comment 

on the SNPR, and to address associated 

hazards through revised voluntary 

standards. ASTM is still working on 

these issues and staff will continue 

working with ASTM to develop a 

voluntary standard that addresses the 

risk of injury associated with infant 

sleep products. If and when ASTM has 

revised ASTM F3118–17a, it may send 

the revised standard to CPSC to 

evaluate, through the update process set 

forth in section 104 of the CPSIA. 

Comment 39: Commenters allege that 

the 2019 SNPR represents an 

unprecedented effort by CPSC to issue 

a mandatory rule that would create a 

pre-market testing and approval process 

for an entire product category. 

Commenters state that creating an 

omnibus rule that requires infant sleep 


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products to meet the bassinet standard, 

instead of creating product specific 

standards, would have the unintended 

consequence of stifling innovation. 

Response 39: As with all of CPSC’s 

regulations to set performance and 

labeling requirements, CPSC’s 

mandatory rules for durable infant or 

toddler products set a floor for safe 

consumer products. CPSC does not 

require pre-market approval of 

consumer products, nor does the agency 

have the authority to do so. However, 

CPSC does have the authority to create 

mandatory performance requirements 

through rulemaking, and to require that 

all products offered for sale in the 

United States meet these requirements 

to protect consumers from injuries or 

death. When the Commission is aware 

of a gap in the regulatory framework for 

infant sleep products, the Commission 

can use its authority to address the 

associated hazards. 

Mandating a safety standard for infant 

sleep products offered for sale in the 

United States that are not already within 

the scope of another CPSC sleep 

standard is not ‘‘unprecedented’’ and is 

no different than standards for other 

durable infant or toddler products that 

contain different product types within 

the same standard, such as strollers and 

high chairs, each of which include a 

variety of product types. No company 

can sell a stroller in the United States 

that does not comply with the stroller 

standard, simply based on the type of 

stroller. Similarly, no company can sell 

a high chair in the United States unless 

it complies with the high chair 

standard. This is not a novel idea. The 

only difference in these product 

categories is how the voluntary 

standards evolved. The scope of the 

stroller and high chair standards are 

broad for the purpose of encapsulating 

all products. Standards for sleep 

products evolved on a different track. 

But the Commission is not required to 

continue a patchwork regulatory scheme 

that does not serve the interests of 

consumer safety. In this case, the 

Commission seeks to ensure that all 

products marketed or intended for 

infant sleep, for infants up to 5 months 

of age, meet the infant sleep product 

standard to set a floor for safe infant 

sleep. CPSC’s mission is to protect 

consumers, and the agency will use its 

authority to protect the most vulnerable 

infants, up to 5 months old, and their 

unsuspecting parents, from sleep 

surfaces that do not follow known safe 

sleep principles, as set forth in the 

existing CPSC sleep standards. 

Accordingly, the Commission’s effort in 

the 2019 SNPR is consistent with 

CPSC’s statutory mandate to protect 

consumers, and specifically, under 

section 104, to promulgate standards for 

product categories that the Commission 

determines to be of the highest priority, 

and to ensure that such standards 

provide the highest level of safety for 

such products that is feasible. 

Because CPSC staff has been working 

with ASTM members on the bassinet 

and cradle subcommittee for years, on 

both inclined sleep products, as well as 

unregulated flat infant sleep products, 

ASTM members should be well aware of 

staff’s efforts and concerns with both 

product types. Once CPSC issues an 

NPR, CPSC’s docket on Regulations.gov 

includes a record of staff’s participation 

through the ASTM process, and ASTM 

records should reflect this participation 

as well. CPSC’s Office of the Secretariat 

maintains meeting logs summarizing 

staff’s participation with external 

parties, such as ASTM, outside of the 

rulemaking process, and these meeting 

logs are searchable on CPSC’s website. 

Finally, performance and labeling 

requirements for consumer products 

allow for innovation with certain 

baseline safety requirements. While we 

understand the concerns that innovation 

beyond the baseline safety requirements 

may be discouraged, we note the 

development of infant inclined sleep 

products as a prime example of 

innovation preceding safety. Infant 

inclined sleep products were first 

marketed as an innovative sleep 

solution for parents; however, no safety 

standard existed for these products 

when they were introduced to the 

market. Commenters to the 2010 NPR 

and 2012 SNPR for bassinets indicated 

that hammocks and inclined sleep 

products should have their own 

standard because they could not meet 

the requirements for bassinets, and 

parents were likely to create their own 

‘‘unsafe’’ alternative if a regulated 

product was not available. The ASTM 

standards development process for 

inclined sleep products took many years 

before the standard was published in 

2015, and during that time, 

manufacturers were designing and 

selling innovative inclined products. As 

time went on, the hazards posed by 

inclined products became apparent in 

the accumulation of infant deaths and 

incidents associated with this product 

category. To avoid a repeat of this 

process, involving the most vulnerable 

infants up to 5 months old, the 

Commission is issuing this infant sleep 

product standard that contains key 

elements of safe sleep, so that product 

innovation does not compromise safe 

sleep for infants up to 5 months old. 

Comment 40: A commenter states that 

section 104 of the CPSIA does not 

permit the application of the bassinet 

standard to an open-ended and 

undefined scope of products. The 

commenter contends that section 104 

requires the Commission to consider 

specific product types, characteristics, 

and hazards. The commenter states that 

the 2019 SNPR approach is ‘‘arbitrary’’ 

and ‘‘is a reversal of the Section 104 

process’’ for existing and new products 

that are sleep products, but not 

bassinets or cradles. The commenter 

states that CPSC must clearly define the 

scope of the rule and the products that 

fall within the scope of the rule. 

Response 40: As set forth in response 

to comment 34, the 2019 SNPR 

provided notice that the rulemaking 

included flat infant sleep products. 

Moreover, the preamble to this final rule 

identifies product types that fall within 

the scope of the rule, as well incident 

data, hazard patterns, and an analysis of 

how the requirements in the bassinet 

and cradle standard address the risk of 

injury associated with flat infant sleep 

products. The purpose of the rule is to 

regulate any product marketed or 

intended as a sleeping accommodation 

for an infant up to five months old that 

is not already regulated by another 

CPSC sleep standard. Accordingly, the 

scope of the rule is not ‘‘open-ended,’’ 

and the final rule demonstrates that the 

bassinet standard provides minimum 

safe sleep characteristics for these infant 

sleep products. 

Comment 41: A commenter states that 

to implement a rule that requires 

specific products to meet the 

requirements of the bassinet standard, 

CPSC must provide a rationale that is 

supported by ‘‘substantial evidence.’’ 

The commenter states that the 2019 

SNPR did not provide a rationale for the 

application of the bassinet standard to 

specific products within the infant sleep 

product category. 

Response 41: As stated in response to 

comment 37, CPSC and stakeholders 

have been working through the ASTM 

process regarding requirements for 

unregulated flat and inclined sleep 

products for many years, as part of 

development of the bassinet standard. 

Accordingly, based on the 2019 SNPR 

and this ongoing work with ASTM, 

staff’s efforts have been to maintain the 

safe sleep requirements in the bassinet 

standard and apply them to all sleep 

products marketed and intended for 

infants up to 5 months old. In response 

to comments, the final rule makes 

clearer the unregulated flat sleep 

products that fall within the scope of 

the rule, provides incident data, 

identifies hazard patterns, analyzes the 

effectiveness of the bassinet standard to 

address the hazards, and compares the 


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performance requirements in 

international standards to demonstrate 

that products within the scope of the 

final rule have similar hazard patterns 

that can be addressed by the 

requirements in the bassinet standard. 

Comment 42: A commenter states that 

the Commission previously recognized 

the importance of product specificity in 

promulgating the consumer registration 

rule, 16 CFR part 1130. Despite this, the 

commenter states that the 2019 SNPR 

failed to discuss which product types 

would be considered ‘‘durable infant or 

toddler products’’ for product 

registration card purposes, and ‘‘simply 

concludes in a circular fashion that 

infant sleep products are durable infant 

or toddler products.’’ The commenter 

believes that a specific rationale is 

required for each product to 

‘‘independently qualify’’ as a durable 

infant or toddler product. The 

commenter concludes that under the 

APA, CPSC must specifically define 

products that fall within an ‘‘infant 

sleep product’’ in another SNPR before 

it can issue a final rule. 

Response 42: The preamble for the 

final rule identifies product types that 

fall within the scope of the rule. 

However, the 2019 SNPR and the final 

rule purposely do not define product 

types by name in the regulation text, 

and instead identify product types by 

purpose and age limit, to ensure that all 

infant sleep products meet minimum 

safe sleep requirements in the bassinet 

standard, including existing products 

and future products. 

Section 104(f)(1) of the CPSIA does 

not require any further product type 

specificity to identify these products as 

durable infant or toddler products. The 

statute 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’’ and 

then provides a list of products that are 

durable infant or toddler products. The 

Commission’s implementing rule at 16 

CFR 1130.2(a) states: 

DEFINITION OF DURABLE INFANT OR 

TODDLER PRODUCT means the following 

products intended for use, or that may be 

reasonably expected to be used, by children 

under the age of 5 years. The listed product 

categories are further defined in the 

applicable standards that the Commission 

issues under section 104(b) of the Consumer 

Product Safety Improvement Act of 2008, and 

include products that are combinations of the 

following product categories . . . 

Based on this definition in part 1130, 

a product marketed or intended as a 

sleeping accommodation for an infant 

up to 5 months old is a durable infant 

or toddler product. Because the 

products are intended for infants up to 

5 months old, the products are 

‘‘intended for use,’’ and ‘‘reasonably 

expected to be used,’’ by children under 

5 years old. Products intended for infant 

sleep are similar to products on the 

statutory list intended for infant sleep, 

such as cribs, and bassinets and cradles. 

Additionally, ‘‘infant sleep products’’ 

are further defined in the final rule. 

Accordingly, adding ‘‘infant sleep 

products’’ as a durable infant or toddler 

product is consistent with the 

Commission’s approach of adding a 

durable infant or toddler product 

category with a mandatory standard to 

the list of products in part 1130, to 

clarify that these products must meet 

the consumer registration rule, and the 

testing and certification requirements 

for durable infant or toddler products. 

Comment 43: A commenter contends 

that the creation of specific types of 

infant sleep products is not by the 

Commission’s choice, but required by 

section 104 of the CPSIA. The 

commenter states that Congress 

purposely listed different types of infant 

sleep products separately in section 104, 

because ‘‘differences between these 

products warrant individual 

consideration in any rulemaking 

proceeding,’’ and that this principle is 

true with the remaining infant sleep 

product types. 

Response 43: The commenter offers 

no legislative history to support the idea 

that Congress listed sleep products 

separately because product differences 

warranted individual rulemaking 

proceedings. The products listed as 

durable infant or toddler products are 

examples of durable infant or toddler 

products that Congress expected the 

Commission to regulate by issuing a 

mandatory standard. Most of these 

products had existing voluntary 

standards in 2008 when Congress 

passed the CPSIA. Congress gave CPSC 

the authority to add products to the list 

of durable infant or toddler products, 

gave CPSC the mission to protect 

consumers, and instructed CPSC to 

‘‘periodically review and revise the 

standards set forth under this subsection 

to ensure that such standards provide 

the highest level of safety for such 

products that is feasible.’’ 

Flat sleep products that are subject to 

the final rule are not currently defined 

or covered by any existing ASTM 

standard. If CPSC could not use its 

authority to expand the scope of a rule 

to include such products, especially 

when staff’s analysis demonstrates that 

the existing bassinets and cradles 

standard would address the risk of 

injury associated with such products, 

ASTM could dictate when and if 

durable infant or toddler products are 

regulated by CPSC. Similarly, when 

products fall within an ASTM standard, 

CPSC should not be bound by ASTM’s 

categorization of such products if CSPC 

can demonstrate that the voluntary 

standard is inadequate to address the 

risk of injury associated with the 

products, but another voluntary 

standard would be adequate. 

