# Safety Standard for Infant Sleep Products > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2021-12723 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** June 23, 2021 - **Citation:** 86 FR 33022 ## Text CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112, 1130, and 1236 [CPSC Docket No. 2017-0020] Safety Standard for Infant Sleep Products AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: Pursuant to the Consumer Product Safety Improvement Act of 2008 (CPSIA), the U.S. Consumer Product Safety Commission (CPSC) is issuing this final rule establishing a safety standard for infant sleep products, which are products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not subject to any of CPSC's mandatory standards for infant sleep. CPSC is also finalizing an amendment to its regulations regarding third party conformity assessment bodies, to include the safety standard for infant sleep products in the list of notices of requirements (NORs) and an amendment to the consumer registration rule, to identify infant sleep products as a durable infant or toddler product subject to consumer registration requirements, as a subcategory of bassinets and cradles. DATES: This rule is effective June 23, 2022. The incorporation by reference of the publication listed in this rule is approved by the Director of the Federal Register as of June 23, 2022. FOR FURTHER INFORMATION CONTACT: Keysha Walker, Compliance Officer, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone: 301-504-6820; email: kwalker@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Statutory Authority and Background A. Statutory Authority Section 104(b) of the CPSIA, 15 U.S.C. 2056a(b), requires the Commission to: (1) Consult with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts, to examine and assess the effectiveness of any voluntary consumer product safety standards for durable infant or toddler products (15 U.S.C. 2056a(b)(1)(A)); and (2) promulgate, in accordance with 5 U.S.C. 553, consumer product safety standards that are substantially the same as such voluntary standards, or are more stringent than such voluntary standards if the Commission determines that more stringent standards would further reduce the risk of injury associated with such products. 15 U.S.C. 2056a(b)(1)(B). Additionally, section 104(b)(2) of the CPSIA directs the Commission to periodically review and revise the standards set forth under this subsection, to ensure that such standards provide the highest level of safety for such products that is feasible. Section 104(d) of the CPSIA requires manufacturers of durable infant or toddler products to establish consumer registration card programs that comply with CPSC's implementing rule, 16 CFR part 1130. Additionally, under section 14 of the CPSA, children's products (such as durable infant or toddler products) must comply with testing and certification requirements that CPSC implemented through 16 CFR parts 1107, 1109, and 1110. Section 104(f)(1) of the CPSIA states that a “durable infant or toddler product” is a “durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years.” Id. 2056a(f)(1). Section 104(f)(2) of the CPSIA provides a non-exhaustive list of categories of products that are durable infant or toddler products, such as cribs, toddler beds, and bassinets and cradles. Id. 2056a(f)(2). The Commission's consumer registration rule at 16 CFR 1130.2(a) defines a “durable infant or toddler product” as: DEFINITION OF DURABLE INFANT OR TODDLER PRODUCT means the following products intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. The listed product categories are further defined in the applicable standards that the Commission issues under section 104(b) of the Consumer Product Safety Improvement Act of 2008, and include products that are combinations of [17 listed] product categories. . . . B. Infant Sleep Products Are Durable Infant or Toddler Products This rule establishes a category of products called “infant sleep products,” which are all products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not already subject to a mandatory CPSC sleep standard. The product category “infant sleep products” is not included in the statutory list of products in section 104(f)(2) of the CPSIA. However, similar sleep products, such as bassinets and cradles, and cribs, are listed in the statute; and the Commission has the authority to add product categories to the statutory list. The Commission adds product categories to the list of “durable infant or toddler products” through a rulemaking to amend 16 CFR 1130.2, the Commission's rule requiring durable infant or toddler products to meet consumer registration rule requirements. All durable infant or toddler products identified in § 1130.2 must meet the product registration card requirement; and because rules issued under section 104 of the CPSIA are children's product safety rules, these products must also meet the third-party testing and certification requirements in section 14 of the CPSA, and implemented by the Commission in 16 CFR parts 1107, 1109, and 1110. CPSC issued a notice of proposed rulemaking in 2017 (the 2017 NPR), proposing to categorize infant inclined sleep products as a “durable infant or toddler product” under section 104 of the CPSIA, as a subset of the bassinet and cradle category. 82 FR 16963, 16969-70 (Apr. 7, 2017). In 2019, CPSC issued a supplemental notice of proposed rulemaking (the 2019 SNPR), proposing to identify an “infant sleep product,” a broader category of infant sleep, as a durable infant or toddler product under section 104(f) of the CPSIA, also as a subcategory of bassinets and cradles. 84 FR 60949, 60957 (Nov. 12, 2019). The 2019 SNPR proposed to remove the term “inclined” from the proposed mandatory standard, which included removing the term “inclined” from the title, scope, introduction, and definitions of ASTM F3118-17a, and to include within the rule, instead: “any infant sleep product not currently covered by another mandatory rule for infant sleep products: Bassinets/cradles, cribs (full-size and non-full-size), play yards, and bedside sleepers.” 84 FR at 60951. Accordingly, the 2019 SNPR proposed that the scope of the rule include two types of sleep products that are currently unregulated by CPSC under any mandatory standard, including inclined sleep products, meaning infant sleep products with a sleep surface angle greater than 10 degrees from horizontal, and flat (non-inclined) sleep products, meaning infant sleep products with a sleep surface angle equal to or less than 10 degrees. For this final rule, CPSC will finalize the definition of an “infant sleep product” as a durable infant or toddler product, a category of products that is a subset of the bassinet and cradle standard, consistent with the 2019 SNPR. The final rule defines an “infant sleep product” as “a product marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age,” and that is not already subject to one of CPSC's mandatory standards for infant sleep: • 16 CFR part 1218—Safety Standard for Bassinets and Cradles • 16 CFR part 1219—Safety Standard for Full-Size Baby Cribs • 16 CFR part 1220—Safety Standard for Non-Full-Size Baby Cribs • 16 CFR part 1221—Safety Standard for Play Yards, or • 16 CFR part 1222—Safety Standard for Bedside Sleepers. As defined in the final rule, an “infant sleep product” meets the definition of a “durable infant or toddler product” because the products are intended for infants up to 5 months old, and the products are “intended for use,” and “reasonably expected to be used,” by children under 5 years old. Moreover, products marketed or intended as a sleeping accommodation for an infant are similar to the products for infant sleep that are already included in the statutory list of durable infant or toddler products, such as cribs and bassinets and cradles. We also note that “infant sleep products” are further defined in the final rule, as provided in part 1130. Accordingly, adding “infant sleep products” as a durable infant or toddler product is consistent with the Commission's approach of adding a durable infant or toddler product category that has a mandatory standard to the list of products in part 1130, to clarify that these products must meet the consumer registration rule, and the third-party testing and certification requirements for children's product safety rules. C. Consultation Regarding the Effectiveness of the Voluntary Standard To meet the first requirement in section 104(b) of the CPSIA that the Commission consult with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts to examine and assess the effectiveness of the relevant voluntary standards, CPSC staff regularly participates in the juvenile products subcommittee meetings of ASTM International (ASTM). Staff's participation in ASTM's voluntary standards process includes providing anonymized incident data, participating in meetings to assess the ability of a voluntary standard to address the incident data, and working through the ASTM process to develop performance and labeling requirements to address identified hazards. Staff also comments or votes on certain ASTM ballots to revise voluntary standards. ASTM subcommittees consist of members who represent producers, users, consumers, government, and academia. 