Safety Standard for Infant Support Cushions, 87467-87498 [2024-25181]

Download as PDF Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 43°22′14″ N, long. 72°22″6 W) for Claremont Municipal Airport contained a typographical error. This action corrects the error by correcting the coordinates (lat. 43°22′14″ N, long. 72°22′06″ W) for Claremont Municipal Airport. Correction to the Final Rule Pursuant to the authority delegated to me, the amendment of Class E airspace extending upward from 700 feet above the surface for Claremont Municipal Airport, Claremont, NH, in Docket No. FAA–2024–1650, as published in the Federal Register on October 3, 2024 (89 FR 80382), is corrected as follows: § 71.1 [Corrected] On page 80383, in the first column, replace the Claremont Municipal Airport coordinates (Lat. 43°22′14″ N, long. 72°22″6 W) with the corrected coordinates (lat. 43°22′14″ N, long. 72°22′06″ W). ■ Issued in College Park, Georgia, on October 28, 2024. Patrick Young, Manager, Airspace & Procedures Team North, Eastern Service Center, Air Traffic Organization. [FR Doc. 2024–25456 Filed 11–1–24; 8:45 am] BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112, 1130, and 1243 [CPSC Docket No. 2023–0047] Safety Standard for Infant Support Cushions Consumer Product Safety Commission. ACTION: Final rule. AGENCY: The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the U.S. Consumer Product Safety Commission (Commission or CPSC) to promulgate consumer product safety standards for durable infant or toddler products. Under this statutory authority, the Commission is issuing a safety standard for infant support cushions. The Commission is also amending CPSC’s consumer registration requirements to identify infant support cushions as durable infant or toddler products and amending CPSC’s list of notices of requirements (NORs) to include infant support cushions. DATES: The rule is effective on May 5, 2025. The incorporation by reference of lotter on DSK11XQN23PROD with RULES1 SUMMARY: VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 the publication listed in this rule is approved by the Director of the Federal Register as of May 5, 2025. FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7945 or (888) 531–9070; email: sbo@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Background and Statutory Authority A. Background Infant support cushions are filled with or comprised of resilient material such as foam, fibrous batting, or granular material or with a gel, liquid, or gas, and are marketed, designed, or intended to support an infant’s weight or any portion of an infant while reclining or in a supine, prone, or recumbent position. CPSC is aware of at least 79 reported fatalities involving infant support cushions from January 1, 2010, through December 31, 2022, as well as 124 nonfatal incidents or reports involving these products within the same time period. There were 17 deaths in 2020, and a minimum of 17 more in 2021.1 More than 80 percent of the known fatalities associated with these products involve infants three months old or younger. In more than 60 percent of the fatalities, the official cause of death was asphyxia or probable asphyxia. These incidents typically involved the use of an infant support cushion placed in or on a sleep-related consumer product such as an adult bed, futon, crib, bassinet, play yard, or couch. For the nonfatal incidents, the most common circumstances involved an infant falling from an infant support cushion placed on a raised surface such as a bed or a sofa, or a threat of asphyxia or entrapment. In 1992, pursuant to authority under the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261–1278, the Commission issued a ban on certain infant cushions and pillows filled with foam, plastic beads, or other granular material. 57 FR 27912 (June 23, 1992). That ban prohibits infant cushions, infant pillows, and similar articles that are: • made with a flexible fabric covering; • loosely filled with granular material, including, but not limited to, polystyrene beads or pellets; • easily flattened; 1 Due to reporting delays, fatality data reported to the CPSC is not considered complete until three years later; thus, the 2021 fatality data were not yet considered complete when the analysis was conducted in 2023. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 87467 • capable of conforming to the body or face of an infant; and • intended or promoted for use by children under one year of age. See 16 CFR 1500.18(a)(16). This final rule for infant support cushions does not change the existing FHSA ban. That ban was limited to products with the specific hazard presented by loosely filled granular material such as polystyrene beads or pellets, and those products will continue to be banned under the FHSA. Infant support cushions that are not subject to the ban are within the scope of this rule and are required to comply with the performance and labeling requirements of this rule.2 B. Statutory Authority Section 104(b)(1)(A) 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 and toddler products. See 15 U.S.C. 2056a(b)(1)(A). The Commission must continue to promulgate standards for all categories of durable infant or toddler products until the Commission has promulgated standards for all such product categories. See 15 U.S.C. 2056a(b)(2). Consistent with section 104(b)(1)(A) of the CPSIA, CPSC consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and the public to develop this rule, including through participation in the juvenile products subcommittee meetings of ASTM.3 However, currently no voluntary or mandatory safety standard for infant support cushions exists to 2 An exemption to the infant pillow ban applies to Boston Billow nursing pillows and substantially similar nursing pillows that are designed to be used only as nursing aids for breastfeeding mothers. 16 CFR 1500.86(a)(9). The exemption applies specifically to the FHSA ban and is not applicable to this rule or to the final rule for nursing pillows. 89 FR 85388 (October 25, 2024). 3 CPSC formally began the consultation process for this rulemaking in December 2021, via a letter from staff requesting that ASTM form a working group to develop a voluntary standard to reduce the risk of death and injury from hazards associated with infant pillow products, including nursing pillows. In response, ASTM formed two subcommittees intended to develop two separate voluntary standards: the F15.16 Infant Feeding Supports subcommittee, intended to develop a standard for nursing pillows; and the F15.21 Infant Loungers subcommittee. Staff has been actively participating in both ASTM subcommittees to develop voluntary standards that address hazards associated with these products. E:\FR\FM\04NOR1.SGM 04NOR1 87468 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 address the hazards posed by these products. Infant support cushions are durable infant or toddler products under section 104(f) of the CPSIA. Section 104(f)(1) defines the term 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. See 15 U.S.C. 2056a(f)(1). Section 104(f)(2) of the CPSIA provides a non-exhaustive list of product categories within the definition of durable infant or toddler products. Although infant support cushions are not specifically listed in section 104(f)(2), they are durable infant or toddler products because (as explained in Part II, below) they: are not disposable; have a useful life of up to several years during which they are often used by multiple children successively; are similar to other soft durable infant and children’s products such as crib mattresses and sling carriers (which the Commission has issued rules for under section 104); are resold and widely available on secondary marketplaces; and are primarily intended to be used by children five years old or younger. 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 rule for product registration cards, 16 CFR part 1130. The final rule amends part 1130 to include infant support cushions in the list of durable infant or toddler products that must comply with these product registration requirements. See 16 CFR 1130.2(a). Manufacturers of children’s products must also comply with the testing and certification requirements for children’s products that are codified in 16 CFR parts 1107 and 1109. Section 14(a)(3) of the Consumer Product Safety Act (CPSA) requires the Commission to publish an NOR for the accreditation of third party conformity assessment bodies (test laboratories) to assess conformity with a children’s product safety rule to which a children’s product is subject. The final rule is a children’s product safety rule that requires issuance of an NOR. C. Notice of Proposed Rulemaking (NPR) On January 16, 2024, the Commission published an NPR under section 104 of the CPSIA that proposed a mandatory consumer product safety standard for infant support cushions to address the risk of death and injury associated with these products. 89 FR 2530. The proposed rule addressed the suffocation, entrapment, and fall hazards associated VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 with infant support cushions by including performance, testing, labeling, and instructional literature requirements. The proposed requirements in the NPR were based on staff’s analysis of the hazards presented by infant support cushions as well as incident, injury and fatality data. The proposed requirements also considered the recommendations in the June 30, 2022, Pillows Product Characterization and Testing, Boise State University Report (BSU Final Report).4 CPSC awarded a contract to Boise State University (BSU) for infant biomechanics and suffocation research and consultancy services. This research included an analysis of the risk of injury or death to infants associated with the use of nursing pillows and infant support cushions during activities such as feeding, nursing, sleeping, propping, and lounging. The BSU Final Report provided recommendations and conclusions related to the performance and design of infant support cushions, including recommendations regarding firmness testing, airflow testing, and sagittal-plane testing. Tab C of Staff’s NPR Briefing Package summarizes how the requirements of the NPR relate to the conclusions and recommendations of the BSU Final Report. The Commission received 18 comments in response to the NPR. On April 23, 2024, CPSC published a notice of availability (NOA) in the Federal Register that announced the availability of the incident data relied upon for the infant support cushions NPR and sought comments from the public. 89 FR 30295. The Commission received one comment in response to the NOA. D. Final Rule Overview Pursuant to section 104 of the CPSIA, 15 U.S.C. 2056a, the Commission is issuing a mandatory standard for infant support cushions based on the proposed requirements in the NPR, with certain modifications in response to public comments, which are discussed in detail in Sections VI and VII of the preamble.5 The final rule defines an infant support cushion as an infant product that is filled with or comprised of resilient material such as foam, fibrous batting, or granular material or with a gel, liquid, or gas, and which is marketed, designed, or intended to support an infant’s weight or any portion of an infant while reclining or in a supine, prone, or recumbent position. This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion. This includes infant pillows, infant loungers, nursing pillows with a lounging function, infant props or cushions used to support an infant for activities such as tummy time, and other similar products. The final rule addresses the risk of death and injury associated with infant support cushions primarily due to suffocation, entrapment, and fall hazards. It addresses positional asphyxiation hazards by requiring that all surfaces be sufficiently firm that they are unlikely to conform to an infant’s face and occlude the airways,6 and by setting a maximum incline angle that would prevent hazardous positioning of an infant’s head and neck along the surfaces of the product. The final rule sets a side angle requirement that addresses the risk of entrapment between the sidewall and the occupant support surface. It addresses fall hazards by effectively limiting sidewall height to discourage caregivers from mistakenly believing these products to be safe for unsupervised infants. Finally, the final rule requires a strongly worded, conspicuous, and permanent on-product warning label. Based on comments received on the NPR, the following changes have been made in the final rule: • For clarity, the definition of infant lounger in § 1243.2 has been revised to change the term infant product to infant support cushion. • For clarity, the definition of infant support cushion in § 1243.2. has been revised to add the sentence ‘‘This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion’’ at the end of the definition. • To avoid ambiguity, a new definition of the term sidewall has been added in § 1243.2 which is defined as any wall at the edge of the occupant support surface. 4 Erin M. Mannen et al; Consumer Prod. Safety Comm’n. Pillows Product Characterization and Testing (2022). www.cpsc.gov/content/PillowsProduct-Characterization-and-Testing. 5 On October 16, 2024, the Commission voted (5– 0) to publish this final rule with changes. Chair Hoehn-Saric issued a statement in connection with his vote, available at: www.cpsc.gov/About-CPSC/ Chairman/Alexander-Hoehn-Saric/Statement/ Statement-of-Chair-Alexander-Hoehn-Saric-onCommission-Approval-of-a-Final-Rule-Establishinga-Safety-Standard-for-Infant-Support-Cushions. 6 Airways occlusion means to block the passage of air from the nose and mouth into the lungs, so that inhaled air cannot reach the lungs. In this case, the airway occlusion is caused by a soft product that covers the nose and mouth. Once an infant’s airflow is compromised, decreased levels of oxygen in the blood can further impair the ability of the infant to respond to the situation. If an infant cannot respond, a feedback loop of decreased heart and respiration rate develops that can eventually lead to cessation of breathing and may become fatal if uninterrupted. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations • For accuracy and consistency, a reference to infant pillow in § 1243.3(d) has been changed to infant support cushion. • The final rule removes proposed § 1243.3(e) regarding side height as this requirement is redundant with the maximum incline angle limits in the rule. The final rule renumbers the paragraphs following proposed § 1243.3(e) to reflect this change. The rule also removes the corresponding test in § 1243.5(d)(8) for consistency. To reflect this change, all numbers after § 1243.5(d)(7) have been renumbered in the final rule. • The performance requirements in § 1243.4(e)(2) and (3) and (f) as well as the corresponding test methods in §§ 1243.5(g) and 1243.4(h) and (i) have been revised to clarify that the performance requirements and test methods apply only to products that contain a sidewall with language stating, for products with a sidewall. • The test method in § 1243.5(f) has been clarified to explain that products sold with a slipcover on or together with the product are to be tested as assembled, with the slipcover on the product. The test method in § 1243.5(f) has also been clarified to explain that all products, including products one inch or less in thickness, shall be tested. • Figure 2 (for products without a tummy time feature) to paragraph (d)(7) in § 1243.6 has been revised and a new figure 3 (for products with a tummy time feature) has been added to reflect changes in warning content made in response to public comments. These changes include adding a statement to address prone use during tummy time, removing references to ‘‘an awake baby,’’ separating the sleep and suffocating-relating warning content to provide clarity, adding a warning to address soft bedding both in and outside of the product, and deleting some of the statements to reduce length and increase clarity. Additionally, § 1243.6(d)(7) clarifies that all infant support cushions are required to contain a warning with the content and format depicted in this section as figure 2 (for products without tummy time) or figure 3 (if the product has a tummy time feature) to paragraph (d)(7), as applicable. • Section 1243.6(e) has been revised to clarify that slipcovers sold on or together with the product shall contain the warning statement shown in figures 2 and 3 to paragraph (d)(7), as applicable. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 II. The Product Category A. Infant Support Cushions Infant support cushions are products that support an infant for lounging, meaning reclining in a supine, prone, or recumbent position. Infant products within this category may or may not have perimeter sidewalls. Most infant support cushions currently on the market are filled with cushy foam or soft fibrous batting, covered by flexible fabric. Some infant support cushions are marketed for use in a crib or other infant sleep product, notwithstanding warnings from the Commission and other institutions, including the American Academy of Pediatrics (AAP), that soft objects, such as pillows and excess bedding, should not be placed in an infant’s sleep environment.7 Illustrative pictures of infant support cushions can be found in Tab C of Staff’s NPR Briefing Package.8 A nonexhaustive list of examples of infant support cushions includes: • head positioner pillows; • flat baby loungers; • crib pillows; • wedge pillows for infants; • infant sleep positioners, unless regulated as medical devices by the Food and Drug Administration (FDA); • stuffed toys marketed for use as an infant support cushion; • infant tummy time or lounging pillows, whether flat or inclined; • multi-purpose pillows marketed for both nursing and lounging; • anti-rollover pillows with or without straps that fasten the pillow to the infant; • infant self-feeding pillows that hold a bottle in front of the face of a reclining or lying infant; • pads and mats; and • accessory pillows and other padded accessories, often marketed for use with an infant car seat, stroller, or bouncer, but not sold with that product and therefore not included in the mandatory safety standard for those products. These in-scope products must meet the requirements of the rule. However, to avoid potentially duplicative or conflicting obligations, the scope of products that would be subject to this 7 Rachel Y. Moon, Rebecca F. Carlin, Ivan Hand, The Task Force On Sudden Infant Death Syndrome And The Committee On Fetus And Newborn, 150(1) American Academy of Pediatrics: Evidence Base for 2022 Updated Recommendations for a Safe Infant Sleeping Environment to Reduce the Risk of SleepRelated Infant Deaths (2022). 8 Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 87469 rule does not include durable infant products that are already regulated by the Commission and included in the list of products at 16 CFR 1130.2(a). The following products are NOT infant support cushions within the scope of this rule: • pillows not marketed, designed, or intended for use by infants, such as adult bed and throw pillows; • nursing pillows if subject to the Commission’s final rule for nursing pillows (89 FR 85388 (October 25, 2024)), unless they are also marketed for lounging; • crib and play yard mattresses that are regulated under the play yard standard (16 CFR part 1221) and crib mattress standard (16 CFR part 1241); • purely decorative nursery pillows, such as those personalized with a baby’s name and birthdate, that are not marketed, designed, or intended for infant use; • stuffed toys (unless they meet the definition of an infant support cushion in this rule); • padded seat liners that are sold with a rocker, stroller, car seat, infant carrier, swing, highchair, or bouncer that are specifically designed to fit that product; • padded seat liners and inserts for a rocker, stroller, car seat, infant carrier, swing, highchair, or bouncer that are sold separately by the manufacturer as a replacement part and specifically designed to fit that product; and • sleeping accommodations that are regulated under the Commission’s infant sleep product rule at 16 CFR part 1236. B. Market Description Most types of new infant support cushions are sold online, including from general online retailers, online sites for ‘‘big box’’ stores, online baby products sites, and online marketplaces for handcrafted items. Some types of infant support cushions, particularly crib pillows and baby loungers, are also available from brick-and-mortar baby specialty stores and general retail stores. Prices for new infant support cushions average roughly $30 and range from less than $15 for a simple head positioner pillow or crib pillow to more than $250 for a lounger with a removable cover or a large stuffed toy marketed for use while an infant sleeps. Several thousand manufacturers and importers, including hundreds of handcrafters and direct foreign shippers, supply infant support cushions to the U.S. market. See Tab E of Staff’s NPR Briefing Package.9 9 Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice- E:\FR\FM\04NOR1.SGM Continued 04NOR1 87470 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations Infant support cushions may be reused for multiple children or resold for use after an infant outgrows the product. For example, in June 2023, staff found listings on Mercari for used changing pads, large stuffed toys marketed for infant sleep, crib wedge pillows, baby neck pillows, baby sleep positioners, baby loungers, baby sleep mats, baby pillow chairs, infant self-feeding pillows, baby/toddler bean bag chairs, and crib pillows. Similar listings were identified on eBay. lotter on DSK11XQN23PROD with RULES1 III. Incident Data and Hazard Patterns Staff searched the Consumer Product Safety Risk Management System (CPSRMS) 10 and National Electronic Injury Surveillance System (NEISS) 11 databases for fatalities, incidents, and concerns associated with infant support cushions and involving infants up to 12 months old, reported to have occurred between January 1, 2010, and December 31, 2022. Staff identified 79 fatal incidents and 124 nonfatal incidents and consumer concerns reported to CPSC from 2010–2022. Of the 124 12 non-fatal reports, 22 consisted of emergency-department-treated injuries, three involved hospital admissions, 45 involved no injury, and for 54 the disposition was either unknown or unspecified. The incident data and hazard patterns cited in support of the NPR support this final rule and are unchanged from the NPR. For further discussion of the incident data and hazard patterns, see the NPR and Tab A of Staff’s NPR Briefing Package, which describe the incident and hazard patterns associated with infant support cushions,13 and the NOA, which of-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. 10 CPSRMS is the epidemiological database that houses all anecdotal reports of incidents received by CPSC, ‘‘external cause’’-based death certificates purchased by CPSC, all in-depth investigations of these anecdotal reports, as well as investigations of select NEISS injuries. CPSRMS documents include hotline reports, online reports, news reports, medical examiner’s reports, death certificates, retailer/manufacturer reports, and documents sent by state and local authorities, among others. 11 NEISS is a statistically valid surveillance system for collecting injury data. NEISS is based on a nationally representative probability sample of hospitals in the U.S. and its territories. Each participating NEISS hospital reports patient information for every emergency department visit associated with a consumer product or a poisoning to a child younger than five years of age. The total number of product-related hospital emergency department visits nationwide can be estimated from the sample of cases reported in the NEISS. See www.cpsc.gov/Research—Statistics/NEISS-InjuryData. 12 The NPR listed 125 nonfatal incidents, but one of those incidents was a duplicate. 13 Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice- VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 describes the incident data and hazard patterns relied on for the rulemaking.14 IV. International and Voluntary Standards for Infant Support Cushions A. International Standards for Infant Support Cushions The Commission is aware of two British standards that contain performance requirements addressing suffocation and asphyxiation hazards associated with infant pillows: BS 1877–8:1974, Specification for Domestic bedding—Part 8: Pillows and bolsters for domestic use (excluding cellular rubber pillows and bolsters) (BS 1877– 8:1974) and BS 4578:1970, Specification for Methods of test for hardness of, and for air flow through, infants’ pillows (BS 4578:1970). The scope of BS 1877– 8:1974 includes both adult and cot pillows (infant pillows) and recommends that cot pillows be filled firmly enough to prevent infants’ heads from sinking into the products and that the pillow covering not be loose enough to be drawn into an infant’s mouth. BS 1877–8:1974 has requirements for cot pillow size, filling, and covering. Under that standard, cot pillows must be 58 x 38 cm (23 x 15 inches) and their covering must be of open construction to allow air permeability. Both the filling and covering must meet performance requirements described in BS 4578:1970 for hardness (i.e., firmness) and air permeability. The hardness test in BS 4578:1970 requires that a 100 mm diameter probe be placed in the center of the product with 10 newtons (N) of force for one minute. BS 1877–8:1974 requires that displacement of the pillow when the force is applied shall not exceed 25 percent of the thickness. The proportional approach used in this standard allows thicker pillows to have a greater displacement than thinner pillows, which staff assesses does not sufficiently protect against the suffocation and asphyxia hazards associated with infant support cushions because that greater displacement could allow the product to obstruct the infant’s airway. B. ASTM Voluntary Standards Work Currently, there are no published U.S. voluntary standards for infant support cushions. ASTM is working on a of-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. 14 Notice of Availability and Request for Comment: Data Regarding Incidents Associated With Infant Support Cushions, 89 FR 30295 (April 23, 2024), available at: www.federalregister.gov/d/ 2024–08605. PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 voluntary standard for infant loungers under the Subcommittee F15.21 on Infant Carriers, Bouncers, and Baby Swings.15 On March 25, 2024, ASTM issued ballot F15.21 (24–01), which included the latest draft of the infant lounger’s voluntary standard. The ballot closed on April 29, 2024, and received eight negative votes and other comments including a comment from staff.16 On September 16, 2024, ASTM issued ballot F15 (24–18), Item #1 which addressed the negative comments and other comments on the draft standard for infant loungers included in ballot F15 (24–01). That ballot closed on October 16, 2024.17 In the ASTM draft voluntary standard, infant loungers would be products with a raised perimeter, a recess, or other area that is intended to be placed on the floor and to provide a place for an infant to sit, lie, recline, or rest, while supervised by an adult, but are not intended or marketed for sleep. The draft definition would apply to only a subset of the products covered by this rule, which includes infant positioners, nursing pillows with dual use for lounging, infant cushions, and other infant pillow-like products, as well as the infant loungers being considered by the ASTM draft standard. ASTM’s draft voluntary standard for infant loungers includes general requirements typically found in other ASTM juvenile product standards, such as requirements addressing lead content, small parts, hazardous sharp edges or points, resistance to collapse and disassembly, openings, protective components, permanency of labels and warnings, and toy accessories that are attached to, removable from, or sold with the products. The ASTM draft standard also specifies that if the lounger can be converted to another product, it shall comply with the applicable requirements of the converted product’s standard. The general requirements of the ASTM draft infant lounger standard also state that the sidewall height of the 15 See Tab B of Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-Support-Cushions.pdf? VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc. This ASTM standard is still in draft form and has not completed the full consensus process to become an approved standard, and thus the draft standard is subject to change. 16 CPSC Staff Comment to Ballot ASTM F15.21 on Infant Loungers, available at: www.cpsc.gov/s3fspublic/CPSCStaffCommenttoBallot ASTMF1521onInfantLoungers.pdf?VersionId =tGM05rvyA6WCUzQxHFCDkVHVxRLbtQLv. 17 CPSC Staff Comment to Ballot ASTM F15.21 on Infant Loungers, available at: www.cpsc.gov/s3fspublic/staff-comment-to-ballot-ASTM–F15–21-oninfant-loungers.pdf?VersionId=oMjqKOhKBI0lEWiQ liiCJ3u3OP2XcB7n. E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations product shall be less than two inches on both the interior and exterior sides of the sidewall when measured according to the sidewall height measurement test method specified in the draft standard. The ASTM draft voluntary standard includes performance requirements that address stability, restraints, occupant support surface angle, fabric/mesh integrity, bounded openings, occupant support surface firmness, sidewall firmness, side angle measurements, and deflection at the occupant support surface and sidewall intersection. Finally, the ASTM draft voluntary standard for loungers also includes marking, labeling, and instructional literature requirements, such as warning the consumer about not using the product for sleep or naps, only using the product when the occupant baby is supervised, only using the product on the floor, keeping soft bedding out of the product, not using the product on raised surfaces, and not using the product to carry or move an infant. As previously noted, the ASTM draft standard for infant loungers primarily differs from the final rule regarding the scope of products subject to the standard. Specifically, the final rule includes all types of infant support cushions such as infant positioners, infant loungers, and other types of infant mats and pads, while the scope of the ASTM draft standard would apply only to infant loungers. Given that the ASTM draft standard for loungers has not been finalized and published and would not cover the same scope of products as the final rule, the Commission finds that no voluntary standard currently exists or will likely exist in the foreseeable future that would adequately address the hazards presented by infant support cushions. This rule is required under section 104 of the CPSIA to address the identified hazards presented by infant support cushions. 15 U.S.C. 2056a. lotter on DSK11XQN23PROD with RULES1 VI. Response to Public Comments CPSC received 18 public comments during the NPR comment period, and one comment during the NOA comment period. The comments are available on: www.regulations.gov, by searching under docket number CPSC–2023–0047. This section describes the significant issues raised in the comments and CPSC’s responses to them. A. Scope of the Final Rule Comment: The Boppy Company, LLC (Boppy), Best Practice Quality LLC (BPQ), Heroes Technology (US) LLC d/ b/a Snuggle Me Organic (Heroes Technology), and Juvenile Products Manufacturers Association (JPMA) VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 object to the broad scope of the proposed rule and argue that the proposed rule does not take into consideration that it is difficult to develop specific standards because of the wide range of infant support cushion designs. Response: We disagree that performance requirements and warning and labeling requirements for a wide range of infant support cushions cannot be comprehensively developed to mitigate the hazards posed to infants from infant support cushions. Although infant support cushions include many different types of products, incident data relied upon to support the rule indicate that infants are at risk from falls and suffocations, and that the hazard patterns are similar for all types of infant support cushions. As indicated in the incident data, caregivers use infant support cushions, which are not intended for sleep, in infant sleep settings and infants tend to fall asleep in these products. Thus, it is reasonably foreseeable that caregivers will use infant support cushions in infant sleep settings, which poses a suffocation hazard. Therefore, the performance requirements and warnings in the rule are designed to reduce the fall and suffocation hazards that these products pose. Comment: JPMA argues that a rule for infant support cushions is unnecessary because CPSC has a safety standard for infant sleep products, codified at 16 CFR part 1236, addressing infant support cushions that are primarily intended or marketed for sleep. Response: The scope of this rule includes products that are not subject to the infant sleep products rule, but that still present a risk of injury or death to infants. Infant support cushions do not meet the definition of infant sleep products because they are not marketed or intended to provide sleeping accommodations. Therefore, this rule is necessary to addresses the hazards posed by infant support cushions because the infant sleep products rule does not apply to infant support cushions. 1. Scope Age Comment: BPQ asserts that the inscope age range in the rule should be changed to align with the ASTM Lounger standard in development, which BPQ states covers infants 0–6 months. Response: Since publication of the NPR, the ASTM F15.21 Infant Loungers Scope Task Group changed the scope of its draft safety standard to include PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 87471 infants up to 12 months of age.18 Incident data, as outlined in the incident data and hazard pattern section of the NPR and Tab A of Staff’s NPR Briefing Package,19 indicate that incidents associated with infant support cushions occur with infants up to 12 months old (i.e., 365 days). Based on the incident data and hazard pattern analysis, the performance requirements and warnings were developed to mitigate the hazards associated with infant support cushions for infants up to 12 months old. The Commission declines to limit the scope of the final rule with a specific age limitation. The Commission’s approach mitigates the hazards associated with infant support cushions for all infants, regardless of age, and discourages manufacturers from making age-based marketing claims specifically to attempt to remove their products from being subject to the rule. 2. Tummy Time Pillows Comment: BPQ, the Toy Association (TA), Boppy, and Graco Children’s Products Inc (Graco) argue that the rule should exempt tummy time pillows. Response: We disagree that tummy time pillows should be exempted from the rule. Tummy time pillows, which are pillow products on which infants may be propped, present the same suffocation and fall hazards as other types of infant support cushions, as indicated in the incident data discussed above. Infants can suffocate when tummy time pillows conform to an infant’s face and occlude the airways; further, infants can roll from a tummy time pillow, creating a fall risk if the tummy time pillow is placed on an elevated surface. Therefore, tummy time pillows are subject to the requirements of the rule because allowing an exemption for tummy time pillows would allow those products to present the same suffocation and fall hazards to infants that this rule is intended to address. We note that AAP and National Institute of Child Health and Human Development (NICHD), while endorsing tummy time, do not specifically 18 ASTM F15.21 Infant Loungers Scope Task Group—MeetingLog, available at: www.cpsc.gov/ content/ASTM–F1521-Infant-Loungers-Scope-TaskGroup-Meeting%E2%80%AFLog-1. 19 Staff’s NPR Briefing Package available at: www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-for-Infant -Support-Cushions.pdf?VersionId= rA60lesWHddS1.wrk_EvV00xeX75dsFc. E:\FR\FM\04NOR1.SGM 04NOR1 87472 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations recommend tummy time pillows for that activity.20 21 lotter on DSK11XQN23PROD with RULES1 3. Dual Use Products Comment: AAP supports the scope of the proposed rule and specifically asserts that dual use products marketed for both nursing and lounging should be within the scope of the rule. BPQ and Boppy state that the rule should exempt dual use products. Boppy asserts that there are distinct differences between nursing pillows and infant support cushions; it further states that the intent of the nursing pillows rule is to limit nursing pillow use to solely breast feeding and bottle feeding, obviating the need to cover nursing pillows of any type, including dual use, in this rule. BPQ further argues that because the draft ASTM nursing pillows standard, at the time of the comment, specifically states that nursing pillows may not be marketed for multipurpose use, nursing pillows should be exempt from this rule even if they otherwise would meet the definition of an infant lounger. Response: We disagree that the rule should exempt dual use products marketed for both nursing and lounging. A nursing pillow that is also marketed for lounging is an infant support cushion subject to this rule. The new nursing pillow standard, ASTM F3669– 24, published on September 10, 2024, specifies that if a nursing pillow can be converted into another product or has use features for which a consumer safety specification exists, the product shall comply with the requirements of all applicable voluntary standards. On October 25, 2024, the Commission final rule for nursing pillows published (89 FR 85388), which does not have a requirement for convertible products. Nursing pillows that meet the definition of infant lounger in § 1243.2 must also meet the requirements of this rule because the two rules are intended to address different hazard patterns. While the nursing pillow performance requirements and warnings discourage lounging, the infant support cushion rule requirements are intended to mitigate suffocation hazard while lounging. It is common for multiple CPSC mandatory safety regulations to apply to a single children’s product, such as the existing regulations for 20 Benefits of Tummy Time | Safe to Sleep® (nih.gov), available at: https://safetosleep. nichd.nih.gov/reduce-risk/tummytime#:∼:text=Babies%20benefit%20from% 20having%20two,of%20total%20tummy%20time% 20daily . 21 American Academy of Pediatrics (2017). Back to sleep, tummy to play. Retrieved August 28, 2018, from www.healthychildren.org/English/ages-stages/ baby/sleep/Pages/Back-to-Sleep-Tummy-toPlay.aspx. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 small parts, phthalates, and lead content. Comment: BPQ recommends the following statement should be added to the rule: If the infant lounger can be converted into another product for which a consumer safety specification exists, the product shall comply with the applicable requirements of that standard. Response: The commenter’s requested statement is unnecessary because § 1243.3(g) of the rule regarding convertible products already states that if the infant support cushion can be converted into another product for which a consumer product safety standard exists, the product also shall comply with the applicable requirements of that standard. 4. Playmats Comments: Bureau Veritas (BV) requests clarification regarding whether playmats are intended to be classified as infant support cushions. Dorel Juvenile Group, Inc. asserts that playmat products subject to the requirements for toys in ASTM F963 and 16 CFR part 1250 and whose base ‘‘pad or mat’’ is a flat layer no greater than one inch in thickness should be exempt from the rule. TA and Graco also assert that playmats that are subject to ASTM F963 and 16 CFR part 1250 should be exempt from the rule. Response: We disagree that the rule should exempt playmats. While playmats must meet the requirements of ASTM F963 and 16 CFR part 1250, those requirements do not address the infant suffocation hazards presented by playmats. Additionally, a playmat could have a flat layer no greater than one inch in thickness but still have greater than 1-inch sides or borders presenting a potential suffocation hazard. Finally, not providing the requested exemption is consistent with the ASTM draft voluntary standard for infant loungers, which currently also does not contain an exemption for playmats. 5. Accessory Pillows and Other Padded Accessories Comment: BV requests clarification on the scope of the final rule regarding accessory pillows and other padded accessories sold with a juvenile product, or accessories sold separately from a juvenile product but intended to be used on a juvenile product. Boppy and Graco assert that the rule should exempt accessory pillows and other padded accessories for durable nursery products that are sold separately. Boppy additionally states that infants are seated while in contact with these pillows and padded accessories, so they PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 do not meet the definition of an infant support cushion. Dorel Juvenile Group argues that the rule should exempt padded seat liners and inserts included with a car seat. BPQ argues that products that are used to keep an infant’s head positioned in an infant carrier should be out of scope of this rule. Response: Padded seat liners that are sold with a rocker, stroller, car seat, infant carrier, swing, highchair, or bouncer and are specifically designed to fit that product are not subject to the rule. However, we agree with BV, Boppy, Graco, and Dorel Juvenile Group that replacement padded seat liners and inserts for these products that are sold separately by the manufacturer as a replacement part and specifically designed to fit a rocker, stroller, car seat, infant carrier, swing, highchair, or bouncer would meet the rule’s definition of an infant support cushion, even though they would be subject to the rules for those specific products as well. To avoid this unintended result, we have added these products to the list of products not within the scope of the rule because they are subject to the specific safety standard for those products discussed in section II.A of the preamble. Under § 1243.1, products subject to another standard listed in 16 CFR 1130.2(a) are exempt from the rule. Aftermarket accessory pillows and other padded accessories, often marketed for use with a rocker, stroller, infant car seat, infant carrier, swing, highchair, or bouncer, but not sold with that specific product or as a replacement part, are subject to this rule, and thus must meet the requirements of the rule. This can include products that are used to keep an infant’s head positioned in an infant carrier, unless they are sold with that product or as a manufacturer’s replacement part. Such portable products can be used for purposes other than their intended use, including as an infant sleep product. Therefore, we disagree with BPQ that products that are used to keep an infant’s head positioned in an infant carrier should be outside the scope of this rule. We also disagree with Boppy that accessory pillows and other padded accessories, used with seated products, should be excluded from the scope of the rule. These accessories present a suffocation hazard to infants because they are highly portable, and therefore can be used not only in the product for which they were intended but also in a variety of other products in which infants sleep, such as cribs, bassinets, and play yards. Because infants sleep for a majority of the day and tend to fall asleep in products intended for lounging, it is reasonably E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations foreseeable that caregivers will use these accessory products in an infant sleep environment or that infants will fall asleep on them. Therefore, the rule has requirements and warnings to reduce the suffocation hazard presented by infant support cushions. lotter on DSK11XQN23PROD with RULES1 6. Infant Sleep Positioners, AntiRollover Pillows, and Wedge Pillows for Infants Comment: BPQ and Boppy argue that the rule should exempt infant sleep positioners and anti-rollover pillows. Boppy states that the rule should exempt wedge pillows for infants. Boppy and Graco additionally state infant wedge pillows, infant sleep positioners, and anti-rollover pillows are all sleep products and thus should be subject to the infant sleep products rule, not this rule. BPQ additionally states that there is precedent to have discrete standards for each product category. Response: We disagree with the commenters’ assertion that infant wedge pillows, infant sleep positioners, and anti-rollover pillows should be outside the scope of the rule because all of these products are sleep products.22 Infant wedge pillows, infant sleep positioners, and anti-rollover pillows do not meet the definition of infant sleep products in 16 CFR part 1236 because they are not marketed or intended to provide sleeping accommodations. Nevertheless, it is reasonably foreseeable that caregivers will use these products in an infant sleep environment. CPSC and FDA have warned against using infant positioning products in an infant sleep environment because they pose suffocation hazards.23 24 The incident data, which includes both fatal and nonfatal incidents, show that infants can suffocate when wedges, sleep positioners, and anti-rollover pillows conform to an infant’s face. Therefore, the performance requirements and warnings of the rule are intended to mitigate the suffocation hazard posed by these products. Because the incident data hazard patterns associated with these products are the same and show that all infant support cushions are used for lounging, we disagree that it is 22 See Safety Standard for Infant Sleep Products, 86 FR 33022 (June 23, 2021), available at: www.federalregister.gov/d/2021–12723. 23 Recommendations for Parents/Caregivers About the Use of Baby Products | FDA, available at: www.fda.gov/medical-devices/baby-products-sidsprevention-claims/recommendationsparentscaregivers-about-use-baby-products. 24 Deaths prompt CPSC, FDA warning on infant sleep positioners | CPSC.gov, available at: www.cpsc.gov/Newsroom/News-Releases/2010/ Deaths-prompt-CPSC–FDA-warning-on-infantsleep-positioners. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 necessary to develop separate standards specifically for these products. 7. Pads and Mats Comments: An anonymous commenter requests clarification on the type of pads and mats subject to the rule because they assert that the term is generic and could apply to products beyond those on which a child could sleep. Response: Pads and mats that are marketed, designed, or intended to support an infant’s weight or any portion of an infant while reclining or in a supine, prone, or recumbent position are subject to the rule. These pads and mats pose a suffocation hazard because they can be used in a variety of products in which infants sleep such as cribs, bassinets, and play yards. In addition, because infants sleep for a majority of the day and tend to fall asleep in products intended for lounging, it is reasonably foreseeable that infants will fall asleep on pads and mats. Pads and mats are associated with both fatal and nonfatal incidents in the incident data, and the performance requirements of the final rule are intended to mitigate the suffocation hazard to infants from these products. 8. Framed Seating Products Comment: Graco argues that framed seating products should be exempt from the rule because these types of framed products do not present the same hazards as soft cushioned infant pillow products and because the NPR did not specifically address hazards associated with seated infant products that have rigid frame containment. Response: We agree with the commenter that framed seating products, including infant floor seats, rockers, strollers, car seats, infant carriers, swings, highchairs, bouncers, or other infant products with rigid components are not infant support cushions as defined in § 1243.2 of the rule. Thus, an exemption is unnecessary because these products are not subject to the requirements of the final rule. B. Definitions Comment: TA requests the term ‘‘infant pillow’’ used in § 1243.3(d), but nowhere else in the proposed rule, be amended to reference the defined term of infant support cushion for consistency. Alternatively, TA argues that ‘‘infant pillow’’ could be included as a discrete term in § 1243.2. Response: For consistency and clarity, the reference to infant pillow in § 1243.3(d) of the proposed rule has been changed to infant support cushion in the final rule. PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 87473 Comment: Graco requests that the definition of infant lounger be modified by to substitute the term infant support cushion for infant product. Graco also requests that the phrase ‘‘infant loungers do not include seated infant products with a rigid frame used as containment’’ be added to the definition of an infant lounger. Response: We agree with the commenter’s recommended change to the definition of infant lounger in § 1243.2 and have replaced the phrase infant product with infant support cushion in the final rule. We disagree that it is necessary to specify that infant loungers do not include seated products with a rigid frame used as containment as these products are not within the scope of infant support cushions and thus are not subject to the requirements of the rule. Comment: JPMA asserts that the definitions used in the rule should align with the ASTM standard, in development, for infant loungers. Response: The draft ASTM standard for infant loungers is in draft form and subject to change as part of the consensus process. Therefore, we decline to align the definitions in the final rule with the ASTM standard in development. Additionally, the final rule’s definition of infant support cushion addresses the hazards presented by different types of infant support cushions, not just the infant loungers under consideration by the ASTM draft standard. Comment: Heroes Technology argues that many of the products within the scope of the rule do not have an occupant support surface and the rule does not address how to test products without an occupant support surface. Response: All infant support cushions contain an occupant support surface, which is defined in § 1243.2 as the area that holds up and bears the infant or any portion of the infant to support the infant’s weight or any portion of the infant while reclining or in a supine, prone, or recumbent position. By definition, every infant support cushion subject to the rule contains an occupant support surface, and thus is required to meet the performance requirements of the rule that involve testing the occupant support surface. Comment: Boppy notes that the proposed rule does not define the term sidewall. Response: The Commission agrees that a definition of the term sidewall is needed for clarity. Thus, a new definition for sidewall, which means any wall at the edge of the occupant support surface, has been added to § 1243.2 of the final rule. E:\FR\FM\04NOR1.SGM 04NOR1 87474 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations C. Use of Substitute Products Comment: Boppy, Heroes Technology and JPMA raised a concern about the potential for consumers to use substitute products such as adult pillows or blankets, instead of infant support cushions. The commenters note that such products would fall outside the scope of the rule but could pose similar suffocation and fall hazards to infants. Response: None of the commenters provide data to support the claim that the requirements in the proposed rule would lead consumers to use substitute products. The rule is intended to ensure that consumers have access to infant support cushions that do not present the same risks of death or injury as some current products, and this rule should not cause consumers to seek out alternative products. The rule also contains warnings that explain why soft surfaces, blankets, and other soft items present a hazard when placed in and around the product, which can further educate consumers on the risks posed by substitute products with soft surfaces. Comment: Boppy questions whether the performance requirements in the proposed rule could negatively impact tummy time rates. Response: The rule is not likely to reduce beneficial tummy time. Regarding tummy time, AAP and NICHD, while endorsing tummy time, do not recommend specifically using tummy time pillows. Additionally, this rule would allow the manufacture and sale of tummy time products as long as those products meet the requirements of the rule. Therefore, tummy time guidance is not likely to change based on this rule. lotter on DSK11XQN23PROD with RULES1 D. Product Misuse and Education Comment: BPQ recommends CPSC develop educational campaigns to address the unsafe sleep settings and misuse of products not intended for infant sleep exhibited in the incident data. Commenter Julian Dreest asks what strategies are currently in place to educate consumers about the proper use of infant support cushions. Response: The use of infant support cushions for sleep, or in an infant sleep setting, is not appropriate. Consumer education campaigns about safe sleep and the safe use of infant support cushions are useful and necessary to assist new parents and older generations of caregivers about safe sleep practices. CPSC actively promotes safe sleep outreach and education throughout the year to reach parents, grandparents, and VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 caregivers on our website 25 and by engaging in targeted safe sleep messaging during Baby Safety month (September). However, education campaigns alone are not enough to address the hazards associated with infant support cushions. Data generally indicate that consumers believe if an infant product is on the market, it must be safe for use with infants—an assumption that is not always true. Therefore, this final rule for infant support cushions, paired with educational campaigns, is needed to better ensure safe uses of these products. Comment: Julian Dreest, BPQ, and Heroes Technology assert that educational strategies should reflect the new requirement for a maximum incline angle of 10 degrees or less, which limits the side height of the product to approximately 1.9 inches. The commenters assert this new requirement will invite some caregivers to improvise or modify the product to achieve the containment level they desire, increase consumer complacency, and provide a false sense of security leading to less supervision. Therefore, they argue, the rule will increase falls from elevated surfaces and the likelihood of roll-out from the product into an unsafe setting. AAP and the Joint Consumer Advocate Commenters strongly support the maximum incline angle requirement of 10 degrees or less in the proposed rule. Response: We disagree that limiting the maximum incline angle to 10 degrees or less will lead to increased falls or suffocations due to decreased supervision. As discussed in Tab D of Staff’s NPR Briefing Package,26 a cushioned sidewall with a height of up to four inches may give caregivers the false perception that the product can safely contain a child without supervision, regardless of what the product warnings might say. The presence of a distinct, raised perimeter surrounding the occupant support surface, as observed in various products on the market, provides a visual cue to consumers that the infant is safely contained in the product. Infant support cushions currently marketed for sale often display images of infants sleeping or resting in such products, and thus convey the appearance of effective containment of infants. The incident data shows that parents may mistakenly 25 Safe Sleep—Cribs and Infant Products, available at: www.cpsc.gov/SafeSleep. 