2022-02414. Safety Standard for Crib Mattresses  

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    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.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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.

    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]

    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 Start Printed Page 8641 Specification for Crib Mattresses, to address the associated hazards.[6]

    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]

    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 Start Printed Page 8642 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]

    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]

    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]

    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:

    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.

    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 Start Printed Page 8643 yard mattresses, but does not address after-market play yard mattresses. The final rule for crib mattresses addresses after-market mattresses for play yards, as set forth in ASTM F2933-21 section 5.9, by requiring that they meet the same specifications and performance requirements for OEM play yard mattresses in ASTM F406, as well as additional requirements for the after-market mattress fit, support structure, and instruction storage accommodations. Additionally, the final rule requires that after-market mattresses intended for use in the bassinet of a play yard with a bassinet attachment must also meet the specifications in ASTM F2194, Consumer Safety Specifications for Bassinets and Cradles.

    B. Market Description [14]

    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.

    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.

    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.

    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]

    III. Incident Data and Hazard Patterns [24]

    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 Start Printed Page 8644 associated with crib mattresses. Accordingly, for the final rule, the Commission is aware of 494 reports associated with a crib mattress, including 139 fatalities and 355 nonfatalities reported from January 1, 2010 through April 30, 2021.[25]

    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.

    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.

    Table 1—Fatal and Nonfatal Reports Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During January 1, 2010-April 30, 2021

    Date received by CPSC January 1, 2010-March 31, 2020 (reported incidents in the NPR)April 1, 2020-April 30, 2021 (reported incidents since the NPR)January 1, 2010-April 30, 2021
    Hazard categoryFatal reportsNonfatal reportsFatal reportsNonfatal reportsTotal reports
    Chemical/Flammability0230326
    Coil or Spring012404128
    Crib Mattress Used in a Play Yard21014
    Expand or Inflate06006
    Face in Mattress1313017
    Fit Issues2088113122
    Found Prone6639078
    Mattress Falls Apart0180018
    Softness03601955
    Multiple Contributing Factors (MCF)15170234
    Other06006
    Total Reports1163232332494
    Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

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

    Table 2—Reports Associated With Crib Mattresses by Year of Incident and Date Received by CPSC During January 1, 2010-April 30, 2021

    Date received by CPSC January 1, 2010-March 31, 2020 (reported incidents in the NPR)April 1, 2020-April 30, 2021 (reported incidents since the NPR)January 1, 2010-April 30, 2021 (total reports)
    Year of incident or deathFatal reportsNonfatal reportsFatal reports 29Nonfatal reportsTotal fatal reportsTotal nonfatal reports
    20102043002043
    20111119001119
    201242700427
    201373100731
    20141328001328
    20151134001134
    201684010940
    20172548002548
    20181333201533
    20194181321720
    202002619621
    202100111111
    Total Reports1163232332139355
    Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.
    Start Printed Page 8645

    A. Fatal Reports

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

    Table 3—Reported Fatalities Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During January 1, 2010-April 30, 2021

    Date received by CPSC January 1, 2010-March 31, 2020April 1, 2020- April 30, 2021January 1, 2010-April 30, 2021
    Hazard categoryReported incidents in the NPRReported incidents since the NPRTotal fatal reports
    Crib Mattress Used in a Play Yard202
    Face in Mattress13316
    Fit Issues201131
    Found Prone66975
    Multiple Contributing Factors (MCF)15015
    Total Reports11623139
    Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.

    Below, we describe the hazard patterns involving a fatality associated with a crib mattress.

    1. Crib Mattress Used in a Play Yard: One percent of the fatalities involved use of a crib mattress in a play yard (2 out of 139). Reports state that infants were found wedged between the crib mattress and the mesh of the play yard, due to the crib mattress not fitting snugly in the play yard.

    2. Face in Mattress: Twelve percent (16 out of 139) of fatalities were associated with the face of an infant, when found, reportedly in contact with a crib mattress or crib sheet covering the crib mattress. Based on the available information about each fatality, bedding was present in the sleeping environment in some of these reports. However, bedding was not touching the infant, nor did staff determine that the bedding was a contributing factor in the death.

    3. Fit Issues: Twenty-two percent (31 out of 139) of fatalities involved issues with the fit of a crib mattress in the sleeping environment. In all of these fatalities, the infants became wedged in gaps between at least one of the sides of a crib mattress and the crib rails or play yard mesh.

    4. Found Prone: Fifty-four percent (75 out of 139) of fatalities involved an infant found in a prone position with no mention of whether the face of the child was in contact with the crib mattress or crib sheet, and no mention of the face being obstructed by other crib bedding, or other items in the sleep environment. Given the available information about each fatality, bedding was present in the sleeping environment in some of these reports, but staff was unable to determine that bedding was a contributing factor in the deaths.

    5. Multiple Contributing Factors (MCF): Eleven percent (15 out of 139) of fatalities involved multiple factors that potentially played a role in the fatality, and the crib mattress was likely one of the contributing factors. Examples of other contributing factors are entrapment between the mattress and bumper pads, entrapment between the mattress and a crib rail with limb entrapment, usage of a swaddle, sharing of the sleep environment with another infant, and congenital or recent health conditions.

    The oldest fatalities were: Two, 3-year-old, and two, 2-year-old children. CPSC observed considerably more reported prone fatalities between the ages of 1-month-old and 5-months-old, and most of the deaths in the fit, face in mattress, and MCF hazard categories involved infants between the ages of 1-month-old and 8-months-old, compared to other ages. Among the 23 deaths reported since the NPR, 19 were to infants 8 months old or younger, and the remainder included one 11-month-old, one 12-month-old, one 21-month-old, and one 38-month-old.

    B. Reported Nonfatal Incidents and Concerns

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

    Table 4—Nonfatal Reports Associated With Crib Mattresses by Hazard Category and Date Received by CPSC During January 1, 2010-April 30, 2021

    Date received by CPSC January 1, 2010-March 31, 2020April 1, 2020- April 30, 2021January 1, 2010-April 30, 2021
    Hazard categoryReported incidents in the NPRReported incidents since the NPRTotal nonfatal reports
    Chemical/Flammability23326
    Coil or Spring1244128
    Crib Mattress Used in a Play Yard112
    Expand or Inflate606
    Face in Mattress101
    Fit Issues88391
    Found Prone303
    Mattress Falls Apart18018
    Softness361955
    Multiple Contributing Factors (MCF)17219
    Other606
    Total Reports32332355
    Source: CPSRMS and NEISS databases. Reporting is ongoing; so 2019-2021 data are incomplete.
    Start Printed Page 8646

    1. Chemical/Flammability: Seven percent (26 out of 355) of the nonfatal incidents reported a crib mattress having a chemical odor (6), causing rashes (8), developing severe allergies (1), or not meeting mandatory federal flammability standards (11). Three of these 26 incidents were reported between April 1, 2020 and April 30, 2021. Among these three incidents, two involved emergency department treatment from rashes or allergy symptoms, and one incident mentions headaches from foul odor with unspecified severity.

    2. Coil or Spring: Thirty-six percent (128 out of 355) of nonfatal incidents involved a coil or spring found protruding through the crib mattress. Four of these 128 incidents were reported between April 1, 2020 and April 30, 2021. Among these four incidents, one involved a knee laceration with the level of care not known, and the other three incidents reported an incident with no injury.

    3. Crib Mattress Used in a Play Yard: One percent (2 out of 355) of nonfatal incidents involved a crib mattress being used in a play yard. One of these two incidents was reported between April 1, 2020 and April 30, 2021. In the one new incident, a child had an arm become entrapped on the side or under the mattress.

    4. Expand or Inflate: Two percent (6 out of 355) of nonfatal incidents involved a crib mattress that failed to expand or inflate properly. None of these six incidents were reported between April 1, 2020 and April 30, 2021. CPSC identified related hazards, including fit issues with gaps appearing around the crib mattress causing entrapment or wedging, and an uneven crib mattress that may cause an infant to roll over.

    5. Face in Mattress: Less than 1 percent (1 out of 355) of nonfatal incidents involved an infant found limp, pale, and with blue around the lips while face down in contact with a crib mattress. CPSC staff found no other details about the sleep environment in this incident involving a 1-month-old infant who was admitted to the hospital. This incident was reported in the NPR data set.

    6. Fit Issue: Twenty-six percent (91 out of 355) of nonfatal incidents involved issues with the fit of a crib mattress in the sleeping environment, three of which were reported between April 1, 2020 and April 30, 2021. Among these three incidents, one child was treated in the emergency department after falling out of the crib due to a mattress that was too thick; one child received marks on the face due to entrapment issues with an unknown level of treatment; and one incident occurred with no injury reported. In all of these reports, staff determined that gaps were present on one or more sides around the perimeter of a crib mattress, creating wedging or entrapment hazard between the crib mattress and the crib rails or play yard mesh.

    7. Found Prone: One percent (3 out of 355) of nonfatal incidents involved an infant found in a prone position without any mention of the face being in contact with the mattress or crib sheet, and no mention of the face being obstructed by other crib bedding or other items in the sleep environment. Staff found no other details about the sleep environment in any of these three reported incidents. None of these three incidents were reported between April 1, 2020 and April 30, 2021.

    8. Mattress Falls Apart: Five percent (18 out of 355) of nonfatal incidents involved part of a crib mattress coming apart. In most of these reports, the seams of the mattress unraveled, causing: A strangulation hazard due to the stitching of the mattress being exposed; and a choking or ingestion hazard due to the inner filling coming out of the mattress in small pieces and into the sleep environment. Examples of reported small pieces of a crib mattress filling that came apart are fibers, string, or wool. Staff found that in six incidents, string from crib mattress seams or piping was found wrapped around the neck of the infant, which could have led to a serious outcome if the child was not found in time. One incident involved an infant choking on a plastic piece of “shredded” crib mattress, and one incident involved a child who was treated and released from the hospital emergency department due to ingesting plastic pieces of a crib mattress. None of these 18 incidents were reported between April 1, 2020 and April 30, 2021.

    9. Softness: Fifteen percent (55 out of 355) of nonfatal incidents involved a crib mattress inner cushioning that was reportedly too soft. CPSC staff found 33 reports of depressions or indentations in the crib mattress, accompanied by the following descriptions: “bunches up/squishy,” “dent/depression/dips/indentation/sags/sinks in/smashed/sunken,” and “deflates/like an air mattress not fully inflated.” Twelve reports describe a crib sheet being placed on a crib mattress and causing the mattress to bend or bow, resulting in a gap or fit issue between the mattress and crib rails, creating an entrapment hazard. Four reports claim that a crib mattress is not breathable. Six reports allege that a crib mattress is too thin and that the inner cushioning is too soft. Of these 55 incidents, 19 were reported between April 1, 2020 and April 30, 2021. All 19 of these incidents involved an incident with no injury reported.

    10. Multiple Contributing Factors (MCF): Five percent (19 out of 355) of nonfatal incidents involved multiple factors that played a role, of which the crib mattress was likely one factor. Two of these 19 incidents were reported between April 1, 2020 and April 30, 2021. One incident involved a mattress that was reported to be too firm and a child who broke out in rashes, with a level of care not known; and one incident involved a slat entrapment hazard, with no injury reported.

    11. Other: Two percent (6 out of 355) of nonfatal incidents involved miscellaneous other issues associated with a crib mattress. None of these six incidents were reported between April 1, 2020 and April 30, 2021. Reports in this category included: A blade found in a crib mattress; an infant's arm was “tangled in a crib mattress”; an infant “slipped on a crib mattress,” causing a slat entrapment; an infant's arm became “stuck on a crib mattress”; a crib mattress had a loose plastic bag for a cover; and a concern about crib mattresses not having proper warning labels to direct caregivers to place infants on their backs when putting them down in a crib.

    The hazard categories with the most reported nonfatal incidents associated with crib mattresses are issues with coils or springs, and crib mattresses that do not fit properly in the sleep environment. In the most recent years, from January 2018 to April 2021, CPSC staff observed fewer nonfatal reports of coil or spring issues associated with crib mattresses, compared to years 2014 through 2017. Eighty-six percent (78 out of 91 nonfatal reports) of nonfatal reports involving fit issues occurred between 2010 and 2015.

    C. Explanation of Hazards Associated With Crib Mattress Use [30]

    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,

    Start Printed Page 8647

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

    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]

    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.

    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]

    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]

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

    • 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 Start Printed Page 8648 assessment is applicable to ASTM F2933-21 as well.[46]

    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]

    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]

    • 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]

    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 Start Printed Page 8649 that are too thick, or do not fit correctly, or attach to a play yard or non-full-size crib. ASTM developed the latest requirements for after-market mattresses, published in ASTM F2933-21, in collaboration with CPSC staff, the ASTM Play Yard Vertical Displacement Task Group, the Play Yard Mattress Fit and Thickness Task Group, and the ASTM Non-Segmented Mattress Task Group. Below we summarize and assess changes to ASTM F2933-21 that occurred after publication of the NPR.

    1. In section 5.9 of ASTM F2933-21, “Product” was clarified to refer to the play yard or non-full-size crib, rather than the mattress. Other clarifications of the mattress and the product were made throughout this section. These term clarifications are appropriate and adequate to clarify which requirements in the standard apply to which products. However, the final rule removes non-full-size cribs from this section, to be consistent with changes to section 5.7.2 regarding non-full-size mattress size and thickness.

    2. In section 5.9.1.1 of ASTM F2933-21, the requirement was removed that the after-market mattress have the same thickness, floor support structure, and attachment method as the mattress it is intended to replace. The thickness and floor support structure requirements were replaced in ASTM F2933-21, as described in paragraphs 5 and 6 below. The final rule adopts these new requirements for after-market mattresses in ASTM F2933-21, as written. Before this change, an after-market mattress for a play yard could meet the requirements of ASTM F406 when tested with the product it is intended to be used with, but still not meet the requirements of this section, due to having a different mattress thickness or different floor support structure design as the OEM mattress. For example, non-segmented, i.e., non-folding, after-market mattresses for products that included a segmented mattress would not be allowed. Similarly, if the OEM play yard mattress was 3/8 inches thick, an after-market mattress with a thickness of 7/8 inches, and that would otherwise meet the requirements of an OEM mattress, would not be allowed.

    ASTM removed the requirement that after-market mattresses be exactly the same as the OEM mattress, and instead, requires that after-market mattresses be tested to the same requirements as OEM mattresses (see 3 below). Moreover, after-market mattresses must meet additional requirements regarding size, floor support structure, and instruction storage (5, 6, and 7 below, respectively). Based on this change, the two examples described above would be allowed, so long as they meet all of the requirements for after-market mattresses. A 3-inch thick, after-market play yard mattress would not be allowed, however, due to it having a greater thickness than allowed for OEM mattresses in ASTM F406. Because after-market mattresses must meet the same dimension and performance requirements as OEM mattresses, as well as additional requirements, this change will not reduce the safety of after-market mattresses.

    3. In the new section 5.9.1.1 of ASTM F2933-21, ASTM added the following list of requirements from ASTM F406: Stability; Cord/Strap Length; Crib Side Height; Height of Sides; and Floor Strength. The following requirements from ASTM F406 were already listed: Mattress; Mattresses for Rigid-Sided Products; Mattress Vertical Displacement. The requirements in ASTM F406 applicable to play yard mattresses are those for Mattress, Stability, Cord/Strap Length, Height of Sides, Floor Strength, and Mattress Vertical Displacement. ASTM F2933-21 now includes all of these listed requirements. The final rule, however, removes Mattresses for Rigid-Sided Products and Crib Side Height from this section, because these requirements apply to non-full-size cribs, which are addressed in the final rule in section 5.7.2.

    4. In the new section 5.9.1.2 of ASTM F2933-21, ASTM replaced the term “replacement mattress” with “aftermarket mattress.” The final rule includes this modification, and it is consistent with modifications proposed in the NPR.

    5. ASTM added the following requirement in a new section 5.9.1.3 in ASTM F2933-21: “The aftermarket mattress must be at least the same size as the original equipment mattress or larger and lay flat on the floor of the product, in contact with the play yard mattress support structure.” Some OEM play yard mattresses are made particularly thin, contributing to the consumer perception that play yard mattresses are uncomfortable, and potentially resulting in consumers placing additional soft bedding in infant sleep environments. With this change, after-market mattresses can be the same size or larger (thicker and/or wider) than the OEM mattress, so long as they lay flat and meet the other applicable dimension and test requirements for play yard mattresses, including maximum dimension requirements. This allows after-market play yard mattresses, which are thicker than OEM mattresses, but continue to meet maximum dimension requirements ( e.g., an after-market mattress with foam 7/8 inches thick may be acceptable, but foam more than 1-inch thick, would not be acceptable). The final rule adopts this change as part of ASTM F2933-21, because it is unlikely to reduce safety, and may improve safety by allowing appropriately sized, after-market mattresses that could combat the consumer perception of uncomfortable play yard mattresses. This change, therefore, is an adequate replacement for the mattress size requirements originally in section 5.9.1.1.

