# Safety Standard for Crib Mattresses

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-02414

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** February 15, 2022
- **Citation:** 87 FR 8640

## Text

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.

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:
jjirgl@cpsc.gov.

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.

1

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.

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.

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

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 voted4-0 to issue this final rule. Commissioner Trumka issued a statement in connection with his vote.

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

Specification for Crib Mattresses,

to address the associated hazards.
6

5
ASTM International website:
www.astm.org,
About ASTM International.

6
The docket for this rulemaking on
Regulations.gov
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.

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

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:
https://www.cpsc.gov/s3fs-public/Notice-of-Proposed-Rulemaking-Safety-Standard-for-Crib-Mattresses.pdf?mDLf.MBLutFluwt6QFjeZRhYdNLFRR.J.
This final rule also relies on information in Staff's NPR Briefing Package.

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 A
S/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:

• 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

equipment manufacturer, but still limit such mattresses to a maximum of 1
1/2
inches, as required by ASTM F406.

• 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

8

See
Tab C of Staff's Final Rule Briefing Package.

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:

• 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;

• 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

• 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

9

See
Tab D, Appendix A of Staff's Final Rule Briefing Package.

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:
https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Crib-Mattresses.pdf?VersionId=62bEXbfu7.mIoiiLfn_fbMWtFnEsgGON.

II. Product Description

A. Scope of Products Within the Final Rule
10

10

See
Staff's Final Rule Briefing Package at Tab C for additional information on the scope of ASTM F2933-21.

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:

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.”

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 ±
5/8
in. (710 ± 16 mm) wide and 52
3/8
±
5/8
in. (1,330 ± 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.

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″.

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

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

14

See
Staff's Final Rule Briefing Package at Tab E for additional information on the marketing and use of crib mattresses.

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.

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.

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.

18
Determinations were made using information from Dun & Bradstreet, as well as from websites.

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).
http://childcarecenter.us/.

22
U.S. Bureau of Labor Statistics, “Quarterly Census of Employment and Wages,” April 2018.
http://www.bls.gov/iag/tgs/iag721.htm.

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

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
Hazard category

January 1, 2010-March 31, 2020
(reported incidents in the NPR)

Fatal reports
Nonfatal reports

April 1, 2020-April 30, 2021
(reported incidents since the NPR)

Fatal reports
Nonfatal reports
January 1, 2010-April 30, 2021
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
Year of incident or death

January 1, 2010-March 31, 2020
(reported incidents in the NPR)

Fatal reports
Nonfatal reports

April 1, 2020-April 30, 2021
(reported incidents since the NPR)

Fatal reports
29

Nonfatal reports

January 1, 2010-April 30, 2021
(total reports)

Total fatal reports

Total nonfatal
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.

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
Hazard category
January 1, 2010-March 31, 2020
Reported incidents in the NPR

April 1, 2020-
April 30, 2021

Reported incidents since the NPR
January 1, 2010-April 30, 2021
Total fatal 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
Hazard category
January 1, 2010-March 31, 2020
Reported incidents in the NPR

April 1, 2020-
April 30, 2021

Reported incidents since the NPR
January 1, 2010-April 30, 2021

Total nonfatal
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.

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,

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
https://www.cdc.gov/sids/about/index.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fsids%2FAboutSUIDandSIDS.htm;
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:
https://pediatrics.aappublications.org/content/pediatrics/138/5/e20162938.full.pdf;
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
https://www.aappublications.org/news/2016/10/24/SIDS102416;
accessed May 7, 2020.

35
See
https://www.cpsc.gov/Safety-Education/Neighborhood-Safety-Network/Posters/Safe-Sleep-for-Babies;
accessed May 6, 2020.

36
See
https://www.cpsc.gov/safety-education/safety-guides/kids-and-babies-cribs/safe-sleepbare-best
and
https://www.nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/safe-sleep-practices-for-babies;
accessed May 11, 2020.

37
See
https://www.cdc.gov/vitalsigns/safesleep/index.html;
accessed May 2, 2020.

38
See
https://kidsindanger.org/protect-your-child/sleep/;
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,
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;
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 ±
5/8
inches wide by 52
3/8
±
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
https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Full-Size-Baby-Cribs/,
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.

• BS EN 16890:2017—Children's Furniture—Mattresses for cots and cribs—Safety requirements and test methods (BS EN 16890); and

• 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

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:

• 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.