1 1 ASTM International website: www.astm.org, “About ASTM International.” In 2011, ASTM began work on a new standard for infant inclined sleep products. Development of this new ASTM standard for infant inclined sleep products, F3118, arose from efforts to update the voluntary standard for bassinets and cradles. Accordingly, staff's consultation process for the inclined sleep product rulemaking commenced in approximately 2011, when ASTM, with CPSC's concurrence, decided to separate hammocks and other inclined sleep products from the development of the bassinet standard, ASTM F2194, to develop a new voluntary standard that would specifically address the characteristics of inclined sleep products. For example, the bassinet standard requires a sleep surface angle of 10 degrees or less, and inclined products have a sleep angle greater than 10 degrees. Since then, staff has been actively participating in developing the voluntary standard for infant inclined sleep products. In addition to working on ASTM's inclined sleep standard, staff also has been working with the ASTM subcommittee developing the bassinet standard since before 2011, and to this day, continues to provide incident data and participate in task group and subcommittee meetings, including meetings and ASTM ballots involving the currently unregulated flat sleep products within the scope of this final rule. Sections V.A.3 and V.B.2 of this preamble contain additional information about CPSC staff's work on the products within the scope of the final rule, both inclined and flat sleep products, through the ASTM standards development process for the bassinet and cradle standard, the infant inclined sleep standard, and a new, unpublished standard for in-bed sleepers. D. 2017 NPR and 2019 Termination Notice When staff began working on the mandatory standard for bassinets and cradles, and participating with the ASTM standards development subcommittee, staff considered whether infant hammocks and other inclined sleep products should fall within the scope of the bassinet and cradle standard. Because the bassinets and cradles voluntary standard did not address products on the market that had a sleep incline greater than 10 degrees, the Commission directed staff to initiate a separate rulemaking effort for infant hammocks and other inclined sleep products, to address the characteristics of inclined products. Accordingly, the infant inclined sleep products safety standard was an outgrowth of the bassinet and cradle standard, intended to address products with an incline greater than 10 degrees from horizontal. In approximately 2011, at the time CPSC separated infant inclined sleep products from the bassinets and cradles standard, ASTM simultaneously began work on developing a voluntary standard for infant inclined sleep products. ASTM published the resulting infant inclined sleep products standard in May 2015, and updated the standard twice in 2016, and twice in 2017. ASTM's latest standard for this product category is designated, ASTM F3118-17a, Standard Consumer Safety Specification for Infant Inclined Sleep Products (ASTM F3118-17a). CPSC's 2017 NPR proposed a mandatory standard for infant inclined sleep products, incorporating by reference the then-current voluntary standard, ASTM F3118-17, with a modification to the standard's definition of “accessory.” 82 FR 16964 (April 7, 2017). The 2017 NPR for infant inclined sleep products, which included hammocks, discussed 14 fatal incidents related to infant inclined sleep products, which were reported to have occurred between January 1, 2005 and September 30, 2016. The 2017 NPR indicated that ASTM F3118-17 addressed the primary hazard patterns CPSC identified in the 657 incidents (including 14 deaths), except for the definition of “accessory,” which was defined too narrowly to address potential hazards. Specifically, the 2017 NPR proposed that CPSC's standard would not include the term “rigid frame” in the definition of “accessory inclined sleep product” in section 3.1.1 of ASTM F3118-17, broadening the definition to encompass a new product that did not have a rigid frame. Id. at 16968-69, and 16975. The Commission concluded that for the mandatory standard, more stringent requirements were necessary to further reduce the risk of injury associated with infant inclined sleep products relating to the use of an inclined sleep product accessory. Id. at 16967. As the 2017 NPR explained, durable infant or toddler products are children's products that must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a); 82 FR at 16969. Certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body (test laboratory). 15 U.S.C. 2063(a)(2). CPSC must publish an NOR for the accreditation of test laboratories to assess a product's conformity with a children's product safety rule. The 2017 NPR proposed that if issued as a final rule, the new Safety Standard for Infant Inclined Sleep Products, to be codified at 16 CFR part 1236, would be added to the list of NORs for children's product safety rules in 16 CFR part 1112, so that test laboratories applying for CPSC acceptance could seek accreditation to test inclined sleep products. 82 FR at 16969. The 2017 NPR also proposed to amend 16 CFR part 1130, the Commission's requirements for consumer registration for durable infant or toddler products, to amend the definition of “durable infant or toddler product” to clarify that infant inclined sleep products fall within the term, and are subject to the consumer registration card requirements. Id. at 16969-70. On June 12, 2019, CPSC staff submitted a briefing package and a draft Federal Register notice to the Commission, recommending that the Commission terminate the 2017 NPR. Staff recommended terminating the 2017 NPR because, since issuing the 2017 NPR, CPSC had received reports of 42 additional fatalities associated with rocker-like inclined sleep products, and because the Commission had issued additional safety alerts and recalls involving infant inclined sleep products. To date, the Commission has not voted on the notice to terminate the 2017 NPR. E. 2019 SNPR On October 16, 2019, staff provided the Commission with a briefing package recommending that instead of terminating the 2017 NPR, the Commission issue an SNPR. During the development of Staff's 2019 SNPR Briefing Package, staff received reports of 451 new incidents; 59 were deaths that occurred in infant inclined sleep products. Commission staff contracted with Dr. Erin Mannen, Ph.D., a mechanical engineer with a biomechanics specialization, to conduct infant testing to evaluate the design of inclined sleep products. Tab B of the Staff's 2019 SNPR Briefing Package contains Dr. Mannen's study, Biomechanical Analysis of Inclined Sleep (Mannen Study). 2 2 The October 16, 2019, Staff Briefing Package: Draft Supplemental Notice of Proposed Rulemaking for Infant Sleep Products under the Danny Keysar Child Product Safety Notification Act (Staff's SNPR Briefing Package) is available at: https://www.cpsc.gov/s3fs-public/SupplementalNoticeofProposedRulemakingforInfantSleepProducts_10_16_2019.pdf?TPVAJZEQcz9x9sKeEGltm4LskkonxUWv. The Commission published an SNPR on November 12, 2019. 84 FR 60949. The 2019 SNPR proposed to issue a standard for “infant sleep products,” meaning products that (1) provide sleeping accommodations for infants and (2) are not currently subject to a CPSC mandatory standard for infant sleep: Bassinets/cradles, cribs (full-size and non-full size), play yards, and bedside sleepers (collectively, CPSC sleep standards). The 2019 SNPR proposed to incorporate by reference ASTM F 3118-17a, with modifications to require that for each infant sleep product: (1) The seat back angle intended for sleep must be equal to or less than 10 degrees from horizontal, and (2) must meet the requirements for a bassinet and cradle in the standard at 16 CFR part 1218. 84 FR at 60956. The Commission also proposed to amend the consumer registration rule to identify “infant sleep products” as a category of durable infant or toddler products under section 104(f) of the CPSIA, and proposed to amend the regulation at 16 CFR part 1112, to add infant sleep products to the list of products that require third-party testing. Id. at 60957. F. Overview of the Final Rule For the final rule, the Commission is finalizing the requirements largely as proposed in the 2019 SNPR. The final rule incorporates by reference the voluntary standard, ASTM F3118-17a, Standard Consumer Safety Specification for Infant Inclined Sleep Products, with modifications to the introduction, scope, performance, and testing requirements, to further reduce the risk of injury associated with infant sleep products, both flat and inclined. The final rule requires that “infant sleep products,” defined as products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not covered by a CPSC sleep standard, be tested to confirm the seat back/sleep surface angle is 10 degrees or less from horizontal, and meet the requirements of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a “bassinet/cradle.” The scope of the final rule is also consistent with this definition of an “infant sleep product.” The final rule specifies CPSC's sleep standards as: • 16 CFR part 1218—Safety Standard for Bassinets and Cradles • 16 CFR part 1219—Safety