    6. ASTM added the following requirement in section 5.9.1.4 of ASTM F2933-21: “If the original equipment mattress includes a floor support structure, the aftermarket mattress must include a floor support structure that is at least as thick as the original equipment mattress floor support structure.” This change allows for after-market mattresses with a different floor support structure than the OEM mattress ( e.g., an after-market non-segmented mattress in place of an OEM segmented mattress), so long as the floor support structure is at least as thick as the original, and the mattress meets the other applicable requirements for play yard mattresses. This change, along with the requirement that the mattress must lay flat on the play yard support structure, will have no effect on safety, because it ensures that after-market play yard mattresses with a different support structure than the OEM mattress will still have a similar level of support. The final rule adopts this change as part of ASTM F2933-21, because it is an adequate replacement for the floor support structure requirements originally in section 5.9.1.1.

    7. ASTM added the following requirement in section 5.9.1.5 of ASTM F2933-21: “If the original equipment mattress includes storage accommodations for the product instruction manual, the aftermarket mattress shall provide equivalent storage accommodations for the product instruction manual.” This is a new requirement for after-market mattresses to have equivalent storage accommodations for instructions as the OEM mattress. The final rule adopts this change as part of ASTM F2933-21, because it improves safety by increasing the likelihood of consumers keeping the product's instruction manual, which may have important safety information, readily accessible.

    Based on the foregoing, the final rule incorporates by reference ASTM F2933-21, and adopts these seven changes, except where a change conflicts with the separation of requirements for play yards from the requirements for non- Start Printed Page 8650 full-size crib mattresses, as noted in this section. Appendix A to Tab C of Staff's Final Rule Briefing Package outlines the changes to section 5.9 of ASTM F2933-21.

    C. Description of Performance Requirements in ASTM F2933-21

    In addition to the general requirements typically found in other ASTM juvenile product standards, such as requirements for openings, label permanency, and the prohibition of sharp points/edges, small parts, and lead in paints, section 5 of ASTM F2933-21 contains the following four additional requirements that apply specifically to mattresses for cribs, non-full-size-cribs, and to after-market mattresses for non-full-size cribs and play yards:

    § 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]

    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 patternApplicable mattressesHow addressed in ASTM F2933-21Adequacy assessmentComments
    Chemical/Flammability Hazards (odors, rash)All16 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 SetsAdequateAssessed as adequate in NPR. No change in standard.
    Start Printed Page 8651
    Coil or Spring (laceration)Coil or spring mattresses (primarily full-size)Prohibition of sharp points (Section 5.2)InadequateFinal 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 mattressesLabeling requirements, requirements for after-market mattresses. Testing requirements harmonized with ASTM F406. (Sections 5.9 and 7.5)AdequateSection 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)AdequateHazard is adequately addressed with F2933's dimensional conformity and mattress thickness.
    Face in Mattress (suffocation)AllLabeling 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)AllDimensional conformity and after-market mattress requirements (Sections 5.7 and 5.9)InadequateFinal 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)AllLabeling 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)AllMattress seam stitching requirement and small parts prohibition (Sections 5.3 and 5.8)AdequateAssessed as adequate in NPR. No change in standard.
    Softness (suffocation due to soft surface)AllNot addressedInadequateFinal 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)AllGeneral requirements and warning labels (Sections 5 and 7)InadequateSome 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.
    OtherAllGeneral requirements and warning labels (Sections 5 and 7)AdequateThis 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

    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 Start Printed Page 8652 revised test location, ASTM has not yet distributed this revised draft to CPSC staff or to other task group members, and there has not been a ballot. Therefore, for the final rule, the Commission clarifies the test procedure and the need for two mattresses, but does not make any additional changes.

    3. Hazard Pattern—Crib Mattress Used in a Play Yard

    One percent (2 out of 139) of fatal incidents and one percent (2 out of 355) of nonfatal incidents, including one nonfatal incident identified since the NPR, are associated with using a crib mattress in a play yard. The incidents were associated with the use of a crib mattress that did not fit properly in a play yard. ASTM F2933-21 addresses this hazard with warning label requirements, and additionally, newer requirements specifying that after-market play yard mattresses must meet the same requirements as OEM mattresses. These revisions will increase the availability of properly fitting after-market mattresses, and will reduce the likelihood of caregivers using an ill-fitting crib mattress in a play yard. For the final rule, the Commission incorporates by reference ASTM F2933-21, to include these revisions.

    One nonfatal incident involved scratches on an infant's back, caused by protruding coils or springs of the crib mattress. The final rule addresses the coil or spring hazard, as described in section VI.A.2, above.

    4. Hazard Pattern—Expand or Inflate

    In two percent (6 out of 355) of reported nonfatal incidents, a crib mattress failed to expand or inflate properly. All of these incidents were reported in the NPR. This hazard can occur when a mattress is tightly rolled for shipping or packaging purposes, and then does not completely decompress. Related hazards include fit issues with gaps appearing around the crib mattress, causing entrapment or wedging, and an uneven crib mattress that may cause an infant to roll over. Although this hazard is adequately addressed with ASTM F2933's dimensional conformity and mattress thickness requirements, the additional proposed mattress compression test, detailed in section VI.A.6 of this preamble, will strengthen the proposed standard and further reduce injuries associated with the failure of a mattress to expand or inflate fully to prevent hazardous gaps.

    5. Hazard Pattern—Face in Mattress

    Twelve percent (16 out of 139) of fatal incidents and less than 1 percent (1 out of 355) of nonfatal incidents, including three fatal incidents identified since the NPR, are associated with an infant found face down on a crib mattress. ASTM F2933 does not address this hazard pattern. The Human Factors assessment in the Staff's NPR and Final Rule Briefing Packages provides strengthened warning label recommendations to address this hazard pattern. As proposed in the NPR, the Commission is finalizing the rule with revised warning labels to address this hazard.

    6. Hazard Pattern—Fit Issues

    Twenty-two percent (31 out of 139) of fatal incidents and 26 percent (91 out of 355) nonfatal incidents, including 11 fatal incidents and three nonfatal incidents identified since the NPR, were associated with the fit of a crib mattress in the sleeping environment.[52] In these reports, gaps between the crib mattress and the crib rail or play yard mesh, on one or more sides around the perimeter of a crib mattress, created a wedging or entrapment hazard. ASTM F2933-21 contains a mattress dimensional conformity test intended to address this hazard. However, staff found from visual inspection and measurement of mattresses tested, that tight-fitting sheets over crib mattresses can create gaps between the corners of the mattress and the interior corner of the crib, creating an entrapment hazard, as seen in Photo 1. Accordingly, ASTM F2933-21 does not adequately address entrapment hazards between the crib mattress and the side of a crib or play yard.

    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.

    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 Start Printed Page 8653 full-size crib mattress. The mattress with the sheet was required to meet all dimensional requirements in ASTM F2933-19.[53] In addition, measured corner gaps were required to be less than 2.25 inches in length, based on the fifth percentile head breadth of 0- to 3-month-old infants,[54] the already-allowed maximum gap of 1 inch between the sides of the crib mattress and the sides of the crib, and a 0.5-inch margin of safety.

    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.

    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 Start Printed Page 8654 selection process. Accordingly, based on available data, the test method proposed in the NPR is the most accurate test method to test for hazardous gaps caused by sheet compression.

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

    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 Start Printed Page 8655 consistent results and the EN 16890 protocol was more appropriate. ASTM members did not provide supporting evidence for this conclusion. ASTM members agreed to test and compare results using both protocols after the February 16, 2021 meeting.

    At a June 10, 2021 subcommittee meeting, several ASTM members reported that they had conducted testing using one or both of the firmness protocols, and they repeated the assertion that the EN 16890 protocol should be favored. One member stated that the AS/NZS 8811.1 protocol results could be inconsistent if the test was not conducted on a flat surface.[56] ASTM members provided no detailed test results, and none were discussed at this meeting.

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

    Additionally, for the NPR staff found that the AS/NZS 8811.1:2013 test protocol is more repeatable and is easier to discern when a mattress does not meet the performance requirements, as compared to the EN16980 method. Some ASTM members and public comments stated that the AS/NZS 8811.1:2013 test protocol does not provide consistent test results, but they have not provided evidence to support this conclusion. Staff's testing has not indicated any such issues. Some ASTM members agreed with staff's assessment of AS/NZS 8811.1:2013, and some public comments, reviewed in section VII of this preamble, supported the use of AS/NZS 8811.1:2013 to determine whether a mattress was too soft. Accordingly, to address mattresses that are too soft, for the draft final rule, the Commission will finalize the rule, as proposed, by adding a test for mattress firmness for all crib mattresses within the scope of the standard, based on sections 6 and 8 in the AS/NZS 8811.1 mattress firmness test.

    10. Hazard Pattern—Multiple Contributing Factors

    Multiple contributing factors accounted for 11 percent (15 out of 139) of fatal and 5 percent (19 out of 355) nonfatal incidents, including two nonfatal incidents identified since the NPR. Examples of contributing factors are: Entrapment between the mattress and crib bumper pads, limb entrapment between the mattress and a crib rail, crib occupant usage of a swaddle, sharing of the crib with another infant, and congenital or recent health conditions of infants. ASTM F2933-21 adequately addresses these hazards in the general requirements sections. ASTM F2933-21 also addresses these hazards with safety information requirements, but these requirements are inadequate. Tab D of Staff's Final Rule Briefing Package, and section VI.B of this preamble, outline the human factors assessment of the ASTM F2933-21 requirements for safety information and the modifications required in this final rule. As proposed in the NPR, the Commission is finalizing the rule with revised safety information to address this hazard.

    11. Hazard Pattern—Other

    Two percent (6 out of 355) of nonfatal incidents involved miscellaneous other issues associated with a crib mattress. Staff did not identify any new incidents since the NPR. Reports include: A blade found in a crib mattress; an infant's arm “tangled in a crib mattress”; an infant “slipped on a crib mattress,” causing a slat entrapment; an infant's arm “stuck on a crib mattress”; a crib mattress is too thick; a crib mattress had a loose plastic bag for a cover; and a concern about crib mattresses not having proper warning labels to direct caregivers to place infants on their backs when putting them down in a crib. Foreign objects are generally not addressable in product standards. For three of these incidents, staff could not determine the exact cause of the incident, or whether ASTM F2933-21 was the appropriate standard to address the hazard. ASTM F2933-21 warning label requirements include a statement that says to place infants on their backs to sleep, and to “only use sheets and mattress pads designed specifically for crib mattresses.”

    B. Adequacy of Marking, Labeling, and Instructions [58]

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

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

    • Clarifying the definition of “conspicuous” in section 3, Terminology; Start Printed Page 8656

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

    1. ASTM Subcommittee Activities and ASTM F2933

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

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

    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- Start Printed Page 8657 market mattresses for rigid-sided, rectangular products, claiming that there are standard sizes for rigid-sided rectangular products. CPSC staff advises that this claim is not factual; excluding full-size cribs, there are no official standardized interior dimensions of rigid-sided, rectangular non-full-size cribs. ASTM F406-19, the applicable mandatory standard, requires only that the interior length dimension is either greater than 55 in. (139.7 cm) or smaller than 49-4 in. (126.3 cm), and/or the interior width dimension is greater than 30 8 in. (77.7 cm) or smaller than 25-8 in. (64.3 cm). Considering that this subsection of the rule excludes full-size cribs, the final rule includes the NPR-proposed language, thereby ensuring that consumers see the additional information for after-market mattresses for rigid-sided, rectangular, non-full-size cribs.

    The NPR included requirements for instructional literature. These requirements are consistent with recommendations from the ASTM Ad Hoc Language Task Group. Several ASTM members argued that instructions are unnecessary for crib mattresses, alleging use of the products is intuitive and that relevant information is provided in the on-product labels. In addition to aligning with Ad Hoc recommendations, given the significance of the hazards, it is important to incorporate another medium, i.e., instructional literature, by which to communicate the SIDS and suffocation hazards to consumers. The NPR demonstrated through incident data and research involving surveys and focus groups that consumers continue to use crib mattresses in ways contrary to the proposed safety information. Given the inherent limitations of safety information, which depends on persuading consumers to behave differently and perhaps inconveniently (such as repositioning a sleeping infant), multiple mediums are critical to communicate hazard-avoidance behaviors to consumers to motivate consumer actions.

    In a June 9, 2021 ASTM meeting, staff raised additional concerns, including the following: (1) The word “product” was used in the ASTM balloted item to refer to both crib mattresses and structures (cribs, non-full-size cribs, and play yards); and (2) the ASTM balloted item used “should” instead of “shall” in reference to required labeling specifying maximum gaps between the mattress and product sides, and that the reference was made in a “Note,” which, by definition, is not mandatory.[70] The ASTM subcommittee agreed that these additional concerns were valid, but determined that the ballot should not be delayed, and that further improvements would be considered in the future. Subcommittee voting members voted on whether CPSC staff's negative was non-persuasive, and the motion passed with 11 affirmatives, one negative, and six abstentions. The full F15 committee upheld the subcommittee's non-persuasive finding on August 2, 2021 (ballot F15 (21-05), item 8). Therefore, a further revision of ASTM F2933-21 was approved on September 1, 2021, and CPSC expects the revision will be published around the end of September 2021. However, this future revision will remain inconsistent with the final rule, and for the reasons detailed in this preamble and Tab D of Staff's Final Rule Briefing Package, the Commission will not include ASTM's revision in the final rule.

    ASTM included the following additional deviations in the ballot (F15 (21-02), item 13), which were not sufficiently discussed in the June 9, 2021 meeting, and the Commission did not receive direct comments on the NPR pertaining to these deviations. However, consistent with comments on the NPR, which requested that CPSC consider ongoing ASTM activities, we assessed whether these deviations added to the safety of crib mattresses. One such deviation was placement of the following warning message lower in the label than in the NPR: “DO NOT cover the faces or heads of babies with a blanket or over-bundle them. Overheating can increase the risk of SIDS.” Staff advises that this important warning should not appear towards the bottom of the label, located below a detailed explanation of how to identify hazardous gaps. The label already includes a warning pertaining to gaps above this warning about overheating, and staff reiterates the importance of addressing the hazardous uses early on in the label, as text lower in the label is less likely to be read. Additionally, the warning label layout proposed in the NPR positions the gap measurement message directly above the related interior dimensions message for cribs, and closer to other required statements pertaining to product size.

    ASTM's balloted item also deviated from the NPR regarding the packaging requirements. The NPR-proposed packaging requirements incorporated recommendations from the ASTM Ad Hoc Language Task Group. The ASTM-balloted packaging requirements expand on these Ad Hoc recommendations, including product-specific clarifications and incorporating formatting requirements from section 7.4 of ASTM F2933-21. After further consideration, CPSC agrees that some of these changes may further improve the safety of crib mattresses, while other changes are merely editorial and do not add to the safety of crib mattresses. Accordingly, the final rule continues to align with the ASTM Ad Hoc committee's recommendations for packaging requirements.

    2. Final Rule Warnings Clarifications

    As requested in comments on the NPR, staff continued efforts with ASTM to further improve the safety information requirements for crib mattresses. Based on these communications and ASTM F15's balloted changes to safety information to be incorporated into ASTM F2933-21, the final rule includes modifications to safety information, to further reduce the risks of death and serious injury associated with crib mattresses. Appendix A to Tab D of Staff's Final Rule Briefing Package contains a redline of all modifications in the final rule.

    • In section 3.1.2, changed “conspicuous, adj—visible while the mattress is being placed in its intended use position,” to “conspicuous, adj—visible when the mattress is being handled by a consumer placing the mattress in its intended use position in a product.” This change aligns with the latest consensus ballot by ASTM F15, and clarifies the intended meaning of “conspicuous” in the NPR-proposed language, that the warning should be conspicuous to the consumer.
    • In section 7.4.6.2, changed “The text in each column needs to be arranged in list or outline format, with precautionary (hazard avoidance) statements preceded by bullet points,” to “The text in each column should be arranged in list or outline format, with precautionary (hazard avoidance) statements preceded by bullet points.” This change, from the mandatory language of “needs to” to the recommended language of “should,” aligns with the latest recommendations from Ad Hoc and the consensus ballot by ASTM F15. This change recognizes the importance of providing manufacturers with flexibility in arranging the bulleted hazard avoidance statements based on mattress-specific requirements, where appropriate.

    • In section 7.5, changed “The blank in the mattress fit statement beginning with `If a gap is larger than,' needs to be Start Printed Page 8658 filled with `1 3/8 in. (3.5 cm)' for full-size crib mattresses and `1 in. (2.5 cm)' for all other mattresses,” to “The blank in the mattress fit statement beginning with `If a gap is larger than,' needs to be filled with `1 1/2 in. (3.8 cm)' for full-size crib mattresses and `1 in. (2.5 cm)' for all other mattresses.” This change for full-size crib mattresses from 1 3/8 inches to 1 1/2 inches aligns with the latest consensus ballot by ASTM F15. This change results in a minor conflict between the warning message and the maximum gap afforded by the performance requirements ( i.e., a conflict of 1/8 in.); however, CPSC agrees with ASTM F15.66, which determined by consensus the following: The difference of 1/8 inch is unlikely to reduce the safety of full-size crib mattresses, the conflict is unlikely to confuse consumers (they are unlikely to be familiar with the requirements in the standard), and the new measurement (1 1/2 in.) is more tangible for consumers to estimate, thereby, increasing the likelihood of consumers attempting to measure, and accurately measuring, gaps between the full-size crib mattress and side walls of the full-size crib.