26 See Tab D of Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 believe that products with cushioned sidewalls greater than two inches surrounding the infant would make them safe on elevated surfaces, that the infant can be left alone on the product, and that the product will safety contain their infant. The incident data further shows that infants suffer falls from products with cushioned sidewalls that are higher than 2 inches surrounding the occupant. Specifically, infants roll out of products with cushioned sidewalls greater than two inches into hazardous settings. With infant support cushions with cushioned sidewalls less than 2 inches, parents can see their infant is not secure in the product, that the product does not contain their infant, and that the infant should not be left alone on the product, particularly on elevated surfaces. Furthermore, the accompanying warnings alert users to the risks of leaving infants unattended or allowing use of the products for sleep or using on elevated surfaces. We note that AAP and the Joint Consumer Advocate Commenters strongly support the maximum incline angle requirement of 10 degrees or less in the proposed rule. Comment: Graco states that in addition to the current infant pillows that are already banned under 16 CFR 1500.18, the CPSC had considered an ‘‘Infant Pillow Ban’’ in former operating plans that would take these dangerous products off the market, but instead has pivoted to allow the very same types of products in the NPR, without sufficient requirements that would address the inherent misuse and hazards. Response: The Commission finds that the requirements in this rule will mitigate the suffocation and fall hazards to infants posed by infant support cushions. Therefore, the Commission concludes, that this rule will better address the known hazards posed by infant support cushions rather than just merely expanding the existing infant pillow ban, while still providing consumers with the utility of infant support cushions for supervised infant use. Comment: JPMA asserts that improper use of infant support cushions has contributed to the majority of incidents associated with these products since 2010. JPMA also contends that the majority of the products in the scope of this rule are not marketed or intended for sleep and have recognized utility for parents who need a safe product in which to place their child during awake time interaction, play, and engagement. Response: The incident data clearly indicate a pattern of use of infant support cushions in infant sleep settings and for sleep. The designs of infant E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations support cushions currently on the market encourage the use of these products for sleep. These products are often used for sleep because of the false perception that the soft, pillow-like design, with high borders/sides, are appropriate for infant sleep and will safely contain an infant, including on elevated surfaces. Further, staff is aware of infant support cushions that are or have previously been marketed and promoted as sleep products. Changing only the marketing of the product, without changing the design of the product, will not adequately discourage the behavior of caregivers allowing infants to sleep on infant support cushions unsupervised. We agree that infant support cushions have utility for parents to place their infant when actively supervised. lotter on DSK11XQN23PROD with RULES1 E. Incident Data Comment: BPQ, Boppy, Heroes Technology, and JPMA state that the percentages of incidents by product category are not provided in the NPR and Tab A of Staff’s NPR Briefing Package. BPQ also argues that the two largest nonfatal hazard patterns, falls and threatened asphyxia, are not broken down by age. Response: The Commission published an NOA announcing the availability of incident data relied upon for the NPR and seeking comment. The data in the NOA released for public comment shows that for fatal incidents, 63 incidents were associated with loungers, 10 incidents were associated with sleep positioners, four incidents were associated with pads/mats, one incident was associated with an infant wedge, and one incident was associated with a tummy time pillow. For nonfatal incidents, 104 incidents were associated with loungers, 13 incidents were associated with sleep positioners, three incidents were associated with infant wedges, two incidents were associated with pads/mats, one incident was associated with a tummy time pillow, and one incident was associated with a small infant pillow. As described above, the hazard patterns throughout these incidents are consistent with the risks of suffocation and falls presented by infant support cushions. Based on the data made available to commenters in the NOA, for incidents involving threatened asphyxia, 21 victims were up to 4 months old, two were 4–6 months old, and in three incidents the age was unreported. For incidents involving falls, 15 victims were up to 4 months old, nine were 4–6 months old, four were over 6 months old, and in one incident the age was unreported. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 Comment: Boppy argues in a comment on the NPR that CPSC provided insufficient data to support that all products proposed to be covered by the rule, and specifically tummy time pillows, need regulation with a mandatory rule. Boppy also argues in a comment on the NOA that there are zero reported incidents related to tummy time pillows, so there is no justification for any inclusion of tummy time pillows within the scope of this proposed rule. Response: The Commission disagrees that tummy time pillows should be excluded from the scope of the rule. Tummy time pillows are products on which infants may be propped, and therefore they must meet the requirements of this rule. Tummy time pillows were associated with one fatal incident and one nonfatal incident as reflected in the incident data and present the same hazards as other infant support cushions. So, allowing a tummy time pillow for infants to be exempted from this regulation is contrary to the regulation’s intent and would allow manufacturers to remarket other types of infant support cushions as tummy time pillows to avoid regulation. We note AAP and NICHD, while endorsing tummy time, do not specifically recommend pillows for tummy time. F. General Requirements Comments: Consumer Federation of America, Consumer Reports, Kids In Danger, National Center for Health Research, Public Citizen, U.S. Public Interest Research Group (Joint Consumer Advocate Commenters), and Safe Infant Sleep recommend that the rule prohibit any type of electronics used inside or attached to an infant support cushion. The commenters also recommend prohibiting battery powered features, including vibration and white noise that can encourage sleep or may overheat presenting a burn risk, or features that contain cords which present a strangulation risk. Response: Some vibrations and music/sounds may lull infants to sleep. However, other music and sounds may engage infants during awake time. Staff has not identified any products in the incident data where an electronic component caused an injury or a death through fire, heat, or otherwise. Because no such products were identified in the incident data as presenting a hazard, this rule does not include a requirement related to electronics. G. Performance Requirements Comment: Heroes Technology requests that CPSC conduct round robin studies of the performance requirements and test methods involving multiple PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 87475 laboratories and multiple exemplar products in each category, with a view to reproposing and ultimately adopting test methods and performance requirements. Response: The Commission considers the performance requirements and test methods in this rule to adequately address the hazards associated with infant support cushions without a need for the type of round robin process suggested by Heroes Technology, which could take years to complete while injuries and deaths continue to occur. The Commission concludes that the urgency of addressing the hazards associated with infant support cushions, and the requirement in CPSIA section 104 to promulgate safety standards, supports the Commission’s promulgation of this rule. The factual and scientific basis for the performance requirements and test methods in the rule are described in Tab C of Staff’s NPR Briefing Package.27 1. Restraint Comments: Graco asserts that the presence of a restraint system on an infant support cushion or lounger would further deter consumers from using them for sleep because the safety standards for sleep products do not allow restraint systems or cords or straps in the occupant area. On this basis, Graco suggests that the rule’s prohibition on restraints could indicate to caregivers that infant support cushions are intended for sleep. Response: The Commission’s yearly report of injuries and deaths associated with nursery products demonstrates that consumers use infant products, both with and without restraints, for infant sleep.28 In addition, restraints indicate to consumers that the infant is secure in the product and will not move, and thus the caregiver can leave the infant unsupervised. Because fall-related incidents have involved unattended infants who were left propped or lounging in the product, consumers are likely to interpret the presence of an infant restraint as meaning that unattended use is acceptable when an infant is restrained. Additionally, as is the case with several other children’s product areas, loops, cords, or strings 27 Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. 28 Injuries and Deaths Associated with Nursery Products Among Children Younger than Age Five, August 2023, available at: www.cpsc.gov/content/ Injuries-and-Deaths-Associated-with-NurseryProducts-Among-Children-Younger-than-Age-Five12. E:\FR\FM\04NOR1.SGM 04NOR1 87476 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 that enter into the occupant space can create an entanglement hazard, as seen in the incident data. Infant support cushions should be used with constant adult supervision, so prohibiting restraints in the rule is appropriate. 2. Maximum Incline Angle Comment: Heroes Technology argues that it is not clear in the rule what ‘‘approximately 1.9 inches’’ means and asserts that this is an arbitrary value. Graco argues that figure 6 in the text of the proposed rule alludes to a side height measurement, without criteria stipulated for the side height. Response: The rule does not include a side height performance requirement or a side height test method. Instead, the maximum incline angle performance requirement of 10 degrees or less in the rule effectively limits the height of the product to approximately 1.9 inches, which reduces the hazard from falls and suffocation when the product could otherwise give the false perception of containment to a caregiver that the product will safely contain the infant. The maximum incline angle test in the rule, as compared to a side height test, can more effectively be applied to all the different types of infant support cushions subject to the rule, which include infant support cushion products other than loungers and even products without a sidewall. Some products subject to the rule contain occupant support surfaces that allow an infant to be placed in various locations on the product. The maximum incline angle requirement applies to all the manufacturer’s recommended use positions, and also to all other infant support cushion surfaces that can feasibly support an infant’s head (occupant support surface-head), including the angle from the sidewall (if present) to the occupant support surface, or from the occupant support surface-head to the floor when no elevated sidewall is present, or from the sidewall to the floor when an elevated sidewall is present. Staff calculated that the side height for very firm products which meet the 10-degree angle requirements would likely be approximately 1.9 inches (4.8 cm) or less based on the geometry of the newborn hinged weight gauge. The side height was not recommended arbitrarily, and is not itself a requirement, but rather describes the geometric calculations of the likely height of a product just meeting the required incline angle of 10 degrees. Comment: BPQ recommends the sidewall height should be set at 2 inches, as in the draft ASTM infant loungers standard, and not 1.9 inches. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 BPQ contends that if the height of the product is set at 1.9 inches, then there would be no need to measure the incline angle. The commenter also recommends that the inclined angle of 10 degrees or less should be applied on the support surface of the base and only if the side height is greater than 2 inches. Response: The Commission disagrees that a maximum sidewall height of 2 inches should be required. The NPR did not propose a maximum side height requirement but instead proposed a maximum incline angle performance requirement. As discussed in the response to the previous comment, the maximum incline angle performance requirement in the rule is based on the varying designs of products and is expected to geometrically result in the height of the product being no more than 1.9 inches in order to comply with the incline angle requirement. Comment: Graco argues that subjecting infant support cushions to a maximum incline angle requirement for products that are not intended for sleep would incorrectly result in them sharing a critical characteristic of infant sleep products, that are also required to have a sleep surface of 10 degrees or less. Response: Infant support cushions are not sleep products, but infants fall asleep in many types of products other than sleep products, including infant support cushions. The maximum incline angle requirement in the rule addresses the suffocation hazard that could result if an infant sleeps in an infant support cushion. Section 1243.5(d) of the rule requires infant support cushions to have an incline angle of 10 degrees or less in order to reduce the hazard of suffocation if an infant falls asleep in the product. Comment: Heroes Technology argues that if there is no incline in the manufacturer’s recommended use location for the product, and other use locations represent misuse, then the product should not be subject to a maximum incline angle requirement. Response: We disagree that products with no incline in the manufacturer’s recommended use location should not be subject to the maximum incline angle requirement of the rule. Some products subject to the rule contain occupant support surfaces that allow a variety of use modes, so the infant may be placed in various locations on the product, while some products do not have sidewalls. With other products, infants may move, roll, or be placed in various positions on the product. To address known hazard patterns, the rule appropriately includes a maximum 10degree incline angle requirement that PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 applies to any foreseeable use position on the infant support cushion’s occupant support surface or sidewall that supports the head for reclining, to mitigate suffocation and fall hazards. The maximum incline angle requirement applies to all manufacturer’s recommended use positions, as well as to all other infant support cushion surfaces that can feasibly support an infant’s head (occupant support surface-head). This includes the angle from the sidewall (if present) to the occupant support surface or from the occupant support surfacehead to the floor when no elevated sidewall is present or from sidewall to floor when an elevated sidewall is present. Comment: Heroes Technology notes that an example of a ‘‘feasible location’’ is provided in the proposed rule, but the term is not defined. The comment also notes that a ‘‘location likely to fail’’ is also not defined in the rule, nor is any guidance provided as to how such a location should be determined. Response: A ‘‘feasible location’’ is language commonly used in ASTM standards and is typically followed by an example of such a location in the requirement. Section 1243.5(d)(8) is the only place in the rule where the term feasible location is used. This section represents the intent for a feasible location by providing an explicit example ‘‘such as perpendicular to the recommended use location(s)’’ without limiting the potential to test any area that is applicable with a discrete definition. The language a ‘‘location likely to fail’’ is language commonly used in ASTM standards and longstanding CPSC safety standards that incorporate these ASTM standards. While a location most likely to fail cannot be determined by the use of a single test, not all locations on the product need to be evaluated. For example, with respect to the maximum incline angle requirement, any extremity with respect to the overall height of the sidewall or occupant support surface should be considered areas likely to fail. Therefore, we disagree that ‘‘feasible location’’ or ‘‘location most likely to fail’’ needs to be defined in the rule. Comment: Graco argues that it is unclear if a two-inch height would prevent infants from rolling out of a product into a dangerous environment. Dony Ly suggests CPSC should recommend a side height that will best mitigate falls, while accounting for the wide range of infant age and ability but did not provide any recommendation as to that height. Julian Dreest proposes revising the sidewall height limitation E:\FR\FM\04NOR1.SGM 04NOR1 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations to a minimum of four inches to mitigate the risk of falls; he also asks if there has been a risk assessment analysis comparing the incidence of falls from products with different sidewall heights, while also taking into account the age of the infant. Heroes Technology asserts that CPSC failed to consider that a shorter sidewall height will increase the fall hazard. Response: As seen in the incident data and proposed in the NPR, a maximum incline angle requirement of 10 degrees or less mathematically limits the side height of the product to less than 2 inches to address potential asphyxiation hazards. The incident data also indicated that caregivers placed infant support cushions into infant sleep settings for unsupervised sleep or on elevated surfaces. Higher sidewall heights give the false perception to the caregiver that the product will safely contain their infant. At the same time, the incident data show that higher sidewall heights do not adequately contain infants or prevent falls and that infants roll out from and fall out of products with a side height of 4 inches or higher. The incident data also indicates that infants can turn over or roll without warning and are at risk of falling when infant support cushions are placed on an elevated surface. In contrast to products with higher side heights, products with side heights of approximately 2 inches or less are less likely to give the false perception to the caregiver that the product will safely contain their infant. Therefore, caregivers are less likely to leave infants unattended in a product with a less than 2-inch side height or to place the product on an elevated surface. When the side height is limited to less than 2 inches it provides a visual cue to caregivers that the product will NOT safely contain their infant which encourages caregivers to place the product on the floor, thus mitigating the fall hazard posed to infants from products placed on elevated surfaces. Furthermore, there is no evidence that a maximum sidewall height of about 2 inches would increase the risk of injury from a fall or lead to different consequences than a higher sidewall because, as reflected in the incident data, infant support cushions with higher side heights do not safely contain infants and infants already roll out of these products. Additionally, products with side heights of more than 2 inches would exceed the maximum incline angle requirement in the final rule and poses a suffocation or positional asphyxiation hazard. Also, the commenter’s proposal to require 4-inchhigh sidewalls would not allow for VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 products such as flat playmats or other infant support cushion products that do not contain sidewalls. Staff’s analysis of incident data did not identify the need for a sidewall requirement and thus the final rule has no requirements for a minimum side height. Therefore, the Commission is not adopting the commenters’ recommendations to require higher sidewalls because higher sidewalls encourage unsafe placement of infants on elevated surfaces, while also failing to adequately contain infants or prevent falls. Finally, staff is unaware of a risk assessment analysis specifically comparing the incidence of falls from infant support cushions of different product heights, while also taking into account the age of the infant. Comment: Heroes Technology asserts that CPSC failed to consider that with reduced side heights consumers will use blankets and towels to create a bumper. Response: Although this rule only regulates infant support cushions, it does contain specific warnings about the serious risks posed by soft bedding and other soft items in and around infant support cushions. Regardless of the side height of a product, some caregivers may use other products such as blankets and pillows to create a barrier around an infant, whether the infant is on an infant support cushion or not. CPSC will continue providing information and education campaigns for safe infant care regarding the hazards associated with soft bedding and soft items in sleep settings. 3. Firmness Comment: Boppy argues that the test requirements and procedures in the proposed rule do not consider products that do not have a sidewall. The performance requirements do not specify if the sidewall firmness and angle requirements only apply to products with a sidewall, and the testing procedures for sidewalls do not include language such as ‘‘if applicable’’ or ‘‘for products with a sidewall.’’ Response: We agree that the rule should clarify whether the performance requirements and test methods apply to products that do not contain a sidewall. Therefore, the final rule adds ‘‘For products with a sidewall’’ to the beginning of the sentence regarding the performance requirements in § 1243.4(e)(2) and (3) and (f) and also adds ‘‘For products with a sidewall’’ to the beginning of the sentence before ‘‘perform’’ in the test methods in §§ 1243.5(g) and 1243.4(h) and (i). Comment: Boppy notes that the rule does not specify how testing is to be performed on products with an PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 87477 occupant support surface of one inch or less. Response: We agree that clarification on how testing is to be performed on products with an occupant support surface of one inch or less is necessary in the final rule. Therefore, § 1243.5(f) of the final rule adds the language ‘‘All products, including products one inch or less in thickness, are required to be tested’’ to clarify how testing is to be performed on products with an occupant support surface of one inch or less. The rule requires all in-scope products, including those with an occupant support surface of one inch or less, to be tested to all of the performance requirements to ensure that they meet the standard. As discussed above, no exception is provided for products of one inch or less in thickness. Comment: Safe Infant Sleep proposes that CPSC should consider a requirement that would not allow covers to have extra padding or cushioning, since such extra padding or cushioning may introduce an additional suffocation hazard. Response: The Commission agrees that slipcovers with extra padding or cushioning may introduce a suffocation hazard that would not be addressed by testing only the firmness of the infant support cushion without the slipcover installed on the product during testing. The Commission also agrees that testing should be performed with slipcovers installed as part of the as assembled product and the product and slipcover, if sold on or together with the product, must meet the test requirements because extra padding or cushioning on a slipcover may introduce an additional suffocation hazard that is not addressed if the product is tested without the slipcover installed. In order to make clear that infant support cushions sold with a slipcover, on or together with the product, are subject to the rule and must be tested as assembled, the definition of infant support cushion in § 1243.2 has been revised to add a new sentence at the end of the definition stating ‘‘This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion.’’ However, aftermarket slipcovers not sold with the product do not meet the definition of an infant support cushion and thus would not be within scope of this rule. Finally, § 1243.5(f) adds the language ‘‘for products sold with a slipcover on or together with the product, products shall be tested as assembled with the slipcover on the product’’ to the final rule to clarify that slipcovers, sold on or together with the E:\FR\FM\04NOR1.SGM 04NOR1 87478 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 product, need to be installed on the product during testing. Comment: Graco argues that infant support cushions should not be tested on a solid or firm testing surface. Response: We disagree. Infant support cushions should be tested on a solid or firm testing surface as the product relies on the underlying surface it is placed upon for support and shape. In order to accurately measure the firmness of the foam, filling, padding, or supporting material in an infant support cushion, the testing surface cannot move in response to the applied force (i.e., displace, shift, bend, deviate, compress, deflect, translate or otherwise), because any movement of the testing surface in response to the applied load would contribute to an under-measured value for the firmness measurement and thus would not provide repeatable results. Comment: Graco argues that the minimum value for acceptable firmness for the firmness test cannot be directly correlated to the firmness values used in other safety standards for children’s products. Graco recommends that all data underlying the performance requirements be published to permit an independent assessment. Graco also argues that the performance requirements are not substantiated by reliable test results. Response: The Commission considered the recommendations of the BSU Final Report when developing the proposed requirements in the rule.29 Additionally, the requirements in the rule reflect staff’s testing of a variety of infant support cushions, as well as an analysis of hazard patterns obtained from incident data associated with infant support cushions. The Commission made this incident data available for public review and comment as described in the NOA. This information was used to develop the specific performance requirements, and labeling and instructional literature requirements that address the suffocation and fall hazards associated with infant support cushions. The development of the firmness test method and test results are discussed in further detail in Tab C of the Staff’s NPR Briefing Package.30 Comment: Heroes Technology argues that the firmness testing described in 29 Erin M. Mannen et al; Consumer Prod. Safety Comm’n. Pillows Product Characterization and Testing (2022). www.cpsc.gov/content/PillowsProduct-Characterization-and-Testing. 30 Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Noticeof-Proposed-Rulemaking-Safety-Standard-forInfant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 the rule regarding the intersection of the occupant support surface and sidewalls is ambiguous and that the term ‘‘location most likely to fail’’ is similarly vague. Response: The firmness test for the intersection of the sidewall and occupant support surface is intended to address suffocation hazards from infant support cushion products due to the presence of a sidewall adjacent to an occupant support surface. The rule provides instructions and guidance to measure firmness at the intersection of the sidewall and occupant support surface. Specifically, firmness is measured at the intersection of sidewall and occupant support surface as the force to deflect the surface 1.0 in (2.54 cm) using the 3-inch hemispherical probe oriented at an angle, determined according to the test method in § 1243.5(h), Intersection of sidewall and occupant support surface firmness. Section 1243.5(h) requires a force greater than 10.0 N (2.24 lbs) to address the suffocation hazard due to soft surfaces. The terms ‘‘most likely to fail’’ or ‘‘likely to fail’’ are standard language commonly used in ASTM standards and longstanding CPSC rules that incorporate these ASTM standards. However, areas where the sidewall appears to be vertical or slanted inward immediately over top of the occupant support surface, even while satisfying the angle requirement for the side as a whole, would be considered areas ‘‘likely to fail.’’ Therefore, the Commission disagrees that ‘‘location most likely to fail’’ needs to be defined in the rule. 4. Sidewall Angle Comment: Heroes Technology argues that the proposed sidewall angle requirement cannot be conducted effectively on the firm’s Snuggle Me infant lounger due to the lounger’s unique design features. Response: The sidewall angle requirement is intended to address the risk of entrapment between the sidewall and the occupant support surface that is not fully addressed by the firmness requirements alone. While the Snuggle Me infant lounger may possess unique design features, such as an unpadded occupant support surface, the product can still be evaluated to the sidewall angle requirement in the rule. The unpadded surface, and the firm flat surface the rule requires the units be tested on, would be considered the occupant support surface for the evaluation and the sidewall angle should be taken with respect to that surface. PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Comment: Heroes Technology argues that the rule provides no instructions or guidance to locate the intersection of the sidewall and occupant support surface. Response: In § 1243.5(i), Sidewall angle determination, the rule provides instructions and guidance regarding the test procedure to locate the intersection of the sidewall and occupant support surface. H. Marking and Labeling Comment: Boppy, AAP, BPQ, the Joint Consumer Advocate Commenters, Safe Infant Sleep, and JPMA all recommend an additional warning for the tummy time infant support cushion subcategory to provide clarity and resolve confusion surrounding the warning ‘‘use only on floor, with baby face up on back’’ when it is used on a product that is also a tummy time pillow. Response: We agree that some infant support cushion products, such as tummy time pillows, may have features that require the infant to be on their stomach while using the product and that different statements are appropriate for products designed for tummy time. Because prone positioning is a risk factor for infants that can lead to suffocation when the mouth and nose are occluded, the final rule adds a new figure 3 in § 1243.6 to accommodate products with multi-use positions. Specifically, the following statement ‘‘Put baby on back after Tummy Time’’ has been added to the warning label after the phrase ‘‘use only on the floor with baby on back, face up’’ in new figure 3. Figure 3 is only required for products that have a tummy time feature because only products that have a tummy time feature should allow prone positioning. Tummy time pillow manufacturers may also omit the word ‘‘only’’ from the statement ‘‘use only on floor with baby on back, face up’’ to accommodate the multi-use positioning of the product which is indicated in new figure 3. This entire warning statement bullet point was also moved up within the warning statement in figures 2 and 3 to reflect the serious hazard to infants from prone positioning. Products without a tummy time feature are required to use figure 2. Comment: The Joint Consumer Advocate Commenters propose requiring the product warning label on replacement covers for infant support cushions. Response: The Commission agrees that warning labels should be included on slipcovers that are sold on or together with infant support cushions. As discussed above regarding slipcovers sold on or together with the product that E:\FR\FM\04NOR1.SGM 04NOR1 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations must be tested with the slipcover installed on the product, the definition of infant support cushion in § 1243.2 has been revised to add a new sentence at the end of the definition, ‘‘This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion,’’ to make clear that slipcovers sold on or together with the product are subject to the requirements of the rule. However, aftermarket slipcovers or third-party covers are considered accessories that are not part of the product and thus not subject to the rule. Finally, in response to this comment, § 1243.6(e) of the final rule has been revised to require warning labels on slipcovers that are sold on or together with an infant support cushion. Comment: Safe Infant Sleep recommends laundering/cleaning instructions to mitigate a mold hazard. Response: Incident data do not indicate there is a mold hazard that would require infant support cushions to have laundering/cleaning instructions as part of this rulemaking. Therefore, the Commission assesses at this time no requirement is needed to address laundering/cleaning. However, if this information is provided, it should not be placed on a warning label because warning labels that have too much information that is not urgent for the user of the product dilute all messages on the label. Comment: The Joint Consumer Advocate Commenters suggest that CPSC should consider more ways to clearly emphasize in the warning label that infant support cushions should not be used for sleep. Response: The Commission assesses that no change to the rule is needed to clearly emphasize the warning against using infant support cushions for sleep because this message is already strongly communicated through the initial sentence of the warning about the deadly consequences of using the product for sleep or naps. Comment: Safe Infant Sleep objects to using the statement ‘‘using this product for sleep or naps can kill’’ because this statement implies that naps are different than sleep and this can be damaging to safe sleep education. The commenter instead recommends ‘‘using this product for ANY duration of sleep, even when supervised can kill.’’ Response: Consumers have indicated that ‘‘sleep’’ and ‘‘naps’’ may mean different things for infants and have indicated that infants ‘‘nap’’ anywhere but should be in a specific sleep product when they are put to ‘‘sleep.’’ 31 31 Fors Marsh Group’s, 2022 ‘‘Consumer Product Safety Commission (CPSC): Sleep Warnings Final VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 Therefore, the rule retains the requirement for the warning label to contain the statement ‘‘using this product for sleep or naps can kill’’ to reinforce that the products are unsafe for all types of sleep. However, the final rule revises the warning labels in figure 2 and new figure 3 of § 1243.6 by separating ‘‘stay near and watch baby during use’’ from ‘‘if a baby falls asleep, move baby to infant sleep product, such as a crib or bassinet.’’ These changes, which provide clearer instruction on what a caregiver should do if their baby falls asleep, have been made to figure 2 and new figure 3 of § 1243.6. Comment: Graco notes that the warning ‘‘use only with an awake baby’’ is a new type of warning and it is not clear if parents understand what level of awake their baby should be. Response: The Commission agrees that the phrase ‘‘use only with an awake baby’’ from the warning statement should be removed because the safety messaging to not use infant support cushions with sleeping infants or in an infant sleep setting is already strongly communicated through the initial sentence of the warning about the deadly consequences of using the product for sleep or lounging. Therefore, the final rule removes ‘‘use only with an awake baby’’ from the warning labels in figure 2 and new figure 3 of § 1243.6. Comment: Heroes Technology recommends changing the proposed warning ‘‘USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL’’ to ‘‘USING THIS PRODUCT FOR INFANT SLEEP OR NAPS CAN LEAD TO SERIOUS INJURIES OR DEATH.’’ Response: We disagree with the commenter’s recommended change to the warning label. First, the warning label statement ‘‘can kill’’ is an accurate and concise statement of the consequences of infants sleeping or napping on infant support cushions. Warning messages on many infant products are often too long, resulting in consumers not reading and heeding the messages. The commenter’s recommended statement ‘‘can lead to serious injuries or death’’ is much less impactful than ‘‘can kill’’ and thus would not be as effective in warning caregivers about the serious suffocation hazard to infants from using these products for sleep or naps. Comment: Heroes Technology suggests stronger warning language surrounding the use of soft bedding in and around infant support cushions. Report’’, available at: www.cpsc.gov/s3fs-public/ Consumer-Product-Safety-Commission%E2%80% 93Sleep-Warnings-Final-Report.pdf? VersionId=MfJcAAip4YNWVf.RllvXQtwNN7chjHyt. PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 87479 Response: Incident data indicate that infant deaths occurred when soft bedding was placed in an infant support cushion. Infant deaths also occurred when the product was used on soft bedding and the infant rolled out of the product into a hazardous setting containing soft bedding around the product. The Commission accordingly agrees that the rule should have stronger warning language regarding the use of soft bedding in and around infant support cushions. Therefore, the warning labels in figure 2 and new figure 3 of § 1243.6 have been revised to add ‘‘Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product.’’ to warn against the hazard presented by soft bedding in and around infant support cushions. Additionally, this revision to figure 2 and new figure 3 of § 1243.6 in the final rule separates this warning statement into a separate bullet point to emphasize the risk to infants from soft bedding. Comment: Heroes Technology suggests stronger and more impactful language surrounding the fall risk from placing the product on elevated surfaces, and warning consumers that infants may roll unexpectedly. Response: We disagree that the warning label in the rule requires stronger and more impactful language regarding the fall risk from placing infant support cushions on elevated surfaces and warning consumers that their infants may roll unexpectedly is necessary. These messages are already presented concisely on the warning labels in figure 2 and new figure 3 of § 1243.6. Comment: Graco states that the warning statements were not provided in the proposed regulatory text and were only provided in figure 2 of the NPR. Response: The proposed rule characterized the warning label in figure 2 as an example. Thus, it was unclear if the exact content and format for the warning label depicted in proposed figure 2 in § 1243.6(d)(7) is required. The final rule clarifies that the required content and format of the warning labels in figure 2 and new figure 3 are to be used exactly as written, as applicable. Additionally, in § 1243.6(d)(7), the word example was removed from the figure 2 and new figure 3 captions. Comment: Graco recommends adding the following statement to the warning label of the infant support cushion rule: ‘‘For babies with medical conditions, developmental delay, or complications relating to premature birth, consult a doctor before use.’’ E:\FR\FM\04NOR1.SGM 04NOR1 87480 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations Response: The Commission disagrees with requiring this information to be placed on the warning label because not all helpful information needs to be included on the warning label in the rule. The warning label in § 1243.6 of the rule includes messaging focused on the serious suffocation and fall hazards posed by infant support cushions. I. Comparative Analysis Comment: JPMA argues that CPSC has not provided a risk/benefit analysis, risk/hazard analysis, or a consumer choice analysis regarding the proposed rule. Response: The types of analysis described by the commenter that would quantify the hazard reduction benefits versus the costs of compliance are not required by section 104 of the CPSIA. A consumer choice model would require detailed consumer demand data that commenters did not provide and would involve quantifying consumer demand for theoretical product alternatives not specified by the commenter and not required by section 104 of the CPSIA. The Initial Regulatory Flexibility Analysis (IRFA) 32 did provide a specific numerical estimate of the cost of compliance, and the staff analysis of incidents found multiple deaths each year associated with these products—17 deaths per year in 2021 and at least 17 in 2022.33 lotter on DSK11XQN23PROD with RULES1 J. Effective Date Comments: Boppy, Heroes Technology, and JPMA contend that a 180-day effective date is insufficient for compliance and argue that a one-year effective date would be appropriate to limit the burdens on manufacturers. Response: While the commenters assert that 180 days is insufficient time to comply with the rule without burdening manufacturers, they do not provide any specific data or information showing that the level of effort to redesign and distribute an infant support cushion would require a oneyear compliance period. Furthermore, JPMA typically allows 180 days for products in their certification program to implement a new voluntary standard such that juvenile product manufacturers are accustomed to 32 See Tab E of Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. 33 See Tab A of Staff’s NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/BriefingPackage-Notice-of-Proposed-Rulemaking-SafetyStandard-for-Infant-SupportCushions.pdf?VersionId=rA60lesWHddS1.wrk_ EvV00xeX75dsFc. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 adjusting to new standards within this time frame. Therefore, the rule provides a reasonable effective date that takes into consideration manufacturers burdens and the risk of continued infant injuries and deaths. Based on the urgency of addressing the hazards associated with infant support cushions, the 180-day effective date proposed in the NPR is appropriate and is being finalized as proposed. K. Stockpiling Comments: AAP and the Joint Consumer Advocate Commenters request that CPSC take action to prevent manufacturers from increasing production of, or stockpiling, noncompliant infant support cushions and to prevent sellers from putting on the market large quantities of products that are noncompliant. Response: The Commission notes the commenters’ recommendations to include a stockpiling provision in the final rule. Commenters provided no evidence that manufacturers or importers are likely to increase significantly their manufacture or importation of infant support cushions before the rule’s effective date. In addition, the 180-day effective date should serve to limit the stockpiling of noncompliant products so as to prevent such manufacturers from circumventing the purpose of the rule. Therefore, the final rule does not include a stockpiling provision. L. Regulatory Procedure Comment: BPQ requests that CPSC revise the NPR and reissue it for public comment to reflect recent revisions to ASTM’s draft infant lounger voluntary standard. Response: As of the date of the publication of the final rule, there is no voluntary standard addressing the suffocation and fall hazards of infant support cushions on which a mandatory rule could be based. Additionally, the draft ASTM standard is in draft form and subject to change as part of the consensus process. Section 104 of the CPSIA does not require an existing voluntary standard in order for the Commission to promulgate a safety standard for a durable infant or toddler product. See 15 U.S.C. 2056a(b)(2); Finnbin, LLC v. Consumer Prod. Safety Comm’n, 45 F.4th 127, 134 (D.C. Cir. 2022). Comment: Boppy and Heroes Technology argue that this rule cannot be promulgated under section 104 of the CPSIA without a preexisting voluntary standard for infant support cushions. Response: Section 104 of the CPSIA does not require an existing voluntary PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 standard in order for the Commission to promulgate a safety standard for a durable infant or toddler product. See 15 U.S.C. 2056a(b)(2); Finnbin, LLC v. CPSC, 45 F.4th 127, 134 (D.C. Cir. 2022). In Finnbin, the court explained that CPSC has an express statutory command to regulate all categories of durable infant or toddler products and must do so for products not covered by voluntary standards. Furthermore, by the terms of 15 U.S.C. 2056a(b)(1), the requirement to examine and assess the effectiveness of any voluntary standards only applies if a voluntary standard exists. Because no voluntary standards currently address the suffocation and fall hazards posed by infant support cushions, the procedural requirements in section 104(b) of the CPSIA, to develop a rule with reference to an existing standard, do not apply to this rule. Comment: Boppy argues that infant support cushions are not durable nursery products because infant support cushions are ‘‘pillow-like’’ and pillows are soft, textile products that are in no way comparable to cribs, strollers, bathtubs, or bed rails. Boppy additionally argues that there are no products in either the original twelve, or additional six product categories of durable goods that can be rationally compared to ‘‘pillows.’’ Response: Infant support cushions meet the statutory requirement for durable infant or toddler products in section 104(f)(1) of the CPSIA because they are intended for use, and may be reasonably expected to be used, by children under the age of 5 years and routinely have a life span of several years. They are not disposable; have a useful life of up to several years and are often used by multiple children in succession; are similar to other soft durable infant and children’s products such as crib mattresses and sling carriers (which the Commission has issued rules for under section 104); are resold and widely available on secondary marketplaces; and are primarily intended to be used by children five years old or younger. Therefore, although infant support cushions are not specifically listed in section 104(f)(2) of the CPSIA, the Commission may reasonably treat them as ‘‘durable infant or toddler products.’’ The Commission has previously added to the statutory list of durable infant or toddler products by including other products for young infants, such as changing products and infant bouncers, that also have a market for secondary use. As the Commission explained in 2009, ‘‘[b]ecause the statute has a broad definition of a durable infant or toddler product but E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations also includes 12 specific product categories, additional items can and should be included in the definition.’’ Requirements for Consumer Registration of Durable Infant or Toddler Products, 74 FR 68668, 68669 (December 29, 2009). Comments: Boppy contends the proposed rule is unconstitutional because it violates the non-delegation doctrine and the Separation of Powers and Appointments Clause of the U.S. Constitution. Response: The rule is being promulgated under the Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, which directs the Commission to promulgate consumer product safety standards for durable infant or toddler products. CPSC is an independent agency and the Commissioners do not exercise Executive power, consistent with the Supreme Court’s holding in Humphrey’s Executor v. United States, 295 U.S. 602 (1935). Several Federal Courts of Appeals have recently rejected similar Constitutional arguments about CPSC. Consumers’ Rsch. v. CPSC, 91 F.4th 342 (2024), petition for cert. filed, (Consumers’ Rsch. v. CPSC, No. 23– 1323 (petition for cert. filed on July 18, 2024)), and Leachco, Inc. v. CPSC, 103 F4th 748 (10th Cir. 2024), petition for cert. pending, No. 22–7060 (filed Aug. 9, 2024)). lotter on DSK11XQN23PROD with RULES1 VII. Description of the Final Rule for Infant Support Cushions As section 104 of the CPSIA requires, to address the risks of death and injury associated with infant suffocations, entrapments, and falls, the Commission is issuing this rule to establish mandatory performance and labeling requirements for infant support cushions. The requirements of the rule are based on an evaluation of incident data and the hazard patterns associated with infant support cushions, and the recommendations of the BSU Final Report. The final rule is summarized below, and the rule is being finalized as proposed in the NPR except as noted. A. Section 1243.1 Scope, Purpose, Applications, and Exemptions Section 1243.1 explains that the rule applies to infant support cushions, including infant positioners, nursing pillows with a dual use for lounging, infant loungers, infant props, or cushions used to support an infant for activities such as tummy time, and other infant pillow-like products. It excludes products already regulated by other Commission mandatory standards for durable infant products, which are listed in 16 CFR 1130.2(a). The rule VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 applies to all infant support cushions manufactured after the effective date of the rule. Section 1243.1 is being finalized without changes as proposed in the NPR. B. Section 1243.2 Definitions Section 1243.2 provides definitions for the following terms used in the rule: conspicuous, infant lounger, infant positioner, infant support cushion, occupant support surface, seat bight line, and sidewall. The definitions in § 1243.2 are being finalized as proposed in the NPR except as discussed below. In response to a comment from Graco and for clarity, the definition of infant lounger has been revised to change the proposed words ‘‘infant product’’ to ‘‘infant support cushion’’ in the final rule. Also, in response to comments from Safe Infant Sleep and The Joint Consumer Advocate Commenters, the definition of infant support cushion has been revised to add a new sentence at the end of the definition ‘‘This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion’’. Finally, in response to a comment from Boppy, a new definition for the term ‘‘sidewall,’’ which is defined as ‘‘any wall at the edge of the occupant support surface’’, has been added to the final rule to provide clarity regarding the meaning of that term. C. Section 1243.3 Requirements General Section 1243.3 provides general requirements for infant support cushions, including requirements addressing hazardous sharp edges or points (§ 1243.3(a)), small parts (§ 1243.3(b), lead in paints (§ 1243.3(c)), toys (§ 1243.3(d)), the removal of components (§ 1243.3(e)), the permanency of labels and warnings (§ 1243.3(f)), and convertible products (§ 1243.3(g)). Section 1243.3 is being finalized as proposed in the NPR except that the reference to ‘‘infant pillow’’ in § 1243.3(d) has been changed in the final rule to ‘‘infant support cushion’’ for accuracy and consistency based on a comment from TA. The final rule also removes proposed § 1243.3(e) regarding side height. Measuring the height of the product is unnecessary and thus duplicative because the maximum incline angle test in § 1243.5(d)(7) already accounts for the height of the product remaining under 2 inches. The final rule renumbers the paragraphs following § 1243.3(d) to reflect this change. PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 D. Section 1243.4 Requirements 87481 Performance Section 1243.4 provides performance requirements for infant support cushions for restraints (§ 1243.4(a)), seam strength (§ 1243.4(b)), bounded openings (§ 1243.4(c)), maximum incline angle (§ 1243.4(d)), firmness (§ 1243.4(e)), and sidewall angle (§ 1243.4(f)). Section 1243.4 is being finalized as proposed in the NPR except as discussed below. In response to a comment from Boppy, two changes have been made in paragraph (e) of § 1243.4 that establishes requirements for firmness. In § 1243.4(e)(2) and (3), ‘‘For products with a sidewall’’ has been added to the beginning of the sentence because the proposed rule did not make clear whether the performance requirements are applicable to products without sidewalls. Additionally, in response to a comment from Boppy, the same change has been made to § 1243.4(f) that establishes requirements for side angles because the proposed rule did not clarify the applicability of performance requirements for products without sidewalls. E. Section 1243.5 Test Methods Section 1243.5 provides the test methods to be used to test for compliance with the requirements of the rule. Section 1243.5 includes test methods for test conditions (§ 1243.5(a)), test for permanence of labeling and markings (§ 1243.5(b)), head entrapment test (§ 1243.5(c)), maximum incline test (§ 1243.5(d)), firmness test setup (§ 1243.5(e), occupant support surface firmness test method (§ 1243.5(f)), sidewall firmness test method (§ 1243.5(g)), test method for the intersection of sidewall and occupant support surface firmness (§ 1243.5(h)), test method for sidewall angle determination (§ 1243.5(i)), seam strength test method (§ 1243.5(j)), and removal of components test method (§ 1243.5(k)). Section 1243.5 is being finalized as proposed in the NPR except as discussed below. For the same reason discussed above for the removal of proposed § 1243.3(e) regarding side height, the final rule removes the corresponding test in § 1243.5(d)(8) for consistency. To reflect this change, all numbers after § 1243.5(d)(7) have been renumbered. In response to a comment from Safe Infant Sleep, the following language has been added after the first sentence of § 1243.5(f): ‘‘For products sold with a slipcover on or together with the product, products shall be tested as assembled with the slipcover on the product.’’ This language has been added E:\FR\FM\04NOR1.SGM 04NOR1 87482 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations to the final rule because slipcovers with extra padding or cushioning may introduce suffocation hazards that would not be addressed if slipcovers sold on or together with an infant support cushion were not required to be tested as assembled with the slipcover on the product. In response to a comment from Boppy, right after the new sentence added above, the following language has been added to § 1243.5(f) of the final rule: ‘‘All products, including products one inch or less in thickness, are required to be tested.’’ This language has been added to the final rule because a product could either vary in thickness or be so close to 1 inch in thickness that it would be difficult to determine thickness without testing. In response to another comment from Boppy, § 1243.5(g) of the final rule adds in the first sentence ‘‘products with a sidewall’’ between ‘‘For’’ and ‘‘perform’’ because the proposed rule did not specifically clarify the applicability of test methods for products without sidewalls. The Boppy comment also resulted in changes to § 1243.5(h) and (i) at the beginning of the first sentence, adding ‘‘For products with a sidewall,’’ before ‘‘perform,’’ to state directly that products with sidewalls must be tested according to the test methods. lotter on DSK11XQN23PROD with RULES1 F. Section 1243.6 Marking and Labeling Section 1243.6 provides the marking and labeling requirements for infant support cushions, including general markings (§ 1243.6(a)), permanency (§ 1243.6(b)), upholstery labeling (§ 1243.6(c)), warning design for product (§ 1243.6(d)), and warning statements (§ 1243.6(e)). Section 1243.6 is being finalized as proposed in the NPR except as discussed below. Several changes have been made to figure 2 in § 1243.6(d)(7) as described below. We also add a new figure 3, Warning for Tummy Time Product, in § 1243.6(d)(7), as described below. • In response to a comment from Graco, the phrase ‘‘use only with an VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 awake baby’’ has been removed from the warning label in figure 2 and new figure 3 because the safety messaging to not use infant support cushions with sleeping infants or in an infant sleep setting is already strongly communicated through the initial sentence of the warning about the deadly consequences of using the product for sleep or naps, and limiting the amount of text on warning labels makes the material being presented more prominent. • The rule clarifies that figure 2 in § 1243.6(d)(7) is required for all infant support cushions that do not have a tummy time feature. • In response to comments from Boppy, AAP, BPQ, the Joint Consumer Advocate Commenters, Safe Infant Sleep, and JPMA, the Commission is adding a new figure 3 in § 1243.6(d)(7) for products with a tummy time feature. The statement bullet point was also moved up within the warning statement to reflect the serious hazard to infants presented by prone positioning. In new figure 3, the statement ‘‘Put baby on back after Tummy Time’’ is added to the warning label after the phrase ‘‘Use only on the floor with baby on back, face up,’’ to accommodate multi-use positions of some infant support cushion products, such as tummy time pillows that may have features that require the infant to be on their stomach while using the product. Figure 3 additionally omits the word ‘‘only’’ from ‘‘use only on the floor with baby on back, face up’’. Figure 3 is required only for products that have a tummy time feature because only those products that have a tummy time feature should allow for prone positioning. • In response to a comment from Safe Infant Sleep the warning labels have been revised with more concise wording and clarity to provide instruction for what a caregiver should do if their baby falls asleep by separating ‘‘stay near and watch baby during use’’ from ‘‘if a baby falls asleep, move baby to infant sleep product, such as a crib or bassinet’’. PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 • In response to a comment from Heroes Technology, the warning labels for figure 2 and new figure 3 now includes the statement ‘‘Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product’’ to discourage soft bedding use in and around the product. This revision also separates these warning statements into a separate bullet point to emphasize the risk to infants from soft bedding placed both in and around the product. • In response to a comment from Graco, the word ‘‘example’’ was removed from the captions on figure 2 and new figure 3 because it was unclear if the exact content and format for the warning labels in § 1243.6(d)(7) is required as depicted in proposed figure 2 and new figure 3. Additionally, the final rule clarifies in § 1243.6(d)(7) that the content and format as depicted in figure 2 and new figure 3 as applicable, are required. • Note 4 to proposed § 1243.6(e) has been removed from the rule as unnecessary because the final rule clarifies that the required content and format of the warning labels in figure 2 and new figure 3, as applicable, are to be used as written. • A new note 4 to § 1243.6(d)(6) has been added below figure 1 for paragraph (d)(6), which was originally the language above figure 1 for paragraph (d)(6), with the new note 4 providing the original text indicating that the depicted warnings are filler text, known as lorem ipsum, commonly used to demonstrate graphic elements. • In figure 2 and new figure 3, a black line has been inserted between the suffocation warnings and the fall warnings to distinguish between the messages. The changes described above are depicted below in the revised figure 2, Warning for Product Without Tummy Time, and new figure 3, Warning for Tummy Time Product, from § 1243.6 of the final rule. E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 87483 Warning for Product Without Tummy Time USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL. Babies can turn over or roll out without warning and CAN SUFFOCATE in only a few minutes. • • • • Only use on the floor with baby on back, face-up. Stay near and watch baby during use. Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product. If baby falls asleep, move baby to infant sleep product, such as a crib or bassinet. Babies have been injured from FALLS. • • Do not use on beds, sofas, or other raised surfaces. Never carry or move product with baby in it. Warning for Tummy Time Product USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL. Babies can turn over or roll out without warning and CAN SUFFOCATE in only a few minutes. • • • • Use on the floor with baby on back, face-up. Put baby on back after Tummy Time. Stay near and watch baby during use. Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product. If baby falls asleep, move baby to infant sleep product, such as a crib or bassinet. Babies have been injured from FALLS. Additionally, in response to a comment from the Joint Consumer Advocate Commenters, the final rule adds language at the end of § 1243.6(e) stating that slipcovers, sold on or together with the product, are required to contain a warning with the content and format depicted in figure 2 or 3, as applicable, to paragraph (d)(7). This VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 language is being added because when an infant support cushion is sold with a slipcover, it is expected that slipcover will hide the warning label that should be visible to a caregiver while placing an infant onto or into the product, when the product is in the manufacturer’s recommended use position. Therefore, the warning label should be PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 conspicuously located on the slipcover as is required for an infant support cushion that does not come with a slipcover. G. Section 1243.7 Literature Instructional Section 1243.7 provides requirements for instructional literature for infant E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.002</GPH> Do not use on beds, sofas, or other raised surfaces. Never carry or move product with baby in it. ER04NO24.001</GPH> lotter on DSK11XQN23PROD with RULES1 • • 87484 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations support cushions, including requiring instructional literature be provided with the product, as well as requirements as to what such information must include. Section 1243.7 also requires that instructional literature meet the requirements of the National Electrical Manufacturers Association’s (NEMA’s) ANSI Z535.4–2011(R2017), American National Standard for Product Safety Signs and Labels (ANSI Z535.4–2011). The final rule specifically requires the warning format requirements in sections 6.1–6.4, 7.2–7.6.3, and 8.1 of ANSI Z535.4–2011(R20217). Finally, under § 1243.7 any instructions provided in addition to those required by § 1243.7 shall not contradict or confuse the meaning of the required information or be otherwise misleading to the consumer. Section 1243.7 is being finalized as proposed in the NPR. lotter on DSK11XQN23PROD with RULES1 H. Section 1243.8 Incorporation by Reference Section 1243.8 incorporates by reference ANSI Z535.4–2011(R20217), American National Standard for Product Safety Signs and Labels, and ASTM D3359–23, Standard Test Methods for Rating Adhesion by Tape Test, and provides information on where those standards are available. ANSI Z535.4–2011 includes requirements related to safety alert symbol use; signal word selection; warning panel format, arrangement, and shape; color requirements for each panel; letter style; to identify and warn against specific hazards; and to provide information to avoid personal injury. ASTM D3359–23 covers procedures for assessing the adhesion of relatively ductile coating films to metallic substrates by applying and removing pressure-sensitive tape over cuts made in the film. VIII. Amendment to 16 CFR Part 1112 To Include NOR for Infant Support Cushions 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 CPSCenforced 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 thirdparty conformity assessment body. 15 U.S.C. 2063(a)(2). The Commission must publish an NOR for the accreditation of testing laboratories as third party conformity assessment bodies to assess conformity with a children’s product safety rule. 15 U.S.C. 2063(a)(3). The VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 infant support cushions rule is a children’s product safety rule that requires the issuance of an NOR. The Commission’s rules, at 16 CFR part 1112, establish requirements for accreditation of third party conformity assessment bodies to test for conformance with a children’s product safety rule in accordance with section 14(a)(2) of the CPSA. Part 1112 also lists the NORs that the CPSC has published. In the NPR the Commission proposed to amend part 1112 to include the Safety Standard for Infant Support Cushions in the list of children’s product safety rules for which the CPSC has issued NORs. Section 1112.15(a)(57) is being finalized as proposed in the NPR. Laboratories applying for acceptance as a CPSC-accepted third party conformity assessment body to test to the new Safety Standard for Infant Support Cushions standard 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 the Safety Standard for Infant Support Cushions included in its scope of accreditation as reflected on the CPSC website at www.cpsc.gov/labsearch. IX. Amendment to 16 CFR Part 1130 To Include Infant Support Cushions Infant support cushions are a category of ‘‘durable infant or toddler product’’ for purposes of CPSIA section 104 because they: are intended for use, and may be reasonably expected to be used, by children under the age of five years; are products similar to other products listed in section 104(f)(2), such as crib mattresses, and sling carriers; and are commonly resold or ‘‘handed down’’ for use by other children over a period of years. In the NPR, the Commission proposed to amend 16 CFR part 1130 to include Infant Support Cushions as durable infant or toddler products. Section 1130.2(a)(20) is being finalized as proposed in the NPR. X. Incorporation by Reference The rule incorporates by reference ANSI Z535.4–2011(R2017), American National Standard for Product Safety Signs and Labels, and ASTM D3359–23, Standard Test Methods for Rating Adhesion by Tape Test. In accordance with the regulations of the Office of the Federal Register, 1 CFR part 51, section VII.H of this preamble summarizes the requirements of the ANSI Z535.4– 2011(R2017) and ASTM D3359–23. Both standards are reasonably available to interested parties in several PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 ways. Interested persons may purchase a copy of ANSI Z535.4–2011(R2017) from the National Electrical Manufacturers Association (NEMA), 1300 17th St. N, Arlington, VA 22209; phone: (703) 841–3200; website: www.nema.org. This standard is also available from ANSI via its website, www.ansi.org, or by mail from ANSI, 25 West 43rd Street, 4th Floor, New York, NY 10036, telephone: (212)–642–4900. Once the rule takes effect, a read-only copy of ANSI Z535.4–2011(R2017) will be available for viewing, at no cost, on the ANSI website at: https://ibr.ansi.org/ Standards/nema.aspx. Interested individuals may purchase a copy of ASTM D3359–23 from ASTM, through its website, www.astm.org, or by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428–2959. Once the rule takes effect, a read-only copy of the standard will be available for viewing, at no cost, on the ASTM website at: www.astm.org/ READINGLIBRARY/. Alternatively, interested parties may inspect a copy of the standards at CPSC’s Office of the Secretary by contacting Alberta E. Mills, Commission Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; phone: (301) 504–7479; email: cpsc-os@ cpsc.gov. XI. 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). In the NPR the Commission proposed an effective date of 180 days after publication of the final rule in the Federal Register. This amount of time is typical for rules issued under section 104 of the CPSIA. We note that the 180-day effective date is the same amount of time that JPMA typically allows for products in their certification program to shift to a new standard once that standard is published. Therefore, juvenile product manufacturers are accustomed to adjusting to new standards within this time frame. We noted in the NPR that a 180-day effective date should also be sufficient for manufacturers to comply with this rule because the proposed requirements do not demand significant preparation by testing laboratories. For example, no new complex testing instruments or devices would be required to test infant support cushions for compliance with this rule. Based on the urgency of addressing the hazards associated with infant support cushions, the 180-day effective date proposed in E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations the NPR is appropriate and is being finalized as proposed. B. Comments and Responses Concerning Impact on Small Entities XII. Regulatory Flexibility Act Comment: Boppy and Heroes Technology state that the maximum incline angle requirement, which limits product height to approximately 1.9 inches, would eliminate most products subject to this rule from the market, resulting in a significant loss of utility to consumers for compliant products, far in excess of CPSC’s estimates. Response: The IRFA stated that consumers might not purchase the redesigned compliant products and estimated a significant impact on a substantial number of small businesses. The commenters did not provide any data on their assertion that consumers might not want to buy products with a shorter side height. Given the number of playmats and similar items with no sides or short sides on the market, there is ample evidence that consumers are willing to purchase such items. The Commission has considered the significant impact on small entities in the IRFA, and it is discussed in the possible alternatives analysis in this FRFA and thus has taken this impact into account as required by the RFA. Comment: JPMA states that this rule would require significant costly changes to make products compliant. Response: JPMA did not provide quantitative estimates of supplier costs or consumer utility impacts to support a change in the burden estimates. The IRFA provided specific estimates of labor and materials costs for redesign. The scope of staff’s analysis of burden, as required by 5 U.S.C. 603, was the impact on small U.S. businesses, and none of the comments provided information to support changing the estimates of impact on small U.S. businesses. The Commission has, however, considered the significant impact on small entities in finalizing this rule. When an agency is required to publish a notice of proposed rulemaking, the Regulatory Flexibility Act (5 U.S.C. 601–612) generally requires that the agency prepare an IRFA for the NPR and a final regulatory flexibility analysis (FRFA) for the final rule. 5 U.S.C. 603, 604. These analyses must describe the impact that the rule would have on small businesses and other entities. The FRFA must contain: (1) a statement of the need for and objectives of the rule; (2) significant issues raised by commenters on the IRFA, the agency’s assessment of those issues, and changes made to the result as a result of the comments; (3) a response to any comments filed by the Chief Counsel for Advocacy of the U.S. Small Business Administration (Advocacy), and changes made as a result of those comments; (4) a description and estimate of the number of small entities to which the rule will apply; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) steps the agency has taken to minimize the significant economic impact on small entities, consistent with the objective of the applicable statute, including the factual, policy, and legal reasons for selecting the alternative in the final rule and why other alternatives were rejected. Staff prepared an IRFA for this rulemaking that was summarized in the NPR and provided in full Tab E of the Staff’s NPR Briefing Package. The FRFA is provided below. lotter on DSK11XQN23PROD with RULES1 A. Need for and Objectives of This Rule Section I of this preamble describes the reasons and legal basis for this final rule. As discussed in sections VI and VII of this preamble, the rule sets mandatory requirements for infant support cushions to address the suffocation, entrapment, and fall hazards associated with these products; adds infant support cushions to the list of products for which a registration card is required; and adds infant support cushions to the list of durable infant products for which an NOR is required. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 C. Issues Raised by the Small Business Administration The Small Business Administration (SBA) did not submit a comment on the proposed rule. D. Small Entities to Which the Rule Would Apply The SBA sets size standards for what constitutes a U.S. small business for the purpose of various Federal Government programs,34 750 employees for manufacturers (NAICS code 314120) and 100 to 150 employees for wholesalers (NAICS codes 424350, 34 The size standards are in listed in the Code of Federal Regulations. See 13 CFR part 121. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 87485 423990, and 424990).35 Based on staff’s assessment of prominent online and brick-and-mortar retail sources for infant support cushions in the Spring of 2023, there appear to be more than 2,000 suppliers of infant support cushions to the U.S. market, including small U.S. crafters, small importers, small manufacturers, and direct foreign shippers. Staff estimates that a significant number of these firms are small U.S. businesses based on the SBA thresholds cited above. E. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of the Rule Suppliers will be required to comply with the performance requirements of the rule; provide a warning label, a consumer registration card, and user instructions; and conduct third-party testing to demonstrate compliance. Suppliers must demonstrate that they meet the performance requirements of the rule by providing certificates of compliance. As specified in 16 CFR part 1109, suppliers who are not the original manufacturer, such as importers, wholesalers, and retailers may rely on a certificate of conformity provided by their suppliers. Suppliers must also provide product registration cards. Recordkeeping and compliance documentation do not require specialized expertise. CPSC’s public website provides instructions and examples for how to develop the certificates of compliance and product registration cards.36 Similarly, because the final rule provides the text and graphics for the required labels and instructions, specialized graphics design expertise will not be required to develop the warnings and instructions. F. Impact of the Rule on Small Entities The rule will likely have a significant impact on a substantial number of U.S. small entities, based on the estimated costs of modifying the product to achieve compliance, and the ongoing cost of testing to demonstrate compliance. Staff considers one percent of annual revenue to be a ‘‘significant’’ 35 The North American Industry Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy. For more information, see www.census.gov/naics/. Some programs use 6digit NAICS codes, which provide more specific information than programs that use more general 3 or 4-digit NAICS codes. 36 See for example: www.cpsc.gov/Business— Manufacturing/Testing-Certification/ChildrensProduct-Certificate; and www.cpsc.gov/Business— Manufacturing/Business-Education/Durable-Infantor-Toddler-Products/FAQs-Durable-Infant-orToddler-Product-Consumer-Registration. E:\FR\FM\04NOR1.SGM 04NOR1 lotter on DSK11XQN23PROD with RULES1 87486 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations economic impact on a company, consistent with economic analysis from other Federal Government agencies. Nearly all of the more than 2,000 suppliers of infant support cushions to the U.S. are small entities, although their products often are not manufactured in United States. Most products on the market will require redesign to meet the requirements in the rule and no products on the market currently have the specific labels, customer registration forms, warnings, and third-party testing required by the rule. The effort required for a one-time redesign of a product is estimated to be 200 hours of professional staff time per model, including in-house testing of the prototypes and development of labels, customer registration forms, and instruction materials. Using the Bureau of Labor Statistics Employer Costs of Employee Compensation as of March 2024 37 the estimated cost per model is $13,648, at a current cost for professional labor of $68.24 per hour, rounded for the purpose of analysis to $14,000 per model. Materials costs for prototyping are estimated to be minimal, likely under $1,000, given that pillows are typically made of fabric and stuffing materials. Third-party testing for infant support cushions will be an additional cost for all suppliers and is estimated to be between $600 and $1,100 per model, per year, depending on where the testing takes place and whether manufacturers’ associations or groups add infant support cushions to their certification programs to receive volume discounts for third-party testing. The total first year costs of redesign are estimated to be approximately $16,000 per model ($14,000 for labor, $1,000 for materials, and $1,000 for third-party testing). Staff considers one percent of annual revenue to be a ‘‘significant’’ economic impact on a small business. Applying the one percent threshold to the estimated redesign and testing costs from this rule, the threshold for a small business that would incur a significant impact are those small firms with less than $1.6 million in revenue ($16,000 costs ÷ 1 percent of revenue), assuming they only sell one product model. This cost estimate will scale with the number of different models each firm manufactures. With an estimated 2,000 models from firms that sell to the U.S. needing to be redesigned, the total cost for the entire industry could be as high as $32 million for redesign in the first year after the rule is published.38 As suppliers will need to redesign their products to comply with this rule, both small and large companies may raise prices to cover costs. Given this uniformity, these costs would not necessarily place small businesses at a competitive disadvantage. JPMA, Boppy, and Heroes Technology questioned whether a small retail price increase would be acceptable to consumers, or could cover compliance costs, but these commenters did not provide an alternative quantitative estimate of compliance costs or probable retail price increases. In summary, given that all U.S. suppliers will have to redesign products to comply with this rule, and that these costs will likely be significant to many small businesses, this FRFA finds that this final rule will have a significant impact on a substantial number of U.S. small businesses. 37 www.bls.gov/news.release/ecec.t02.htm. The estimated costs in the link reflect the employers’ cost for salaries, wages, and benefits for civilian workers. 38 As noted earlier, this estimate is slightly higher than the estimate in the IRFA, because the relevant labor rate as reported by the Bureau of Labor Statistics has risen since the NPR was published. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 G. Other Federal Rules That May Duplicate, Overlap, or Conflict With the Final Rule CPSC has not identified any other Federal rules that duplicate, overlap, or conflict with the final rule. H. Alternatives Considered To Reduce the Impact on Small Entities The Commission considered alternatives to the final rule to reduce the impact on small businesses. The Commission considered using a public education campaign that would result in no regulatory impact on small businesses. However, given the education campaigns on safe sleep practices that CPSC and others have been undertaking for years, this approach would likely result in little to no mitigation of the current rates of deaths and injuries from infant support cushions. The Commission also considered allowing the voluntary standards process additional time to develop a voluntary standard to address the hazards posed by infant support cushions. However, there is no certainty that such a voluntary standard would be adopted, and a potential voluntary standard, if published, may not adequately address the identified hazards to infants. For example, the current ASTM draft voluntary standard for infant loungers would only cover infant loungers whereas the Commission’s rule covers all infant support cushions and has more PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 stringent performance requirements and warnings. XIII. Paperwork Reduction Act This rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501–3521). The preamble to the NPR discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of CPSC’s estimates. 89 FR 2530 (January 16, 2024). The NPR described the provisions of the proposed rule and provided an estimate of the annual reporting burden for the rule under the PRA. See 89 FR 2542. The estimated burden of this collection of information is unchanged from the NPR. CPSC did not receive any comments regarding the information collection burden in the NPR through OMB. OMB has assigned control number 3041–0202 to this information collection. XIV. Preemption Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a standard or regulation that prescribes requirements for the performance, composition, contents, design, finish, construction, packaging, or labeling of such product dealing with the same risk of injury unless the state requirement is identical to the Federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as consumer product safety rules. Therefore, the preemption provision of section 26(a) of the CPSA apply to this final rule for infant support cushions. XV. Environmental Considerations Certain categories of CPSC actions normally have ‘‘little or no potential for affecting the human environment’’ and therefore do not require an environmental assessment or an environmental impact statement. Safety standards providing requirements for consumer products come under this categorical exclusion. 16 CFR 1021.5(c)(1). The final rule for infant support cushions falls within the categorical exclusion. E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations XVI. Congressional Review Act The Congressional Review Act (CRA; 5 U.S.C. 801–808) states that before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission must indicate whether the rule is a major rule. The CRA states that the Office of Information and Regulatory Affairs determines whether a rule qualifies as a major rule. Pursuant to the CRA, OMB’s Office of Information and Regulatory Affairs has determined that this rule does not qualify as a major rule, as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit the required information to each House of Congress and the Comptroller General. List of Subjects 16 CFR Part 1112 Administrative practice and procedure, Audit, Consumer protection, Reporting and recordkeeping requirements, Third party conformity assessment body. 16 CFR Part 1243 Consumer protection, Imports, Incorporation by reference, Infants and children, Labeling, Law enforcement, Pillows, Toys. For the reasons discussed in the preamble, the Commission amends chapter II of title 16 of the Code of Federal Regulations as follows: PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 1. The authority citation for 16 CFR part 1112 continues to read as follows: ■ Authority: 15 U.S.C. 2063. 2. Amend § 1112.15 by adding paragraph (b)(57) to read as follows: ■ lotter on DSK11XQN23PROD with RULES1 Authority: 15 U.S.C. 2056a, 2065(b). 4. Amend § 1130.2 by adding paragraph (a)(20) to read as follows: ■ § 1130.2 Definitions. * * * * * (a) * * * (20) Infant support cushions. * * * * * ■ 5. Add part 1243 to read as follows: PART 1243—SAFETY STANDARD FOR INFANT SUPPORT CUSHIONS Sec. 1243.1 Scope, purpose, application, and exemptions. 1243.2 Definitions. 1243.3 General requirements. 1243.4 Performance requirements. 1243.5 Test methods. 1243.6 Marking and labeling. 1243.7 Instructional literature. 1243.8 Incorporation by reference. § 1243.1 Scope, purpose, application, and exemptions. Administrative practice and procedure, Business and industry, Consumer protection, Reporting and recordkeeping requirements. § 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule or test method? * * * * * (b) * * * (57) 16 CFR part 1243, Safety Standard for Infant Support Cushions. * * * * * 15:57 Nov 01, 2024 3. The authority citation for 16 CFR part 1130 continues to read as follows: ■ Authority: 15 U.S.C. 2056a. 16 CFR Part 1130 VerDate Sep<11>2014 PART 1130—REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT OR TODDLER PRODUCTS Jkt 265001 (a) Scope and purpose. The consumer product safety standard in this part prescribes requirements to reduce the risk of death and injury from hazards associated with infant support cushions, as defined in § 1243.2. This includes but is not limited to infant positioners, nursing pillows with a dual use for lounging, infant loungers, and infant props or cushions used to support an infant. All infant support cushions must be tested according to the requirements of § 1243.5 and comply with all requirements of this part. (b) Application. All infant support cushions manufactured after May 5, 2025, are subject to the requirements of this part. (c) Exemptions. Products subject to another standard listed in 16 CFR 1130.2(a) are exempt from this part. Nursing pillows that also meet the definition of infant lounger in § 1243.2, however, are not exempt from this part. § 1243.2 Definitions. Conspicuous means visible, when the product is in each manufacturer’s recommended use position, to a person while placing an infant into or onto the product. Infant lounger means an infant support cushion with a raised perimeter, a recess, or other area that PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 87487 provides a place for an infant to recline or to be in a supine, prone, or recumbent position. Infant positioner means a product intended to help keep an infant in a particular position while supine or prone. Infant support cushion means an infant product that is filled with or comprised of resilient material such as foam, fibrous batting, or granular material or with a gel, liquid, or gas, and which is marketed, designed, or intended to support an infant’s weight or any portion of an infant while reclining or in a supine, prone, or recumbent position. This definition includes any removable covers, or slipcovers, sold on or together with an infant support cushion. Occupant support surface (OSS) means the area that holds up and bears the infant or any portion of the infant. Seat bight line means the intersection of the seat back surface with the seat bottom surface. Sidewall means any wall at the edge of the occupant support surface. § 1243.3 General requirements. (a) Hazardous sharp edges or points. There shall be no hazardous sharp points or edges as determined by 16 CFR 1500.48 and 1500.49 before or after the product has been tested. (b) Small parts. There shall be no small parts as determined by 16 CFR part 1501 before testing or presented as a result of testing. (c) Lead in paints. All paint and surface coatings on the product shall comply with the requirements of 16 CFR part 1303. (d) Toys. Toy accessories attached to, removable from, or sold with an infant support cushion, as well as their means of attachment, shall comply with the applicable requirements of 16 CFR part 1250. (e) Removal of components. When tested in accordance with § 1243.5(k), any removal of components that are accessible to an infant while in the product or from any position around the product shall not present a small part, sharp point, or sharp edge as required in paragraphs (a) and (b) of this section. (f) Permanency of labeling and warnings. (1) Warning labels, whether paper or non-paper, shall be permanent when tested in accordance with § 1243.5(b)(1) through (3). (2) Warning statements applied directly onto the surface of the product by hot stamping, heat transfer, printing, wood burning, or any other method shall be permanent when tested in accordance with § 1243.5(b)(4). E:\FR\FM\04NOR1.SGM 04NOR1 87488 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations (3) Non-paper labels shall not liberate small parts when tested in accordance with § 1243.5(b)(5). (4) Warning labels that are attached to the fabric of the product with seams shall remain in contact with the fabric around the entire perimeter of the label when the product is in all manufacturerrecommended use positions and when tested in accordance with § 1243.5(b)(3). (g) Convertible products. If the infant support cushion can be converted into another product for which a consumer product safety standard exists, the product also shall comply with the applicable requirements of that standard. § 1243.4 Performance requirements. (a) Restraint. The product shall not include a restraint system. (b) Seam strength. When tested in accordance with § 1243.5(j), fabric/mesh seams and points of attachment shall not fail such that a small part, sharp point, or sharp edge is presented, as required in § 1243.3(a) and (b). (c) Bounded openings. When tested to § 1243.5(c), all completely bounded openings that exist in the front, sides, or back of the occupant lounging area, or that are created when an accessory is attached to the product, shall not allow complete passage of the small head probe unless it allows the complete passage of the large head probe. (d) Maximum incline angle. The maximum incline angle shall not exceed 10 degrees when tested in accordance with § 1243.5(d). (e) Firmness—(1) Occupant support surface firmness. When the 3-inch diameter (figure 1 to this paragraph (e)(1)) hemispherical head probe is applied according to the test method for occupant support surface firmness, § 1243.5(f), the force required for a oneinch displacement shall be greater than 10 Newtons (N). Figure 1 to paragraph (e)(1)—3-inch Head Probe 3-in. Hemispherical Surface, L J (2) Sidewall firmness. For products with a sidewall, when the 3-inch diameter hemispherical head probe is applied according to the test method for sidewall firmness in § 1243.5(g), the force required for a one-inch displacement shall be greater than 10 N. (3) Firmness at intersection of sidewall and occupant support surface. For products with a sidewall, when the 3-inch diameter hemispherical head probe is applied according to the test method for firmness at the intersection of sidewall and occupant support surface in § 1243.5(h), the force required for a one-inch displacement shall be greater than 10 N. (f) Sidewall angle. For products with a sidewall, the sidewall angle shall be greater than 90 degrees when determined according to the sidewall angle determination in § 1243.5(i). § 1243.5 Test methods. (a) Test conditions. Condition the product for 48 hours at 23 °C +/¥ 2 °C (73.4 °F +/¥ 3.6 °F) and a relative humidity of 50% +/¥ 5%. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (b) Permanence of labels and warnings. (1) A paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed, it tears into pieces upon removal, or such action damages the surface to which it is attached. (2) A non-paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed or such action damages the surface to which it is attached. (3) A warning label attached by a seam shall be considered permanent if it does not detach when subjected to a 15-lbs (67–N) pull force applied in any direction using a 3⁄4-inch diameter clamp surface. (4) Adhesion test for warnings applied directly onto the surface of the product. (i) Apply the tape test defined in Test Method B, Cross-Cut Tape Test of ASTM D3359 (incorporated by reference, see § 1243.8), eliminating parallel cuts. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 (ii) Perform this test once in each different location where warnings are applied. (iii) The warning statements will be considered permanent if the printing in the area tested is still legible and attached after being subjected to this test. (5) A non-paper label, during an attempt to remove it without the aid of tools or solvents, shall not be removed or shall not fit entirely within the small parts cylinder defined in 16 CFR part 1501 if it can be removed. (c) Head entrapment test. For all applicable openings, rotate the small head probe (figure 1 to this paragraph (c)) to the orientation most likely to fail and gradually apply an outward force from the occupant lounging area of 25 lbs (111 N). Apply the force to the probe in the direction most likely to fail within a period of 5 seconds and maintain it for an additional 10 seconds. If the small head probe can pass entirely through the opening in any orientation, determine if the large head probe (figure 2 to this paragraph (c)) can be freely inserted through the opening. E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.003</GPH> lotter on DSK11XQN23PROD with RULES1 1-2in. Recommended L.'.ength Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 87489 Figure 1 to paragraph (c)—Small Head Probe 4.31n. (109mm) - - - 5.71n. (14Smm)--- 5.2 In. (132mm) l Base of Probe Handle Figure 2 to paragraph (c)—Large Head Probe _.,_ . . . . . --. . . -dfN. r ,-----. ------------f1i--> -- ----uaDJA---.... (3110nmi) 1-4-----um.-.,----tH VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (ii) Hinged weight gauge—newborn, requirements for part masses and assembly (figure 3 to this paragraph (d)(1)(ii)); BILLING CODE 6355–01–P PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.005</GPH> (d) Maximum incline test. (1) Equipment shall include: (i) Digital protractor with accuracy +/¥1 degree; ER04NO24.004</GPH> lotter on DSK11XQN23PROD with RULES1 (230mm) 87490 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations Figure 3 to paragraph (d)(1)(ii)—Hinged Weight Gauge—Newborn, Requirements for Part Masses and Assembly 3.378 ± .02 kg (7.447 ± .05 lb.) 1 Upper Plate 2.275 kg (5.116 lb) 289.8 cmA3 (17.68 jnA3) 2 Lewer Plate 1.u, kg (2.379 lb) 137.4 cmA3 (8.385 cmA3) 3 Pin tU)24 kg (0.153 Ill>) 3.03 cmA3 (D.185 inA3) Note 1. Part mass is calculated as Volume divided by the density for mild steel of 7.85 g/cmA3 (0.283 lbs/inA3). ,___--(27!>.4 [1U)O in])----- . . - - - - - - - - - - - ( 4 ( ; 2 . 0 [18.19 i n ] ) - - ~ (iii) Hinged weight gauge-newborn, requirements for part dimensions (figure 4 to this paragraph (d)(1)(iii)); and VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.006</GPH> lotter on DSK11XQN23PROD with RULES1 □ Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 87491 Figure 4 to paragraph (d)(1)(iii)— Hinged Weight Gauge—Newborn, Requirements for Part Dimensions 12.79 [.510 In] I :I ✓ ~.35 Slip Flt [.250} I 0.8 [.83 In] Break Edges AIIAreuna 182.6 [7.19 In] 6.36 [.251\l in] I 7.il,[.JH in] (22.9 [.91\l inJ} 1, .6.351 [.251\l] 25.S[UUin] 149.4 [ .Nin] 2 .8 [.83.in] X45°CH 60.H [2.362 in] 3 - ---- -------- 183.6 [4.08 in) R12.7 [R.59 in] R3.2 [R.13 ln] ·2PLC R15.D [R.59 in] -2 PLC 17 i]nlo] i------(189.9 [7.44 in]1------1 f!ii.35 Press F i t ~ [.251] 1.,1. _ _ _ _ _ _ _-_--_--_-_--_--_ 12.70 [.508 In] -_--_--,---t-f c-=-==-=-::=--..:._____________ _,___~ I 6.35 [.251 ill] I r u [.83 in] Break Eages All Around 213.9 [8.42 in] 279.4 [11.H in] ~1.J__I. L , _ _ _ _ _ ~ : : - - - - ~ - - - - - r 1 95.9 [3.78 in] 63.5 [2.58 In] nete 1 56.8 [2.20 in] -------1 l - ' . - - - - - - - - - t 2 8 5 . 8 [11.25 i n ] ) - - - - - - - - - - i (iv) A test base that is horizontal, flat, firm, and smooth. (2) If applicable, place the product in the manufacturer’s recommended highest seat back angle position intended for lounging. (3) If applicable, place the hinged weight gauge—newborn in the product VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 and position the gauge with the hinge centered over the seat bight line and the upper plate of the gauge back. Place a digital protractor on the upper torso/ head area lengthwise and measure the incline angle. (4) Place the head/torso portion of the newborn hinged weight gauge on the PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 product according to the manufacturer’s recommended use position with the seat portion of the gauge, depending on the product design, allowed to lay freely on the product or on the test base (figure 5 to this paragraph (d)(4)). E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.007</GPH> lotter on DSK11XQN23PROD with RULES1 BILLING CODE 6355–01–C 87492 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations Figure 5 to paragraph (d)(4)—Test Fixture Configuration to Measure Incline Angle on an Infant Support Cushion Product ASTM HINGED WEIGHT GAUGE -NEWBORN SEAT BIGHT LINE oss------ (5) Move and rotate the newborn hinged weight gauge the minimum amount necessary such that the head/ torso portion rests on an OSS that could foreseeably support an infant’s head, and place the head/torso portion of the gauge according to all situations that apply: (i) In tests on products with an OSS for the infant’s body, align the top edge of the head/torso portion of the gauge to coincide with a plumb line to the outermost edge of the OSS-head. (ii) In all tests, place the seat portion of the gauge on the test base, adjust the newborn gauge to the greatest incline angle in which the top edge of the gauge maintains contact with the top surface of the product. (6) If a product’s seating bight area prevents reasonable positioning of the head/torso portion to the outermost edge, then position the seat portion of the newborn hinged weight gauge as far forward as possible towards the outermost edge and allow the head/ torso portion of the gauge to rest on the product. (7) Place a digital protractor lengthwise on the head/torso portion of the gauge and measure the incline angle. (8) Measure the incline angle at the manufacturer’s recommended use location(s), at feasible locations such as perpendicular to the recommended use location(s), and at least one location likely to fail in which the newborn gauge seat is supported on the test surface. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (9) Determine the maximum incline angle from the incline angle measurements. (e) Firmness test setup. (1) Equipment shall include: (i) Force gauge with accuracy +/¥ 0.05 N (0.01 lbs). (ii) Distance gauge with accuracy +/¥ 0.01 inches (0.03 cm). (2) Align the axis of the 3-inch head probe (figure 1 to paragraph (e)(1) of § 1243.4) with a force gauge and parallel to a distance measurement device or gauge. (3) Use a lead screw or similar device to control movement along a single direction. (4) Support the firmness fixture to a test base such that the head probe does not deflect more than 0.01 inches (0.025 cm) under a 10.0 N (2.24 lbs) load applied in each orientation required in the test methods. (f) Occupant support surface firmness test method. Perform the following steps to determine the occupant support surface firmness of the product as received from the manufacturer. For products sold with a slipcover on or together with the product, products shall be tested as assembled with the slipcover on the product. All products, including products one inch or less in thickness, are required to be tested. See figure 6 to this paragraph (f). (1) Orient the axis of the 3-inch head probe perpendicular to the surface of the product at each test location that is oriented greater than five degrees relative to the test base or align the axis PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 of the probe perpendicular to the test base (vertically) at each test location that is oriented equal to or less than five degrees to the test base. (2) The first test location shall be at the location of maximum thickness of the surface being tested, perpendicular to the test base. (3) Lay the product, with the occupant support surface facing up, on a test base that is horizontal, flat, firm, and smooth. (4) Prevent movement of the product in a manner that does not affect the force or deflection measurement of the product surface under test. Provide no additional support beneath the product. (5) Advance the probe into the product and set the deflection to 0.0 inches when a force of 0.1 N (0.02 lbs) force is reached. (6) Continue to advance the head probe into the product at a rate not to exceed 0.1 inch per second and pause when the force exceeds 10.0 N (2.24 lbs), or the deflection is equal to 1.00 inches (2.54 cm). (7) Wait 30 seconds. If the deflection is less than 1.00 inches and the force is 10.0 N or less, repeat the steps in paragraphs (f)(6) and (7) of this section. (8) Record the final force and deflection when the deflection has reached 1.00 inches or when the force has exceeded 10.0 N. (9) If the maximum thickness of the OSS is greater than 1.0 inches (2.54 cm), perform additional tests, space permitting, at the geometric center of the OSS, at four locations along the product’s longitudinal and lateral axes E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.008</GPH> lotter on DSK11XQN23PROD with RULES1 SIDEWALL Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations therefrom, 1.5 inches (3.8 cm) towards center from the intersection of the sidewall and OSS, and at one location most likely to fail. (10) Repeat the occupant support surface firmness tests on any other occupant support surface and in all intended and feasible configurations that could affect an occupant support 87493 surface, such as the folding or layering of parts of the product. Figure 6 to paragraph (f)—Test Configuration for Occupant Support Surface Firmness Test lON 3-lN HEMISPHERICAL TEST PROBE OCCUPANT SUPPORT SURFACE TEST BASE VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (h) Intersection of sidewall and occupant support surface firmness. For products with a sidewall, perform the following steps to determine the intersection firmness of the product as received from the manufacturer (figure 7 to this paragraph (h)). (1) Orient the axis of the 3-inch head probe perpendicular to the sidewall perimeter at an angle from horizontal that bisects the angle determined in sidewall angle determination with the axis directed at the intersection of the occupant support surface and the sidewall. (2) The first test location shall be at the location of maximum product thickness parallel to the test base. PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 (3) Perform the steps in paragraphs (f)(3) through (8) of this section. (4) Perform a minimum of four additional tests, located at intervals not to exceed six inches along the entire inside perimeter of the intersection of the sidewall and OSS, and at one additional location most likely to fail. (5) Repeat the intersection of sidewall and occupant support surface firmness test in all the intended or feasible configurations that could affect the intersection firmness, such as the folding or layering of parts of the product. E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.009</GPH> lotter on DSK11XQN23PROD with RULES1 (g) Sidewall firmness test method. For products with a sidewall, perform the steps in paragraphs (f)(1) through (8) of this section to determine the sidewall firmness of the product as received from the manufacturer and then perform the following: (1) Perform a minimum of four additional tests, located at intervals not to exceed 6 inches along the entire top perimeter of the sidewall, starting from the maximum side height location, and at one additional location most likely to fail. (2) Repeat the sidewall firmness test in all the intended or feasible configurations that could affect the sidewall firmness, such as the folding or layering of parts of the product. 87494 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations Figure 7 to paragraph (h)—Test Configuration for Intersection of Sidewall and Occupant Support Surface Firmness - - - - - - ' r - 3 - I N HEMISPHERICAL TEST PRCIBE Q5l5 ~ - - - T E T BASE ~-----INTERSECTION SIIDEWALL/1:JSS (i) Sidewall angle determination. For products with a sidewall, perform the following steps to determine if the angle between the sidewall and OSS is 90 degrees or less, or to measure the angle above 90 degrees. See figure 8 to this paragraph (i). (1) Orient the 3-inch (7.62 cm) diameter hemispherical head probe vertically and place it over the OSS with the cylindrical surface of the probe tangent to the intersection of the sidewall and the OSS. Advance the probe into the product until a downward force of 10 N (2.2 lbs) force is reached. (2) After 30 seconds, determine whether the sidewall is in contact with the cylindrical side of the 3-inch head probe. If the sidewall contacts the cylindrical part of the probe, the sidewall angle is equal to or less than 90 degrees. (3) For sidewall angles greater than 90 degrees, calculate the sidewall angle as 90 degrees plus the measured angle between the cylindrical side of the 3inch head probe and the sidewall. (4) Determine a minimum of four sidewall angles at locations not to exceed 6-inch (15.2 cm) intervals along the intersection of the sidewall and OSS. (5) Measure the angle with a protractor or gauge placed to the depth of and in contact with the cylindrical side of the 3-inch probe side and the sidewall. Figure 8 to paragraph (i)—Test Fixture Configuration for Sidewall Angle Measurement - -----3-IN HEMJSPffERJQL ER04NO24.011</GPH> ----TEST BASE ------JNTERS£C110N SIDEWAU/GS'S VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4725 E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.010</GPH> lotter on DSK11XQN23PROD with RULES1 TESTPRGE Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 87495 (j) Seam strength test method. (1) Equipment shall include: (i) Clamps with 0.75 inches (1.9 cm) diameter clamping surfaces capable of holding fabric and with a means to attach a force gauge. See figure 9 to this paragraph (j)(1), or equivalent. (ii) A force gauge, accuracy +/¥ 0.5 lbs (1.1 N). Figure 9 to paragraph (j)(1)—Seam Clamp (2) Clamp the fabric of the infant support cushion on each side of the seam under test with the 0.75 inches clamping surfaces placed not less than 0.5 inches (1.2 cm) from the seam. (3) Apply a tension of 15 lbs (67 N) evenly over 5 seconds and maintain for an additional 10 seconds. (4) Repeat the test on every distinct seam and every 12 inches (15 cm) along each seam. (k) Removal of components test method—(1) Suitable devices. For torque and tension tests, any suitable device may be used to grasp the component that does not interfere with the attachment elements that are stressed during the tests. (2) Torque test. Gradually apply a 4 lbs-in (0.4 N–m) torque over 5 seconds in a clockwise rotation to 180 degrees or until 4 lbs-in has been reached. Maintain for 10 seconds. Release and allow component to return to relaxed state. Repeat the torque test in a counterclockwise rotation. (3) Tension test. For components that can reasonably be grasped between thumb and forefinger, or teeth, apply a 15 lbs (67 N) force over 5 seconds, in a direction to remove the component. Maintain for 10 seconds. A clamp such as shown in figure 10 to this paragraph (k)(3) may be used if the gap between the back of the component and the base material is 0.04 inches (0.1 cm) or more. Figure 10 to paragraph (k)(3)—Tension Test Adapter Clamp Marking and labeling. (a) General markings. Each product and its retail package shall be marked or labeled clearly and legibly to indicate the following: VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (1) The name, place of business (city, state, and mailing address, including zip code), and telephone number of the manufacturer, distributor, or seller. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 (2) A code mark or other means that identifies the date (month and year as a minimum) of manufacture. (3) The marking or labeling in paragraphs (a)(1) and (2) of this section E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.013</GPH> § 1243.6 ER04NO24.012</GPH> lotter on DSK11XQN23PROD with RULES1 0 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations are not required on the retail package if they are on the product and are visible in their entirety through the retail package. When no retail packaging is used to enclose the product, the information provided on the product shall be used for determining compliance with paragraphs (a)(1) and (2) of this section. Cartons and other materials used exclusively for shipping the product are not considered retail packaging. (b) Permanency. The marking and labeling on the product shall be permanent. (c) Upholstery labeling. Any upholstery labeling required by law shall not be used to meet the requirements of this section. (d) Warning design for product. (1) The warnings shall be easy to read and understand and be in the English language at a minimum. (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. lotter on DSK11XQN23PROD with RULES1 Note 4 to figure 1 to paragraph (d)(6): The text shown for the warnings in figure 1 to this paragraph (d)(6) is filler text, known as lorem ipsum, commonly used to demonstrate graphic elements. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 (3) The warnings shall be conspicuous and permanent. (4) The warnings shall conform to ANSI Z535.4–2011(R2017) (incorporated by reference, see § 1243.8) sections 6.1–6.4, 7.2–7.6.3, and 8.1, with the following changes. (i) In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace ‘‘should’’ with ‘‘shall.’’ (ii) In section 7.6.3, replace ‘‘should (when feasible)’’ with ‘‘shall.’’ (iii) Strike the word ‘‘safety’’ when used immediately before a color (for example, replace ‘‘safety white’’ with ‘‘white’’). Note 1 to paragraph (d)(4)(iii): For reference, ANSI Z535.1, American National Standard for Safety Colors, provides a system for specifying safety colors. See note 1 to § 1243.8(a) for ANSI contact information. (5) The safety alert symbol and the signal word ‘‘WARNING’’ shall be at least 0.2 inches (5 mm) high. The remainder of the text shall be in characters whose upper case shall be at least 0.1 inches (2.5 mm), except where otherwise specified. (7) All infant support cushions are required to contain a warning with the content and format depicted in this section as figure 2 (for products without PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 Note 2 to paragraph (d)(5): For improved warning readability, typefaces with large height-to- width ratios, which are commonly identified as ‘‘condensed,’’ ‘‘compressed,’’ ‘‘narrow,’’ or similar, should be avoided. (6) The message panel shall have the following text layout requirements: (i) The text shall be left-aligned, ragged-right for all but one-line text messages, which can be left-aligned or centered. See figure 1 to this paragraph (d)(6) for examples of left-aligned text. Note 3 to paragraph (d)(6)(i): 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. (ii) 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. Figure 1 to paragraph (d)(6)—Examples of Left-Aligned Text tummy time) or figure 3 (if the product has a tummy time feature) to this paragraph (d)(7). E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.014</GPH> 87496 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations 87497 Figure 2 to paragraph (d)(7)—Warning for Product Without Tummy Time USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL. Babies can turn over or roll out without warning and CAN SUFFOCATE in only a few minutes. • • • • Only use on the floor with baby on back, face-up. Stay near and watch baby during use. Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product. If baby falls asleep, move baby to infant sleep product, such as a crib or bassinet. Babies have been injured from FALLS. • • Do not use on beds, sofas, or other raised surfaces. Never carry or move product with baby in it. Figure 3 to paragraph (d)(7)—Warning for Tummy Time Product USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL. Babies can turn over or roll out without warning and CAN SUFFOCATE in only a few minutes. • • • • Use on the floor with baby on back, face-up. Put baby on back after Tummy Time. Stay near and watch baby during use. Do not use on soft surfaces or in sleep products like cribs or bassinets. Keep blankets and other soft items out of and away from product. If baby falls asleep, move baby to infant sleep product, such as a crib or bassinet. Babies have been injured from FALLS. Do not use on beds, sofas, or other raised surfaces. Never carry or move product with baby in it. VerDate Sep<11>2014 15:57 Nov 01, 2024 Jkt 265001 Slipcovers sold on, or together with the product, shall contain the warning statement shown on figure 2 or 3 to paragraph (d)(7) of this section, as applicable. PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 § 1243.7 Instructional literature. (a) Instructions shall be provided with the product and shall be easy to read and understand and shall be in the English language at a minimum. These instructions shall include information E:\FR\FM\04NOR1.SGM 04NOR1 ER04NO24.016</GPH> (e) Warning statements. Each product shall contain the warning statements shown on figure 2 (for products without tummy time) or figure 3 (if the product has a tummy time feature) to paragraph (d)(7) of this section, at a minimum. ER04NO24.015</GPH> lotter on DSK11XQN23PROD with RULES1 • • 87498 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Rules and Regulations on assembly, maintenance, cleaning, and use, where applicable. (b) The instructions shall address the following additional warnings: (1) Read all instructions before using this product. (2) Keep instructions for future use. (3) Do not use this product if it is damaged or broken. (4) Instructions shall indicate the manufacturer’s recommended maximum weight, height, age, developmental level, or combination thereof, of the occupant for which the infant support cushion is intended. If this product is not intended for use by a child for a specific reason, the instructions shall state this limitation. (c) The cautions and warnings in the instructions shall meet the requirements specified in § 1243.6(d)(4) though (6), except that section 6.4 and sections 7.2– 7.6.3 of ANSI Z535.4–2011(R2017) (incorporated by reference, see § 1243.8) 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. Note 1 to paragraph (c): 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. (d) 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. lotter on DSK11XQN23PROD with RULES1 § 1243.8 Incorporation by reference. 15:57 Nov 01, 2024 Jkt 265001 Note 1 to paragraph (a): NEMA standards are also available from the American National Standards Institute (ANSI), which provides a free, read-only copy of the standard at https://ibr.ansi.org/Standards/ nema.aspx. Contact ANSI by mail at American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, USA; phone: (212) 642–4900; website: www.ansi.org. (b) ASTM International (ASTM), 100 Barr Harbor Drive, P.O. Box CB700, West Conshohocken, Pennsylvania 19428–2959; phone: (800) 262–1373; website: www.astm.org. (1) ASTM D3359–23, Standard Test Methods for Rating Adhesion by Tape Test, approved February 1, 2023; approved for § 1243.5. (2) [Reserved] Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2024–25181 Filed 11–1–24; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG–2024–0745] RIN 1625–AA09 Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the U.S. Consumer Product Safety Commission and at the National Archives and Records Administration (NARA). Contact the U.S. Consumer Product Safety Commission at: the Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; phone (301) 504–7479; email: cpsc-os@ cpsc.gov. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from the following sources: VerDate Sep<11>2014 (a) National Electrical Manufacturers Association (NEMA), 1300 17th St. N, Arlington, VA 22209; phone: (703) 841– 3200; website: www.nema.org. (1) ANSI Z535.4–2011(R2017), American National Standard for Product Safety Signs and Labels, approved October 20, 2017; approved for §§ 1243.6 and 1243.7. (2) [Reserved] Drawbridge Operation Regulation; Sacramento River, Rio Vista, CA Coast Guard, DHS. Temporary interim rule with request for comments. AGENCY: ACTION: The Coast Guard is temporarily modifying the operating schedule that governs the draw of the California Department of Transportation Rio Vista (State Route 12) highway bridge across the Sacramento River, mile 12.8, at Rio Vista, CA. This action is necessary to allow the bridge owner to complete rehabilitation of the bridge. DATES: This temporary interim rule is effective from November 4, 2024 through 5 p.m. on August 29, 2025. Comments and related material must reach the Coast Guard on or before December 4, 2024. SUMMARY: PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov. Type the docket number (USCG–2024–0745) in the ‘‘SEARCH’’ box and click ‘‘SEARCH’’. In the Document Type column, select ‘‘Supporting & Related Material’’. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary interim rule, call or email Carl Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510–219– 4366, email D11Bridges@uscg.mil. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Table of Abbreviations Caltrans California Department of Transportation CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register MHW Mean High Water NOTD Notice of Temporary Deviation NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary interim rule without prior notice and opportunity to comment pursuant to authority under the authority in 5 U.S.C. 553(b)(B). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest due to Caltrans Headquarters continuing to add projects to the ongoing rehabilitation project, which will require extending the length of time for advance notice for opening the span. The current NOTD expires November 1, 2024 and the Coast Guard cannot add additional dates to that NOTD because it will extend the NOTD beyond the allowed 180 days. The continuation of the temporary deviation is necessary for the safety of the work crews on the bridge. Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because Caltrans has allocated funds for additional rehabilitation work on the E:\FR\FM\04NOR1.SGM 04NOR1