Comment 44: A commenter states that 

CPSC must not only specifically identify 

product types that fall within the infant 

sleep product category, but must also 

provide the rationale for applying the 

bassinet and cradle standard 

requirements to each product type 

within the category, as well as 

establishing the product type is a 

durable infant or toddler product. The 

commenter contends that this analysis 

must identify the specific characteristics 

for each product type and the related 

hazards, to describe how the bassinet 

standard would address each hazard 

pattern. The commenter contends that a 

requirement that may be applicable to 

one product type may not be applicable 

to another product type. The commenter 

contends that ‘‘[n]o broad product 

category to date has ever been subject to 

a rule without such specificity.’’ The 

commenter states this level of 

specificity is required to avoid banning 

existing safe products or chilling future 

innovation. 

Response 44: As set forth in response 

to comment 34, the 2019 SNPR 

provided notice that the rulemaking 

included flat infant sleep products, and 

multiple other efforts, including those at 

ASTM, reinforced this. In response to 

comments, the preamble to this final 

rule provides further clarity, identifying 

product types that fall within the scope 

of the rule, including inclined and flat 

sleep products, as well associated 

incident data and hazard patterns. This 

final rule also provides an analysis 

demonstrating that the requirements of 

the bassinet standard are adequate to 

address each risk of injury associated 

with infant sleep products, both flat and 

inclined product types. As set forth in 

response to comment 39, we disagree 

that a rule under section 104 of the 

CPSIA cannot have a scope that is 

broader than one product type. For 

example, many types of carriages and 

strollers fall within the Safety Standard 

for Carriage and Strollers. Strollers 

offered for sale in the United States 

must meet the requirements in this 

regulation, regardless of product type. 

The Commission’s statutory mandate 

under section 104 of the CPSIA is to 

ensure that durable infant or toddler 

product standards provide the highest 

level of safety for such products that is 


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feasible. Congress specifically included 

five products intended for infant sleep 

in the statutory list of durable infant or 

toddler products (full-size cribs, nonfull-size cribs, play yards, and bassinets 

and cradles), demonstrating intent for 

CPSC to regulate such products. 

Currently, multiple flat and inclined 

sleep products are not subject to a CPSC 

regulation, but CPSC has the authority 

to add ‘‘infant sleep products’’ as a 

durable infant or toddler product, and to 

regulate this product category. 

Accordingly, the final rule regulates any 

product marketed or intended as a 

sleeping accommodation for an infant 

up to 5 months old, that is not already 

regulated by another CPSC sleep 

standard. In response to comments, the 

final rule expands the justification from 

the 2019 SNPR to demonstrate that the 

bassinet standard provides the 

minimum safe sleep characteristics for 

these infant sleep products. Finally, the 

scope of the final rule is well-defined, 

and allows a manufacturer to 

intentionally design and market a 

product as an infant sleep product, or to 

choose not to design and market a 

product as an infant sleep product. 

VIII. Final Rule Establishing a Safety 

Standard for Infant Sleep Products 

This final rule establishes a children’s 

product safety standard for infant sleep 

products as a type of durable infant or 

toddler product under section 104 of the 

CPSIA. The Mannen Study and CPSC 

staff’s analysis of the incident reports, 

hazard patterns, and adequacy of the 

voluntary standard, demonstrate that 

ASTM F3118–17a is inadequate to 

address the risk of injury associated 

with inclined sleep products. ASTM 

F3118–17a is inadequate to address the 

risk of injury associated with inclined 

sleep products, because it allows 

products with a seat back angle greater 

than 10 degrees, and does not address 

additional hazard patterns associated 

with inclined sleep products, such as 

containing the infant. The Commission 

determines that more stringent 

requirements are necessary in the 

mandatory standard to further reduce 

the risk of injury associated with 

inclined sleep products. Staff’s 

assessment in the 2019 SNPR, and 

section VI of this preamble, demonstrate 

that the performance requirements in 

the current voluntary standard for 

bassinets and cradles, ASTM F2194, 

which is incorporated into the 

Commission’s mandatory standard, 16 

CFR part 1218, is adequate to address 

the risk of injury associated with infant 

inclined sleep products, and will further 

reduce the risk of injury associated with 

inclined sleep products. 

As proposed in the 2019 SNPR, the 

definition of an ‘‘infant sleep product’’ 

in the final rule also includes flat sleep 

products, such as in-bed sleepers, baby 

boxes, compact bassinets, and baby 

tents, which currently do not fall within 

the scope of any voluntary or mandatory 

standard. Staff’s assessment of the 

incident reports and hazard patterns 

associated with flat sleep products in 

this final rule demonstrates that the risk 

of injury and death associated with flat 

sleep products are similar, and can be 

addressed by meeting the requirements 

in the current voluntary standard for 

bassinets and cradles, ASTM F2194, 

which is incorporated into the 

Commission’s mandatory standard, 16 

CFR part 1218. 

Accordingly, the final rule 

incorporates by reference ASTM F3118– 

17a as the mandatory standard for infant 

sleep products, both inclined and flat, 

with the following modifications to the 

voluntary standard: 

• Revise the introduction of the 

standard, to state the purpose of the 

standard is to address infant sleep 

products not already covered by 

traditional sleep product standards, to 

reduce deaths associated with known 

sleep hazards, including but not limited 

to, a seat back or sleep surface angle that 

is greater than 10 degrees from the 

horizontal. This requirement is intended 

to broaden the purpose of the standard 

to more clearly address inclined and flat 

sleep products, including known 

hazards associated with infant sleep. 

• Revise the scope of the standard, to 

remove the term ‘‘inclined’’ and 

broaden the scope to include infant 

sleep products, including inclined and 

flat sleep surfaces, marketed or intended 

to provide a sleeping accommodation 

for an infant up to 5 months old, and 

that are not already subject to a 

mandatory CPSC sleep standard: 

Æ 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles, incorporating 

by reference ASTM F2194, Standard 

Consumer Safety Specification for 

Bassinets and Cradles; 

Æ 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs, incorporating 

by reference ASTM F1169, Standard 

Consumer Safety Specification for FullSize Baby Cribs; 

Æ 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs, 

incorporating by reference applicable 

requirements in ASTM F406, Standard 

Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards; 

Æ 16 CFR part 1221—Safety Standard 

for Play Yards, incorporating by 

reference applicable requirements in 

ASTM F406, Standard Consumer Safety 

Specification for Non-Full-Size Baby 

Cribs/Play Yards; 

Æ 16 CFR part 1222—Safety Standard 

for Bedside Sleepers, incorporating by 

reference ASTM F2906, Standard 

Consumer Safety Specification for 

Bedside Sleepers. 

The purpose of this revision is to 

more clearly establish the scope of the 

final rule, which includes all products 

marketed or intended for infant sleep for 

children up to 5 months of age, so that 

these products that are currently 

unregulated must now meet one of the 

mandatory standards for infant sleep. 

• Revise the scope of the standard to 

explicitly state that crib mattresses that 

meet the requirements of ASTM F2933 

do not fall within the scope of the 

standard. This exclusion clarifies that 

crib mattresses that meet the voluntary 

standard do not meet the definition of 

an infant sleep product, and are always 

used in conjunction with a sleep 

product, such as a crib or play yard, that 

falls within one of CPSC’s sleep 

standards. The final rule also modifies 

referenced documents in the standard, 

to add the voluntary standard for crib 

mattresses, ASTM F2933; 

• Modify the definition of ‘‘infant 

inclined sleep product’’ to remove the 

term ‘‘inclined’’ and revise the 

definition to state that an ‘‘infant sleep 

product’’ is ‘‘a product marketed or 

intended to provide a sleeping 

accommodation for an infant up to 5 

months of age, and that is not subject to 

any of the following: 

Æ 16 CFR part 1218—Safety Standard 

for Bassinets and Cradles 

Æ 16 CFR part 1219—Safety Standard 

for Full-Size Baby Cribs 

Æ 16 CFR part 1220—Safety Standard 

for Non-Full-Size Baby Cribs 

Æ 16 CFR part 1221—Safety Standard 

for Play Yards 

Æ 16 CFR part 1222—Safety Standard 

for Bedside Sleepers 

This requirement aligns the definition of 

‘‘infant sleep product’’ with the scope of 

the rule, including the intent of the rule 

to ensure that all infant sleep products, 

inclined and flat, are subject to a 

mandatory CPSC sleep standard, to 

address the risk of injury associated 

with infant sleep products. 

• Remove the definitions of 

accessory, compact, and newborn 

inclined sleep products because they are 

no longer necessary and have no unique 

requirements in the standard, because 

all infant sleep products are subsumed 

under the definition of ‘‘infant sleep 

product.’’ 

• Modify seat back/sleep surface 

angle so the maximum allowable angle, 

as tested per the rule, must be equal to 


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or less than 10 degrees from horizontal 

in all positions recommended for sleep. 

Although the bassinet standard also 

requires a sleep surface equal to or less 

than 10 degrees, the bassinet standard 

does not have a test for the sleep surface 

angle. Accordingly, infant sleep 

products are required to test for the 

sleep surface angle, in addition to 

meeting the bassinet standard. 

• Add a new requirement that infant 

sleep products must meet 16 CFR part 

1218, Safety Standard for Bassinets and 

Cradles, including conforming to the 

definition of bassinet/cradle. As the 

final rule analysis demonstrates, 

conforming to the requirements in the 

bassinet standard addresses the risk of 

injury associated with infant sleep 

products. Requiring products to meet 

the definition of a bassinet/cradle also 

ensures that the products meet the 

requirement to have a stand. 

• Remove all the performance 

requirements except for the above new 

or modified requirements. 

• Remove all test methods except for 

maximum seat back/sleep surface angle. 

The name of CPSC’s final rule does 

not include the term ‘‘inclined,’’ and 

will be codified as 16 CFR part 1236, 

Safety Standard for Infant Sleep 

Products. Finally, as proposed in the 

2019 SNPR, because infant sleep 

products must meet the bassinet 

standard, infant sleep products must 

also meet the warning requirements in 

the bassinet and cradle standard, 

instead of those stated in ASTM F3118– 

17a. 84 FR at 60956–57. An Appendix 

to Tab C of Staff’s Final Rule Briefing 

Package contains a redline of the final 

rule changes, compared to the 

requirements in ASTM F3118–17a. 

IX. Amendment to 16 CFR Part 1112 To 

Include NOR for Infant Sleep Products 

The CPSA establishes certain 

requirements for product certification 

and testing. Products subject to a 

consumer product safety rule under the 

CPSA, or to a similar rule, ban, standard 

or regulation under any other act 

enforced by the Commission, must be 

certified as complying with all 

applicable CPSC-enforced requirements. 

15 U.S.C. 2063(a). Certification of 

children’s products subject to a 

children’s product safety rule must be 

based on testing conducted by a CPSCaccepted 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 Commission published a final 

rule, Requirements Pertaining to Third 

Party Conformity Assessment Bodies, 78 

FR 15836 (March 12, 2013), codified at 

16 CFR part 1112 (‘‘part 1112’’) and 

effective on June 10, 2013, which 

establishes requirements for 

accreditation of third party conformity 

assessment bodies to test for conformity 

with a children’s product safety rule in 

accordance with section 14(a)(2) of the 

CPSA. Part 1112 also codifies all of the 

NORs issued previously by the 

Commission. 