    • In section 7.5.3, changed “Manufacturers are permitted to include additional warnings between the warnings specified in 7.5 and 7.6 if desired,” to “Additional manufacturer warnings are permitted between the warnings specified in 7.5 and 7.6, if desired.” This editorial change clarifies further the allowance in the rule, and it is consistent with the latest consensus ballot by ASTM F15.
    • Section 7.8 includes several changes to the requirements for retail packaging, as specified in Appendix A to Tab D of Staff's Final Rule Briefing Package. These changes take into consideration the latest consensus ballot by ASTM F15, and further improve the safety of crib mattresses by: (1) Incorporating formatting requirements from section 7.4, and (2) clarifying the warnings and statements required for specific mattress types.
    • Renumber Figures 7-10 to Figures 8-11. This shift in numbering accounts for an additional figure added to ASTM F2933-21, Section 6, as part of the final rule, as discussed in Tab C of Staff's Final Rule Briefing Package.
    • For Figure 10, now renumbered as Figure 11, changed the caption from “Example of Warning Label for After-Market Mattress for Rigid-Sided Rectangular Products. Items italicized in brackets are to be added as appropriate. The blanks are to be filled in as appropriate,” to “Example of Warning Label for After-Market Mattress for Rigid-Sided, Rectangular, Non-Full-Size Cribs. Items italicized in brackets are to be added as appropriate.” This change provides an important clarification that the example is not for full-size crib mattresses; full-size crib mattresses have a different warning label than these products.

    To illustrate the changes to the warning labels, Figure 3 below shows a comparison of warning label examples from the NPR-proposed label, the latest consensus ballot label to be incorporated into ASTM F2933-21, and final rule warning labels for full-size crib mattresses.[71]

    VII. Response to Comments

    The Commission received 13 comments on the NPR before the comment period closed on January 11, 2021, and two late-filed comments, in July and September 2021. You can access comments by searching for docket number CPSC-2020-0023 at http://www.regulations.gov. The comments fell into several broad categories: (1) Testing requirements and modifications; (2) after-market mattress fit for play yards; (3) improving communication to caregivers; and (4) procedure. Below we summarize and respond to the comments by topic. Start Printed Page 8659

    A. Testing Requirements and Modifications

    Comment 1: Commenters generally supported requirements for cyclic testing of full-size coil spring mattresses, but they encouraged continued work with ASTM to address outstanding issues.

    Response 1: Requirements in the final rule for cyclic testing of full-size coil spring mattresses are based on staff's work with the ASTM cyclic testing task group before the NPR. Since the NPR published, staff continued to work with the task group to develop this test. The task group last met on December 9, 2020. Public comments specifically refer to ASTM work to further define requirements for support of the plywood/oriented strand board (OSB) mattress support board, and to further clarify how the test method can allow for dual-sided mattresses. Staff advises that they generally agree with these comments. However, the task group's work has not been balloted, and any updates to the test procedure since the December 2020 meeting have not been made available to staff for review. Therefore, for the final rule, the Commission is updating the cyclic test method by clarifying that the test method should be performed on each side of the mattress, using different mattresses, to address how the test should proceed with dual-sided mattresses. The Commission does not have enough information to proceed with any changes to the mattress support board. Should ASTM propose any updates to the test method in the future, the update process under Public Law 112-28 provides a method for the Commission to consider whether a revised test method improves the safety of crib mattresses.

    Comment 2: The CPSC received several comments related to the proposed corner gap test using a twice-washed fitted sheet, including: (1) That there should be a shrinkage performance requirement for a sheet, in lieu of testing mattresses with a shrunken sheet; and (2) that each mattress corner should be subjected to a certain, unspecified force or pressure before measuring the subsequent gap, instead of using a shrunken sheet. One commenter suggested that issues with sheets not fitting appropriately are better addressed by the ASTM infant bedding subcommittee. A commenter stated that as currently written, the test methodology may result in inconsistent, variable test results across testing labs and settings, because sheets can vary in quality and sizing. The same commenter also said the testing methodology may penalize full-size crib mattresses designed with greater-than-nominal dimensions.

    Response 2: Staff advises that issues with sheets shrinking or not fitting full-size-crib mattresses are appropriate for the infant bedding subcommittee. The ASTM infant bedding subcommittee has formed a task group, which held its initial meeting on March 22, 2021. CPSC staff is a member of the task group and participated in the initial meeting. CPSC staff will continue working with the ASTM infant bedding subcommittee to develop appropriate performance requirements for fitted sheets. Once that work is complete, staff can work with the ASTM crib mattress subcommittee to refer to new requirements for sheets, if appropriate. Staff's work with the ASTM infant bedding subcommittee will also help resolve concerns about inconsistent test results due to variability in sheet quality and sizing. The Commission encourages test laboratories to identify cotton sheets that are the appropriate size for the mattress to be tested.

    Addressing the fact that sheets shrink, however, does not address the issue of mattresses that do not hold their shape when sheets are applied. Therefore, the final rule contains a test for potentially hazardous gaps created when sheets are placed on a crib mattress. Staff advises that the ASTM subcommittee created a task group to work on creating a test that uses an appropriate force to apply to crib mattress corners, to simulate sheets, which could create a more repeatable test and more consistent results. However, CPSC received no comments or test data to support a test protocol, or an appropriate force. As noted in the NPR, foam mattresses and innerspring mattresses have different compressive behavior when a sheet is placed on them, resulting in inconsistent forces to replicate sheet behavior. Staff will continue to work with the ASTM subcommittee and task group, and if ASTM should publish a voluntary standard with a revised compression test, CPSC can evaluate the updated voluntary standard under the revision process pursuant to Public Law No. 112-28.

    For the final rule, in response to comments, the Commission will revise the method of measuring for the compression test. Staff advises that the methodology proposed in the NPR may be overly restrictive for full-size crib mattresses designed to be greater-than-nominal dimensions, because the test method assumed that every mattress would have the 1-inch maximum allowable gap between the crib and the crib mattress, regardless of size. Commenters state that this assumption is overly restrictive for mattresses that were designed to fill the space between the crib and crib mattress. Accordingly, to address this comment, the final rule modifies the measurement method in the test procedure, such that the corner gap is measured from a projected crib corner.

    Comment 3: Several commenters expressed opinions regarding the mattress firmness test proposed in the NPR. Overall, it appeared that industry prefers the mattress firmness test in the ISO 23767 standard, Children's furniture—Mattresses for cots and cribs—Safety requirements and test methods, over the proposed mattress firmness test based on the AS/NZS 8811.1:2013 standard, Methods of testing infant products—Method 1: Sleep Surfaces—Test. Consumer groups expressed support for the test based on AS/NZS 8811.1:2013. One consumer group submitted an undergraduate engineering report describing a potential new test fixture for consideration, but the submission did not include additional information, such as test protocols and performance criteria.

    Response 3: The Commission agrees with commenters who support a firmness test that would address the suffocation hazard associated with excessively soft mattresses. Although several commenters expressed support for specific tests, none of the commenters provided testing data to support the use of one test protocol over another. In the NPR, CPSC compared the AS/NZS 8811.1:2013 and the ISO 23767 test protocols [72] for measuring mattress firmness, and found that the AS/NZS 8811.1:2013 test method was more stringent because it resulted in failures on more test surfaces. Additionally, although the Commission appreciates the work to develop a test fixture that can be used to compare mattress firmness, the undergraduate engineering report offers no performance criteria by which to judge the results.

    Accordingly, based on the available data, the Commission will finalize the crib mattress rule, as proposed, by requiring use of a firmness test based on the requirements in AS/NZS 8811.1:2013 test for mattress firmness. CPSC staff continues to work with the ASTM subcommittee to investigate firmness requirements, as discussed in section VI.A of this preamble and Tab C of the Staff Final Rule Briefing Start Printed Page 8660 Package. If ASTM updates the voluntary standard to include a different mattress firmness test, and the revision is based on supporting data, ASTM can provide to the Commission the updated standard and supporting data for evaluation through the update process, pursuant to Public Law 112-28.

    B. After-Market Mattress Fit for Play Yards

    Comment 4: One commenter stated that having standard-sized play yards and mattresses could help to address mattress fit issues, similar to the method employed by full-size cribs and full-size crib mattresses.

    Response 4: The play yard and non-full-size cribs voluntary standard (ASTM F406-19, incorporated by reference into 16 CFR parts 1220 and 1221) currently does not contain provisions requiring the products to be of a standard size. We further note that the commenter did not provide a proposal for a specific size or range of sizes that would be necessary for such a requirement, and the NPR did not discuss standardizing sizes for play yard mattresses; nor did it solicit comment on the issue. Therefore, changes to play yard mattresses in 16 CFR part 1220 are outside the scope of this specific rulemaking on crib mattresses. The commenter should pursue this idea with the ASTM F15.18 subcommittee on play yards.

    Comment 5: A commenter requested that the Commission set a minimum thickness for play yard mattresses to reduce the likelihood consumers would find a mattress too thin and add hazardous padding. The same commenter requested that the Commission delay finalizing the rule until a task group organized by the ASTM play yard subcommittee, the play yard mattress fit and thickness task group, completes their work.

    Response 5: Regarding the request that the Commission set a minimum thickness for play yard mattresses, we note that CPSC staff expressed similar concerns with consumer perception of mattress thickness/comfort in the briefing package on Petition CP 15-2, stating, “Because incident data demonstrate that consumers perceive play yard mattresses to be uncomfortable, and then place additional soft bedding in infant sleep environments, CPSC staff does not recommend banning supplemental mattresses.” However, based on staff's advice, we believe that setting a minimum mattress thickness would not address the resilience of a mattress, which is not based on thickness alone, but also on the density of underlaying foam. For example, staff advises that they are aware of bassinet mattresses that meet the thickness limit, but are dense enough not to “bottom out” on the hard backer-board, which supports that a denser foam pad could also address consumer complaints.

    Regarding the work of the play yard fit and thickness task group, this work is ongoing and has neither reached consensus in the task group, nor been balloted. Staff has also voiced concern that this task group is focused on identifying the gap size between the mattress and the flexible play yard side while the play yard side is in a resting position, while staff believes the focus should be on a test that accounts for the flexible nature of play yard sides to create a three-dimensional pocket from the existing gap. Staff remains engaged in efforts to address mattress thickness.

    Work on the play yard standard is outside the scope of this rulemaking, and therefore, that work should not delay the current rulemaking for crib mattresses. If, in the future, F406 is updated to address the work of the fit and thickness task group, then ASTM can notify the Commission under the provision in Public Law 112-28, and the Commission will evaluate the potential effect on the safety of play yard mattresses.

    Comment 6: Some commenters who manufacture crib mattresses objected to allowing after-market mattresses for play yards because all play yards are sold with a mattress designed for use with the play yard. One manufacturer questioned the safety and necessity of after-market mattresses.

    Response 6: In 2015, the Commission docketed a petition to ban supplemental mattresses for play yards. In response to that petition, the Commission directed staff to address hazards associated with supplemental play yard mattresses, as well as crib mattresses, through rulemaking under section 104. Staff's petition package stated: “[b]ecause incident data demonstrate that consumers perceive play yard mattresses to be uncomfortable, and then place additional soft bedding in infant sleep environments, CPSC staff does not recommend banning supplemental mattresses.” Although the Commission understands the concerns with after-market mattresses that can be used to supplement an existing play yard mattress, the Commission can address the hazard better, by directing CPSC staff to continue working through the voluntary standards committees to address the hazards associated with the use of after-market mattresses, and thereafter, incorporate the voluntary standard into a mandatory standard, to address both the safety of after-market mattress and consumers' perceived need for after-market mattresses.

    Comment 7: Commenters raised concerns that manufacturers make numerous, frequent changes in names and model numbers of play yards, rendering any list of compatible play yard models for after-market play yard mattresses “out of date as or soon after it is printed.” One commenter stated that the proposed rule would endorse misuse and, in effect, contradict the mandatory warning stipulated in 16 CFR 1221.2(b)(5)(i) that only the OEM mattress should be used with the play yard.

    Response 7: Although some type of certificate of compatibility could address issues with mattress fit and manufacturer concerns with third party manufacturers claiming compatibility, CPSC does not have the authority to regulate inter-business arrangements, such as certificates of compatibility. However, this final rule will require after-market mattresses to be “tested with each brand and model of product” [73] in which they are intended to be used. In addition, the final rule will require each mattress to “specifically identify the brand(s) and Model(s) numbers of products in which it is intended to be used.” [74] Accordingly, through the requirement in section 14 of the CPSC, as set forth in 16 CFR parts 1107 and 1110, an after-market mattress that complies with this rule will have third party certification that it meets the requirements for play yard mattresses in 16 CFR part 1221, incorporating ASTM F406.

    Because the final rule will require that an after-market mattress meet the same dimension and test requirements as the mattress supplied with the product, and must be tested and certified to the same standard, CSPC concludes that there is likely no safety concern for consumers, because the testing and certification require labeling that accomplishes the same goal. Additionally, because the labeling may create some confusion between ASTM F406, section 9.4.2.10 (“Use ONLY mattress/pad provided by manufacturer”), and 16 CFR 1221.2(b)(5)(i), the ASTM F15.18 task group on ad hoc warnings is actively working to revise this message.

    Comment 8: Several commenters stated that after-market mattresses should have to meet the same requirements as OEM mattresses. Another commenter stated that staff should continue working with ASTM to include more performance-based testing Start Printed Page 8661 for after-market mattresses. Several commenters supported the revised requirements for after-market mattresses developed by the ASTM non-segmented mattress task group, which were approved (and now published) in ASTM F2933-21. A commenter also requested that the final rule wait until the play yard fit and thickness task group completes work.

    Response 8: The Commission agrees that after-market play yard and non-full-size crib mattresses should meet the same requirements as OEM mattresses. The Commission addressed these points in the NPR, by proposing that after-market, non-full-size crib mattresses meet the same requirements listed for these products in ASTM F406 section 5.17, Mattress for Rigid Sided Products, and by proposing that after-market play yard mattresses meet the ASTM F2933-19 requirement to have the same “thickness, floor support structure and attachment method as the mattress it is intended to replace.” The revisions in ASTM F2933-21 replace the design requirement for after-market mattresses with the performance requirements that they are tested to, such that after-market mattresses must meet the same performance requirements as OEM mattresses. Additionally, ASTM F2933-21 requires that after-market mattresses be “at least the same size,” and the floor support structure must be “at least as thick,” as the OEM mattress. CPSC staff advises that they support these changes to the standard, which appear to be in line with comments CPSC received on the NPR. Accordingly, for the final rule, the Commission will incorporate by reference ASTM's newly revised voluntary standard, ASTM F2933-21. The Commission will not delay this final rule to wait until work is completed in the play yard subcommittee on mattress fit and thickness. Although staff remains engaged on the play yard task group for fit and thickness, changes to the play yard standard are out of scope for this specific rulemaking on crib mattresses.

    Moreover, although the commenter implied that the play yard fit and thickness work was nearing completion, staff advises that the task group is focused on measuring the gap between the play yard side and mattress only along the plane of the top of the mattress, without accounting for the flexible nature of fabric or mesh sides. As described in the briefing package on the supplemental mattress petition, a gap alone may not create a hazard if a three-dimensional pocket cannot form to entrap an infant. Staff informs that the task group is generally resistant to using a probe to identify hazardous gaps, and instead, is focused on measuring a gap alone. The figure below was included in the staff briefing package on Petition CP 15-2, illustrating that a one-dimensional measurement may not achieve the desired hazard identification.

    C. Improving Communication to Caregivers

    Comment 9: One commenter recommended that the Commission engage with child safety advocates and other interested parties to undertake a coordinated campaign to communicate to consumers appropriate behaviors that will enhance the safety of infant sleep.

    Response 9: The Commission agrees that a coordinated campaign to communicate to consumers the importance of placing an infant on their back to sleep without any covering beyond a light blanket would promote safe infant sleep behaviors for caregivers. However, the Commission acknowledges that a warning label statement on a consumer product cannot guarantee that consumers will read, understand, or heed the warning regarding the hazard.

    Comment 10: A commenter recommended a maximum of three warning statements on the product, and provided the suggested language below (verbatim):

    1. Place your baby on his/her back only.

    2. Do not add soft bedding (blankets, pillows, etc) under or over your baby, or anywhere in play yard. Instead, dress baby in a wearable blanket or sleep sack to keep them warm.

