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Rule2022-02414

Safety Standard for Crib Mattresses

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Published

February 15, 2022

Effective

August 15, 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 crib mattresses, which includes full-size and non-full-size crib mattresses, as well as after-market mattresses for play yards and non-full-size cribs. CPSC is also finalizing an amendment to its regulations regarding third party conformity assessment bodies, to include the safety standard for crib mattresses in the list of notices of requirements (NORs) along with an amendment to the consumer registration rule, to identify crib mattresses as a durable infant or toddler product subject to consumer registration requirements.

Full Text

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<title>Federal Register, Volume 87 Issue 31 (Tuesday, February 15, 2022)</title>
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[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Rules and Regulations]
[Pages 8640-8684]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02414]

[[Page 8639]]

Vol. 87

Tuesday,

No. 31

February 15, 2022

Part II

Consumer Product Safety Commission

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16 CFR Parts 1112, 1130, and 1241

Safety Standard for Crib Mattresses; Final Rule

Federal Register / Vol. 87 , No. 31 / Tuesday, February 15, 2022 /
Rules and Regulations

[[Page 8640]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1241

[CPSC Docket No. 2020-0023]

Safety Standard for Crib Mattresses

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 crib
mattresses, which includes full-size and non-full-size crib mattresses,
as well as after-market mattresses for play yards and non-full-size
cribs. CPSC is also finalizing an amendment to its regulations
regarding third party conformity assessment bodies, to include the
safety standard for crib mattresses in the list of notices of
requirements (NORs) along with an amendment to the consumer
registration rule, to identify crib mattresses as a durable infant or
toddler product subject to consumer registration requirements.

DATES: This rule will become effective August 15, 2022. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of August 15, 2022.

FOR FURTHER INFORMATION CONTACT: Justin Jirgl, Compliance Officer, U.S.
Consumer Product Safety Commission, 4330 East-West Highway, Bethesda,
MD 20814; telephone: (301) 504-7814; email: <a href="/cdn-cgi/l/email-protection#086262617a6f64486b787b6b266f677e">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

A. Background

On June 16, 2015, the president of Keeping Babies Safe (KBS) and
the mother of a child who died in an incident involving an after-market
play yard mattress, petitioned the CPSC, requesting a ban on
supplemental mattresses for play yards with non-rigid sides (petition
CP 15-2: Petition Requesting Rulemaking on Supplemental Mattresses for
Play Yards with Non-Rigid Sides). The petitioner alleged that ``thicker
mattresses create a suffocation hazard because they create a gap
between the mattress pad sides and the side of the portable crib where
a baby can suffocate when the baby's head falls in such gap while lying
in the prone position.'' Petitioner asserted that ``no feasible
consumer product safety standard would adequately protect babies from
the unreasonable risk of injury and death associated with the
product.''
CPSC staff prepared a briefing package for the petition,
recommending that the Commission defer action on the petition, so that
staff could work on voluntary standards for crib mattresses and play
yards to address the hazards identified in the petition. Staff noted
that any work on the play yard voluntary standard could become a
mandatory standard through the Public Law 112-28 update process,
because the Commission has an existing mandatory standard for play
yards (16 CFR part 1221); however, any changes to the crib mattress
voluntary standard would remain a voluntary standard, because the
Commission does not have a mandatory rule for crib mattresses.
On May 25, 2017, in response to the petition request and staff's
recommendation to defer the petition, the Commission voted \1\ (3-2) to
``take other action'' and granted the petition, directing staff to: (1)
Initiate a rulemaking under section 104 of the CPSIA for a mandatory
consumer product safety standard that will address the risk of injury
associated with the use of crib mattresses; (2) include ``supplemental
and aftermarket mattresses used in play yards and portable cribs'' \2\
within the scope of the crib mattress rulemaking; and (3) update the
product registration card rule (16 CFR part 1130) to include ``crib
mattresses'' in the list of durable infant or toddler products subject
to the rule.
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\1\ <a href="https://www.cpsc.gov/s3fs-public/RCA-Petition_CP_15-2_Requesting_Ban_on_Supplemental_Mattresses_for_Play_Yards_with_Non-Rigid_Sides_052517.pdf">https://www.cpsc.gov/s3fs-public/RCA-Petition_CP_15-2_Requesting_Ban_on_Supplemental_Mattresses_for_Play_Yards_with_Non-Rigid_Sides_052517.pdf</a>.
\2\ Although the petitioner used the term ``supplemental
mattress,'' ASTM F2933-21 uses and defines the term ``after-market''
mattress. Both terms refer to a mattress that is bought separately
from a play yard or non-full-size crib. Like the NPR, the final rule
will use the defined term ``after-market'' mattress. Section 3.1.1
of ASTM F2933-21 defines an ``after-market mattress for a play yard
or non-full-size crib'' as ``a mattress sold or distributed for a
play yard or non-full-sized crib.'' Section 3.1.1.1 of ASTM F2933-21
states that the definition does not include a replacement mattress
sold by an original equipment manufacturer as a replacement, if it
is equivalent to the mattress originally provided with the product.
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On October 26, 2020, the Commission issued a notice of proposed
rulemaking (NPR) under section 104 of the CPSIA, proposing a mandatory
consumer product safety standard for crib mattresses, based on ASTM
F2933-19, Standard Consumer Safety Specification for Crib Mattresses
(ASTM F2933-19), with five modifications, to make the standard more
stringent, to further reduce the risk of injury associated with crib
mattresses.\3\ 85 FR 67906. The Commission is finalizing the rule by
incorporating by reference the most recent voluntary standard for crib
mattresses, ASTM F2933-21, with modifications substantially as proposed
in the NPR, to further reduce the risk of injury to children associated
with crib mattresses.\4\
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\3\ Previously, on November 21, 2016, the Commission issued an
NPR for a Safety Standard for Portable Generators, proposing to
codify the standard at 16 CFR part 1241. 81 FR 83556. The Commission
is reusing part 1241 for this final rule for a Safety Standard for
Crib Mattresses, to keep all regulations for durable infant or
toddler products in one section of the Code of Federal Regulations
(CFR). The Commission intends to renumber the CFR citation for
portable generators when that rulemaking is finalized.
\4\ On January 26, 2022, the Commission voted 4-0 to issue this
final rule. Commissioner Trumka issued a statement in connection
with his vote.
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B. Statutory Authority

Section 104(b) of the CPSIA requires the Commission to: (1) Examine
and assess the effectiveness of voluntary consumer product safety
standards for durable infant or toddler products, in consultation with
representatives of consumer groups, juvenile product manufacturers, and
independent child product engineers and experts; and (2) promulgate
consumer product safety standards for durable infant or toddler
products. 15 U.S.C. 2056a(b). Standards issued under section 104 are to
be ``substantially the same as'' the applicable voluntary standards, or
more stringent than the voluntary standard, if the Commission
determines that more stringent requirements would further reduce the
risk of injury associated with the product. Id. at 2056a(b)(1)(B).
Regarding the consultation requirement in section 104(b)(1) of the
CPSIA, CPSC staff regularly participates in the juvenile products
subcommittee meetings of ASTM International (ASTM). ASTM subcommittees
consist of members who represent producers, users, consumers,
government, and academia.\5\ The consultation process for the crib
mattresses rulemaking commenced during the ASTM subcommittee meeting in
May 2018, when CPSC staff presented initial recommendations for
updating the crib mattress voluntary standard to address the incident
data. Since then, staff has actively participated with the ASTM F15.66
subcommittee for Crib Mattresses in revising ASTM F2933, Standard
Consumer Safety

[[Page 8641]]

Specification for Crib Mattresses, to address the associated
hazards.\6\
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\5\ ASTM International website: <a href="http://www.astm.org">www.astm.org</a>, About ASTM
International.
\6\ The docket for this rulemaking on <a href="http://Regulations.gov">Regulations.gov</a> contains
meeting logs for all CPSC staff-attended ASTM meetings related to
the crib mattresses voluntary standard that occurred between
issuance of the NPR and completing this final rule. CPSC's Division
of the Secretariat maintains all other CPSC staff-attended meetings
with outside stakeholders related to crib mattresses.
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Section 104(d) of the CPSIA requires manufacturers of durable
infant or toddler products to establish a product registration program
and comply with CPSC's implementing rule, 16 CFR part 1130. Any product
defined as a ``durable infant or toddler product'' in part 1130 must
comply with the product registration requirements, as well as testing
and certification requirements for children's products, as codified in
16 CFR parts 1107 and 1109. Section 104(f)(1) of the CPSIA defines a
``durable infant or toddler product'' as a ``durable product intended
for use, or that may be reasonably expected to be used, by children
under the age of 5 years.'' 15 U.S.C. 2056a(f)(1). Section 104(f)(2) of
the CPSIA includes a list of categories of products that are durable
infant or toddler products, including products used for infant sleep,
such as cribs (full-size and non-full-size), toddler beds, bassinets
and cradles, and play yards. Id. 2056a(f)(2).
Although crib mattresses are used with products for infant sleep,
crib mattresses are not included in the statutory list of durable
infant or toddler products. This final rule amends part 1130 to include
``crib mattresses'' within the scope of ASTM F2933 as durable infant or
toddler products, as proposed in the NPR, because: (1) They are
intended for use, and may be reasonably expected to be used, by
children under the age of 5 years; (2) they are products similar to the
products listed in section 104(f)(2) of the CPSIA; (3) they are used in
conjunction with other durable infant or toddler products used for
infant sleep, such as cribs and play yards; and (4) CPSC cannot fully
address the risk of injury associated with products for infant sleep
without addressing the hazards associated with the use of crib
mattresses.
Finally, products subject to a consumer product safety rule under
the CPSA must be certified as complying with all applicable CPSC-
enforced requirements, based on testing conducted by a CPSC-accepted
third party conformity assessment body. 15 U.S.C. 2063(a). The
Commission must publish an NOR for the accreditation of third party
conformity assessment bodies to assess conformity with a children's
product safety rule to which a children's product is subject. Id.
2063(a)(3). Accordingly, we now finalize an amendment to part 1112, as
proposed in the NPR, to add the new Safety Standard for Crib
Mattresses, 16 CFR part 1241, to the list of NORs for children's
product safety rules. The amendment allows test laboratories applying
for CPSC acceptance to seek accreditation to test crib mattresses
within the scope of the rule.

C. NPR 7
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\7\ The NPR was based on information provided in the September
30, 2020, Staff Briefing Package: Draft Notice of Proposed
Rulemaking for Crib Mattresses Under the Danny Keysar Child Product
Safety Notification Act (Staff's NPR Briefing Package), available
at: <a href="https://www.cpsc.gov/s3fs-public/Notice-of-Proposed-Rulemaking-Safety-Standard-for-Crib-Mattresses.pdf?mDLf.MBLutFluwt6QFjeZRhYdNLFRR.J">https://www.cpsc.gov/s3fs-public/Notice-of-Proposed-Rulemaking-Safety-Standard-for-Crib-Mattresses.pdf?mDLf.MBLutFluwt6QFjeZRhYdNLFRR.J</a>. This final rule
also relies on information in Staff's NPR Briefing Package.
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On October 26, 2020, the Commission issued an NPR under section 104
of the CPSIA, proposing a mandatory consumer product safety standard
for crib mattresses, based on ASTM F2933-19, Standard Consumer Safety
Specification for Crib Mattresses (ASTM F2933-19), with five
modifications, to make the standard more stringent, to further reduce
the risk of injury associated with crib mattresses. 85 FR 67906. The
scope of the NPR included ``crib mattresses'' within the scope of the
voluntary standard for crib mattresses: Full-size crib mattresses, non-
full-size mattresses, and after-market mattresses for play yards and
non-full-size crib mattresses.
The five proposed modifications to the voluntary standard in the
NPR addressed the following hazards: (1) Suffocation hazards associated
with crib mattresses, due to overly soft mattresses, by adding a test
for mattress firmness based on sections 6 and 8 of AS/NZS 8811.1:2013--
Methods of testing infant products--Method 1: Sleep Surfaces--Test (AS/
NZS 8811.1); (2) entrapment hazards associated with full-size crib
mattresses, due to poor mattress fit from compression by sheets, by
repeating the dimensional conformity test and measuring for corner
gaps, after installing a shrunken (by washing twice) cotton sheet; (3)
entrapment hazards associated with after-market, non-full-size crib
mattresses, due to lack of dimensional requirements for rectangular-
shaped products, by extending the dimensional requirements in ASTM
F2933-19 section 5.7.2 to all non-full-size crib mattresses, regardless
of mattress shape, and regardless of whether the mattress is sold with
a non-full-size crib or as an after-market mattress; (4) laceration
hazards associated with coils and springs breaking and poking through
mattresses, by adding a cyclic impact test for mattresses that use
coils and springs; and (5) the risks of SIDS and suffocation related to
infant positioning, soft bedding, and gap entrapment, by improving the
labeling and instructional literature requirements to communicate risks
better to consumers, and to clarify requirements for manufacturers and
test labs.
In the NPR, the Commission also proposed to amend the consumer
registration rule, part 1130, to identify ``crib mattresses'' as a
category of ``durable infant or toddler products'' subject to the
consumer registration rule and testing and certification as a
children's product. Finally, the Commission proposed to amend its
regulation at 16 CFR part 1112 to add ``crib mattresses'' to the list
of products that require third party testing as a basis for
certification.

D. Update to ASTM F2933

Since the publication of the NPR, ASTM revised F2933-19 and
published ASTM F2933-21. Like ASTM F2933-19, ASTM F2933-21 provides
performance and labeling standards for ``crib mattresses'' intended for
full-size cribs, non-full-size cribs, after-market mattresses for play
yards, and after-market mattresses for non-full-size cribs. ASTM F2933-
21 updates the requirements for after-market play yard and non-full-
size crib mattresses as follows:
<bullet> Replaces requirement that ``aftermarket mattresses for
soft-sided and non-rectangular, rigid-sided products shall have the
same thickness, floor support structure, and attachment method as the
mattress it is intended to replace'' with: (1) A requirement to test to
specific sections in ASTM F406, Standard Consumer Safety Specification
for Non-Full-Size Baby Cribs/Play Yards, including: Stability; Cord/
Strap Length; Mattress; Mattresses for Rigid-Sided Products; Crib Side
Height; Height of Sides; Floor Strength; and Mattress Vertical
Displacement, when tested in the product it was designed for or
intended to fit; (2) a requirement that the after-market mattress must
be at least the same size as the original equipment mattress, so long
as it lays flat on the support structure; and (3) a requirement that
the after-market mattress floor support structure be at least as thick
as the original equipment mattress floor support structure. These
revisions allow play yard mattresses that may be thicker than what is
provided by the original

[[Page 8642]]

equipment manufacturer, but still limit such mattresses to a maximum of
1\1/2\ inches, as required by ASTM F406.
<bullet> Adds requirement specifying that after-market mattresses
must have equivalent storage accommodations for instructions as the
original equipment mattress.
We assess the revisions to the voluntary standard in section V.B of
this preamble. Although the revisions in ASTM F2933-21 improve the
safety of crib mattresses, by improving requirements for after-market
mattresses for play yards and non-full-size cribs, ASTM's revised
voluntary standard does not address all of the hazards identified in
the NPR.\8\
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\8\ See Tab C of Staff's Final Rule Briefing Package.
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E. Final Rule Overview

The Commission is finalizing the rule for crib mattresses by
incorporating by reference the most recent version of the voluntary
standard, ASTM F2933-21, with the five modifications described in
section I.C of this preamble, to make the standard more stringent.
However, based on comments on the NPR, and staff's continued work with
the ASTM subcommittee on crib mattresses, the final rule contains the
following clarifications from the NPR:
<bullet> Fitted Sheet Test Procedure for Full-Size Crib
Mattresses--The final rule improves the test method proposed in the NPR
for the fitted sheet test, by measuring corner gaps from a projected
crib corner, to accommodate crib mattresses with larger dimensions
while maintaining test veracity;
<bullet> Cyclic Impact Test Procedure--The final rule clarifies the
test method, by requiring the use of two different mattresses for
testing each side of a mattress sleep surface, to address the potential
for testing to be destructive; and
<bullet> Safety Information--The final rule modifies the
requirements for on-product and package labeling, to include important
clarifications, and to communicate better to consumers the risks and
preventative actions related to SIDS and suffocation.\9\
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\9\ See Tab D, Appendix A of Staff's Final Rule Briefing
Package.
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Section VI of this preamble contains additional discussion and
assessment of the revisions to the voluntary standard, and section VIII
of this preamble describes the final rule in more detail. This final
rule is based on information provided in the September 29, 2021, Draft
Final Rule for Crib Mattresses Under the Danny Keysar Child Product
Safety Notification Act (Staff's Final Rule Briefing Package),
available at: <a href="https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Crib-Mattresses.pdf?VersionId=62bEXbfu7.mIoiiLfn_fbMWtFnEsgGON">https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Crib-Mattresses.pdf?VersionId=62bEXbfu7.mIoiiLfn_fbMWtFnEsgGON</a>.