All new NORs for new children’s 

product safety rules, such as the infant 

sleep products standard, require an 

amendment to part 1112. Accordingly, 

the 2019 SNPR proposed to amend the 

existing rule that codifies the list of all 

NORs issued by the Commission, 16 

CFR part 1112, to add 16 CFR part 1236, 

Standard Consumer Safety 

Specification for Infant Sleep Products, 

to the list of children’s product safety 

rules for which CPSC has issued an 

NOR, because a final rule would be a 

children’s product safety rule that 

requires third party testing by a CPSCaccepted third party conformity 

assessment body. 84 FR at 60957. The 

Commission received no comment on 

the proposed amendment, and is 

finalizing the amendment as proposed 

in the SNPR. 

Test laboratories applying for 

acceptance as a CPSC-accepted third 

party conformity assessment body to 

test to the new standard for infant sleep 

products 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 CPSC to have 16 

CFR part 1236, Standard Consumer 

Safety Specification for Infant Sleep 

Products, included in the laboratory’s 

scope of accreditation of CPSC safety 

rules listed for the laboratory on CPSC’s 

website at: www.cpsc.gov/labsearch. 

Part 1236 includes one performance test 

to check for a seat back/sleep surface 

angle that is 10 degrees or less, and then 

requires infant sleep products to meet 

16 CFR part 1218, Safety Standard for 

Bassinets and Cradles. 

The new 16 CFR part 1236 for infant 

sleep products should have sufficient 

testing capacity by the effective date of 

the final rule. The test to check the sleep 

surface angle required in part 1236 

involves use of the ‘‘Hinged Weight 

Gage—Infant’’ identified in F3118–17a. 

Because the gage is also used for testing 

to the 16 CFR part 1223, Safety Standard 

for Infant Swings (incorporating by 

reference ASTM F2088), labs 

conducting infant swing testing will 

already have the gage. Staff advises that 

33 labs are currently CPSC-accepted to 

test to the bassinet and cradle standard. 

Of these 33, 19 of the labs are also 

accredited to test to the infant swings 

standard, meaning these labs have all of 

the test equipment required to test to the 

new part 1236. These labs should be 

able to more easily become accredited to 

test to part 1236. Also, labs that already 

test to part 1218 bassinets, must only 

acquire the test gage, which staff advises 

is manufactured with readily available 

metal and is estimated to cost $800. 

Moreover, labs that previously tested to 

the current ASTM F3118–17a for the 

JPMA certification program have the 

gage, because F3118 contains a test to 

measure the seat back angle using the 

gage. Finally, the effective date of this 

final rule is 12 months from publication 

in the Federal Register. Accordingly, 

labs seeking to become accredited to 

part 1236 have a full year to obtain the 

necessary test equipment, become ISO 

accredited, and have CPSC-accept their 

accreditation to test to part 1236. 

The Commission certified in the 2019 

SNPR that the proposed NOR for infant 

sleep products would not have a 

significant impact on a substantial 

number of small laboratories. 84 FR 

60959. CPSC expects that laboratories 

that are already accredited to test to the 

bassinet and cradle standard will find it 

relatively easy to become accredited to 

test to this standard, because the 

primary substantive requirement added 

by this standard is the sleep surface 

angle. Moreover, CPSC did not receive 

any comments regarding the NOR. 

Therefore, for the final rule, the 

Commission continues to certify that 

amending part 1112 to include the NOR 

for the infant sleep products final rule 

will not have a significant impact on a 

substantial number of small 

laboratories. 

X. Amendment to Definitions in 

Consumer 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. 

Section 104(d) of the CPSIA. 

In 2009, the Commission issued a rule 

implementing the consumer registration 

requirement. 16 CFR part 1130. As the 

CPSIA directs, the consumer registration 

rule requires each manufacturer of a 


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durable infant or toddler product to: 

Provide a postage-paid consumer 

registration form with each product; 

keep records of consumers who register 

their products with the manufacturer; 

and permanently place the 

manufacturer’s name and certain other 

identifying information on the product. 

When the Commission issued the 

consumer registration rule, the 

Commission identified six additional 

products as ‘‘durable infant or toddler 

products’’ to add to the statutory list in 

section 104(f)(2) of the CPSIA: 

D children’s folding chairs 

D changing tables; 

D infant bouncers; 

D infant bathtubs; 

D bed rails; and 

D infant slings. 

16 CFR 1130.2. The Commission stated 

that the specified statutory categories 

were not exclusive, but that the 

Commission should explicitly identify 

the product categories that are covered. 

The preamble to the 2009 final 

consumer registration rule states: 

‘‘Because 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, but should also be 

specifically listed in the rule.’’ 74 FR 

68668, 68669 (Dec. 29, 2009). 

In the SNPR, the Commission 

proposed to amend the definition of 

‘‘durable infant or toddler product’’ in 

the consumer registration rule to clarify 

that ‘‘infant sleep products’’ fall within 

the term ‘‘durable infant or toddler 

product’’ as a subset of bassinets and 

cradles, and must comply with the 

consumer registration rule and section 

104 of the CPSIA. CPSC received a 

comment stating that the SNPR failed to 

discuss which product types would be 

considered ‘‘durable infant or toddler 

products’’ for product registration card 

purposes, and ‘‘simply concludes in a 

circular fashion that infant sleep 

products are durable infant or toddler 

products.’’ The commenter believes that 

a specific rationale is required for each 

product to ‘‘independently qualify’’ as a 

durable infant or toddler product. The 

commenter concludes that under the 

APA, the Commission must specifically 

define products that fall within an 

‘‘infant sleep product’’ in another SNPR 

before it can issue a final rule. 

We disagree with the commenter and 

finalize the amendment to part 1130, as 

proposed in the 2019 SNPR, to include 

‘‘infant sleep products’’ as a durable 

infant or toddler product, as a 

subcategory of bassinets and cradles. 

Based on the definition of a ‘‘durable 

infant or toddler product’’ in section 

104(f) of the CPSIA, and in § 1130.2, 

which define the term as products 

‘‘intended for use, or that may be 

reasonably expected to be used, by 

children under the age of 5 years,’’ 

‘‘infant sleep products’’ are a durable 

infant or toddler product. ‘‘Infant sleep 

products’’ are defined in the final rule 

as a product marketed or intended as a 

sleeping accommodation for an infant 

up to 5 months old. Accordingly, the 

products are ‘‘intended for use,’’ and 

‘‘reasonably expected to be used,’’ by 

children under 5 years old. Moreover, 

products intended for infant sleep are 

similar to products on the statutory list 

intended for infant sleep, such as cribs, 

bassinets and cradles. Moreover, ‘‘infant 

sleep products’’ are further defined in 

the final rule. Finally, as discussed in 

section V of this preamble, the Safety 

Standard for Infant Sleep Products, for 

both inclined and flat sleep products, is 

an outgrowth of efforts to develop a 

safety standard for bassinets and 

cradles, and may be considered a 

subcategory of bassinets. To provide 

greater clarity that inclined sleep 

products are durable infant or toddler 

products subject to the consumer 

registration rule, as well as third party 

testing and certification requirements 

for durable infant or toddler products, 

the Commission finalizes the 

amendment to 16 CFR 1130.2(a)(12), as 

proposed, to explicitly include ‘‘infant 

sleep products’’ as a subcategory of 

bassinets and cradles. 

XI. Incorporation by Reference 

Section 1236.2(a) of the final rule 

provides that each infant sleep product 

must comply with applicable provisions 

of ASTM F3118–17a. 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 the OFR’s 

requirements, sections VI.A and VIII of 

this preamble summarize the provisions 

of ASTM F3118–17a that the 

Commission is incorporating by 

reference. ASTM F3118–17a is 

copyrighted. Before the effective date of 

this rule, you may view a copy of ASTM 

F3118–17a at: https://www.astm.org/ 

cpsc.htm. Once the rule becomes 

effective, ASTM F3118–17a can be 

viewed free of charge as a read-only 

document at: https://www.astm.org/ 

READINGLIBRARY/. To download or 

print the standard, interested persons 

may purchase a copy of ASTM F3118– 

17a from ASTM, through its website 

(http://www.astm.org), or by mail from 

ASTM International, 100 Bar Harbor 

Drive, P.O. Box 0700, West 

Conshohocken, PA 19428; http://

www.astm.org. Alternatively, interested 

parties may inspect a copy of the 

standard free of charge by contacting 

Alberta E. Mills, Division of the 

Secretariat, U.S. Consumer Product 

Safety Commission, 4330 East-West 

Highway, Bethesda, MD 20814; 

telephone: 301–504–7479; email: cpscos@cpsc.gov. 

XII. 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). CPSC generally 

considers 6 months to be sufficient time 

for suppliers of durable infant and 

toddler products to come into 

compliance with a new standard under 

section 104 of the CPSIA. Six months is 

also the period that the Juvenile 

Products Manufacturers Association 

(JPMA) typically allows for products in 

the JPMA certification program to 

transition to a new standard once that 

standard is published. 

The 2019 SNPR proposed 12-month 

effective date after publication of the 

final rule, for products manufactured or 

imported on or after that date, because: 

(1) the Commission was proposing to 

incorporate by reference, ASTM F3118– 

17a, a relatively new voluntary standard 

that covers a variety of products whose 

manufacturers may not be aware that 

their product must comply; and (2) the 

Commission proposed to make 

substantial modifications to ASTM 

F3118–17a, and a 12-month effective 

date would allow time for infant sleep 

product manufacturers to bring their 

products into compliance after a final 

rule is issued. 84 FR 60958. The 2019 

SNPR stated that the Commission 

expects that most firms should be able 

to comply within the 12-month 

timeframe. The 2019 SNPR also 

requested comment on the proposed 12- 

month effective date, because of the 

hazards involved with infant inclined 

sleep products, and stated that the final 

rule could issue with a shorter effective 

date, so that safer products would be 

available sooner. Id. 

The 2019 SNPR commenters both 

supported and opposed the 12-month 

effective date. Some commenters 

supported a 6-month effective date, 

urging that additional time for the rule 

to become effective puts infants at risk. 


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Other commenters requested a longer 

effective date, or an indefinite delay of 

the rulemaking, until ASTM completes 

additional standards for specific 

products covered by the final rule. 

For the final rule, the Commission 

will maintain the 2019 SNPR proposed 

effective date of 12 months after the date 

of publication in the Federal Register. 

Accordingly, as of the effective date of 

the final rule, it is unlawful to ‘‘sell, 

offer for sale, manufacture for sale, 

distribute in commerce, or import into 

the United States,’’ any infant sleep 

product, as defined in the rule, that is 

not in conformity with the final rule. 15 

U.S.C. 2068(a)(1). 

A 6-month effective date may seem 

reasonable because suppliers have had 

ample lead time to prepare for this rule 

since the SNPR was published in 2019, 

and many of the products within the 

scope of the final rule have been 

withdrawn from the market or 

redesigned, particularly for inclined 

sleep products. However, some 

manufacturers of flat sleep products that 

remain in the market will likely 

experience a significant economic 

impact as a result of this final rule. 

While some suppliers can reduce the 

impact of this rule by relabeling their 

products as not for infant sleep, not all 

manufacturers can simply remarket the 

product if the physical form of the 

product demonstrates that it is intended 

for sleep. For some of these products, 

manufacturers could relabel them as 

intended for infants older than five 

months, or, in some cases, for pets. 

However, the demand for infant sleep 

products for pet use is probably limited. 

Accordingly, maintaining the proposed 

12-month effective date will provide 

manufacturers and importers time to 

spread the impact of the rule over a 12 

month time period, to reduce the 

economic impact of the final rule. 