Standard for Full-Size Baby Cribs • 16 CFR part 1220—Safety Standard for Non-Full-Size Baby Cribs • 16 CFR part 1221—Safety Standard for Play Yards, or • 16 CFR part 1222—Safety Standard for Bedside Sleepers. Products intended for sleep that already conform to a CPSC sleep standard in this list are not within the scope of the final rule. The scope of the final rule, and the definition of “infant sleep product,” are purposely broader than the scope of the bassinet and cradle standard, and the definition of a “bassinet/cradle,” to capture within the scope of the final rule all products marketed for infant sleep for infants up to 5 months old that are not covered by a CPSC sleep standard; those that are currently on the market, and any future products developed for this age group. CPSC's intent is to set a baseline of safety for infant sleep products so that all of these products must, at a minimum, meet the performance and labeling requirements in 16 CFR part 1218, including conforming to the definition of a “bassinet/cradle,” and being tested and certified as meeting these requirements. Based on the Commission's review of inclined and flat sleep product incident data, and consideration of the comments on the 2017 NPR and the 2019 SNPR, the Commission is finalizing the requirements as proposed in the 2019 SNPR, with the following clarifications in the: 1. Scope of the final rule, 16 CFR 1236.1, by removing the examples of infant inclined sleep products, and aligning the scope of the rule to be consistent with the definition of “infant sleep product,” to avoid confusion about the scope of the rule, which includes inclined and flat products; 2. Introduction of ASTM F3118-17a, by explaining more clearly that both inclined and flat sleep products fall within the definition of an “infant sleep product,” and that the purpose of the rule is to reduce deaths associated with known infant sleep hazards, including, but not limited to, seat back or sleep surface angles that are greater than 10 degrees from horizontal; 3. Scope of ASTM F3118-17a, by revising section 1.3 to explain more clearly that inclined and flat products fall within the scope of the rule, and that products subject to the rule are infant sleep products that do not already meet a mandatory standard for a product intended for infant sleep. Consistent with the 2019 SNPR, revised section 1.3 lists existing infant sleep standards, but the final rule lists the five CPSC sleep standards with a reference to the ASTM standard incorporated by reference in each mandatory standard; 4. Scope of ASTM F3118-17a, by adding a new section 1.3.2 stating that crib mattresses that meet the voluntary standard for crib mattresses, ASTM F2933, are not included within the scope of the rule. The final rule does not cover a crib mattress because a crib mattress is not used by itself, and instead, is used as the sleep surface in a crib, a product that already must conform to a CPSC sleep standard; 5. Referenced documents in ASTM F3118-17a, by revising section 2.1 to add the voluntary standard for crib mattresses, ASTM F2933; 6. Definition of “infant sleep product” in ASTM F3118-17a, by revising section 3.1.7 to remove the phrases “freestanding” and “generally supported by a stationary or rocker base” from the definition, to not inadvertently exclude certain infant sleep products from the scope of the rule, such as those that may not initially have a base, or may be sold as an attachment to another product. Additionally, we revised the age limit in this definition from “approximately 5 months of age” by removing the term “approximately.” This revision is intended to reduce confusion about which products fall within the scope of the rule, and to clarify that any infant sleep product marketed or intended for an infant up to 5 months of age, and that is not already covered by a CPSC sleep standard, falls within the scope of the final rule; 7. Definitions in ASTM F3118-17a, by revising section 3.1 to remove the definitions for “accessory inclined sleep product,” “compact inclined sleep product,” and “newborn inclined sleep product,” to simplify the regulation text, because these definitions are unnecessary based on the other modifications made to ASTM F3118-17a in the final rule, and because these products are subsumed within the definition of an “infant sleep product,” and the final rule does not contain any unique requirements for these products; 3 3 Note that in the 2019 SNPR the Commission proposed to revise these terms by removing the word “inclined.” 8. Requirements in ASTM F3118-17a, by revising section 6.9 to remove separate “Maximum Seat Back Angle” tests for three product types (accessory, compact, and newborn), and leaving only the test for “infant sleep products,” because all products fall within the definition of an “infant sleep product” in the final rule, and because this test is the same for all products; 9. Requirements in ASTM F3118-17a, by revising section 6.9 and 6.9.1 to more accurately describe the name of the test by clarifying that the seat back angle also refers to a “sleep surface angle.” This revision is intended to reduce confusion, because flat sleep surfaces do not have a seat back; and 10. Requirements in ASTM F3118-17a, by revising section 6.9.3 to remove the references to accessory, compact, and newborn sleep products, and to state that infant sleep products must meet the requirements of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a bassinet/cradle. This revision is intended to streamline the regulation text to reduce confusion, and to add a specific requirement to meet the definition of a bassinet, which clarifies that infant sleep products must have a stand to meet the performance and labeling requirements in part 1218. The Commission is also finalizing the amendment to part 1112, to include “infant sleep products” in the list of children's product safety rules for which CPSC has issued NORs, as well as the amendment to part 1130, to identify “infant sleep products” specifically as a subcategory of bassinets and cradles. This final rule is based on information and analysis provided in Staff's Final Rule Briefing Package, submitted to the Commission on May 12, 2021, which can be found on the Commission's website at: https://www.cpsc.gov/s3fs-public/FinalRuleSafetyStandardforInfantSleepProducts.pdf?7s3LjLlkZ4Vm_0GWP2.vstoEzBylG8xg. II. Product Description A. Scope of Products Within the Final Rule The scope of products covered by the 2017 NPR tracked the scope of ASTM F3118-17, covering “a free standing product with an inclined sleep surface primarily intended and marketed to provide sleeping accommodations for an infant up to 5 months old or when the infant begins to roll over or pull up on sides, whichever comes first.” The scope of products covered by the 2019 SNPR broadened from the 2017 NPR, proposing to incorporate by reference ASTM F3118-17a with substantial modifications, including revisions in the scope of the standard, section 1.3, to remove the term “inclined,” and to include any infant sleep product not currently covered by another CPSC mandatory rule for a product intended for infant sleep: Bassinets/cradles, cribs (full-size and non-full-size), play yards, and bedside sleepers. 84 FR at 60951. For the final rule, the scope of products that fall within the rule is consistent with the 2019 SNPR, and includes all of the inclined sleep products in the 2017 NPR, plus additional products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not currently covered by any of the five CPSC sleep standards. Accordingly, as proposed in the 2019 SNPR, the final rule includes the currently unregulated inclined sleep products, such as frame-type inclined sleep products, hammocks, compact inclined sleep products, and accessory inclined sleep products (collectively, inclined sleep products). The final rule also includes the currently unregulated non-inclined, flat, infant sleep products, which means products with a seat back or sleep surface angle that is already 10 degrees or less from horizontal ( i.e., baby boxes, in-bed sleepers, baby nests and pods, rigid-sided and rigid-framed compact bassinets without a stand or legs, various designs of “travel bassinets” with soft padded or mesh sides, and baby tents (collectively, flat sleep products)). 