    3. Use mattress and sheets that fit this product—Use play yard mattress only. If mattress is too small, your baby can roll into gap and suffocate.

    For more information, go to www.cpsc.com/​sleepsafety

    Save this warning!

    [Link above is a placeholder for a functioning link to more information.]

    Start Printed Page 8662

    Response 10: Consistent with the NPR, CPSC agrees with several points raised by the commenter, including that: (1) Consumers are less likely to read lengthy text warnings on familiar products; (2) it is critical to communicate successfully to consumers the hazards related to prone positioning, soft bedding, and gaps created by ill-fitting mattresses; and (3) the prone positioning message needs to be prioritized. While, in general, staff advises that warning labels should be as concise as possible, circumstances specific to these products and hazards warrant more information on the labels, and consumers may not check a website identified on the label. Hazardous use patterns associated with products for infant sleep are common and are likely to be misunderstood by consumers. Consumers may not find short warning statements for crib mattresses convincing, absent elaboration and repetition with rephrasing, especially if the statements contradict the consumers' knowledge, expectations, and experiences. The warning labels in the final rule begin with clear and concise statements pertaining to the typical use patterns involved in SIDS and suffocation incidents, beginning with the prone positioning message. These statements are organized and worded such that they are more likely to be seen and understood, and act as reminders, even if the consumer does not read the rest of the label. The rest of the messaging reiterates, rephrases, and explains the hazards. For example, consumers must consider and understand what it means for a mattress to be ill-fitting. As discussed in Staff's Final Rule Briefing Package, a mattress in an uncompressed state may not visually produce worrisome gaps; yet, various factors can cause a compressed mattress to form hazardous gaps. With few exceptions, including placing the prone positioning warning foremost in the label, the final rule warning label is consistent with recommendations from ASTM F15. Tab D of Staff's Final Rule Briefing Package, and section VI.B of this preamble, outline other exceptions.

    Comment 11: A commenter recommended modifying the proposed hazard identifier from “SIDS and SUFFOCATION HAZARDS” to “Help Prevent SIDS and Suffocation.”

    Response 11: The Commission declines to adopt the modifications to the warning label as set forth by the commenter. Among other concerns, the comment-proposed hazard identifier may confuse the consumer viewing the warning label. The viewer of the label may infer that the statement, “Help Prevent SIDS and Suffocation,” is a standalone statement, unrelated to the rest of the warning message. Use of “Help,” although accurate, may soften the language, and perhaps, demotivate the reader. ASTM subcommittee members do not support the commenter's warning approach. During the ASTM F15.66 subcommittee meeting on June 9, 2021, attendees stated that such a change would dilute the warning message, and opined that the hazard identifier should remain as balloted in F15 (21-02) ( i.e., “SUFFOCATION HAZARDS”). The hazard identifier and ballot are discussed further in Tab D of Staff's Final Rule Briefing Package and section VI.B of this preamble.

    Comment 12: A commenter advised against all-caps lettering to emphasize words that “lack concrete meaning,” such as “DO NOT” and “USE ONLY.” A commenter posited that this capitalization will be inferred by the consumer to mean the adjacent text is not as important, and therefore, the adjacent text, which pertains to hazardous use, will not be read by the consumer.

    Response 12: The Commission declines to follow the commenter's suggestion. Based on staff's advice, we conclude that the all-caps lettering used in the final rule warning label plays an important role in attracting a consumer's attention to the hazardous-use warnings. Recent regulations use capitalization in this manner: [75] All-caps lettering is used in the recommendations from the Ad Hoc Language Task Group; and all-caps lettering pertaining to crib mattresses has been supported in ASTM F15.66 and balloted by ASTM F15 without objection. For more information on this ballot, see Tab D of Staff's Final Rule Briefing Package and section VI.B of this preamble.

    Comment 13: A commenter advised the Commission to eliminate warning statements that can and should be addressed through performance standards. The commenter's point is provided in the context of a recommendation to standardize sizes of play yards and play yard mattress sheets.

    Response 13: The Commission agrees that performance requirements should be used instead of warning statements, where feasible, and that warning statements should be omitted if they do not contribute to the safety of the product. Warnings are inherently limited in effectiveness, because they depend fallibly on persuading consumers to alter their behaviors in ways to avoid hazards. In contrast, performance requirements attempt to reduce or eliminate access to the hazards. The Commission's approach is to make warnings as motivating as possible, given their inherent fallibility, and particularly when they must be used instead of performance requirements, or when they are used in a supporting role to performance requirements that minimize, rather than eliminate, exposure to hazards.

    The commenter is referring to a separate standard, ASTM F406, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards (incorporated into 16 CFR part 1221), and ongoing activity by the ASTM F15.18 subcommittee contributing to that effort, which is out of scope for the current rulemaking. However, the Commission encourages the ASTM F15.18 subcommittee to develop more effective performance requirements to reduce the reliance on warnings.

    Comment 14: A commenter stated that to support the crib mattress warnings, CPSC should develop pictograms and evaluate comprehension of pictograms using the methods outlined in ANSI Z535.3.

    Response 14: Well-designed graphics may be able to supplement the crib mattress warnings, such as by increasing the noticeability of the warnings. Graphics are also helpful for consumers with limited or no English literacy. However, the design of effective graphics is a complicated matter that requires comprehension testing with the target audience. A poorly designed graphic may have limited or no effectiveness, and may even elicit the opposite effect than intended; i.e., a “critical confusion,” in which the reader infers that s/he should take the prohibited action to avoid the hazard. Although CPSC is not opposed to considering suitable graphics pertaining to crib mattress warnings, the agency will not delay the final rule until suitable graphics are developed.

    Comment 15: A commenter recommended revising the play yard mattress warning language, as set forth in the comment, in part, because the Flesch-Kincaid readability assessment tool in MS Word indicated the message required only a “5.9 grade reading level.”

    Response 15: For consistency and comparison purposes, staff used the Flesch-Kincaid readability assessment Start Printed Page 8663 tool in MS Word (Microsoft Office Professional Plus 2019) on the play yard mattress warning set forth by the commenter and the final rule label for after-market mattresses for mesh/fabric-sided products.[76] Staff found that the play yard mattress warning urged by the commenter returned a 5.4 Flesch-Kincaid Grade Level with a reading ease of 77.1. The final rule after-market mattress for mesh/fabric-sided products warning returned a 3.4 Flesch-Kincaid Grade Level with a reading ease of 80.8. However, the rating for the final rule label, as proposed in the NPR, does not include the product-specific information to be added:

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

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

    Comment 16: A commenter stated that CPSC should determine whether it is appropriate to add warnings content regarding fall or strangulation.

    Response 16: Based on staff's advice, the Commission does not find it appropriate to add to the crib mattress warnings content regarding fall or strangulation. Warnings pertaining to these hazards are addressed by other standards, including ASTM F1169, Standard Consumer Safety Specification for Full-Size Baby Cribs (incorporated into 16 CFR part 1219), and ASTM F406 (incorporated into 16 CFR parts 1220 and 1221). As discussed by the commenter, adding more information to the final rule warnings may dilute the message, resulting in some consumers being less likely to read the warnings. Furthermore, ASTM F15 did not find it appropriate to include warning content regarding falls or strangulations. Staff will continue to monitor the data for evidence that these additional warnings should be added.

    Comment 17: A commenter stated that the warnings proposed in the NPR are incompatible with the warnings in ASTM F406, because the requirements in the NPR allow after-market mattresses in play yards, which are not from the OEM; whereas, ASTM F406 includes warnings to use only the mattress provided by the manufacturer.

    Response 17: The Commission is aware of the warning labels required by the separate rules. Although modifications to warnings in F406 are outside the scope of this rulemaking for crib mattresses, we note that the play yard subcommittee, ASTM F15.18, has an active task group working to update the warning section of ASTM F406 to include the ad-hoc warning recommendation and to address other issues. This play yard task group is actively discussing how to update [79] this warning message. If the play yard voluntary standard is revised, the CPSC will evaluate the revision for inclusion in the mandatory standard for play yards through the Public Law 112-28 update process.

    Comment 18: A commenter stated that CPSC should consider the developments to safety information requirements discussed in the crib mattress ASTM task group and subcommittee in the period between the NPR and final rule.

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

    D. Procedural Comments

    Comment 19: Commenters both supported and opposed the proposed 6-month effective date for the final rule. Some commenters urged the effective date of a final rule to be as soon as possible, because additional time for the rule to become effective would put infants at risk. Other commenters requested an indefinite delay of the rulemaking, until ASTM completes changes and updates to the voluntary standard for crib mattresses (ASTM F2933), and the standard associated with play yards (ASTM F406).

    Response 19: For the final rule, the Commission will retain the proposed 6-month effective date. Crib mattress suppliers have had lead time to prepare for the final rule since the NPR was published on October 26, 2020. Many crib mattresses within the scope of the final rule require no change in design to achieve compliance with the final rule. Furthermore, 6 months from the change in a voluntary standard is the time frame that JPMA uses for its certification program. Consequently, compliant manufacturers are used to this time frame to comply with a modified standard. Additionally, the Commission will not wait for completion of work in the ASTM F406 standard to finalize this crib mattress rule, because modifications to ASTM F406 are out of the scope of this proceeding.

    Comment 20: A commenter states that the NPR is unconstitutional because CPSC proposed to incorporate by a reference a voluntary standard, instead of publishing all of the regulatory text for the crib mattress rule in the Federal Register . The commenter asserted that the CPSC forces the public to pay for access to the law, thereby offending “our constitutional structure, due process, the First Amendment, and equal protection.” The commenter, in support of their contention that incorporation by reference (IBR) is unconstitutional, stated:

    • No one can own the law, privatizing the law is not in accordance with our form of constitutional government and grants ASTM a monopoly ownership over the law;

    • Due process under the Fifth Amendment requires the public to have free access to the laws that regulate people or entities, and the NPR allegedly violates due process by failing to provide the public with fair notice of the standard because the commenter Start Printed Page 8664 contends that to view the content of the voluntary standard, the NPR requires the public to pay ASTM or to travel to Bethesda, MD, to see a copy at CPSC headquarters;

    • CPSC is creating a monopoly for ASTM and forcing the public “to rely on the whims of ASTM,” whom the commenter states is a private company that is incentivized to increase the prices of its standards, and which harms consumers more than businesses because it creates a financial barrier to accessing product safety standards;
    • IBR violates the First Amendment because it does not allow free dissemination of the law and discussion of its contents; and
    • IBR violates equal protection of the laws under the Fifth Amendment because it gives ASTM members a preference over non-members, because ASTM members have access to the voluntary standard as it is being developed and during the comment period, while non-members do not. The commenter believes that ASTM only makes the voluntary standard available to view for free after the public comment period closes.

    Response 20: We disagree that the regulatory text is behind a paywall and that the draft final rule is unconstitutional. As set forth in more detail below, the commenter's factual premise is inaccurate, because the regulatory text for every CPSC-proposed rule is printed in the Federal Register . Additionally, the content of the law is available to the public, both before and after the voluntary standard is incorporated by reference, because the text of the voluntary standard is described in detail in the staff's proposed rule briefing package, draft final rule briefing package, and in the proposed and final rulemaking notices printed in the Federal Register . Stakeholders also have access to the text of the voluntary standard online, for free, both during the comment period ( https://www.astm.org/​CPSC.htm ), and after the rule becomes final (at https://www.astm.org/​READINGLIBRARY/​ ). Any person can “disseminate” the proposed rule by citing the Federal Register , providing a link, or providing a copy of the notice. Additionally, anyone can “disseminate” the content of the voluntary standard by providing a link to ASTM's website. Finally, anyone can participate in ASTM meetings to develop the voluntary standard, and CPSC encourages the public to participate. Although only ASTM members can vote on a voluntary standard, ASTM provides discounts on membership for certain members of the public, such as students. Please contact ASTM for more information.

    Section 104 of the CPSIA directs the Commission to issue standards for durable infant or toddler products that are “substantially the same as,” or more stringent than, applicable voluntary standards, if the Commission determines that more stringent requirements would further reduce the risk of injury. In this case, the final rule would incorporate by reference ASTM F2933-21, with modifications to make the standard more stringent, to further reduce the risk of injury associated with crib mattresses. Staff notes that staff's proposed rule and draft final rule briefing packages contain a description of the performance and labeling requirements in the ASTM standard, including a side-by-side chart showing regulatory text and the changes made by the rule.

    With regard to IBR procedures, we note that ASTM's voluntary standards are protected by copyright, which the Commission (and the federal government generally) must observe. The United States may be held liable for copyright infringement. 28 U.S.C. 1498. Accordingly, the Commission cannot violate copyright law by publishing ASTM's voluntary standards in the CFR. The Office of the Federal Register (OFR) has established procedures for incorporation by reference that seek to balance the interests of copyright protection and public accessibility of material. 1 CFR part 51. OFR's regulations are based on Freedom of Information Act provisions that require materials to be “reasonably available” when incorporated by reference with approval of the Director of the Federal Register. 5 U.S.C. 552(a)(1). Under the OFR's requirements, an agency may incorporate by reference specific publications, including standards, if they are “reasonably available to and usable by the class of persons affected.” 1 CFR 51.7. To ensure the material is “reasonably available,” an agency must summarize the material it will incorporate by reference and discuss in the Federal Register notice how that material is available to interested parties. Id. §§ 51.3(a), 51.5(a).

    The Commission complies with the requirement that publications, including standards, are “reasonably available to and usable by the class of persons affected,” whenever incorporating material by reference. For example, when the Commission proposes a rule under section 104 of the CPSIA, the Commission describes and summarizes the requirements of the rule, including the voluntary standard, in the preamble of the rule printed in the Federal Register , and explains that ASTM's copyrighted voluntary standards are available to review online for free during the comment period at https://www.astm.org/​CPSC.htm. Once a rule becomes effective, ASTM provides a read-only copy of the standard for review on the ASTM website at: https://www.astm.org/​READINGLIBRARY/​. As always, any person can purchase a voluntary standard from ASTM, or may schedule a time to review a voluntary standard (for free) at the Commission's headquarters in Bethesda, MD, or at the National Archives and Records Administration (NARA). Accordingly, citizens who are interested in the content of the law have unimpeded access to the regulation, and have several avenues for free access to the text of voluntary standards incorporated by reference into a mandatory CPSC standard for a durable infant or toddler product.

    Comment 21: A commenter stated that they intend their comment to be a significant adverse comment that requires CPSC to withdraw the NPR, citing eight previous times the commenter has submitted a similar comment on CPSC's IBR process for rules updating a section 104 standard.

    Response 21: The commenter is referencing previous comments made regarding the Commission's direct final rules to update durable infant or toddler product rules that have already been issued under section 104 of the CPSIA. The Commission did not find similar comments on those updates to be a significant adverse comment. In this case, the Commission issued a proposed rule, and is now issuing a final rule, to establish a consumer product safety standard for crib mattresses, and is not updating an existing rule using a direct final rule. Accordingly, the “significant adverse comment” designation is inapplicable to the current rulemaking. In any event, the Commission declines to withdraw the proposed rule based on the inaccurate factual premise regarding IBR procedure contained in this comment.

    Comment 22: A commenter asserted that section 9 of the CPSA requires the CPSC to publish the text of a proposed consumer product safety rule in the Federal Register . Because section 104 rules are considered consumer product safety rules under the CPSA, the commenter argued that CPSC is required to published the text of the regulation in the Federal Register , and the CPSC did not meet this requirement in the NPR for crib mattresses.

    Response 22: The Commission publishes the text of proposed rules under section 104 of the CPSIA in the Start Printed Page 8665 Federal Register . However, the rulemaking procedure described in section 9 of the CPSA, cited by the commenter, is inapplicable to rules issued under section 104 of the CPSIA. Section 104 of the CPSIA contains a different rulemaking authority and different rulemaking procedures. For example, 15 U.S.C. 2058(c), cited by the commenter, also requires a preliminary regulatory analysis that is inapplicable to rules issued under section 104.

    Comment 23: A commenter stated that the Freedom of Information Act (FOIA) requires agencies to publish the text of its substantive rules in the Federal Register , citing 5 U.S.C. 552(a)(1)(D). The commenter stated that § 552(a) creates an exception to this requirement for agencies that incorporate by reference a provision that is “reasonably available to the class of persons affected thereby . . . with the approval of the Director of the Federal Register.” The commenter asserted that the CPSA, which allegedly requires publishing the text of a proposed rule in the Federal Register , and the FOIA are in conflict, and that CPSC must follow the CPSA because it is a more specific, later-enacted, requirement and presents a “clear congressional imperative for CPSC to follow the text of the [CPSA],” citing 15 U.S.C. 2058(c). The commenter asserted that based on the CPSA, the Commission must publish the text of the NPR and cannot direct the public to buy a copy of the regulatory text from someone else.