XIII. Regulatory Flexibility Act 

A. Introduction 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601–612, requires that agencies 

review a proposed rule and a final rule 

for the rule’s potential economic impact 

on small entities, including small 

businesses. Section 604 of the RFA 

generally requires that agencies prepare 

a final regulatory flexibility analysis 

(FRFA) when promulgating final rules, 

unless the head of the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. Staff prepared 

a FRFA that is available at Tab E of 

Staff’s Final Rule Briefing Package. 

The scope of this FRFA and the 

number of firms impacted is different 

from the Initial Regulatory Flexibility 

Analysis (IRFA) that accompanied the 

2017 NPR, because the scope of the NPR 

was inclined sleep products, while the 

scope of the final rule is infant sleep 

products, defined in the final rule as 

products that are marketed or intended 

to provide sleeping accommodations for 

an infant up to 5 months of age, and that 

are not already covered by a mandatory 

CPSC sleep standard: Full-size cribs, 

non-full-size cribs, play yards, bassinets 

and cradles, or bedside sleepers. This 

change in scope from the proposed rule 

was specified in the 2019 SNPR, and 

includes inclined and non-inclined 

(flat) infant sleep products. Some 

inclined sleep products have been 

recalled or otherwise voluntarily 

removed from the market since 2019, so 

some firms that were forecast to be 

impacted in the IRFA are not likely to 

be impacted by this final rule, because 

the firms have already stopped selling 

those products. However, a significant 

economic impact is possible for 

suppliers of flat sleep products that 

were not analyzed in the IRFA, as well 

as remaining suppliers of inclined 

products. Flat sleep products without 

inclined sleep surfaces include: Baby 

boxes, compact and travel bassinets that 

do not meet the bassinet standard, inbed sleepers, baby tents marketed for 

infant sleep, baby pods, and baby nests. 

Pursuant to the final rule, firms whose 

infant sleep products do not comply 

with any CPSC sleep standard will need 

to evaluate their products, determine 

what changes would be required to meet 

an existing CPSC standard, or 16 CFR 

part 1218, the Safety Standard for 

Bassinets and Cradles, and decide how 

to proceed. Noncompliant products 

would need to be removed from the U.S. 

market, modified to meet the mandatory 

standard as specified in this final rule, 

remarketed for children older than 5 

months, or remarketed as not intended 

for infant sleep. New infant sleep 

products introduced to the market 

would also need to comply with the 

standard, or one of the other CPSC sleep 

standards. The final rule defines an 

‘‘infant sleep product’’ as a product 

marketed or intended to provide a 

sleeping accommodation for an infant 

up to 5 months of age, and that does not 

already meet a mandatory CPSC sleep 

standard. CPSC interprets this definition 

to include products that are marketed 

for ‘‘napping,’’ ‘‘snoozing,’’ ‘‘dreaming,’’ 

or any other word that implies sleeping, 

or that are called a ‘‘bed,’’ and items 

marketed with a picture of a sleeping 

infant, to be an infant sleep product. 

Based on the staff’s analysis, the 

Commission anticipates a possible 

significant economic impact for twelve 

small importers and nine small 

domestic manufacturers that supply 

infant sleep products to the U.S. market, 

as well as for hundreds of home-based 

small businesses that ship from the U.S. 

We provide a summary of the FRFA 

below. 

B. The Market for Infant Sleep Products 

Section II of this preamble describes 

the infant sleep products within the 

scope of the final rule, the products 

excluded from the final rule, and a 

description of the market for infant 

sleep products, including a summary of 

retail prices for various types of infant 

sleep products. 

C. Products and Small Entities to Which 

the Final Rule Would Apply 

1. Overview of Products Covered by, 

and Excluded From, the Final Rule 

Section II.A and B of this preamble 

describe the products subject to, and 

excluded from, the final rule. This rule 

is intended to cover ‘‘infant sleep 

products,’’ defined in the final rule as 

products that are marketed or intended 

to provide a sleeping accommodation 

for an infant up to 5 months of age, and 

that are not already covered by a 

mandatory CPSC sleep standard: Fullsize cribs, non-full-size cribs, play 

yards, bassinets and cradles, or bedside 

sleepers. A detailed description of the 

products covered by the final rule is set 

forth in section II.C of this preamble, 

and includes: 

• Inclined products, such as: Hard 

frame inclined sleepers, compact 

foam inclined sleepers, inclined play 

yard accessories, and baby hammocks; 

and 

• Flat products, such as: Soft-sided 

products (baby pods and baby nests, 

soft-sided travel bassinets or travel 

beds, hand-held carriers marketed for 

sleep, and in-bed sleepers), rigidsided and rigid-framed compact 

bassinets, travel bassinets, and similar 

products (baby boxes, compact, 

portable, or travel bassinets, or infant 

travel beds), and baby tents. 

None of these products is covered by an 

existing CPSC sleep standard. CPSC 

considers that any items marketed for 

‘‘napping,’’ ‘‘snoozing,’’ or ‘‘dreaming,’’ 

or any other word that implies sleeping, 

or that are called a ‘‘bed,’’ as well as 

items marketed with a picture of a 

sleeping infant, to be an infant sleep 

product. 

Products that are subject to another 

CPSC sleep standard, or to another 

durable infant or toddler product rule 

that is not marketed for sleep, such as 

infant bouncers or swings, are not 

subject to the final rule. Moreover, a crib 


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mattress, as defined in ASTM F2933–19, 

is not an infant sleep product covered 

by the final rule. 

2. Suppliers to This Market 

Manufacturers of infant sleep 

products are categorized under many 

different North American Classification 

System (NAICS) categories, because 

there is not a NAICS code specifically 

for infant sleep products. These items 

are made by companies that have baby 

furniture, baby bedding items, 

mattresses, other durable baby items 

including strollers or car seats, toys, or 

general merchandise as their primary 

business. Businesses are generally 

considered small per the Small Business 

Administration (SBA) size standards if 

they have fewer than 100 employees for 

importers or wholesalers, or fewer than 

500 employees for most of the relevant 

types of manufacturers for this rule. The 

SBA size standard for mattress 

manufacturing is 1,000 employees. The 

relevant NAICS codes include: 

314999 (All Other Miscellaneous Textile 

Product Mills) 

337910 (Mattress Manufacturing) 

339930 (Doll, Toy, and Game Manufacturing) 

339999 (All Other Miscellaneous 

Manufacturing) 

423220 (Home Furnishing Merchant 

Wholesalers) 

424330 (Women’s, Children’s, and Infants’ 

Clothing and Accessories Merchant 

Wholesalers) 

The SBA size standards for ‘‘small’’ 

for the relevant NAICS codes mean that 

most suppliers in this product category 

are considered ‘‘small.’’ A U.S. company 

that has a factory employing 100 people 

might be a top 10 supplier in a 

particular infant sleep product category, 

but would be considered ‘‘small’’ by 

SBA standards. Similarly, an importer 

with a U.S. warehouse staff of 50 people 

would also be considered ‘‘small.’’ 

Prior to the recalls of some infant 

inclined sleep products, large domestic 

and foreign companies and the larger 

‘‘small’’ companies by SBA size 

standards were responsible for most of 

the sales volume for the hard frame 

inclined sleep products and inclined 

play yard sleeper accessories. Many of 

the inclined sleep products were 

available at big box chain retailers, and 

a few were available at mattress 

retailers. The larger companies have 

recalled or discontinued these products, 

and most big box stores have stopped 

stocking them. However, inclined sleep 

products are still available from small 

manufacturers and importers, and 

discontinued items made by large 

companies are still available from 

online merchants. Small companies 

have always accounted for a majority of 

the suppliers of the unregulated flatbottomed sleep products and infant 

hammock categories. A large number of 

suppliers exist for these products; the 

market is fragmented with many sellers. 

Many of the products covered by the 

final rule, particularly the soft-sided 

products and the products sold by small 

businesses, are only available online. 

The majority of the suppliers to which 

this final rule would apply are small by 

SBA standards. At least 60 small U.S.- 

based manufacturers and importers are 

in this market, as well as 5 large 

domestic companies, and dozens of 

foreign companies, some of which ship 

these items directly to customers in the 

U.S. via online marketplaces. In 

addition, more than a thousand homebased businesses supply flat sleep 

products that would be subject to the 

final rule, of which hundreds ship from 

the U.S. Some firms sell these items 

under multiple brand names and 

models, including small manufacturers 

that make ‘‘store brands’’ for larger 

companies. The number of importers 

selling flat sleep products is 

approximate because the proliferation of 

online retail makes it possible for 

importers to quickly change their 

product offerings based on demand for 

particular products. The number of 

foreign companies is approximate for 

the same reason. In addition to the 

foreign companies that ship from U.S. 

distribution sites, dozens of third-party 

sellers are on major internet retail sites 

that ship products to U.S. consumers 

directly from a foreign country. The 

analysis in this FRFA focuses on the 

impact on small U.S. manufacturers and 

importers that ship from the U.S., as 

well as U.S.-based home businesses, but 

the large and foreign companies will 

also be impacted by the cost of 

complying with this rule. The large 

number of companies in the flat sleep 

products market covered by this rule 

reflects both a strong market demand for 

these products and a competitive market 

with relatively low margins. 

D. Testing and Certification 

Under section 14 of the CPSA, once 

the new infant sleep product mandatory 

standard become effective, all suppliers 

will be subject to the third party testing 

and certification requirements under the 

CPSA and the Testing and Labeling 

Pertaining to Product Certification rule 

(16 CFR 1107), which requires that 

manufacturers and importers certify that 

their products comply with the 

applicable children’s product safety 

standards, based on third party testing, 

and subject their products to third party 

testing periodically. Third party testing 

costs are in addition to the costs of 

modifying the infant sleeper products to 

meet the standard. 

For infant sleep products, the thirdparty testing costs are expected to be 

about $1,500 per testing cycle per 

model, including both the costs of the 

testing and the costs of the samples to 

be tested. This is consistent with the 

IRFA in the SNPR, which estimated a 

cost of $1,100 for testing alone, not 

including the cost of the samples to be 

tested; we did not receive any 

comments on the SNPR providing a 

different estimate. Based on comments 

received on the bassinet and cradle final 

rule published in 2013, one-time costs 

of redesigning a product to meet the 

standard could be as high as $500,000 

for products requiring major redesign. 

As allowed by the component part 

testing rule (16 CFR 1109), importers 

may rely upon third party tests obtained 

by their suppliers, which could reduce 

the impact on importers. In addition, all 

businesses selling products covered by 

this rule were already required to certify 

compliance to general children’s 

product rules for lead, phthalates, and 

small parts with third party testing, so 

those third-party testing costs would not 

be considered new costs of compliance 

for this rule. 

E. Impact of Final Rule by Product 

Category 

The impact on small businesses 

would vary by product category. We 

describe each product, provide 

information on the types of firms that 

supply the product, and describe the 

impacts for each product type for 

complying with this rule or taking 

action to exit the market sector. 

1. Inclined Sleep Products 

(a) Hard Frame Inclined Sleepers, 

Compact Foam Inclined Sleepers, and 

Play Yard Accessories 

Since the NPR was published in 2017, 

some inclined sleep products have been 

recalled or otherwise removed from the 

market. However, while resale of 

recalled products is prohibited, 

discontinued items that were not 

recalled are still available on the 

secondary market, as well as additional 

physically similar products sold by 

small companies that were not recalled. 

JPMA has two manufacturers that are 

certified as compliant to the current 

ASTM F3118 standard for inclined 

sleepers. While larger companies have 

removed most of their inclined products 

from the market or remarketed them as 

chairs or loungers, some smaller 

importers and foreign direct shippers 

still offer them as sleep products. Some 

play yards with inclined sleep 


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44Baby feeding, care, and travel accessory unit 

sales in the United States in 2018, by product 

type—https://www.statista.com/statistics/891908/ 

baby-feeding-care-and-travel-accessory-unit-salesby-product-type-us/ And Baby feeding, care, and 

travel accessory sales in the United States in 2018, 

by product type https://www.statista.com/statistics/ 

891889/baby-feeding-care-and-travel-accessorysales-by-product-type-us/. 