II. Product Description

A. Scope of Products Within the Final Rule 10
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\10\ See Staff's Final Rule Briefing Package at Tab C for
additional information on the scope of ASTM F2933-21.
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The scope of the final rule includes all crib mattresses \11\
within the scope of ASTM F2933-21, which addresses three types of crib
mattresses:
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\11\ Section 3.1.4 of ASTM F2933-21 defines a ``crib'' as a
``bed that is designed to provide sleeping accommodations for an
infant which have specific interior dimensions as determined by it
being either a full size or non-full size crib.'' Section 3.1.5 of
ASTM F2933-21 defines a ``mattress'' as ``ticking filled with a
resilient material used alone or in combination with other products
intended or promoted for sleeping on it.''
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1. Full-size crib mattresses--Full-size crib mattresses within the
scope of the final rule are typically sold separately from the crib in
which they are intended to be used. Industry refers to full-size crib
mattresses as ``standard'' crib mattresses. Full-size crib mattresses
are also used for toddler beds, meaning that one full-size crib
mattress may be used from birth through the toddler years. The fit of a
crib mattress inside of a crib is key to preventing infants from
becoming trapped between the side of the crib and the mattress, and
suffocating. Accordingly, section 5.7 of ASTM F2933-21 requires that
the dimensions of a full-size crib mattress shall measure at least
27\1/4\ in. wide and 51\5/8\ in. long. The interior dimensions of full-
size cribs are 28 <plus-minus> \5/8\ in. (710 <plus-minus> 16 mm) wide
and 52\3/8\ <plus-minus> \5/8\ in. (1,330 <plus-minus> 16 mm) long.
Full-size crib mattresses come in a variety of designs and are made of
a broad array of materials. Full-size crib mattresses typically have a
fabric or vinyl ticking, which covers innerspring coils or foam.
Innerspring mattresses often have a layer of foam or batting between
the springs and the ticking.
2. Non-full-size crib mattresses--Non-full-size cribs are cribs
that differ in dimension or shape from ``standard'' full-size cribs.
The final rule addresses all non-full-size crib mattresses, regardless
of whether they are sold separately (after-market), or are sold with a
non-full-size crib (referred to as ``original equipment manufactured
mattresses'' or ``OEM'' mattresses), and regardless of whether they are
rectangular or non-rectangular in shape.\12\ Because non-full-size
cribs do not come in a standard size, non-full-size crib mattresses do
not have defined dimensions. Rather, each non-full-size crib is
required to be sold with a properly fitting OEM mattress that meets the
performance requirements in ASTM F406. Accordingly, for mattresses that
are sold separately from the product and meant to replace OEM
mattresses (after-market mattresses), ASTM F2933-21 sets a minimum
effective crib-side height for non-full-size cribs and a maximum gap
between the mattress edge and the crib side.\13\ Section 5.7.2.1 of
ASTM F2933-21 requires that the dimensions of a mattress supplied with
a non-full-size baby crib shall be such that the mattress, when
inserted in the center of the crib, in a non-compressed state, shall
not leave a gap of more than \1/2\ in. at any point between the
perimeter of the mattress and the perimeter of the crib. Currently,
section 5.9 of ASTM F2933-21 requires that after-market, non-
rectangular, non-full-size crib mattresses meet the same performance
requirements in ASTM F406 as the non-full-size crib mattresses they are
intended to replace; and furthermore, section 5.9 requires after-
market, non-rectangular, non-full-size crib mattresses to have labeling
identifying the ``brand(s) and Model(s) numbers of products in which it
is intended to be used,'' but only requires warning labels regarding
dimensions on after-market, rectangular-shaped, non-full-size crib
mattresses. The final rule extends the ASTM F406 performance
requirements for mattresses sold with a non-full-size crib to all non-
full-size crib mattresses, including OEMs, after-market, non-
rectangular, and rectangular non-full-size crib mattresses.
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\12\ We note that OEM non-full-size crib mattresses are also
addressed in the Commission's mandatory rule for non-full-size
cribs, 16 CFR part 1220, which incorporates by reference ASTM F406.
The requirements in F406 for OEM non-full-size crib mattresses are
the same requirements that appear in ASTM F2933 section 5.7.
\13\ The most common rectangular, non-full-size crib mattress
available for sale in the U.S. crib mattress market is the ``mini''
crib mattress. The mini crib mattress is smaller than the so-called
``standard'' or full-size crib mattress. The typical size of a
``mini'' crib mattress is 24'' wide and 38'' long. The depth of a
``mini'' crib mattress varies, but typically ranges from 1'' to 6''.
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3. After-market mattresses for play yards--After-market mattresses
are products sold separately from a play yard,\2\ and that are not sold
by the OEM as a replacement mattress for their product. Pursuant to
CPSC's mandatory rule for play yards, part 1221, which incorporates by
reference ASTM F406-19, Standard Consumer Safety Specification for Non-
Full-Size Baby Cribs/Play Yards (ASTM F406), all play yards must be
sold with a mattress that is specifically designed to fit that product.
Part 1221 regulates OEM play

[[Page 8643]]

yard mattresses, but does not address after-market play yard
mattresses. The final rule for crib mattresses addresses after-market
mattresses for play yards, as set forth in ASTM F2933-21 section 5.9,
by requiring that they meet the same specifications and performance
requirements for OEM play yard mattresses in ASTM F406, as well as
additional requirements for the after-market mattress fit, support
structure, and instruction storage accommodations. Additionally, the
final rule requires that after-market mattresses intended for use in
the bassinet of a play yard with a bassinet attachment must also meet
the specifications in ASTM F2194, Consumer Safety Specifications for
Bassinets and Cradles.

B. Market Description 14
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\14\ See Staff's Final Rule Briefing Package at Tab E for
additional information on the marketing and use of crib mattresses.
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Crib mattresses are designed to be used with products, such as
full-size cribs, non-full-size cribs, bassinets and cradles, and play
yards, intended to provide sleeping accommodations for an infant.
According to estimates published by Statista-Grand View Research, the
size of the U.S. market for standard and portable cribs was $86.8
million in 2018.\15\ Currently, staff estimates that there are more
than 300 crib mattress models available in the market.\16\ According to
data collected by staff, approximately 75 percent of crib mattresses
available for sale in the United States are standard (full-size) crib
mattresses. Crib mattresses range in price from $20 to $500, with the
more expensive crib mattresses typically being full-size crib
mattresses with a firm coil or high-end foam core. The average cost of
a crib mattress available for sale in the United States is $150.\17\
For consumers with limited income, smaller, less-expensive crib
mattresses may appear to be a suitable alternative to higher-priced,
full-size crib mattresses.
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\15\ November 2019 Statista estimates, Grand View Research.
\16\ Based on staff's compiled search results of data available
on the internet, April-June 2021.
\17\ Price estimated from data available on the internet,
collected between April-June 2021.
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CPSC staff estimates that there are currently at least 32 domestic
manufacturers or importers supplying crib mattresses to the U.S.
market; 19 are domestic manufacturers, and 13 are domestic importers.
In addition, six foreign companies distribute crib mattresses to the
United States.\18\ Among the 38 firms identified, roughly half are
members of the Juvenile Products Manufacturers Association (JPMA), the
major U.S. trade association that represents juvenile product
manufacturers and importers. Many domestic suppliers of crib mattress
are also members of ASTM. The typical manufacturer or importer of crib
mattresses carries on average 10 mattress models. While some
manufacturers produce a large variety of crib mattress models, others
produce only a small selection of one or two models. The majority of
domestic manufacturers of crib mattresses are considered small
businesses, according to U.S. Small Business Administration (SBA)
guidelines, and many of these small firms are JPMA or ASTM members.
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\18\ Determinations were made using information from Dun &
Bradstreet, as well as from websites.
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This mandatory rule for crib mattresses will require not only third
party testing for conformance to the new crib mattress rule, 16 CFR
part 1241, but also a certificate of compliance. Crib mattresses
already require third party testing and certification, because crib
mattresses are already defined as ``children's products,'' and are
currently subject to various other federal safety rules, such as
mattress flammability, lead, and phthalate testing. Accordingly, a
final rule for crib mattresses will incrementally increase the amount
of crib mattress testing and certification requirements already in
place.

C. Crib Mattress Use 14

Based on information from the 2013 CPSC Durable Nursery Products
Exposure Survey (DNPES) of U.S. households with children under 6 years
old, an estimated 9.2 million cribs were in use in households with
young children in 2013.\19\ This represented about 73 percent of the
estimated 12.6 million total cribs owned by households (i.e., about 3.4
million cribs were owned, but not in use). Cribs, for the purposes of
the DNPES, included both full-size and non-full-size cribs, which are
designed to be used with a crib mattress. Therefore, staff estimates at
least 9.2 million (full-size and non-full-size) crib mattresses were in
use in 2013.\20\ According to DNPES results, 84 percent of respondents
indicated they used a fitted sheet on the crib mattresses, and 50
percent indicated they used a mattress pad. Six percent of respondents
indicated that nothing was placed under the child in the crib, other
than the intended mattress, indicating that the crib mattress was used
bare.
---------------------------------------------------------------------------

\19\ Respondents were asked to include in their count of cribs
owned, cribs that had been converted into toddler beds; but they
were instructed to include only the time used in the product as a
crib, in response to use questions.
\20\ In addition to the products in use in households with young
children, as estimated from the survey, cribs and crib mattresses
are probably in use in some households without young children (e.g.,
un-surveyed homes of older adults providing care for grandchildren).
---------------------------------------------------------------------------

According to the same survey, an estimated 5.8 million play yards
were in use in households with young children. This represented about
54 percent of the estimated 10.9 million total play yards owned by
households (i.e., about 5.1 million play yards were owned, but not in
use). Most play yards are designed to be used with a play yard
mattress; therefore, staff estimates at least 5.8 million play yard
mattresses were in use in 2013. Twenty-five percent of respondents
indicated that nothing was placed under the child in the play yard,
other than the intended mattress; 12 percent indicated they used a
mattress pad, but no respondents indicated that they used a fitted
sheet.
The DNPES did not cover child care facilities. One child care
industry group's 2018 directory \21\ lists more than 115,000 licensed
child care centers and more than 137,000 home daycare providers, some
of which may use crib or play yard mattresses. Furthermore, the survey
did not cover hotels or other commercial lodging establishments. The
U.S. Bureau of Labor Statistics (BLS) reports that there are about
70,000 lodging establishments in the accommodation industry sector,
North American Industry Classification System (NAICS) code 721.\22\
Based on the Commission's contacts with child care and lodging
facilities, crib, play yard, and crib mattresses are commonly used in
such establishments.\23\
---------------------------------------------------------------------------

\21\ Child Care Center estimate of entire United States (2018,
April 27). <a href="http://childcarecenter.us/">http://childcarecenter.us/</a>.
\22\ U.S. Bureau of Labor Statistics, ``Quarterly Census of
Employment and Wages,'' April 2018. <a href="http://www.bls.gov/iag/tgs/iag721.htm">http://www.bls.gov/iag/tgs/iag721.htm</a>.
\23\ Staff contacts included phone inquiries with day care and
hotel establishments.
---------------------------------------------------------------------------

III. Incident Data and Hazard Patterns 24
---------------------------------------------------------------------------

\24\ See Staff's Final Rule Briefing Package at Tab B, for
additional information on staff's review of crib mattress incidents.
---------------------------------------------------------------------------

In the NPR, the Commission discussed a total of 439 incidents
associated with crib mattresses, including 116 reported fatalities and
323 reported nonfatal incidents or concerns, occurring from January 1,
2010 to March 31, 2020. Since that data extraction, CPSC staff
identified an additional 55 incidents entered into the CPSRMS and the
NEISS databases from April 1, 2020 to April 30, 2021, including 23
reported fatalities and 32 reported nonfatal incidents or concerns

[[Page 8644]]

associated with crib mattresses. Accordingly, for the final rule, the
Commission is aware of 494 reports associated with a crib mattress,
including 139 fatalities and 355 nonfatalities reported from January 1,
2010 through April 30, 2021.\25\
---------------------------------------------------------------------------

\25\ Of the 494 reports, 21 were from the NEISS.
---------------------------------------------------------------------------

CPSC staff identified 21 NEISS cases associated with a crib
mattress in the NPR, and zero NEISS cases received during the update
between April 1, 2020 and April 30, 2021. Because the data did not meet
the minimum criteria for reporting an estimate,\26\ the Commission
includes the 19 NEISS injuries and two NEISS fatalities with the rest
of the reported incident data described in this final rule.
---------------------------------------------------------------------------

\26\ NEISS estimates are reportable, provided the sample count
is greater than 20, the national estimate is 1,200 or greater, and
the coefficient of variation (CV) is less than 0.33.
---------------------------------------------------------------------------

Table 1 presents hazard categories for all incidents reported from
January 1, 2010 through April 30, 2021. Since the NPR, CPSC received 11
reported fatalities \27\ involving crib mattress fit issues, and 19
reports of nonfatal incidents involving mattresses that are considered
too soft.\28\ Generally, the cause of death in reports describing a
fatal incident stated the death to be caused by asphyxia, suffocation,
or SIDS. CPSC staff categorized the fatal and nonfatal reports into
hazard scenarios based on the best available information.
---------------------------------------------------------------------------

\27\ None of the fatal incident reports stated that the fatality
had a witness. Thus, each case involves some degree of speculation
as to how the incident occurred. Incident details are often vague
concerning how the infant was positioned when initially found and
what additional items present in the crib environment may have
contributed to the fatality. Some incidents have conflicting reports
from multiple sources describing the details of the incident.
\28\ Staff initially extracted incident reports and NEISS injury
cases using nine product codes, with no other restrictions on the
extraction criteria. Staff then reviewed each record to determine
whether a report was associated with a crib mattress. Staff searched
the following product codes: Playpens and play yards (1513),
portable cribs (1529), bassinets or cradles (1537), baby mattresses
or pads (1542), cribs, nonportable (1543), cribs, not specified
(1545), mattresses, not specified (4010), toddler beds (4082), and a
catch-all product code 9101. As in the data extraction for the NPR,
some of the nonfatal reports described concerns about potential
hazards associated with a crib mattress, without an actual incident
occurring.
\29\ CPSC received a death certificate for one fatality in
September 2017, and subsequently, CPSC investigated this incident.
However, staff did not receive the investigation information until
November 2020.

Table 1--Fatal and Nonfatal Reports Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During January 1, 2010-April 30, 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date received by CPSC January 1, 2010-March 31, 2020 April 1, 2020-April 30, 2021 January 1, 2010-
---------------------------------------------------------- (reported incidents in the NPR) (reported incidents since the NPR) April 30, 2021
----------------------------------------------------------------------------
Hazard category ------------------
Fatal reports Nonfatal reports Fatal reports Nonfatal reports Total reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical/Flammability.................................... 0 23 0 3 26
Coil or Spring........................................... 0 124 0 4 128
Crib Mattress Used in a Play Yard........................ 2 1 0 1 4
Expand or Inflate........................................ 0 6 0 0 6
Face in Mattress......................................... 13 1 3 0 17
Fit Issues............................................... 20 88 11 3 122
Found Prone.............................................. 66 3 9 0 78
Mattress Falls Apart..................................... 0 18 0 0 18
Softness................................................. 0 36 0 19 55
Multiple Contributing Factors (MCF)...................... 15 17 0 2 34
Other.................................................... 0 6 0 0 6
----------------------------------------------------------------------------------------------
Total Reports........................................ 116 323 23 32 494
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

Table 2 presents the year of incident or death of the reported
cases, for the incidents reported in the NPR and incidents reported
since the NPR. Since the NPR, deaths continue to be reported in the
most recent years, 2018 and 2019, even when there is typically an
approximate 2-year time lag in complete reporting of deaths to CPSC.
The NPR stated that 13 deaths were reported to have occurred in 2018,
and 4 deaths in 2019. Since the NPR, 15 and 17 deaths were reported to
have occurred in the years 2018 and 2019, respectively.

Table 2--Reports Associated With Crib Mattresses by Year of Incident and Date Received by CPSC During January 1, 2010-April 30, 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date received by CPSC January 1, 2010-March 31, 2020 April 1, 2020-April 30, 2021 January 1, 2010-April 30, 2021
--------------------------------------- (reported incidents in the NPR) (reported incidents since the NPR) (total reports)
-----------------------------------------------------------------------------------------------------------------
Year of incident or death Fatal reports Total fatal Total nonfatal
Fatal reports Nonfatal reports \29\ Nonfatal reports reports reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
2010.................................. 20 43 0 0 20 43
2011.................................. 11 19 0 0 11 19
2012.................................. 4 27 0 0 4 27
2013.................................. 7 31 0 0 7 31
2014.................................. 13 28 0 0 13 28
2015.................................. 11 34 0 0 11 34
2016.................................. 8 40 1 0 9 40
2017.................................. 25 48 0 0 25 48
2018.................................. 13 33 2 0 15 33
2019.................................. 4 18 13 2 17 20
2020.................................. 0 2 6 19 6 21
2021.................................. 0 0 1 11 1 11
-----------------------------------------------------------------------------------------------------------------
Total Reports..................... 116 323 23 32 139 355
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

[[Page 8645]]

A. Fatal Reports

CPSC is aware of 139 reported deaths associated with crib
mattresses that were reported to have occurred between January 1, 2010
and April 30, 2021. Table 3 presents hazard categories for these
reported fatalities.

Table 3--Reported Fatalities Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During
January 1, 2010-April 30, 2021
----------------------------------------------------------------------------------------------------------------
Date received by CPSC January 1, 2010- April 1, 2020- January 1, 2010-
-------------------------------------------------------- March 31, 2020 April 30, 2021 April 30, 2021
-------------------
------------------- ------------------
Hazard category Reported Reported
incidents in the incidents since Total fatal
NPR the NPR reports
----------------------------------------------------------------------------------------------------------------
Crib Mattress Used in a Play Yard...................... 2 0 2
Face in Mattress....................................... 13 3 16
Fit Issues............................................. 20 11 31
Found Prone............................................ 66 9 75
Multiple Contributing Factors (MCF).................... 15 0 15
--------------------------------------------------------
Total Reports...................................... 116 23 139
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

Below, we describe the hazard patterns involving a fatality
associated with a crib mattress.
1. Crib Mattress Used in a Play Yard: One percent of the fatalities
involved use of a crib mattress in a play yard (2 out of 139). Reports
state that infants were found wedged between the crib mattress and the
mesh of the play yard, due to the crib mattress not fitting snugly in
the play yard.
2. Face in Mattress: Twelve percent (16 out of 139) of fatalities
were associated with the face of an infant, when found, reportedly in
contact with a crib mattress or crib sheet covering the crib mattress.
Based on the available information about each fatality, bedding was
present in the sleeping environment in some of these reports. However,
bedding was not touching the infant, nor did staff determine that the
bedding was a contributing factor in the death.
3. Fit Issues: Twenty-two percent (31 out of 139) of fatalities
involved issues with the fit of a crib mattress in the sleeping
environment. In all of these fatalities, the infants became wedged in
gaps between at least one of the sides of a crib mattress and the crib
rails or play yard mesh.
4. Found Prone: Fifty-four percent (75 out of 139) of fatalities
involved an infant found in a prone position with no mention of whether
the face of the child was in contact with the crib mattress or crib
sheet, and no mention of the face being obstructed by other crib
bedding, or other items in the sleep environment. Given the available
information about each fatality, bedding was present in the sleeping
environment in some of these reports, but staff was unable to determine
that bedding was a contributing factor in the deaths.
5. Multiple Contributing Factors (MCF): Eleven percent (15 out of
139) of fatalities involved multiple factors that potentially played a
role in the fatality, and the crib mattress was likely one of the
contributing factors. Examples of other contributing factors are
entrapment between the mattress and bumper pads, entrapment between the
mattress and a crib rail with limb entrapment, usage of a swaddle,
sharing of the sleep environment with another infant, and congenital or
recent health conditions.
The oldest fatalities were: Two, 3-year-old, and two, 2-year-old
children. CPSC observed considerably more reported prone fatalities
between the ages of 1-month-old and 5-months-old, and most of the
deaths in the fit, face in mattress, and MCF hazard categories involved
infants between the ages of 1-month-old and 8-months-old, compared to
other ages. Among the 23 deaths reported since the NPR, 19 were to
infants 8 months old or younger, and the remainder included one 11-
month-old, one 12-month-old, one 21-month-old, and one 38-month-old.

B. Reported Nonfatal Incidents and Concerns

CPSC is aware of 355 reported nonfatal incidents and concerns
associated with crib mattresses that were reported to have occurred
between January 1, 2010 and April 30, 2021. Table 4 presents the hazard
categories associated with these reported nonfatal crib mattress
incidents.