    Response 23: As stated in response to the preceding comments, stakeholders do not need to purchase a copy of the voluntary standard to comment on the rule, and the Commission publishes the text of proposed rules under section 104 of the CPSIA in the Federal Register . A summary of the regulatory text is available for free in the staff briefing package and the proposed rule. A free copy of the voluntary standard is available through ASTM's website, NARA, and at the Commission's headquarters in Bethesda, MD, as described in response to preceding comments. Additionally, section 104 of the CPSIA contains a different rulemaking authority and procedures than the statutory provision cited by the commenter for CPSA section 7 and 9 rules. The statute cited by the commenter is inapplicable to section 104 rules. Finally, CPSC follows the OFR's requirements for incorporation by reference, including the exception in 5 U.S.C. 552(a), which allows incorporation by reference when the material is “reasonably available to the class of persons affected thereby . . . with the approval of the Director of the Federal Register.”

    Comment 24: A commenter contended that the CPSC should not rely on the Office of the Federal Register's interpretation of the exception for IBR materials in 1 CFR 51.5, and should instead publish the text of the voluntary standard.

    Response 24: We disagree. The OFR's interpretation of the exception is consistent with the statute, has not been struck down by any court, and the CPSC declines to potentially infringe a copyright. Additionally, as reviewed in response to preceding comments, stakeholders have free access to the content of the proposed and final rules, including the regulatory text and the voluntary standards upon which the standards are based.

    Comment 25: A commenter alleged that CPSC's proposal to IBR the crib mattress voluntary standard, rather than set forth the text of the regulation in the OFR, is procedurally deficient because the rule allegedly only allows access to the text of the voluntary standard after a rule is in effect, and because it leaves access to the law up to the “whims” of ASTM. The commenter alleged that ASTM can raise the cost of the voluntary standard, and can “renege” on its promise to keep the standard available in a reading room.

    Response 25: The text of the proposed rule, and a summary of the voluntary standard, are available for free on the Commission's website in the staff's briefing packages and in the draft rules, which are also available, when published, in the Federal Register . Moreover, the text of the voluntary standard is available for free both before and after the comment period, as described in response to preceding comments. Finally, stakeholders can view the rule for free by contacting NARA and by coming to view the standard at the Commission's headquarters in Bethesda, MD.

    VIII. Mandatory Standard for Crib Mattresses

    The final mandatory standard for crib mattresses incorporates by reference the most recent voluntary standard for crib mattresses, ASTM F2933-21, with modifications, largely as proposed in the NPR, to make the standard more stringent, to further reduce the risk of injury associated with crib mattresses. Below we summarize modifications made to the voluntary standard in the final rule.

    A. Cyclic Test for Coil or Spring Lacerations

    To further reduce the risk of infant lacerations from exposed coils and springs, the Commission will require a cyclic loading test for all crib mattresses that use coils and springs, as follows:

    1. Mattress shall be tested in an enclosed frame measuring 29 inches x 53 inches (737 mm x 1346 mm) for the purpose of restricting mattress movement. A crib meeting the requirements of ASTM F1169-19 would suffice.

    2. The mattress can be placed on top of a 3/4 -inch piece of plywood or oriented strand board (OSB), which is rigidly supported along the perimeter.

    3. An impactor with the dimensions of the vertical impactor of ASTM F1169-19 weighing 30 lbs. shall be dropped from a height of 6 inches from the top of the mattress surface to the bottom of the impactor, 250 times in four locations (specified in Figure 5), for a total of 1,000 cycles. Cyclic loading rate shall be one drop every 4 ± 1 seconds.

    4. At the conclusion of the cyclic loading test, the mattress shall be removed from the test enclosure and visually inspected for exposed wires or coil springs.

    5. The coil spring test shall be repeated on each sleep surface of the mattress. The test shall not be repeated using a mattress that has been previously tested with the coil spring test.

    The final rule clarifies that two mattresses are required for cyclic load testing, one mattress for each side of the mattress being tested, because testing can be destructive to the test sample.

    Start Printed Page 8666

    B. Test for Mattress Compression From Fitted Sheets

    To further reduce the risk of injury associated with corner gap entrapment from compression by fitted sheets, the final rule requires a new test for full-size crib mattresses:

    1. To condition the sheet for compression testing, a store-bought, fitted mattress sheet, intended for the tested mattress size, consisting of 100 percent cotton, shall be washed in hot water (50 °C [122 °F] or higher), and dried a minimum of two times on the highest setting, using household textile laundering units.

    2. The shrunken fitted sheet shall be placed fully on the mattress, such that each sheet edge is wrapped fully around and under the mattress.

    3. The mattress, with the shrunken sheet, shall be positioned in the corner, following section 6.2.2.1 of ASTM F2933-21.

    4. After positioning, while no force is being applied, measure the gap from the projected crib corner, located 53 in. from Wall C and 2858 in. from Wall D, and the crib mattress. See Figure 6 for illustration. The gap shall not exceed 3.15 in.

    5. Rotate the mattress 180°, and repeat steps 3 and 4.

    Start Printed Page 8667

    The Commission is not aware of incidents related to non-full-size crib mattresses compressing when sheets are installed, and received no comments on the issue. Therefore, at this time, the final rule does not require a similar sheet compression test for non-full-size crib mattresses. However, the final rule modifies the test procedure to accommodate larger crib mattresses, by requiring the corner gap to be measured from a projected crib corner.

    C. Dimension Requirements for After-Market Non-Full-Size Crib Mattresses

    To further reduce the risk of injury associated with after-market, non-full-size crib mattresses, the final rule requires a dimensional performance requirement for all non-full-size crib mattresses. The Stability; Cord/Strap Length; and Crib-Side Height requirements in F406 are also applicable to non-full-size crib mattresses, but the requirements were not referenced in ASTM F2933-19, or by modifications in the NPR. The newly published ASTM F2933-21 added a reference to these requirements in section 5.9 of the standard. The final rule adds a reference to Crib-Side Height to the list of F406 requirements referred to in section 5.7.2 of ASTM F2933-21, and removes this reference from section 5.9, because it does not apply to play yard mattresses. Accordingly, the final rule references the F406 requirements for Stability and Cord/Strap Length in section 5.7.2 and section 5.9 of ASTM F2933-21, because these are general requirements applicable to non-full-size crib and play yard mattresses. This change is consistent with the changes proposed in the NPR, to ensure that all after-market, non-full-size crib mattresses are subject to the same requirements as OEM non-full-size crib mattresses.

    ASTM F2933-21 includes additional requirements for after-market non-rectangular non-full-size crib mattresses, which ensure the after-market mattress maintains the proper fit, support, and instruction storage accommodations. The final rule extends these requirements to all after-market, non-full-size crib mattresses, to be consistent with the NPR proposal to extend requirements to all non-full-size crib mattresses, regardless of shape.

    Appendix A to Tab C of Staff's Final Rule Briefing Package contains a redline of changes in the final rule to section 5.7.2 of ASTM F2933-21.

    D. Corrections to Section 5.9 of ASTM F2933-21

    To accommodate the modification for non-full-size cribs in section 5.7, the final rule removes references to after-market, non-full-size crib mattresses from section 5.9 of ASTM F2933-21, such that section 5.9 focuses solely upon performance requirements for after-market play yard mattresses.

    The NPR proposed to replace the term “replacement mattress” in ASTM F2933-19 section 5.9.1.3, with the term “after-market” mattresses. ASTM F2933-21 made this revision, and thus, the final rule does not require this revision, if the Commission incorporates by reference ASTM F2933-21.

    E. Mattress Firmness Test

    To further reduce the risk of infant suffocation associated with surface softness in crib mattresses, the final rule requires a mattress firmness test for all crib mattresses within the scope of the standard, based on a test for mattress firmness in section 8 of AS/NZS 8811.1:2013:

    1. Mark three equidistant points along the longitudinal center line, with one at the center, and the other two equidistantly between the center and the edge of the mattress. Choose one more “worst-case” scenario test location(s) where an infant's head might lay in a particularly soft spot, or an infant's nose or mouth might contact a protrusion above the sleep surface.

    2. Hold the test fixture with its base horizontally, and rotate it so the feeler arm is aligned with the center line of the sleep surface, and pointing in the same direction for each test; then gently set down the fixture on one of the test locations, ensuring that the edge of the bottom disk does not extend beyond the edge of the sleep surface.

    3. If the level indicates that the feeler arm is approximately level when the fixture is resting on the sleep surface, observe whether the feeler arm makes any contact with the top of the sleep surface or cover. If the feeler arm is not level, decompress the mattress, allow it to settle, and start again. If the feeler arm contacts the sleep surface even when the test fixture is tilted back so as to raise the feeler arm, assume that such contact would occur had the fixture come to rest horizontally.

    4. Repeat steps at remaining locations. Start Printed Page 8668

    F. Modifications to Safety Information

    As detailed in Tab D, Appendix A, of Staff's Final Rule Briefing Package, the final rule includes a redline of the modifications to the requirements for the safety information that accompanies crib mattresses, as proposed in the NPR, including warning labels, packaging, and instructions. Labeling modifications include the following:

    • Improved definition of “conspicuous” to clarify that the warning label's placement must make it visible to someone who positions the mattress for use;
    • Updated the general marking and labeling requirements;
    • Improved warning labels and examples;
    • Re-organized and clarified the marking and labeling requirements for manufacturers, test labs, and other viewers of the standard;
    • Added warning requirements for full-size crib mattress packaging and improved the warning requirements for packaging of after-market mattresses for play yards and non-full-size cribs; and
    • Added a new section on instructional literature, which provides an additional medium by which to communicate safe-use information.

    These modifications are intended to further reduce the risk of death and serious injury associated with crib mattresses, such as SUID related to prone positioning of infants, soft bedding in sleep areas, and hazardous gaps between crib mattresses and product sides. The majority of the modifications incorporate recommendations from stakeholders participating in ASTM F15, with several deviations based on CPSC staff's further consideration of the available data. While safety information is unlikely to effectively address the identified hazards, these modifications are likely to support the effectiveness of the performance requirements, increase the likelihood of consumers understanding the hazards, and clarify the requirements for manufacturers, test labs, and other viewers of the standard. Section VI.B of this preamble, and Tab D of Staff's Final Rule Briefing Package contains a detailed list of the final rule modifications.

    IX. Amendment to 16 CFR Part 1112 To Include NOR for Crib Mattresses

    The CPSA establishes certain requirements for product certification and testing. Products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Certification of children's products subject to a children's product safety rule must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. 2063(a)(2). The Commission must publish an NOR for the accreditation of third party conformity assessment bodies to assess conformity with a children's product safety rule to which a children's product is subject. Id. 2063(a)(3). The final rule, to be codified as 16 CFR part 1241, Standard Consumer Safety Specification for Crib Mattresses, is a children's product safety rule that requires the issuance of an NOR.

    The Commission published a final rule, Requirements Pertaining to Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013), codified at 16 CFR part 1112 (“part 1112”) and effective on June 10, 2013, which establishes requirements for accreditation of third party conformity assessment bodies to test for conformity with a children's product safety rule in accordance with section 14(a)(2) of the CPSA. Part 1112 also codifies all of the NORs issued previously by the Commission. All new NORs for new children's product safety rules, such as the crib mattress standard, require an amendment to part 1112. Accordingly, in the NPR, the Commission proposed to amend part 1112 to add part 1241, Safety Standard for Crib Mattresses, in the list of NORs.

    Test laboratories applying for acceptance as a CPSC-accepted third party conformity assessment body to test to the new standard for crib mattresses are required to meet the third party conformity assessment body accreditation requirements in part 1112. When a laboratory meets the requirements as a CPSC-accepted third party conformity assessment body, the laboratory can apply to the CPSC to have 16 CFR part 1241, Standard Consumer Safety Specification for Crib Mattresses, included in the laboratory's scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC website at: www.cpsc.gov/​labsearch.

    X. Amendment to Definitions in Consumer Registration Rule

    The statutory definition of “durable infant or toddler product” in section 104(f) applies to all of section 104 of the CPSIA. In addition to requiring the Commission to issue safety standards for durable infant or toddler products, section 104 of the CPSIA also directed the Commission to issue a rule requiring that manufacturers of durable infant or toddler products establish a program for consumer registration of those products. Public Law 110-314, section 104(d).

    Section 104(f) of the CPSIA defines the term “durable infant or toddler product” and lists examples of such products:

    (f) DEFINITION OF DURABLE INFANT OR TODDLER PRODUCT. As used in this section, the term “durable infant or toddler product” —

    (1) means a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years; and

    (2) includes —

    (A) full-size cribs and non-full-size cribs;

    (B) toddler beds;

    (C) high chairs; booster chairs, and hook-on-chairs;

    (D) bath seats;

    (E) gates and other enclosures for confining a child;

    (F) play yards;

    (G) stationary activity centers;

    (H) infant carriers;

    (I) strollers;

    (J) walkers;

    (K) swings; and

    (L) bassinets and cradles.

    Public Law 110-314, section 104(f).

    The product categories listed in section 104(f)(2) of the CPSIA represent a non-exhaustive list of durable infant or toddler product categories, including products 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 infant sleep products, crib mattresses are not included in the statutory list of durable infant or toddler products.

    In 2009, the Commission issued a rule implementing the consumer registration requirement. 16 CFR part 1130. As the CPSIA directs, the consumer registration rule requires each manufacturer of a durable infant or toddler product to: Provide a postage-paid consumer registration form with each product; keep records of consumers who register their products with the manufacturer; and permanently place the manufacturer's name and certain other identifying information on the product. When the Commission issued the consumer registration rule, the Commission identified six additional products as “durable infant or toddler products”:

    Children's folding chairs,

    changing tables,

    infant bouncers,

    infant bathtubs,

    bed rails, and

    infant slings.

    16 CFR 1130.2. The Commission stated that the specified statutory categories were not exclusive, but that the Commission should explicitly identify the product categories that are covered. The preamble to the 2009 final Start Printed Page 8669 consumer registration rule states: “Because the statute has a broad definition of a durable infant or toddler product but also includes 12 specific product categories, additional items can and should be included in the definition, but should also be specifically listed in the rule.” 74 FR 68668, 68669 (Dec. 29, 2009).

    In the NPR, the Commission proposed to amend part 1130 to include “crib mattresses,” as defined in ASTM F2933, including full-size crib mattresses, non-full-size crib mattresses, and after-market mattresses for play yards and non-full-size cribs, as durable infant or toddler products. 85 FR at 67923. The Commission proposed to include “crib mattresses” as a “durable infant or toddler product” 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 unattended infant sleep, such as cribs, bassinets, and play yards; and (4) CPSC cannot fully address the risk of injury associated with such infant sleep products without addressing the hazards associated with the use of crib mattresses in these infant sleep products. Id. The Commission received no comments on this proposal, and now finalizes the amendment to part 1130 to add “crib mattresses” to the list of durable infant or toddler products.

    XI. Incorporation by Reference

    Section 1241.2(a) of the final rule provides that each crib mattress must comply with applicable provisions of ASTM F2933-21. The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. 1 CFR part 51. For a final rule, agencies must discuss in the preamble to the rule the way in which materials that the agency incorporates by reference are reasonably available to interested persons, and how interested parties can obtain the materials. Additionally, the preamble to the rule must summarize the material. 1 CFR 51.5(b).

    In accordance with the OFR's requirements, sections V, VI, and VIII of this preamble summarize the provisions of ASTM F2933-21 that the Commission is incorporating by reference. ASTM F2933-21 is copyrighted. Before the effective date of this rule, you can view a copy of ASTM F2933-21 at: https://www.astm.org/​cpsc.htm. Once the rule becomes effective, ASTM F2933-21 can be viewed free of charge as a read-only document at: https://www.astm.org/​READINGLIBRARY/​. To download or print the standard, interested persons can purchase a copy of ASTM F2933-21 from ASTM, through its website ( http://www.astm.org ), or by mail from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; http://www.astm.org. Alternatively, interested parties can inspect a copy of the standard free of charge by contacting Alberta E. Mills, Division of the Secretariat, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-7479; email: cpsc-os@cpsc.gov.

    XII. Effective Date

    The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). The NPR proposed a 6-month effective date for the final rule. Commenters both supported and opposed the 6-month effective date. Some commenters urged the effective date be as soon as possible, indicating that additional time for the rule to become effective would put infants at risk. Other commenters requested an indefinite delay of the rulemakings until ASTM completes changes and updates to the voluntary standard, and those associated with crib mattresses.

    After considering the comments, the Commission now finalizes the rule with a 6-month effective date, because 6 months typically is sufficient time for suppliers to come into compliance with a new standard; typical for other CPSIA section 104 rules; and usually is the period that JPMA allows for products in their certification program to shift to a new standard, once that new standard is published. Accordingly, juvenile product manufacturers are accustomed to adjusting to new standards within 6 months, and suppliers have now had lead time to prepare for this rule since the NPR was published on October 26, 2020. Finally, many crib mattresses within the scope of the final rule require no change in design to achieve compliance with the final rule.

