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Rule2021-12723

Safety Standard for Infant Sleep Products

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Published

June 23, 2021

Effective

June 23, 2022

Issuing agencies

Consumer Product Safety Commission

Abstract

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.

Full Text

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[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Rules and Regulations]
[Pages 33022-33072]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12723]

[[Page 33021]]

Vol. 86

Wednesday,

No. 118

June 23, 2021

Part II

Consumer Product Safety Commission

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16 CFR Parts 1112, 1130, and 1236

Safety Standard for Infant Sleep Products; Final Rule

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

[[Page 33022]]

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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.

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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: <a href="/cdn-cgi/l/email-protection#bcd7cbddd0d7d9cefcdfcccfdf92dbd3ca"><span class="__cf_email__" data-cfemail="5e35293f32353b2c1e3d2e2d3d70393128">[email&#160;protected]</span></a>.

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 Sec. 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 (full-size 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:

[[Page 33023]]

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\
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\1\ ASTM International website: <a href="http://www.astm.org">www.astm.org</a>, ``About ASTM
International.''
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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 CPSC-enforced 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

[[Page 33024]]

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\
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\2\ The 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: <a href="https://www.cpsc.gov/s3fs-public/SupplementalNoticeofProposedRulemakingforInfantSleepProducts_10_16_2019.pdf?TPVAJZEQcz9x9sKeEGltm4LskkonxUWv">https://www.cpsc.gov/s3fs-public/SupplementalNoticeofProposedRulemakingforInfantSleepProducts_10_16_2019.pdf?TPVAJZEQcz9x9sKeEGltm4LskkonxUWv</a>.
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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:

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

[[Page 33025]]

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\
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\3\ Note that in the 2019 SNPR the Commission proposed to revise
these terms by removing the word ``inclined.''
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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: <a href="https://www.cpsc.gov/s3fs-public/FinalRuleSafetyStandardforInfantSleepProducts.pdf?7s3LjLlkZ4Vm_0GWP2.vstoEzBylG8xg">https://www.cpsc.gov/s3fs-public/FinalRuleSafetyStandardforInfantSleepProducts.pdf?7s3LjLlkZ4Vm_0GWP2.vstoEzBylG8xg</a>.

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, hand-held
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
Sec. 1500.18, ``Banned toys and other banned articles intended for use

[[Page 33026]]

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 <SUP>4</SUP>
---------------------------------------------------------------------------

\4\ Tab E of Staff's Final Rule Briefing Package contains CPSC
staff's analysis of the market for infant sleep products.
---------------------------------------------------------------------------

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, in-bed sleepers, and hammocks, in particular, are marketed as
primary sleep spaces for babies.
---------------------------------------------------------------------------

\5\ Tab D of Staff's Final Rule Briefing Package contains CPSC
staff's analysis of the hazards associated with bed-sharing.
---------------------------------------------------------------------------

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. Hard-frame 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.
---------------------------------------------------------------------------

\6\ The 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.
\7\ <a href="https://www.cdc.gov/nchs/nvss/births.htm">https://www.cdc.gov/nchs/nvss/births.htm</a>.
\8\ <a href="https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/adoption-statistics-esri.html">https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/adoption-statistics-esri.html</a>.
---------------------------------------------------------------------------

(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 third-party 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

[[Page 33027]]

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 soft-sided 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:

<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
---------------------------------------------------------------------------

\9\ This 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.
---------------------------------------------------------------------------

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 in-bed 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.
---------------------------------------------------------------------------

\10\ A 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.
\11\ Bombard 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:
<a href="http://dx.doi.org/10.15585/mmwr.mm6701e1">http://dx.doi.org/10.15585/mmwr.mm6701e1</a>.
---------------------------------------------------------------------------

(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, rigid-sided 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,

[[Page 33028]]

this sector does not have many home-based 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.
---------------------------------------------------------------------------

\12\ A public comment estimated 2018 sales from two of the three
U.S. baby box companies at more than 10,000.
\13\ Similar programs now offer free cribs or play yards.
---------------------------------------------------------------------------