Table 4--Nonfatal Reports Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During
January 1, 2010-April 30, 2021
----------------------------------------------------------------------------------------------------------------
Date received by CPSC January 1, 2010- April 1, 2020- January 1, 2010-
-------------------------------------------------------- March 31, 2020 April 30, 2021 April 30, 2021
-------------------
------------------- ------------------
Hazard category Reported Reported
incidents in the incidents since Total nonfatal
NPR the NPR reports
----------------------------------------------------------------------------------------------------------------
Chemical/Flammability.................................. 23 3 26
Coil or Spring......................................... 124 4 128
Crib Mattress Used in a Play Yard...................... 1 1 2
Expand or Inflate...................................... 6 0 6
Face in Mattress....................................... 1 0 1
Fit Issues............................................. 88 3 91
Found Prone............................................ 3 0 3
Mattress Falls Apart................................... 18 0 18
Softness............................................... 36 19 55
Multiple Contributing Factors (MCF).................... 17 2 19
Other.................................................. 6 0 6
--------------------------------------------------------
Total Reports...................................... 323 32 355
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

[[Page 8646]]

1. Chemical/Flammability: Seven percent (26 out of 355) of the
nonfatal incidents reported a crib mattress having a chemical odor (6),
causing rashes (8), developing severe allergies (1), or not meeting
mandatory federal flammability standards (11). Three of these 26
incidents were reported between April 1, 2020 and April 30, 2021. Among
these three incidents, two involved emergency department treatment from
rashes or allergy symptoms, and one incident mentions headaches from
foul odor with unspecified severity.
2. Coil or Spring: Thirty-six percent (128 out of 355) of nonfatal
incidents involved a coil or spring found protruding through the crib
mattress. Four of these 128 incidents were reported between April 1,
2020 and April 30, 2021. Among these four incidents, one involved a
knee laceration with the level of care not known, and the other three
incidents reported an incident with no injury.
3. Crib Mattress Used in a Play Yard: One percent (2 out of 355) of
nonfatal incidents involved a crib mattress being used in a play yard.
One of these two incidents was reported between April 1, 2020 and April
30, 2021. In the one new incident, a child had an arm become entrapped
on the side or under the mattress.
4. Expand or Inflate: Two percent (6 out of 355) of nonfatal
incidents involved a crib mattress that failed to expand or inflate
properly. None of these six incidents were reported between April 1,
2020 and April 30, 2021. CPSC identified related hazards, including fit
issues with gaps appearing around the crib mattress causing entrapment
or wedging, and an uneven crib mattress that may cause an infant to
roll over.
5. Face in Mattress: Less than 1 percent (1 out of 355) of nonfatal
incidents involved an infant found limp, pale, and with blue around the
lips while face down in contact with a crib mattress. CPSC staff found
no other details about the sleep environment in this incident involving
a 1-month-old infant who was admitted to the hospital. This incident
was reported in the NPR data set.
6. Fit Issue: Twenty-six percent (91 out of 355) of nonfatal
incidents involved issues with the fit of a crib mattress in the
sleeping environment, three of which were reported between April 1,
2020 and April 30, 2021. Among these three incidents, one child was
treated in the emergency department after falling out of the crib due
to a mattress that was too thick; one child received marks on the face
due to entrapment issues with an unknown level of treatment; and one
incident occurred with no injury reported. In all of these reports,
staff determined that gaps were present on one or more sides around the
perimeter of a crib mattress, creating wedging or entrapment hazard
between the crib mattress and the crib rails or play yard mesh.
7. Found Prone: One percent (3 out of 355) of nonfatal incidents
involved an infant found in a prone position without any mention of the
face being in contact with the mattress or crib sheet, and no mention
of the face being obstructed by other crib bedding or other items in
the sleep environment. Staff found no other details about the sleep
environment in any of these three reported incidents. None of these
three incidents were reported between April 1, 2020 and April 30, 2021.
8. Mattress Falls Apart: Five percent (18 out of 355) of nonfatal
incidents involved part of a crib mattress coming apart. In most of
these reports, the seams of the mattress unraveled, causing: A
strangulation hazard due to the stitching of the mattress being
exposed; and a choking or ingestion hazard due to the inner filling
coming out of the mattress in small pieces and into the sleep
environment. Examples of reported small pieces of a crib mattress
filling that came apart are fibers, string, or wool. Staff found that
in six incidents, string from crib mattress seams or piping was found
wrapped around the neck of the infant, which could have led to a
serious outcome if the child was not found in time. One incident
involved an infant choking on a plastic piece of ``shredded'' crib
mattress, and one incident involved a child who was treated and
released from the hospital emergency department due to ingesting
plastic pieces of a crib mattress. None of these 18 incidents were
reported between April 1, 2020 and April 30, 2021.
9. Softness: Fifteen percent (55 out of 355) of nonfatal incidents
involved a crib mattress inner cushioning that was reportedly too soft.
CPSC staff found 33 reports of depressions or indentations in the crib
mattress, accompanied by the following descriptions: ``bunches up/
squishy,'' ``dent/depression/dips/indentation/sags/sinks in/smashed/
sunken,'' and ``deflates/like an air mattress not fully inflated.''
Twelve reports describe a crib sheet being placed on a crib mattress
and causing the mattress to bend or bow, resulting in a gap or fit
issue between the mattress and crib rails, creating an entrapment
hazard. Four reports claim that a crib mattress is not breathable. Six
reports allege that a crib mattress is too thin and that the inner
cushioning is too soft. Of these 55 incidents, 19 were reported between
April 1, 2020 and April 30, 2021. All 19 of these incidents involved an
incident with no injury reported.
10. Multiple Contributing Factors (MCF): Five percent (19 out of
355) of nonfatal incidents involved multiple factors that played a
role, of which the crib mattress was likely one factor. Two of these 19
incidents were reported between April 1, 2020 and April 30, 2021. One
incident involved a mattress that was reported to be too firm and a
child who broke out in rashes, with a level of care not known; and one
incident involved a slat entrapment hazard, with no injury reported.
11. Other: Two percent (6 out of 355) of nonfatal incidents
involved miscellaneous other issues associated with a crib mattress.
None of these six incidents were reported between April 1, 2020 and
April 30, 2021. Reports in this category included: A blade found in a
crib mattress; an infant's arm was ``tangled in a crib mattress''; an
infant ``slipped on a crib mattress,'' causing a slat entrapment; an
infant's arm became ``stuck on a crib mattress''; a crib mattress had a
loose plastic bag for a cover; and a concern about crib mattresses not
having proper warning labels to direct caregivers to place infants on
their backs when putting them down in a crib.
The hazard categories with the most reported nonfatal incidents
associated with crib mattresses are issues with coils or springs, and
crib mattresses that do not fit properly in the sleep environment. In
the most recent years, from January 2018 to April 2021, CPSC staff
observed fewer nonfatal reports of coil or spring issues associated
with crib mattresses, compared to years 2014 through 2017. Eighty-six
percent (78 out of 91 nonfatal reports) of nonfatal reports involving
fit issues occurred between 2010 and 2015.

C. Explanation of Hazards Associated With Crib Mattress Use
30
---------------------------------------------------------------------------

\30\ Staff's NPR Briefing Package at Tabs C and E contain more
detailed analysis of incidents and hazards associated with crib
mattress use.
---------------------------------------------------------------------------

After reviewing the incident data, CPSC staff identified various
mattress-use factors associated with deaths and serious injuries
related to sudden and unexpected infant death (SUID), including, but
not limited to, prone positioning of sleeping infants, soft bedding
added to sleep areas,

[[Page 8647]]

and gaps/pockets between mattresses and infant product
sides.31 32 33 Physiologically, infants experiencing a
compromised airflow are likely to undergo a cycle of decreased heart
and respiration rate, resulting eventually in fatal cessation of
breathing. Numerous public awareness campaigns have aimed to educate
caregivers regarding the identified hazards; these campaigns include:
``Back to Sleep'' (Moon et al., 2016, as cited in Fors Marsh Group,
2019), the ``ABCs of Safe Sleep'' (alone (no bed sharing), back-
sleeping, and crib uncluttered),\34\ and ``Safe Sleep/Bare is Best.''
35 36 Health and safety advocates, including the AAP,
CDC,\37\ CPSC, and Kids in Danger (KID) \38\ support these efforts.
---------------------------------------------------------------------------

\31\ The Centers for Disease Control and Prevention (CDC)
defines ``SUID'' as the sudden and unexpected death of a baby less
than 1-year-old, in which the cause was not obvious before
investigation. See <a href="https://www.cdc.gov/sids/about/index.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fsids%2FAboutSUIDandSIDS.htm">https://www.cdc.gov/sids/about/index.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fsids%2FAboutSUIDandSIDS.htm</a>; accessed July 20, 2020.
\32\ The American Academy of Pediatrics (AAP, 2016) explains
that SUID, also known as ``sudden unexpected death in infancy''
(SUDI), includes explained and unexplained deaths, and it can be
attributed to suffocation, asphyxia, entrapment, infection,
ingestions, metabolic diseases, arrhythmia-associated cardiac
channelopathies, and trauma. See: <a href="https://pediatrics.aappublications.org/content/pediatrics/138/5/e20162938.full.pdf">https://pediatrics.aappublications.org/content/pediatrics/138/5/e20162938.full.pdf</a>; accessed May 5, 2020.
\33\ Sudden infant death syndrome (SIDS) is a subcategory of
SUID that refers to infant deaths that cannot be explained after a
thorough case investigation. The terms SUID and SIDS are used
interchangeably, as SIDS commonly is used to refer to SUID in
warning labels and articles and given that consumers are more
familiar with the term SIDS as opposed to SUID.
\34\ See <a href="https://www.aappublications.org/news/2016/10/24/SIDS102416">https://www.aappublications.org/news/2016/10/24/SIDS102416</a>; accessed May 7, 2020.
\35\ See <a href="https://www.cpsc.gov/Safety-Education/Neighborhood-Safety-Network/Posters/Safe-Sleep-for-Babies">https://www.cpsc.gov/Safety-Education/Neighborhood-Safety-Network/Posters/Safe-Sleep-for-Babies</a>; accessed May 6, 2020.
\36\ See <a href="https://www.cpsc.gov/safety-education/safety-guides/kids-and-babies-cribs/safe-sleepbare-best">https://www.cpsc.gov/safety-education/safety-guides/kids-and-babies-cribs/safe-sleepbare-best</a> and <a href="https://www.nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/safe-sleep-practices-for-babies">https://www.nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/safe-sleep-practices-for-babies</a>; accessed May 11, 2020.
\37\ See <a href="https://www.cdc.gov/vitalsigns/safesleep/index.html">https://www.cdc.gov/vitalsigns/safesleep/index.html</a>;
accessed May 2, 2020.
\38\ See <a href="https://kidsindanger.org/protect-your-child/sleep/">https://kidsindanger.org/protect-your-child/sleep/</a>;
accessed May 6, 2020.
---------------------------------------------------------------------------

To make infant sleep environments more comfortable, caregivers
commonly use soft bedding and after-market mattresses, instead of, or
in addition to, an OEM mattress. Infants can maneuver themselves into
vulnerable positions in a sleep environment, from which they cannot
free themselves:

Infants in the age range associated with fatal incidents, i.e.,
between 2 and 6 months, develop new skills, such as rolling over and
crawling, in stages. According to Bayley (1969), several
developmental milestones occur within the first 6 months of life;
some notable motor skills typically achieved are turning from side
to back (average age: 1.8 months old), turning from back to side
(average age: 4.4 months old), and turning from back to stomach
(average age: 6.4 months old). Children as young as 8 to 12 weeks
are likely to move around a play yard, including moving to the edge
and possibly moving into vulnerable situations. However, children
may not be able to remove themselves by reversing their actions
because they may not have developed the skill.\39\
---------------------------------------------------------------------------

\39\ See page 5, <a href="https://www.cpsc.gov/s3fs-public/Petition%20CP%2015-2%20%20Petition%20Requesting%20Ban%20on%20Supplemental%20Matress%20for%20Play%20Yards%20with%20non-Rigid%20Sides%20May%2010%202017_3.pdf">https://www.cpsc.gov/s3fs-public/Petition%20CP%2015-2%20%20Petition%20Requesting%20Ban%20on%20Supplemental%20Matress%20for%20Play%20Yards%20with%20non-Rigid%20Sides%20May%2010%202017_3.pdf</a>;
accessed September 14, 2020.

Infants can become trapped in a gap between a crib mattress and the
side wall(s) of their sleep environment, with their nose and mouth
pressed against the mattress or side wall, experiencing compromised
airflow. Gap entrapment is a hazard associated with ill-fitting
mattresses in full-size cribs, play yards, and non-full-size cribs. To
minimize the risk for entrapment in a gap, a full-size crib and full-
size crib mattress that meet the applicable standards would allow a
maximum side gap of 1\3/8\ inches.\40\ Given non-flexible sides and
infant head dimensions,\41\ requirements in these standards work in
tandem to help prevent head entrapment and suffocation between the
mattress and crib sides, even though a full-size crib manufacturer is
not required to provide the mattress.\42\ Still, incidents of gap
entrapment involving these products continue to occur, including when
the full-size crib and non-compressed full-size crib mattress measure
the appropriate dimensions. For example, gaps involving full-size crib
mattresses can develop if the mattresses are too soft, such as when the
mattress is compressed by mattress sheets.
---------------------------------------------------------------------------

\40\ Per 16 CFR part 1219, and by reference ASTM F1169-1919, a
full-size crib must have interior dimensions of 28 <plus-minus> \5/
8\ inches wide by 52\3/8\ <plus-minus> \5/8\ inches long. Per the
existing voluntary standard for crib mattresses, ASTM F2933-21, a
full-size crib mattress shall measure at least 27\1/4\ inches wide
by 51\5/8\ inches long by 6 inches thick.
\41\ According to Snyder (1975), the 5th percentile head
breadth, i.e., the maximum breadth of the head above and behind the
ears, of children 0 to 3 months old is approximately 3\3/10\ inches,
which is more than twice as wide as the maximum allowable side gap
between full-size cribs and full-size crib mattresses. ESHF staff
selected head ``breadth,'' as opposed to length or height, to err on
the side of caution, as head breadth is the smallest of these three
head dimensions that could cause a fatal entrapment. Similarly,
staff selected the 5th percentile measurement for 0-to-3-month-old
infants to reduce the likelihood of death or serious injury to those
most vulnerable to the identified hazards.
\42\ See <a href="https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Full-Size-Baby-Cribs/">https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Full-Size-Baby-Cribs/</a>, accessed May 1,
2020.
---------------------------------------------------------------------------

Gaps between the infant's mattress and sleep product sides are
especially hazardous when after-market mattresses with thicker depth
dimensions than the OEM mattress are used in products with flexible
(e.g., mesh or fabric) sides, such as play yards and non-rigid-sided
portable cribs. The side walls of these products typically expand more
towards the center of the side wall, and consequently, as the thickness
of mattresses used in these products increases, the risk of gap
entrapment often increases as well.

D. Product Recalls 43
---------------------------------------------------------------------------

\43\ See Briefing Memorandum, Staff's Final Rule Briefing
Package.
---------------------------------------------------------------------------

In the NPR, CPSC stated that from June 1, 2010 to June 1, 2020,
CPSC negotiated five consumer-level recalls involving crib mattresses
to mitigate against risks of flammability and suffocation. Four recalls
involved non-compliance with mandatory federal flammability
requirements. These four recalls included approximately 80,000 units in
total. The Commission cannot provide an exact number of units because
of a lack of differentiation between crib and adult mattress
populations in recalls that included both. The fifth recall of crib
mattresses involved a dimensional issue, where the crib mattress models
were ill-fitting, presenting an entrapment hazard. This recall included
approximately 300,000 units. CPSC has not announced any crib mattress
recalls since the NPR.

IV. International Standards for Crib Mattresses 44
---------------------------------------------------------------------------

\44\ See Staff's NPR Briefing Package at Tab B.
---------------------------------------------------------------------------

As stated in the NPR, the Commission is aware of two international
voluntary standards pertaining to crib mattresses: \45\
---------------------------------------------------------------------------

\45\ The Commission is also aware of a draft, unpublished,
standard, ISO 23767 Children's furniture--Mattresses for cots and
cribs--Safety requirements and test methods. Although this draft ISO
standard is not yet an official standard, CPSC staff reviewed it for
relevancy and found that it is nearly identical to BS EN 16890.
---------------------------------------------------------------------------

<bullet> BS EN 16890:2017--Children's Furniture--Mattresses for
cots and cribs--Safety requirements and test methods (BS EN 16890); and
<bullet> Australian/New Zealand Standard 8811.1:2013--Methods of
testing infant products (AS/NZS 8811.1).
In the NPR, the Commission compared ASTM F2933-19 to the
international standards AS/NZS 8811.1 and EN 16890, and determined that
the ASTM standard is equivalent or more stringent than these standards
to address most incidents associated with the use of crib mattresses in
the United States. 85 FR at 67913-14. This

[[Page 8648]]

assessment is applicable to ASTM F2933-21 as well.\46\
---------------------------------------------------------------------------

\46\ See Staff's Final Rule Briefing Package at Tab C.
---------------------------------------------------------------------------

Each of these international standards includes a mattress firmness
test, while the ASTM standard does not. To address this issue, the
final rule includes a mattress firmness test, as proposed in the NPR,
based on the mattress firmness test in the AS/NZS standard. With the
exception of mattress firmness, the Commission concludes that ASTM
F2933-21 is equivalent to, or more stringent than, AS/NZS 8811.1 or EN
16890, because it more fully addresses the hazard patterns identified
by CPSC staff in the reported incident data. Compared to these
international standards, ASTM F2933-21 is more comprehensive because it
also addresses non-full-size crib mattresses and after-market
mattresses for play yards and non-full-size cribs. Furthermore, the
Commission notes that like ASTM F2933-19, ASTM F2933-21 was developed
through collaboration between CPSC staff and stakeholders. The
voluntary standard has been revised four times to address incident data
provided by CPSC staff. Therefore, the Commission concludes that ASTM
F2933-21, when modified to include a test for mattress firmness based
on sections 6 and 8 of AS/NZS 8811.1:2013, is more appropriate than AS/
NZS 8811.1:2013 or EN 16890 to address hazard patterns associated with
crib mattresses.