    XIII. Regulatory Flexibility Act [80]

    A. Introduction

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires that agencies review a proposed rule and a final rule for the rule's potential economic impact on small entities, including small businesses. Section 604 of the RFA generally requires that agencies prepare a final regulatory flexibility analysis (FRFA) when promulgating final rules, unless the head of the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Staff prepared a FRFA that is available at Tab E of Staff's Final Rule Briefing Package. An FRFA is required to describe the impact of the rule on small entities and identify any alternatives that may reduce the impact. Based on staff's analysis, the Commission anticipates a possible significant economic impact for one small domestic importer and two small domestic manufacturers that supply crib mattress products to the U.S. market.

    B. Final Rule Objectives, Legal Basis, Product Description, and Market

    The objective of the final rule is to reduce the risk of injury and death associated with full-size crib mattresses, non-full-size crib mattresses, and after-market mattresses for play yards and non-full-size cribs (collectively referred to as “crib mattresses”). A detailed analysis of the objectives and statutory basis for the rule are set forth in section I of the preamble. Section II.A of this preamble describes the products subject to this final rule, section II.B describes the market for crib mattresses, and section II.C describes consumer use of crib mattresses.

    C. Small Entities To Which the Draft Proposed Rule Would Apply

    Manufacturers of crib mattresses are typically categorized under the NAICS category 337910 (Mattress Manufacturing). The Small Business Administration (SBA) guidelines consider mattress manufacturing establishments to be small if they have fewer than 1,000 employees.[81] Importers of crib mattresses are typically categorized under NAICS code 423210 (Furniture Merchant Wholesalers) and SBA guidelines would consider them small if they have fewer than 100 employees.

    Staff estimates that approximately 32 domestic firms supply crib mattresses to the U.S. market. Following SBA size guidelines, 27 are small firms—14 domestic manufacturers and 13 domestic importers. The five remaining domestic firms are large manufacturers. The expected impact of the draft final rule on small manufacturers and importers of crib mattresses will differ based on whether their crib mattresses are already compliant with ASTM F2933-21, the size-type of crib mattress the firm supplies to the market, and the materials used in the crib mattresses. Start Printed Page 8670 Staff estimates that approximately 75 percent of crib mattresses on the market are full-size crib mattresses; approximately 40 percent of full-size crib mattresses are coil/innerspring mattresses; and the remaining majority are foam-core mattresses.[82] Staff identified at least 15 small firms that only produce foam-core mattresses, while many small entities produce a combination of both coil and foam-core crib mattresses.

    Section VIII of this preamble describes the requirements of the final rule. Firms whose crib mattresses do not already comply with the rule will need to evaluate their products, determine what changes would be required to meet the standard, and decide how to proceed. Noncompliant products would need to be removed from the U.S. market, modified to meet the mandatory standard, or remarketed for purposes other than use as crib mattresses. New crib mattress products introduced to the market would also need to comply with the standard.

    Crib mattresses will be subject to the third party testing and certification requirements under the CPSA, as codified in 16 CFR part 1107 (children's product testing rule) and 16 CFR part 1110 (certificate rule), which require that manufacturers and importers certify that their products comply with the applicable children's product safety standards, based on third party testing, and subject their products to third party testing periodically. Third party testing costs are in addition to the costs of modifying the crib mattresses to meet the standard. For crib mattresses, the third party testing costs are expected to be about $950 per testing cycle per model. This is an increase in the costs as estimated in the IRFA in the 2020 NPR, which estimated a cost of $325 per sample.

    D. Impact of Draft Proposed Rule on Small Manufacturers and Importers

    Of the 27 small manufacturers and importers identified by staff, 14 (9 manufacturers and 5 importers) are members of the JPMA, but staff cannot determine how many crib mattresses are currently certified to ASTM F2933-21. Many of the firms that would be subject to the final rule are known to produce a variety of children's products that are already subject to a children's product safety rule, and therefore, are familiar with such requirements.[83] Additionally, two firms that are not known to be JPMA members, are members of ASTM.

    As required by section 14 of the CPSA and its implementing regulations, manufacturers and importers of crib mattresses would be required to certify that their crib mattresses comply with the requirements of the draft final rule, based on the results of third party testing by a CPSC-accepted third party conformity assessment body ( i.e., testing laboratory). However, crib mattresses are also already subject to third party testing requirements, and therefore, firms that supply crib mattresses to the U.S. market are already familiar with third party testing requirements.[84 85] Crib mattresses must already comply with two federal mattress flammability standards: 16 CFR parts 1632 and 1633. Firms that supply crib mattresses that are designed or intended primarily for children age 12 or under need to prepare a Children's Product Certification (CPC) that references parts 1632 and/or part 1633, when applicable. At this time, CPSC staff is not aware of any small domestic firms that supply crib mattresses to the U.S. market that are not compliant with CPSC's mattress flammability standards. Additionally, crib mattresses are subject to lead testing, unless exempt, phthalate testing for certain child care articles, and small parts testing and small parts labeling, as applicable. The final rule will augment these existing requirements.

    As part of the 2020 NPR, the Commission requested comments from small firms on the number of crib mattress models they would typically certify to the ASTM standard annually. However, the Commission did not receive any comments on the request. Some small manufacturers and importers of crib mattresses to the U.S. market would not be subject to all the tests proposed in the final rule, because the firm may only supply foam-core and/or non-full-size crib mattress products to the market.

    1. Costs Associated With Modifying Products

    The majority of crib mattresses tested by staff already meet the performance requirements of the final rule, and they will not require any modification to comply. Although we do not know the exact costs of modifying crib mattresses to comply with the final rule, we do know that such costs would vary by product model. During the public comment period, CPSC did not receive any comments related to one-time costs of redesigning a product to meet the standard, as proposed. Nonetheless, it is possible that some manufacturers of noncomplying mattresses might choose to drop the model, rather than incur the expense associated with modifying it.[86] Therefore, a possibility exists that the final rule could result in the removal of one or more crib mattress models from commerce.

    Changes to marking and labeling will be necessary on crib mattress products. Generally, costs associated marking and labeling, as well as providing instructional materials, are low on a per-unit basis. Many crib mattress suppliers already provide instructions with their crib products, but firms will need to ensure that the content and formatting of the instructions required for crib mattresses meet the requirements of the draft final rule.[87] Likewise, the cost of warning labels is generally low, especially if some warning labels are already present, and the product does not need to be modified to accommodate new labels.

    2. Third Party Testing Costs

    The final rule will require all manufacturers and importers of crib mattresses to meet additional third party testing requirements under section 14 of the CPSA. As allowed by the component part testing rule (16 CFR 1109), importers can rely upon third party tests obtained by their suppliers, which could reduce the impact on importers. In addition, businesses selling products covered by this rule were already required to certify compliance to general children's product rules for lead, phthalates, and small parts with third party testing. Accordingly, those third party testing costs would not be considered new costs of compliance with this rule. Start Printed Page 8671

    Although CPSC did not receive any comments on the NPR cost estimates provided in the IRFA, ongoing discussions with suppliers through ASTM indicate third party testing bodies will need to develop protocols for the testing proposed in the draft final rule, as well as establish prices for the prescribed testing. Based on information from a testing laboratory, the cost of testing to the current version of ASTM F2933 is $200 to $250 per sample. However, the cost of testing varies, based on the type of crib mattress and the number of samples tested. Furthermore, testing rates may have changed by accredited labs. According to new information provided by one crib mattress supplier, the price charged to test to ASTM F2933 for suppliers with very few models may be as high as $400 per model tested.[88] Costs for additional testing required by the final rule could increase the cost of testing substantially, although not all crib mattresses would be subject to all of the testing requirements.

    Staff estimates that for a manufacturer or importer with 10 crib mattress models that require only one test per model to provide a high degree of assurance, the full cost of third party testing will be approximately $4,000, plus $2,000 in costs for compression testing, plus $1,000 for the cost of possible cyclic load testing, plus $2,500 for required firmness testing, for a total of $9,500 in third party testing costs or an average of $950 per model.[89]

    3. Summary of Impacts

    Generally, based on SBA guidelines, CPSC considers impacts that exceed 1 percent of a firm's revenue to be potentially significant. The lowest reported annual revenue for any small domestic firm producing crib mattress models was $1.07 million. One percent of annual revenue for the firm is $10,700 ($1,070,000 × 0.01). Consequently, if the costs of modifying their mattresses to comply with the standard exceeds $10,700, the rule should be considered to have a significant impact for the firm. This would include the costs of modifying noncompliant mattresses to comply with the requirements, the loss of revenue that results from removing noncompliant mattresses from their product line, and the cost of third party testing. For manufacturers or importers with greater revenue, the impact of the draft proposed rule would have to be higher than this for the impact to be considered significant.

    Given that a substantial number of crib mattresses already comply with the requirements of the final rule and some of the testing costs are already being borne by firms that certify to the current voluntary standard, it seems unlikely that the rule would have a significant impact on a substantial number of small entities. Furthermore, CPSC did not receive any public comments on the costs of the proposed rule, or impediments to modifying existing crib mattress products to conform to the rule, especially those that would result in the removal of the mattress product from the market. Likewise, CPSC did not receive any other comments on possible impacts the rule might have on small domestic manufacturers or importers. Nevertheless, to the extent that a crib mattress supplier would need to remove a crib mattress model from commerce because it will not meet the standards of the draft final rule, or the product cannot be modified in a cost-efficient manner, a few small firms could potentially consider the costs of adopting the final rule to be significant. Based on limited data available for small private firms serving this market, staff identified three small domestic firms—two small domestic manufacturers and one small domestic importer who might consider the impact significant and might drop one or more crib mattress models from their line.

    E. Other Federal Rules That May Duplicate, Overlap, or Conflict With the Final Rule

    CPSC staff has not identified any other federal rules that duplicate, overlap, or conflict with the final rule.

    F. Alternatives Considered To Reduce the Impact on Small Entities

    CPSC attempted to minimize the impact of the final rule on small entities as discussed below:

    1. Requesting Public Comments

    CPSC published an NPR in the Federal Register on October 26, 2020 (85 FR 67906) and requested comments on any alternatives to the proposed rule that could reduce the burden on small entities. Among others, these proposed alternatives included adopting the ASTM standard, without modification, and delaying the effective date of the requirements. None of the comments CPSC received mentioned a burden or impact on small entities, nor expressed any concern that the final rule might impose on small entities. Additionally, CPSC did not receive comments raising significant issues in response to the IRFA. CPSC did not receive any comments from the SBA.

    2. Delay the Effective Date of the Requirements

    The APA generally requires that the effective date of the rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). CPSC generally considers 6 months to be sufficient time for suppliers of durable infant or toddler products to come into compliance with a new standard under section 104 of the CPSIA. Six months is also the period that JPMA typically allows for products in the JPMA certification program to transition to a new standard once that standard is published. The NPR proposed a 6-month effective date after publication of the final rule, for products manufactured or imported on or after that date. Commenters both supported and opposed the 6-month effective date. Some commenters urged the effective date to be as soon as possible, indicating that additional time for the rule to become effective would put infants at risk. Other commenters requested an indefinite delay of the rulemakings, until ASTM completes changes and updates to the voluntary standard, and those associated with crib mattresses.

    For the final rule, the Commission will retain the proposed 6-month effective date for the final rule, because suppliers have had lead time to prepare for this rule since the NPR was published on October 26, 2020. Many crib mattresses within the scope of the final rule require no change in design to achieve compliance with the final rule. Furthermore, 6 months from the change in a voluntary standard is the time frame that JPMA uses for its certification program. Consequently, compliant manufacturers are accustomed to this time frame to comply with a modified standard.

    Because some manufacturers of crib mattresses may experience some kind of economic impact as a result of the final rule, providing a 6-month effective date should mitigate the effects of the rule on small businesses. A 6-month effective date will provide manufacturers and importers time to spread the impact of the rule over a 6-month period, to reduce any sudden economic impact of the draft final rule. For businesses that would choose to exit the crib mattress market, or discontinue certain crib mattress models currently in production (rather than produce conforming products), such a delay might provide them with time to adjust marketing Start Printed Page 8672 towards other product offerings, sell inventory, or consider alternative business opportunities.

    3. Consultation With ASTM

    CPSC staff has worked extensively with ASTM in the continued development and improvement of voluntary safety standards for crib mattresses referenced in the final rule. Members of ASTM include small domestic manufacturers and importers of products to which the draft final rule would apply. Small entities to whom the final rule will apply have taken part in discussions and engaged in product testing during the development of the standard. Feedback from these entities was considered by ASTM and CPSC in developing the revised voluntary standard and final rule, respectively.

    XIV. Environmental Considerations

    The Commission's regulations address whether the agency is required to prepare an environmental assessment or an environmental impact statement. Under these regulations, certain categories of CPSC actions normally have “little or no potential for affecting the human environment,” and therefore, they do not require an environmental assessment or an environmental impact statement. Safety standards providing requirements for products come under this categorical exclusion. 16 CFR 1021.5(c)(1). The final rule for crib mattresses falls within the categorical exclusion.

    XV. Paperwork Reduction Act

    This final rule for crib mattresses contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (“OMB”) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth:

    A title for the collection of information;

    a summary of the collection of information;

    a brief description of the need for the information, and the proposed use of the information;

    a description of the likely respondents and proposed frequency of response to the collection of information;

    an estimate of the burden that shall result from the collection of information; and

    notice that comments may be submitted to the OMB.

    The preamble to the NPR (85 FR 67927-28) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. The OMB assigned control number 3041-0185 for this information collection. We did not receive any comment regarding the information collection burden of the proposal in the NPR. For the final rule, we update the estimated number of crib mattress manufacturers, from 26 to 28, and the estimated average number of models per manufacturer, from 12 to 10, which alters the estimated total burden, as described below. In accordance with PRA requirements, the Commission provides the following information:

    Title: Safety Standard for Crib Mattresses.

    Description: The final rule requires each crib mattress within the scope of the rule to comply with ASTM F2933-21, Standard Consumer Safety Specification for Crib Mattresses, including the additional requirements summarized in section VIII of this preamble. Section 7 of ASTM F2933-21, and a new section 8 in the final rule, contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of “collection of information,” as defined in 44 U.S.C. 3502(3).

    Description of Respondents: Persons who manufacture or import crib mattresses.

    Estimated Burden: We estimate the burden of this collection of information as follows:

    Table 8—Estimated Annual Reporting Burden

    16 CFR sectionNumber of respondentsFrequency of responsesTotal annual responsesHours per responseTotal burden hours
    1241.2(a), (b)38103801380

    Our estimate is based on the following:

    The Commission is finalizing the proposal in the NPR to modify several sections of the voluntary standard for crib mattresses, ASTM F2933, but is now making these modifications to the newly revised ASTM F2933-21. As proposed, the Commission is modifying section 7 of ASTM F2933 and adding a new section 8 on instructional literature, to bring the standard into alignment with other safety standards for durable infant or toddler products. For example, in addition to improved warning format and content, modifications to section 7.1.1 of ASTM F2933-21 will require that the name and the place of business (city, state, and mailing address, including zip code) or telephone number of the manufacturer, distributor, or seller be marked clearly and legibly on each product and its retail package. Modifications to section 7.1.2 of ASTM F2933 also require a code mark or other means that identifies the date (month and year, as a minimum) of manufacture. Modifications to section 7.2 of ASTM F2933 require marking and labeling on the product to be permanent.

    For the final rule, we update the number of known entities supplying crib mattresses in the U.S. market from 26 to 38. To comply with the final rule, these entities may need to make some modifications to existing product labels. We estimate that the time required to make these modifications is about 1 hour per model. Based on an evaluation of supplier product lines, for the final rule, we have also revised the average number of crib mattress models for each manufacturer from 12 to 10.[90] The revised estimated burden associated with labels for the final rule is 1 hour per model × 38 entities × 10 models per entity = 380 hours. The updated estimate of the hourly compensation for the time required to create and update labels is $33.78 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2021, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/​ncs/​ ). Therefore, for the final rule, our estimated annual cost to industry associated with the labeling requirements is $12,836.40 ($33.78 per hour × 380 hours = $12,836.40). No operating, maintenance, or capital costs are associated with the collection.

    Start Printed Page 8673

    As proposed, the final rule also adds a new section 8 that requires instructions to be supplied with the crib mattress. The instructions are required to: (a) Be easy to read and understand; (b) include information regarding assembly, maintenance, cleaning, and use, where applicable; and (c) address the same warning and safety-related statements that must appear on the product, with similar formatting requirements, but without the need to be in color. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the “normal course of their activities” are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are “usual and customary.” Based on staff's review of product information online, approximately 76 percent of firms that supply cribs to the crib mattress market already provide instructional literature to consumers for products intended for use by children. All of the firms that supply crib mattresses already provide customer support for use of their children's products. Therefore, we estimate that no burden hours are associated with the addition of section 8 to ASTM F2933-21 in the final rule, because any burden associated with supplying instructions with crib mattresses are “usual and customary” and not within the definition of “burden” under the OMB's regulations.