(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
non-injury 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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.
<bullet> Three infants were treated and released from emergency
departments. Those infants were treated for respiratory problems from
exposure to mold or for fall injuries.
<bullet> 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

[[Page 33029]]

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. Thirty-
four 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, non-product-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 CPSC-issued 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, non-ED 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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total incidents Deaths Injuries
Issues -------------------------------------------------------------------------------------------------
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

[[Page 33030]]

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 standard-sized 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\
---------------------------------------------------------------------------

\14\ According 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.
---------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
All incidents Injuries and fatalities
Age of child ----------------------------------------------------------------
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

[[Page 33031]]

fatality reports describe a suffocation death, as follows:
<bullet> A 1-month-old was found partially rolled over onto their
side in a soft-sided compact bassinet/travel bed.
<bullet> A 2-month-old infant was found completely rolled over the
edge of an in-bed sleeper.
<bullet> A 2-month-old was placed in an in-bed 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> A 1-month-old was placed in an in-bed 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.
<bullet> A 7-month-old was placed in an in-bed 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.
<bullet> 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:
<bullet> 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.
<bullet> 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, closed-head injury, and head
contusion, or other injuries, such as face abrasion and knee contusion.
<bullet> 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 staff-identified 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 near-suffocation 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.

[[Page 33032]]

(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\
---------------------------------------------------------------------------

\16\ <a href="https://www.cpsc.gov/content/cpsc-consumer-alert-caregivers-urged-to-use-restraints-with-inclined-sleep-products">https://www.cpsc.gov/content/cpsc-consumer-alert-caregivers-urged-to-use-restraints-with-inclined-sleep-products</a>.
\17\ <a href="https://www.cpsc.gov/Newsroom/News-Releases/2019/CPSC-ALERT-CPSC-and-Fisher-Price-Warn-Consumers-About-Fisher-Price-Rock-N-Play-Due-to-Reports-of-Death-When-Infants-Roll-Over-in-the-Product">https://www.cpsc.gov/Newsroom/News-Releases/2019/CPSC-ALERT-CPSC-and-Fisher-Price-Warn-Consumers-About-Fisher-Price-Rock-N-Play-Due-to-Reports-of-Death-When-Infants-Roll-Over-in-the-Product</a>.
\18\ <a href="https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Warns-Consumers-to-Stop-Using-Summer-Infant-USA-Inc-s-SwaddleMe-By-Your-Bed-Sleeper">https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Warns-Consumers-to-Stop-Using-Summer-Infant-USA-Inc-s-SwaddleMe-By-Your-Bed-Sleeper</a>.
\19\ <a href="https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Cautions-Consumers-Not-to-Use-Inclined-Infant-Sleep-Products">https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Cautions-Consumers-Not-to-Use-Inclined-Infant-Sleep-Products</a>.
---------------------------------------------------------------------------

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 consumer-level 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\
---------------------------------------------------------------------------

\20\ Tab 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.

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
CPSC-accepted 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.
---------------------------------------------------------------------------

\21\ Under 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).

[[Page 33033]]

Table 3--Regulated Infant Sleep Products and Applicable Standards
----------------------------------------------------------------------------------------------------------------
Product Voluntary standard Mandatory standard
----------------------------------------------------------------------------------------------------------------
Bassinet/Cradle....................... ASTM F2194-16[egr]1 \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.
---------------------------------------------------------------------------

\22\ CPSC'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
F2194-16[egr]1 is substantially similar to the mandatory standard,
and we assess this version of the voluntary standard in this
preamble, to simplify our analysis.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