Agencies

[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Rules and Regulations]
[Pages 87467-87498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25181]


=======================================================================
-----------------------------------------------------------------------

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1243

[CPSC Docket No. 2023-0047]


Safety Standard for Infant Support Cushions

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
section 104 of the Consumer Product Safety Improvement Act of 2008 
(CPSIA), requires the U.S. Consumer Product Safety Commission 
(Commission or CPSC) to promulgate consumer product safety standards 
for durable infant or toddler products. Under this statutory authority, 
the Commission is issuing a safety standard for infant support 
cushions. The Commission is also amending CPSC's consumer registration 
requirements to identify infant support cushions as durable infant or 
toddler products and amending CPSC's list of notices of requirements 
(NORs) to include infant support cushions.

DATES: The rule is effective on May 5, 2025. The incorporation by 
reference of the publication listed in this rule is approved by the 
Director of the Federal Register as of May 5, 2025.

FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman, 
U.S. Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7945 or (888) 531-9070; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

A. Background

    Infant support cushions are filled with or comprised of resilient 
material such as foam, fibrous batting, or granular material or with a 
gel, liquid, or gas, and are marketed, designed, or intended to support 
an infant's weight or any portion of an infant while reclining or in a 
supine, prone, or recumbent position. CPSC is aware of at least 79 
reported fatalities involving infant support cushions from January 1, 
2010, through December 31, 2022, as well as 124 nonfatal incidents or 
reports involving these products within the same time period. There 
were 17 deaths in 2020, and a minimum of 17 more in 2021.\1\ More than 
80 percent of the known fatalities associated with these products 
involve infants three months old or younger. In more than 60 percent of 
the fatalities, the official cause of death was asphyxia or probable 
asphyxia. These incidents typically involved the use of an infant 
support cushion placed in or on a sleep-related consumer product such 
as an adult bed, futon, crib, bassinet, play yard, or couch. For the 
nonfatal incidents, the most common circumstances involved an infant 
falling from an infant support cushion placed on a raised surface such 
as a bed or a sofa, or a threat of asphyxia or entrapment.
---------------------------------------------------------------------------

    \1\ Due to reporting delays, fatality data reported to the CPSC 
is not considered complete until three years later; thus, the 2021 
fatality data were not yet considered complete when the analysis was 
conducted in 2023.
---------------------------------------------------------------------------

    In 1992, pursuant to authority under the Federal Hazardous 
Substances Act (FHSA), 15 U.S.C. 1261-1278, the Commission issued a ban 
on certain infant cushions and pillows filled with foam, plastic beads, 
or other granular material. 57 FR 27912 (June 23, 1992). That ban 
prohibits infant cushions, infant pillows, and similar articles that 
are:
     made with a flexible fabric covering;
     loosely filled with granular material, including, but not 
limited to, polystyrene beads or pellets;
     easily flattened;
     capable of conforming to the body or face of an infant; 
and
     intended or promoted for use by children under one year of 
age.