84 FR at 60951. Tabs C and E of Staff's Final Rule Briefing Package contain additional information and characteristics, as well as pictures of the infant sleep products subject to the final rule. B. Products Excluded From the Scope of the Final Rule Consistent with the 2019 SNPR, for the final rule, products with inclined or adjustable seat back positions that are covered by other CPSC standards, such as infant bouncer seats, strollers, hand-held carriers, frame carriers, and infant swings, are excluded from the scope of the ASTM infant inclined sleeper standard, and they are also excluded from the scope of the final rule, unless the product is specifically marketed for infant sleep for an infant up to 5 months of age. Id. at 60951-52. If a product's packaging, marketing materials, inserts, or instructions indicate that the product is for sleep, or includes pictures of sleeping infants, then CPSC will consider the product to be marketed for sleep. Products that are already compliant with another CPSC sleep standard, such as the bassinet standard (16 CFR part 1218), or the crib standard (16 CFR part 1219), are excluded from the scope of the final rule. Sleep wedge pillows and sleep positioners are out of scope for the final rule, and may be covered by Food and Drug Administration (FDA) regulations as medical devices, if they are marketed to treat a medical condition, such as acid reflux. Infant pillows are also out of scope for the final rule, and these products are subject to 16 CFR § 1500.18, “Banned toys and other banned articles intended for use by children.” Hammocks intended as photo props are out of scope for the final rule. Hammock accessories intended for shopping carts are also not in scope, as those products are not intended for infant sleep. Bath chairs with inclined backs are out of scope, as they are covered by another standard and are not intended for infant sleep. Pet beds, toy hammocks, and play tents labeled for children over 5 months are out of scope of the final rule. Loungers, floor chairs, and rockers are out of scope of the final rule, unless they are marketed for infant sleep on the product itself or its packaging, marketing materials, inserts, or instructions, or the product is advertised with pictures of sleeping infants. Finally, in response to a comment on the 2019 SNPR, the Commission specifically is excluding from the scope of the final rule crib mattresses that fall within the scope of the voluntary standard for crib mattresses, ASTM F2933. A crib mattress, alone, does not meet the definition of an “infant sleep product,” and is always used in conjunction with a sleep product, such as a crib or play yard, that falls within one of CPSC's sleep standards. The Commission issued a notice of proposed rulemaking for crib mattresses in 2020, and intends to finalize a separate rule later this fiscal year, providing performance and labeling requirements for crib mattresses, based on ASTM F2933. C. Market Description 4 4 Tab E of Staff's Final Rule Briefing Package contains CPSC staff's analysis of the market for infant sleep products. Infant sleep products covered by this rule may be purchased at general retailers, online retailers, mattress and bedding stores, and baby specialty stores. At least 60 small U.S.-based manufacturers and importers are in this market, as well as five large domestic companies, and dozens of foreign companies, some that ship these items directly to customers in the United States via online marketplaces. More than a thousand home-based manufacturers, hundreds based in the United States, sell soft-sided baby nests and pods, in-bed sleepers, and infant hammocks directly to consumers via online marketplaces and as third-party sellers via major retailers' websites. We estimate total sales in this market at more than $125 million per year, to at least a third of U.S. households with newborns. Products within the scope of the final rule compete with products for infant sleep that are compliant with one of CPSC's sleep standards and with other small, portable products that are not marketed for sleep. One goal of the final rule is to make it clearer to consumers which products are certified as compliant with a CPSC sleep standard, regardless of the product name or advertising. The proliferation of physically different products with similar names (particularly “bassinets”), the many suppliers in the market, and new product types each season, reflect a competitive market for innovative sleep products. New sleep products are marketed as filling a need for a small, portable sleeping or napping space. Many items are also marketed specifically to facilitate bed-sharing. 5 In addition to the marketing as secondary sleeping options, some of these compact and relatively inexpensive sleep products are also marketed as primary sleep spaces for families with limited living space and budget. Baby boxes, in-bed sleepers, and hammocks, in particular, are marketed as primary sleep spaces for babies. 5 Tab D of Staff's Final Rule Briefing Package contains CPSC staff's analysis of the hazards associated with bed-sharing. CPSC did not find any evidence that consumer demand for compact, inexpensive, and portable sleep spaces cannot be met by products compliant with an existing CPSC sleep standard. Many small bassinets that are compliant with CPSC's bassinet standard sell for $50 to $75 and have a footprint similar to the flat sleep products covered by this rule. As for bed-sharing, bedside sleepers retail for as little as $100. Cradles compliant with the bassinet and cradle standard have a swinging function similar to a hammock with a frame, often at a lower retail price. Innovative products compliant with the existing CPSC sleep standards have been introduced in recent years, including small, foldable play yards, oval cribs and bassinets, bassinets that are attached to an adult chair, bassinets with rocking functions, and bedside sleepers with a rocking base. 1. Inclined Sleep Products The 2019 SNPR described four types of inclined sleep products within the scope of the rule: Frame-type inclined sleep products, hammocks, compact inclined sleep products, and accessory inclined sleep products. 84 FR at 60951. We update the market for these products below, grouping frame-type, compact, and accessory inclined products into one category, and hammocks into another category. (a) Hard-Frame Inclined Sleepers, Compact Foam Inclined Sleepers, and Play Yard Accessories Freestanding, inclined hard-frame sleepers retail for $40 to $120, depending on brand and features, such as attached toys, fabric coverings, battery-operated sounds, and adjustable positions. Compact foam inclined sleepers retail for about $100. Hard-frame inclined play yard accessories are not sold separately; they are included in the price of the play yard. In recent years, sales of inclined sleepers have totaled at least 722,000 units per year. 6 The sales of these products alone total nearly a quarter of all households with newborn infants, given that just under 3.8 million live births occurred in the United States in 2018. 7 Additionally, more than 4,000 adoptions from foreign countries occurred, but most of those infants were at least 1-year-olds by the time the adoption was finalized. 8 We assume that some of the market for inclined sleepers has shifted to other flat sleep product categories covered by this rule, or shifted to small portable sleep products compliant with existing CPSC sleep standards. Since the CPSC published the NPR in 2017, some inclined sleep products have been recalled or otherwise removed from the market. However, although reselling recalled products is prohibited, discontinued items sold on the secondary market that have not been recalled, as well as non-recalled physically similar products sold by small companies, are still available. 6 The recalled inclined products alone had sales of nearly 6.5 million from May 2010 to August 2019. Assuming that the recalled products represented most of the market, 6.5 million divided by 9 years is 722,000. 7 https://www.cdc.gov/nchs/nvss/births.htm. 8 https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/adoption-statistics-esri.html. (b) Baby Hammocks Hammocks range in price from about $50 for a simple fabric hammock without a frame, to more than $300 for a hammock with a wooden or metal stand. Crib hammocks, which are intended to attach to cribs or play yards of any brand, retail for about $50 to $100. Baby hammocks are widely available from small domestic companies, importers, and home-based sellers. The websites of several major general retailers sell these items from third-party sellers. Hammocks are made of a variety of fabrics and may include padded sides or bottoms. They may come without a frame, or with a wooden or metal stand. Some items are solid fabric, while others are mesh or crochet. The market is fragmented, and all of the sellers in the United States are small companies, although some sellers are importers of items made by large foreign companies. The large number of sellers, including at least one company that sells only baby hammocks, and dozens of home-based sellers, suggests that thousands of baby hammocks are sold each year. 2. Flat Sleep Products (a) Flat Sleep Surface, Soft-Sided Products The flat sleep surface, soft-sided products that are not covered by a CPSC sleep standard include baby pods or baby nests, which are marketed for use on a hard surface or as in-bed sleepers, and soft-sided “bassinets.” Some soft-sided products are marketed for use inside a crib or bassinet. Some sleep products are marketed as portable or travel infant beds. The flat infant sleep products currently not covered by any voluntary or mandatory sleep standard, but would be regulated under the final rule, include: • Baby pods and baby nests—These products have a soft floor, usually padded in some way, with low soft fabric or mesh sides, resembling a small pet bed. They can be rectangular, oval, or figure 8-shaped. Some come with a wedge pillow. They are sometimes marketed as suitable for use inside a crib or play yard. • Soft-sided “travel bassinets” or “travel beds”—These products can have either a soft or semi-rigid floor. Some products come with straps and zippers so that they can be rolled up and carried