    Based on this analysis, the mandatory standard for crib mattresses will impose a burden to industry of 380 hours at a cost of $12,836.40 annually. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this final rule to the OMB.

    XVI. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a standard or regulation that prescribes requirements for the performance, composition, contents, design, finish, construction, packaging, or labeling of such product dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules.” Therefore, once this final rule for crib mattresses issued under section 104 of the CPSIA takes effect, the rule will preempt in accordance with section 26(a) of the CPSA.

    XVII. Congressional Review Act

    The Congressional Review Act (CRA; 5 U.S.C. 801 through 808) states that, before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must indicate whether the rule is a “major rule.” The CRA states that the Office of Information and Regulatory Affairs (“OIRA”) determines whether a rule qualifies as a “major rule.” Pursuant to the CRA, OIRA designated this rule as not a “major rule,” as defined in 5 U.S.C. 804(2). A “major rule” is one that the Administrator of OIRA finds has resulted in, or is likely to result in: (A) An annual effect on the economy of $100,000,000 or more; (B) a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or (C) a significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit the required information to each House of Congress and the Comptroller General.

    Start List of Subjects

    List of Subjects

    16 CFR Part 1112

    • Administrative practice and procedure
    • Audit
    • Consumer protection
    • Reporting and recordkeeping requirements
    • Third party conformity assessment body

    16 CFR Part 1130

    • Administrative practice and procedure
    • Business and industry
    • Consumer protection
    • Reporting and recordkeeping requirements

    16 CFR Part 1241

    • Consumer protection
    • Imports
    • Incorporation by reference
    • Infants and children
    • Labeling
    • Law enforcement, and Mattresses
    End List of Subjects

    For the reasons discussed in the preamble, the Commission amends Title 16 of the Code of Federal Regulations as follows:

    Start Part

    PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES

    End Part Start Amendment Part

    1. The authority citation for part 1112 continues to read as follows:

    End Amendment Part Start Authority

    Authority: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 (2008).

    End Authority Start Amendment Part

    2. Amend § 1112.15 by adding paragraph (b)(50) to read as follows:

    End Amendment Part
    When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method?
    * * * * *

    (b) * * *

    (50) 16 CFR part 1241, Safety Standard for Crib Mattresses.

    * * * * *
    Start Part

    PART 1130—REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT OR TODDLER PRODUCTS

    End Part Start Amendment Part

    3. The authority citation for part 1130 continues to read as follows:

    End Amendment Part Start Authority

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

    End Authority Start Amendment Part

    4. Amend § 1130.2 by revising paragraphs (a)(16) and (a)(17), and adding paragraph (a)(18) to read as follows:

    End Amendment Part
    Definitions.
    * * * * *

    (a) * * *

    (16) Infant bathtubs;

    (17) Bed rails; and

    (18) Crib mattresses.

    * * * * *
    Start Amendment Part

    5. Add part 1241 to read as follows:

    End Amendment Part Start Part

    PART 1241—SAFETY STANDARD FOR CRIB MATTRESSES

    1241.1
    Scope.
    1241.2
    Requirements for crib mattresses.
    Start Authority

    Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (15 U.S.C. 2056a); Sec. 3, Pub. L. 112-28, 125 Stat. 273.

    End Authority
    Scope.

    This part establishes a consumer product safety standard for crib mattresses. The scope of this standard for crib mattresses includes all crib mattresses within the scope of ASTM F2933, Standard Consumer Safety Specification for Crib Mattresses, including: Full-size crib mattresses, non-full-size crib mattresses, and after-market mattresses for play yards and non-full-size cribs.

    Start Printed Page 8674
    Requirements for crib mattresses.

    (a) Except as provided in paragraph (b) of this section, each crib mattress must comply with all applicable provisions of ASTM F2933-21, Standard Consumer Safety Specification for Crib Mattresses (approved on June 15, 2021). The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; http://www.astm.org/​cpsc.htm. Once incorporated by reference, you may review a read-only copy of ASTM F2933-21 at http://www.astm.org/​READINGROOM/​. You may also inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to: https://www.archives.gov/​federal-register/​cfr/​ibr-locations.html.

    (b) Comply with ASTM F2933-21 with the following additions or exclusions:

    (1) Instead of complying with section 3.1.2 of ASTM F2933-21, comply with the following:

    (i) 3.1.2  conspicuous, adj —visible when the mattress is being handled by a consumer placing the mattress in its intended use position in a product.

    (ii) [Reserved]

    (2) Add the following paragraph to section 3.1 of ASTM F2933-21:

    (i) 3.1.11  sleep surface, n —The product component, or group of components, providing the horizontal plane, or nearly horizontal plane (≤10°), intended to support an infant during sleep.

    (ii) [Reserved]

    (3) Instead of complying with section 5.7.1.1 of ASTM F2933-21, comply with the following:

    (i) 5.7.1.1  Mattress Size —The dimensions of a full-size crib mattress shall measure at least 27 1/4 in. (690 mm) wide and 51 5/8 in. (1310 mm) long. When the mattress with the test mattress sheet is placed against the perimeter and in the corner of the crib, the corner gap shall not exceed 3.15 in. (80.0 mm). Dimensions shall be tested in accordance with 6.2.

    (ii) [Reserved]

    (4) Instead of complying with section 5.7.2 through 5.7.2.2 of ASTM F2933-21, comply with the following:

    (i) 5.7.2  Non-Full-Size Crib Mattresses —For the purposes of this section, the term product refers to a non-full-size crib.

    (ii) 5.7.2.1  Mattress supplied with a non-full-size crib: Shall meet the specifications of Stability; Cord/Strap Length; Mattresses for Rigid sided products; and Crib Side Height of 16 CFR part 1220, Safety Standard for Non-Full-Size Baby Cribs, when tested with the product with which it is supplied.

    (iii) 5.7.2.2  After-market mattresses for non-full-size cribs: Shall be treated as though the mattresses were “the mattress supplied with a non-full-size crib” and shall meet the specifications of Stability; Cord/Strap Length; Mattresses for Rigid sided products; and Crib Side Height in 16 CFR part 1220, Safety Standard for Non-Full-Size Baby Cribs, when tested to the equivalent interior dimension of the product for which it is intended to be used.

    (iv) 5.7.2.3 The after-market 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 product mattress support structure.

    (v) 5.7.2.4 If the original equipment mattress includes a floor support structure, the after-market mattress must include a floor support structure that is at least as thick as the original equipment mattress floor support structure.

    (vi) 5.7.2.5 If the original equipment mattress includes storage accommodations for the product instruction manual, the after-market mattress shall provide equivalent storage accommodations for the product instruction manual.

    (5) Instead of complying with section 5.9 through 5.9.1.2 of ASTM F2933-21, comply with the following:

    (i) 5.9  After-Market Mattress for Play Yard —For the purposes of this section, the term “product” refers to a play yard.

    (ii) 5.9.1  For Mesh/Fabric Sided Play Yard Products:

    (iii) 5.9.1.1 The after-market mattress and product it is tested in shall meet the applicable requirements of the following sections of 16 CFR part 1221, Safety Standard for Play Yards, when tested with each brand and model of product for which it is intended to replace the mattress: Stability; Cord/Strap Length; Mattress; Height of Sides; Floor Strength; Mattress Vertical Displacement.

    (iv) 5.9.1.2 If the aftermarket mattress is intended to be used in the bassinet of a play yard with a bassinet attachment, the mattress shall also meet the specifications of the following sections of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, when tested with each brand and model for which it is intended to replace the mattress: Pad Thickness for Fabric or Mesh Sided Products; Pad dimensions; Side Height; Bassinets with Segmented Mattresses. This section applies only to a play yard mattress that is interchangeably used as a play yard mattress and as a bassinet mattress/pad.

    (6) Add the following paragraphs to section 5 of ASTM F2933-21:

    (i) 5.10 Mattress Firmness.

    (ii) 5.10.1 All crib mattresses within the scope of this standard, when tested in accordance with 6.3, the feeler arm shall not contact the sleep surface of the crib mattress.

    (iii) 5.11 Coil Springs. The requirements in this section only pertain to crib mattresses with coil springs.

    (iv) 5.11.1 When tested in accordance with 6.4, there shall be no exposed coil springs or metal wires.

    (7) Renumber section 6.2.2 of ASTM F2933-21 to section 6.2.3.

    (8) Renumber section 6.2.2.1 of ASTM F2933-21 to section 6.2.3.1.

    (9) Renumber section 6.2.2.2 of ASTM F2933-21 to section 6.2.3.2.

    (10) Renumber section 6.2.2.3 of ASTM F2933-21 to section 6.2.3.3.

    (11) Renumber section 6.2.2.4 of ASTM F2933021 to section 6.2.3.4.

    (12) Add the following paragraphs to section 6.2.3 of ASTM F2933021:

    (i) 6.2.3.5 The test mattress sheet shall be placed on the mattress such that each sheet edge is wrapped fully around and under the mattress.

    (ii) 6.2.3.6 Repeat step 6.2.3.2. Then measure the shortest gap between the mattress and the projected crib corner after the dimensions of the mattress have been recorded. The projected crib corner is located 53 in. ± 1/8 in. (1346 mm ± 3.2 mm) from Wall C and 28 5/8 in. ± 1/8 in. (727 mm ± 3.2 mm) from Wall D, as shown in Fig. 2. The mattress shall not be moved during measurement. This shall be the corner gap measurement.

    (iii) 6.2.3.7 Rotate the mattress 180° such that the opposing corner is adjacent to Walls C and D, then repeat 6.2.3.6.

    (13) Instead of complying with section 6.2.2 of ASTM F2933-21, comply with the following:

    (i) 6.2.2  Test Equipment-Mattress Sheet:

    (ii) 6.2.2.1 The mattress sheet shall be 100% cotton and fitted for the mattress to be tested.

    (iii) 6.2.2.2 The mattress sheet shall be washed in hot water (50 °C [122 °F] or higher) and dried a minimum of two times on the highest setting using household textile laundering units. This shall be the test mattress sheet. Start Printed Page 8675

    (14) Add the following paragraphs as section 6.3 of ASTM F2933-21.

    (i) 6.3 Mattress Firmness.

    (ii) 6.3.1  Test Fixture:

    (iii) 6.3.1.1 The fixture, as shown in Fig. 3, shall be a rigid, robust object with a round footprint of diameter 203 mm ± 1 mm, and an overall mass of 5200 g ± 20 g. The lower edge of the fixture shall have a radius not larger than 1 mm. Overhanging the footprint by 40 mm ± 2 mm shall be a flexible, flat bar of width 12 mm ± 0.2 mm with square-cut ends. This bar may be fashioned from a shortened hacksaw blade. The bar shall rest parallel to the bottom surface of the fixture and shall be positioned at a height of 15 mm ± 0.2 mm above the bottom surface of the fixture. The bar shall lay directly over a radial axis of the footprint ( i.e., such that a longitudinal centerline of the bar would pass over the center of the footprint).

    (iv) 6.3.1.2 Included on the fixture, but not overhanging the footprint, shall be a linear level that is positioned on a plane parallel to the bar, and in a direction parallel to the bar.

    (v) 6.3.1.3 Other parts of the fixture, including any handle arrangement and any clamping arrangement for the bar, shall not comprise more that 30% of the total mass of the fixture, and shall be mounted as concentric and as low as possible.

    (vi) 6.3.2  Test Method:

    (vii) 6.3.2.1 Mattresses that are supplied with a product shall be tested when positioned on that product. Mattresses sold independent of a product, shall be tested on a flat, rigid, horizontal support. After-market mattresses for play yards and non-full-size cribs shall be tested with each brand and model of product it is intended to replace.

    (viii) 6.3.2.2 Where a user of a mattress could possibly position either side face up, even if this is not an intended use, then both sides of the mattress shall be tested.

    (ix) 6.3.2.3 Before testing each mattress, the following steps shall be followed:

    (A) Verify there is no excess moisture in the mattress, beyond reasonable laboratory humidity levels.

    (B) Allow sufficient time per the manufacturer's instructions to fully inflate, if shipped in a vacuum sealed package.

    (C) Shake and or agitate the mattress in order to fully aerate and distribute all internal components evenly.

    (D) Place the mattress in the manufacturer's recommended use position if there is one, in the supplied product, or on a flat, rigid, horizontal support.

    (E) Let the mattress rest for at least 5 minutes.

    (F) Mark a longitudinal centerline on the mattress sleep surface, and divide this line in half. This point will be the first test location. Then further divide the two lines on either side of the first test location into halves. These will be the second and third test locations.

    (x) 6.3.2.4. Position the test fixture on each of the test locations, with the footprint of the fixture centered on the location, with the bar extending over the centerline and always pointing at the same end of the mattress sleep surface.

    (A) At each test location in turn, rotate the bar to point in the required direction, and gently set the fixture down on the mattress sleep surface, ensuring that the footprint of the fixture does not extend beyond the edge of the mattress. The fixture shall be placed as horizontal as possible, using the level to verify. If the bar makes contact with the top of the mattress sleep surface, even slightly, the mattress is considered to have failed the test.

    (B) Repeat Step (A) at the remaining locations identified in 6.3.2.3(F).

    (C) Repeat Step (A) at a location away from the centerline most likely to fail ( e.g. a very soft spot on the sleep surface or at a raised portion of the sleep surface). In the case of testing a raised portion of a sleep surface, position center of the fixture such that the bar is over the raised portion, to simulate the position of an infant's nose.

    (D) In the event that the fixture is not resting in a nearly horizontal orientation, repeat the test procedure at that location by beginning again from paragraph (b)(14)(x)(A). However, if the test produces a fail even with the device tilted back away from the bar so as to raise it, then a fail can be recorded.

    (15) Add the following paragraphs as section 6.4 of ASTM F2933-21:

    (i) 6.4 Coil Spring Test.

    (ii) 6.4.1 General—This test consists of dropping a specified weight repeatedly onto the mattress. The test assists in evaluating the structural integrity of a mattress with coil springs.

    (iii) 6.4.2 Test Fixture:

    (iv) 6.4.2.1 A guided free-fall impacting system machine (which keeps the upper surface of the impact mass parallel to the horizontal surface on which the crib is secured) (See Fig. 4).

    (v) 6.4.2.2 A 30-lb (13.6-kg) impact mass (see Fig. 5 and Fig. 6).

    (vi) 6.4.2.3 A 6-in. (150-mm) long gauge.

    (vii) 6.4.2.4 An enclosed frame measuring 29 inches by 53 inches (737 mm by 1346 mm) for the purpose of restricting mattress movement. When testing full-size mattresses, a full-size crib meeting the requirements of ASTM F1169-19 would suffice.

    (viii) 6.4.2.5 A 3/4 ″ piece of plywood or oriented strand board (OSB) that is rigidly supported along the perimeter.

    (ix) 6.4.3  Test Method:

    (x) 6.4.3.1 Place the mattress on the wooden support and inside the enclosed frame.

    (xi) 6.4.3.2 Position geometric center of the impact mass above the geometric center of the test mattress.

    (xii) 6.4.3.3 Adjust the distance between the top surface of the mattress and bottom surface of the impact mass to 6 in. (150 mm) (using the 6-in. (150-mm) long gauge, per 6.4.2.3) when the impact mass is in its highest position. Lock the impactor mechanism at this height and do not adjust the height during impacting to compensate for any change in distance as a result of the mattress compressing or the mattress support deforming or moving during impacting.

    (xiii) 6.4.3.4 Allow the 30-lb (13.6-kg) impact mass to fall freely 250 times at the rate of one impact every 4 s. Load retraction shall not begin until at least 2 s after the start of the drop.

    (xiv) 6.4.3.5 Repeat the step described in 6.4.3.4 at the other test locations shown in Fig. 7.

    (xv) 6.4.4 The coil spring test shall be repeated on each surface of the mattress. The test shall not be repeated using a mattress that has been previously tested with the coil spring test.

    (16) Add the following Figures to section 6 of ASTM F2933-21:

    (i) Figure 2.

    Start Printed Page 8676

    (ii) Figure 3.

    Start Printed Page 8677

    (iii) Figure 4.[91]

    (iv) Figure 5.

    Start Printed Page 8678

    (v) Figure 6.

    (vi) Figure 7.

    (17) Instead of complying with sections 7.1 and 7.2 of ASTM F2933-21, comply with the following:

    (i) 7.1 Each mattress and its retail package shall be marked or labeled clearly and legibly to indicate the following:

    (ii) 7.1.1 The name, place of business (city, state, and mailing address, including zip code), and telephone number of the manufacturer, distributor, or seller.

    (iii) 7.1.2 A code mark or other means that identifies the date (month and year at a minimum) of manufacture.

    (iv) 7.2 The marking and labeling on the product shall be permanent.

    (18) Do not comply with sections 7.2.1, 7.2.2, 7.2.2.1, 7.2.2.2, and 7.2.2.3 of ASTM F2933-21.