See 16 CFR 1500.18(a)(16). This final rule for infant support cushions 
does not change the existing FHSA ban. That ban was limited to products 
with the specific hazard presented by loosely filled granular material 
such as polystyrene beads or pellets, and those products will continue 
to be banned under the FHSA. Infant support cushions that are not 
subject to the ban are within the scope of this rule and are required 
to comply with the performance and labeling requirements of this 
rule.\2\
---------------------------------------------------------------------------

    \2\ An exemption to the infant pillow ban applies to Boston 
Billow nursing pillows and substantially similar nursing pillows 
that are designed to be used only as nursing aids for breastfeeding 
mothers. 16 CFR 1500.86(a)(9). The exemption applies specifically to 
the FHSA ban and is not applicable to this rule or to the final rule 
for nursing pillows. 89 FR 85388 (October 25, 2024).
---------------------------------------------------------------------------

B. Statutory Authority

    Section 104(b)(1)(A) 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 and 
toddler products. See 15 U.S.C. 2056a(b)(1)(A). The Commission must 
continue to promulgate standards for all categories of durable infant 
or toddler products until the Commission has promulgated standards for 
all such product categories. See 15 U.S.C. 2056a(b)(2).
    Consistent with section 104(b)(1)(A) of the CPSIA, CPSC consulted 
with manufacturers, retailers, trade organizations, laboratories, 
consumer advocacy groups, consultants, and the public to develop this 
rule, including through participation in the juvenile products 
subcommittee meetings of ASTM.\3\ However, currently no voluntary or 
mandatory safety standard for infant support cushions exists to

[[Page 87468]]

address the hazards posed by these products.
---------------------------------------------------------------------------

    \3\ CPSC formally began the consultation process for this 
rulemaking in December 2021, via a letter from staff requesting that 
ASTM form a working group to develop a voluntary standard to reduce 
the risk of death and injury from hazards associated with infant 
pillow products, including nursing pillows. In response, ASTM formed 
two subcommittees intended to develop two separate voluntary 
standards: the F15.16 Infant Feeding Supports subcommittee, intended 
to develop a standard for nursing pillows; and the F15.21 Infant 
Loungers subcommittee. Staff has been actively participating in both 
ASTM subcommittees to develop voluntary standards that address 
hazards associated with these products.
---------------------------------------------------------------------------

    Infant support cushions are durable infant or toddler products 
under section 104(f) of the CPSIA. Section 104(f)(1) defines the term 
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. See 15 U.S.C. 2056a(f)(1). Section 104(f)(2) of the 
CPSIA provides a non-exhaustive list of product categories within the 
definition of durable infant or toddler products. Although infant 
support cushions are not specifically listed in section 104(f)(2), they 
are durable infant or toddler products because (as explained in Part 
II, below) they: are not disposable; have a useful life of up to 
several years during which they are often used by multiple children 
successively; are similar to other soft durable infant and children's 
products such as crib mattresses and sling carriers (which the 
Commission has issued rules for under section 104); are resold and 
widely available on secondary marketplaces; and are primarily intended 
to be used by children five years old or younger.
    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 rule for product registration cards, 16 CFR part 
1130. The final rule amends part 1130 to include infant support 
cushions in the list of durable infant or toddler products that must 
comply with these product registration requirements. See 16 CFR 
1130.2(a).
    Manufacturers of children's products must also comply with the 
testing and certification requirements for children's products that are 
codified in 16 CFR parts 1107 and 1109. Section 14(a)(3) of the 
Consumer Product Safety Act (CPSA) requires the Commission to publish 
an NOR for the accreditation of third party conformity assessment 
bodies (test laboratories) to assess conformity with a children's 
product safety rule to which a children's product is subject. The final 
rule is a children's product safety rule that requires issuance of an 
NOR.

C. Notice of Proposed Rulemaking (NPR)

    On January 16, 2024, the Commission published an NPR under section 
104 of the CPSIA that proposed a mandatory consumer product safety 
standard for infant support cushions to address the risk of death and 
injury associated with these products. 89 FR 2530. The proposed rule 
addressed the suffocation, entrapment, and fall hazards associated with 
infant support cushions by including performance, testing, labeling, 
and instructional literature requirements. The proposed requirements in 
the NPR were based on staff's analysis of the hazards presented by 
infant support cushions as well as incident, injury and fatality data. 
The proposed requirements also considered the recommendations in the 
June 30, 2022, Pillows Product Characterization and Testing, Boise 
State University Report (BSU Final Report).\4\ CPSC awarded a contract 
to Boise State University (BSU) for infant biomechanics and suffocation 
research and consultancy services. This research included an analysis 
of the risk of injury or death to infants associated with the use of 
nursing pillows and infant support cushions during activities such as 
feeding, nursing, sleeping, propping, and lounging. The BSU Final 
Report provided recommendations and conclusions related to the 
performance and design of infant support cushions, including 
recommendations regarding firmness testing, airflow testing, and 
sagittal-plane testing. Tab C of Staff's NPR Briefing Package 
summarizes how the requirements of the NPR relate to the conclusions 
and recommendations of the BSU Final Report. The Commission received 18 
comments in response to the NPR.
---------------------------------------------------------------------------

    \4\ Erin M. Mannen et al; Consumer Prod. Safety Comm'n. Pillows 
Product Characterization and Testing (2022). www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
---------------------------------------------------------------------------

    On April 23, 2024, CPSC published a notice of availability (NOA) in 
the Federal Register that announced the availability of the incident 
data relied upon for the infant support cushions NPR and sought 
comments from the public. 89 FR 30295. The Commission received one 
comment in response to the NOA.

D. Final Rule Overview

    Pursuant to section 104 of the CPSIA, 15 U.S.C. 2056a, the 
Commission is issuing a mandatory standard for infant support cushions 
based on the proposed requirements in the NPR, with certain 
modifications in response to public comments, which are discussed in 
detail in Sections VI and VII of the preamble.\5\ The final rule 
defines an infant support cushion as an infant product that is filled 
with or comprised of resilient material such as foam, fibrous batting, 
or granular material or with a gel, liquid, or gas, and which is 
marketed, designed, or intended to support an infant's weight or any 
portion of an infant while reclining or in a supine, prone, or 
recumbent position. This definition includes any removable covers, or 
slipcovers, sold on or together with an infant support cushion. This 
includes infant pillows, infant loungers, nursing pillows with a 
lounging function, infant props or cushions used to support an infant 
for activities such as tummy time, and other similar products. The 
final rule addresses the risk of death and injury associated with 
infant support cushions primarily due to suffocation, entrapment, and 
fall hazards. It addresses positional asphyxiation hazards by requiring 
that all surfaces be sufficiently firm that they are unlikely to 
conform to an infant's face and occlude the airways,\6\ and by setting 
a maximum incline angle that would prevent hazardous positioning of an 
infant's head and neck along the surfaces of the product. The final 
rule sets a side angle requirement that addresses the risk of 
entrapment between the sidewall and the occupant support surface. It 
addresses fall hazards by effectively limiting sidewall height to 
discourage caregivers from mistakenly believing these products to be 
safe for unsupervised infants. Finally, the final rule requires a 
strongly worded, conspicuous, and permanent on-product warning label.
---------------------------------------------------------------------------

    \5\ On October 16, 2024, the Commission voted (5-0) to publish 
this final rule with changes. Chair Hoehn-Saric issued a statement 
in connection with his vote, available at: www.cpsc.gov/About-CPSC/Chairman/Alexander-Hoehn-Saric/Statement/Statement-of-Chair-Alexander-Hoehn-Saric-on-Commission-Approval-of-a-Final-Rule-Establishing-a-Safety-Standard-for-Infant-Support-Cushions.
    \6\ Airways occlusion means to block the passage of air from the 
nose and mouth into the lungs, so that inhaled air cannot reach the 
lungs. In this case, the airway occlusion is caused by a soft 
product that covers the nose and mouth. Once an infant's airflow is 
compromised, decreased levels of oxygen in the blood can further 
impair the ability of the infant to respond to the situation. If an 
infant cannot respond, a feedback loop of decreased heart and 
respiration rate develops that can eventually lead to cessation of 
breathing and may become fatal if uninterrupted.
---------------------------------------------------------------------------

    Based on comments received on the NPR, the following changes have 
been made in the final rule:
     For clarity, the definition of infant lounger in Sec.  
1243.2 has been revised to change the term infant product to infant 
support cushion.
     For clarity, the definition of infant support cushion in 
Sec.  1243.2. has been revised to add the sentence ``This definition 
includes any removable covers, or slipcovers, sold on or together with 
an infant support cushion'' at the end of the definition.
     To avoid ambiguity, a new definition of the term sidewall 
has been added in Sec.  1243.2 which is defined as any wall at the edge 
of the occupant support surface.

[[Page 87469]]

     For accuracy and consistency, a reference to infant pillow 
in Sec.  1243.3(d) has been changed to infant support cushion.
     The final rule removes proposed Sec.  1243.3(e) regarding 
side height as this requirement is redundant with the maximum incline 
angle limits in the rule. The final rule renumbers the paragraphs 
following proposed Sec.  1243.3(e) to reflect this change. The rule 
also removes the corresponding test in Sec.  1243.5(d)(8) for 
consistency. To reflect this change, all numbers after Sec.  
1243.5(d)(7) have been renumbered in the final rule.
     The performance requirements in Sec.  1243.4(e)(2) and (3) 
and (f) as well as the corresponding test methods in Sec. Sec.  
1243.5(g) and 1243.4(h) and (i) have been revised to clarify that the 
performance requirements and test methods apply only to products that 
contain a sidewall with language stating, for products with a sidewall.
     The test method in Sec.  1243.5(f) has been clarified to 
explain that products sold with a slipcover on or together with the 
product are to be tested as assembled, with the slipcover on the 
product. The test method in Sec.  1243.5(f) has also been clarified to 
explain that all products, including products one inch or less in 
thickness, shall be tested.
     Figure 2 (for products without a tummy time feature) to 
paragraph (d)(7) in Sec.  1243.6 has been revised and a new figure 3 
(for products with a tummy time feature) has been added to reflect 
changes in warning content made in response to public comments. These 
changes include adding a statement to address prone use during tummy 
time, removing references to ``an awake baby,'' separating the sleep 
and suffocating-relating warning content to provide clarity, adding a 
warning to address soft bedding both in and outside of the product, and 
deleting some of the statements to reduce length and increase clarity. 
Additionally, Sec.  1243.6(d)(7) clarifies that all infant support 
cushions are required to contain a warning with the content and format 
depicted in this section as figure 2 (for products without tummy time) 
or figure 3 (if the product has a tummy time feature) to paragraph 
(d)(7), as applicable.
     Section 1243.6(e) has been revised to clarify that 
slipcovers sold on or together with the product shall contain the 
warning statement shown in figures 2 and 3 to paragraph (d)(7), as 
applicable.

II. The Product Category

A. Infant Support Cushions

    Infant support cushions are products that support an infant for 
lounging, meaning reclining in a supine, prone, or recumbent position. 
Infant products within this category may or may not have perimeter 
sidewalls. Most infant support cushions currently on the market are 
filled with cushy foam or soft fibrous batting, covered by flexible 
fabric. Some infant support cushions are marketed for use in a crib or 
other infant sleep product, notwithstanding warnings from the 
Commission and other institutions, including the American Academy of 
Pediatrics (AAP), that soft objects, such as pillows and excess 
bedding, should not be placed in an infant's sleep environment.\7\
---------------------------------------------------------------------------

    \7\ Rachel Y. Moon, Rebecca F. Carlin, Ivan Hand, The Task Force 
On Sudden Infant Death Syndrome And The Committee On Fetus And 
Newborn, 150(1) American Academy of Pediatrics: Evidence Base for 
2022 Updated Recommendations for a Safe Infant Sleeping Environment 
to Reduce the Risk of Sleep-Related Infant Deaths (2022).
---------------------------------------------------------------------------

    Illustrative pictures of infant support cushions can be found in 
Tab C of Staff's NPR Briefing Package.\8\ A non-exhaustive list of 
examples of infant support cushions includes:
---------------------------------------------------------------------------

    \8\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

     head positioner pillows;
     flat baby loungers;
     crib pillows;
     wedge pillows for infants;
     infant sleep positioners, unless regulated as medical 
devices by the Food and Drug Administration (FDA);
     stuffed toys marketed for use as an infant support 
cushion;
     infant tummy time or lounging pillows, whether flat or 
inclined;
     multi-purpose pillows marketed for both nursing and 
lounging;
     anti-rollover pillows with or without straps that fasten 
the pillow to the infant;
     infant self-feeding pillows that hold a bottle in front of 
the face of a reclining or lying infant;
     pads and mats; and
     accessory pillows and other padded accessories, often 
marketed for use with an infant car seat, stroller, or bouncer, but not 
sold with that product and therefore not included in the mandatory 
safety standard for those products.
    These in-scope products must meet the requirements of the rule. 
However, to avoid potentially duplicative or conflicting obligations, 
the scope of products that would be subject to this rule does not 
include durable infant products that are already regulated by the 
Commission and included in the list of products at 16 CFR 1130.2(a).
    The following products are NOT infant support cushions within the 
scope of this rule:
     pillows not marketed, designed, or intended for use by 
infants, such as adult bed and throw pillows;
     nursing pillows if subject to the Commission's final rule 
for nursing pillows (89 FR 85388 (October 25, 2024)), unless they are 
also marketed for lounging;
     crib and play yard mattresses that are regulated under the 
play yard standard (16 CFR part 1221) and crib mattress standard (16 
CFR part 1241);
     purely decorative nursery pillows, such as those 
personalized with a baby's name and birthdate, that are not marketed, 
designed, or intended for infant use;
     stuffed toys (unless they meet the definition of an infant 
support cushion in this rule);
     padded seat liners that are sold with a rocker, stroller, 
car seat, infant carrier, swing, highchair, or bouncer that are 
specifically designed to fit that product;
     padded seat liners and inserts for a rocker, stroller, car 
seat, infant carrier, swing, highchair, or bouncer that are sold 
separately by the manufacturer as a replacement part and specifically 
designed to fit that product; and
     sleeping accommodations that are regulated under the 
Commission's infant sleep product rule at 16 CFR part 1236.

B. Market Description

    Most types of new infant support cushions are sold online, 
including from general online retailers, online sites for ``big box'' 
stores, online baby products sites, and online marketplaces for hand-
crafted items. Some types of infant support cushions, particularly crib 
pillows and baby loungers, are also available from brick-and-mortar 
baby specialty stores and general retail stores. Prices for new infant 
support cushions average roughly $30 and range from less than $15 for a 
simple head positioner pillow or crib pillow to more than $250 for a 
lounger with a removable cover or a large stuffed toy marketed for use 
while an infant sleeps. Several thousand manufacturers and importers, 
including hundreds of handcrafters and direct foreign shippers, supply 
infant support cushions to the U.S. market. See Tab E of Staff's NPR 
Briefing Package.\9\
---------------------------------------------------------------------------

    \9\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.

---------------------------------------------------------------------------

[[Page 87470]]

    Infant support cushions may be re-used for multiple children or 
resold for use after an infant outgrows the product. For example, in 
June 2023, staff found listings on Mercari for used changing pads, 
large stuffed toys marketed for infant sleep, crib wedge pillows, baby 
neck pillows, baby sleep positioners, baby loungers, baby sleep mats, 
baby pillow chairs, infant self-feeding pillows, baby/toddler bean bag 
chairs, and crib pillows. Similar listings were identified on eBay.

III. Incident Data and Hazard Patterns

    Staff searched the Consumer Product Safety Risk Management System 
(CPSRMS) \10\ and National Electronic Injury Surveillance System 
(NEISS) \11\ databases for fatalities, incidents, and concerns 
associated with infant support cushions and involving infants up to 12 
months old, reported to have occurred between January 1, 2010, and 
December 31, 2022. Staff identified 79 fatal incidents and 124 nonfatal 
incidents and consumer concerns reported to CPSC from 2010-2022. Of the 
124 \12\ non-fatal reports, 22 consisted of emergency-department-
treated injuries, three involved hospital admissions, 45 involved no 
injury, and for 54 the disposition was either unknown or unspecified. 
The incident data and hazard patterns cited in support of the NPR 
support this final rule and are unchanged from the NPR. For further 
discussion of the incident data and hazard patterns, see the NPR and 
Tab A of Staff's NPR Briefing Package, which describe the incident and 
hazard patterns associated with infant support cushions,\13\ and the 
NOA, which describes the incident data and hazard patterns relied on 
for the rulemaking.\14\
---------------------------------------------------------------------------

    \10\ CPSRMS is the epidemiological database that houses all 
anecdotal reports of incidents received by CPSC, ``external cause''-
based death certificates purchased by CPSC, all in-depth 
investigations of these anecdotal reports, as well as investigations 
of select NEISS injuries. CPSRMS documents include hotline reports, 
online reports, news reports, medical examiner's reports, death 
certificates, retailer/manufacturer reports, and documents sent by 
state and local authorities, among others.
    \11\ NEISS is a statistically valid surveillance system for 
collecting injury data. NEISS is based on a nationally 
representative probability sample of hospitals in the U.S. and its 
territories. Each participating NEISS hospital reports patient 
information for every emergency department visit associated with a 
consumer product or a poisoning to a child younger than five years 
of age. The total number of product-related hospital emergency 
department visits nationwide can be estimated from the sample of 
cases reported in the NEISS. See www.cpsc.gov/Research--Statistics/
NEISS-Injury-Data.
    \12\ The NPR listed 125 nonfatal incidents, but one of those 
incidents was a duplicate.
    \13\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
    \14\ Notice of Availability and Request for Comment: Data 
Regarding Incidents Associated With Infant Support Cushions, 89 FR 
30295 (April 23, 2024), available at: www.federalregister.gov/d/2024-08605.
---------------------------------------------------------------------------

IV. International and Voluntary Standards for Infant Support Cushions

A. International Standards for Infant Support Cushions

    The Commission is aware of two British standards that contain 
performance requirements addressing suffocation and asphyxiation 
hazards associated with infant pillows: BS 1877-8:1974, Specification 
for Domestic bedding--Part 8: Pillows and bolsters for domestic use 
(excluding cellular rubber pillows and bolsters) (BS 1877-8:1974) and 
BS 4578:1970, Specification for Methods of test for hardness of, and 
for air flow through, infants' pillows (BS 4578:1970). The scope of BS 
1877-8:1974 includes both adult and cot pillows (infant pillows) and 
recommends that cot pillows be filled firmly enough to prevent infants' 
heads from sinking into the products and that the pillow covering not 
be loose enough to be drawn into an infant's mouth. BS 1877-8:1974 has 
requirements for cot pillow size, filling, and covering. Under that 
standard, cot pillows must be 58 x 38 cm (23 x 15 inches) and their 
covering must be of open construction to allow air permeability. Both 
the filling and covering must meet performance requirements described 
in BS 4578:1970 for hardness (i.e., firmness) and air permeability.
    The hardness test in BS 4578:1970 requires that a 100 mm diameter 
probe be placed in the center of the product with 10 newtons (N) of 
force for one minute. BS 1877-8:1974 requires that displacement of the 
pillow when the force is applied shall not exceed 25 percent of the 
thickness. The proportional approach used in this standard allows 
thicker pillows to have a greater displacement than thinner pillows, 
which staff assesses does not sufficiently protect against the 
suffocation and asphyxia hazards associated with infant support 
cushions because that greater displacement could allow the product to 
obstruct the infant's airway.

B. ASTM Voluntary Standards Work

    Currently, there are no published U.S. voluntary standards for 
infant support cushions. ASTM is working on a voluntary standard for 
infant loungers under the Subcommittee F15.21 on Infant Carriers, 
Bouncers, and Baby Swings.\15\ On March 25, 2024, ASTM issued ballot 
F15.21 (24-01), which included the latest draft of the infant lounger's 
voluntary standard. The ballot closed on April 29, 2024, and received 
eight negative votes and other comments including a comment from 
staff.\16\ On September 16, 2024, ASTM issued ballot F15 (24-18), Item 
#1 which addressed the negative comments and other comments on the 
draft standard for infant loungers included in ballot F15 (24-01). That 
ballot closed on October 16, 2024.\17\
---------------------------------------------------------------------------

    \15\ See Tab B of Staff's NPR Briefing Package, available at: 
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc. This ASTM 
standard is still in draft form and has not completed the full 
consensus process to become an approved standard, and thus the draft 
standard is subject to change.
    \16\ CPSC Staff Comment to Ballot ASTM F15.21 on Infant 
Loungers, available at: www.cpsc.gov/s3fs-public/CPSCStaffCommenttoBallotASTMF1521onInfantLoungers.pdf?VersionId=tGM05rvyA6WCUzQxHFCDkVHVxRLbtQLv.
    \17\ CPSC Staff Comment to Ballot ASTM F15.21 on Infant 
Loungers, available at: www.cpsc.gov/s3fs-public/staff-comment-to-ballot-ASTM-F15-21-on-infant-loungers.pdf?VersionId=oMjqKOhKBI0lEWiQliiCJ3u3OP2XcB7n.
---------------------------------------------------------------------------

    In the ASTM draft voluntary standard, infant loungers would be 
products with a raised perimeter, a recess, or other area that is 
intended to be placed on the floor and to provide a place for an infant 
to sit, lie, recline, or rest, while supervised by an adult, but are 
not intended or marketed for sleep. The draft definition would apply to 
only a subset of the products covered by this rule, which includes 
infant positioners, nursing pillows with dual use for lounging, infant 
cushions, and other infant pillow-like products, as well as the infant 
loungers being considered by the ASTM draft standard. ASTM's draft 
voluntary standard for infant loungers includes general requirements 
typically found in other ASTM juvenile product standards, such as 
requirements addressing lead content, small parts, hazardous sharp 
edges or points, resistance to collapse and disassembly, openings, 
protective components, permanency of labels and warnings, and toy 
accessories that are attached to, removable from, or sold with the 
products. The ASTM draft standard also specifies that if the lounger 
can be converted to another product, it shall comply with the 
applicable requirements of the converted product's standard. The 
general requirements of the ASTM draft infant lounger standard also 
state that the sidewall height of the

[[Page 87471]]

product shall be less than two inches on both the interior and exterior 
sides of the sidewall when measured according to the sidewall height 
measurement test method specified in the draft standard. The ASTM draft 
voluntary standard includes performance requirements that address 
stability, restraints, occupant support surface angle, fabric/mesh 
integrity, bounded openings, occupant support surface firmness, 
sidewall firmness, side angle measurements, and deflection at the 
occupant support surface and sidewall intersection. Finally, the ASTM 
draft voluntary standard for loungers also includes marking, labeling, 
and instructional literature requirements, such as warning the consumer 
about not using the product for sleep or naps, only using the product 
when the occupant baby is supervised, only using the product on the 
floor, keeping soft bedding out of the product, not using the product 
on raised surfaces, and not using the product to carry or move an 
infant.
    As previously noted, the ASTM draft standard for infant loungers 
primarily differs from the final rule regarding the scope of products 
subject to the standard. Specifically, the final rule includes all 
types of infant support cushions such as infant positioners, infant 
loungers, and other types of infant mats and pads, while the scope of 
the ASTM draft standard would apply only to infant loungers. Given that 
the ASTM draft standard for loungers has not been finalized and 
published and would not cover the same scope of products as the final 
rule, the Commission finds that no voluntary standard currently exists 
or will likely exist in the foreseeable future that would adequately 
address the hazards presented by infant support cushions. This rule is 
required under section 104 of the CPSIA to address the identified 
hazards presented by infant support cushions. 15 U.S.C. 2056a.

VI. Response to Public Comments

    CPSC received 18 public comments during the NPR comment period, and 
one comment during the NOA comment period. The comments are available 
on: www.regulations.gov, by searching under docket number CPSC-2023-
0047. This section describes the significant issues raised in the 
comments and CPSC's responses to them.

A. Scope of the Final Rule

    Comment: The Boppy Company, LLC (Boppy), Best Practice Quality LLC 
(BPQ), Heroes Technology (US) LLC d/b/a Snuggle Me Organic (Heroes 
Technology), and Juvenile Products Manufacturers Association (JPMA) 
object to the broad scope of the proposed rule and argue that the 
proposed rule does not take into consideration that it is difficult to 
develop specific standards because of the wide range of infant support 
cushion designs.
    Response: We disagree that performance requirements and warning and 
labeling requirements for a wide range of infant support cushions 
cannot be comprehensively developed to mitigate the hazards posed to 
infants from infant support cushions. Although infant support cushions 
include many different types of products, incident data relied upon to 
support the rule indicate that infants are at risk from falls and 
suffocations, and that the hazard patterns are similar for all types of 
infant support cushions. As indicated in the incident data, caregivers 
use infant support cushions, which are not intended for sleep, in 
infant sleep settings and infants tend to fall asleep in these 
products. Thus, it is reasonably foreseeable that caregivers will use 
infant support cushions in infant sleep settings, which poses a 
suffocation hazard. Therefore, the performance requirements and 
warnings in the rule are designed to reduce the fall and suffocation 
hazards that these products pose.
    Comment: JPMA argues that a rule for infant support cushions is 
unnecessary because CPSC has a safety standard for infant sleep 
products, codified at 16 CFR part 1236, addressing infant support 
cushions that are primarily intended or marketed for sleep.
    Response: The scope of this rule includes products that are not 
subject to the infant sleep products rule, but that still present a 
risk of injury or death to infants. Infant support cushions do not meet 
the definition of infant sleep products because they are not marketed 
or intended to provide sleeping accommodations. Therefore, this rule is 
necessary to addresses the hazards posed by infant support cushions 
because the infant sleep products rule does not apply to infant support 
cushions.
1. Scope Age
    Comment: BPQ asserts that the in-scope age range in the rule should 
be changed to align with the ASTM Lounger standard in development, 
which BPQ states covers infants 0-6 months.
    Response: Since publication of the NPR, the ASTM F15.21 Infant 
Loungers Scope Task Group changed the scope of its draft safety 
standard to include infants up to 12 months of age.\18\ Incident data, 
as outlined in the incident data and hazard pattern section of the NPR 
and Tab A of Staff's NPR Briefing Package,\19\ indicate that incidents 
associated with infant support cushions occur with infants up to 12 
months old (i.e., 365 days). Based on the incident data and hazard 
pattern analysis, the performance requirements and warnings were 
developed to mitigate the hazards associated with infant support 
cushions for infants up to 12 months old. The Commission declines to 
limit the scope of the final rule with a specific age limitation. The 
Commission's approach mitigates the hazards associated with infant 
support cushions for all infants, regardless of age, and discourages 
manufacturers from making age-based marketing claims specifically to 
attempt to remove their products from being subject to the rule.
---------------------------------------------------------------------------

    \18\ ASTM F15.21 Infant Loungers Scope Task Group--MeetingLog, 
available at: www.cpsc.gov/content/ASTM-F1521-Infant-Loungers-Scope-Task-Group-Meeting%E2%80%AFLog-1.
    \19\ Staff's NPR Briefing Package available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

2. Tummy Time Pillows
    Comment: BPQ, the Toy Association (TA), Boppy, and Graco Children's 
Products Inc (Graco) argue that the rule should exempt tummy time 
pillows.
    Response: We disagree that tummy time pillows should be exempted 
from the rule. Tummy time pillows, which are pillow products on which 
infants may be propped, present the same suffocation and fall hazards 
as other types of infant support cushions, as indicated in the incident 
data discussed above. Infants can suffocate when tummy time pillows 
conform to an infant's face and occlude the airways; further, infants 
can roll from a tummy time pillow, creating a fall risk if the tummy 
time pillow is placed on an elevated surface. Therefore, tummy time 
pillows are subject to the requirements of the rule because allowing an 
exemption for tummy time pillows would allow those products to present 
the same suffocation and fall hazards to infants that this rule is 
intended to address. We note that AAP and National Institute of Child 
Health and Human Development (NICHD), while endorsing tummy time, do 
not specifically

[[Page 87472]]

recommend tummy time pillows for that activity.20 21
---------------------------------------------------------------------------

    \20\ Benefits of Tummy Time [verbar] Safe to Sleep[supreg] 
(nih.gov), available at: https://safetosleep.nichd.nih.gov/reduce-
risk/tummy-
time#:~:text=Babies%20benefit%20from%20having%20two,of%20total%20tumm
y%20time%20daily .
    \21\ American Academy of Pediatrics (2017). Back to sleep, tummy 
to play. Retrieved August 28, 2018, from www.healthychildren.org/English/ages-stages/baby/sleep/Pages/Back-to-Sleep-Tummy-to-Play.aspx.
---------------------------------------------------------------------------

3. Dual Use Products
    Comment: AAP supports the scope of the proposed rule and 
specifically asserts that dual use products marketed for both nursing 
and lounging should be within the scope of the rule. BPQ and Boppy 
state that the rule should exempt dual use products. Boppy asserts that 
there are distinct differences between nursing pillows and infant 
support cushions; it further states that the intent of the nursing 
pillows rule is to limit nursing pillow use to solely breast feeding 
and bottle feeding, obviating the need to cover nursing pillows of any 
type, including dual use, in this rule. BPQ further argues that because 
the draft ASTM nursing pillows standard, at the time of the comment, 
specifically states that nursing pillows may not be marketed for 
multipurpose use, nursing pillows should be exempt from this rule even 
if they otherwise would meet the definition of an infant lounger.
    Response: We disagree that the rule should exempt dual use products 
marketed for both nursing and lounging. A nursing pillow that is also 
marketed for lounging is an infant support cushion subject to this 
rule. The new nursing pillow standard, ASTM F3669-24, published on 
September 10, 2024, specifies that if a nursing pillow can be converted 
into another product or has use features for which a consumer safety 
specification exists, the product shall comply with the requirements of 
all applicable voluntary standards. On October 25, 2024, the Commission 
final rule for nursing pillows published (89 FR 85388), which does not 
have a requirement for convertible products. Nursing pillows that meet 
the definition of infant lounger in Sec.  1243.2 must also meet the 
requirements of this rule because the two rules are intended to address 
different hazard patterns. While the nursing pillow performance 
requirements and warnings discourage lounging, the infant support 
cushion rule requirements are intended to mitigate suffocation hazard 
while lounging. It is common for multiple CPSC mandatory safety 
regulations to apply to a single children's product, such as the 
existing regulations for small parts, phthalates, and lead content.
    Comment: BPQ recommends the following statement should be added to 
the rule: If the infant lounger can be converted into another product 
for which a consumer safety specification exists, the product shall 
comply with the applicable requirements of that standard.
    Response: The commenter's requested statement is unnecessary 
because Sec.  1243.3(g) of the rule regarding convertible products 
already states that if the infant support cushion can be converted into 
another product for which a consumer product safety standard exists, 
the product also shall comply with the applicable requirements of that 
standard.
4. Playmats
    Comments: Bureau Veritas (BV) requests clarification regarding 
whether playmats are intended to be classified as infant support 
cushions. Dorel Juvenile Group, Inc. asserts that playmat products 
subject to the requirements for toys in ASTM F963 and 16 CFR part 1250 
and whose base ``pad or mat'' is a flat layer no greater than one inch 
in thickness should be exempt from the rule. TA and Graco also assert 
that playmats that are subject to ASTM F963 and 16 CFR part 1250 should 
be exempt from the rule.
    Response: We disagree that the rule should exempt playmats. While 
playmats must meet the requirements of ASTM F963 and 16 CFR part 1250, 
those requirements do not address the infant suffocation hazards 
presented by playmats. Additionally, a playmat could have a flat layer 
no greater than one inch in thickness but still have greater than 1-
inch sides or borders presenting a potential suffocation hazard. 
Finally, not providing the requested exemption is consistent with the 
ASTM draft voluntary standard for infant loungers, which currently also 
does not contain an exemption for playmats.
5. Accessory Pillows and Other Padded Accessories
    Comment: BV requests clarification on the scope of the final rule 
regarding accessory pillows and other padded accessories sold with a 
juvenile product, or accessories sold separately from a juvenile 
product but intended to be used on a juvenile product. Boppy and Graco 
assert that the rule should exempt accessory pillows and other padded 
accessories for durable nursery products that are sold separately. 
Boppy additionally states that infants are seated while in contact with 
these pillows and padded accessories, so they do not meet the 
definition of an infant support cushion. Dorel Juvenile Group argues 
that the rule should exempt padded seat liners and inserts included 
with a car seat. BPQ argues that products that are used to keep an 
infant's head positioned in an infant carrier should be out of scope of 
this rule.
    Response: Padded seat liners that are sold with a rocker, stroller, 
car seat, infant carrier, swing, highchair, or bouncer and are 
specifically designed to fit that product are not subject to the rule. 
However, we agree with BV, Boppy, Graco, and Dorel Juvenile Group that 
replacement padded seat liners and inserts for these products that are 
sold separately by the manufacturer as a replacement part and 
specifically designed to fit a rocker, stroller, car seat, infant 
carrier, swing, highchair, or bouncer would meet the rule's definition 
of an infant support cushion, even though they would be subject to the 
rules for those specific products as well. To avoid this unintended 
result, we have added these products to the list of products not within 
the scope of the rule because they are subject to the specific safety 
standard for those products discussed in section II.A of the preamble. 
Under Sec.  1243.1, products subject to another standard listed in 16 
CFR 1130.2(a) are exempt from the rule.
    Aftermarket accessory pillows and other padded accessories, often 
marketed for use with a rocker, stroller, infant car seat, infant 
carrier, swing, highchair, or bouncer, but not sold with that specific 
product or as a replacement part, are subject to this rule, and thus 
must meet the requirements of the rule. This can include products that 
are used to keep an infant's head positioned in an infant carrier, 
unless they are sold with that product or as a manufacturer's 
replacement part. Such portable products can be used for purposes other 
than their intended use, including as an infant sleep product. 
Therefore, we disagree with BPQ that products that are used to keep an 
infant's head positioned in an infant carrier should be outside the 
scope of this rule. We also disagree with Boppy that accessory pillows 
and other padded accessories, used with seated products, should be 
excluded from the scope of the rule. These accessories present a 
suffocation hazard to infants because they are highly portable, and 
therefore can be used not only in the product for which they were 
intended but also in a variety of other products in which infants 
sleep, such as cribs, bassinets, and play yards. Because infants sleep 
for a majority of the day and tend to fall asleep in products intended 
for lounging, it is reasonably

[[Page 87473]]

foreseeable that caregivers will use these accessory products in an 
infant sleep environment or that infants will fall asleep on them. 
Therefore, the rule has requirements and warnings to reduce the 
suffocation hazard presented by infant support cushions.
6. Infant Sleep Positioners, Anti-Rollover Pillows, and Wedge Pillows 
for Infants
    Comment: BPQ and Boppy argue that the rule should exempt infant 
sleep positioners and anti-rollover pillows. Boppy states that the rule 
should exempt wedge pillows for infants. Boppy and Graco additionally 
state infant wedge pillows, infant sleep positioners, and anti-rollover 
pillows are all sleep products and thus should be subject to the infant 
sleep products rule, not this rule. BPQ additionally states that there 
is precedent to have discrete standards for each product category.
    Response: We disagree with the commenters' assertion that infant 
wedge pillows, infant sleep positioners, and anti-rollover pillows 
should be outside the scope of the rule because all of these products 
are sleep products.\22\ Infant wedge pillows, infant sleep positioners, 
and anti-rollover pillows do not meet the definition of infant sleep 
products in 16 CFR part 1236 because they are not marketed or intended 
to provide sleeping accommodations. Nevertheless, it is reasonably 
foreseeable that caregivers will use these products in an infant sleep 
environment. CPSC and FDA have warned against using infant positioning 
products in an infant sleep environment because they pose suffocation 
hazards.23 24 The incident data, which includes both fatal 
and nonfatal incidents, show that infants can suffocate when wedges, 
sleep positioners, and anti-rollover pillows conform to an infant's 
face. Therefore, the performance requirements and warnings of the rule 
are intended to mitigate the suffocation hazard posed by these 
products. Because the incident data hazard patterns associated with 
these products are the same and show that all infant support cushions 
are used for lounging, we disagree that it is necessary to develop 
separate standards specifically for these products.
---------------------------------------------------------------------------

    \22\ See Safety Standard for Infant Sleep Products, 86 FR 33022 
(June 23, 2021), available at: www.federalregister.gov/d/2021-12723.
    \23\ Recommendations for Parents/Caregivers About the Use of 
Baby Products [verbar] FDA, available at: www.fda.gov/medical-devices/baby-products-sids-prevention-claims/recommendations-parentscaregivers-about-use-baby-products.
    \24\ Deaths prompt CPSC, FDA warning on infant sleep positioners 
[verbar] CPSC.gov, available at: www.cpsc.gov/Newsroom/News-Releases/2010/Deaths-prompt-CPSC-FDA-warning-on-infant-sleep-positioners.
---------------------------------------------------------------------------

7. Pads and Mats
    Comments: An anonymous commenter requests clarification on the type 
of pads and mats subject to the rule because they assert that the term 
is generic and could apply to products beyond those on which a child 
could sleep.
    Response: Pads and mats that are marketed, designed, or intended to 
support an infant's weight or any portion of an infant while reclining 
or in a supine, prone, or recumbent position are subject to the rule. 
These pads and mats pose a suffocation hazard because they can be used 
in a variety of products in which infants sleep such as cribs, 
bassinets, and play yards. In addition, because infants sleep for a 
majority of the day and tend to fall asleep in products intended for 
lounging, it is reasonably foreseeable that infants will fall asleep on 
pads and mats. Pads and mats are associated with both fatal and 
nonfatal incidents in the incident data, and the performance 
requirements of the final rule are intended to mitigate the suffocation 
hazard to infants from these products.
8. Framed Seating Products
    Comment: Graco argues that framed seating products should be exempt 
from the rule because these types of framed products do not present the 
same hazards as soft cushioned infant pillow products and because the 
NPR did not specifically address hazards associated with seated infant 
products that have rigid frame containment.
    Response: We agree with the commenter that framed seating products, 
including infant floor seats, rockers, strollers, car seats, infant 
carriers, swings, highchairs, bouncers, or other infant products with 
rigid components are not infant support cushions as defined in Sec.  
1243.2 of the rule. Thus, an exemption is unnecessary because these 
products are not subject to the requirements of the final rule.