• Small parts,

• Lead and other toxic substances in paints,

• Finger entrapment,

• Mattress dimension conformity,

• Mattress thickness, and

• 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):

• 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):

• Revised scope to include a new section 1.5, stating the standard was developed in accordance with internationally recognized principles on standardization;

• Added definition of “after-market mattress for play yard or non-full-size crib,” to section 3, Terminology;

• 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;

• 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):

• 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):

• 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.

• 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

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-

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:

•
§ 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.

•
§ 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
§ 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.

•
§ 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.

•
§ 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

Hazard pattern

Applicable
mattresses

How addressed in ASTM F2933-21

Adequacy
assessment

Comments

Chemical/Flammability Hazards (odors, rash)
All

16 CFR part 1303 Ban of Lead-Containing Paint 16 CFR part 1500 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

Adequate
Assessed as adequate in NPR. No change in standard.

Coil or Spring (laceration)
Coil or spring mattresses (primarily full-size)
Prohibition of sharp points (Section 5.2)
Inadequate
Final rule includes additional cyclic testing to identify potential for springs to break through surface during foreseeable use and misuse.

Crib Mattress Used in a Play Yard (suffocation due to ill-fitting mattress)
Aftermarket play yard mattresses
Labeling requirements, requirements for after-market mattresses. Testing requirements harmonized with ASTM F406. (Sections 5.9 and 7.5)
Adequate
Section VI.A.3 of the preamble assesses the revised requirements for after-market mattresses.

Expand or Inflate (suffocation due to ill-fitting mattress that does not expand or inflate properly)
Foam products, typically full-size and shipped as “bed in a box”
Dimensional conformity, mattress thickness, and labeling requirements (Section 5.7)
Adequate
Hazard is adequately addressed with F2933's dimensional conformity and mattress thickness.

Face in Mattress (suffocation)
All
Labeling requirements (Section 7.3)

Inadequate: See also ESHF
51
memo (Tab D)

Final rule contains a firmness test based on sections 6 and 8 of AS/NZS 8811.1 and revised labeling.

Fit Issues (suffocation due to ill-fitting mattress)
All
Dimensional conformity and after-market mattress requirements (Sections 5.7 and 5.9)
Inadequate
Final rule contains additional fitted sheet compression test for full-size mattresses and extends dimensional requirements in section 5.7 to all after-market non-full-size crib mattresses.

Found Prone (suffocation due to prone position)
All
Labeling requirements (Section 7.3)
Inadequate: See also ESHF memo (Tab D)
Final rule contains a firmness test based on sections 6 and 8 of AS/NZS 8811.1 and revised labeling.

Mattress Falls Apart (choking/ingestion)
All
Mattress seam stitching requirement and small parts prohibition (Sections 5.3 and 5.8)
Adequate
Assessed as adequate in NPR. No change in standard.

Softness (suffocation due to soft surface)
All
Not addressed
Inadequate
Final rule contains a firmness test based on sections 6 and 8 of AS/NZS 8811.1.

Multiple Contributing Factors (MCF) (
e.g.,
entrapment in bumper pads, limb entrapment, crib sharing with another infant, existing health condition)

All
General requirements and warning labels (Sections 5 and 7)
Inadequate
Some of these contributing factors are addressed by additional 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 requirements and warning labels (Sections 5 and 7)
Adequate
This category includes hazards which are out of scope of the ASTM 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

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.

ER15FE22.000

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

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.

ER15FE22.001

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

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

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.
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ASTM members provided no detailed test results, and none were discussed at this meeting.

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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.
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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.

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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
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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:
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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.

• A description of the hazard;

• information about the consequences of exposure to the hazard; and

• 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.
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The Commission's NPR recommended the following changes to the safety information requirements specified in ASTM F2933-19:

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

• Clarifying the definition of “conspicuous” in section 3,
Terminology;

• Improving marking and labeling requirements in section 7,
Marking and Labeling;
and

• Adding instructional literature requirements in a new section 8,
Instructional Literature.

The NPR explained that CPSC staff considered incident data,
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results from survey
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and focus group research,
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relevant literature,
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requirements in ANZI Z535.4,
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recommendations from the ASTM Ad Hoc Language Task Group,
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and suggestions from other stakeholders participating in the ASTM F15.66 subcommittee on crib mattresses and the greater ASTM F15 committee on consumer products.
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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.

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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.

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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.

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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.
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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.

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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.
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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-

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.
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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.

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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-02414. Public record. Not legal advice.