45Please note that the number of companies 

impacted for each product type sums to more than 

the total number of impacted companies for the rule 

as a whole, because several small companies sell 

products in multiple product categories impacted 

by this rule. 

accessories are still available. To date, 

the lack of a CPSC mandatory standard 

means that new entrants are free to enter 

this market sector with new inclined 

sleep products that do not comply with 

the existing ASTM standard, ASTM 

F3118–17a, or any other ASTM or CPSC 

sleep standard. Many of the recalled 

items were still available from smaller 

internet merchants in the spring and 

summer of 2020. Some items that were 

not recalled, but merely discontinued by 

the manufacturer, are still available for 

sale from retailers, at least until the 

remaining stock is sold. 

Once the final rule is published and 

becomes effective, suppliers of inclined 

sleep products must either redesign 

existing products to comply with the 

standard and conduct third-party testing 

to demonstrate compliance, stop selling 

the products, or remarket the products 

as not intended for infant sleep. The 

impact of those options will depend 

upon how much redesign the product 

requires, and what portion of the 

company’s sales are inclined sleep 

products. The impact on small 

companies that sell many different 

products in different categories, which 

is relatively common, especially for 

importers, will likely not be as 

significant as the impact on small 

companies that sell only a few types of 

products or that concentrate on sleep 

products covered by this rule. 

The impact of remarketing products 

for a different use, such as for an older 

child, a pet, or not for sleep, will 

depend on the extent to which 

consumers demand the product for the 

different use. Given the proliferation of 

floor chairs, lounger chairs, rockers, and 

bouncer seats on the market, it seems 

likely that consumers find value in 

physically similar products that are 

marketed for a different use, and that 

remarketing will not reduce demand. 

U.S. sales of the combined category of 

bouncer seats, rockers, and sleepers 

totaled more than 2 million units and 

$126 million dollars in 2018.44

Suppliers of the hard-plastic framed 

rocker-type items may choose to 

redesign their items to meet the 

requirements of a different mandatory 

safety standard, particularly the one for 

infant bouncer seats. Most of the hardframed products were made by large or 

foreign companies, although the market 

volume has shifted to smaller 

companies as the larger companies have 

already removed these items from the 

market or remarketed them as chairs, 

rockers, or chair/swing combos. Two 

small domestic companies that make 

inclined sleep products may experience 

a significant economic impact 45 as these 

were some of their best-selling products, 

and one of them also supplied the 

product as a ‘‘store brand’’ to another 

company. The other sells multiple types 

of sleepers within the scope of the final 

rule. Redesigning, relabeling, or 

discontinuing the products could be a 

significant impact on these firms. The 

rest of the small domestic companies 

that sold this product and small 

importers will likely not be significantly 

impacted because they sell many other 

products that would not be subject to 

the final rule. 

Suppliers of inclined compact foam 

products will need to redesign their 

products with an incline of 10 degrees 

or less and meet other requirements of 

this standard, remove these products 

from the market, or relabel them as not 

being intended for sleep by children 

under 5 months of age. Some of these 

products have restraining harnesses to 

keep the infant from sliding down on 

the slanted product, which is not 

compliant with any of the existing CPSC 

sleep standards. Some suppliers have 

already remarketed the products as 

loungers or floor chairs without 

changing the design. Several of the 

companies that sell these products sell 

larger wedge pillow products for adults 

and older children as ‘‘body pillows’’ or 

sleeping positioners, so the infant sleep 

products are not their only product line. 

Redesign or remarketing could have a 

significant impact for the three small 

domestic companies and one importer 

that have such products, as well as other 

products in the scope of this rule, as a 

large portion of their product line. 

Suppliers of inclined play yard 

accessories will need to redesign their 

products with an incline of 10 degrees 

or less and meet other requirements of 

this standard, remove these products 

from the market, or relabel them as not 

being intended for sleep by children 

under 5 months of age, if appropriate. 

Most play yard suppliers have already 

discontinued or recalled the inclined 

accessory products and replaced them 

with flat products instead. The ASTM 

standard for non-full-size-cribs and play 

yards, F406–19, already specifies that 

bassinet, changing table, or similar 

accessories must comply with the 

applicable requirements of ASTM 

standards addressing those product 

types. Play yard suppliers were already 

required to comply with the 

requirement that bassinet accessories 

meet the bassinet standard. Because the 

main product is the play yard, not the 

particular accessories, and suppliers 

were already required to comply with 

the bassinet standard for bassinet-type 

accessories, this rule should not have a 

significant impact on any of the 

suppliers of play yards, unless they had 

‘‘napper’’ or ‘‘inclined sleeper’’ 

accessories that did not meet the 

bassinet standard. The impact could be 

significant for one small domestic 

company that still sells inclined play 

yard accessories, and has other products 

in the scope of this rule. 

(b) Baby Hammocks 

Suppliers of baby hammocks are 

unlikely to be able to redesign their 

product to meet any of the existing 

CPSC infant sleep standards. An 

inclined sleep angle is inherent in the 

design of hammocks, which shift shape 

as the infant moves. Sleeping pads in 

the bottom of a hammock would still 

leave the product with sides that shift 

shape in use. For hammock accessory 

products sold separately that attach to 

the corners of a crib or play yard, there 

is no standard installation that could be 

tested to meet incline, gap, side heights, 

or stability requirements: The incline 

would depend on the size of the crib or 

play yard and the weight of the infant, 

and the gaps between the hammock side 

and the side of the crib or play yard 

would depend on the size of the crib or 

play yard. Therefore, relabeling and 

remarketing baby hammocks as being 

not for sleep or as being intended only 

for children at over 5 months of age may 

be the only compliance option, other 

than removing the products from the 

market altogether. 

Since the NPR was published, some 

baby hammocks have been withdrawn 

from the market by small companies 

that make and import other types of 

baby products or adult hammocks. 

However, many home-based suppliers 

remain in the market, as well as several 

small domestic businesses, one of which 

appears to have infant crib hammocks as 

its only product. Multiple importers 

based in the U.S. also sell hammocks 

with frames made by foreign companies, 

but those companies will not be 

significantly impacted because they sell 

many other products that would not be 

impacted by the final rule. Several 

foreign companies that make baby 

hammocks will have to stop distributing 


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them in the U.S., or conspicuously label 

them as being for use only by children 

over 5 months of age. 

If baby hammocks are removed from 

the market, the impact will likely be 

significant for one small domestic 

company for which baby hammocks 

constitute most, if not all, of their 

product line, as well as possibly 

significant for several small importers 

that do not appear to have many other 

products. The impact will likely be 

significant for dozens of home-based 

manufacturers that have crib hammocks 

or other fabric hammocks without a 

frame as their main or only product, if 

they choose to exit the market. 

However, it is possible that some sellers 

of hammocks will simply relabel and 

remarket them for older children or as 

toy storage hammocks. The demand for 

these products for older children or toy 

storage uses is unknown. 

2. Flat Sleep Products 

(a) Flat, Soft-Sided Products 

Many of the suppliers of flat, softsided products would likely be 

significantly impacted by the final rule. 

This is because compliance with any of 

the sleep product standards, particularly 

the stability, side height, and occupant 

containment requirements, would be 

difficult for a product with low, soft 

sides. A product with low, soft sides 

cannot meet the bassinet standard by 

simply adding a stand, nor can it meet 

the hand-held carrier standard by 

simply adding handles. Also, adding 

rigid higher sides may be contrary to the 

intended product use as in-bed sleepers. 

Relabeling the products as being not 

intended for infant sleep might not be 

an option if the product is clearly 

intended for infant sleep, and is not 

large enough for an older child, 

although these items could be 

remarketed as pet beds. At least nine 

small importers and four domestic 

manufacturers that supply these 

products have these products as most or 

all of their product line. There are also 

potentially hundreds of small, homebased businesses for which such low, 

soft-sided products appear to be their 

major product line. The impact for 

suppliers that have these products as 

most of their product line would likely 

be significant. In addition, the many 

home-based businesses do not currently 

have warning labels, instruction 

manuals, or certification to other CPSC 

or ASTM standards. Some products are 

already being remarketed as loungers, 

nappers, or ‘‘for tummy time’’, but will 

be required to comply with the final 

rule if they are marketed for sleep, 

including napping. 

Flat play yard accessories are already 

required to meet the bassinet or other 

applicable standard. The ASTM 

standard for non-full-size-cribs and play 

yards, F406–19, already specifies that 

bassinet, changing table, or similar 

accessories must comply with the 

applicable requirements of ASTM 

standards addressing those accessories. 

Most flat play yard accessories are hardframed, not soft-sided, and are 

discussed in the next section. Because 

the main product is the play yard, not 

the particular accessories, and suppliers 

were already required to comply with 

the bassinet standard for bassinet-type 

accessories, this rule should not have a 

significant impact on any of the 

suppliers of flat play yard accessories, 

unless they have ‘‘napper’’ accessories 

that are not compliant with the bassinet 

standard. One importer has only one 

model of play yard with a flat mesh 

accessory as their main product; that 

importer could be significantly 

impacted if their product is not 

compliant and they cannot find another 

supplier with a compliant product. 

(b) Flat, Rigid-Sided and Rigid-Framed 

Compact Bassinets, Travel Bassinets, 

and Similar Products 

Compact bassinets with rigid sides or 

rigid-framed sides but without a stand 

or legs cannot meet the stability or 

physical requirements of CPSC’s 

bassinet and cradle standard or this 

standard, independent of whether the 

product has an incline. Suppliers may 

choose to offer their products with a 

stand to meet this standard, or add a 

handle and redesign the product to meet 

the hand-held carrier standard. In either 

case, the cost of redesigning the product 

could be significant. These products 

usually already have flat sleep surface 

and rigid sides, as required by the 

bassinet/cradle standard, but may not 

meet the side-height requirement of the 

bassinet/cradle standard. However, the 

cost to redesign could still be 

significant, as even a simple re-design 

could cost hundreds of thousands of 

dollars per model and require new 

third-party testing, and all of the 

product marketing, instructions, and 

packaging would have to be revised. 

Adding a stand would also increase the 

retail price of the product, which would 

likely reduce sales, assuming that 

demand is responsive to price and that 

other products like hand-held carriers 

are considered by consumers to be 

reasonable substitutes. Moreover, these 

products likely cannot be remarketed for 

another use by infants 5 months and 

younger, as the physical design suggests 

the product is for sleep, although they 

could be remarketed for older children 

or for pets, depending on whether the 

size is appropriate for those uses. For 

the importers, the impact is likely not 

significant, as they do not have these 

products as most of their product line 

and can therefore either stop selling the 

product or obtain a compliant product 

from a different supplier at minimal cost 

to them. For the two domestic 

manufacturers of these products that 

have these products as most of their 

product line, or sell multiple products 

covered by this rule, the cost of 

compliance could be significant. 

Baby boxes have similar compliance 

impacts to the larger category of 

compact bassinets. Some compact 

bassinets are marketed as suitable for 

bed-sharing, so may be considered as 

rigid in-bed sleepers. Suppliers of baby 

boxes and in-bed sleepers with rigid or 

rigid-framed sides may also choose to 

offer their products with a stand to meet 

the bassinet standard. Given that these 

products already have rigid sides and 

flat sleeping surfaces, the redesign may 

be relatively minor, but could still cost 

hundreds of thousands of dollars to 

implement and test, especially given the 

need to adapt them to meet stability 

requirements. These suppliers could 

also choose to add a handle to these 

products and make other design, 

instructions and labeling changes in 

order to comply with the hand-held 

carrier standard. Labeling these 

products as not for infant sleep is likely 

not an option, as these items are 

intended for sleep, and are too small to 

be used by older children. Remarketing 

as storage boxes is possible, but likely 

a much lower price point. The impact 

could be significant for two suppliers of 

baby boxes. 