B. Definitions

    Comment: TA requests the term ``infant pillow'' used in Sec.  
1243.3(d), but nowhere else in the proposed rule, be amended to 
reference the defined term of infant support cushion for consistency. 
Alternatively, TA argues that ``infant pillow'' could be included as a 
discrete term in Sec.  1243.2.
    Response: For consistency and clarity, the reference to infant 
pillow in Sec.  1243.3(d) of the proposed rule has been changed to 
infant support cushion in the final rule.
    Comment: Graco requests that the definition of infant lounger be 
modified by to substitute the term infant support cushion for infant 
product. Graco also requests that the phrase ``infant loungers do not 
include seated infant products with a rigid frame used as containment'' 
be added to the definition of an infant lounger.
    Response: We agree with the commenter's recommended change to the 
definition of infant lounger in Sec.  1243.2 and have replaced the 
phrase infant product with infant support cushion in the final rule. We 
disagree that it is necessary to specify that infant loungers do not 
include seated products with a rigid frame used as containment as these 
products are not within the scope of infant support cushions and thus 
are not subject to the requirements of the rule.
    Comment: JPMA asserts that the definitions used in the rule should 
align with the ASTM standard, in development, for infant loungers.
    Response: The draft ASTM standard for infant loungers is in draft 
form and subject to change as part of the consensus process. Therefore, 
we decline to align the definitions in the final rule with the ASTM 
standard in development. Additionally, the final rule's definition of 
infant support cushion addresses the hazards presented by different 
types of infant support cushions, not just the infant loungers under 
consideration by the ASTM draft standard.
    Comment: Heroes Technology argues that many of the products within 
the scope of the rule do not have an occupant support surface and the 
rule does not address how to test products without an occupant support 
surface.
    Response: All infant support cushions contain an occupant support 
surface, which is defined in Sec.  1243.2 as the area that holds up and 
bears the infant or any portion of the infant to support the infant's 
weight or any portion of the infant while reclining or in a supine, 
prone, or recumbent position. By definition, every infant support 
cushion subject to the rule contains an occupant support surface, and 
thus is required to meet the performance requirements of the rule that 
involve testing the occupant support surface.
    Comment: Boppy notes that the proposed rule does not define the 
term sidewall.
    Response: The Commission agrees that a definition of the term 
sidewall is needed for clarity. Thus, a new definition for sidewall, 
which means any wall at the edge of the occupant support surface, has 
been added to Sec.  1243.2 of the final rule.

[[Page 87474]]

C. Use of Substitute Products

    Comment: Boppy, Heroes Technology and JPMA raised a concern about 
the potential for consumers to use substitute products such as adult 
pillows or blankets, instead of infant support cushions. The commenters 
note that such products would fall outside the scope of the rule but 
could pose similar suffocation and fall hazards to infants.
    Response: None of the commenters provide data to support the claim 
that the requirements in the proposed rule would lead consumers to use 
substitute products. The rule is intended to ensure that consumers have 
access to infant support cushions that do not present the same risks of 
death or injury as some current products, and this rule should not 
cause consumers to seek out alternative products. The rule also 
contains warnings that explain why soft surfaces, blankets, and other 
soft items present a hazard when placed in and around the product, 
which can further educate consumers on the risks posed by substitute 
products with soft surfaces.
    Comment: Boppy questions whether the performance requirements in 
the proposed rule could negatively impact tummy time rates.
    Response: The rule is not likely to reduce beneficial tummy time. 
Regarding tummy time, AAP and NICHD, while endorsing tummy time, do not 
recommend specifically using tummy time pillows. Additionally, this 
rule would allow the manufacture and sale of tummy time products as 
long as those products meet the requirements of the rule. Therefore, 
tummy time guidance is not likely to change based on this rule.

D. Product Misuse and Education

    Comment: BPQ recommends CPSC develop educational campaigns to 
address the unsafe sleep settings and misuse of products not intended 
for infant sleep exhibited in the incident data. Commenter Julian 
Dreest asks what strategies are currently in place to educate consumers 
about the proper use of infant support cushions.
    Response: The use of infant support cushions for sleep, or in an 
infant sleep setting, is not appropriate. Consumer education campaigns 
about safe sleep and the safe use of infant support cushions are useful 
and necessary to assist new parents and older generations of caregivers 
about safe sleep practices. CPSC actively promotes safe sleep outreach 
and education throughout the year to reach parents, grandparents, and 
caregivers on our website \25\ and by engaging in targeted safe sleep 
messaging during Baby Safety month (September).
---------------------------------------------------------------------------

    \25\ Safe Sleep--Cribs and Infant Products, available at: 
www.cpsc.gov/SafeSleep.
---------------------------------------------------------------------------

    However, education campaigns alone are not enough to address the 
hazards associated with infant support cushions. Data generally 
indicate that consumers believe if an infant product is on the market, 
it must be safe for use with infants--an assumption that is not always 
true. Therefore, this final rule for infant support cushions, paired 
with educational campaigns, is needed to better ensure safe uses of 
these products.
    Comment: Julian Dreest, BPQ, and Heroes Technology assert that 
educational strategies should reflect the new requirement for a maximum 
incline angle of 10 degrees or less, which limits the side height of 
the product to approximately 1.9 inches. The commenters assert this new 
requirement will invite some caregivers to improvise or modify the 
product to achieve the containment level they desire, increase consumer 
complacency, and provide a false sense of security leading to less 
supervision. Therefore, they argue, the rule will increase falls from 
elevated surfaces and the likelihood of roll-out from the product into 
an unsafe setting. AAP and the Joint Consumer Advocate Commenters 
strongly support the maximum incline angle requirement of 10 degrees or 
less in the proposed rule.
    Response: We disagree that limiting the maximum incline angle to 10 
degrees or less will lead to increased falls or suffocations due to 
decreased supervision. As discussed in Tab D of Staff's NPR Briefing 
Package,\26\ a cushioned sidewall with a height of up to four inches 
may give caregivers the false perception that the product can safely 
contain a child without supervision, regardless of what the product 
warnings might say. The presence of a distinct, raised perimeter 
surrounding the occupant support surface, as observed in various 
products on the market, provides a visual cue to consumers that the 
infant is safely contained in the product. Infant support cushions 
currently marketed for sale often display images of infants sleeping or 
resting in such products, and thus convey the appearance of effective 
containment of infants. The incident data shows that parents may 
mistakenly believe that products with cushioned sidewalls greater than 
two inches surrounding the infant would make them safe on elevated 
surfaces, that the infant can be left alone on the product, and that 
the product will safety contain their infant. The incident data further 
shows that infants suffer falls from products with cushioned sidewalls 
that are higher than 2 inches surrounding the occupant. Specifically, 
infants roll out of products with cushioned sidewalls greater than two 
inches into hazardous settings. With infant support cushions with 
cushioned sidewalls less than 2 inches, parents can see their infant is 
not secure in the product, that the product does not contain their 
infant, and that the infant should not be left alone on the product, 
particularly on elevated surfaces. Furthermore, the accompanying 
warnings alert users to the risks of leaving infants unattended or 
allowing use of the products for sleep or using on elevated surfaces. 
We note that AAP and the Joint Consumer Advocate Commenters strongly 
support the maximum incline angle requirement of 10 degrees or less in 
the proposed rule.
---------------------------------------------------------------------------

    \26\ See Tab D of Staff's NPR Briefing Package, available at: 
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

    Comment: Graco states that in addition to the current infant 
pillows that are already banned under 16 CFR 1500.18, the CPSC had 
considered an ``Infant Pillow Ban'' in former operating plans that 
would take these dangerous products off the market, but instead has 
pivoted to allow the very same types of products in the NPR, without 
sufficient requirements that would address the inherent misuse and 
hazards.
    Response: The Commission finds that the requirements in this rule 
will mitigate the suffocation and fall hazards to infants posed by 
infant support cushions. Therefore, the Commission concludes, that this 
rule will better address the known hazards posed by infant support 
cushions rather than just merely expanding the existing infant pillow 
ban, while still providing consumers with the utility of infant support 
cushions for supervised infant use.
    Comment: JPMA asserts that improper use of infant support cushions 
has contributed to the majority of incidents associated with these 
products since 2010. JPMA also contends that the majority of the 
products in the scope of this rule are not marketed or intended for 
sleep and have recognized utility for parents who need a safe product 
in which to place their child during awake time interaction, play, and 
engagement.
    Response: The incident data clearly indicate a pattern of use of 
infant support cushions in infant sleep settings and for sleep. The 
designs of infant

[[Page 87475]]

support cushions currently on the market encourage the use of these 
products for sleep. These products are often used for sleep because of 
the false perception that the soft, pillow-like design, with high 
borders/sides, are appropriate for infant sleep and will safely contain 
an infant, including on elevated surfaces. Further, staff is aware of 
infant support cushions that are or have previously been marketed and 
promoted as sleep products. Changing only the marketing of the product, 
without changing the design of the product, will not adequately 
discourage the behavior of caregivers allowing infants to sleep on 
infant support cushions unsupervised. We agree that infant support 
cushions have utility for parents to place their infant when actively 
supervised.

E. Incident Data

    Comment: BPQ, Boppy, Heroes Technology, and JPMA state that the 
percentages of incidents by product category are not provided in the 
NPR and Tab A of Staff's NPR Briefing Package. BPQ also argues that the 
two largest nonfatal hazard patterns, falls and threatened asphyxia, 
are not broken down by age.
    Response: The Commission published an NOA announcing the 
availability of incident data relied upon for the NPR and seeking 
comment. The data in the NOA released for public comment shows that for 
fatal incidents, 63 incidents were associated with loungers, 10 
incidents were associated with sleep positioners, four incidents were 
associated with pads/mats, one incident was associated with an infant 
wedge, and one incident was associated with a tummy time pillow. For 
nonfatal incidents, 104 incidents were associated with loungers, 13 
incidents were associated with sleep positioners, three incidents were 
associated with infant wedges, two incidents were associated with pads/
mats, one incident was associated with a tummy time pillow, and one 
incident was associated with a small infant pillow. As described above, 
the hazard patterns throughout these incidents are consistent with the 
risks of suffocation and falls presented by infant support cushions. 
Based on the data made available to commenters in the NOA, for 
incidents involving threatened asphyxia, 21 victims were up to 4 months 
old, two were 4-6 months old, and in three incidents the age was 
unreported. For incidents involving falls, 15 victims were up to 4 
months old, nine were 4-6 months old, four were over 6 months old, and 
in one incident the age was unreported.
    Comment: Boppy argues in a comment on the NPR that CPSC provided 
insufficient data to support that all products proposed to be covered 
by the rule, and specifically tummy time pillows, need regulation with 
a mandatory rule. Boppy also argues in a comment on the NOA that there 
are zero reported incidents related to tummy time pillows, so there is 
no justification for any inclusion of tummy time pillows within the 
scope of this proposed rule.
    Response: The Commission disagrees that tummy time pillows should 
be excluded from the scope of the rule. Tummy time pillows are products 
on which infants may be propped, and therefore they must meet the 
requirements of this rule. Tummy time pillows were associated with one 
fatal incident and one nonfatal incident as reflected in the incident 
data and present the same hazards as other infant support cushions. So, 
allowing a tummy time pillow for infants to be exempted from this 
regulation is contrary to the regulation's intent and would allow 
manufacturers to remarket other types of infant support cushions as 
tummy time pillows to avoid regulation. We note AAP and NICHD, while 
endorsing tummy time, do not specifically recommend pillows for tummy 
time.

F. General Requirements

    Comments: Consumer Federation of America, Consumer Reports, Kids In 
Danger, National Center for Health Research, Public Citizen, U.S. 
Public Interest Research Group (Joint Consumer Advocate Commenters), 
and Safe Infant Sleep recommend that the rule prohibit any type of 
electronics used inside or attached to an infant support cushion. The 
commenters also recommend prohibiting battery powered features, 
including vibration and white noise that can encourage sleep or may 
overheat presenting a burn risk, or features that contain cords which 
present a strangulation risk.
    Response: Some vibrations and music/sounds may lull infants to 
sleep. However, other music and sounds may engage infants during awake 
time. Staff has not identified any products in the incident data where 
an electronic component caused an injury or a death through fire, heat, 
or otherwise. Because no such products were identified in the incident 
data as presenting a hazard, this rule does not include a requirement 
related to electronics.

G. Performance Requirements

    Comment: Heroes Technology requests that CPSC conduct round robin 
studies of the performance requirements and test methods involving 
multiple laboratories and multiple exemplar products in each category, 
with a view to reproposing and ultimately adopting test methods and 
performance requirements.
    Response: The Commission considers the performance requirements and 
test methods in this rule to adequately address the hazards associated 
with infant support cushions without a need for the type of round robin 
process suggested by Heroes Technology, which could take years to 
complete while injuries and deaths continue to occur. The Commission 
concludes that the urgency of addressing the hazards associated with 
infant support cushions, and the requirement in CPSIA section 104 to 
promulgate safety standards, supports the Commission's promulgation of 
this rule. The factual and scientific basis for the performance 
requirements and test methods in the rule are described in Tab C of 
Staff's NPR Briefing Package.\27\
---------------------------------------------------------------------------

    \27\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

1. Restraint
    Comments: Graco asserts that the presence of a restraint system on 
an infant support cushion or lounger would further deter consumers from 
using them for sleep because the safety standards for sleep products do 
not allow restraint systems or cords or straps in the occupant area. On 
this basis, Graco suggests that the rule's prohibition on restraints 
could indicate to caregivers that infant support cushions are intended 
for sleep.
    Response: The Commission's yearly report of injuries and deaths 
associated with nursery products demonstrates that consumers use infant 
products, both with and without restraints, for infant sleep.\28\ In 
addition, restraints indicate to consumers that the infant is secure in 
the product and will not move, and thus the caregiver can leave the 
infant unsupervised. Because fall-related incidents have involved 
unattended infants who were left propped or lounging in the product, 
consumers are likely to interpret the presence of an infant restraint 
as meaning that unattended use is acceptable when an infant is 
restrained. Additionally, as is the case with several other children's 
product areas, loops, cords, or strings

[[Page 87476]]

that enter into the occupant space can create an entanglement hazard, 
as seen in the incident data. Infant support cushions should be used 
with constant adult supervision, so prohibiting restraints in the rule 
is appropriate.
---------------------------------------------------------------------------

    \28\ Injuries and Deaths Associated with Nursery Products Among 
Children Younger than Age Five, August 2023, available at: 
www.cpsc.gov/content/Injuries-and-Deaths-Associated-with-Nursery-Products-Among-Children-Younger-than-Age-Five-12.
---------------------------------------------------------------------------

2. Maximum Incline Angle
    Comment: Heroes Technology argues that it is not clear in the rule 
what ``approximately 1.9 inches'' means and asserts that this is an 
arbitrary value. Graco argues that figure 6 in the text of the proposed 
rule alludes to a side height measurement, without criteria stipulated 
for the side height.
    Response: The rule does not include a side height performance 
requirement or a side height test method. Instead, the maximum incline 
angle performance requirement of 10 degrees or less in the rule 
effectively limits the height of the product to approximately 1.9 
inches, which reduces the hazard from falls and suffocation when the 
product could otherwise give the false perception of containment to a 
caregiver that the product will safely contain the infant. The maximum 
incline angle test in the rule, as compared to a side height test, can 
more effectively be applied to all the different types of infant 
support cushions subject to the rule, which include infant support 
cushion products other than loungers and even products without a 
sidewall. Some products subject to the rule contain occupant support 
surfaces that allow an infant to be placed in various locations on the 
product. The maximum incline angle requirement applies to all the 
manufacturer's recommended use positions, and also to all other infant 
support cushion surfaces that can feasibly support an infant's head 
(occupant support surface-head), including the angle from the sidewall 
(if present) to the occupant support surface, or from the occupant 
support surface-head to the floor when no elevated sidewall is present, 
or from the sidewall to the floor when an elevated sidewall is present. 
Staff calculated that the side height for very firm products which meet 
the 10-degree angle requirements would likely be approximately 1.9 
inches (4.8 cm) or less based on the geometry of the newborn hinged 
weight gauge. The side height was not recommended arbitrarily, and is 
not itself a requirement, but rather describes the geometric 
calculations of the likely height of a product just meeting the 
required incline angle of 10 degrees.
    Comment: BPQ recommends the sidewall height should be set at 2 
inches, as in the draft ASTM infant loungers standard, and not 1.9 
inches. BPQ contends that if the height of the product is set at 1.9 
inches, then there would be no need to measure the incline angle. The 
commenter also recommends that the inclined angle of 10 degrees or less 
should be applied on the support surface of the base and only if the 
side height is greater than 2 inches.
    Response: The Commission disagrees that a maximum sidewall height 
of 2 inches should be required. The NPR did not propose a maximum side 
height requirement but instead proposed a maximum incline angle 
performance requirement. As discussed in the response to the previous 
comment, the maximum incline angle performance requirement in the rule 
is based on the varying designs of products and is expected to 
geometrically result in the height of the product being no more than 
1.9 inches in order to comply with the incline angle requirement.
    Comment: Graco argues that subjecting infant support cushions to a 
maximum incline angle requirement for products that are not intended 
for sleep would incorrectly result in them sharing a critical 
characteristic of infant sleep products, that are also required to have 
a sleep surface of 10 degrees or less.
    Response: Infant support cushions are not sleep products, but 
infants fall asleep in many types of products other than sleep 
products, including infant support cushions. The maximum incline angle 
requirement in the rule addresses the suffocation hazard that could 
result if an infant sleeps in an infant support cushion. Section 
1243.5(d) of the rule requires infant support cushions to have an 
incline angle of 10 degrees or less in order to reduce the hazard of 
suffocation if an infant falls asleep in the product.
    Comment: Heroes Technology argues that if there is no incline in 
the manufacturer's recommended use location for the product, and other 
use locations represent misuse, then the product should not be subject 
to a maximum incline angle requirement.
    Response: We disagree that products with no incline in the 
manufacturer's recommended use location should not be subject to the 
maximum incline angle requirement of the rule. Some products subject to 
the rule contain occupant support surfaces that allow a variety of use 
modes, so the infant may be placed in various locations on the product, 
while some products do not have sidewalls. With other products, infants 
may move, roll, or be placed in various positions on the product. To 
address known hazard patterns, the rule appropriately includes a 
maximum 10-degree incline angle requirement that applies to any 
foreseeable use position on the infant support cushion's occupant 
support surface or sidewall that supports the head for reclining, to 
mitigate suffocation and fall hazards. The maximum incline angle 
requirement applies to all manufacturer's recommended use positions, as 
well as to all other infant support cushion surfaces that can feasibly 
support an infant's head (occupant support surface-head). This includes 
the angle from the sidewall (if present) to the occupant support 
surface or from the occupant support surface-head to the floor when no 
elevated sidewall is present or from sidewall to floor when an elevated 
sidewall is present.
    Comment: Heroes Technology notes that an example of a ``feasible 
location'' is provided in the proposed rule, but the term is not 
defined. The comment also notes that a ``location likely to fail'' is 
also not defined in the rule, nor is any guidance provided as to how 
such a location should be determined.
    Response: A ``feasible location'' is language commonly used in ASTM 
standards and is typically followed by an example of such a location in 
the requirement. Section 1243.5(d)(8) is the only place in the rule 
where the term feasible location is used. This section represents the 
intent for a feasible location by providing an explicit example ``such 
as perpendicular to the recommended use location(s)'' without limiting 
the potential to test any area that is applicable with a discrete 
definition.
    The language a ``location likely to fail'' is language commonly 
used in ASTM standards and longstanding CPSC safety standards that 
incorporate these ASTM standards. While a location most likely to fail 
cannot be determined by the use of a single test, not all locations on 
the product need to be evaluated. For example, with respect to the 
maximum incline angle requirement, any extremity with respect to the 
overall height of the sidewall or occupant support surface should be 
considered areas likely to fail. Therefore, we disagree that ``feasible 
location'' or ``location most likely to fail'' needs to be defined in 
the rule.
    Comment: Graco argues that it is unclear if a two-inch height would 
prevent infants from rolling out of a product into a dangerous 
environment. Dony Ly suggests CPSC should recommend a side height that 
will best mitigate falls, while accounting for the wide range of infant 
age and ability but did not provide any recommendation as to that 
height. Julian Dreest proposes revising the sidewall height limitation

[[Page 87477]]

to a minimum of four inches to mitigate the risk of falls; he also asks 
if there has been a risk assessment analysis comparing the incidence of 
falls from products with different sidewall heights, while also taking 
into account the age of the infant. Heroes Technology asserts that CPSC 
failed to consider that a shorter sidewall height will increase the 
fall hazard.
    Response: As seen in the incident data and proposed in the NPR, a 
maximum incline angle requirement of 10 degrees or less mathematically 
limits the side height of the product to less than 2 inches to address 
potential asphyxiation hazards. The incident data also indicated that 
caregivers placed infant support cushions into infant sleep settings 
for unsupervised sleep or on elevated surfaces. Higher sidewall heights 
give the false perception to the caregiver that the product will safely 
contain their infant. At the same time, the incident data show that 
higher sidewall heights do not adequately contain infants or prevent 
falls and that infants roll out from and fall out of products with a 
side height of 4 inches or higher. The incident data also indicates 
that infants can turn over or roll without warning and are at risk of 
falling when infant support cushions are placed on an elevated surface.
    In contrast to products with higher side heights, products with 
side heights of approximately 2 inches or less are less likely to give 
the false perception to the caregiver that the product will safely 
contain their infant. Therefore, caregivers are less likely to leave 
infants unattended in a product with a less than 2-inch side height or 
to place the product on an elevated surface. When the side height is 
limited to less than 2 inches it provides a visual cue to caregivers 
that the product will NOT safely contain their infant which encourages 
caregivers to place the product on the floor, thus mitigating the fall 
hazard posed to infants from products placed on elevated surfaces. 
Furthermore, there is no evidence that a maximum sidewall height of 
about 2 inches would increase the risk of injury from a fall or lead to 
different consequences than a higher sidewall because, as reflected in 
the incident data, infant support cushions with higher side heights do 
not safely contain infants and infants already roll out of these 
products. Additionally, products with side heights of more than 2 
inches would exceed the maximum incline angle requirement in the final 
rule and poses a suffocation or positional asphyxiation hazard. Also, 
the commenter's proposal to require 4-inch-high sidewalls would not 
allow for products such as flat playmats or other infant support 
cushion products that do not contain sidewalls. Staff's analysis of 
incident data did not identify the need for a sidewall requirement and 
thus the final rule has no requirements for a minimum side height. 
Therefore, the Commission is not adopting the commenters' 
recommendations to require higher sidewalls because higher sidewalls 
encourage unsafe placement of infants on elevated surfaces, while also 
failing to adequately contain infants or prevent falls. Finally, staff 
is unaware of a risk assessment analysis specifically comparing the 
incidence of falls from infant support cushions of different product 
heights, while also taking into account the age of the infant.
    Comment: Heroes Technology asserts that CPSC failed to consider 
that with reduced side heights consumers will use blankets and towels 
to create a bumper.
    Response: Although this rule only regulates infant support 
cushions, it does contain specific warnings about the serious risks 
posed by soft bedding and other soft items in and around infant support 
cushions. Regardless of the side height of a product, some caregivers 
may use other products such as blankets and pillows to create a barrier 
around an infant, whether the infant is on an infant support cushion or 
not. CPSC will continue providing information and education campaigns 
for safe infant care regarding the hazards associated with soft bedding 
and soft items in sleep settings.
3. Firmness
    Comment: Boppy argues that the test requirements and procedures in 
the proposed rule do not consider products that do not have a sidewall. 
The performance requirements do not specify if the sidewall firmness 
and angle requirements only apply to products with a sidewall, and the 
testing procedures for sidewalls do not include language such as ``if 
applicable'' or ``for products with a sidewall.''
    Response: We agree that the rule should clarify whether the 
performance requirements and test methods apply to products that do not 
contain a sidewall. Therefore, the final rule adds ``For products with 
a sidewall'' to the beginning of the sentence regarding the performance 
requirements in Sec.  1243.4(e)(2) and (3) and (f) and also adds ``For 
products with a sidewall'' to the beginning of the sentence before 
``perform'' in the test methods in Sec. Sec.  1243.5(g) and 1243.4(h) 
and (i).
    Comment: Boppy notes that the rule does not specify how testing is 
to be performed on products with an occupant support surface of one 
inch or less.
    Response: We agree that clarification on how testing is to be 
performed on products with an occupant support surface of one inch or 
less is necessary in the final rule. Therefore, Sec.  1243.5(f) of the 
final rule adds the language ``All products, including products one 
inch or less in thickness, are required to be tested'' to clarify how 
testing is to be performed on products with an occupant support surface 
of one inch or less. The rule requires all in-scope products, including 
those with an occupant support surface of one inch or less, to be 
tested to all of the performance requirements to ensure that they meet 
the standard. As discussed above, no exception is provided for products 
of one inch or less in thickness.
    Comment: Safe Infant Sleep proposes that CPSC should consider a 
requirement that would not allow covers to have extra padding or 
cushioning, since such extra padding or cushioning may introduce an 
additional suffocation hazard.
    Response: The Commission agrees that slipcovers with extra padding 
or cushioning may introduce a suffocation hazard that would not be 
addressed by testing only the firmness of the infant support cushion 
without the slipcover installed on the product during testing. The 
Commission also agrees that testing should be performed with slipcovers 
installed as part of the as assembled product and the product and 
slipcover, if sold on or together with the product, must meet the test 
requirements because extra padding or cushioning on a slipcover may 
introduce an additional suffocation hazard that is not addressed if the 
product is tested without the slipcover installed. In order to make 
clear that infant support cushions sold with a slipcover, on or 
together with the product, are subject to the rule and must be tested 
as assembled, the definition of infant support cushion in Sec.  1243.2 
has been revised to add a new sentence at the end of the definition 
stating ``This definition includes any removable covers, or slipcovers, 
sold on or together with an infant support cushion.'' However, 
aftermarket slipcovers not sold with the product do not meet the 
definition of an infant support cushion and thus would not be within 
scope of this rule. Finally, Sec.  1243.5(f) adds the language ``for 
products sold with a slipcover on or together with the product, 
products shall be tested as assembled with the slipcover on the 
product'' to the final rule to clarify that slipcovers, sold on or 
together with the

[[Page 87478]]

product, need to be installed on the product during testing.
    Comment: Graco argues that infant support cushions should not be 
tested on a solid or firm testing surface.
    Response: We disagree. Infant support cushions should be tested on 
a solid or firm testing surface as the product relies on the underlying 
surface it is placed upon for support and shape. In order to accurately 
measure the firmness of the foam, filling, padding, or supporting 
material in an infant support cushion, the testing surface cannot move 
in response to the applied force (i.e., displace, shift, bend, deviate, 
compress, deflect, translate or otherwise), because any movement of the 
testing surface in response to the applied load would contribute to an 
under-measured value for the firmness measurement and thus would not 
provide repeatable results.
    Comment: Graco argues that the minimum value for acceptable 
firmness for the firmness test cannot be directly correlated to the 
firmness values used in other safety standards for children's products. 
Graco recommends that all data underlying the performance requirements 
be published to permit an independent assessment. Graco also argues 
that the performance requirements are not substantiated by reliable 
test results.
    Response: The Commission considered the recommendations of the BSU 
Final Report when developing the proposed requirements in the rule.\29\ 
Additionally, the requirements in the rule reflect staff's testing of a 
variety of infant support cushions, as well as an analysis of hazard 
patterns obtained from incident data associated with infant support 
cushions. The Commission made this incident data available for public 
review and comment as described in the NOA. This information was used 
to develop the specific performance requirements, and labeling and 
instructional literature requirements that address the suffocation and 
fall hazards associated with infant support cushions. The development 
of the firmness test method and test results are discussed in further 
detail in Tab C of the Staff's NPR Briefing Package.\30\
---------------------------------------------------------------------------

    \29\ Erin M. Mannen et al; Consumer Prod. Safety Comm'n. Pillows 
Product Characterization and Testing (2022). www.cpsc.gov/content/Pillows-Product-Characterization-and-Testing.
    \30\ Staff's NPR Briefing Package, available at: www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

    Comment: Heroes Technology argues that the firmness testing 
described in the rule regarding the intersection of the occupant 
support surface and sidewalls is ambiguous and that the term ``location 
most likely to fail'' is similarly vague.
    Response: The firmness test for the intersection of the sidewall 
and occupant support surface is intended to address suffocation hazards 
from infant support cushion products due to the presence of a sidewall 
adjacent to an occupant support surface. The rule provides instructions 
and guidance to measure firmness at the intersection of the sidewall 
and occupant support surface. Specifically, firmness is measured at the 
intersection of sidewall and occupant support surface as the force to 
deflect the surface 1.0 in (2.54 cm) using the 3-inch hemispherical 
probe oriented at an angle, determined according to the test method in 
Sec.  1243.5(h), Intersection of sidewall and occupant support surface 
firmness. Section 1243.5(h) requires a force greater than 10.0 N (2.24 
lbs) to address the suffocation hazard due to soft surfaces. The terms 
``most likely to fail'' or ``likely to fail'' are standard language 
commonly used in ASTM standards and longstanding CPSC rules that 
incorporate these ASTM standards. However, areas where the sidewall 
appears to be vertical or slanted inward immediately over top of the 
occupant support surface, even while satisfying the angle requirement 
for the side as a whole, would be considered areas ``likely to fail.'' 
Therefore, the Commission disagrees that ``location most likely to 
fail'' needs to be defined in the rule.
4. Sidewall Angle
    Comment: Heroes Technology argues that the proposed sidewall angle 
requirement cannot be conducted effectively on the firm's Snuggle Me 
infant lounger due to the lounger's unique design features.
    Response: The sidewall angle requirement is intended to address the 
risk of entrapment between the sidewall and the occupant support 
surface that is not fully addressed by the firmness requirements alone. 
While the Snuggle Me infant lounger may possess unique design features, 
such as an unpadded occupant support surface, the product can still be 
evaluated to the sidewall angle requirement in the rule. The unpadded 
surface, and the firm flat surface the rule requires the units be 
tested on, would be considered the occupant support surface for the 
evaluation and the sidewall angle should be taken with respect to that 
surface.
    Comment: Heroes Technology argues that the rule provides no 
instructions or guidance to locate the intersection of the sidewall and 
occupant support surface.
    Response: In Sec.  1243.5(i), Sidewall angle determination, the 
rule provides instructions and guidance regarding the test procedure to 
locate the intersection of the sidewall and occupant support surface.