\23\ Meeting logs detailing CPSC's work with ASTM on the infant
inclined sleep product voluntary standard can be found here: <a href="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">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</a>.
\24\ CPSC staff's correspondence with ASTM since issuing the
2017 NPR regarding these products can be found on
<a href="http://www.regulations.gov">www.regulations.gov</a> under supporting materials: <a href="https://www.regulations.gov/docket/CPSC-2017-0020/document?documentTypes=Supporting%20%26%20Related%20Material">https://www.regulations.gov/docket/CPSC-2017-0020/document?documentTypes=Supporting%20%26%20Related%20Material</a>.
---------------------------------------------------------------------------

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

[[Page 33034]]

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:
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\25\ Available at: <a href="https://www.cpsc.gov/s3fs-public/IISPLettertoASTM-07162020.pdf?6ntZUkyau.r2mlrQnM31s0B3g1EkUg.9">https://www.cpsc.gov/s3fs-public/IISPLettertoASTM-07162020.pdf?6ntZUkyau.r2mlrQnM31s0B3g1EkUg.9</a>.

<bullet> Remove the word ``inclined'' throughout the standard.
<bullet> Include in the scope, products intended for infants up to 12
months old.
<bullet> Include in the scope, products marketed or intended to provide
sleeping accommodations.
<bullet> Change the scope to include all infant sleep products that do
not fall within the scope of an existing infant sleep product standard:
[ssquf] Full-Sized Cribs (F1169)
[ssquf] Bassinets (F2194)
[ssquf] Bedside Sleepers (F2906)
[ssquf] Non-Full-Size Cribs/Play Yards (F406)
<bullet> Exempt crib mattresses from the scope of the standard.
<bullet> 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\
---------------------------------------------------------------------------

\26\ The 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.
---------------------------------------------------------------------------

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 F2194-16[egr]1, 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 F2194-16[egr]1, 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,

[[Page 33035]]

and advises that the changes are either non-substantive, or an
improvement in safety. We evaluate and discuss ASTM F2194-16[egr]1 in
this preamble to the final rule, and CPSC will update the reference in
part 1218 to ASTM F2194-16[egr]1 as soon as feasible.
The more significant requirements of ASTM F2194 include:
<bullet> Scope--describes the types of products intended to be
covered under the standard.
<bullet> Spacing of rigid-side components--is intended to prevent
child entrapment between both uniformly and non-uniformly spaced
components, such as slats.
<bullet> Openings for mesh/fabric--is intended to prevent the
entrapment of children's fingers and toes, as well as button
ensnarement.
<bullet> Static load test--is intended to ensure structural
integrity even when a child three times the recommended (or 95th
percentile) weight uses the product.
<bullet> Stability requirements--is intended to ensure that the
product does not tip over when pulled on by a 2-year-old male.
<bullet> Sleeping pad thickness and dimensions--is intended to
minimize gaps and the possibility of suffocation due to excessive
padding.
<bullet> Tests of locking and latching mechanisms--is intended to
prevent unintentional folding while in use.
<bullet> Suffocation warning label--is intended to help prevent
soft bedding incidents.
<bullet> Fabric-sided openings test--is intended to prevent
entrapments.
<bullet> 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.
<bullet> Occupant restraints--is intended to prevent incidents
where unused restraints have entrapped and strangled children.
<bullet> Side height requirement--is intended to prevent falls.
<bullet> 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 then-current 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 in-bed sleepers, since approximately 2015. ASTM has not
yet been successful in adding any of these flat sleep products to the
bassinet standard.
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\27\ CPSC meeting logs associated with staff's work with ASTM
can be found here: <a href="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">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</a>.
\28\ CPSC correspondence with the ASTM Subcommittee for
Bassinets and Cradles can be found here: <a href="https://cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI">https://cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI</a>.
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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.
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\29\ Available at: <a href="https://www.cpsc.gov/s3fs-public/LetterToASTMBassinet_IISP_121219.pdf?uMq_ImMYhtrDmFkoDH9I6vdwNI0hsm00">https://www.cpsc.gov/s3fs-public/LetterToASTMBassinet_IISP_121219.pdf?uMq_ImMYhtrDmFkoDH9I6vdwNI0hsm00</a>
.
\30\ Available at: <a href="https://www.cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI">https://www.cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI</a>. CPSC's website, at <a href="https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards">https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards</a>, contains information on staff
activities as well as correspondence with voluntary standards
organizations.
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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:
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\31\ Meeting logs describing ASTM meetings are available on
CPSC' website: <a href="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">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</a>.