V. Voluntary Standard--ASTM F2933 47
---------------------------------------------------------------------------

\47\ See Staff's NPR Briefing Package at Tab B for additional
information about the history and performance requirements up
through the 2019 version of ASTM F2933. Tab C of Staff's Final Rule
Briefing Package contains information about the revisions in ASTM
F2933-21.
---------------------------------------------------------------------------

A. History of ASTM F2933

The ASTM Committee F15 on Consumer Products first published the
voluntary standard for crib mattresses in 2013, as ASTM F2933-13,
Standard Consumer Safety Specification for Crib Mattresses. The first
publication established requirements for the standard and addressed the
following issues:
<bullet> Sharp points and sharp edges,\48\
---------------------------------------------------------------------------

\48\ Tapered ends that do not meet the requirements of 16 CFR
1500.48 and metal or glass tapered surfaces that do not meet the
requirements of 16 CFR 1500.49.
---------------------------------------------------------------------------

<bullet> Small parts,
<bullet> Lead and other toxic substances in paints,
<bullet> Finger entrapment,
<bullet> Mattress dimension conformity,
<bullet> Mattress thickness, and
<bullet> Marking and labeling.
Since 2013, ASTM has revised and updated the voluntary standard
four times to address safety issues, as outlined below:
ASTM F2933-16 (approved on 12/1/2016):
<bullet> Revised warning label permanency requirements in 5.6.1, to
include requirement that ``[n]on-coated paper warning label shall not
be applied on either side of sleeping surface.'' Added a note under
this section, stating that non-coated paper label may absorb water and
can deteriorate.
ASTM F2933-18 (approved 8/15/2018):
<bullet> Revised scope to include a new section 1.5, stating the
standard was developed in accordance with internationally recognized
principles on standardization;
<bullet> Added definition of ``after-market mattress for play yard
or non-full-size crib,'' to section 3, Terminology;
<bullet> Added a new requirement for after-market mattresses for
play yards and non-full-size crib mattresses in section 5, General
Requirements, stating that after-market mattresses for soft-sided and
non-rectangular, rigid-sided products shall have the same thickness,
floor support structure, and attachment method as the mattress it is
intended to replace and shall meet the specifications of Mattress
Vertical Displacement test from ASTM F406-19, Standard Consumer Safety
Specification for Non-Full-Size Baby Cribs/Play Yards;
<bullet> Added additional marking and labeling requirements for
after-market mattresses in sections 7.5 through 7.7. To comply with
these sections, after-market mattresses and their retail packaging
shall include specified suffocation warning language related to
hazardous gaps and stacked mattresses. Sections 7.5 and 7.6 have
additional requirements that distinguish between types of products.
Section 7.5 has requirements specific to mesh/fabric-sided and rigid-
sided, non-rectangular products, including as follows: After-market
mattresses shall have all the warnings that the original manufacturer
had and provide instructions that are on the original mattress, and
both the after-market mattress and the retail packaging shall identify
the brand and model numbers of products in which it is intended to be
used. Section 7.6 contains requirements specific to rigid sided
rectangular products including as follows: After-market mattresses and
their retail packaging shall have a specified statement regarding
mattress dimensions and fit.
ASTM F2933-19 (approved on 6/15/2019):
<bullet> Added a new requirement for mattress seam stitching in
section 5, General Requirements, requiring that all seam stitching that
is accessible to the occupant be lock stitching.
ASTM F2933-21 (approved on 6/15/2021):
<bullet> Replaced requirement that ``aftermarket mattresses for
soft-sided and non-rectangular, rigid-sided products shall have the
same thickness, floor support structure, and attachment method as the
mattress it is intended to replace'' with: (1) A requirement that
aftermarket mattresses meet all applicable listed requirements of ASTM
F406 Standard Consumer Safety Specification for Non-Full-Size Baby
Cribs/Play Yards for the OEM mattresses that they are intended to
replace; (2) requirements that the after-market mattress must be at
least the same size as the original equipment mattress, so long as it
lays flat on the support structure; and (3) requirements that the
after-market mattress floor support structure be at least as thick as
the original equipment mattress floor support structure. Accordingly,
play yard mattresses may be thicker than that provided by the original
equipment manufacturer, but are still limited to a maximum of 1\1/2\
inches, as required by ASTM F406.
<bullet> Adds requirement specifying that after-market mattresses
must have equivalent storage accommodations for instructions as the
original equipment mattress.

B. Assessment of ASTM F2933-21 49
---------------------------------------------------------------------------

\49\ See Tab C of Staff's Final Rule Briefing Package for the
full assessment of ASTM F2933-21.
---------------------------------------------------------------------------

ASTM published ASTM F2933-21 in July 2021, to address requirements
for after-market mattresses for non-full-size cribs and play yards.
Beginning with ASTM F2933-18, after-market mattresses were required to
meet the same requirements of OEM mattresses for play yards. ASTM
members believed that, as written, the requirements for after-market
mattresses were design restrictive. Accordingly, the rationale for the
2021 revisions for after-market mattress requirements was to be less
design restrictive, by more directly relying on performance
requirements under the appropriate product standard, including
additional references to requirements in the voluntary standard for
play yards and non-full-size cribs, ASTM F406.
The purpose of having after-market mattresses meet the same
requirements as OEM mattresses is to reduce the risk of infant
entrapment and suffocation associated with after-market mattresses

[[Page 8649]]

that are too thick, or do not fit correctly, or attach to a play yard
or non-full-size crib. ASTM developed the latest requirements for
after-market mattresses, published in ASTM F2933-21, in collaboration
with CPSC staff, the ASTM Play Yard Vertical Displacement Task Group,
the Play Yard Mattress Fit and Thickness Task Group, and the ASTM Non-
Segmented Mattress Task Group. Below we summarize and assess changes to
ASTM F2933-21 that occurred after publication of the NPR.
1. In section 5.9 of ASTM F2933-21, ``Product'' was clarified to
refer to the play yard or non-full-size crib, rather than the mattress.
Other clarifications of the mattress and the product were made
throughout this section. These term clarifications are appropriate and
adequate to clarify which requirements in the standard apply to which
products. However, the final rule removes non-full-size cribs from this
section, to be consistent with changes to section 5.7.2 regarding non-
full-size mattress size and thickness.
2. In section 5.9.1.1 of ASTM F2933-21, the requirement was removed
that the after-market mattress have the same thickness, floor support
structure, and attachment method as the mattress it is intended to
replace. The thickness and floor support structure requirements were
replaced in ASTM F2933-21, as described in paragraphs 5 and 6 below.
The final rule adopts these new requirements for after-market
mattresses in ASTM F2933-21, as written. Before this change, an after-
market mattress for a play yard could meet the requirements of ASTM
F406 when tested with the product it is intended to be used with, but
still not meet the requirements of this section, due to having a
different mattress thickness or different floor support structure
design as the OEM mattress. For example, non-segmented, i.e., non-
folding, after-market mattresses for products that included a segmented
mattress would not be allowed. Similarly, if the OEM play yard mattress
was \3/8\ inches thick, an after-market mattress with a thickness of
\7/8\ inches, and that would otherwise meet the requirements of an OEM
mattress, would not be allowed.
ASTM removed the requirement that after-market mattresses be
exactly the same as the OEM mattress, and instead, requires that after-
market mattresses be tested to the same requirements as OEM mattresses
(see 3 below). Moreover, after-market mattresses must meet additional
requirements regarding size, floor support structure, and instruction
storage (5, 6, and 7 below, respectively). Based on this change, the
two examples described above would be allowed, so long as they meet all
of the requirements for after-market mattresses. A 3-inch thick, after-
market play yard mattress would not be allowed, however, due to it
having a greater thickness than allowed for OEM mattresses in ASTM
F406. Because after-market mattresses must meet the same dimension and
performance requirements as OEM mattresses, as well as additional
requirements, this change will not reduce the safety of after-market
mattresses.
3. In the new section 5.9.1.1 of ASTM F2933-21, ASTM added the
following list of requirements from ASTM F406: Stability; Cord/Strap
Length; Crib Side Height; Height of Sides; and Floor Strength. The
following requirements from ASTM F406 were already listed: Mattress;
Mattresses for Rigid-Sided Products; Mattress Vertical Displacement.
The requirements in ASTM F406 applicable to play yard mattresses are
those for Mattress, Stability, Cord/Strap Length, Height of Sides,
Floor Strength, and Mattress Vertical Displacement. ASTM F2933-21 now
includes all of these listed requirements. The final rule, however,
removes Mattresses for Rigid-Sided Products and Crib Side Height from
this section, because these requirements apply to non-full-size cribs,
which are addressed in the final rule in section 5.7.2.
4. In the new section 5.9.1.2 of ASTM F2933-21, ASTM replaced the
term ``replacement mattress'' with ``aftermarket mattress.'' The final
rule includes this modification, and it is consistent with
modifications proposed in the NPR.
5. ASTM added the following requirement in a new section 5.9.1.3 in
ASTM F2933-21: ``The aftermarket mattress must be at least the same
size as the original equipment mattress or larger and lay flat on the
floor of the product, in contact with the play yard mattress support
structure.'' Some OEM play yard mattresses are made particularly thin,
contributing to the consumer perception that play yard mattresses are
uncomfortable, and potentially resulting in consumers placing
additional soft bedding in infant sleep environments. With this change,
after-market mattresses can be the same size or larger (thicker and/or
wider) than the OEM mattress, so long as they lay flat and meet the
other applicable dimension and test requirements for play yard
mattresses, including maximum dimension requirements. This allows
after-market play yard mattresses, which are thicker than OEM
mattresses, but continue to meet maximum dimension requirements (e.g.,
an after-market mattress with foam \7/8\ inches thick may be
acceptable, but foam more than 1-inch thick, would not be acceptable).
The final rule adopts this change as part of ASTM F2933-21, because it
is unlikely to reduce safety, and may improve safety by allowing
appropriately sized, after-market mattresses that could combat the
consumer perception of uncomfortable play yard mattresses. This change,
therefore, is an adequate replacement for the mattress size
requirements originally in section 5.9.1.1.
6. ASTM added the following requirement in section 5.9.1.4 of ASTM
F2933-21: ``If the original equipment mattress includes a floor support
structure, the aftermarket mattress must include a floor support
structure that is at least as thick as the original equipment mattress
floor support structure.'' This change allows for after-market
mattresses with a different floor support structure than the OEM
mattress (e.g., an after-market non-segmented mattress in place of an
OEM segmented mattress), so long as the floor support structure is at
least as thick as the original, and the mattress meets the other
applicable requirements for play yard mattresses. This change, along
with the requirement that the mattress must lay flat on the play yard
support structure, will have no effect on safety, because it ensures
that after-market play yard mattresses with a different support
structure than the OEM mattress will still have a similar level of
support. The final rule adopts this change as part of ASTM F2933-21,
because it is an adequate replacement for the floor support structure
requirements originally in section 5.9.1.1.
7. ASTM added the following requirement in section 5.9.1.5 of ASTM
F2933-21: ``If the original equipment mattress includes storage
accommodations for the product instruction manual, the aftermarket
mattress shall provide equivalent storage accommodations for the
product instruction manual.'' This is a new requirement for after-
market mattresses to have equivalent storage accommodations for
instructions as the OEM mattress. The final rule adopts this change as
part of ASTM F2933-21, because it improves safety by increasing the
likelihood of consumers keeping the product's instruction manual, which
may have important safety information, readily accessible.
Based on the foregoing, the final rule incorporates by reference
ASTM F2933-21, and adopts these seven changes, except where a change
conflicts with the separation of requirements for play yards from the
requirements for non-

[[Page 8650]]

full-size crib mattresses, as noted in this section. Appendix A to Tab
C of Staff's Final Rule Briefing Package outlines the changes to
section 5.9 of ASTM F2933-21.

C. Description of Performance Requirements in ASTM F2933-21

In addition to the general requirements typically found in other
ASTM juvenile product standards, such as requirements for openings,
label permanency, and the prohibition of sharp points/edges, small
parts, and lead in paints, section 5 of ASTM F2933-21 contains the
following four additional requirements that apply specifically to
mattresses for cribs, non-full-size-cribs, and to after-market
mattresses for non-full-size cribs and play yards:
<bullet> Sec. 5.7 Mattress Dimensions: This section describes the
dimensional requirements for full-size crib mattresses, and for non-
full-size crib mattresses that are supplied with a non-full-size crib,
to prevent an infant from becoming wedged in a gap caused by a too-
small crib mattress. To ensure that the crib mattress dimensions are
within the allowable range, the test requires a mattress to be placed
in a test box and pushed against the side of the box with a force
prescribed in the test method.
<bullet> Sec. 5.7.2.2 Mattress Thickness: This requirement applies
to non-full-size crib mattresses supplied with a non-full-size crib, to
prevent occupants from falling out of the product (and extends to
after-market mattresses for non-rectangular, non-full-size cribs, as
described below for Sec. 5.9). The requirement states that a mattress
supplied with a non-full-size crib shall have a thickness that will
provide a minimum effective crib-side height dimension of at least 20
inches when the crib side is in its highest adjustable position and the
mattress support is in its lowest adjustable position. Additionally,
the mattress shall have a thickness that will provide a minimum
effective crib-side height dimension of at least 3 inches when the crib
side is in its lowest adjustable position, and the mattress support is
in its highest adjustable position.
<bullet> Sec. 5.8 Mattress Seam Stitching: This requirement
applies to all crib mattresses within the scope of the standard and
states that all seam stitching that is accessible to the occupant shall
be lock stitching to prevent accessible stitching from becoming loose
and creating a small part or strangulation hazard.
<bullet> Sec. 5.9 After-Market Mattress for Play Yards and Non-
Full-Size Cribs: This requirement is for after-market mattresses for
play yards and non-full-size cribs, and states that after-market
mattresses for soft-sided and non-rectangular, rigid-sided products
must meet the following applicable requirements from ASTM F406,
Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/
Play Yards: Stability; Cord/Strap Length; Mattress; Mattresses for
Rigid sided products; Crib Side Height; Height of Sides; Floor
Strength; and Mattress Vertical Displacement. Additionally, the after-
market mattress and floor support structure must be at least the same
size as the original equipment mattress; it must lay flat on the play
yard support structure or floor; and must include equivalent storage
accommodations for the instruction manual. Accordingly, these after-
market mattresses must meet the same requirements as the OEM mattress.
Requirements for OEM mattresses sold with play yards and non-full-size
cribs are codified at 16 CFR parts 1220 (non-full-size cribs) and 1221
(play yards), which incorporate by reference ASTM F406. Finally, if the
after-market mattress is also intended to be used in a bassinet, it
must also meet the requirements in the following sections of ASTM
F2194, Standard Consumer Safety Specification for Bassinets and
Cradles, when tested with each brand and model of product for which it
is intended to replace the mattress: Pad Thickness for Fabric or Mesh-
Sided Products; Pad dimensions; Side Height; and Bassinets with
Segmented Mattresses.

VI. Adequacy of the Voluntary Standard To Address Crib Mattress Hazards

A. Adequacy of Performance Requirements 50
---------------------------------------------------------------------------

\50\ Staff's NPR Briefing Package at Tab B contains additional
details on the CPSC staff's analysis of ASTM F2933-19 and its
ability to address identified hazards.
---------------------------------------------------------------------------

ASTM developed ASTM F2933 to mitigate the risk of injury associated
with the use of crib mattresses. Hazard-mitigation strategies include
performance requirements and instructions and on-product warnings to
help inform caretakers of the primary hazards during use of the
product. Based on CPSC staff's Engineering, Human Factors, and Health
Sciences assessments, Tabs B, C, and E, respectively, of Staff's NPR
Briefing Package, and Tabs C and D of Staff's Final Rule Briefing
Package, the requirements in the voluntary standard, ASTM F2933-21,
adequately address the hazard patterns related to expanding or
inflating crib mattresses, mattresses falling apart, and most hazards
associated with multiple contributing factors, or other hazards.
However, ASTM F2933-21 does not adequately address the most
prevalent or severe identified hazards associated with the use of crib
mattresses, such as coil spring issues, face in mattress, fit issues,
infants found prone, and mattress softness. The warning labeling for
hazard patterns that are within the multiple contributing factors
category (i.e., face in mattress, found prone, and softness) are also
inadequate. Accordingly, the Commission will finalize the rule with
additional requirements, as proposed in the NPR, to make the standard
more stringent, to further reduce the risks of death and injury from
these hazard patterns. Table 5, based on the final rule incident data,
summarizes the staff-identified hazard patterns and states how ASTM
F2933-21 addresses each hazard pattern.

Table 5--Assessment of ASTM F2933-21 To Address Identified Hazard Patterns
----------------------------------------------------------------------------------------------------------------
Applicable How addressed in Adequacy
Hazard pattern mattresses ASTM F2933-21 assessment Comments
----------------------------------------------------------------------------------------------------------------
Chemical/Flammability Hazards All............... 16 CFR part 1303 Adequate.......... Assessed as
(odors, rash). Ban of Lead- adequate in NPR.
Containing Paint No change in
16 CFR part 1500 standard.
Hazardous
Substances Act
Regulations
(Sections 5.1 and
5.4).
16 CFR part 1632
Standard for the
Flammability of
Mattresses and
Mattress Pads.
16 CFR part 1633
Standard for the
Flammability
(Open Flame) of
Mattress Sets.