Flat sleep surface play yard 

accessories are already required to meet 

the bassinet or other applicable 

standard. The ASTM standard for nonfull-size-cribs and play yards, F406–19, 

already specifies that bassinet, changing 

table, or similar accessories must 

comply with the applicable 

requirements of ASTM standards 

addressing those accessories. Because 

the main product is the play yard, not 

the particular accessories, and suppliers 

were already required to comply with 

the bassinet standard for bassinet-type 

accessories, this rule should not have a 

significant impact on any of the 

suppliers of flat rigid-sided play yard 

accessories, with the possible exception 

of a few ‘‘napper’’ products from small 

importers. Those importers should be 

able to find a new compliant supplier 

relatively easily, or relabel the items as 

not for sleep. 


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(c) Baby Tents 

Baby tents cannot meet any of CPSC’s 

sleep standards, due to the physical 

form of these products, which includes 

slanted flexible sides connected to the 

floor, sometimes with hanging cords 

and anchoring spikes. Therefore, 

relabeling these products as not for 

infant sleep or removing the products 

from the market are the only compliance 

options. We assume that most suppliers 

will choose to remarket their items as 

not for sleep or for older children, and 

that this will not reduce sales, because 

the advertised primary purpose of the 

product is shade and insect screen. 

Also, most suppliers in this product 

sector are importers with many other 

unrelated products or foreign direct 

shippers. CPSC believes it unlikely most 

of the suppliers in this category will 

experience a significant economic 

impact as a result of this rule. One small 

importer does not appear to have any 

other products that might be 

significantly impacted if they cannot 

find a compliant supplier. 

F. Summary of Costs and the Economic 

Impact of the Final Rule 

Suppliers that choose to stay in the 

market for infant sleep products will 

need to comply with the final rule, or 

another CPSC sleep standard, and 

certify compliance through third party 

testing. Suppliers that choose to relabel 

their products as bouncer seats or 

swings will need to meet the standards 

for those products. Suppliers that 

relabel their products for use by 

children over 5 months will still need 

to meet general testing and certification 

requirements required for all children’s 

products, such as testing for lead 

content and phthalates, as well as small 

parts, but they were already required to 

meet those requirements. 

Based on costs for compliance with 

other ASTM and CPSC standards for 

durable nursery products, the expected 

cost to comply with third party testing 

will be about $1,500 per model tested, 

including the costs of the samples to be 

tested. This is for compliance with the 

specific standard for infant sleep 

products only; the costs for complying 

with general requirements for children’s 

products should not be new costs for 

any suppliers. Some of the companies 

that are small by SBA standards have up 

to a dozen models of different products 

impacted by this rule, each of which 

will have to be tested for compliance 

with this standard. This would suggest 

testing costs of about $18,000 per testing 

cycle. 

The suppliers of low, soft-sided 

products and hammocks are unlikely to 

be able to redesign their products to 

meet any of the sleep standards, so they 

will need to decide whether to exit the 

market or relabel their products for use 

by older children. The impact is likely 

to be significant for suppliers of these 

products if these products constitute a 

substantial portion of their product line, 

and they choose to exit the market 

rather than remarketing the items for 

older children or pets. 

Some manufacturers and importers, 

both large and small, may be able to 

minimize the impact of this rule by 

marketing their products as not for 

infant sleep, thus effectively putting 

their products out of scope of this rule. 

This may involve conspicuously 

labeling and marketing their items as 

not for sleep by children under 5 

months. Some flat sleep surface rigidsided products could demonstrate 

compliance with this standard and the 

bassinet standard with the addition of a 

stand or other rigid support. Some noncompliant items might be remarketed 

for pet use, which has apparently 

happened with some former children’s 

products, but the market for such 

products is probably limited. 

Remarketing these products could still 

result in significant impact of suppliers 

if such relabeling results in a substantial 

reduction in product demand. 

While some items can be credibly 

remarketed as not for infant sleep, such 

as items that resemble chairs or swings, 

the design of other items suggest they 

are intended for infant sleep, including 

hammock crib accessories, baby boxes, 

and in-bed sleepers, as are most 

compact bassinets and anything 

marketed as a ‘‘bed’’. Some of these 

products could be marketed for children 

over 5 months, depending on the size of 

the product, but many are too small for 

a larger child. Suppliers of products 

where the design and function of the 

product communicates to the consumer 

that the product is intended for infant 

sleep may experience a significant 

economic impact if those products are a 

substantial portion of their product line. 

Most home-based manufacturers will 

have the choice of either remarketing 

their products as not for infant sleep or 

stopping the sale of the products. The 

cost of redesigning the product to 

comply with the standard could be a 

significant portion of revenue for homebased manufacturers, and redesign 

might not even be possible for some 

products commonly sold by home-based 

manufacturers, such as baby hammocks 

and low, soft-sided flat products. 

Additionally, even if redesign were 

possible, the testing costs alone could be 

sufficient to induce these home-based 

manufacturers to withdraw from the 

market for these products. The 

economic impact of the rule on these 

home-based manufacturers is likely to 

be significant. In some cases, these 

manufacturers might be able to relabel 

their products for older children, or for 

pet use. In the case of hammocks, the 

items could also be marketed for toy 

storage. However, the demand for infant 

sleep products for these types of 

alternative uses is likely to be limited. 

We discussed earlier the impacts for 

specific types of sleeper markets. In 

summary, the suppliers of inclined 

sleepers can redesign their items to meet 

this standard, remove them from the 

market, relabel them for use by older 

children, or remarket them as some type 

of chair. Some inclined items have 

already been remarketed as types of 

chairs or chair/swing combination 

products. The impact would depend on 

the demand for these products as chairs; 

the current remarketing suggests that 

companies have found there is indeed 

demand for these products as chairs. 

Suppliers of inclined play yard 

accessories have similar options; it 

appears that most play yard suppliers 

have chosen to remove these items from 

the market and replace them with flat 

sleep surface accessories instead. 

Because play yards were already 

required to comply with the bassinet 

standard if in bassinet mode, this may 

not be a significant impact. Suppliers of 

compact rigid-sided and rigid-framed 

products without a stand may be able to 

redesign their products to meet this 

standard, or remarket them for use by 

older children. The size of some of these 

products would be appropriate for use 

by older children. Some suppliers of 

soft-sided ‘‘travel’’ and ‘‘compact’’ 

bassinets are unlikely to be able to 

redesign their products to comply with 

this standard, but may be able to 

remarket them for use by older children. 

Similarly, suppliers of in-bed sleepers 

and baby hammocks are unlikely to be 

able to redesign their products to 

comply with this rule, but some may be 

able to remarket them for use by older 

children or pets, depending on the size 

of the products, although demand for 

those uses may be limited. 

In general, suppliers of products with 

limited remarketing options, where the 

size of the product is not conducive to 

use by older children, the low, soft sides 

cannot easily be redesigned to meet this 

standard, and the physical configuration 

of the product limits uses other than 

sleep, are likely to be significantly 

impacted. Some suppliers may be able 

to remarket their infant sleep products 

for alternative uses. However, this 

market is probably limited; otherwise, 

some of these suppliers would already 


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46The DNPES reported that in households with 

children under 6, children slept in bouncer seats at 

least once a week in 70% of households that owned 

a bouncer seat, slept in swings at least once a week 

in 91% of households with a swing, and slept in 

hand-held carriers at least once a week in 87% of 

households with hand-held carriers. 

have been producing products for these 

alternative uses. At least nine small 

domestic companies and twelve small 

importers are likely to be significantly 

impacted because products in scope of 

this rule represent most or a substantial 

portion of their product line. Hundreds 

of home-based manufacturers based in 

the U.S. supply baby nests, baby pods, 

in-bed sleepers, hammocks, and crib 

hammocks are likely to be significantly 

impacted, although some may be able to 

relabel their items as not for sleep or for 

older children. If the products cannot be 

remarketed, many of these home-based 

manufacturers may eliminate infant 

sleep products from their product lines; 

it also possible that a significant 

proportion may go out of business. 

In summary, taking all of these factors 

into account, the final rule is likely to 

have a significant economic impact on 

a substantial number of small entities. 

G. Other Potential Impacts of the Final 

Rule 

The final rule would make it illegal to 

sell, offer for sale, manufacture for sale, 

distribute in commerce, or import into 

the United States products not 

compliant with the rule 12 months after 

the publication of the rule in the 

Federal Register. This means that 

parents and other caregivers would not 

be able to purchase these items. The 

large volume of these products sold or 

home-made reflect that these products 

all address a demand for a compact 

sleep space for babies, so it is reasonable 

to assume that demand will continue for 

new or redesigned products that meet 

one of CPSC’s sleep standards. As 

discussed earlier, products that are 

compliant with the current CPSC sleep 

standards are already widely available, 

provide compact sleep spaces, and are 

in the same general price range as the 

items covered by this rule. 

Several public commenters suggested 

that this rule would cause caregivers to 

resort to less safe sleep solutions, such 

as putting infants to sleep in car seats, 

or using pillows to position infants on 

adult beds. Caregivers may already 

make home-made sleep places or misuse other types of products, and CPSC 

is unaware of data to support the 

assertion that this rule would further 

encourage such practices. Directions for 

making home-made baby nests were 

widely available on the internet before 

CPSC published the 2017 NPR. The 

DNPES, which was done in 2014, found 

that a majority of parents were using 

products for sleep that are not marketed 

for sleep, such as swings, bouncer seats, 

and hand-held carriers at least once a 

week.46 In addition, many inclined 

products have already been removed 

from the market or relabeled as not for 

sleep since publication of the 2017 NPR. 

While some of the inclined products 

may be remarketed as not for infant 

sleep, the final rule will provide parents 

and other caregivers clearer information 

as to the manufacturer’s intended safe 

use. 

The effective date is a ‘‘sold by’’ date. 

This means that retailers will need to 

sell or otherwise dispose of their stock 

by that date. Given that this rule has 

been in progress for several years 

through a notice and comment 

rulemaking, and that many of the 

inclined products have already been 

withdrawn from the market, this should 

not have a significant impact on small 

retailers. 

This rule would require all infant 

sleep products not in the scope of other 

CPSC sleep standards to comply with 

this rule. This means that new products 

would have to comply with this rule, or 

one of the other sleep standards. 

Suppliers may introduce new products 

that comply with any of those 

standards, such as an innovative 

bassinet design that meets all the 

requirements of the bassinet standard. 

They may also work with ASTM to 

revise one of the ASTM sleep standards 

to cover their new product, and then 

CPSC could consider such revision as 

part of CPSC’s procedures for accepting 

revisions to voluntary standards that are 

the basis for CPSC mandatory standards. 

Suppliers of innovative products may 

also work with ASTM to develop a 

separate, new sleep standard, then seek 

to have CPSC codify the new ASTM 

standard as a mandatory infant sleep 

standard under section 104 of the 

CPSIA. 

H. Efforts to Minimize the Impact on 

Small Entities (Alternatives) 

CPSC has attempted to minimize the 

impact of the final rule on small entities 

by defining the scope of this rule to only 

include infant sleep products that are: 

• Not within the scope of another 

standard; 

• marketed or intended for infant 

sleep, including napping; and 

• marketed or intended for use by 

children up to 5 months old. 