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 in-bed sleeper voluntary
standard that differs

[[Page 33036]]

from the current bassinet standard will result in a safe sleep
product.\32\
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\32\ See July 8, 2020 Letter from C. Kish to ASTM Subcommittee
for In-bed Sleepers, available at: <a href="https://www.cpsc.gov/s3fs-public/InbedSleepers_07082020ASTM%20Letter.pdf?3SpzS3cG3zvPjCLFamcCz.9FxNjpUu2s">https://www.cpsc.gov/s3fs-public/InbedSleepers_07082020ASTM%20Letter.pdf?3SpzS3cG3zvPjCLFamcCz.9FxNjpUu2s</a>.
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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 F2194-16[egr]1, 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):
<bullet> 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.
Thirty-three percent of the reported incidents involved infants rolling
from their original supine (on their back) position.
<bullet> Electrical issues (28 percent). This hazard involved no
deaths and two reports of injuries.
<bullet> 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).
<bullet> Structural Integrity (6 percent). This hazard involved no
deaths and two injuries.
<bullet> 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.
<bullet> 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.
<bullet> 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

[[Page 33037]]

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 F2194-16[egr]1, 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 F2194-16[egr]1, 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.
---------------------------------------------------------------------------

\33\ Beal 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.
---------------------------------------------------------------------------

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 F2194-16[egr]1, 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
F2194-16[egr]1, as codified in 16 CFR part 1218, to further reduce the
risk of death from suffocation.
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\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.
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(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 F2194-16[egr]1, 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-
16[egr]1, 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.

[[Page 33038]]

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 F2194-16[egr]1), 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 F2194-16[egr]1, 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 F2194-16[egr]1,
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-year-old 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 F2194-16[egr]1, 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 F2194-16[egr]1, 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 one-third 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 F2194-16[egr]1 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 F2194-16[egr]1, 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 F2194-16[egr]1,
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.

[[Page 33039]]

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 F2194-16[egr]1
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 F2194-16[egr]1
requires a higher side. For bassinets not on a stand, ASTM F2194-
16[egr]1 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 F2194-16[egr]1
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 F2194-16[egr]1
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 F2194-16[egr]1 bassinet
standard tests both the stand and the bassinet as a fully assembled
product.
The ASTM F2194-16[egr]1 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 F2194-16[egr]1 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-
16[egr]1 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 F2194-16[egr]1
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-
16[egr]1 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- 16[egr]1's bassinet
standard. However, the ASTM F2194-16[egr]1 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
F2194-16[egr]1. 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 F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 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
dual-action 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

[[Page 33040]]

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 F2194-16[egr]1 bassinet standard
tests both the standard and the bassinet as a fully assembled product.
The ASTM F2194-16[egr]1 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-
16[egr]1 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 F2194-16[egr]1
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 F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 bassinet standard; however, the ASTM F2194-16[egr]1
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
F2194-16[egr]1 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 F2194-16[egr]1 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
F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 bassinet standard. However, the ASTM F2194-16[egr]1
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 cm\2\ (620 in\2\).
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-
16[egr]1 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 F2194-16[egr]1
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

[[Page 33041]]

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 auto-
locking mechanism that requires a dual-simultaneous 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 F2194-16[egr]1 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
F2194-16[egr]1 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-
16[egr]1 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 F2194-16[egr]1. 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-
16[egr]1 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 F2194-16[egr]1 bassinet standard. While the
Canadian standard has a more stringent sleep surface angle requirement,
the ASTM F2194-16[egr]1 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\
---------------------------------------------------------------------------