H. Marking and Labeling

    Comment: Boppy, AAP, BPQ, the Joint Consumer Advocate Commenters, 
Safe Infant Sleep, and JPMA all recommend an additional warning for the 
tummy time infant support cushion subcategory to provide clarity and 
resolve confusion surrounding the warning ``use only on floor, with 
baby face up on back'' when it is used on a product that is also a 
tummy time pillow.
    Response: We agree that some infant support cushion products, such 
as tummy time pillows, may have features that require the infant to be 
on their stomach while using the product and that different statements 
are appropriate for products designed for tummy time. Because prone 
positioning is a risk factor for infants that can lead to suffocation 
when the mouth and nose are occluded, the final rule adds a new figure 
3 in Sec.  1243.6 to accommodate products with multi-use positions. 
Specifically, the following statement ``Put baby on back after Tummy 
Time'' has been added to the warning label after the phrase ``use only 
on the floor with baby on back, face up'' in new figure 3. Figure 3 is 
only required for products that have a tummy time feature because only 
products that have a tummy time feature should allow prone positioning. 
Tummy time pillow manufacturers may also omit the word ``only'' from 
the statement ``use only on floor with baby on back, face up'' to 
accommodate the multi-use positioning of the product which is indicated 
in new figure 3. This entire warning statement bullet point was also 
moved up within the warning statement in figures 2 and 3 to reflect the 
serious hazard to infants from prone positioning. Products without a 
tummy time feature are required to use figure 2.
    Comment: The Joint Consumer Advocate Commenters propose requiring 
the product warning label on replacement covers for infant support 
cushions.
    Response: The Commission agrees that warning labels should be 
included on slipcovers that are sold on or together with infant support 
cushions. As discussed above regarding slipcovers sold on or together 
with the product that

[[Page 87479]]

must be tested with the slipcover installed on the product, the 
definition of infant support cushion in Sec.  1243.2 has been revised 
to add a new sentence at the end of the definition, ``This definition 
includes any removable covers, or slipcovers, sold on or together with 
an infant support cushion,'' to make clear that slipcovers sold on or 
together with the product are subject to the requirements of the rule. 
However, aftermarket slipcovers or third-party covers are considered 
accessories that are not part of the product and thus not subject to 
the rule. Finally, in response to this comment, Sec.  1243.6(e) of the 
final rule has been revised to require warning labels on slipcovers 
that are sold on or together with an infant support cushion.
    Comment: Safe Infant Sleep recommends laundering/cleaning 
instructions to mitigate a mold hazard.
    Response: Incident data do not indicate there is a mold hazard that 
would require infant support cushions to have laundering/cleaning 
instructions as part of this rulemaking. Therefore, the Commission 
assesses at this time no requirement is needed to address laundering/
cleaning. However, if this information is provided, it should not be 
placed on a warning label because warning labels that have too much 
information that is not urgent for the user of the product dilute all 
messages on the label.
    Comment: The Joint Consumer Advocate Commenters suggest that CPSC 
should consider more ways to clearly emphasize in the warning label 
that infant support cushions should not be used for sleep.
    Response: The Commission assesses that no change to the rule is 
needed to clearly emphasize the warning against using infant support 
cushions for sleep because this message is already strongly 
communicated through the initial sentence of the warning about the 
deadly consequences of using the product for sleep or naps.
    Comment: Safe Infant Sleep objects to using the statement ``using 
this product for sleep or naps can kill'' because this statement 
implies that naps are different than sleep and this can be damaging to 
safe sleep education. The commenter instead recommends ``using this 
product for ANY duration of sleep, even when supervised can kill.''
    Response: Consumers have indicated that ``sleep'' and ``naps'' may 
mean different things for infants and have indicated that infants 
``nap'' anywhere but should be in a specific sleep product when they 
are put to ``sleep.'' \31\ Therefore, the rule retains the requirement 
for the warning label to contain the statement ``using this product for 
sleep or naps can kill'' to reinforce that the products are unsafe for 
all types of sleep. However, the final rule revises the warning labels 
in figure 2 and new figure 3 of Sec.  1243.6 by separating ``stay near 
and watch baby during use'' from ``if a baby falls asleep, move baby to 
infant sleep product, such as a crib or bassinet.'' These changes, 
which provide clearer instruction on what a caregiver should do if 
their baby falls asleep, have been made to figure 2 and new figure 3 of 
Sec.  1243.6.
---------------------------------------------------------------------------

    \31\ Fors Marsh Group's, 2022 ``Consumer Product Safety 
Commission (CPSC): Sleep Warnings Final Report'', available at: 
www.cpsc.gov/s3fs-public/Consumer-Product-Safety-Commission%E2%80%93Sleep-Warnings-Final-Report.pdf?VersionId=MfJcAAip4YNWVf.RllvXQtwNN7chjHyt.
---------------------------------------------------------------------------

    Comment: Graco notes that the warning ``use only with an awake 
baby'' is a new type of warning and it is not clear if parents 
understand what level of awake their baby should be.
    Response: The Commission agrees that the phrase ``use only with an 
awake baby'' from the warning statement should be removed because the 
safety messaging to not use infant support cushions with sleeping 
infants or in an infant sleep setting is already strongly communicated 
through the initial sentence of the warning about the deadly 
consequences of using the product for sleep or lounging. Therefore, the 
final rule removes ``use only with an awake baby'' from the warning 
labels in figure 2 and new figure 3 of Sec.  1243.6.
    Comment: Heroes Technology recommends changing the proposed warning 
``USING THIS PRODUCT FOR SLEEP OR NAPS CAN KILL'' to ``USING THIS 
PRODUCT FOR INFANT SLEEP OR NAPS CAN LEAD TO SERIOUS INJURIES OR 
DEATH.''
    Response: We disagree with the commenter's recommended change to 
the warning label. First, the warning label statement ``can kill'' is 
an accurate and concise statement of the consequences of infants 
sleeping or napping on infant support cushions. Warning messages on 
many infant products are often too long, resulting in consumers not 
reading and heeding the messages. The commenter's recommended statement 
``can lead to serious injuries or death'' is much less impactful than 
``can kill'' and thus would not be as effective in warning caregivers 
about the serious suffocation hazard to infants from using these 
products for sleep or naps.
    Comment: Heroes Technology suggests stronger warning language 
surrounding the use of soft bedding in and around infant support 
cushions.
    Response: Incident data indicate that infant deaths occurred when 
soft bedding was placed in an infant support cushion. Infant deaths 
also occurred when the product was used on soft bedding and the infant 
rolled out of the product into a hazardous setting containing soft 
bedding around the product. The Commission accordingly agrees that the 
rule should have stronger warning language regarding the use of soft 
bedding in and around infant support cushions. Therefore, the warning 
labels in figure 2 and new figure 3 of Sec.  1243.6 have been revised 
to add ``Do not use on soft surfaces or in sleep products like cribs or 
bassinets. Keep blankets and other soft items out of and away from 
product.'' to warn against the hazard presented by soft bedding in and 
around infant support cushions. Additionally, this revision to figure 2 
and new figure 3 of Sec.  1243.6 in the final rule separates this 
warning statement into a separate bullet point to emphasize the risk to 
infants from soft bedding.
    Comment: Heroes Technology suggests stronger and more impactful 
language surrounding the fall risk from placing the product on elevated 
surfaces, and warning consumers that infants may roll unexpectedly.
    Response: We disagree that the warning label in the rule requires 
stronger and more impactful language regarding the fall risk from 
placing infant support cushions on elevated surfaces and warning 
consumers that their infants may roll unexpectedly is necessary. These 
messages are already presented concisely on the warning labels in 
figure 2 and new figure 3 of Sec.  1243.6.
    Comment: Graco states that the warning statements were not provided 
in the proposed regulatory text and were only provided in figure 2 of 
the NPR.
    Response: The proposed rule characterized the warning label in 
figure 2 as an example. Thus, it was unclear if the exact content and 
format for the warning label depicted in proposed figure 2 in Sec.  
1243.6(d)(7) is required. The final rule clarifies that the required 
content and format of the warning labels in figure 2 and new figure 3 
are to be used exactly as written, as applicable. Additionally, in 
Sec.  1243.6(d)(7), the word example was removed from the figure 2 and 
new figure 3 captions.
    Comment: Graco recommends adding the following statement to the 
warning label of the infant support cushion rule: ``For babies with 
medical conditions, developmental delay, or complications relating to 
premature birth, consult a doctor before use.''

[[Page 87480]]

    Response: The Commission disagrees with requiring this information 
to be placed on the warning label because not all helpful information 
needs to be included on the warning label in the rule. The warning 
label in Sec.  1243.6 of the rule includes messaging focused on the 
serious suffocation and fall hazards posed by infant support cushions.

I. Comparative Analysis

    Comment: JPMA argues that CPSC has not provided a risk/benefit 
analysis, risk/hazard analysis, or a consumer choice analysis regarding 
the proposed rule.
    Response: The types of analysis described by the commenter that 
would quantify the hazard reduction benefits versus the costs of 
compliance are not required by section 104 of the CPSIA. A consumer 
choice model would require detailed consumer demand data that 
commenters did not provide and would involve quantifying consumer 
demand for theoretical product alternatives not specified by the 
commenter and not required by section 104 of the CPSIA. The Initial 
Regulatory Flexibility Analysis (IRFA) \32\ did provide a specific 
numerical estimate of the cost of compliance, and the staff analysis of 
incidents found multiple deaths each year associated with these 
products--17 deaths per year in 2021 and at least 17 in 2022.\33\
---------------------------------------------------------------------------

    \32\ See Tab E of Staff's NPR Briefing Package, available at: 
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
    \33\ See Tab A of Staff's NPR Briefing Package, available at: 
www.cpsc.gov/s3fs-public/Briefing-Package-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Infant-Support-Cushions.pdf?VersionId=rA60lesWHddS1.wrk_EvV00xeX75dsFc.
---------------------------------------------------------------------------

J. Effective Date

    Comments: Boppy, Heroes Technology, and JPMA contend that a 180-day 
effective date is insufficient for compliance and argue that a one-year 
effective date would be appropriate to limit the burdens on 
manufacturers.
    Response: While the commenters assert that 180 days is insufficient 
time to comply with the rule without burdening manufacturers, they do 
not provide any specific data or information showing that the level of 
effort to redesign and distribute an infant support cushion would 
require a one-year compliance period. Furthermore, JPMA typically 
allows 180 days for products in their certification program to 
implement a new voluntary standard such that juvenile product 
manufacturers are accustomed to adjusting to new standards within this 
time frame. Therefore, the rule provides a reasonable effective date 
that takes into consideration manufacturers burdens and the risk of 
continued infant injuries and deaths. Based on the urgency of 
addressing the hazards associated with infant support cushions, the 
180-day effective date proposed in the NPR is appropriate and is being 
finalized as proposed.

K. Stockpiling

    Comments: AAP and the Joint Consumer Advocate Commenters request 
that CPSC take action to prevent manufacturers from increasing 
production of, or stockpiling, noncompliant infant support cushions and 
to prevent sellers from putting on the market large quantities of 
products that are noncompliant.
    Response: The Commission notes the commenters' recommendations to 
include a stockpiling provision in the final rule. Commenters provided 
no evidence that manufacturers or importers are likely to increase 
significantly their manufacture or importation of infant support 
cushions before the rule's effective date. In addition, the 180-day 
effective date should serve to limit the stockpiling of noncompliant 
products so as to prevent such manufacturers from circumventing the 
purpose of the rule. Therefore, the final rule does not include a 
stockpiling provision.

L. Regulatory Procedure

    Comment: BPQ requests that CPSC revise the NPR and reissue it for 
public comment to reflect recent revisions to ASTM's draft infant 
lounger voluntary standard.
    Response: As of the date of the publication of the final rule, 
there is no voluntary standard addressing the suffocation and fall 
hazards of infant support cushions on which a mandatory rule could be 
based. Additionally, the draft ASTM standard is in draft form and 
subject to change as part of the consensus process. Section 104 of the 
CPSIA does not require an existing voluntary standard in order for the 
Commission to promulgate a safety standard for a durable infant or 
toddler product. See 15 U.S.C. 2056a(b)(2); Finnbin, LLC v. Consumer 
Prod. Safety Comm'n, 45 F.4th 127, 134 (D.C. Cir. 2022).
    Comment: Boppy and Heroes Technology argue that this rule cannot be 
promulgated under section 104 of the CPSIA without a preexisting 
voluntary standard for infant support cushions.
    Response: Section 104 of the CPSIA does not require an existing 
voluntary standard in order for the Commission to promulgate a safety 
standard for a durable infant or toddler product. See 15 U.S.C. 
2056a(b)(2); Finnbin, LLC v. CPSC, 45 F.4th 127, 134 (D.C. Cir. 2022). 
In Finnbin, the court explained that CPSC has an express statutory 
command to regulate all categories of durable infant or toddler 
products and must do so for products not covered by voluntary 
standards. Furthermore, by the terms of 15 U.S.C. 2056a(b)(1), the 
requirement to examine and assess the effectiveness of any voluntary 
standards only applies if a voluntary standard exists. Because no 
voluntary standards currently address the suffocation and fall hazards 
posed by infant support cushions, the procedural requirements in 
section 104(b) of the CPSIA, to develop a rule with reference to an 
existing standard, do not apply to this rule.
    Comment: Boppy argues that infant support cushions are not durable 
nursery products because infant support cushions are ``pillow-like'' 
and pillows are soft, textile products that are in no way comparable to 
cribs, strollers, bathtubs, or bed rails. Boppy additionally argues 
that there are no products in either the original twelve, or additional 
six product categories of durable goods that can be rationally compared 
to ``pillows.''
    Response: Infant support cushions meet the statutory requirement 
for durable infant or toddler products in section 104(f)(1) of the 
CPSIA because they are intended for use, and may be reasonably expected 
to be used, by children under the age of 5 years and routinely have a 
life span of several years. They are not disposable; have a useful life 
of up to several years and are often used by multiple children in 
succession; are similar to other soft durable infant and children's 
products such as crib mattresses and sling carriers (which the 
Commission has issued rules for under section 104); are resold and 
widely available on secondary marketplaces; and are primarily intended 
to be used by children five years old or younger. Therefore, although 
infant support cushions are not specifically listed in section 
104(f)(2) of the CPSIA, the Commission may reasonably treat them as 
``durable infant or toddler products.''
    The Commission has previously added to the statutory list of 
durable infant or toddler products by including other products for 
young infants, such as changing products and infant bouncers, that also 
have a market for secondary use. As the Commission explained in 2009, 
``[b]ecause the statute has a broad definition of a durable infant or 
toddler product but

[[Page 87481]]

also includes 12 specific product categories, additional items can and 
should be included in the definition.'' Requirements for Consumer 
Registration of Durable Infant or Toddler Products, 74 FR 68668, 68669 
(December 29, 2009).
    Comments: Boppy contends the proposed rule is unconstitutional 
because it violates the non-delegation doctrine and the Separation of 
Powers and Appointments Clause of the U.S. Constitution.
    Response: The rule is being promulgated under the Danny Keysar 
Child Product Safety Notification Act, section 104 of the CPSIA, which 
directs the Commission to promulgate consumer product safety standards 
for durable infant or toddler products. CPSC is an independent agency 
and the Commissioners do not exercise Executive power, consistent with 
the Supreme Court's holding in Humphrey's Executor v. United States, 
295 U.S. 602 (1935). Several Federal Courts of Appeals have recently 
rejected similar Constitutional arguments about CPSC. Consumers' Rsch. 
v. CPSC, 91 F.4th 342 (2024), petition for cert. filed, (Consumers' 
Rsch. v. CPSC, No. 23-1323 (petition for cert. filed on July 18, 
2024)), and Leachco, Inc. v. CPSC, 103 F4th 748 (10th Cir. 2024), 
petition for cert. pending, No. 22-7060 (filed Aug. 9, 2024)).

VII. Description of the Final Rule for Infant Support Cushions

    As section 104 of the CPSIA requires, to address the risks of death 
and injury associated with infant suffocations, entrapments, and falls, 
the Commission is issuing this rule to establish mandatory performance 
and labeling requirements for infant support cushions. The requirements 
of the rule are based on an evaluation of incident data and the hazard 
patterns associated with infant support cushions, and the 
recommendations of the BSU Final Report. The final rule is summarized 
below, and the rule is being finalized as proposed in the NPR except as 
noted.

A. Section 1243.1 Scope, Purpose, Applications, and Exemptions

    Section 1243.1 explains that the rule applies to infant support 
cushions, including infant positioners, nursing pillows with a dual use 
for lounging, infant loungers, infant props, or cushions used to 
support an infant for activities such as tummy time, and other infant 
pillow-like products. It excludes products already regulated by other 
Commission mandatory standards for durable infant products, which are 
listed in 16 CFR 1130.2(a). The rule applies to all infant support 
cushions manufactured after the effective date of the rule. Section 
1243.1 is being finalized without changes as proposed in the NPR.

B. Section 1243.2 Definitions

    Section 1243.2 provides definitions for the following terms used in 
the rule: conspicuous, infant lounger, infant positioner, infant 
support cushion, occupant support surface, seat bight line, and 
sidewall. The definitions in Sec.  1243.2 are being finalized as 
proposed in the NPR except as discussed below. In response to a comment 
from Graco and for clarity, the definition of infant lounger has been 
revised to change the proposed words ``infant product'' to ``infant 
support cushion'' in the final rule. Also, in response to comments from 
Safe Infant Sleep and The Joint Consumer Advocate Commenters, the 
definition of infant support cushion has been revised to add a new 
sentence at the end of the definition ``This definition includes any 
removable covers, or slipcovers, sold on or together with an infant 
support cushion''. Finally, in response to a comment from Boppy, a new 
definition for the term ``sidewall,'' which is defined as ``any wall at 
the edge of the occupant support surface'', has been added to the final 
rule to provide clarity regarding the meaning of that term.

C. Section 1243.3 General Requirements

    Section 1243.3 provides general requirements for infant support 
cushions, including requirements addressing hazardous sharp edges or 
points (Sec.  1243.3(a)), small parts (Sec.  1243.3(b), lead in paints 
(Sec.  1243.3(c)), toys (Sec.  1243.3(d)), the removal of components 
(Sec.  1243.3(e)), the permanency of labels and warnings (Sec.  
1243.3(f)), and convertible products (Sec.  1243.3(g)). Section 1243.3 
is being finalized as proposed in the NPR except that the reference to 
``infant pillow'' in Sec.  1243.3(d) has been changed in the final rule 
to ``infant support cushion'' for accuracy and consistency based on a 
comment from TA. The final rule also removes proposed Sec.  1243.3(e) 
regarding side height. Measuring the height of the product is 
unnecessary and thus duplicative because the maximum incline angle test 
in Sec.  1243.5(d)(7) already accounts for the height of the product 
remaining under 2 inches. The final rule renumbers the paragraphs 
following Sec.  1243.3(d) to reflect this change.

D. Section 1243.4 Performance Requirements

    Section 1243.4 provides performance requirements for infant support 
cushions for restraints (Sec.  1243.4(a)), seam strength (Sec.  
1243.4(b)), bounded openings (Sec.  1243.4(c)), maximum incline angle 
(Sec.  1243.4(d)), firmness (Sec.  1243.4(e)), and sidewall angle 
(Sec.  1243.4(f)). Section 1243.4 is being finalized as proposed in the 
NPR except as discussed below. In response to a comment from Boppy, two 
changes have been made in paragraph (e) of Sec.  1243.4 that 
establishes requirements for firmness. In Sec.  1243.4(e)(2) and (3), 
``For products with a sidewall'' has been added to the beginning of the 
sentence because the proposed rule did not make clear whether the 
performance requirements are applicable to products without sidewalls. 
Additionally, in response to a comment from Boppy, the same change has 
been made to Sec.  1243.4(f) that establishes requirements for side 
angles because the proposed rule did not clarify the applicability of 
performance requirements for products without sidewalls.

E. Section 1243.5 Test Methods

    Section 1243.5 provides the test methods to be used to test for 
compliance with the requirements of the rule. Section 1243.5 includes 
test methods for test conditions (Sec.  1243.5(a)), test for permanence 
of labeling and markings (Sec.  1243.5(b)), head entrapment test (Sec.  
1243.5(c)), maximum incline test (Sec.  1243.5(d)), firmness test setup 
(Sec.  1243.5(e), occupant support surface firmness test method (Sec.  
1243.5(f)), sidewall firmness test method (Sec.  1243.5(g)), test 
method for the intersection of sidewall and occupant support surface 
firmness (Sec.  1243.5(h)), test method for sidewall angle 
determination (Sec.  1243.5(i)), seam strength test method (Sec.  
1243.5(j)), and removal of components test method (Sec.  1243.5(k)). 
Section 1243.5 is being finalized as proposed in the NPR except as 
discussed below.
    For the same reason discussed above for the removal of proposed 
Sec.  1243.3(e) regarding side height, the final rule removes the 
corresponding test in Sec.  1243.5(d)(8) for consistency. To reflect 
this change, all numbers after Sec.  1243.5(d)(7) have been renumbered.
    In response to a comment from Safe Infant Sleep, the following 
language has been added after the first sentence of Sec.  1243.5(f): 
``For products sold with a slipcover on or together with the product, 
products shall be tested as assembled with the slipcover on the 
product.'' This language has been added

[[Page 87482]]

to the final rule because slipcovers with extra padding or cushioning 
may introduce suffocation hazards that would not be addressed if 
slipcovers sold on or together with an infant support cushion were not 
required to be tested as assembled with the slipcover on the product. 
In response to a comment from Boppy, right after the new sentence added 
above, the following language has been added to Sec.  1243.5(f) of the 
final rule: ``All products, including products one inch or less in 
thickness, are required to be tested.'' This language has been added to 
the final rule because a product could either vary in thickness or be 
so close to 1 inch in thickness that it would be difficult to determine 
thickness without testing. In response to another comment from Boppy, 
Sec.  1243.5(g) of the final rule adds in the first sentence ``products 
with a sidewall'' between ``For'' and ``perform'' because the proposed 
rule did not specifically clarify the applicability of test methods for 
products without sidewalls. The Boppy comment also resulted in changes 
to Sec.  1243.5(h) and (i) at the beginning of the first sentence, 
adding ``For products with a sidewall,'' before ``perform,'' to state 
directly that products with sidewalls must be tested according to the 
test methods.

F. Section 1243.6 Marking and Labeling

    Section 1243.6 provides the marking and labeling requirements for 
infant support cushions, including general markings (Sec.  1243.6(a)), 
permanency (Sec.  1243.6(b)), upholstery labeling (Sec.  1243.6(c)), 
warning design for product (Sec.  1243.6(d)), and warning statements 
(Sec.  1243.6(e)). Section 1243.6 is being finalized as proposed in the 
NPR except as discussed below.
    Several changes have been made to figure 2 in Sec.  1243.6(d)(7) as 
described below. We also add a new figure 3, Warning for Tummy Time 
Product, in Sec.  1243.6(d)(7), as described below.
     In response to a comment from Graco, the phrase ``use only 
with an awake baby'' has been removed from the warning label in figure 
2 and new figure 3 because the safety messaging to not use infant 
support cushions with sleeping infants or in an infant sleep setting is 
already strongly communicated through the initial sentence of the 
warning about the deadly consequences of using the product for sleep or 
naps, and limiting the amount of text on warning labels makes the 
material being presented more prominent.
     The rule clarifies that figure 2 in Sec.  1243.6(d)(7) is 
required for all infant support cushions that do not have a tummy time 
feature.
     In response to comments from Boppy, AAP, BPQ, the Joint 
Consumer Advocate Commenters, Safe Infant Sleep, and JPMA, the 
Commission is adding a new figure 3 in Sec.  1243.6(d)(7) for products 
with a tummy time feature. The statement bullet point was also moved up 
within the warning statement to reflect the serious hazard to infants 
presented by prone positioning. In new figure 3, the statement ``Put 
baby on back after Tummy Time'' is added to the warning label after the 
phrase ``Use only on the floor with baby on back, face up,'' to 
accommodate multi-use positions of some infant support cushion 
products, such as tummy time pillows that may have features that 
require the infant to be on their stomach while using the product. 
Figure 3 additionally omits the word ``only'' from ``use only on the 
floor with baby on back, face up''. Figure 3 is required only for 
products that have a tummy time feature because only those products 
that have a tummy time feature should allow for prone positioning.
     In response to a comment from Safe Infant Sleep the 
warning labels have been revised with more concise wording and clarity 
to provide instruction for what a caregiver should do if their baby 
falls asleep by separating ``stay near and watch baby during use'' from 
``if a baby falls asleep, move baby to infant sleep product, such as a 
crib or bassinet''.
     In response to a comment from Heroes Technology, the 
warning labels for figure 2 and new figure 3 now includes the statement 
``Do not use on soft surfaces or in sleep products like cribs or 
bassinets. Keep blankets and other soft items out of and away from 
product'' to discourage soft bedding use in and around the product. 
This revision also separates these warning statements into a separate 
bullet point to emphasize the risk to infants from soft bedding placed 
both in and around the product.
     In response to a comment from Graco, the word ``example'' 
was removed from the captions on figure 2 and new figure 3 because it 
was unclear if the exact content and format for the warning labels in 
Sec.  1243.6(d)(7) is required as depicted in proposed figure 2 and new 
figure 3. Additionally, the final rule clarifies in Sec.  1243.6(d)(7) 
that the content and format as depicted in figure 2 and new figure 3 as 
applicable, are required.
     Note 4 to proposed Sec.  1243.6(e) has been removed from 
the rule as unnecessary because the final rule clarifies that the 
required content and format of the warning labels in figure 2 and new 
figure 3, as applicable, are to be used as written.
     A new note 4 to Sec.  1243.6(d)(6) has been added below 
figure 1 for paragraph (d)(6), which was originally the language above 
figure 1 for paragraph (d)(6), with the new note 4 providing the 
original text indicating that the depicted warnings are filler text, 
known as lorem ipsum, commonly used to demonstrate graphic elements.
     In figure 2 and new figure 3, a black line has been 
inserted between the suffocation warnings and the fall warnings to 
distinguish between the messages.
    The changes described above are depicted below in the revised 
figure 2, Warning for Product Without Tummy Time, and new figure 3, 
Warning for Tummy Time Product, from Sec.  1243.6 of the final rule.

[[Page 87483]]

[GRAPHIC] [TIFF OMITTED] TR04NO24.001

[GRAPHIC] [TIFF OMITTED] TR04NO24.002

    Additionally, in response to a comment from the Joint Consumer 
Advocate Commenters, the final rule adds language at the end of Sec.  
1243.6(e) stating that slipcovers, sold on or together with the 
product, are required to contain a warning with the content and format 
depicted in figure 2 or 3, as applicable, to paragraph (d)(7). This 
language is being added because when an infant support cushion is sold 
with a slipcover, it is expected that slipcover will hide the warning 
label that should be visible to a caregiver while placing an infant 
onto or into the product, when the product is in the manufacturer's 
recommended use position. Therefore, the warning label should be 
conspicuously located on the slipcover as is required for an infant 
support cushion that does not come with a slipcover.

G. Section 1243.7 Instructional Literature

    Section 1243.7 provides requirements for instructional literature 
for infant

[[Page 87484]]

support cushions, including requiring instructional literature be 
provided with the product, as well as requirements as to what such 
information must include. Section 1243.7 also requires that 
instructional literature meet the requirements of the National 
Electrical Manufacturers Association's (NEMA's) ANSI Z535.4-
2011(R2017), American National Standard for Product Safety Signs and 
Labels (ANSI Z535.4-2011). The final rule specifically requires the 
warning format requirements in sections 6.1-6.4, 7.2-7.6.3, and 8.1 of 
ANSI Z535.4-2011(R20217). Finally, under Sec.  1243.7 any instructions 
provided in addition to those required by Sec.  1243.7 shall not 
contradict or confuse the meaning of the required information or be 
otherwise misleading to the consumer. Section 1243.7 is being finalized 
as proposed in the NPR.

H. Section 1243.8 Incorporation by Reference

    Section 1243.8 incorporates by reference ANSI Z535.4-2011(R20217), 
American National Standard for Product Safety Signs and Labels, and 
ASTM D3359-23, Standard Test Methods for Rating Adhesion by Tape Test, 
and provides information on where those standards are available. ANSI 
Z535.4-2011 includes requirements related to safety alert symbol use; 
signal word selection; warning panel format, arrangement, and shape; 
color requirements for each panel; letter style; to identify and warn 
against specific hazards; and to provide information to avoid personal 
injury. ASTM D3359-23 covers procedures for assessing the adhesion of 
relatively ductile coating films to metallic substrates by applying and 
removing pressure-sensitive tape over cuts made in the film.

VIII. Amendment to 16 CFR Part 1112 To Include NOR for Infant Support 
Cushions

    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. 15 U.S.C. 2063(a)(2). The Commission must publish an 
NOR for the accreditation of testing laboratories as third party 
conformity assessment bodies to assess conformity with a children's 
product safety rule. 15 U.S.C. 2063(a)(3). The infant support cushions 
rule is a children's product safety rule that requires the issuance of 
an NOR.
    The Commission's rules, at 16 CFR part 1112, establish requirements 
for accreditation of third party conformity assessment bodies to test 
for conformance with a children's product safety rule in accordance 
with section 14(a)(2) of the CPSA. Part 1112 also lists the NORs that 
the CPSC has published. In the NPR the Commission proposed to amend 
part 1112 to include the Safety Standard for Infant Support Cushions in 
the list of children's product safety rules for which the CPSC has 
issued NORs. Section 1112.15(a)(57) is being finalized as proposed in 
the NPR.
    Laboratories applying for acceptance as a CPSC-accepted third party 
conformity assessment body to test to the new Safety Standard for 
Infant Support Cushions standard 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 the Safety Standard for Infant Support Cushions included in its 
scope of accreditation as reflected on the CPSC website at 
www.cpsc.gov/labsearch.

IX. Amendment to 16 CFR Part 1130 To Include Infant Support Cushions

    Infant support cushions are a category of ``durable infant or 
toddler product'' for purposes of CPSIA section 104 because they: are 
intended for use, and may be reasonably expected to be used, by 
children under the age of five years; are products similar to other 
products listed in section 104(f)(2), such as crib mattresses, and 
sling carriers; and are commonly resold or ``handed down'' for use by 
other children over a period of years. In the NPR, the Commission 
proposed to amend 16 CFR part 1130 to include Infant Support Cushions 
as durable infant or toddler products. Section 1130.2(a)(20) is being 
finalized as proposed in the NPR.

X. Incorporation by Reference

    The rule incorporates by reference ANSI Z535.4-2011(R2017), 
American National Standard for Product Safety Signs and Labels, and 
ASTM D3359-23, Standard Test Methods for Rating Adhesion by Tape Test. 
In accordance with the regulations of the Office of the Federal 
Register, 1 CFR part 51, section VII.H of this preamble summarizes the 
requirements of the ANSI Z535.4-2011(R2017) and ASTM D3359-23.
    Both standards are reasonably available to interested parties in 
several ways. Interested persons may purchase a copy of ANSI Z535.4-
2011(R2017) from the National Electrical Manufacturers Association 
(NEMA), 1300 17th St. N, Arlington, VA 22209; phone: (703) 841-3200; 
website: www.nema.org. This standard is also available from ANSI via 
its website, www.ansi.org, or by mail from ANSI, 25 West 43rd Street, 
4th Floor, New York, NY 10036, telephone: (212)-642-4900. Once the rule 
takes effect, a read-only copy of ANSI Z535.4-2011(R2017) will be 
available for viewing, at no cost, on the ANSI website at: https://ibr.ansi.org/Standards/nema.aspx. Interested individuals may purchase a 
copy of ASTM D3359-23 from ASTM, through its website, www.astm.org, or 
by mail from ASTM International, 100 Barr Harbor Drive, P.O. Box 0700, 
West Conshohocken, PA 19428-2959. Once the rule takes effect, a read-
only copy of the standard will be available for viewing, at no cost, on 
the ASTM website at: www.astm.org/READINGLIBRARY/. Alternatively, 
interested parties may inspect a copy of the standards at CPSC's Office 
of the Secretary by contacting Alberta E. Mills, Commission Secretary, 
U.S. Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; phone: (301) 504-7479; email: [email protected].

XI. 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). In the NPR the Commission proposed an 
effective date of 180 days after publication of the final rule in the 
Federal Register. This amount of time is typical for rules issued under 
section 104 of the CPSIA. We note that the 180-day effective date is 
the same amount of time that JPMA typically allows for products in 
their certification program to shift to a new standard once that 
standard is published. Therefore, juvenile product manufacturers are 
accustomed to adjusting to new standards within this time frame. We 
noted in the NPR that a 180-day effective date should also be 
sufficient for manufacturers to comply with this rule because the 
proposed requirements do not demand significant preparation by testing 
laboratories. For example, no new complex testing instruments or 
devices would be required to test infant support cushions for 
compliance with this rule. Based on the urgency of addressing the 
hazards associated with infant support cushions, the 180-day effective 
date proposed in

[[Page 87485]]

the NPR is appropriate and is being finalized as proposed.

XII. Regulatory Flexibility Act

    When an agency is required to publish a notice of proposed 
rulemaking, the Regulatory Flexibility Act (5 U.S.C. 601-612) generally 
requires that the agency prepare an IRFA for the NPR and a final 
regulatory flexibility analysis (FRFA) for the final rule. 5 U.S.C. 
603, 604. These analyses must describe the impact that the rule would 
have on small businesses and other entities. The FRFA must contain:
    (1) a statement of the need for and objectives of the rule;
    (2) significant issues raised by commenters on the IRFA, the 
agency's assessment of those issues, and changes made to the result as 
a result of the comments;
    (3) a response to any comments filed by the Chief Counsel for 
Advocacy of the U.S. Small Business Administration (Advocacy), and 
changes made as a result of those comments;
    (4) a description and estimate of the number of small entities to 
which the rule will apply;
    (5) a description of the projected reporting, recordkeeping, and 
other compliance requirements of the rule, including an estimate of the 
classes of small entities which will be subject to the requirement and 
the type of professional skills necessary for preparation of the report 
or record; and
    (6) steps the agency has taken to minimize the significant economic 
impact on small entities, consistent with the objective of the 
applicable statute, including the factual, policy, and legal reasons 
for selecting the alternative in the final rule and why other 
alternatives were rejected.
    Staff prepared an IRFA for this rulemaking that was summarized in 
the NPR and provided in full Tab E of the Staff's NPR Briefing Package. 
The FRFA is provided below.

A. Need for and Objectives of This Rule

    Section I of this preamble describes the reasons and legal basis 
for this final rule. As discussed in sections VI and VII of this 
preamble, the rule sets mandatory requirements for infant support 
cushions to address the suffocation, entrapment, and fall hazards 
associated with these products; adds infant support cushions to the 
list of products for which a registration card is required; and adds 
infant support cushions to the list of durable infant products for 
which an NOR is required.

B. Comments and Responses Concerning Impact on Small Entities

    Comment: Boppy and Heroes Technology state that the maximum incline 
angle requirement, which limits product height to approximately 1.9 
inches, would eliminate most products subject to this rule from the 
market, resulting in a significant loss of utility to consumers for 
compliant products, far in excess of CPSC's estimates.
    Response: The IRFA stated that consumers might not purchase the 
redesigned compliant products and estimated a significant impact on a 
substantial number of small businesses. The commenters did not provide 
any data on their assertion that consumers might not want to buy 
products with a shorter side height. Given the number of playmats and 
similar items with no sides or short sides on the market, there is 
ample evidence that consumers are willing to purchase such items. The 
Commission has considered the significant impact on small entities in 
the IRFA, and it is discussed in the possible alternatives analysis in 
this FRFA and thus has taken this impact into account as required by 
the RFA.
    Comment: JPMA states that this rule would require significant 
costly changes to make products compliant.
    Response: JPMA did not provide quantitative estimates of supplier 
costs or consumer utility impacts to support a change in the burden 
estimates. The IRFA provided specific estimates of labor and materials 
costs for redesign. The scope of staff's analysis of burden, as 
required by 5 U.S.C. 603, was the impact on small U.S. businesses, and 
none of the comments provided information to support changing the 
estimates of impact on small U.S. businesses. The Commission has, 
however, considered the significant impact on small entities in 
finalizing this rule.