[[Page 8651]]

Coil or Spring (laceration)..... Coil or spring Prohibition of Inadequate........ Final rule
mattresses sharp points includes
(primarily full- (Section 5.2). additional cyclic
size). testing to
identify
potential for
springs to break
through surface
during
foreseeable use
and misuse.
Crib Mattress Used in a Play Aftermarket play Labeling Adequate.......... Section VI.A.3 of
Yard (suffocation due to ill- yard mattresses. requirements, the preamble
fitting mattress). requirements for assesses the
after-market revised
mattresses. requirements for
Testing after-market
requirements mattresses.
harmonized with
ASTM F406.
(Sections 5.9 and
7.5).
Expand or Inflate (suffocation Foam products, Dimensional Adequate.......... Hazard is
due to ill-fitting mattress typically full- conformity, adequately
that does not expand or inflate size and shipped mattress addressed with
properly). as ``bed in a thickness, and F2933's
box''. labeling dimensional
requirements conformity and
(Section 5.7). mattress
thickness.
Face in Mattress (suffocation).. All............... Labeling Inadequate: See Final rule
requirements also ESHF \51\ contains a
(Section 7.3). memo (Tab D). firmness test
based on sections
6 and 8 of AS/NZS
8811.1 and
revised labeling.
Fit Issues (suffocation due to All............... Dimensional Inadequate........ Final rule
ill-fitting mattress). conformity and contains
after-market additional fitted
mattress sheet compression
requirements test for full-
(Sections 5.7 and size mattresses
5.9). and extends
dimensional
requirements in
section 5.7 to
all after-market
non-full-size
crib mattresses.
Found Prone (suffocation due to All............... Labeling Inadequate: See Final rule
prone position). requirements also ESHF memo contains a
(Section 7.3). (Tab D). firmness test
based on sections
6 and 8 of AS/NZS
8811.1 and
revised labeling.
Mattress Falls Apart (choking/ All............... Mattress seam Adequate.......... Assessed as
ingestion). stitching adequate in NPR.
requirement and No change in
small parts standard.
prohibition
(Sections 5.3 and
5.8).
Softness (suffocation due to All............... Not addressed..... Inadequate........ Final rule
soft surface). contains a
firmness test
based on sections
6 and 8 of AS/NZS
8811.1.
Multiple Contributing Factors All............... General Inadequate........ Some of these
(MCF) (e.g., entrapment in requirements and contributing
bumper pads, limb entrapment, warning labels factors are
crib sharing with another (Sections 5 and addressed by
infant, existing health 7). additional
condition). requirements in
the final rule
described above,
while others are
related to
another product
use or other
factor out of the
scope of the crib
mattresses
standard.
Other........................... All............... General Adequate.......... This category
requirements and includes hazards
warning labels which are out of
(Sections 5 and scope of the ASTM
7). standard or for
which the cause
is unclear.
----------------------------------------------------------------------------------------------------------------

1. Hazard Pattern--Chemical/Flammability Hazards
---------------------------------------------------------------------------

\51\ CPSC's Directorate for Engineering Sciences, Division of
Human Factors (ESHF).
---------------------------------------------------------------------------

Seven percent (26 out of 355) of the nonfatal incidents, including
3 incidents identified since the NPR, reported a crib mattress having a
chemical odor (6), causing rashes (8), causing severe allergies (1), or
mattresses not meeting mandatory federal flammability standards (11).
Reports describe infants suffering from rashes, upper respiratory
issues, and headaches. The ASTM F2933-21 general requirements section
addresses these hazards with the inclusion of 16 CFR part 1632,
Standard for the Flammability of Mattresses and Mattress Pads, 16 CFR
part 1633, Standard for the Flammability (Open Flame) of Mattress Sets,
and 16 CFR part 1303, Ban of Lead-Containing Paint and Certain Consumer
Products Bearing Lead-Containing Paint.
2. Hazard Pattern--Coil or Spring
Potential laceration hazards due to an exposed coil or spring
account for 36 percent (128 out of 355) of the nonfatal incident
reports, including four incidents identified since the NPR. ASTM F2933-
21 addresses this hazard by prohibiting sharp points. Due to the high
proportion of reported nonfatal incidents, the final rule strengthens
the standard with a cyclic impact test, as proposed in the NPR, which
entails dropping a 30-pound test mass 250 times in four locations on a
test mattress.
Since publication of the NPR, CPSC staff has continued working with
the crib mattress cyclic testing task group to refine test requirements
that will address the hazard of potential lacerations to infants from
an exposed coil or spring. The test was discussed at subcommittee and
task group meetings on November 10, 2020, December 9, 2020, and
February 16, 2021. During these meetings, ASTM members discussed points
they felt needed clarification if the voluntary standard is revised,
including the desire for a means to prevent the mattress from moving
around during testing. ASTM members stated, for example, that the
standard should clarify that the test only applies to coil spring
mattresses, and that two mattresses should be required to test both
sides of a mattress, because of the potential for destruction of the
sample during testing. Accordingly, the final rule includes a
modification to the test method, to require two mattresses for testing
each side of a mattress.
CPSC staff has typically been in alignment with ASTM members of the
Crib Mattress Cyclic Testing task group on how to conduct testing to
address the hazard of potential lacerations to infants caused by
exposed coils or springs. Public comments were also generally
supportive of the test proposed by staff; and the comments encouraged
staff to continue working with ASTM to develop the test. Although ASTM
informed staff at a subcommittee meeting on June 10, 2021, that a new
draft of the ASTM test method had been developed, and members were
shown a drawing that appeared to depict a

[[Page 8652]]

revised test location, ASTM has not yet distributed this revised draft
to CPSC staff or to other task group members, and there has not been a
ballot. Therefore, for the final rule, the Commission clarifies the
test procedure and the need for two mattresses, but does not make any
additional changes.
3. Hazard Pattern--Crib Mattress Used in a Play Yard
One percent (2 out of 139) of fatal incidents and one percent (2
out of 355) of nonfatal incidents, including one nonfatal incident
identified since the NPR, are associated with using a crib mattress in
a play yard. The incidents were associated with the use of a crib
mattress that did not fit properly in a play yard. ASTM F2933-21
addresses this hazard with warning label requirements, and
additionally, newer requirements specifying that after-market play yard
mattresses must meet the same requirements as OEM mattresses. These
revisions will increase the availability of properly fitting after-
market mattresses, and will reduce the likelihood of caregivers using
an ill-fitting crib mattress in a play yard. For the final rule, the
Commission incorporates by reference ASTM F2933-21, to include these
revisions.
One nonfatal incident involved scratches on an infant's back,
caused by protruding coils or springs of the crib mattress. The final
rule addresses the coil or spring hazard, as described in section
VI.A.2, above.
4. Hazard Pattern--Expand or Inflate
In two percent (6 out of 355) of reported nonfatal incidents, a
crib mattress failed to expand or inflate properly. All of these
incidents were reported in the NPR. This hazard can occur when a
mattress is tightly rolled for shipping or packaging purposes, and then
does not completely decompress. Related hazards include fit issues with
gaps appearing around the crib mattress, causing entrapment or wedging,
and an uneven crib mattress that may cause an infant to roll over.
Although this hazard is adequately addressed with ASTM F2933's
dimensional conformity and mattress thickness requirements, the
additional proposed mattress compression test, detailed in section
VI.A.6 of this preamble, will strengthen the proposed standard and
further reduce injuries associated with the failure of a mattress to
expand or inflate fully to prevent hazardous gaps.
5. Hazard Pattern--Face in Mattress
Twelve percent (16 out of 139) of fatal incidents and less than 1
percent (1 out of 355) of nonfatal incidents, including three fatal
incidents identified since the NPR, are associated with an infant found
face down on a crib mattress. ASTM F2933 does not address this hazard
pattern. The Human Factors assessment in the Staff's NPR and Final Rule
Briefing Packages provides strengthened warning label recommendations
to address this hazard pattern. As proposed in the NPR, the Commission
is finalizing the rule with revised warning labels to address this
hazard.
6. Hazard Pattern--Fit Issues
Twenty-two percent (31 out of 139) of fatal incidents and 26
percent (91 out of 355) nonfatal incidents, including 11 fatal
incidents and three nonfatal incidents identified since the NPR, were
associated with the fit of a crib mattress in the sleeping
environment.\52\ In these reports, gaps between the crib mattress and
the crib rail or play yard mesh, on one or more sides around the
perimeter of a crib mattress, created a wedging or entrapment hazard.
ASTM F2933-21 contains a mattress dimensional conformity test intended
to address this hazard. However, staff found from visual inspection and
measurement of mattresses tested, that tight-fitting sheets over crib
mattresses can create gaps between the corners of the mattress and the
interior corner of the crib, creating an entrapment hazard, as seen in
Photo 1. Accordingly, ASTM F2933-21 does not adequately address
entrapment hazards between the crib mattress and the side of a crib or
play yard.
---------------------------------------------------------------------------

\52\ Nearly half (11 out of 23) of fatal incidents identified
since the NPR are associated with fit issues.
---------------------------------------------------------------------------

a. Mattress Compression
To strengthen the standard, the Commission is finalizing the rule
with the sheet compression test, as proposed in the NPR, with
modifications to address the fit issues caused by a tight-fitting
sheet.
[GRAPHIC] [TIFF OMITTED] TR15FE22.000

The NPR proposed a test method to address the hazard associated
with tight-fitting sheets that compressed a crib mattress to create
potentially hazardous gaps. The test method had a conditioned fitted
sheet placed on a

[[Page 8653]]

full-size crib mattress. The mattress with the sheet was required to
meet all dimensional requirements in ASTM F2933-19.\53\ In addition,
measured corner gaps were required to be less than 2.25 inches in
length, based on the fifth percentile head breadth of 0- to 3-month-old
infants,\54\ the already-allowed maximum gap of 1 inch between the
sides of the crib mattress and the sides of the crib, and a 0.5-inch
margin of safety.
---------------------------------------------------------------------------

\53\ The dimensional requirements are unchanged in ASTM F2933-
21.
\54\ The 5th percentile head breadth, i.e., the maximum breadth
of the head above and behind the ears, of children 0 to 3 months old
is approximately 3.66 inches; Snyder, R.G., Schneider, L.W., Owings,
C.L., Reynolds, H.M., Golomb, D.H., & Schork, M.A. (1977).
Anthropometry of Infants, Children and Youths to Age 18 for Product
Safety Design (Report No. UM-HSRI-77-17). Prepared for the U.S.
Consumer Product Safety Commission, Washington, DC.
---------------------------------------------------------------------------

After publication of the NPR, ASTM members discussed the NPR test
methods during ASTM crib mattress subcommittee and task group meetings
on November 10, 2020, December 3, 2020, and February 16, 2021. At these
meetings, ASTM members expressed that for the ASTM voluntary standard,
they were not in favor of the test method proposed by CPSC in the NPR.
Members stated that crib mattress sheets can vary widely in quality and
size; and that by assuming the maximum gap of 1 inch between the sides
of the crib mattress and the sides of the crib, the test method
unfairly penalized larger mattresses. Additionally, ASTM members
pointed out that the dimension measurement method in ASTM F2933 was
established with soft materials in mind, and that the NPR-proposed test
method was overly restrictive for mattresses, by compressing them
twice, due to the requirement that this measurement be conducted with
the sheet installed.
The ASTM task group decided to develop an alternative test method,
presented during meetings on February 25, 2021, and June 9, 2021. In
this test method, the maximum allowable 1-inch gap is applied to the
minimum allowable mattress dimensions of 51.625 inches x 27.25 inches,
to create a rectangle measuring 52.625 inches x 28.25 inches. This
rectangle is the projected crib interior. Then, using the head breadth
dimension proposed by staff (3.66 inches) minus a 0.51-inch margin of
safety, a line is marked 3.15 inches away from the projected crib
interior corner, at an angle of 45 degrees to each of the projected
crib sides. A 6-inch-high x 6-inch-wide wood block is then used to
apply a 2-pound force to the corner of the mattress to recreate the
compression force of a fitted sheet. If the front of the block moves
beyond the marked line, then the mattress fails. The test is repeated
in each corner. ASTM has not balloted the proposed test method.
[GRAPHIC] [TIFF OMITTED] TR15FE22.001

ASTM members expressed two primary reasons against the test method
proposed in the NPR. First, ASTM members stated that crib mattress
sheets can vary widely in quality and size. Some public comments agree
with this point, suggesting fitted sheets should have separate
performance requirements addressed by the ASTM infant bedding
subcommittee. CPSC staff has engaged with members of the ASTM Infant
Bedding Task Group to reduce the risk of ill-fitting crib mattress
fitted sheets and improve sheet performance. Regardless, a crib
mattress should not allow a poorly fitted sheet to adjust its
dimensions and create a hazardous gap. Staff will continue working with
ASTM's Infant Bedding Task Group to address quality concerns regarding
fitted sheets intended for crib mattresses, and thereafter, will work
with the ASTM Crib Mattress subcommittee to refer to these
requirements, as applicable. However, for the final rule, test
laboratories can determine the most appropriate sheet for the test,
meaning a crib mattress sheet that fits the crib mattress snugly and
can be wrapped around the four corners. The Commission did not receive
comments that suggested additional methods to improve the sheet

[[Page 8654]]

selection process. Accordingly, based on available data, the test
method proposed in the NPR is the most accurate test method to test for
hazardous gaps caused by sheet compression.
Second, ASTM members stated that the proposed test has the
potential to be overly restrictive towards mattresses that are larger
than the minimum allowable size. Some public comments make the same
point. CPSC agrees with ASTM members and public comments on this
point.\55\ The proposal in the NPR assumed that every mattress would
have the 1-inch maximum allowable gap between the crib and the crib
mattress, regardless of size. This assumption is overly restrictive
towards mattresses that were designed to fill the space between the
crib and crib mattress. The final rule improves the test method to
address this point, by incorporating projected crib dimensions that
consider the maximum allowable crib interior dimensions of 53 inches x
28\5/8\ inches to be an appropriate position, because a crib with the
maximum interior dimensions will be the worst-case product to consider
hazardous corner gaps. Accordingly, the final rule incorporates changes
to the measurement method, such that the corner gap is measured from
the projected corner of a crib, as described in section VIII of this
preamble.
---------------------------------------------------------------------------

\55\ Staff notes that of the 11 mattresses tested for the NPR,
all of which were larger than the minimum size, none failed the
draft proposed test method.
---------------------------------------------------------------------------

Additionally, ASTM members commented that the mattress measurement
method described in section 6.2 was established with concerns about
foam compression in mind. As mentioned in the appendix of ASTM F2933-
21, the rationale for using a dynamic measuring box was ``to provide a
more repeatable measurement that would take away the variability caused
by soft materials.'' The test method proposed in the NPR would have
repeated these measurements with the fitted sheet on the mattress,
essentially compressing the mattress twice when taking dimension
measurements. In response to these comments, the final rule removes the
requirement that the mattress with the fitted sheet must meet the same
dimension requirements as the mattress without the fitted sheet.
Instead, the final rule requires the corner gap measurement to be taken
separately from the dimension measurements.
b. After-Market Mattresses for Play Yards and Non-Rectangular, Non-
Full-Size Cribs
ASTM F2933-21 also includes provisions to address fit issues with
after-market mattresses for play yards and non-rectangular, non-full-
size cribs. These provisions require that after-market mattresses meet
the same requirements as OEM play yard and non-full-size crib
mattresses, as specified in ASTM F406. The dimensional requirements for
after-market non-full-size crib mattresses in section 5.9 of ASTM
F2933-21 currently only apply to non-rectangular, non-full-size crib
mattresses, and the dimensional requirements in section 5.7 of the
standard only apply to OEM non-full-size crib mattresses. This is
consistent with staff's assessment of ASTM F2933-19 in the NPR.
Although labeling requirements in section 7 of the standard apply to
all non-full-size crib mattresses, regardless of shape, or whether they
are after-market or OEM, ASTM F2933-21 contains no dimensional
requirements that apply to after-market, rectangular, non-full-size
crib mattresses. To address this gap in the standard, the final rule
modifies section 5.7 of ASTM F2933, as proposed, to apply the
dimensional requirements to all non-full-size crib mattresses,
regardless of shape or whether they are provided with the crib or sold
after-market. The Commission is also finalizing the modification to
section 5.9 of ASTM F2933, as proposed, to remove non-full-size cribs
from that section and to clarify requirements for after-market play
yard mattresses.
7. Hazard Pattern--Found Prone
Fifty-four percent (75 out of 139) of fatal and 1 percent (3 out of
355) of nonfatal incidents, including nine fatal incidents identified
since the NPR, are associated with infants found in a prone position on
a crib mattress, without any mention of the face being in contact with
the mattress or crib sheet, and no mention of the face being obstructed
by other crib bedding or other items in the sleep environment. ASTM
F2933-21 does not address this hazard pattern with a performance test;
however, it does address it with warning labels. The Human Factors
assessment in Tab D of Staff's Final Rule Briefing Package provides
warning label recommendations to strengthen the standard to address
this hazard pattern. The Commission will finalize the rule, as
proposed, with revised warning labels to address this hazard.
8. Hazard Pattern--Mattress Falling Apart
Five percent (18 out of 355) of nonfatal incidents are associated
with mattresses falling apart. Staff did not identify any new incidents
since the NPR. In most of these reports, the seams of the mattresses
unraveled, causing a strangulation hazard because the thread or cord
used for stitching the mattress was exposed. This failure also resulted
in a choking or ingestion hazard because the inner filling came out of
the mattress in small pieces and into the sleep environment of the
crib. ASTM F2933-21 adequately addresses this hazard with a mattress
seam-stitching requirement and small parts prohibition.
9. Hazard Pattern--Softness
Fifteen percent (55 out of 355) of nonfatal incidents, including 19
incidents identified since the NPR, are associated with mattress
softness. Mattress softness hazards include depressions or indentations
found in the crib mattress that could increase the risk of asphyxia.
Twelve of these 55 incidents relate to bending, buckling, or mattress
compression occurring when a crib sheet was placed on a mattress,
shrinking the mattress, and creating an entrapment hazard. ASTM F2933-
21 does not address firmness or softness hazards; nor does it address
mattress buckling. However, other international standards, Australian/
New Zealand Standard (AS/NZS) 8811.1:2013, and EN 16890:2017,
Children's Furniture--Mattresses for Cots and Cribs--Safety
Requirements and Test Methods, both address mattress firmness.
The NPR proposed a firmness test method based on the AS/NZS
8811.1:2013 test method for firmness. After the Commission issued the
NPR, CPSC staff continued to engage with ASTM to address the hazard
pattern created by soft crib mattresses in the ASTM standard. ASTM
members discussed this firmness test at ASTM crib mattress subcommittee
and task group meetings on November 10, 2020, December 3, 2020, and
February 16, 2021. At these meetings, ASTM members agreed that a
firmness test was needed in the standard, but debated whether the AS/
NZS 8811.1 protocol or the EN 16890 protocol would be more appropriate.
Some members agreed with CPSC staff's assessment that the AS/NZS 8811.1
protocol was more appropriate, and found that test results using the EN
16890 protocol could be difficult to interpret. Other ASTM members
disagreed, stating that the AS/NZS 8811.1 protocol did not produce

[[Page 8655]]

consistent results and the EN 16890 protocol was more appropriate. ASTM
members did not provide supporting evidence for this conclusion. ASTM
members agreed to test and compare results using both protocols after
the February 16, 2021 meeting.
At a June 10, 2021 subcommittee meeting, several ASTM members
reported that they had conducted testing using one or both of the
firmness protocols, and they repeated the assertion that the EN 16890
protocol should be favored. One member stated that the AS/NZS 8811.1
protocol results could be inconsistent if the test was not conducted on
a flat surface.\56\ ASTM members provided no detailed test results, and
none were discussed at this meeting.
---------------------------------------------------------------------------

\56\ Stitching patterns often contribute to uneven surfaces on
crib mattresses.
---------------------------------------------------------------------------

For the NPR, staff compared the AS/NZS 8811.1:2013 and EN 16890,
section 8.2.3 test protocols for firmness, and they found that the AS/
NZS 8811.1:2013 test method was more stringent.\57\ CPSC staff came to
this conclusion after comparing test results obtained using each
protocol on 11 full-size crib mattresses. Only one mattress failed the
firmness tests outlined in each standard. The mattress was a two-stage
mattress, indicating it had a firmer side intended for infants and a
softer side intended for toddlers. Both sides of the mattress failed
the AS/NZS protocol. The mattress failed the EN 16890 protocol only on
the ``toddler'' side, which is intentionally made softer.
---------------------------------------------------------------------------

\57\ See NPR at 85 FR 67913-14 and 67918 for a discussion of the
AS/NZ 8811.1:2013 test for mattress firmness.
---------------------------------------------------------------------------

Additionally, for the NPR staff found that the AS/NZS 8811.1:2013
test protocol is more repeatable and is easier to discern when a
mattress does not meet the performance requirements, as compared to the
EN16980 method. Some ASTM members and public comments stated that the
AS/NZS 8811.1:2013 test protocol does not provide consistent test
results, but they have not provided evidence to support this
conclusion. Staff's testing has not indicated any such issues. Some
ASTM members agreed with staff's assessment of AS/NZS 8811.1:2013, and
some public comments, reviewed in section VII of this preamble,
supported the use of AS/NZS 8811.1:2013 to determine whether a mattress
was too soft. Accordingly, to address mattresses that are too soft, for
the draft final rule, the Commission will finalize the rule, as
proposed, by adding a test for mattress firmness for all crib
mattresses within the scope of the standard, based on sections 6 and 8
in the AS/NZS 8811.1 mattress firmness test.
10. Hazard Pattern--Multiple Contributing Factors
Multiple contributing factors accounted for 11 percent (15 out of
139) of fatal and 5 percent (19 out of 355) nonfatal incidents,
including two nonfatal incidents identified since the NPR. Examples of
contributing factors are: Entrapment between the mattress and crib
bumper pads, limb entrapment between the mattress and a crib rail, crib
occupant usage of a swaddle, sharing of the crib with another infant,
and congenital or recent health conditions of infants. ASTM F2933-21
adequately addresses these hazards in the general requirements
sections. ASTM F2933-21 also addresses these hazards with safety
information requirements, but these requirements are inadequate. Tab D
of Staff's Final Rule Briefing Package, and section VI.B of this
preamble, outline the human factors assessment of the ASTM F2933-21
requirements for safety information and the modifications required in
this final rule. As proposed in the NPR, the Commission is finalizing
the rule with revised safety information to address this hazard.
11. Hazard Pattern--Other
Two percent (6 out of 355) of nonfatal incidents involved
miscellaneous other issues associated with a crib mattress. Staff did
not identify any new incidents since the NPR. Reports include: A blade
found in a crib mattress; an infant's arm ``tangled in a crib
mattress''; an infant ``slipped on a crib mattress,'' causing a slat
entrapment; an infant's arm ``stuck on a crib mattress''; a crib
mattress is too thick; a crib mattress had a loose plastic bag for a
cover; and a concern about crib mattresses not having proper warning
labels to direct caregivers to place infants on their backs when
putting them down in a crib. Foreign objects are generally not
addressable in product standards. For three of these incidents, staff
could not determine the exact cause of the incident, or whether ASTM
F2933-21 was the appropriate standard to address the hazard. ASTM
F2933-21 warning label requirements include a statement that says to
place infants on their backs to sleep, and to ``only use sheets and
mattress pads designed specifically for crib mattresses.''