\35\ Tab C of Staff's Final Rule Briefing Package contains CPSC
staff's assessment of the adequacy of ASTM F2194-16[egr]1 to address
incidents associated with flat sleep products.
---------------------------------------------------------------------------

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 F2194-16[egr]1, 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, product-related issues, and undetermined causes.
Engineering staff analyzed whether the voluntary standard for
bassinets, ASTM F2194-16[egr]1, would address the identified hazards
for flat sleep products. The voluntary standard for bassinets, ASTM
F2194-16[egr]1, 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 F2194-16[egr]1 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 F2194-16[egr]1 bassinets standard addresses
hazards posed by a lock/latch failure with an unintentional folding

[[Page 33042]]

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
F2194-16[egr]1 bassinets standard's unintentional folding requirement.
The ASTM F2194-16[egr]1 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:

<bullet> Not be supported by the bassinet stand in an unlocked/latched
configuration;
<bullet> automatically lock to the bassinet stand and can't be placed
in an unlocked position on the bassinet stand;
<bullet> clearly and obviously be unstable when the product is
unlocked/latched by placing the sleeping surface at a 20-degree
incline;
<bullet> have a false latch/lock visual indicator designed to visually
alert caregivers when the bed is not properly locked to the stand; or
<bullet> 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 F2194-16[egr]1 bassinets
standard's requirement adequately simulates the action of a bassinet
unintentionally unlatching from its stand. Staff also assesses that the
ASTM F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1. Canada requires a side height of 230 mm (9
inches), measured from the mattress support. Because ASTM F2194-
16[egr]1 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.
---------------------------------------------------------------------------

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

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
Speci[filig]cation 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
------------------------------------------------------------------------
Side height
Standard requirement Age range
------------------------------------------------------------------------
16 CFR 1218--Safety Standard for 7.5 inches........ 0-5 months, or sit
Bassinets and Cradles. up.
ASTM F2194-16[egr]1, Standard
Consumer Safety Specification
for Bassinets and Cradles..
16 CFR 1219--Safety Standard for 9 inches.......... 0-35 inches tall
Full-Size Baby Cribs. (95th percentile
ASTM F1169-19, Standard Consumer 21-month old).
Safety Specification for Full-
Size Baby Cribs..

[[Page 33043]]

16 CFR 1220--Safety Standards 9 inches.......... 0-35 inches tall
for Non-Full-Size Baby Cribs. (95th percentile
16 CFR 1221--Safety Standards 21-month old).
for Play Yards..
ASTM F 406-19, Standard Consumer
Safety Specification for Non-
Full-Size Baby Cribs/Play
Yards..
16 CFR 1222--Safety Standard for 4 inches on side 0-5 months, or sit
Bedside Sleepers. next to adult up.
ASTM F2906-13, Standard Consumer bed. 7.5 inches
Safety Specification for for other 3 sides.
Bedside Sleepers..
ASTM F3118-17a, Standard 3 inches.......... 0-5 months, or sit
Consumer Safety Specification 2 inches.......... up.
for Infant Inclined Sleep 0-3 months.
Products.
16 CFR part 1225 Safety Standard No requirements...
for Hand-Held Infant Carrier.
ASTM F2050-19 Standard Consumer
Safety Specification for Hand-
Held Infant Carrier..
------------------------------------------------------------------------

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 F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1
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 F2194-16[egr]1 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 F2194-16[egr]1
bassinets standard addresses this hazard scenario by requiring
bassinets to have a stand/base/frame. ASTM F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1 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-
16[egr]1, 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 F2194-16[egr]1. 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