C. Issues Raised by the Small Business Administration

    The Small Business Administration (SBA) did not submit a comment on 
the proposed rule.

D. Small Entities to Which the Rule Would Apply

    The SBA sets size standards for what constitutes a U.S. small 
business for the purpose of various Federal Government programs,\34\ 
750 employees for manufacturers (NAICS code 314120) and 100 to 150 
employees for wholesalers (NAICS codes 424350, 423990, and 424990).\35\ 
Based on staff's assessment of prominent online and brick-and-mortar 
retail sources for infant support cushions in the Spring of 2023, there 
appear to be more than 2,000 suppliers of infant support cushions to 
the U.S. market, including small U.S. crafters, small importers, small 
manufacturers, and direct foreign shippers. Staff estimates that a 
significant number of these firms are small U.S. businesses based on 
the SBA thresholds cited above.
---------------------------------------------------------------------------

    \34\ The size standards are in listed in the Code of Federal 
Regulations. See 13 CFR part 121.
    \35\ The North American Industry Classification System (NAICS) 
is the standard used by Federal statistical agencies in classifying 
business establishments for the purpose of collecting, analyzing, 
and publishing statistical data related to the U.S. business 
economy. For more information, see www.census.gov/naics/. Some 
programs use 6-digit NAICS codes, which provide more specific 
information than programs that use more general 3 or 4-digit NAICS 
codes.
---------------------------------------------------------------------------

E. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of 
the Rule

    Suppliers will be required to comply with the performance 
requirements of the rule; provide a warning label, a consumer 
registration card, and user instructions; and conduct third-party 
testing to demonstrate compliance. Suppliers must demonstrate that they 
meet the performance requirements of the rule by providing certificates 
of compliance. As specified in 16 CFR part 1109, suppliers who are not 
the original manufacturer, such as importers, wholesalers, and 
retailers may rely on a certificate of conformity provided by their 
suppliers. Suppliers must also provide product registration cards. 
Recordkeeping and compliance documentation do not require specialized 
expertise. CPSC's public website provides instructions and examples for 
how to develop the certificates of compliance and product registration 
cards.\36\ Similarly, because the final rule provides the text and 
graphics for the required labels and instructions, specialized graphics 
design expertise will not be required to develop the warnings and 
instructions.
---------------------------------------------------------------------------

    \36\ See for example: www.cpsc.gov/Business--Manufacturing/
Testing-Certification/Childrens-Product-Certificate; and 
www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-
Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-
Consumer-Registration.
---------------------------------------------------------------------------

F. Impact of the Rule on Small Entities

    The rule will likely have a significant impact on a substantial 
number of U.S. small entities, based on the estimated costs of 
modifying the product to achieve compliance, and the ongoing cost of 
testing to demonstrate compliance. Staff considers one percent of 
annual revenue to be a ``significant''

[[Page 87486]]

economic impact on a company, consistent with economic analysis from 
other Federal Government agencies. Nearly all of the more than 2,000 
suppliers of infant support cushions to the U.S. are small entities, 
although their products often are not manufactured in United States.
    Most products on the market will require redesign to meet the 
requirements in the rule and no products on the market currently have 
the specific labels, customer registration forms, warnings, and third-
party testing required by the rule. The effort required for a one-time 
redesign of a product is estimated to be 200 hours of professional 
staff time per model, including in-house testing of the prototypes and 
development of labels, customer registration forms, and instruction 
materials. Using the Bureau of Labor Statistics Employer Costs of 
Employee Compensation as of March 2024 \37\ the estimated cost per 
model is $13,648, at a current cost for professional labor of $68.24 
per hour, rounded for the purpose of analysis to $14,000 per model. 
Materials costs for prototyping are estimated to be minimal, likely 
under $1,000, given that pillows are typically made of fabric and 
stuffing materials. Third-party testing for infant support cushions 
will be an additional cost for all suppliers and is estimated to be 
between $600 and $1,100 per model, per year, depending on where the 
testing takes place and whether manufacturers' associations or groups 
add infant support cushions to their certification programs to receive 
volume discounts for third-party testing. The total first year costs of 
redesign are estimated to be approximately $16,000 per model ($14,000 
for labor, $1,000 for materials, and $1,000 for third-party testing).
---------------------------------------------------------------------------

    \37\ www.bls.gov/news.release/ecec.t02.htm. The estimated costs 
in the link reflect the employers' cost for salaries, wages, and 
benefits for civilian workers.
---------------------------------------------------------------------------

    Staff considers one percent of annual revenue to be a 
``significant'' economic impact on a small business. Applying the one 
percent threshold to the estimated redesign and testing costs from this 
rule, the threshold for a small business that would incur a significant 
impact are those small firms with less than $1.6 million in revenue 
($16,000 costs / 1 percent of revenue), assuming they only sell one 
product model. This cost estimate will scale with the number of 
different models each firm manufactures. With an estimated 2,000 models 
from firms that sell to the U.S. needing to be redesigned, the total 
cost for the entire industry could be as high as $32 million for 
redesign in the first year after the rule is published.\38\
---------------------------------------------------------------------------

    \38\ As noted earlier, this estimate is slightly higher than the 
estimate in the IRFA, because the relevant labor rate as reported by 
the Bureau of Labor Statistics has risen since the NPR was 
published.
---------------------------------------------------------------------------

    As suppliers will need to redesign their products to comply with 
this rule, both small and large companies may raise prices to cover 
costs. Given this uniformity, these costs would not necessarily place 
small businesses at a competitive disadvantage. JPMA, Boppy, and Heroes 
Technology questioned whether a small retail price increase would be 
acceptable to consumers, or could cover compliance costs, but these 
commenters did not provide an alternative quantitative estimate of 
compliance costs or probable retail price increases.
    In summary, given that all U.S. suppliers will have to redesign 
products to comply with this rule, and that these costs will likely be 
significant to many small businesses, this FRFA finds that this final 
rule will have a significant impact on a substantial number of U.S. 
small businesses.

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

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

H. Alternatives Considered To Reduce the Impact on Small Entities

    The Commission considered alternatives to the final rule to reduce 
the impact on small businesses. The Commission considered using a 
public education campaign that would result in no regulatory impact on 
small businesses. However, given the education campaigns on safe sleep 
practices that CPSC and others have been undertaking for years, this 
approach would likely result in little to no mitigation of the current 
rates of deaths and injuries from infant support cushions. The 
Commission also considered allowing the voluntary standards process 
additional time to develop a voluntary standard to address the hazards 
posed by infant support cushions. However, there is no certainty that 
such a voluntary standard would be adopted, and a potential voluntary 
standard, if published, may not adequately address the identified 
hazards to infants. For example, the current ASTM draft voluntary 
standard for infant loungers would only cover infant loungers whereas 
the Commission's rule covers all infant support cushions and has more 
stringent performance requirements and warnings.

XIII. Paperwork Reduction Act

    This rule contains information collection requirements that are 
subject to public comment and review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 
3501-3521). The preamble to the NPR discussed the information 
collection burden of the proposed rule and specifically requested 
comments on the accuracy of CPSC's estimates. 89 FR 2530 (January 16, 
2024). The NPR described the provisions of the proposed rule and 
provided an estimate of the annual reporting burden for the rule under 
the PRA. See 89 FR 2542. The estimated burden of this collection of 
information is unchanged from the NPR. CPSC did not receive any 
comments regarding the information collection burden in the NPR through 
OMB. OMB has assigned control number 3041-0202 to this information 
collection.

XIV. Preemption

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

XV. Environmental Considerations

    Certain categories of CPSC actions normally have ``little or no 
potential for affecting the human environment'' and therefore do not 
require an environmental assessment or an environmental impact 
statement. Safety standards providing requirements for consumer 
products come under this categorical exclusion. 16 CFR 1021.5(c)(1). 
The final rule for infant support cushions falls within the categorical 
exclusion.

[[Page 87487]]

XVI. Congressional Review Act

    The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that 
before a rule may take effect, the agency issuing the rule must submit 
the rule, and certain related information, to each House of Congress 
and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission 
must indicate whether the rule is a major rule. The CRA states that the 
Office of Information and Regulatory Affairs determines whether a rule 
qualifies as a major rule.
    Pursuant to the CRA, OMB's Office of Information and Regulatory 
Affairs has determined that this rule does not qualify as a major rule, 
as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit 
the required information to each House of Congress and the Comptroller 
General.

List of Subjects

16 CFR Part 1112

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

16 CFR Part 1130

    Administrative practice and procedure, Business and industry, 
Consumer protection, Reporting and recordkeeping requirements.

16 CFR Part 1243

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, Law enforcement, Pillows, Toys.

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

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
1. The authority citation for 16 CFR part 1112 continues to read as 
follows:

    Authority: 15 U.S.C. 2063.


0
2. Amend Sec.  1112.15 by adding paragraph (b)(57) to read as follows:


Sec.  1112.15  When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (57) 16 CFR part 1243, Safety Standard for Infant Support Cushions.
* * * * *

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

0
3. The authority citation for 16 CFR part 1130 continues to read as 
follows:

    Authority: 15 U.S.C. 2056a, 2065(b).


0
4. Amend Sec.  1130.2 by adding paragraph (a)(20) to read as follows:


Sec.  1130.2  Definitions.

* * * * *
    (a) * * *
    (20) Infant support cushions.
* * * * *


0
5. Add part 1243 to read as follows:

PART 1243--SAFETY STANDARD FOR INFANT SUPPORT CUSHIONS

Sec.
1243.1 Scope, purpose, application, and exemptions.
1243.2 Definitions.
1243.3 General requirements.
1243.4 Performance requirements.
1243.5 Test methods.
1243.6 Marking and labeling.
1243.7 Instructional literature.
1243.8 Incorporation by reference.

    Authority:  15 U.S.C. 2056a.


Sec.  1243.1  Scope, purpose, application, and exemptions.

    (a) Scope and purpose. The consumer product safety standard in this 
part prescribes requirements to reduce the risk of death and injury 
from hazards associated with infant support cushions, as defined in 
Sec.  1243.2. This includes but is not limited to infant positioners, 
nursing pillows with a dual use for lounging, infant loungers, and 
infant props or cushions used to support an infant. All infant support 
cushions must be tested according to the requirements of Sec.  1243.5 
and comply with all requirements of this part.
    (b) Application. All infant support cushions manufactured after May 
5, 2025, are subject to the requirements of this part.
    (c) Exemptions. Products subject to another standard listed in 16 
CFR 1130.2(a) are exempt from this part. Nursing pillows that also meet 
the definition of infant lounger in Sec.  1243.2, however, are not 
exempt from this part.


Sec.  1243.2  Definitions.

    Conspicuous means visible, when the product is in each 
manufacturer's recommended use position, to a person while placing an 
infant into or onto the product.
    Infant lounger means an infant support cushion with a raised 
perimeter, a recess, or other area that provides a place for an infant 
to recline or to be in a supine, prone, or recumbent position.
    Infant positioner means a product intended to help keep an infant 
in a particular position while supine or prone.
    Infant support cushion means an infant product that is filled with 
or comprised of resilient material such as foam, fibrous batting, or 
granular material or with a gel, liquid, or gas, and which is marketed, 
designed, or intended to support an infant's weight or any portion of 
an infant while reclining or in a supine, prone, or recumbent position. 
This definition includes any removable covers, or slipcovers, sold on 
or together with an infant support cushion.
    Occupant support surface (OSS) means the area that holds up and 
bears the infant or any portion of the infant.
    Seat bight line means the intersection of the seat back surface 
with the seat bottom surface.
    Sidewall means any wall at the edge of the occupant support 
surface.


Sec.  1243.3  General requirements.

    (a) Hazardous sharp edges or points. There shall be no hazardous 
sharp points or edges as determined by 16 CFR 1500.48 and 1500.49 
before or after the product has been tested.
    (b) Small parts. There shall be no small parts as determined by 16 
CFR part 1501 before testing or presented as a result of testing.
    (c) Lead in paints. All paint and surface coatings on the product 
shall comply with the requirements of 16 CFR part 1303.
    (d) Toys. Toy accessories attached to, removable from, or sold with 
an infant support cushion, as well as their means of attachment, shall 
comply with the applicable requirements of 16 CFR part 1250.
    (e) Removal of components. When tested in accordance with Sec.  
1243.5(k), any removal of components that are accessible to an infant 
while in the product or from any position around the product shall not 
present a small part, sharp point, or sharp edge as required in 
paragraphs (a) and (b) of this section.
    (f) Permanency of labeling and warnings. (1) Warning labels, 
whether paper or non-paper, shall be permanent when tested in 
accordance with Sec.  1243.5(b)(1) through (3).
    (2) Warning statements applied directly onto the surface of the 
product by hot stamping, heat transfer, printing, wood burning, or any 
other method shall be permanent when tested in accordance with Sec.  
1243.5(b)(4).

[[Page 87488]]

    (3) Non-paper labels shall not liberate small parts when tested in 
accordance with Sec.  1243.5(b)(5).
    (4) Warning labels that are attached to the fabric of the product 
with seams shall remain in contact with the fabric around the entire 
perimeter of the label when the product is in all manufacturer-
recommended use positions and when tested in accordance with Sec.  
1243.5(b)(3).
    (g) Convertible products. If the infant support cushion can be 
converted into another product for which a consumer product safety 
standard exists, the product also shall comply with the applicable 
requirements of that standard.


Sec.  1243.4  Performance requirements.

    (a) Restraint. The product shall not include a restraint system.
    (b) Seam strength. When tested in accordance with Sec.  1243.5(j), 
fabric/mesh seams and points of attachment shall not fail such that a 
small part, sharp point, or sharp edge is presented, as required in 
Sec.  1243.3(a) and (b).
    (c) Bounded openings. When tested to Sec.  1243.5(c), all 
completely bounded openings that exist in the front, sides, or back of 
the occupant lounging area, or that are created when an accessory is 
attached to the product, shall not allow complete passage of the small 
head probe unless it allows the complete passage of the large head 
probe.
    (d) Maximum incline angle. The maximum incline angle shall not 
exceed 10 degrees when tested in accordance with Sec.  1243.5(d).
    (e) Firmness--(1) Occupant support surface firmness. When the 3-
inch diameter (figure 1 to this paragraph (e)(1)) hemispherical head 
probe is applied according to the test method for occupant support 
surface firmness, Sec.  1243.5(f), the force required for a one-inch 
displacement shall be greater than 10 Newtons (N).

Figure 1 to paragraph (e)(1)--3-inch Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.003

    (2) Sidewall firmness. For products with a sidewall, when the 3-
inch diameter hemispherical head probe is applied according to the test 
method for sidewall firmness in Sec.  1243.5(g), the force required for 
a one-inch displacement shall be greater than 10 N.
    (3) Firmness at intersection of sidewall and occupant support 
surface. For products with a sidewall, when the 3-inch diameter 
hemispherical head probe is applied according to the test method for 
firmness at the intersection of sidewall and occupant support surface 
in Sec.  1243.5(h), the force required for a one-inch displacement 
shall be greater than 10 N.
    (f) Sidewall angle. For products with a sidewall, the sidewall 
angle shall be greater than 90 degrees when determined according to the 
sidewall angle determination in Sec.  1243.5(i).


Sec.  1243.5  Test methods.

    (a) Test conditions. Condition the product for 48 hours at 23 
[deg]C +/- 2 [deg]C (73.4 [deg]F +/- 3.6 [deg]F) and a relative 
humidity of 50% +/- 5%.
    (b) Permanence of labels and warnings. (1) A paper label (excluding 
labels attached by a seam) shall be considered permanent if, during an 
attempt to remove it without the aid of tools or solvents, it cannot be 
removed, it tears into pieces upon removal, or such action damages the 
surface to which it is attached.
    (2) A non-paper label (excluding labels attached by a seam) shall 
be considered permanent if, during an attempt to remove it without the 
aid of tools or solvents, it cannot be removed or such action damages 
the surface to which it is attached.
    (3) A warning label attached by a seam shall be considered 
permanent if it does not detach when subjected to a 15-lbs (67-N) pull 
force applied in any direction using a \3/4\-inch diameter clamp 
surface.
    (4) Adhesion test for warnings applied directly onto the surface of 
the product.
    (i) Apply the tape test defined in Test Method B, Cross-Cut Tape 
Test of ASTM D3359 (incorporated by reference, see Sec.  1243.8), 
eliminating parallel cuts.
    (ii) Perform this test once in each different location where 
warnings are applied.
    (iii) The warning statements will be considered permanent if the 
printing in the area tested is still legible and attached after being 
subjected to this test.
    (5) A non-paper label, during an attempt to remove it without the 
aid of tools or solvents, shall not be removed or shall not fit 
entirely within the small parts cylinder defined in 16 CFR part 1501 if 
it can be removed.
    (c) Head entrapment test. For all applicable openings, rotate the 
small head probe (figure 1 to this paragraph (c)) to the orientation 
most likely to fail and gradually apply an outward force from the 
occupant lounging area of 25 lbs (111 N). Apply the force to the probe 
in the direction most likely to fail within a period of 5 seconds and 
maintain it for an additional 10 seconds. If the small head probe can 
pass entirely through the opening in any orientation, determine if the 
large head probe (figure 2 to this paragraph (c)) can be freely 
inserted through the opening.


[[Page 87489]]


Figure 1 to paragraph (c)--Small Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.004

Figure 2 to paragraph (c)--Large Head Probe
[GRAPHIC] [TIFF OMITTED] TR04NO24.005

    (d) Maximum incline test. (1) Equipment shall include:
    (i) Digital protractor with accuracy +/-1 degree;
    (ii) Hinged weight gauge--newborn, requirements for part masses and 
assembly (figure 3 to this paragraph (d)(1)(ii));

BILLING CODE 6355-01-P

[[Page 87490]]

Figure 3 to paragraph (d)(1)(ii)--Hinged Weight Gauge--Newborn, 
Requirements for Part Masses and Assembly
[GRAPHIC] [TIFF OMITTED] TR04NO24.006

    (iii) Hinged weight gauge-newborn, requirements for part dimensions 
(figure 4 to this paragraph (d)(1)(iii)); and


[[Page 87491]]


Figure 4 to paragraph (d)(1)(iii)--Hinged Weight Gauge--Newborn, 
Requirements for Part Dimensions
[GRAPHIC] [TIFF OMITTED] TR04NO24.007

BILLING CODE 6355-01-C
    (iv) A test base that is horizontal, flat, firm, and smooth.
    (2) If applicable, place the product in the manufacturer's 
recommended highest seat back angle position intended for lounging.
    (3) If applicable, place the hinged weight gauge--newborn in the 
product and position the gauge with the hinge centered over the seat 
bight line and the upper plate of the gauge back. Place a digital 
protractor on the upper torso/head area lengthwise and measure the 
incline angle.
    (4) Place the head/torso portion of the newborn hinged weight gauge 
on the product according to the manufacturer's recommended use position 
with the seat portion of the gauge, depending on the product design, 
allowed to lay freely on the product or on the test base (figure 5 to 
this paragraph (d)(4)).


[[Page 87492]]


Figure 5 to paragraph (d)(4)--Test Fixture Configuration to Measure 
Incline Angle on an Infant Support Cushion Product
[GRAPHIC] [TIFF OMITTED] TR04NO24.008

    (5) Move and rotate the newborn hinged weight gauge the minimum 
amount necessary such that the head/torso portion rests on an OSS that 
could foreseeably support an infant's head, and place the head/torso 
portion of the gauge according to all situations that apply:
    (i) In tests on products with an OSS for the infant's body, align 
the top edge of the head/torso portion of the gauge to coincide with a 
plumb line to the outermost edge of the OSS-head.
    (ii) In all tests, place the seat portion of the gauge on the test 
base, adjust the newborn gauge to the greatest incline angle in which 
the top edge of the gauge maintains contact with the top surface of the 
product.
    (6) If a product's seating bight area prevents reasonable 
positioning of the head/torso portion to the outermost edge, then 
position the seat portion of the newborn hinged weight gauge as far 
forward as possible towards the outermost edge and allow the head/torso 
portion of the gauge to rest on the product.
    (7) Place a digital protractor lengthwise on the head/torso portion 
of the gauge and measure the incline angle.
    (8) Measure the incline angle at the manufacturer's recommended use 
location(s), at feasible locations such as perpendicular to the 
recommended use location(s), and at least one location likely to fail 
in which the newborn gauge seat is supported on the test surface.
    (9) Determine the maximum incline angle from the incline angle 
measurements.
    (e) Firmness test setup. (1) Equipment shall include:
    (i) Force gauge with accuracy +/- 0.05 N (0.01 lbs).
    (ii) Distance gauge with accuracy +/- 0.01 inches (0.03 cm).
    (2) Align the axis of the 3-inch head probe (figure 1 to paragraph 
(e)(1) of Sec.  1243.4) with a force gauge and parallel to a distance 
measurement device or gauge.
    (3) Use a lead screw or similar device to control movement along a 
single direction.
    (4) Support the firmness fixture to a test base such that the head 
probe does not deflect more than 0.01 inches (0.025 cm) under a 10.0 N 
(2.24 lbs) load applied in each orientation required in the test 
methods.
    (f) Occupant support surface firmness test method. Perform the 
following steps to determine the occupant support surface firmness of 
the product as received from the manufacturer. For products sold with a 
slipcover on or together with the product, products shall be tested as 
assembled with the slipcover on the product. All products, including 
products one inch or less in thickness, are required to be tested. See 
figure 6 to this paragraph (f).
    (1) Orient the axis of the 3-inch head probe perpendicular to the 
surface of the product at each test location that is oriented greater 
than five degrees relative to the test base or align the axis of the 
probe perpendicular to the test base (vertically) at each test location 
that is oriented equal to or less than five degrees to the test base.
    (2) The first test location shall be at the location of maximum 
thickness of the surface being tested, perpendicular to the test base.
    (3) Lay the product, with the occupant support surface facing up, 
on a test base that is horizontal, flat, firm, and smooth.
    (4) Prevent movement of the product in a manner that does not 
affect the force or deflection measurement of the product surface under 
test. Provide no additional support beneath the product.
    (5) Advance the probe into the product and set the deflection to 
0.0 inches when a force of 0.1 N (0.02 lbs) force is reached.
    (6) Continue to advance the head probe into the product at a rate 
not to exceed 0.1 inch per second and pause when the force exceeds 10.0 
N (2.24 lbs), or the deflection is equal to 1.00 inches (2.54 cm).
    (7) Wait 30 seconds. If the deflection is less than 1.00 inches and 
the force is 10.0 N or less, repeat the steps in paragraphs (f)(6) and 
(7) of this section.
    (8) Record the final force and deflection when the deflection has 
reached 1.00 inches or when the force has exceeded 10.0 N.
    (9) If the maximum thickness of the OSS is greater than 1.0 inches 
(2.54 cm), perform additional tests, space permitting, at the geometric 
center of the OSS, at four locations along the product's longitudinal 
and lateral axes

[[Page 87493]]

therefrom, 1.5 inches (3.8 cm) towards center from the intersection of 
the sidewall and OSS, and at one location most likely to fail.
    (10) Repeat the occupant support surface firmness tests on any 
other occupant support surface and in all intended and feasible 
configurations that could affect an occupant support surface, such as 
the folding or layering of parts of the product.

Figure 6 to paragraph (f)--Test Configuration for Occupant Support 
Surface Firmness Test
[GRAPHIC] [TIFF OMITTED] TR04NO24.009

    (g) Sidewall firmness test method. For products with a sidewall, 
perform the steps in paragraphs (f)(1) through (8) of this section to 
determine the sidewall firmness of the product as received from the 
manufacturer and then perform the following:
    (1) Perform a minimum of four additional tests, located at 
intervals not to exceed 6 inches along the entire top perimeter of the 
sidewall, starting from the maximum side height location, and at one 
additional location most likely to fail.
    (2) Repeat the sidewall firmness test in all the intended or 
feasible configurations that could affect the sidewall firmness, such 
as the folding or layering of parts of the product.
    (h) Intersection of sidewall and occupant support surface firmness. 
For products with a sidewall, perform the following steps to determine 
the intersection firmness of the product as received from the 
manufacturer (figure 7 to this paragraph (h)).
    (1) Orient the axis of the 3-inch head probe perpendicular to the 
sidewall perimeter at an angle from horizontal that bisects the angle 
determined in sidewall angle determination with the axis directed at 
the intersection of the occupant support surface and the sidewall.
    (2) The first test location shall be at the location of maximum 
product thickness parallel to the test base.
    (3) Perform the steps in paragraphs (f)(3) through (8) of this 
section.
    (4) Perform a minimum of four additional tests, located at 
intervals not to exceed six inches along the entire inside perimeter of 
the intersection of the sidewall and OSS, and at one additional 
location most likely to fail.
    (5) Repeat the intersection of sidewall and occupant support 
surface firmness test in all the intended or feasible configurations 
that could affect the intersection firmness, such as the folding or 
layering of parts of the product.


[[Page 87494]]


Figure 7 to paragraph (h)--Test Configuration for Intersection of 
Sidewall and Occupant Support Surface Firmness
[GRAPHIC] [TIFF OMITTED] TR04NO24.010

    (i) Sidewall angle determination. For products with a sidewall, 
perform the following steps to determine if the angle between the 
sidewall and OSS is 90 degrees or less, or to measure the angle above 
90 degrees. See figure 8 to this paragraph (i).
    (1) Orient the 3-inch (7.62 cm) diameter hemispherical head probe 
vertically and place it over the OSS with the cylindrical surface of 
the probe tangent to the intersection of the sidewall and the OSS. 
Advance the probe into the product until a downward force of 10 N (2.2 
lbs) force is reached.
    (2) After 30 seconds, determine whether the sidewall is in contact 
with the cylindrical side of the 3-inch head probe. If the sidewall 
contacts the cylindrical part of the probe, the sidewall angle is equal 
to or less than 90 degrees.
    (3) For sidewall angles greater than 90 degrees, calculate the 
sidewall angle as 90 degrees plus the measured angle between the 
cylindrical side of the 3-inch head probe and the sidewall.
    (4) Determine a minimum of four sidewall angles at locations not to 
exceed 6-inch (15.2 cm) intervals along the intersection of the 
sidewall and OSS.
    (5) Measure the angle with a protractor or gauge placed to the 
depth of and in contact with the cylindrical side of the 3-inch probe 
side and the sidewall.

Figure 8 to paragraph (i)--Test Fixture Configuration for Sidewall 
Angle Measurement
[GRAPHIC] [TIFF OMITTED] TR04NO24.011


[[Page 87495]]


    (j) Seam strength test method. (1) Equipment shall include:
    (i) Clamps with 0.75 inches (1.9 cm) diameter clamping surfaces 
capable of holding fabric and with a means to attach a force gauge. See 
figure 9 to this paragraph (j)(1), or equivalent.
    (ii) A force gauge, accuracy +/- 0.5 lbs (1.1 N).

Figure 9 to paragraph (j)(1)--Seam Clamp
[GRAPHIC] [TIFF OMITTED] TR04NO24.012

    (2) Clamp the fabric of the infant support cushion on each side of 
the seam under test with the 0.75 inches clamping surfaces placed not 
less than 0.5 inches (1.2 cm) from the seam.
    (3) Apply a tension of 15 lbs (67 N) evenly over 5 seconds and 
maintain for an additional 10 seconds.
    (4) Repeat the test on every distinct seam and every 12 inches (15 
cm) along each seam.
    (k) Removal of components test method--(1) Suitable devices. For 
torque and tension tests, any suitable device may be used to grasp the 
component that does not interfere with the attachment elements that are 
stressed during the tests.
    (2) Torque test. Gradually apply a 4 lbs-in (0.4 N-m) torque over 5 
seconds in a clockwise rotation to 180 degrees or until 4 lbs-in has 
been reached. Maintain for 10 seconds. Release and allow component to 
return to relaxed state. Repeat the torque test in a counterclockwise 
rotation.
    (3) Tension test. For components that can reasonably be grasped 
between thumb and forefinger, or teeth, apply a 15 lbs (67 N) force 
over 5 seconds, in a direction to remove the component. Maintain for 10 
seconds. A clamp such as shown in figure 10 to this paragraph (k)(3) 
may be used if the gap between the back of the component and the base 
material is 0.04 inches (0.1 cm) or more.

Figure 10 to paragraph (k)(3)--Tension Test Adapter Clamp
[GRAPHIC] [TIFF OMITTED] TR04NO24.013

Sec.  1243.6  Marking and labeling.

    (a) General markings. Each product and its retail package shall be 
marked or labeled clearly and legibly to indicate the following:
    (1) The name, place of business (city, state, and mailing address, 
including zip code), and telephone number of the manufacturer, 
distributor, or seller.
    (2) A code mark or other means that identifies the date (month and 
year as a minimum) of manufacture.
    (3) The marking or labeling in paragraphs (a)(1) and (2) of this 
section

[[Page 87496]]

are not required on the retail package if they are on the product and 
are visible in their entirety through the retail package. When no 
retail packaging is used to enclose the product, the information 
provided on the product shall be used for determining compliance with 
paragraphs (a)(1) and (2) of this section. Cartons and other materials 
used exclusively for shipping the product are not considered retail 
packaging.
    (b) Permanency. The marking and labeling on the product shall be 
permanent.
    (c) Upholstery labeling. Any upholstery labeling required by law 
shall not be used to meet the requirements of this section.
    (d) Warning design for product. (1) The warnings shall be easy to 
read and understand and be in the English language at a minimum.
    (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.
    (3) The warnings shall be conspicuous and permanent.
    (4) The warnings shall conform to ANSI Z535.4-2011(R2017) 
(incorporated by reference, see Sec.  1243.8) sections 6.1-6.4, 7.2-
7.6.3, and 8.1, with the following changes.
    (i) In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace ``should'' with 
``shall.''
    (ii) In section 7.6.3, replace ``should (when feasible)'' with 
``shall.''
    (iii) Strike the word ``safety'' when used immediately before a 
color (for example, replace ``safety white'' with ``white'').

    Note 1 to paragraph (d)(4)(iii): For reference, ANSI Z535.1, 
American National Standard for Safety Colors, provides a system for 
specifying safety colors. See note 1 to Sec.  1243.8(a) for ANSI 
contact information.

    (5) The safety alert symbol and the signal word ``WARNING'' shall 
be at least 0.2 inches (5 mm) high. The remainder of the text shall be 
in characters whose upper case shall be at least 0.1 inches (2.5 mm), 
except where otherwise specified.

    Note 2 to paragraph (d)(5): For improved warning readability, 
typefaces with large height-to- width ratios, which are commonly 
identified as ``condensed,'' ``compressed,'' ``narrow,'' or similar, 
should be avoided.

    (6) The message panel shall have the following text layout 
requirements:
    (i) The text shall be left-aligned, ragged-right for all but one-
line text messages, which can be left-aligned or centered. See figure 1 
to this paragraph (d)(6) for examples of left-aligned text.

    Note 3 to paragraph (d)(6)(i):  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.

    (ii) 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.

Figure 1 to paragraph (d)(6)--Examples of Left-Aligned Text
[GRAPHIC] [TIFF OMITTED] TR04NO24.014


    Note 4 to figure 1 to paragraph (d)(6):  The text shown for the 
warnings in figure 1 to this paragraph (d)(6) is filler text, known 
as lorem ipsum, commonly used to demonstrate graphic elements.

    (7) All infant support cushions are required to contain a warning 
with the content and format depicted in this section as figure 2 (for 
products without tummy time) or figure 3 (if the product has a tummy 
time feature) to this paragraph (d)(7).


[[Page 87497]]


Figure 2 to paragraph (d)(7)--Warning for Product Without Tummy Time
[GRAPHIC] [TIFF OMITTED] TR04NO24.015

Figure 3 to paragraph (d)(7)--Warning for Tummy Time Product
[GRAPHIC] [TIFF OMITTED] TR04NO24.016

    (e) Warning statements. Each product shall contain the warning 
statements shown on figure 2 (for products without tummy time) or 
figure 3 (if the product has a tummy time feature) to paragraph (d)(7) 
of this section, at a minimum. Slipcovers sold on, or together with the 
product, shall contain the warning statement shown on figure 2 or 3 to 
paragraph (d)(7) of this section, as applicable.


Sec.  1243.7  Instructional literature.

    (a) Instructions shall be provided with the product and shall be 
easy to read and understand and shall be in the English language at a 
minimum. These instructions shall include information

[[Page 87498]]

on assembly, maintenance, cleaning, and use, where applicable.
    (b) The instructions shall address the following additional 
warnings:
    (1) Read all instructions before using this product.
    (2) Keep instructions for future use.
    (3) Do not use this product if it is damaged or broken.
    (4) Instructions shall indicate the manufacturer's recommended 
maximum weight, height, age, developmental level, or combination 
thereof, of the occupant for which the infant support cushion is 
intended. If this product is not intended for use by a child for a 
specific reason, the instructions shall state this limitation.
    (c) The cautions and warnings in the instructions shall meet the 
requirements specified in Sec.  1243.6(d)(4) though (6), except that 
section 6.4 and sections 7.2-7.6.3 of ANSI Z535.4-2011(R2017) 
(incorporated by reference, see Sec.  1243.8) 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.

    Note 1 to paragraph (c): 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.

    (d) 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.


Sec.  1243.8  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) 
material is available for inspection at the U.S. Consumer Product 
Safety Commission and at the National Archives and Records 
Administration (NARA). Contact the U.S. Consumer Product Safety 
Commission at: the Office of the Secretary, U.S. Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, MD 20814; phone 
(301) 504-7479; email: [email protected]. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from the following sources:
    (a) National Electrical Manufacturers Association (NEMA), 1300 17th 
St. N, Arlington, VA 22209; phone: (703) 841-3200; website: 
www.nema.org.
    (1) ANSI Z535.4-2011(R2017), American National Standard for Product 
Safety Signs and Labels, approved October 20, 2017; approved for 
Sec. Sec.  1243.6 and 1243.7.
    (2) [Reserved]

    Note 1 to paragraph (a): NEMA standards are also available from 
the American National Standards Institute (ANSI), which provides a 
free, read-only copy of the standard at https://ibr.ansi.org/Standards/nema.aspx. Contact ANSI by mail at American National 
Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 
10036, USA; phone: (212) 642-4900; website: www.ansi.org.

    (b) ASTM International (ASTM), 100 Barr Harbor Drive, P.O. Box 
CB700, West Conshohocken, Pennsylvania 19428-2959; phone: (800) 262-
1373; website: www.astm.org.
    (1) ASTM D3359-23, Standard Test Methods for Rating Adhesion by 
Tape Test, approved February 1, 2023; approved for Sec.  1243.5.
    (2) [Reserved]

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-25181 Filed 11-1-24; 8:45 am]
BILLING CODE 6355-01-P


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.