like a backpack when not in use. Some are marketed as “3-in-1” products that can also be used as a changing mat and include pockets for diapers. Some products have a “cocoon” design, with a soft padded top, intended to cover the body of the occupant. • Hand-held carriers marketed for sleep—These products are marketed as both a hand-held carrier and a (soft) bassinet, suitable for napping or sleeping. • In-bed sleepers—These products have low, soft sides and a soft floor, specifically intended and marketed for bed-sharing. Play yard accessories have mesh or fabric sides that attach to the rails of the play yard and are marketed for infant sleep, including “napping”; and they would not fall within the scope of the rule if they are already compliant with the bassinet standard. Items marketed as changing pads are not considered to be infant sleep products. The prices for baby nests, baby pods, and in-bed sleepers range from about $40 to $200, with the lower-priced items tending to come from home-based manufacturers and foreign direct shippers, and the more expensive items coming from larger U.S. companies. Smaller products intended only for infants up to 5 months of age also tend to be cheaper than larger products intended for children up to 2 years old. The various soft-sided travel bassinets and “travel beds,” some that fold up into a backpack, have a similar price range. At least 30 small businesses, mostly importers, sell the soft-sided flat sleep surface products. 9 Dozens of foreign companies ship these sleep products directly to U.S. customers via U.S. Internet retailers, and there are more than 1,000 home-based sellers of baby pods and baby nests. 9 This number is approximate, as the proliferation of internet retailing allows importers to enter and exit the market quickly, and to switch their product line based on demand. The estimated annual sales of in-bed sleepers alone are 1 million units, 10 based on public comment and staff analysis. The Durable Nursery Products Exposure survey (DNPES) indicated that 38 percent of parents slept with their child under 1 year of age at least once a week, with 18 percent indicating they sleep with their child under 1 year of age every night. The CDC similarly found 11 that 24.4 percent of parents bed-shared with their infant “often or always” and 37 percent indicated they bed-shared “rarely or sometimes.” If parents who regularly sleep with their infants commonly purchase or make a soft-sided baby nest or other type of in-bed sleeper, then these products could be owned by 25 percent of households with newborns, representing about 1 million units sold per year, which is consistent with the estimate from a public comment on the 2019 SNPR. 10 A public comment on the SNPR estimated the annual sales of “in-bed sleep products” at 500,000 to 1.5 million units, which is consistent with the estimates in the DNPES and from CDC on prevalence of bed-sharing. 11 Bombard JM, Kortsmit K, Warner L, et al., Vital Signs: Trends and Disparities in Infant Safe Sleep Practices—United States, 2009-2015. MMWR Morb Mortal Wkly Rep 2018;67:39-46. DOI: http://dx.doi.org/10.15585/mmwr.mm6701e1. (b) Flat Sleep Surface, Rigid-Sided and Rigid-Framed Compact Bassinets, Travel Bassinets, and Similar Products This infant sleep product category includes flat sleep surface, free-standing products that resemble a bassinet without a stand or legs. Baby boxes and other rigid-sided products without a stand are marketed for infant sleep, sometimes as “compact” or “travel” bassinets. Some compact bassinets have mesh sides with a rigid metal or plastic frame. Larger rigid-sided items that comply with the play yard standard, and play yard accessories that are compliant with the bassinet standard, are out of scope for the final rule. Most flat sleep surface, rigid-sided products are rectangular, but oval and round ones are also available. As noted, some flat, soft-sided items are also marketed as “travel” bassinets. The term “bassinet” is used in product names for rigid-sided items with a stand that meet CPSC's bassinet standard, but the term is also used in product names of flat and inclined items without a stand, some with low and soft padded sides, which do not meet the bassinet standard. The final rule addresses this issue, and, in part, is intended to make it clearer to consumers which products are safe for infant sleep, regardless of the product name. Rigid-sided and rigid-framed compact bassinets and travel bassinets typically sell for about $50 to $150, which is comparable to the lower end of the price range of bassinets that comply with the bassinet standard. Retail prices for baby boxes start at about $50 to $75, depending on the brand and decorative design, although some are sold only as part of a $300, or more, bundle with clothes, diapers, and other baby items. Baby boxes were given away for free by some state governments and hospitals, so the cost to the consumer was $0, although those organizations purchased them from a small domestic company that is no longer offering them. Play yard accessories are not priced or sold separately; rather, they are included in the price of the play yard. Products in this category have a variety of names. Several small domestic manufacturers and small importers, as well as large domestic and foreign companies, sell small, rigid-sided or rigid-framed products that resemble a bassinet without a stand as “compact,” “portable,” or “travel” bassinets, or as infant “travel beds.” About a dozen sellers ship these products from the United States, and a few foreign companies sell through internet marketplaces. The presence of several large domestic and foreign companies in this market, as well as introductions of innovative products each year, indicate that a strong consumer demand for these products. CPSC believes it likely that some of the demand for inclined rigid-sided products has shifted to this market sector. Unlike the soft-sided products, this sector does not have many home-based businesses or foreign direct shippers. Baby boxes are a sub-type of compact bassinet that are made of cardboard. They are sold in the United States by two small domestic companies and one foreign company and can also be purchased directly from several foreign companies. The sales are relatively small; estimated at under 20,000 per year. 12 This means that less than 1 percent of households with newborns purchase these items. Baby boxes are sometimes marketed as “Finnish” baby boxes, because the government of Finland provides new parents with a baby box or cash equivalent. As noted, in the past, some state and local hospitals gave away baby boxes to new parents or made them widely available through social service agencies. 13 Like other compact bassinets, baby boxes are marketed as a primary sleep environment for newborns. 12 A public comment estimated 2018 sales from two of the three U.S. baby box companies at more than 10,000. 13 Similar programs now offer free cribs or play yards. (c) Baby Tents Baby tents, which are a small mesh or solid fabric products with a fabric floor are marketed for sun protection, play, and baby sleep. They are sometimes marketed as a combination of tent and “travel bed” or “travel bassinet.” Some baby tents come with flaps, covers, or shades so that the baby can sleep in darkness. Some products come with poles or stakes to fasten the tent to the ground or in the sand at the beach. Some tents have a shallow fillable pool/sandbox in the bottom, which indicates they are not intended primarily for sleep, but rather, for play. Baby tents retail for about $20 to $75; larger and more expensive tents are available, but they are marketed for older children. Baby tents are offered for sale on major internet general retailer websites and in general retail stores by about a dozen small importers and a few large companies. Dozens of foreign companies ship these baby tents directly to U.S. customers via U.S. Internet retailers; the majority of suppliers in this category are foreign direct shippers. Baby tents are marketed as a specialty item for outdoor use, particularly beach trips or camping, to shade the baby from sun and provide a place for playing and sleeping. Indoor “play” tents are also marketed for sleep, but those products are mostly marketed for children over 3 years of age. Indoor play yards with tent-like covers are in the scope of the play yard standard. Although baby tents are a relatively niche product, compared to some of the other types of sleepers, there appears to be sufficient demand for baby tents to support the market presence of dozens of companies, including a few large companies selling a variety of other baby products. III. Incident Data and Hazard Patterns A. Inclined Sleep Products 1. Incident Data The 2017 NPR discussed 14 fatal incidents related to inclined sleep products, which were reported to have occurred between January 1, 2005 and September 30, 2016. Eight of the 14 deaths involved rocker-like inclined sleep products; in three cases, the unstrapped decedent was found to have rolled over into a facedown position. Two additional cases also reported a rollover into a facedown position, but the reports did not include any information about the use of a restraint. CPSC had little information about the cause or manner of the three remaining deaths. The 2017 NPR recognized that reporting was ongoing and that the number of reported fatalities could change. 