[[Page 33044]]

resulted in a near-suffocation prevented by a nearby parent.
The voluntary standard for bassinets, ASTM F2194-16[egr]1,
addresses the asphyxiation/suffocation hazard with the following
general/performance requirements:
<bullet> 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-full-sized cribs) and ASTM
F1169-19 (full-sized cribs) standards that CPSC staff previously
concluded adequately address the corner post entanglement hazard.
<bullet> 6.1 Spacing of Rigid-Sided Bassinet/Cradle Components.
This requirement limits the distance between slats to less than 2\3/8\
inches to mitigate the suffocation hazard from feet-first head
entrapment.
<bullet> 6.2 Openings for Mesh/Fabric-Sided 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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 F2194-16[egr]1, 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
F2194-16[egr]1, 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 F2194-16[egr]1 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 F2194-16[egr]1 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:
<bullet> Require 50N (11.24 pounds-force) to unlatch after
operating the latch 300 times;
<bullet> Require a tool to unlatch;
<bullet> Require two consecutive actions to unlatch; or
<bullet> 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 F2194-16[egr]1

[[Page 33045]]

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 F2194-16[egr]1 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 F2194-16[egr]1 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-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. EN 12790:2009 Summary
The EN 12790:2009 reclined cradle standard is less stringent than
the ASTM F2194-16[egr]1 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 F2194-16[egr]1 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 F2194-16[egr]1. Table 5 demonstrates that four hazard
categories (shaded) are addressed by ASTM F2194-16[egr]1: Latching,
Falls/Containment, Instability, and Asphyxiation/Suffocation.

Table 5--Flat Sleep Product Hazards Addressed by Bassinets Voluntary Standard
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant sleep hazards
Applicable --------------------------------------------------------------------------------------------------------
Product voluntary Falls/ Asphyxiation/ Miscellaneous
standard Latching containment Instability suffocation product-related Undetermined
--------------------------------------------------------------------------------------------------------------------------------------------------------
Flat Sleep Products (flat and ................ 115 incidents: 12 incidents: 1 12 incidents: 2 9 incidents: 8 3 mold-related 3 incidents:
inclined). Not currently death. Not injuries. Not deaths; not incidents; not Two deaths.
addressed. currently currently currently currently Too little
addressed. addressed. addressed. addressed. information to
determine
addressability
.
Bassinet/Cradle.............. ASTM F2194- Unintentional Side height Stability Max sleep Not currently Too little
16[egr]1. folding requirement. requirement. surface angle addressed; information to
requirement. defined in task group determine
definition; work. addressability
Restraints not .
allowed;
Flatness/
hazardous Vs
identified;
Pad
dimensions;
Corner posts;
fabric sided
enclosed
openings;
Spacing; Mesh
openings.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 F2194-16[egr]1 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-full-size), 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 then-current 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

[[Page 33046]]

recommendations. One commenter also indicated that the Commission
should:
<bullet> Conduct more research on the 30-degree seat back angle;
<bullet> Conduct more research on developmental implications when
an infant is restrained while sleeping;
<bullet> Provide performance requirements to address product
misassembly;
<bullet> Make the side height requirement match the 7.5 side height
requirement in the bassinets and cradles standard;
<bullet> Develop performance or design changes for compact units so
they cannot be placed on a raised surface, in crib, or on soft surface;
<bullet> Add seat back height requirement for infant products like
newborn products;
<bullet> Add requirements for hammocks to increase stability;
<bullet> Add requirements for flat sleep products, so an infant
cannot move into an unsafe chin to chest position;
<bullet> Add pictograms to warnings like slings and hand-held
carriers;
<bullet> Include ``marking'' on products to show compliance with
new regulations;
<bullet> Conduct market surveillance after a regulation becomes
effective; and
<bullet> 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 Sec.
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

[[Page 33047]]

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:

<bullet> 16 CFR part 1218--Safety Standard for Bassinets and Cradles
<bullet> 16 CFR part 1219--Safety Standard for Full-Size Baby Cribs
<bullet> 16 CFR part 1220--Safety Standard for Non-Full-Size Baby Cribs
<bullet> 16 CFR part 1221--Safety Standard for Play Yards
<bullet> 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.
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\37\ <a href="https://www.stanfordchildrens.org/en/topic/default?id=infant-sleep-90-P02237">https://www.stanfordchildrens.org/en/topic/default?id=infant-sleep-90-P02237</a>.
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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-full-sized 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 s

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