These requirements provide small 

businesses the opportunity to remove 

their products from the scope of this 

standard by marketing them as not 

intended for sleep, or only intended for 

use by older children, or for pets. 

Companies can also redesign their 

products to meet the requirements of 

another standard, such as infant 

bouncer seats or hand-held carriers. In 

some cases where there is another use 

for the product, the only change 

required to make a product subject to 

one of these other standards is to relabel 

or remarket the product, removing any 

references to its use for sleeping. 

CPSC also published an SNPR in 

2019, which means firms have been 

aware of this rulemaking effort and have 

had several years to prepare for 

implementation of the final rule. Many 

companies that had inclined products 

that were in the scope of the 2017 NPR 

have removed those products from the 

market since 2019, or remarketed them 

as loungers, bouncer seats, or other 

products not for sleep. 

While the Commission has exempted 

small batch manufacturers from the 

testing requirements proposed under 

other rules, under Section 14(d)(4)(C)(ii) 

of the CPSA, the Commission cannot 

‘‘provide any alternative requirements 

or exemption’’ from third party testing 

for ‘‘durable infant or toddler products,’’ 

as defined in section 104(f) of the 

CPSIA. Consequently, staff cannot 

recommend a small batch exemption for 

small baby nest and hammock homebased manufacturers absent a statutory 

change. 

The ASTM F3118 committee 

considered wording that would allow 

manufacturers to choose whether to 

comply with F3118 or another ASTM 

sleep standard, to allow innovative 

products to enter the market more 

easily. This final rule requires suppliers 

to comply with this rule or one of CPSC 

mandatory standards for full-size cribs, 

non-full-size cribs, bassinets and 

cradles, play yards, or bedside sleepers. 

The approach considered by ASTM to 

allow suppliers to choose other ASTM 

sleep product standards would allow 

suppliers to sell products that did not 

meet an existing CPSC sleep standard, 

such as a drop side crib, so long as that 

product had a sleep surface incline of 

less than 10 degrees and otherwise 

complied with ASTM F3118. Staff did 

not recommend this approach, which 

would effectively allow potentially 

unsafe, non-compliant sleep products to 

re-enter the market. 

Finally, the IRFA discussed allowing 

a later effective date. A later effective 

date would reduce the economic impact 

on firms in two ways. Firms would be 

less likely to experience a lapse in 

production/importation, which could 

result if they are unable to comply and 


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third-party test within the required 

timeframe. Also, firms could spread 

costs over a longer time period, thereby 

reducing their annual costs, as well as 

the present value of their total costs. 

CPSC received comments both 

supporting and opposing a later 

effective date. Given that many of the 

products have already been removed 

from the market or otherwise 

remarketed to be out of scope of this 

rule, reducing the impact on domestic 

small businesses, and that companies 

already had notice that this final rule 

was in progress since November 2019, 

the Commission will maintain a 12- 

month effective date, as proposed in the 

2019 SNPR. 

XIV. Environmental Considerations 

The Commission’s regulations address 

whether the agency is required to 

prepare an environmental assessment or 

an environmental impact statement. 

Under these regulations, certain 

categories of CPSC actions normally 

have ‘‘little or no potential for affecting 

the human environment,’’ and therefore, 

they do not require an environmental 

assessment or an environmental impact 

statement. Safety standards providing 

requirements for products come under 

this categorical exclusion. 16 CFR 

1021.5(c)(1). The final rule for infant 

sleep products falls within the 

categorical exemption. 

XV. Paperwork Reduction Act 

The final rule contains information 

collection requirements that are subject 

to public comment and review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA; 44 U.S.C. 3501–3521). 

Under 44 U.S.C. 3507(a)(1)(D), an 

agency must publish the following 

information: 

• A title for the collection of 

information; 

• a summary of the collection of 

information; 

• a brief description of the need for 

the information and the proposed use of 

the information; 

• a description of the likely 

respondents and proposed frequency of 

response to the collection of 

information; 

• an estimate of the burden that shall 

result from the collection of 

information; and 

• notice that comments may be 

submitted to the OMB. 

The preamble to the 2019 SNPR (84 

FR 60959–61) discussed the information 

collection burden of the supplemental 

proposed rule and specifically requested 

comments on the accuracy of our 

estimates. The OMB assigned control 

number 3041–0177 for this information 

collection. We did not receive any 

comment regarding the information 

collection burden of the proposal in the 

2019 SNPR. For the final rule, CPSC 

adjusts the number of small home-based 

manufacturers from 6 to 1,200, and the 

number of other suppliers from 13 to 

125. In accordance with PRA 

requirements, the Commission provides 

the following information: 

Title: Safety Standard for Infant Sleep 

Products. 

Description: The final rule defines an 

‘‘infant sleep product’’ as a product 

marketed or intended to provide a 

sleeping accommodation for an infant 

up to 5 months of age, and that is not 

already subject to one of the mandatory 

CPSC sleep standards: Full-size cribs, 

non-full-size cribs, play yards, bassinets, 

cradles, or bed-side sleepers. The infant 

sleep products covered by this rule 

include inclined and flat sleep products, 

such as inclined sleepers, play yard 

infant sleep accessories, baby nests and 

pods, in-bed sleepers, baby hammocks, 

compact or travel bassinets without a 

stand or legs, and baby tents. This final 

rule for infant sleep products 

incorporates by reference the voluntary 

standard for infant inclined sleep 

products issued by ASTM International, 

ASTM F3118–17a, Standard Consumer 

Safety Specification for Infant Inclined 

Sleep Products, with modifications to 

further reduce the risk of injury 

associated with infant sleep products. 

The final rule sets a safety floor for all 

infant sleep products sold in the United 

States, by requiring infant sleep 

products to have a seat back/sleep 

surface angle of 10 degrees or less from 

horizontal, and to meet the 

requirements of 16 CFR part 1218, 

Safety Standard for Bassinets and 

Cradles, including conforming to the 

definition of a bassinet/cradle. Part 1218 

incorporates by reference the 

performance and labeling requirements 

of ASTM F2194–16e1. Sections 8 and 9 

of ASTM F2194–16e1 contain 

requirements for marking, labeling, and 

instructional literature. These 

requirements fall within the definition 

of ‘‘collection of information,’’ as 

defined in 44 U.S.C. 3502(3). 

Description of Respondents: Persons 

who manufacture or import infant sleep 

products. 

Estimated Burden: We estimate the 

burden of this collection of information 

as follows: 

TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN

Burden type Type of supplier Number of 

respondents 

Frequency of 

responses 

Total annual 

responses 

Hours per 

response 

Total burden 

hours 

Labeling ............................... Home-based manufacturers 1,200 1 1,200 7 8,400 

Other Suppliers .................. 125 2 250 1 250 

Labeling Total .............. ............................................. ........................ ........................ ........................ ........................ 8,650 

Instructional literature .......... Home-based manufacturers 1,200 1 1,200 50 60,000 

Total burden ................. ............................................. ........................ ........................ ........................ ........................ 68,650 

Two groups of quantifiable entities 

supply infant sleep products to the U.S. 

market that will likely need to make 

some modifications to their existing 

warning labels to meet the requirements 

for warnings. The first group consists of 

very small home-based manufacturers, 

which may not currently have warning 

labels on their infant sleep products. 

Similar rulemakings (such as that for 

sling carriers) assumed that it would 

take home-based manufacturers 

approximately 15 hours to develop a 

new label. Given that some home-based 

manufacturers supply infant sleep 

products with warning labels already, 

we have estimated approximately 7 

hours per response for this group of 

suppliers. Therefore, the total burden 

hours for very small home-based 

manufacturers is 7 hours per model × 

1,200 entities × 1 models per entity = 

8,400 hours. 

The second group of quantifiable 

entities supplying infant sleep products 

to the U.S. market that will need to 

make some modifications to their 

existing warning labels are non-homebased manufacturers and importers. 

These firms do not operate at the low 


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production volume of the home-based 

firms. All of the firms in this second 

group have existing warning labels on 

their products, but not necessarily labels 

that are compliant with the 

requirements of ASTM F2194, as 

specified in 16 CFR part 1218, and 

would therefore, have to make label 

modifications. Given that these firms are 

used to working with warning labels, we 

estimate that the time required to make 

any modifications now or in the future 

would be about 1 hour per model. Based 

on an evaluation of supplier product 

lines, each entity supplies an average of 

2 models of infant sleep products; 

therefore, the estimated burden 

associated with labels for this second 

group is 1 hours per model × 125 

entities × 2 models per entity = 250 

hours. 

The total burden hours attributable to 

warning labels is the sum of the burden 

hours for both entity groups: Very small 

home-based manufacturers (8,400 

burden hours) + non-home-based 

manufacturers and importers (250 

burden hours) = 8,650 burden hours. We 

estimate the hourly compensation for 

the time required to create and update 

labels is $33.71 (U.S. Bureau of Labor 

Statistics, ‘‘Employer Costs for 

Employee Compensation,’’ December 

2020, Supplementary table 1, total 

compensation for all sales and office 

workers in goods-producing private 

industries: https://www.bls.gov/web/ 

ecec/ecsuptc.pdf. Therefore, the 

estimated annual cost to industry 

associated with the labeling 

requirements is $291,591.50 ($33.71 per 

hour × 8,650 hours = $291,591.50). No 

operating, maintenance, or capital costs 

are associated with the collection. 

ASTM F2194 (section 9) requires 

instructions to be supplied with the 

product. As already noted, the proposed 

Safety Standard for Infant Sleep 

Products requires infant sleep products 

to meet these requirements. Under the 

OMB’s regulations (5 CFR 1320.3(b)(2)), 

the time, effort, and financial resources 

necessary to comply with a collection of 

information that would be incurred by 

persons in the ‘‘normal course of their 

activities’’ are excluded from a burden 

estimate, where an agency demonstrates 

that the disclosure activities required to 

comply are ‘‘usual and customary.’’ 

We are unaware of infant sleep 

products that generally require use 

instructions but lack such instructions. 

However, it is possible that the 1,200 

home-based manufacturers of infant 

hammocks, baby nests, and in-bed 

sleepers may not supply instruction 

manuals as part of their ‘‘normal course 

of activities.’’ Based on information 

collected for the infant slings 

rulemaking, staff tentatively estimates 

that each small entity supplying 

homemade infant hammocks, baby 

nests, or in-bed sleepers might require 

50 hours to develop an instruction 

manual to accompany their products. 

These firms typically supply only one 

infant sleep product model. Therefore, 

the costs of designing an instruction 

manual for these firms could be as high 

as $2,022,600 (50 hours per model × 1 

model per entity × 1,200 entities = 

$2,022,600). However, this cost estimate 

may overestimate the annual cost to 

industry because many home-based 

firms might not pay average U.S. 

domestic wage rates. Not all firms 

would incur these costs every year, but 

new firms that enter the market would 

incur these costs, and this is a highly 

fluctuating market. Other firms are 

estimated to have no burden hours 

associated with instruction manuals 

because any burden associated with 

supplying instructions with infant sleep 

products would be ‘‘usual and 

customary’’ and not within the 

definition of ‘‘burden’’ under the OMB’s 

regulations. 

Based on this analysis, CPSC staff 

estimates that the final rule for infant 

sleep products would impose a burden 

to industry of 68,650 hours at a cost of 

$2,314,191.50 annually. In compliance 

with the Paperwork Reduction Act of 

1995 (44 U.S.C. 3507(d)), we have 

submitted the information collection 

requirements of this final rule to the 

OMB. 

XVI. 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 deems rules issued under 

that provision ‘‘consumer product safety 

standards.’’ Therefore, once this final 

rule for infant sleep products issued 

under section 104 of the CPSIA takes 

effect, the rule will preempt in 

accordance with section 26(a) of the 

CPSA. 