82 FR at 16965-66. The 2019 SNPR updated fatal and nonfatal incident reports associated with the use of an inclined sleep product. At the time of the 2019 SNPR, CPSC was aware of 451 incidents (59 fatal and 392 nonfatal) related to inclined sleep products that occurred from January 1, 2005 through June 30, 2019, and reported between October 1, 2016 and June 30, 2019. This count included incidents reported after the reporting end date stated in the 2017 NPR. Forty-three percent of the incident reports (196 out of 451) were based solely on information from manufacturers/retailers. Various sources, such as hotlines, internet reports, newspaper clippings, medical examiners, and other state/local authorities provided the remaining incident reports to CPSC. 84 FR at 60952-53. Tab A of the October 16, 2019 Staff SNPR Briefing Package describes the incident data and the hazard patterns associated with infant inclined sleep products at the time of the SNPR. For the final rule, the Directorate for Epidemiology staff, Tab B of Staff's Final Rule Briefing Package, describes 71 new incident reports associated with inclined sleep products since the 2019 SNPR. Of the 71 new reported incidents, 10 are fatalities; among the remaining 61 nonfatal incidents, 17 reported an injury. Reporting is ongoing, and therefore, the number of reported fatalities, nonfatal injuries, and non-injury incidents may change in the future. (a) Fatalities Since the 2019 SNPR, the Commission is aware of 10 fatalities associated with the use of an inclined sleep product that reportedly occurred during the period from January 1, 2019 through December 31, 2020. • Three of the 10 fatal reports describe infants placed supine (on their back) in a rocker-like sleeper product, but who ended up rolling over, fully or partially, resulting in suffocations or positional asphyxiations. Staff does not know whether a restraint was used in any of these cases. All three decedents were 3- or 4-month-old infants. • One report describes a fatality involving a foam-type reclined infant seat. The seat was placed on an adult bed, where the parents were also asleep. The seat was found tipped over on the floor, with the 4-month-old decedent found underneath the seat. • One incident reports a fatality of a 3-month-old infant, found supine in an infant rocker-like product (in the same position as originally placed) with a blanket covering the infant's face. • Five remaining fatality reports provide very little information on the incidents. Lack of any information on the circumstances leading up to the death does not allow CPSC staff to classify these deaths. Of the known ages, the decedents ranged in age from 1 to 6 months old. (b) Nonfatal Incidents Since the 2019 SNPR, the Commission has received reports of 61 nonfatal incidents associated with the use of an inclined sleep product that occurred between January 1, 2019 and December 31, 2020. Among these 61 reports, 17 reports involved an injury. We describe the severity of the 17 injuries below: • Four infants required hospital admission. Three of the hospitalizations were for respiratory problems due to mold on the sleep product, and one was for treatment of injuries from a fall when an accessory-type product collapsed. • Three infants were treated and released from emergency departments. Those infants were treated for respiratory problems from exposure to mold or for fall injuries. • Ten infants required other medical care, mostly for plagiocephaly (flat head syndrome), torticollis (twisted neck syndrome), or both conditions, which were associated with prolonged use of inclined sleep products; two of the 10 infants suffered minor bumps/bruises due to falls or near falls. The remaining 44 incidents reported no injuries, or provided no information about any injury. However, many of the descriptions indicated the potential for a serious injury, or even death. Thirty-four percent of the incidents involved infants 0 to 5 months of age, and 9 percent involved infants 6 months to 12 months of age. CPSC does not know the infant's age in 58 percent of the incidents. 2. Hazard Patterns The 2017 NPR identified nine hazard patterns among the 657 reported incidents associated with inclined sleep products. These hazard patterns included: Design issues, lack of structural integrity, inadequate restraints, electrical issues, non-product-related or unknown issues, difficulty with correct positioning, miscellaneous product-related issues, unspecified falls, and consumer comments. 82 FR at 16965-66. For the 2019 SNPR, CPSC staff considered all 451 reported incidents (59 fatal and 392 nonfatal) to identify hazard patterns associated with inclined sleep products; and staff described the variety of sleep products considered, such as: Hammocks, which are suspended in air, seat-like products meant to be placed on a floor level (yet incident reports indicate these products often were not placed on floor level), and products that sit on top of larger nursery products as attachments. CPSC staff identified eight hazard patterns among 451 reported incidents in the 2019 SNPR, which differed, depending on which product was involved, and how the product was being used: Design issues, electrical issues, consumer comments, undetermined issues (due to confounding information), structural integrity issues, other product-related issues, infant placement issues, and insufficient information. Staff's identified hazard pattern categories were very similar between the 2017 NPR and the 2019 SNPR. 84 FR at 60952-53. For the final rule, staff again reports that the staff-identified hazard categories for inclined sleep products are very similar to those identified in the 2019 SNPR. Following a CPSC-issued safety recall on inclined sleep products in April 2019, staff observed a surge of reports related to the recall; these reports are combined with other consumer comments in the hazard categories. Staff identified the following hazard patterns among the 71 reported incidents (10 fatal and 61 nonfatal) associated with the use of infant inclined sleep products. The categories are presented in descending order of frequency: (a) Consumer comments: Thirty-one of the 71 reported incidents (44 percent) fall into this category. The reports consist of consumer comments/observations of perceived safety hazards, complaints about unauthorized sale of infant inclined sleep products, or inquiries regarding the April 2019 safety recall on inclined sleep products. Although one complaint describes a minor injury incident, none of the remaining reports indicate that an incident actually occurred. (b) Design of the inclined sleep product: Twenty-four of the 71 reported incidents (34 percent) fall into this category. (i) Ten incidents report that infants rolled over—fully or partially—from their original supine (on their back) position. Although a few of the infants were strapped into the product, for others, whether a restraint was used is unreported. Reports describe infants as young as 1 month of age rolling over. Some parents/caregivers, who witnessed and reported some of the nonfatal incidents, were able to rescue distressed infants quickly; some of the other infants died due to suffocation or asphyxiation. (ii) One infant stopped breathing temporarily, due to difficulty positioning his head correctly. (iii) Eight incidents report that infants developed physical deformations, such as plagiocephaly (flat head syndrome) and/or torticollis (twisted neck syndrome), from extended product use. (iv) According to five reported incidents, infants developed respiratory ailments due to the growth of mold on the product. The design category includes three deaths, three hospitalizations, one ED visit, and eight non-hospitalized, non-ED injuries. (c) Other product-related issues: Four of the 71 incidents (6 percent) report other product-related issues, such as instability (posed by products that have completely or nearly flipped over) or lock/latch problem ( i.e., the sleep surface failed to remain in position during use). One of the three instability incidents was a fatality that occurred when a foam-type reclined seat tipped over and fell from the adult bed to the floor, trapping the decedent underneath. No injury is reported in this category. (d) Lack of structural integrity: Three of the 71 incidents (4 percent) report components breaking, such as the rail, hardware, or other unspecified part. This category includes one hospitalization and one non-ED-treated injury due to a fall. (e) Electrical issue: One of the 71 incidents (1 percent) describes an odor emanating from the product after a short period of use indicative of overheating; further investigation revealed molten plastic inside. No injury is reported. (f) Non-product-related issues: One of the 71 incidents (1 percent) reports a fatality in an unsafe sleep environment. A 3-month-old was placed supine (on their back) in an infant rocker-like product with a blanket covering the face; the decedent was found in the same position, with the blanket still covering the face. (g) Insufficient information: Seven of the 71 incident reports (10 percent) contain insufficient