B. Adequacy of Marking, Labeling, and Instructions 58
---------------------------------------------------------------------------

\58\ The NPR contained an explanation of the proposed
modifications to the warnings associated with crib mattresses. 85 FR
67918-21. Staff's NPR Briefing Package at Tab F contains additional
details on the basis for the Commission's proposed modifications to
the marking, labeling, and instructional literature requirements for
crib mattresses. Staff's Final Rule Briefing Package at Tab D
explains the clarifications made in the final rule, compared to the
NPR.
---------------------------------------------------------------------------

Universally, labeling experts view warning about a hazard as less
effective at addressing hazards than designing the hazard out of a
product, or guarding the consumer from the hazard. The use of warnings
is lower in the hazard-control hierarchy than design-based approaches,
because the effectiveness of the warning depends on persuading
consumers to alter their behavior in some way to avoid hazards, rather
than eliminating hazards or inhibiting exposure to hazards. Therefore,
when a standard relies on warnings to address a hazard, warning
statements must be as strong as possible; i.e., the warnings must be
noticeable, understandable, and motivating. The primary U.S. voluntary
consensus standard for product safety signs and labels, ANSI Z535.4,
American National Standard for Product Safety Signs and Labels,
recommends that on-product warnings include content that addresses the
following three elements: \59\
---------------------------------------------------------------------------

\59\ All three elements may not be necessary in some cases, such
as if certain information is open and obvious or can be readily
inferred by consumers. However, people often overestimate the
obviousness of such information to consumers.
---------------------------------------------------------------------------

<bullet> A description of the hazard;
<bullet> information about the consequences of exposure to the
hazard; and
<bullet> instructions regarding appropriate hazard-avoidance
behaviors.
Section 7 of ASTM F2933 specifies requirements for marking and
labeling for full-size crib mattresses, non-full-size crib mattresses,
and after-market mattresses for play yards and non-full-size cribs. In
the NPR, the Commission stated that, based on CPSC staff's examination
of literature, incident data, and consumer feedback, the crib mattress
warnings specified in ASTM F2933-19 did not adequately address these
warning elements regarding the identified hazards. Although the
standard contained warnings pertaining to infant positioning, soft
bedding, and gap entrapment, the wording and formatting of the warning
message needed to be improved to communicate the hazards
effectively.\60\ The Commission's NPR recommended the following changes
to the safety information requirements specified in ASTM F2933-19:
---------------------------------------------------------------------------

\60\ The NPR discusses safety information inadequacies at 85 FR
67918-21.
---------------------------------------------------------------------------

<bullet> Clarifying the definition of ``conspicuous'' in section 3,
Terminology;

[[Page 8656]]

<bullet> Improving marking and labeling requirements in section 7,
Marking and Labeling; and
<bullet> Adding instructional literature requirements in a new
section 8, Instructional Literature.
The NPR explained that CPSC staff considered incident data,\61\
results from survey \62\ and focus group research,\63\ relevant
literature,\64\ requirements in ANZI Z535.4,\65\ recommendations from
the ASTM Ad Hoc Language Task Group,\66\ and suggestions from other
stakeholders participating in the ASTM F15.66 subcommittee on crib
mattresses and the greater ASTM F15 committee on consumer products.\67\
Since the NPR published, CPSC received comments from the public
pertaining to the NPR's safety information requirements. Section VII of
this preamble contains comment summaries and the Commission's
responses. Two of the comments requested that staff continue
collaborative efforts with ASTM to address weaknesses in safety
information requirements for crib mattresses. Below we describe
warnings-related ASTM activities and changes in the final rule intended
to further improve the safety of crib mattresses. Appendix A to Tab D
of Staff's Final Rule Briefing Package contains a side-by-side
comparison of the NPR, ASTM's latest recommendations, and the final
rule.
---------------------------------------------------------------------------

\61\ The ESHF memorandum in CPSC staff's NPR briefing package
details staff's findings regarding the prevalence in incident data
of infant prone positioning, soft bedding, and mattress size/corner
gaps.
\62\ The 2014 ``Durable Nursery Products Exposure Survey
(DNPES): Final Summary Report,'' by Westat, details the findings of
a survey conducted in 2013, which collected information about
durable infant and toddler products.
\63\ The 2019 ``Consumer Product Safety Commission (CPSC):
Caregiver Perceptions and Reactions to Safety Messaging Final
Report'' (Safety Messaging Report) by Fors Marsh Group, summarizes
focus group research and a literature review pertaining to safe
sleep practices in various products, including cribs and play yards.
\64\ For example, Joyner et al. (2009) as cited in the Safety
Messaging Report, posited that caregivers are likely to trust
implicitly the safety of products under the misconception that if a
product is sold to the public, then it is likely safe to use. Staff
finds this common misconception particularly likely with regards to
infant products; the greater vulnerability of infants to product
hazards is likely to support the expectation of caregivers that
infant products are designed to be safe.
\65\ ANSI Z535.4, American National Standard for Product Safety
Signs and Labels, is the primary U.S. voluntary consensus standard
for product safety signs and labels.
\66\ ASTM juvenile products standards have begun adopting ``Ad
Hoc'' recommendations since 2016, to increase the consistency of on-
product warning design among juvenile products, and to address
numerous warning format issues related to capturing consumer
attention, improving readability, and increasing hazard perception
and avoidance behavior.
\67\ Since May 2018, CPSC staff has been participating in ASTM
F15.66 to address the identified hazards. Subcommittee members
include manufacturers, safety and health advocacy groups, and other
critical stakeholders. Changes to ASTM F2933 proposed by ASTM F15.66
have been balloted by ASTM F15 (see discussion of ASTM Ballot F15
(21-02), below).
---------------------------------------------------------------------------

1. ASTM Subcommittee Activities and ASTM F2933
After the NPR published, staff continued to work with ASTM F15.66
to address deficiencies in the safety information requirements in ASTM
F2933. ASTM F15 balloted revised sections of the standard, closing on
April 12, 2021. The ballot, F15 (21-02), addressed safety information
requirements in item 13, Revision of F2933-2019 Consumer Safety
Specification for Crib Mattresses WK72077. The ballot item received
three negative votes, two of which were administrative. One negative
vote, submitted by CPSC staff on April 6, 2021, included a letter
identifying deviations from the NPR.\68\ On June 9, 2021, ASTM F15.66
reviewed staff's letter, and voted on whether the letter was
persuasive. Several attendees shared rationales for some of the
substantive deviations from the NPR, which we discuss below.
---------------------------------------------------------------------------

\68\ See Appendix B to Staff's Final Rule Briefing Package.
---------------------------------------------------------------------------

ASTM members stated that the NPR includes SIDS (Sudden Infant Death
Syndrome) in the hazard identifier (i.e., ``SIDS AND SUFFOCATION
HAZARDS''), which in the balloted version reads: ``SUFFOCATION
HAZARD.'' In addition to requesting rationale for this incongruity,
staff asked ASTM F15.66 to discuss a public comment on the NPR, which
recommends making the hazard identifier active; i.e., ``Help Prevent
SIDS and Suffocation.'' Several ASTM members argued that the hazard
identifier should remain as balloted to keep the focus on the
suffocation hazard, which they believed to be the most important
message. ASTM members also claimed that SIDS is already well known, and
therefore, it does not need to be included in the hazard identifier. As
discussed in Staff's NPR Briefing Package and staff's ballot letter,
the Commission agrees with staff that it is important to include
``SIDS'' in the hazard identifier for numerous reasons, including the
following: (1) SIDS, in addition to suffocation, is cited frequently in
reports of fatal incidents; (2) several statements in the warning label
address the SIDS hazard; and (3) SIDS, by definition, is a poorly
understood hazard, and consumers are more likely to read the warning
message if they know it includes actions by which to limit the risk of
SIDS.\69\
---------------------------------------------------------------------------

\69\ Detailed in the NPR package, SIDS is a subcategory of SUID
that refers to infant deaths that cannot be explained after a
thorough case investigation.
---------------------------------------------------------------------------

The NPR prioritized the prone sleep message, ``ALWAYS place baby on
back to sleep to reduce the risks of SIDS and suffocation,'' directly
after the hazard identifier. In ASTM's balloted version, this message
appears much lower in the warning label. Several ASTM members argued
that addressing the suffocation hazard involving soft bedding needs to
be the primary thrust of the warnings, and that the prone sleep message
should be lower in the warning. The Commission's prioritization of the
prone sleep message, which is supported by a public comment, is
important for communicating to consumers the most common hazardous use
pattern that staff observed in fatal crib mattress incidents. As
detailed in Tab B of Staff's Final Rule Briefing Package, and Tab A of
Staff's NPR Briefing Package, the majority of the deaths involved prone
positioning, often with no other known contributing factors. The prone
sleep message needs to be communicated foremost, and the likelihood
that consumers will see this critical message will be improved by
placing it at the top of the warning label. Prioritizing the prone
sleep message will not make it less likely that consumers will read and
follow the messages pertaining to suffocation from soft bedding, which
are emphasized in the label, because the prone sleep message is
followed by a suffocation-specific heading (i.e., ``Babies have
suffocated'') and several statements, including bulleted points, about
soft bedding. The arrangement of warnings in the final rule increases
the likelihood that consumers will be made aware of the SIDS and
suffocation hazards in the event that they read only the first half of
the label.
The NPR included the following additional requirements for after-
market mattresses for rigid-sided, rectangular, non-full-size cribs:
(1) All warnings added by the original manufacturer in addition to
those required by this standard; (2) assembly/attachment instructions
that were provided on the original mattress; and (3) the brand(s) and
model(s) number(s) of the product(s) in which the mattress is intended
to be used. In ASTM's balloted version, these requirements apply only
to mesh/fabric-sided products and rigid-sided non-rectangular products.
Several ASTM members argued that these warnings are not suitable for
after-

[[Page 8657]]

market mattresses for rigid-sided, rectangular products, claiming that
there are standard sizes for rigid-sided rectangular products. CPSC
staff advises that this claim is not factual; excluding full-size
cribs, there are no official standardized interior dimensions of rigid-
sided, rectangular non-full-size cribs. ASTM F406-19, the applicable
mandatory standard, requires only that the interior length dimension is
either greater than 55 in. (139.7 cm) or smaller than 49-4 in. (126.3
cm), and/or the interior width dimension is greater than 30 8 in. (77.7
cm) or smaller than 25-8 in. (64.3 cm). Considering that this
subsection of the rule excludes full-size cribs, the final rule
includes the NPR-proposed language, thereby ensuring that consumers see
the additional information for after-market mattresses for rigid-sided,
rectangular, non-full-size cribs.
The NPR included requirements for instructional literature. These
requirements are consistent with recommendations from the ASTM Ad Hoc
Language Task Group. Several ASTM members argued that instructions are
unnecessary for crib mattresses, alleging use of the products is
intuitive and that relevant information is provided in the on-product
labels. In addition to aligning with Ad Hoc recommendations, given the
significance of the hazards, it is important to incorporate another
medium, i.e., instructional literature, by which to communicate the
SIDS and suffocation hazards to consumers. The NPR demonstrated through
incident data and research involving surveys and focus groups that
consumers continue to use crib mattresses in ways contrary to the
proposed safety information. Given the inherent limitations of safety
information, which depends on persuading consumers to behave
differently and perhaps inconveniently (such as repositioning a
sleeping infant), multiple mediums are critical to communicate hazard-
avoidance behaviors to consumers to motivate consumer actions.
In a June 9, 2021 ASTM meeting, staff raised additional concerns,
including the following: (1) The word ``product'' was used in the ASTM
balloted item to refer to both crib mattresses and structures (cribs,
non-full-size cribs, and play yards); and (2) the ASTM balloted item
used ``should'' instead of ``shall'' in reference to required labeling
specifying maximum gaps between the mattress and product sides, and
that the reference was made in a ``Note,'' which, by definition, is not
mandatory.\70\ The ASTM subcommittee agreed that these additional
concerns were valid, but determined that the ballot should not be
delayed, and that further improvements would be considered in the
future. Subcommittee voting members voted on whether CPSC staff's
negative was non-persuasive, and the motion passed with 11
affirmatives, one negative, and six abstentions. The full F15 committee
upheld the subcommittee's non-persuasive finding on August 2, 2021
(ballot F15 (21-05), item 8). Therefore, a further revision of ASTM
F2933-21 was approved on September 1, 2021, and CPSC expects the
revision will be published around the end of September 2021. However,
this future revision will remain inconsistent with the final rule, and
for the reasons detailed in this preamble and Tab D of Staff's Final
Rule Briefing Package, the Commission will not include ASTM's revision
in the final rule.
---------------------------------------------------------------------------

\70\ See Ballot F15 (21-02), item 13, note 7 in Appendix A to
Tab D of Staff's Final Rule Briefing Package.
---------------------------------------------------------------------------

ASTM included the following additional deviations in the ballot
(F15 (21-02), item 13), which were not sufficiently discussed in the
June 9, 2021 meeting, and the Commission did not receive direct
comments on the NPR pertaining to these deviations. However, consistent
with comments on the NPR, which requested that CPSC consider ongoing
ASTM activities, we assessed whether these deviations added to the
safety of crib mattresses. One such deviation was placement of the
following warning message lower in the label than in the NPR: ``DO NOT
cover the faces or heads of babies with a blanket or over-bundle them.
Overheating can increase the risk of SIDS.'' Staff advises that this
important warning should not appear towards the bottom of the label,
located below a detailed explanation of how to identify hazardous gaps.
The label already includes a warning pertaining to gaps above this
warning about overheating, and staff reiterates the importance of
addressing the hazardous uses early on in the label, as text lower in
the label is less likely to be read. Additionally, the warning label
layout proposed in the NPR positions the gap measurement message
directly above the related interior dimensions message for cribs, and
closer to other required statements pertaining to product size.
ASTM's balloted item also deviated from the NPR regarding the
packaging requirements. The NPR-proposed packaging requirements
incorporated recommendations from the ASTM Ad Hoc Language Task Group.
The ASTM-balloted packaging requirements expand on these Ad Hoc
recommendations, including product-specific clarifications and
incorporating formatting requirements from section 7.4 of ASTM F2933-
21. After further consideration, CPSC agrees that some of these changes
may further improve the safety of crib mattresses, while other changes
are merely editorial and do not add to the safety of crib mattresses.
Accordingly, the final rule continues to align with the ASTM Ad Hoc
committee's recommendations for packaging requirements.
2. Final Rule Warnings Clarifications
As requested in comments on the NPR, staff continued efforts with
ASTM to further improve the safety information requirements for crib
mattresses. Based on these communications and ASTM F15's balloted
changes to safety information to be incorporated into ASTM F2933-21,
the final rule includes modifications to safety information, to further
reduce the risks of death and serious injury associated with crib
mattresses. Appendix A to Tab D of Staff's Final Rule Briefing Package
contains a redline of all modifications in the final rule.
<bullet> In section 3.1.2, changed ``conspicuous, adj--visible
while the mattress is being placed in its intended use position,'' to
``conspicuous, adj--visible when the mattress is being handled by a
consumer placing the mattress in its intended use position in a
product.'' This change aligns with the latest consensus ballot by ASTM
F15, and clarifies the intended meaning of ``conspicuous'' in the NPR-
proposed language, that the warning should be conspicuous to the
consumer.
<bullet> In section 7.4.6.2, changed ``The text in each column
needs to be arranged in list or outline format, with precautionary
(hazard avoidance) statements preceded by bullet points,'' to ``The
text in each column should be arranged in list or outline format, with
precautionary (hazard avoidance) statements preceded by bullet
points.'' This change, from the mandatory language of ``needs to'' to
the recommended language of ``should,'' aligns with the latest
recommendations from Ad Hoc and the consensus ballot by ASTM F15. This
change recognizes the importance of providing manufacturers with
flexibility in arranging the bulleted hazard avoidance statements based
on mattress-specific requirements, where appropriate.
<bullet> In section 7.5, changed ``The blank in the mattress fit
statement beginning with `If a gap is larger than,' needs to be

[[Page 8658]]

filled with `1\3/8\ in. (3.5 cm)' for full-size crib mattresses and `1
in. (2.5 cm)' for all other mattresses,'' to ``The blank in the
mattress fit statement beginning with `If a gap is larger than,' needs
to be filled with `1\1/2\ in. (3.8 cm)' for full-size crib mattresses
and `1 in. (2.5 cm)' for all other mattresses.'' This change for full-
size crib mattresses from 1\3/8\ inches to 1\1/2\ inches aligns with
the latest consensus ballot by ASTM F15. This change results in a minor
conflict between the warning message and the maximum gap afforded by
the performance requirements (i.e., a conflict of \1/8\ in.); however,
CPSC agrees with ASTM F15.66, which determined by consensus the
following: The difference of \1/8\ inch is unlikely to reduce the
safety of full-size crib mattresses, the conflict is unlikely to
confuse consumers (they are unlikely to be familiar with the
requirements in the standard), and the new measurement (1\1/2\ in.) is
more tangible for consumers to estimate, thereby, increasing the
likelihood of consumers attempting to measure, and accurately
measuring, gaps between the full-size crib mattress and side walls of
the full-size crib.
<bullet> In section 7.5.3, changed ``Manufacturers are permitted to
include additional warnings between the warnings specified in 7.5 and
7.6 if desired,'' to ``Additional manufacturer warnings are permitted
between the warnings specified in 7.5 and 7.6, if desired.'' This
editorial change clarifies further the allowance in the rule, and it is
consistent with the latest consensus ballot by ASTM F15.
<bullet> Section 7.8 includes several changes to the requirements
for retail packaging, as specified in Appendix A to Tab D of Staff's
Final Rule Briefing Package. These changes take into consideration the
latest consensus ballot by ASTM F15, and further improve the safety of
crib mattresses by: (1) Incorporating formatting requirements from
section 7.4, and (2) clarifying the warnings and statements required
for specific mattress types.
<bullet> Renumber Figures 7-10 to Figures 8-11. This shift in
numbering accounts for an additional figure added to ASTM F2933-21,
Section 6, as part of the final rule, as discussed in Tab C of Staff's
Final Rule Briefing Package.
<bullet> For Figure 10, now renumbered as Figure 11, changed the
caption from ``Example of Warning Label for After-Market Mattress for
Rigid-Sided Rectangular Products. Items italicized in brackets are to
be added as appropriate. The blanks are to be filled in as
appropriate,'' to ``Example of Warning Label for After-Market Mattress
for Rigid-Sided, Rectangular, Non-Full-Size Cribs. Items italicized in
brackets are to be added as appropriate.'' This change provides an
important clarification that the example is not for full-size crib
mattresses; full-size crib mattresses have a different warning label
than these products.
To illustrate the changes to the warning labels, Figure 3 below
shows a comparison of warning label examples from the NPR-proposed
label, the latest consensus ballot label to be incorporated into ASTM
F2933-21, and final rule warning labels for full-size crib
mattresses.\71\
---------------------------------------------------------------------------

\71\ See Appendix A to Tab D of Staff's Final Rule Briefing
Package, Figures 10 and 11, for examples of the draft final rule
warnings for non-full-size crib mattresses and after-market
mattresses for play yards and non-full-size cribs.
[GRAPHIC] [TIFF OMITTED] TR15FE22.002

VII. Response to Comments

The Commission received 13 comments on the NPR before the comment
period closed on January 11, 2021, and two late-filed comments, in July
and September 2021. You can access comments by searching for docket
number CPSC-2020-0023 at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. The comments fell
into several broad categories: (1) Testing requirements and
modifications; (2) after-market mattress fit for play yards; (3)
improving communication to caregivers; and (4) procedure. Below we
summarize and respond to the comments by topic.