XVII. 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). A 

‘‘major rule’’ is one that the 

Administrator of OIRA finds has 

resulted in, or is likely to result in: (A) 

An annual effect on the economy of 

$100,000,000 or more; (B) a major 

increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or (C) a 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

enterprises to compete with foreignbased enterprises in domestic and 

export markets. 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. 

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 1236 

Consumer protection, Imports, 

Incorporation by reference, Infants and 

children, Labeling, Law enforcement, 

and Toys. 

For the reasons discussed in the 

preamble, the Commission amends Title 

16 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: 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 33071 

Authority: 15 U.S.C. 2063; Pub. L. 110– 

314, section 3, 122 Stat. 3016, 3017 (2008). 

■ 2. Amend § 1112.15 by adding 

paragraph (b)(46) 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) * * * 

(46) 16 CFR part 1236, Safety 

Standard for Infant Sleep Products. 

* * * * * 

■ 3. The authority citation for part 1130 

continues to read as follows: 

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

■ 4. Amend § 1130.2 by revising 

paragraph (a)(12) to read as follows: 

PART 1130—REQUIREMENTS FOR 

CONSUMER REGISTRATION OF 

DURABLE INFANT OR TODDLER 

PRODUCTS 

§ 1130.2 Definitions. 

* * * * * 

(a) * * * 

(12) Bassinets and cradles, including 

bedside sleepers and infant sleep 

products; 

* * * * * 

■ 5. Add part 1236 to read as follows: 

PART 1236—SAFETY STANDARD FOR 

INFANT SLEEP PRODUCTS 

Sec. 

1236.1 Scope. 

1236.2 Requirements for infant sleep 

products. 

Authority: Sec. 104, Pub. L. 110–314, 122 

Stat. 3016 (15 U.S.C. 2056a); Sec. 3, Pub. L. 

112–28, 125 Stat. 273. 

§ 1236.1 Scope. 

This part establishes a consumer 

product safety standard for infant sleep 

products, including inclined and flat 

sleep surfaces, that applies to all 

products marketed or intended to 

provide a sleeping accommodation for 

an infant up to 5 months of age, and that 

are not already subject to any of the 

following standards: 

(a) 16 CFR part 1218 Safety Standard 

for Bassinets and Cradles; 

(b) 16 CFR part 1219 Safety Standard 

for Full-Size Baby Cribs; 

(c) 16 CFR part 1220 Safety Standard 

for Non-Full-Size Baby Cribs; 

(d) 16 CFR part 1221 Safety Standard 

for Play Yards; 

(e) 16 CFR part 1222 Safety Standard 

for Bedside Sleepers. 

§ 1236.2 Requirements for infant sleep 

products. 

(a) Except as provided in paragraph 

(b) of this section, each infant sleep 

product must comply with ASTM 

F3118–17a, Standard Consumer Safety 

Specification for Infant Inclined Sleep 

Products (approved on September 1, 

2017). 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. You may 

obtain a copy from ASTM International, 

100 Barr Harbor Drive, P.O. Box C700, 

West Conshohocken, PA 19428–2959; 

phone: (610) 832–9585; www.astm.org. 

A read-only copy of the standard is 

available for viewing on the ASTM 

website at https://www.astm.org/ 

READINGLIBRARY/. You may inspect a 

copy at the Division of the Secretariat, 

U.S. Consumer Product Safety 

Commission, Room 820, 4330 East-West 

Highway, Bethesda, MD 20814, 

telephone (301) 504–7479, email: cpscos@cpsc.gov, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, email 

fedreg.legal@nara.gov, or go to: 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

(b) Comply with ASTM F3118–17a 

with the following additions or 

exclusions: 

(1) Instead of complying with 

Introduction of ASTM F3118–17a, 

comply with the following: 

(i) Introduction. This consumer safety 

specification addresses incidents 

associated with infant sleep products 

identified by the U.S. Consumer Product 

Safety Commission (CPSC). 

(A) In response to incident data 

compiled by CPSC, this consumer safety 

specification attempts to minimize the 

following: 

(1) Fall hazards, 

(2) Asphyxiation and suffocation, and 

(3) Obstruction of nose and mouth by 

bedding. 

(B) The purpose of the standard is to 

address infant sleep products not 

already covered by traditional sleep 

product standards and to reduce deaths 

associated with known infant sleep 

hazards, including, but not limited to, a 

seat back or sleep surface angle that is 

greater than 10 degrees from the 

horizontal. 

(C) This consumer safety specification 

is written within the current state-ofthe-art of infant sleep product 

technology and will be updated 

whenever substantive information 

becomes available that necessitates 

additional requirements or justifies the 

revision of existing requirements. 

(ii) [Reserved] 

(2) In section 1.1 of ASTM F3118–17a, 

replace the term ‘‘infant inclined sleep 

products’’ with ‘‘infant sleep products.’’ 

(3) In section 1.2 of ASTM F3118–17a, 

replace the term ‘‘infant inclined sleep 

products’’ with ‘‘infant sleep products.’’ 

(4) Instead of complying with section 

1.3 of ASTM F3118–17a, comply with 

the following: 

(i) 1.3 This consumer safety 

performance specification covers infant 

sleep products, including inclined and 

flat sleep surfaces, marketed or intended 

to provide a sleeping accommodation 

for an infant up to 5 months old, and 

that are not already subject to any of the 

following standards: 

(A) 16 CFR part 1218—Safety 

Standard for Bassinets and Cradles, 

incorporating by reference ASTM 

F2194, Standard Consumer Safety 

Specification for Bassinets and Cradles; 

(B) 16 CFR part 1219—Safety 

Standard for Full-Size Baby Cribs, 

incorporating by reference ASTM 

F1169, Standard Consumer Safety 

Specification for Full-Size Baby Cribs; 

(C) 16 CFR part 1220—Safety 

Standard for Non-Full-Size Baby Cribs, 

incorporating by reference applicable 

requirements in ASTM F406, Standard 

Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards; 

(D) 16 CFR part 1221—Safety 

Standard for Play Yards, incorporating 

by reference applicable requirements in 

ASTM F406, Standard Consumer Safety 

Specification for Non-Full-Size Baby 

Cribs/Play Yards; 

(E) 16 CFR part 1222—Safety 

Standard for Bedside Sleepers, 

incorporating by reference ASTM 

F2906, Standard Consumer Safety 

Specification for Bedside Sleepers. 

(ii) 1.3.1 If the infant sleep product 

can be converted into a product for 

which a CPSC regulation exists, the 

product shall meet the applicable 

requirements of the CPSC regulation, 

when in that use mode. If the infant 

sleep product can be converted into a 

product for which no CPSC regulation 

exists, but another ASTM consumer 

safety specification exists, the product 

shall meet the applicable requirements 

of the ASTM consumer safety 

specification, when in that use mode. 

(iii) 1.3.2 Crib mattresses that meet 

the requirements of ASTM F2933 are 

not covered by the specifications of this 

standard. 

(5) In section 1.4 of ASTM F3118–17a, 

replace the term ‘‘infant inclined sleep 

product’’ with ‘‘infant sleep product.’’ 

(6) Instead of complying with section 

2.1 of ASTM F3118–17a, comply with 

the following: 

(i) F406 Standard Consumer Safety 

Specification for Non-Full-Size Baby 

Cribs/Play Yards; 

(ii) F1169 Standard Consumer Safety 

Specification for Full-Size Baby Cribs; 


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33072 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations 

(iii) F2194 Standard Consumer Safety 

Specification for Bassinets and Cradles; 

(iv) F2906 Standard Consumer Safety 

Specification for Bedside Sleepers; 

(v) F2933 Standard Consumer Safety 

Specification for Crib Mattresses. 

(7) Instead of complying with section 

2.2 of ASTM F3118–17a, comply with 

the following: 

(i) 16 CFR 1218—Safety Standard for 

Bassinets and Cradles; 

(ii) 16 CFR 1219—Safety Standard for 

Full-Size Baby Cribs; 

(iii) 16 CFR 1220—Safety Standard for 

Non-Full-Size Baby Cribs; 

(iv) 16 CFR 1221—Safety Standard for 

Play Yards; 

(v) 16 CFR 1222—Safety Standard for 

Bedside Sleepers. 

(8) Do not comply with sections 2.3 

and 2.4 of ASTM F3118–17a, including 

Figures 1 and 2. 

(9) Do not comply with sections 3.1.1 

through 3.1.6 of ASTM F3118–17a. 

(10) Instead of complying with section 

3.1.7 of ASTM F3118–17a, comply with 

the following: 

(i) 3.1.7 infant sleep product, n—a 

product marketed or intended to 

provide a sleeping accommodation for 

an infant up to 5 months of age, and that 

is not subject to any of the following: 

(A) 16 CFR part 1218—Safety 

Standard for Bassinets and Cradles; 

(B) 16 CFR part 1219—Safety 

Standard for Full-Size Baby Cribs; 

(C) 16 CFR part 1220—Safety 

Standard for Non-Full-Size Baby Cribs; 

(D) 16 CFR part 1221– Safety 

Standard for Play Yards; 

(E) 16 CFR part 1222—Safety 

Standard for Bedside Sleepers. 

(ii) [Reserved] 

(11) Do not comply with sections 

3.1.7.1 through 3.1.13 of ASTM F3118– 

17a. 

(12) Do not comply with section 

3.1.15 through 3.1.16 of ASTM F3118– 

17a. 

(13) Do not comply with section 5 of 

ASTM F3118–17a. 

(14) Do not comply with sections 6.1 

through 6.8 of ASTM F3118–17a. 

(15) Instead of complying with section 

6.9 of ASTM F3118–17a, comply with 

the following: 

(i) 6.9 Maximum Seat Back/Sleep 

Surface Angle: 

(ii) 6.9.1 Infant Sleep Product—The 

angle of the seat back/sleep surface 

intended for sleep along the occupant’s 

head to toe axis relative to the 

horizontal shall not exceed 10 degrees 

when tested in accordance with 7.11.2. 

(iii) Do not comply with 6.9.2. 

(iv) 6.9.3 Infant Sleep Products—shall 

meet, 16 CFR part 1218, Safety Standard 

for Bassinets and Cradles, including 

conforming to the definition of a 

‘‘bassinet/cradle.’’ 

(16) Do not comply with sections 6.10 

through 7.10 of ASTM F3118–17a. 

(17) Do not comply with section 

7.11.1.3 of ASTM F3118–17a. 

(18) In section 7.11.2 of ASTM 

F3118–17a, replace ‘‘Infant Inclined 

Sleep Product and Infant Inclined Sleep 

Product Accessory’’ with ‘‘Infant Sleep 

Products.’’ 

(19) Instead of complying with section 

7.11.2.1 and 7.11.2.2 of ASTM F3118– 

17a, comply with the following: 

(i) 7.11.2.1 If applicable, place the 

product in the manufacturer’s 

recommended highest seat back/sleep 

surface angle position intended for 

sleep. 

(ii) 7.11.2.2 Place the hinged weight 

gage–infant in the product and position 

the gage with the hinge centered over 

the seat bight line and the upper plate 

of the gage on the seat back/sleep 

surface. Place a digital protractor on the 

upper torso/head area lengthwise. 

(20) Do not comply with sections 

7.11.3 through 9, or the Appendix, of 

ASTM F3118–17a. 

(21) Add section 10.2 to ASTM 

F3118–17a: 

(i) 10.2 infant sleep product 

(ii) [Reserved] 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2021–12723 Filed 6–22–21; 8:45 am] 

BILLING CODE 6355–01–P 


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