information for staff to categorize them accurately. For five deaths, staff has no information on the circumstances of the deaths. Reports for two injuries in this category describe unspecified falls treated in hospital EDs, with no information on restraint usage. Table 1 presents the distribution of the 71 reported incidents by hazard patterns and severity of incidents. Table 1—Hazard Patterns and Incident Severity Associated With Infant Inclined Products 2019-2020 Incidents [Reported since 2019 SNPR] Issues Total incidents Count Percentage Deaths Count Percentage Injuries Count Percentage Product-Related 63 89 4 40 15 88 Comments/Concerns 31 44 1 6 Design 24 34 3 30 12 71 Other Product-Related 4 6 1 10 Structural Integrity 3 4 2 12 Electrical 1 1 Non-Product-Related 1 1 1 10 Unsafe Sleep Environment 1 1 1 10 Insufficient Information 7 10 5 50 2 12 Total 71 100 10 100 17 100 Source: CPSC epidemiological databases CPSRMS and NEISS. Percentages may not add to sub-totals and totals due to rounding. B. Flat Sleep Products In response to the 2019 SNPR, the Commission received public comments regarding the safety of non-inclined sleep products, or flat sleep products, that do not fall within an existing CPSC sleep standard or a voluntary standard that are available in the marketplace. Staff completed a review of CPSC's epidemiological databases, CPSRMS and NEISS, to respond to these comments and concerns. Flat sleep products include: In-bed sleepers, baskets (that can function as hand-held carriers as well), baby boxes, compact bassinets (most of which are portable for travel), and baby tents. Based on the descriptions in the incident reports received, some have soft, puffy sides along the sleep area perimeter; others have semi-rigid sides, with mesh or soft-padded sidewalls held in place by tubular structures along the perimeter. Baby boxes have cardboard walls, while baby tents have flexible wires which provide structural support for fabric/mesh tent walls. All of these non-inclined sleep products are flat and come with mattress pads. Some products have short legs; many can sit on the floor or can be used on a bed or a couch. The data show that some products were placed inside a standard-sized crib, play yard, or bassinet. For the final rule, we characterize the number of deaths and injuries and the types of hazards related to flat sleep products. CPSC's characterizations are based on anecdotal incident reports received by the Commission. The number of emergency department (ED)-treated injuries associated with flat sleep products, for the covered time frame, is insufficient to derive any reportable national estimates. 14 Accordingly, we do not present injury estimates here, but include ED-treated injuries in the total count of reported incidents. Moreover, reporting is ongoing and staff considers 2019-2020 data incomplete, so the number of reported fatalities, nonfatal injuries, and non-injury incidents reported here may change in the future. 15 14 According to the NEISS publication criteria, an estimate must be 1,200 or greater, the sample size must be 20 or greater, and the coefficient of variation must be 33 percent or smaller. 15 In the reports received by CPSC, consumers referred to flat sleep products as “cribs,” “bassinets,” “cosleepers,” “cribettes,” “nests,” “pads,” or “positioners.” Because of the variety of terms used by consumers to describe these products—often unfamiliar to CPSC staff—staff's data search for this analysis was challenging, and staff believes it is possible that some relevant reports may have been missed. 1. Incident Data CPSC staff received a total of 183 incident reports related to flat sleep products available in the marketplace. These incidents reported a date of occurrence between January 1, 2019 and December 31, 2020. Manufacturer and retailer reports submitted through CPSC's “Retailer Reporting Program” serve as the only source of information for 73 percent (133 out of 183) of the incidents. Of the 183 reported incidents, 11 are fatalities. Among the remaining 172 nonfatal incidents, 16 reported an injury. Additionally, staff's flat sleep product data search was limited to children age 12 months or under, because that is typically the manufacturer-recommended use age for these products. One hundred and fifteen incident reports provided the victim's age; among them, 24 involved a fatality or injury. Table 2 provides the age breakdown among the 183 incident reports. Table 2—Age Distribution in Flat Sleep Products-Related Incidents in 2019-2020 Age of child All incidents Frequency Percentage Injuries and fatalities Frequency Percentage Unreported * 68 37 3 11 One-Five Months 89 49 19 70 Six-Eight Months 18 10 4 15 Nine-Twelve Months 8 4 1 4 Total 183 100 27 100 Source: CPSC epidemiological databases CPSRMS and NEISS. * Age may be “unreported” under two circumstances: age was unknown, or age was not reported, because the incident involved no injury. (a) Fatalities The Commission is aware of 11 fatalities associated with the use of a flat sleep product, meaning flat sleep surface products marketed for infant sleep that are not currently within the scope of an existing CPSC sleep standard or a voluntary standard, reported to have occurred during the period of January 1, 2019 through December 31, 2020. Seven of the 11 fatality reports describe a suffocation death, as follows: • A 1-month-old was found partially rolled over onto their side in a soft-sided compact bassinet/travel bed. • A 2-month-old infant was found completely rolled over the edge of an in-bed sleeper. • A 2-month-old was placed in an in-bed sleeper, in a prone position, stomach down, with his face turned to one side; he was discovered with part of his body outside the sleeper, face down into a blanket. • A 2-month-old infant was put into a compact bassinet/travel bed placed on top of an adult bed, with one side of the compact bassinet/travel bed leaning against the wall. According to the official report, the combination of the travel bed's non-reinforced flexible bottom, along with the soft surface of the adult bed, allowed the infant to sink; he was found trapped between the bed and the wall. • A 3-month-old, in a handheld basket that was placed on an adult bed, was found completely rolled over from her original supine position. • A 4-month-old was placed on his back in an in-bed sleeper that was placed inside a standard bassinet; the infant was discovered in a prone position deceased. • A 7-month-old was wrapped in a blanket and placed supine in an in-bed sleeper. The infant was found deceased, having rolled over into a prone position. The remaining four fatalities are as follows: • A 1-month-old was placed in an in-bed sleeper inside a play yard. The official reports describe the decedent as having suffocated on the puffy sides of the sleeper or becoming entrapped somehow, suffering positional asphyxia. • A 7-month-old was placed in an in-bed sleeper for a nap. According to official reports, at some point, the infant got to the edge of the adult bed and became entrapped between the footboard and the mattress of the adult bed and died of positional asphyxia. • Official reports deemed the cause and manner of death for two additional fatalities as undetermined. Both decedents were 1-month-olds, one placed in a basket, while the other was in an in-bed sleeper. (b) Nonfatalities From among the 172 nonfatal reports, CPSC identified 16 injury reports associated with the use of flat sleep products that occurred between January 1, 2019 and December 31, 2020. We describe the severity of the injury type among the 16 injuries below: • Two infants required hospital admission. An 8-day-old infant suffered unspecified breathing difficulties; another 2-month-old infant fell out of an in-bed sleeper and suffered head injuries when a sibling jumped onto the couch where the in-bed sleeper was situated. • Ten infants, ranging in age from 1 month to 9 months, required emergency department (ED) visits after falling out of the sleeper product. For most cases, the sequence of events leading to each fall was unreported. In two cases, the infant fell while being transported in the sleeper; and in another case, the sleeper slipped off of the adult bed on which it was placed. The injuries included head injuries, such as a skull fracture, closed-head injury, and head contusion, or other injuries, such as face abrasion and knee contusion. • Four other injury incidents reported an allergic reaction; a mold-related breathing difficulty episode; laceration of the nose on the rough mesh wall surface on the sleeper; and a fall when a sibling pulled on the sleeper, causing it to flip over. One of these infants required repeated visits to a medical professional, but the level of care the other infants received was unspecified. The remaining 156 incidents reported no injuries, or provided no information about any injury. However, many of the descriptions were similar to incidents in which a serious injury or death occurred. Therefore, CPSC staff indicated the potential for a serious injury or even death. Forty-nine percent of the incidents involved infants 0 to 5 months of age, and 4 percent involved infants 6 to 12 months of age. The age was unknown in 37 percent of the incidents. 