[[Page 8659]]

A. Testing Requirements and Modifications

Comment 1: Commenters generally supported requirements for cyclic
testing of full-size coil spring mattresses, but they encouraged
continued work with ASTM to address outstanding issues.
Response 1: Requirements in the final rule for cyclic testing of
full-size coil spring mattresses are based on staff's work with the
ASTM cyclic testing task group before the NPR. Since the NPR published,
staff continued to work with the task group to develop this test. The
task group last met on December 9, 2020. Public comments specifically
refer to ASTM work to further define requirements for support of the
plywood/oriented strand board (OSB) mattress support board, and to
further clarify how the test method can allow for dual-sided
mattresses. Staff advises that they generally agree with these
comments. However, the task group's work has not been balloted, and any
updates to the test procedure since the December 2020 meeting have not
been made available to staff for review. Therefore, for the final rule,
the Commission is updating the cyclic test method by clarifying that
the test method should be performed on each side of the mattress, using
different mattresses, to address how the test should proceed with dual-
sided mattresses. The Commission does not have enough information to
proceed with any changes to the mattress support board. Should ASTM
propose any updates to the test method in the future, the update
process under Public Law 112-28 provides a method for the Commission to
consider whether a revised test method improves the safety of crib
mattresses.
Comment 2: The CPSC received several comments related to the
proposed corner gap test using a twice-washed fitted sheet, including:
(1) That there should be a shrinkage performance requirement for a
sheet, in lieu of testing mattresses with a shrunken sheet; and (2)
that each mattress corner should be subjected to a certain, unspecified
force or pressure before measuring the subsequent gap, instead of using
a shrunken sheet. One commenter suggested that issues with sheets not
fitting appropriately are better addressed by the ASTM infant bedding
subcommittee. A commenter stated that as currently written, the test
methodology may result in inconsistent, variable test results across
testing labs and settings, because sheets can vary in quality and
sizing. The same commenter also said the testing methodology may
penalize full-size crib mattresses designed with greater-than-nominal
dimensions.
Response 2: Staff advises that issues with sheets shrinking or not
fitting full-size-crib mattresses are appropriate for the infant
bedding subcommittee. The ASTM infant bedding subcommittee has formed a
task group, which held its initial meeting on March 22, 2021. CPSC
staff is a member of the task group and participated in the initial
meeting. CPSC staff will continue working with the ASTM infant bedding
subcommittee to develop appropriate performance requirements for fitted
sheets. Once that work is complete, staff can work with the ASTM crib
mattress subcommittee to refer to new requirements for sheets, if
appropriate. Staff's work with the ASTM infant bedding subcommittee
will also help resolve concerns about inconsistent test results due to
variability in sheet quality and sizing. The Commission encourages test
laboratories to identify cotton sheets that are the appropriate size
for the mattress to be tested.
Addressing the fact that sheets shrink, however, does not address
the issue of mattresses that do not hold their shape when sheets are
applied. Therefore, the final rule contains a test for potentially
hazardous gaps created when sheets are placed on a crib mattress. Staff
advises that the ASTM subcommittee created a task group to work on
creating a test that uses an appropriate force to apply to crib
mattress corners, to simulate sheets, which could create a more
repeatable test and more consistent results. However, CPSC received no
comments or test data to support a test protocol, or an appropriate
force. As noted in the NPR, foam mattresses and innerspring mattresses
have different compressive behavior when a sheet is placed on them,
resulting in inconsistent forces to replicate sheet behavior. Staff
will continue to work with the ASTM subcommittee and task group, and if
ASTM should publish a voluntary standard with a revised compression
test, CPSC can evaluate the updated voluntary standard under the
revision process pursuant to Public Law No. 112-28.
For the final rule, in response to comments, the Commission will
revise the method of measuring for the compression test. Staff advises
that the methodology proposed in the NPR may be overly restrictive for
full-size crib mattresses designed to be greater-than-nominal
dimensions, because the test method assumed that every mattress would
have the 1-inch maximum allowable gap between the crib and the crib
mattress, regardless of size. Commenters state that this assumption is
overly restrictive for mattresses that were designed to fill the space
between the crib and crib mattress. Accordingly, to address this
comment, the final rule modifies the measurement method in the test
procedure, such that the corner gap is measured from a projected crib
corner.
Comment 3: Several commenters expressed opinions regarding the
mattress firmness test proposed in the NPR. Overall, it appeared that
industry prefers the mattress firmness test in the ISO 23767 standard,
Children's furniture--Mattresses for cots and cribs--Safety
requirements and test methods, over the proposed mattress firmness test
based on the AS/NZS 8811.1:2013 standard, Methods of testing infant
products--Method 1: Sleep Surfaces--Test. Consumer groups expressed
support for the test based on AS/NZS 8811.1:2013. One consumer group
submitted an undergraduate engineering report describing a potential
new test fixture for consideration, but the submission did not include
additional information, such as test protocols and performance
criteria.
Response 3: The Commission agrees with commenters who support a
firmness test that would address the suffocation hazard associated with
excessively soft mattresses. Although several commenters expressed
support for specific tests, none of the commenters provided testing
data to support the use of one test protocol over another. In the NPR,
CPSC compared the AS/NZS 8811.1:2013 and the ISO 23767 test protocols
\72\ for measuring mattress firmness, and found that the AS/NZS
8811.1:2013 test method was more stringent because it resulted in
failures on more test surfaces. Additionally, although the Commission
appreciates the work to develop a test fixture that can be used to
compare mattress firmness, the undergraduate engineering report offers
no performance criteria by which to judge the results.
---------------------------------------------------------------------------

\72\ The ISO 23767 test protocol is the same as the EN
16890:2017, Children's Furniture--Mattresses for Cots and Cribs--
Safety Requirements and Test Methods, section 8.2.3 firmness test
protocol.
---------------------------------------------------------------------------

Accordingly, based on the available data, the Commission will
finalize the crib mattress rule, as proposed, by requiring use of a
firmness test based on the requirements in AS/NZS 8811.1:2013 test for
mattress firmness. CPSC staff continues to work with the ASTM
subcommittee to investigate firmness requirements, as discussed in
section VI.A of this preamble and Tab C of the Staff Final Rule
Briefing

[[Page 8660]]

Package. If ASTM updates the voluntary standard to include a different
mattress firmness test, and the revision is based on supporting data,
ASTM can provide to the Commission the updated standard and supporting
data for evaluation through the update process, pursuant to Public Law
112-28.

B. After-Market Mattress Fit for Play Yards

Comment 4: One commenter stated that having standard-sized play
yards and mattresses could help to address mattress fit issues, similar
to the method employed by full-size cribs and full-size crib
mattresses.
Response 4: The play yard and non-full-size cribs voluntary
standard (ASTM F406-19, incorporated by reference into 16 CFR parts
1220 and 1221) currently does not contain provisions requiring the
products to be of a standard size. We further note that the commenter
did not provide a proposal for a specific size or range of sizes that
would be necessary for such a requirement, and the NPR did not discuss
standardizing sizes for play yard mattresses; nor did it solicit
comment on the issue. Therefore, changes to play yard mattresses in 16
CFR part 1220 are outside the scope of this specific rulemaking on crib
mattresses. The commenter should pursue this idea with the ASTM F15.18
subcommittee on play yards.
Comment 5: A commenter requested that the Commission set a minimum
thickness for play yard mattresses to reduce the likelihood consumers
would find a mattress too thin and add hazardous padding. The same
commenter requested that the Commission delay finalizing the rule until
a task group organized by the ASTM play yard subcommittee, the play
yard mattress fit and thickness task group, completes their work.
Response 5: Regarding the request that the Commission set a minimum
thickness for play yard mattresses, we note that CPSC staff expressed
similar concerns with consumer perception of mattress thickness/comfort
in the briefing package on Petition CP 15-2, stating, ``Because
incident data demonstrate that consumers perceive play yard mattresses
to be uncomfortable, and then place additional soft bedding in infant
sleep environments, CPSC staff does not recommend banning supplemental
mattresses.'' However, based on staff's advice, we believe that setting
a minimum mattress thickness would not address the resilience of a
mattress, which is not based on thickness alone, but also on the
density of underlaying foam. For example, staff advises that they are
aware of bassinet mattresses that meet the thickness limit, but are
dense enough not to ``bottom out'' on the hard backer-board, which
supports that a denser foam pad could also address consumer complaints.
Regarding the work of the play yard fit and thickness task group,
this work is ongoing and has neither reached consensus in the task
group, nor been balloted. Staff has also voiced concern that this task
group is focused on identifying the gap size between the mattress and
the flexible play yard side while the play yard side is in a resting
position, while staff believes the focus should be on a test that
accounts for the flexible nature of play yard sides to create a three-
dimensional pocket from the existing gap. Staff remains engaged in
efforts to address mattress thickness.
Work on the play yard standard is outside the scope of this
rulemaking, and therefore, that work should not delay the current
rulemaking for crib mattresses. If, in the future, F406 is updated to
address the work of the fit and thickness task group, then ASTM can
notify the Commission under the provision in Public Law 112-28, and the
Commission will evaluate the potential effect on the safety of play
yard mattresses.
Comment 6: Some commenters who manufacture crib mattresses objected
to allowing after-market mattresses for play yards because all play
yards are sold with a mattress designed for use with the play yard. One
manufacturer questioned the safety and necessity of after-market
mattresses.
Response 6: In 2015, the Commission docketed a petition to ban
supplemental mattresses for play yards. In response to that petition,
the Commission directed staff to address hazards associated with
supplemental play yard mattresses, as well as crib mattresses, through
rulemaking under section 104. Staff's petition package stated:
``[b]ecause incident data demonstrate that consumers perceive play yard
mattresses to be uncomfortable, and then place additional soft bedding
in infant sleep environments, CPSC staff does not recommend banning
supplemental mattresses.'' Although the Commission understands the
concerns with after-market mattresses that can be used to supplement an
existing play yard mattress, the Commission can address the hazard
better, by directing CPSC staff to continue working through the
voluntary standards committees to address the hazards associated with
the use of after-market mattresses, and thereafter, incorporate the
voluntary standard into a mandatory standard, to address both the
safety of after-market mattress and consumers' perceived need for
after-market mattresses.
Comment 7: Commenters raised concerns that manufacturers make
numerous, frequent changes in names and model numbers of play yards,
rendering any list of compatible play yard models for after-market play
yard mattresses ``out of date as or soon after it is printed.'' One
commenter stated that the proposed rule would endorse misuse and, in
effect, contradict the mandatory warning stipulated in 16 CFR
1221.2(b)(5)(i) that only the OEM mattress should be used with the play
yard.
Response 7: Although some type of certificate of compatibility
could address issues with mattress fit and manufacturer concerns with
third party manufacturers claiming compatibility, CPSC does not have
the authority to regulate inter-business arrangements, such as
certificates of compatibility. However, this final rule will require
after-market mattresses to be ``tested with each brand and model of
product'' \73\ in which they are intended to be used. In addition, the
final rule will require each mattress to ``specifically identify the
brand(s) and Model(s) numbers of products in which it is intended to be
used.'' \74\ Accordingly, through the requirement in section 14 of the
CPSC, as set forth in 16 CFR parts 1107 and 1110, an after-market
mattress that complies with this rule will have third party
certification that it meets the requirements for play yard mattresses
in 16 CFR part 1221, incorporating ASTM F406.
---------------------------------------------------------------------------

\73\ ASTM F2933-21, section 5.8.1.2.
\74\ ASTM F2933-21, section 7.5.3.1.
---------------------------------------------------------------------------

Because the final rule will require that an after-market mattress
meet the same dimension and test requirements as the mattress supplied
with the product, and must be tested and certified to the same
standard, CSPC concludes that there is likely no safety concern for
consumers, because the testing and certification require labeling that
accomplishes the same goal. Additionally, because the labeling may
create some confusion between ASTM F406, section 9.4.2.10 (``Use ONLY
mattress/pad provided by manufacturer''), and 16 CFR 1221.2(b)(5)(i),
the ASTM F15.18 task group on ad hoc warnings is actively working to
revise this message.
Comment 8: Several commenters stated that after-market mattresses
should have to meet the same requirements as OEM mattresses. Another
commenter stated that staff should continue working with ASTM to
include more performance-based testing

[[Page 8661]]

for after-market mattresses. Several commenters supported the revised
requirements for after-market mattresses developed by the ASTM non-
segmented mattress task group, which were approved (and now published)
in ASTM F2933-21. A commenter also requested that the final rule wait
until the play yard fit and thickness task group completes work.
Response 8: The Commission agrees that after-market play yard and
non-full-size crib mattresses should meet the same requirements as OEM
mattresses. The Commission addressed these points in the NPR, by
proposing that after-market, non-full-size crib mattresses meet the
same requirements listed for these products in ASTM F406 section 5.17,
Mattress for Rigid Sided Products, and by proposing that after-market
play yard mattresses meet the ASTM F2933-19 requirement to have the
same ``thickness, floor support structure and attachment method as the
mattress it is intended to replace.'' The revisions in ASTM F2933-21
replace the design requirement for after-market mattresses with the
performance requirements that they are tested to, such that after-
market mattresses must meet the same performance requirements as OEM
mattresses. Additionally, ASTM F2933-21 requires that after-market
mattresses be ``at least the same size,'' and the floor support
structure must be ``at least as thick,'' as the OEM mattress. CPSC
staff advises that they support these changes to the standard, which
appear to be in line with comments CPSC received on the NPR.
Accordingly, for the final rule, the Commission will incorporate by
reference ASTM's newly revised voluntary standard, ASTM F2933-21. The
Commission will not delay this final rule to wait until work is
completed in the play yard subcommittee on mattress fit and thickness.
Although staff remains engaged on the play yard task group for fit and
thickness, changes to the play yard standard are out of scope for this
specific rulemaking on crib mattresses.
Moreover, although the commenter implied that the play yard fit and
thickness work was nearing completion, staff advises that the task
group is focused on measuring the gap between the play yard side and
mattress only along the plane of the top of the mattress, without
accounting for the flexible nature of fabric or mesh sides. As
described in the briefing package on the supplemental mattress
petition, a gap alone may not create a hazard if a three-dimensional
pocket cannot form to entrap an infant. Staff informs that the task
group is generally resistant to using a probe to identify hazardous
gaps, and instead, is focused on measuring a gap alone. The figure
below was included in the staff briefing package on Petition CP 15-2,
illustrating that a one-dimensional measurement may not achieve the
desired hazard identification.
[GRAPHIC] [TIFF OMITTED] TR15FE22.003

C. Improving Communication to Caregivers

Comment 9: One commenter recommended that the Commission engage
with child safety advocates and other interested parties to undertake a
coordinated campaign to communicate to consumers appropriate behaviors
that will enhance the safety of infant sleep.
Response 9: The Commission agrees that a coordinated campaign to
communicate to consumers the importance of placing an infant on their
back to sleep without any covering beyond a light blanket would promote
safe infant sleep behaviors for caregivers. However, the Commission
acknowledges that a warning label statement on a consumer product
cannot guarantee that consumers will read, understand, or heed the
warning regarding the hazard.
Comment 10: A commenter recommended a maximum of three warning
statements on the product, and provided the suggested language below
(verbatim):

1. Place your baby on his/her back only.
2. Do not add soft bedding (blankets, pillows, etc) under or
over your baby, or anywhere in play yard. Instead, dress baby in a
wearable blanket or sleep sack to keep them warm.
3. Use mattress and sheets that fit this product--Use play yard
mattress only. If mattress is too small, your baby can roll into gap
and suffocate.

For more information, go to <a href="http://www.cpsc.com/sleepsafety">www.cpsc.com/sleepsafety</a>
Save this warning!
[Link above is a placeholder for a functioning link to more
information.]