    (19) Instead of complying with sections 7.3, 7.3.1, 7.3.2, and 7.3.3 of ASTM F2933-21, comply with the following:

    (i) 7.3 Any upholstery labeling required by law shall not be used to meet the requirements of this section.

    (ii) [Reserved]

    (20) Instead of complying with sections 7.4 and 7.4.1 of ASTM F2933-21, comply with the following:

    (i) 7.4 Warning Design for Mattresses:

    (ii) 7.4.1 The warnings shall be easy to read and understand and be in the English language at a minimum.

    (iii) 7.4.2 Any marking or labeling provided in addition to those required by this section shall not contradict or confuse the meaning of the required information, or be otherwise misleading to the consumer.

    (iv) 7.4.3 The warnings shall be conspicuous and permanent.

    (v) 7.4.4 The warnings shall conform to ANSI Z535.4—2011, American National Standard for Product Safety Signs and Labels, sections 6.1-6.4, 7.2-7.6.3, and 8.1, with the following changes.

    (vi) 7.4.4.1 In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace “should” with “shall.”

    (vii) 7.4.4.2 In section 7.6.3, replace “should (when feasible)” with “shall.”

    (viii) 7.4.4.3 Strike the word “safety” when used immediately before a color ( e.g., replace “safety white” with “white”). Start Printed Page 8679

    (ix) Note 3 —For reference, ANSI Z535.1 provides a system for specifying safety colors.

    (x) 7.4.5 The safety alert symbol “[Safety Alert Symbol]” and the signal word “WARNING” shall be at least 0.2 in. (5 mm) high. The remainder of the text shall be in characters whose upper case shall be at least 0.1 in. (2.5 mm), except where otherwise specified.

    (xi) Note 4 —For improved warning readability, typefaces with large height-to-width ratios, which are commonly identified as “condensed,” “compressed,” “narrow,” or similar should be avoided.

    (xii) 7.4.6  Message Panel Text Layout:

    (xiii) 7.4.6.1 The text shall be left aligned, ragged right for all but one-line text messages, which can be left aligned or centered.

    (xiv) Note 5 —Left aligned means that the text is aligned along the left margin, and, in the case of multiple columns of text, along the left side of each individual column. Please see FIG. 8 for examples of left aligned text.

    (xv) 7.4.6.2 The text in each column should be arranged in list or outline format, with precautionary (hazard avoidance) statements preceded by bullet points. Multiple precautionary statements shall be separated by bullet points if paragraph formatting is used.

    (xvi) 7.4.7 Example warnings in the format described in this section are shown in FIGS. 9, 10, and 11.

    (21) Instead of complying with sections 7.5, 7.5.1, 7.5.2, 7.5.3, 7.5.3.1, and 7.5.3.2 of ASTM F2933-21, comply with the following:

    (i) 7.5 Warning Statements—Each mattress shall have warning statements to address the following, at a minimum, unless otherwise specified. The blank in the mattress fit statement beginning with “If a gap is larger than,” needs to be filled with “1 1/2 in. (3.8 cm)” for full-size crib mattresses and “1 in. (2.5 cm)” for all other mattresses.

    (ii) Note 6 —Address means that verbiage other than what is shown can be used as long as the meaning is the same or information that is product-specific is presented.

    SIDS AND SUFFOCATION HAZARDS

    ALWAYS place baby on back to sleep to reduce the risks of SIDS and suffocation.

    Babies have suffocated:

    • on pillows, comforters, and extra padding
    • in gaps between a wrong-size mattress, or extra padding, and side walls of product.

    NEVER add soft bedding, padding, or an extra mattress.

    USE ONLY one mattress at a time.

    DO NOT cover the faces or heads of babies with a blanket or over-bundle them. Overheating can increase the risk of SIDS.

    ALWAYS check mattress fit every time you change the sheets, by pushing mattress tight to one corner. Look for any gaps between the mattress and the side walls. If a gap is larger than __, the mattress does not fit— do not use it.

    (iii) Renumber section 7.3.1 of ASTM F2933-21 to section 7.5.1.

    (iv) In section 7.5.1, replace the reference to “7.3” with a reference to “7.5.”

    (v) In section 7.5.1, replace the term “Only use” with the term “ USE ONLY .”

    (vi) Renumber section 7.3.2 of ASTM F2933-21 to section 7.5.2.

    (vii) In section 7.5.2, replace the term “For non-full-size crib mattresses” with the term “For non-full-size crib mattresses and after-market mattresses for play yards and non-full-size cribs.”

    (viii) In section 7.5.2, replace the reference to “7.3” with a reference to “7.5.”

    (ix) In section 7.5.2, replace the term “Only use” with the term “ USE ONLY .”

    (x) Renumber section 7.3.3 of ASTM F2933-21 to section 7.5.3.

    (xi) In section 7.5.3, replace the term “may be included” with “are permitted, and replace the term “7.3 and 7.4” with “7.5 and 7.6”.

    (22) Instead of complying with sections 7.6, 7.6.1, 7.6.1.1, 7.6.1.2, or 7.7 of ASTM F2933-21, comply with the following:

    (i) 7.6 The following warning statement shall be included exactly as stated in this paragraph (b)(22)(i) and shall be located at the bottom of the warnings on each mattress:

    DO NOT remove these important safety warnings.

    (ii) 7.7  Additional Marking and Warnings for After-Market Mattresses for Play Yards and Non-Full-Size Cribs— The mattress shall have:

    (iii) 7.7.1 All warnings added by the original manufacturer which are in addition to those required by this standard.

    (iv) 7.7.2 Assembly/attachment instructions that were provided on the original mattress.

    (v) 7.7.3 The specific brand(s) and model(s) number(s) of the product(s) in which it is intended to be used.

    (vi) 7.7.4  For Rigid Sided Rectangular Products —the following statement shall appear exactly as stated in this paragraph (b)(22)(vi) (the blanks are to be filled in as appropriate).

    This mattress measures __ long, __ wide, and __ thick when measured from seam to seam.

    (23) Add the following paragraphs as section 7.8 of ASTM F2933-21:

    (i) 7.8 Warning Design for Retail Packages.

    (ii) 7.8.1 The warnings and statements are not required on the retail package if they are on the mattress and are visible in their entirety through the retail package. Cartons and other materials used exclusively for shipping the mattress are not considered retail packaging.

    (iii) 7.8.2 Warning Statements—Each mattress' retail package shall have statements to address the following, at a minimum, and as specified in 7.4.1, 7.4.2, and 7.4.4-7.4.6.

    (iv) 7.8.2.1 For full-size crib mattresses, each mattress' retail package shall be labeled with the warnings and statements specified in 7.5 and 7.5.1.

    (v) 7.8.2.2 For non-full-size crib mattresses and after-market mattresses for play yards and non-full-size cribs, each mattress' retail package shall be labeled with the warnings and statements specified in 7.5, 7.5.2, 7.7.1-7.7.4, as applicable.

    (24) Add the following figures to section 7 of ASTM F2933-21:

    Start Printed Page 8680

    (i) Figure 8.

    Start Printed Page 8681

    (ii) Figure 9.

    Start Printed Page 8682

    (iii) Figure 10.

    Start Printed Page 8683

    (iv) Figure 11.

    (25) Redesignate section 8 of ASTM F2933-21 as section 9.

    (26) Add a new section 8 of ASTM F2933-21:

    (i) 8. Instructional Literature .

    (ii) 8.1 Instructions shall be provided with the mattress and shall be easy to read and understand, and shall be in the English language, at a minimum. These instructions shall include information on assembly, maintenance, cleaning, and use, where applicable.

    (iii) 8.2 The instructions shall have statements to address the following, at a minimum.

    (iv) 8.2.1 All warnings included in section 7.5, as applicable.

    Start Printed Page 8684

    (v) 8.2.2 All additional markings and warnings included in section 7.7, as applicable.

    (vi) 8.3 The warnings in the instructions shall meet the requirements specified in 7.4.4, 7.4.5, and 7.4.6, except that sections 6.4 and 7.2-7.6.3 of ANSI Z535.4 need not be applied. However, the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the cautions and warnings shall contrast with the background of the instructional literature.

    (vii) Note 7 —For example, the signal word, safety alert symbol, and the warnings may be black letters on a white background, white letters on a black background, navy blue letters on an off-white background, or some other high-contrast combination.

    (viii) 8.4 Any instructions provided in addition to those required by this section shall not contradict or confuse the meaning of the required information, or be otherwise misleading to the consumer.

    (ix) Note 8 —For additional guidance on the design of warnings for instructional literature, please refer to ANSI Z535.6, American National Standard: Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.

    End Part Start Signature

    Alberta E. Mills,

    Secretary, Consumer Product Safety Commission.

    End Signature End Supplemental Information

    Footnotes

    2.  Although the petitioner used the term “supplemental mattress,” ASTM F2933-21 uses and defines the term “after-market” mattress. Both terms refer to a mattress that is bought separately from a play yard or non-full-size crib. Like the NPR, the final rule will use the defined term “after-market” mattress. Section 3.1.1 of ASTM F2933-21 defines an “after-market mattress for a play yard or non-full-size crib” as “a mattress sold or distributed for a play yard or non-full-sized crib.” Section 3.1.1.1 of ASTM F2933-21 states that the definition does not include a replacement mattress sold by an original equipment manufacturer as a replacement, if it is equivalent to the mattress originally provided with the product.

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    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.

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    4.  On January 26, 2022, the Commission voted4-0 to issue this final rule. Commissioner Trumka issued a statement in connection with his vote.

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

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    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.

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    7.  The NPR was based on information provided in the September 30, 2020, Staff Briefing Package: Draft Notice of Proposed Rulemaking for Crib Mattresses Under the Danny Keysar Child Product Safety Notification Act (Staff's NPR Briefing Package), available at: 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.

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

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

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

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    11.  Section 3.1.4 of ASTM F2933-21 defines a “crib” as a “bed that is designed to provide sleeping accommodations for an infant which have specific interior dimensions as determined by it being either a full size or non-full size crib.” Section 3.1.5 of ASTM F2933-21 defines a “mattress” as “ticking filled with a resilient material used alone or in combination with other products intended or promoted for sleeping on it.”

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    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.

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    13.  The most common rectangular, non-full-size crib mattress available for sale in the U.S. crib mattress market is the “mini” crib mattress. The mini crib mattress is smaller than the so-called “standard” or full-size crib mattress. The typical size of a “mini” crib mattress is 24″ wide and 38″ long. The depth of a “mini” crib mattress varies, but typically ranges from 1″ to 6″.

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

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    15.  November 2019 Statista estimates, Grand View Research.

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    16.  Based on staff's compiled search results of data available on the internet, April-June 2021.

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    17.  Price estimated from data available on the internet, collected between April-June 2021.

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

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    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.

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    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).

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    21.  Child Care Center estimate of entire United States (2018, April 27). http://childcarecenter.us/​.

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

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    23.  Staff contacts included phone inquiries with day care and hotel establishments.

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

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

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    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.

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    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.

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    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.

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    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.

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

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    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.

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    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.

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    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.

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

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

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    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.

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

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    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.

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    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.

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

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    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.

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

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

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    53.  The dimensional requirements are unchanged in ASTM F2933-21.

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    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.

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    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.

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

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

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

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

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

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    61.  The ESHF memorandum in CPSC staff's NPR briefing package details staff's findings regarding the prevalence in incident data of infant prone positioning, soft bedding, and mattress size/corner gaps.

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    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.

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    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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    64.  For example, Joyner et al. (2009) as cited in the Safety Messaging Report, posited that caregivers are likely to trust implicitly the safety of products under the misconception that if a product is sold to the public, then it is likely safe to use. Staff finds this common misconception particularly likely with regards to infant products; the greater vulnerability of infants to product hazards is likely to support the expectation of caregivers that infant products are designed to be safe.

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    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.

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    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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    67.  Since May 2018, CPSC staff has been participating in ASTM F15.66 to address the identified hazards. Subcommittee members include manufacturers, safety and health advocacy groups, and other critical stakeholders. Changes to ASTM F2933 proposed by ASTM F15.66 have been balloted by ASTM F15 (see discussion of ASTM Ballot F15 (21-02), below).

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

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

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

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

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

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    73.  ASTM F2933-21, section 5.8.1.2.

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    74.  ASTM F2933-21, section 7.5.3.1.

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    75.  For example, see the Commission Briefing Package: Final Rule—Safety Standard for Gates and Enclosures: https://cpsc.gov/​s3fs-public/​Final%20Rule%20-%20Safety%20Standard%20for%20Gates%20and%20Enclosures.pdf?​lHExt6trsEuD56jiQTi7Ab0TjzdVQ_​HH.

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

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    77.  Figure 8 in the Appendix of the ESHF memorandum of Staff's NPR Briefing Package.

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    78.  Leonard, S.D., Otani, H., Wogalter, M.S. (1999). Comprehension and memory. In M.S. Wogalter, D.M. DeJoy, K.R. Laughery (Eds.), Warnings and risk communication (pp. 149-187). Philadelphia: Taylor Francis.

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    80.   See Tab E of Staff's Final Rule Briefing Package for additional information on the RFA.

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    81.  The size guidelines are established by the SBA.

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    82.  Based on staff's compiled search results of data available on the internet, April-June 2021.

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    83.  Crib mattresses listed for sale on a variety of online retail websites often include product descriptions indicating that the crib mattress product meets CPSC general safety standards, while not referencing any one specific CPSC safety standard.

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    84.  Manufacturers and importers of children's products must certify compliance with applicable federal safety requirements in a Children's Product Certificate (CPC). Testing by a third party CPSC-Accepted Laboratory must serve as the basis for the production of the CPC.

    85.  Mattresses intended for children must be tested at a third-party test laboratory or a fire-walled internal laboratory: https://cpsc.gov/​s3fs-public/​pdfs/​blk_​media_​mattress.pdf. In either case, the lab would need to be CPSC-accepted to test to the standards since crib mattresses are considered to be primarily intended for children 12 and under.

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    86.  Costs associated with modification of a crib mattress might include, but are not limited to, costs of skilled labor for the modification or redesign; costs associated with finding and changing to a new materials supplier, if necessary; flammability testing costs for the modified model if new ticking materials are used; and additional testing costs prescribed in ASTM F2933 and those of the final rule.

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    87.  Instructions required shall be provided with the mattress and shall be easy to read and understand, and shall be in the English language, at a minimum. These instructions shall include information on assembly, maintenance, cleaning, and use, where applicable.

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    88.  Information provided by the crib mattress supplier included quotes received from two prominent testing laboratories.

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    89.  The estimated costs of $950 per model for testing in the FRFA is an increase over the amount estimated in the IFRA. The cost for third party testing was estimated to be $250 to $325, per sample, in the IRFA.

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    90.  This number was derived during the market research phase of the initial regulatory flexibility analysis by dividing the total number of crib mattresses supplied by all crib mattress suppliers by the total number of crib mattress suppliers.

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    91.  Reprinted, with permission, from ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. A copy of the complete standard may be obtained from ASTM International, www.astm.org.

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    BILLING CODE 6355-01-P

    [FR Doc. 2022-02414 Filed 2-14-22; 8:45 am]

    BILLING CODE 6355-01-C

Document Information

Effective Date:
8/15/2022
Published:
02/15/2022
Department:
Consumer Product Safety Commission
Entry Type:
Rule
Action:
Final rule.
Document Number:
2022-02414
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.
Pages:
8640-8684 (45 pages)
Docket Numbers:
CPSC Docket No. 2020-0023
Topics:
Accounting, Administrative practice and procedure, Business and industry, Consumer protection, Imports, Incorporation by reference, Infants and children, Labeling, Law enforcement, Reporting and recordkeeping requirements
PDF File:
2022-02414.pdf
Supporting Documents:
» Safety Standard for Crib Mattresses; Correction
» Log of Meeting of the ASTM Crib Mattress Subcommittee dated June 9 2021
» Log of Phone Call - R Omansky-S Bacchus-C Campbell- Dream on Me- A Schoem counsel to Dream on Me-C Pollack-Nelson Indep. Safety Consult LLC-Comm Kaye and staff with agenda slide presentation May 17 2021
» Letter from Alan Schoem to Commissioner Kaye re Aftermarket Play Yard Mattresses dated May 27 2021
» Log of Phone Conversation between Jonathan Lee Chair ASTM F15.66 subcommittee on crib mattresses and Hope Nesteruk CPSC staff dated November 12 2020
» Log of Phone Conversation between Carol Pollack-Nelson Independent Safety Consulting LLC and Hope Nesteruk CPSC staff dated December 2 2020
» Log of Meeting of the ASTM F15.66 Standard Language Review for Crib Mattresses Task Group -focused on Cyclic Testing- dated December 8 2020
» Log of Meeting of the ASTM Crib Mattress Firmness Task Group dated February 10 2021
» Safety Standard for Crib Mattresses
» RE email update to commissioners - R. Omansky (Dream on Me)
CFR: (4)
16 CFR 1112.15
16 CFR 1130.2
16 CFR 1241.1
16 CFR 1241.2