[[Page 8662]]

Response 10: Consistent with the NPR, CPSC agrees with several
points raised by the commenter, including that: (1) Consumers are less
likely to read lengthy text warnings on familiar products; (2) it is
critical to communicate successfully to consumers the hazards related
to prone positioning, soft bedding, and gaps created by ill-fitting
mattresses; and (3) the prone positioning message needs to be
prioritized. While, in general, staff advises that warning labels
should be as concise as possible, circumstances specific to these
products and hazards warrant more information on the labels, and
consumers may not check a website identified on the label. Hazardous
use patterns associated with products for infant sleep are common and
are likely to be misunderstood by consumers. Consumers may not find
short warning statements for crib mattresses convincing, absent
elaboration and repetition with rephrasing, especially if the
statements contradict the consumers' knowledge, expectations, and
experiences. The warning labels in the final rule begin with clear and
concise statements pertaining to the typical use patterns involved in
SIDS and suffocation incidents, beginning with the prone positioning
message. These statements are organized and worded such that they are
more likely to be seen and understood, and act as reminders, even if
the consumer does not read the rest of the label. The rest of the
messaging reiterates, rephrases, and explains the hazards. For example,
consumers must consider and understand what it means for a mattress to
be ill-fitting. As discussed in Staff's Final Rule Briefing Package, a
mattress in an uncompressed state may not visually produce worrisome
gaps; yet, various factors can cause a compressed mattress to form
hazardous gaps. With few exceptions, including placing the prone
positioning warning foremost in the label, the final rule warning label
is consistent with recommendations from ASTM F15. Tab D of Staff's
Final Rule Briefing Package, and section VI.B of this preamble, outline
other exceptions.
Comment 11: A commenter recommended modifying the proposed hazard
identifier from ``SIDS and SUFFOCATION HAZARDS'' to ``Help Prevent SIDS
and Suffocation.''
Response 11: The Commission declines to adopt the modifications to
the warning label as set forth by the commenter. Among other concerns,
the comment-proposed hazard identifier may confuse the consumer viewing
the warning label. The viewer of the label may infer that the
statement, ``Help Prevent SIDS and Suffocation,'' is a standalone
statement, unrelated to the rest of the warning message. Use of
``Help,'' although accurate, may soften the language, and perhaps,
demotivate the reader. ASTM subcommittee members do not support the
commenter's warning approach. During the ASTM F15.66 subcommittee
meeting on June 9, 2021, attendees stated that such a change would
dilute the warning message, and opined that the hazard identifier
should remain as balloted in F15 (21-02) (i.e., ``SUFFOCATION
HAZARDS''). The hazard identifier and ballot are discussed further in
Tab D of Staff's Final Rule Briefing Package and section VI.B of this
preamble.

Comment 12: A commenter advised against all-caps lettering to
emphasize words that ``lack concrete meaning,'' such as ``DO NOT'' and
``USE ONLY.'' A commenter posited that this capitalization will be
inferred by the consumer to mean the adjacent text is not as important,
and therefore, the adjacent text, which pertains to hazardous use, will
not be read by the consumer.
Response 12: The Commission declines to follow the commenter's
suggestion. Based on staff's advice, we conclude that the all-caps
lettering used in the final rule warning label plays an important role
in attracting a consumer's attention to the hazardous-use warnings.
Recent regulations use capitalization in this manner: \75\ All-caps
lettering is used in the recommendations from the Ad Hoc Language Task
Group; and all-caps lettering pertaining to crib mattresses has been
supported in ASTM F15.66 and balloted by ASTM F15 without objection.
For more information on this ballot, see Tab D of Staff's Final Rule
Briefing Package and section VI.B of this preamble.
---------------------------------------------------------------------------

\75\ For example, see the Commission Briefing Package: Final
Rule--Safety Standard for Gates and Enclosures: <a href="https://cpsc.gov/s3fs-public/Final%20Rule%20-%20Safety%20Standard%20for%20Gates%20and%20Enclosures.pdf?lHExt6trsEuD56jiQTi7Ab0TjzdVQ_HH">https://cpsc.gov/s3fs-public/Final%20Rule%20-%20Safety%20Standard%20for%20Gates%20and%20Enclosures.pdf?lHExt6trsEuD56jiQTi7Ab0TjzdVQ_HH</a>.
---------------------------------------------------------------------------

Comment 13: A commenter advised the Commission to eliminate warning
statements that can and should be addressed through performance
standards. The commenter's point is provided in the context of a
recommendation to standardize sizes of play yards and play yard
mattress sheets.
Response 13: The Commission agrees that performance requirements
should be used instead of warning statements, where feasible, and that
warning statements should be omitted if they do not contribute to the
safety of the product. Warnings are inherently limited in
effectiveness, because they depend fallibly on persuading consumers to
alter their behaviors in ways to avoid hazards. In contrast,
performance requirements attempt to reduce or eliminate access to the
hazards. The Commission's approach is to make warnings as motivating as
possible, given their inherent fallibility, and particularly when they
must be used instead of performance requirements, or when they are used
in a supporting role to performance requirements that minimize, rather
than eliminate, exposure to hazards.
The commenter is referring to a separate standard, ASTM F406,
Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/
Play Yards (incorporated into 16 CFR part 1221), and ongoing activity
by the ASTM F15.18 subcommittee contributing to that effort, which is
out of scope for the current rulemaking. However, the Commission
encourages the ASTM F15.18 subcommittee to develop more effective
performance requirements to reduce the reliance on warnings.
Comment 14: A commenter stated that to support the crib mattress
warnings, CPSC should develop pictograms and evaluate comprehension of
pictograms using the methods outlined in ANSI Z535.3.
Response 14: Well-designed graphics may be able to supplement the
crib mattress warnings, such as by increasing the noticeability of the
warnings. Graphics are also helpful for consumers with limited or no
English literacy. However, the design of effective graphics is a
complicated matter that requires comprehension testing with the target
audience. A poorly designed graphic may have limited or no
effectiveness, and may even elicit the opposite effect than intended;
i.e., a ``critical confusion,'' in which the reader infers that s/he
should take the prohibited action to avoid the hazard. Although CPSC is
not opposed to considering suitable graphics pertaining to crib
mattress warnings, the agency will not delay the final rule until
suitable graphics are developed.
Comment 15: A commenter recommended revising the play yard mattress
warning language, as set forth in the comment, in part, because the
Flesch-Kincaid readability assessment tool in MS Word indicated the
message required only a ``5.9 grade reading level.''
Response 15: For consistency and comparison purposes, staff used
the Flesch-Kincaid readability assessment

[[Page 8663]]

tool in MS Word (Microsoft Office Professional Plus 2019) on the play
yard mattress warning set forth by the commenter and the final rule
label for after-market mattresses for mesh/fabric-sided products.\76\
Staff found that the play yard mattress warning urged by the commenter
returned a 5.4 Flesch-Kincaid Grade Level with a reading ease of 77.1.
The final rule after-market mattress for mesh/fabric-sided products
warning returned a 3.4 Flesch-Kincaid Grade Level with a reading ease
of 80.8. However, the rating for the final rule label, as proposed in
the NPR, does not include the product-specific information to be added:
---------------------------------------------------------------------------

\76\ Figure 9 in the Appendix of the ESHF memorandum of the
Commission NPR Briefing Package on Crib Mattresses.

[All warnings added by the original manufacturer which are in
addition to those required by this standard.] [Assembly/attachment
instructions that were provided on the original mattress.] [The
specific brand(s) and model(s) number(s) of the product(s) in which
---------------------------------------------------------------------------
the mattress is intended to be used].

Therefore, staff also tested the reading level for the final rule
warning label for full-size crib mattresses,\77\ and found it had a 3.8
Flesch-Kincaid Grade Level with a reading ease of 77.7. A reading ease
score of 70 to 80 is considered U.S. 7th grade school level, and a
score of 80 to 90 is considered U.S. 6th grade school level. In
general, the Commission prefers for warnings to be at the 6th grade
level or lower, consistent with literature from Leonard, Otani, and
Wogalter (1999); \78\ however, the 8th grade level is considered
``plain English.'' Notably, the Flesch-Kincaid tool provides an
imperfect assessment of readability, because it considers only the
number of words, sentences, and syllables, meaning that text with low
reading-level thresholds are not necessarily more meaningful or
understandable. With few exceptions, the final rule language is
consistent with recommendations from ASTM F15 (regarding the
exceptions, see Tab D of Staff's Final Rule Briefing Package).
---------------------------------------------------------------------------

\77\ Figure 8 in the Appendix of the ESHF memorandum of Staff's
NPR Briefing Package.
\78\ Leonard, S.D., Otani, H., & Wogalter, M.S. (1999).
Comprehension and memory. In M.S. Wogalter, D.M. DeJoy, & K.R.
Laughery (Eds.), Warnings and risk communication (pp. 149-187).
Philadelphia: Taylor & Francis.
---------------------------------------------------------------------------

Comment 16: A commenter stated that CPSC should determine whether
it is appropriate to add warnings content regarding fall or
strangulation.
Response 16: Based on staff's advice, the Commission does not find
it appropriate to add to the crib mattress warnings content regarding
fall or strangulation. Warnings pertaining to these hazards are
addressed by other standards, including ASTM F1169, Standard Consumer
Safety Specification for Full-Size Baby Cribs (incorporated into 16 CFR
part 1219), and ASTM F406 (incorporated into 16 CFR parts 1220 and
1221). As discussed by the commenter, adding more information to the
final rule warnings may dilute the message, resulting in some consumers
being less likely to read the warnings. Furthermore, ASTM F15 did not
find it appropriate to include warning content regarding falls or
strangulations. Staff will continue to monitor the data for evidence
that these additional warnings should be added.
Comment 17: A commenter stated that the warnings proposed in the
NPR are incompatible with the warnings in ASTM F406, because the
requirements in the NPR allow after-market mattresses in play yards,
which are not from the OEM; whereas, ASTM F406 includes warnings to use
only the mattress provided by the manufacturer.
Response 17: The Commission is aware of the warning labels required
by the separate rules. Although modifications to warnings in F406 are
outside the scope of this rulemaking for crib mattresses, we note that
the play yard subcommittee, ASTM F15.18, has an active task group
working to update the warning section of ASTM F406 to include the ad-
hoc warning recommendation and to address other issues. This play yard
task group is actively discussing how to update \79\ this warning
message. If the play yard voluntary standard is revised, the CPSC will
evaluate the revision for inclusion in the mandatory standard for play
yards through the Public Law 112-28 update process.
---------------------------------------------------------------------------

\79\ <a href="https://www.cpsc.gov/s3fs-public/2021-07-08-ASTM-Play-Yard-Ad-hoc-language-meeting.pdf">https://www.cpsc.gov/s3fs-public/2021-07-08-ASTM-Play-Yard-Ad-hoc-language-meeting.pdf</a>.
---------------------------------------------------------------------------

Comment 18: A commenter stated that CPSC should consider the
developments to safety information requirements discussed in the crib
mattress ASTM task group and subcommittee in the period between the NPR
and final rule.
Response 18: After the NPR was published, staff continued to work
with ASTM to address deficiencies in the safety information
requirements in ASTM F2933. The final rule includes some of the safety
information recommendations from ASTM task groups and subcommittees,
including subcommittee F15.66, such as the maximum side gap between a
full-size crib mattress and full-size crib. The final rule does not
incorporate other suggestions from ASTM members, such as excluding
``SIDS'' from the hazard identifier, and presenting the prone
positioning warning lower in the warning labels. Tab D of Staff's Final
Rule Briefing Package contains additional information.

D. Procedural Comments

Comment 19: Commenters both supported and opposed the proposed 6-
month effective date for the final rule. Some commenters urged the
effective date of a final rule to be as soon as possible, because
additional time for the rule to become effective would put infants at
risk. Other commenters requested an indefinite delay of the rulemaking,
until ASTM completes changes and updates to the voluntary standard for
crib mattresses (ASTM F2933), and the standard associated with play
yards (ASTM F406).
Response 19: For the final rule, the Commission will retain the
proposed 6-month effective date. Crib mattress suppliers have had lead
time to prepare for the final rule since the NPR was published on
October 26, 2020. Many crib mattresses within the scope of the final
rule require no change in design to achieve compliance with the final
rule. Furthermore, 6 months from the change in a voluntary standard is
the time frame that JPMA uses for its certification program.
Consequently, compliant manufacturers are used to this time frame to
comply with a modified standard. Additionally, the Commission will not
wait for completion of work in the ASTM F406 standard to finalize this
crib mattress rule, because modifications to ASTM F406 are out of the
scope of this proceeding.
Comment 20: A commenter states that the NPR is unconstitutional
because CPSC proposed to incorporate by a reference a voluntary
standard, instead of publishing all of the regulatory text for the crib
mattress rule in the Federal Register. The commenter asserted that the
CPSC forces the public to pay for access to the law, thereby offending
``our constitutional structure, due process, the First Amendment, and
equal protection.'' The commenter, in support of their contention that
incorporation by reference (IBR) is unconstitutional, stated:
<bullet> No one can own the law, privatizing the law is not in
accordance with our form of constitutional government and grants ASTM a
monopoly ownership over the law;
<bullet> Due process under the Fifth Amendment requires the public
to have free access to the laws that regulate people or entities, and
the NPR allegedly violates due process by failing to provide the public
with fair notice of the standard because the commenter

[[Page 8664]]

contends that to view the content of the voluntary standard, the NPR
requires the public to pay ASTM or to travel to Bethesda, MD, to see a
copy at CPSC headquarters;
<bullet> CPSC is creating a monopoly for ASTM and forcing the
public ``to rely on the whims of ASTM,'' whom the commenter states is a
private company that is incentivized to increase the prices of its
standards, and which harms consumers more than businesses because it
creates a financial barrier to accessing product safety standards;
<bullet> IBR violates the First Amendment because it does not allow
free dissemination of the law and discussion of its contents; and
<bullet> IBR violates equal protection of the laws under the Fifth
Amendment because it gives ASTM members a preference over non-members,
because ASTM members have access to the voluntary standard as it is
being developed and during the comment period, while non-members do
not. The commenter believes that ASTM only makes the voluntary standard
available to view for free after the public comment period closes.
Response 20: We disagree that the regulatory text is behind a
paywall and that the draft final rule is unconstitutional. As set forth
in more detail below, the commenter's factual premise is inaccurate,
because the regulatory text for every CPSC-proposed rule is printed in
the Federal Register. Additionally, the content of the law is available
to the public, both before and after the voluntary standard is
incorporated by reference, because the text of the voluntary standard
is described in detail in the staff's proposed rule briefing package,
draft final rule briefing package, and in the proposed and final
rulemaking notices printed in the Federal Register. Stakeholders also
have access to the text of the voluntary standard online, for free,
both during the comment period (<a href="https://www.astm.org/CPSC.htm">https://www.astm.org/CPSC.htm</a>), and
after the rule becomes final (at <a href="https://www.astm.org/READINGLIBRARY/">https://www.astm.org/READINGLIBRARY/</a>).
Any person can ``disseminate'' the proposed rule by citing the Federal
Register, providing a link, or providing a copy of the notice.
Additionally, anyone can ``disseminate'' the content of the voluntary
standard by providing a link to ASTM's website. Finally, anyone can
participate in ASTM meetings to develop the voluntary standard, and
CPSC encourages the public to participate. Although only ASTM members
can vote on a voluntary standard, ASTM provides discounts on membership
for certain members of the public, such as students. Please contact
ASTM for more information.
Section 104 of the CPSIA directs the Commission to issue standards
for durable infant or toddler products that are ``substantially the
same as,'' or more stringent than, applicable voluntary standards, if
the Commission determines that more stringent requirements would
further reduce the risk of injury. In this case, the final rule would
incorporate by reference ASTM F2933-21, with modifications to make the
standard more stringent, to further reduce the risk of injury
associated with crib mattresses. Staff notes that staff's proposed rule
and draft final rule briefing packages contain a description of the
performance and labeling requirements in the ASTM standard, including a
side-by-side chart showing regulatory text and the changes made by the
rule.
With regard to IBR procedures, we note that ASTM's voluntary
standards are protected by copyright, which the Commission (and the
federal government generally) must observe. The United States may be
held liable for copyright infringement. 28 U.S.C. 1498. Accordingly,
the Commission cannot violate copyright law by publishing ASTM's
voluntary standards in the CFR. The Office of the Federal Register
(OFR) has established procedures for incorporation by reference that
seek to balance the interests of copyright protection and public
accessibility of material. 1 CFR part 51. OFR's regulations are based
on Freedom of Information Act provisions that require materials to be
``reasonably available'' when incorporated by reference with approval
of the Director of the Federal Register. 5 U.S.C. 552(a)(1). Under the
OFR's requirements, an agency may incorporate by reference specific
publications, including standards, if they are ``reasonably available
to and usable by the class of persons affected.'' 1 CFR 51.7. To ensure
the material is ``reasonably available,'' an agency must summarize the
material it will incorporate by reference and discuss in the Federal
Register notice how that material is available to interested parties.
Id. Sec. Sec. 51.3(a), 51.5(a).
The Commission complies with the requirement that publications,
including standards, are ``reasonably available to and usable by the
class of persons affected,'' whenever incorporating material by
reference. For example, when the Commission proposes a rule under
section 104 of the CPSIA, the Commission describes and summarizes the
requirements of the rule, including the voluntary standard, in the
preamble of the rule printed in the Federal Register, and explains that
ASTM's copyrighted voluntary standards are available to review online
for free during the comment period at <a href="https://www.astm.org/CPSC.htm">https://www.astm.org/CPSC.htm</a>.
Once a rule becomes effective, ASTM provides a read-only copy of the
standard for review on the ASTM website at: <a href="https://www.astm.org/READINGLIBRARY/">https://www.astm.org/READINGLIBRARY/</a>. As always, any person can purchase a voluntary
standard from ASTM, or may schedule a time to review a voluntary
standard (for free) at the Commission's headquarters in Bethesda, MD,
or at the National Archives and Records Administration (NARA).
Accordingly, citizens who are interested in the content of the law have
unimpeded access to the regulation, and have several avenues for free
access to the text of voluntary standards incorporated by reference
into a mandatory CPSC standard for a durable infant or toddler product.
Comment 21: A commenter stated that they intend their comment to be
a significant adverse comment that requires CPSC to withdraw the NPR,
citing eight previous times the commenter has submitted a similar
comment on CPSC's IBR process for rules updating a section 104
standard.
Response 21: The commenter is referencing previous comments made
regarding the Commission's direct final rules to update durable infant
or toddler product rules that have already been issued under section
104 of the CPSIA. The Commission did not find similar comments on those
updates to be a significant adverse comment. In this case, the
Commission issued a proposed rule, and is now issuing a final rule, to
establish a consumer product safety standard for crib mattresses, and
is not updating an existing rule using a direct final rule.
Accordingly, the ``significant adverse comment'' designation is
inapplicable to the current rulemaking. In any event, the Commission
declines to withdraw the proposed rule based on the inaccurate factual
premise regarding IBR procedure contained in this comment.
Comment 22: A commenter asserted that section 9 of the CPSA
requires the CPSC to publish the text of a proposed consumer product
safety rule in the Federal Register. Because section 104 rules are
considered consumer product safety rules under the CPSA, the commenter
argued that CPSC is required to published the text of the regulation in
the Federal Register, and the CPSC did not meet this requirement in the
NPR for crib mattresses.
Response 22: The Commission publishes the text of proposed rules
under section 104 of the CPSIA in the

[[Page 8665]]

Federal Register. However, the rulemaking procedure described in
section 9 of the CPSA, cited by the commenter, is inapplicable to rules
issued under section 104 of the CPSIA. Section 104 of the CPSIA
contains a different rulemaking authority and different rulemaking
procedures. For example, 15 U.S.C. 2058(c), cited by the commenter,
also requires a preliminary regulatory analysis that is inapplicable to
rules issued under section 104.
Comment 23: A commenter stated that the Freedom of Information Act
(FOIA) requires agencies to publish the text of its substantive rules
in the Federal Register, citing 5 U.S.C. 552(a)(1)(D). The commenter
stated that Sec. 552(a) creates a

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