2. Hazard Patterns Similar to the inclined sleep products, the hazard patterns reported for the flat sleep products varied according to the type and usage pattern of the product. Many of the products are new in the marketplace, and consumers and safety advocates expressed concern about their safety. Staff identified the hazard patterns among the 183 reported incidents (11 fatal and 172 nonfatal) associated with the use of these flat sleep products. We present the staff-identified hazard patterns below in descending order of frequency among the reports. (a) Lock/Latch problems: One hundred and fifteen of the 183 reports (63 percent) fall in this category. All but one of these reports pertain to different models of a particular stand-alone compact bassinet. The locking/latching mechanism that controls the opening/closing of the cover on the product failed. Some reports describe that the inability of the cover to open completely results in the product not lying flat. The single report about a different product describes a foldable sleeper not remaining flat; the unit reportedly folds up while the baby is in the product. None of the reports mention any injuries. (b) Comments/Concerns: Twenty-nine of the 183 reports (16 percent) expressed consumers' or safety advocates' concerns about the perceived safety hazard of a product, non-compliance with the relevant standard(s) for which a product is being labeled, and/or misleading marketing statements about a product. None of the reports indicate that an incident actually occurred. (c) Falls/Containment issues: Twelve of the 183 incidents (7 percent) report an infant falling out of the product or an infant not being kept contained within the product. Examples include infants rolling out of a sleeper onto an adult bed and then onto floor; an infant falling out of a sleeper when a sibling jumped onto the couch containing the sleeper; an infant crawling/rolling (unwitnessed) out of a sleeper and getting entrapped between an adult bed frame and mattress. This category includes one death, one hospital admission, and nine ED visits. (d) Instability issues: Twelve of the 183 reported incidents (7 percent) describe problems with the product not remaining stable. The incident reports describe some products with legs lifting up higher or leaning on one side; other products have slipped off or flipped over from the adult beds/couches on which they were resting. This category includes two reported injuries, one involving an ED visit. (e) Asphyxiation/Suffocation hazard: Nine of the 183 indents (5 percent) fall into this category. The products were compact bassinets/travel beds, baskets, as well as in-bed sleepers, one being used inside a standard bassinet and another, inside a play yard. All but one of the infants had rolled over from their initial position—either fully or partially; positional information is not available for one infant. Eight of the incidents were fatalities due to suffocation or positional asphyxia; one was a near-suffocation episode, with a parent nearby to rescue the infant. (f) Miscellaneous product-related issues: Three of the 183 incident reports (2 percent) are about mold or quality of the product material. Two of the three products were in-bed sleepers, and the third was a compact bassinet/travel bed. All three report an injury. (g) Undetermined issues: In three of the 183 incident reports (2 percent), staff could not definitively identify the issue involved. Two of the incidents were fatalities; in both cases, CPSC Field investigation reports indicate that the cause of death is undetermined. The third incident resulted in a hospitalization due to unspecified breathing difficulties suffered by the infant. C. Safety Alerts, Press Releases, and Product Recalls The Commission issued two safety alerts involving infant inclined sleep products. A May 31, 2018 safety alert 16 advised of infant rollover deaths in inclined sleep products, and reminded caregivers to always use restraints and to stop using the product as soon as an infant can roll over. An April 5, 2019 safety alert 17 advised consumers to stop using the inclined sleep product when an infant reaches 3 months of age, or as soon as an infant exhibits rollover capabilities. Since issuing the 2019 SNPR, the Commission issued two press releases regarding infant inclined sleep products. A January 16, 2020 press release warned the public about the risk of suffocation associated with the Summer Infant SwaddleMe By Your Bed Sleeper, an infant inclined sleeper. The release advised consumers to stop using the product immediately. 18 An October 31, 2020 press release warned consumers that infant inclined sleep products were not safe for infant sleep based on the results of the Mannen Study, and advised caregivers to stop using infant sleep products with an inclined seat back of more than 10 degrees. 19 16 https://www.cpsc.gov/content/cpsc-consumer-alert-caregivers-urged-to-use-restraints-with-inclined-sleep-products . 17 https://www.cpsc.gov/Newsroom/News-Releases/2019/CPSC-ALERT-CPSC-and-Fisher-Price-Warn-Consumers-About-Fisher-Price-Rock-N-Play-Due-to-Reports-of-Death-When-Infants-Roll-Over-in-the-Product . 18 https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Warns-Consumers-to-Stop-Using-Summer-Infant-USA-Inc-s-SwaddleMe-By-Your-Bed-Sleeper . 19 https://www.cpsc.gov/Newsroom/News-Releases/2020/CPSC-Cautions-Consumers-Not-to-Use-Inclined-Infant-Sleep-Products . The Commission also conducted numerous recalls involving infant inclined sleep products. The 2019 SNPR stated that from May 10, 2000 to August 20, 2019, CPSC conducted 13 consumer-level recalls involving infant inclined sleep products. 84 FR at 60953-54. CPSC conducted recalls in response to hazards involving strangulation, suffocation, falls, structural stability, entrapment, exposure to mold, and death. Six recalls involved infant hammocks, six recalls involved infant inclined sleep products, and one recall involved an infant inclined sleep accessory included with a play yard. Id. Tab G in the October 2019 Staff SNPR Briefing Package contains a detailed chart outlining recalls involving infant inclined sleep products up through August 20, 2019. Since the issuance of the 2019 SNPR, CPSC conducted six additional recalls for a suffocation hazard involving infant inclined sleep products. These six recalls affected approximately 268,300 units. Tab F of Staff's Final Rule Briefing Package contains a chart outlining these recalls. CPSC did not conduct any recalls for flat sleep products from August 2019 through January 2021. IV. Overview of CPSC Sleep Standards The final rule would require that any “infant sleep product,” defined as a product marketed or intended to provide a sleeping accommodation for an infant up to 5 months old, and that is not already subject to one of CPSC's mandatory standards for infant sleep, must meet the requirements of the mandatory standard for bassinets and cradles, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a “bassinet/cradle.” Currently, the five mandatory CPSC sleep standards are: 20 20 Tab E of Staff's Final Rule Briefing Package contains a description of each CPSC sleep standard and the associated voluntary standard the rule is based upon. • 16 CFR part 1218— Safety Standard for Bassinets and Cradles • 16 CFR part 1219— Safety Standard for Full-Size Baby Cribs • 16 CFR part 1220— Safety Standards for Non-Full-Size Baby Cribs • 16 CFR part 1221— Safety Standards for Play Yards, and • 16 CFR part 1222— Safety Standard for Bedside Sleepers . The Commission considers products that fall within the scope of a CPSC sleep standard to generally follow safe sleep principles. Additionally, caregivers can expect that regulated products intended for infant sleep are tested for compliance to the applicable standard, as well as to any other applicable CPSC rule, such as lead in paint and lead content. Pursuant to section 14 of the CPSA, products within the scope of a children's product safety rule, which includes all of CPSC's sleep standards, must be tested for compliance to the standard by a CPSC-accepted third party laboratory, and such compliance must be certified by the manufacturer or importer of the product. Staff regularly participates in ASTM subcommittees for these products, and routinely updates incident data associated with regulated products, to address identified hazards through the ASTM process. If a voluntary standard that has been adopted by the Commission is revised to address identified hazards, section 104(b)(4)(B) of the CPSIA provides an update process, whereby the revised voluntary standard becomes the new mandatory standard. 21 Additionally, section 104(b)(2) of the CPSIA requires the Commission to periodically review and revise rules issued under section 104, to ensure that such rules provide the highest level of safety for such products that is feasible. Table 3 summarizes CPSC sleep standards applicable to regulated infant sleep products. 21 Under section 104(b)(4)(B) of the CPSIA, the organization must notify the Commission of a revised voluntary standard, and the revised standard becomes a consumer product safety standard issued by the Commission unless within 90 days after notification, the Commission determines that the revised standard does not improve the safety of the consumer product covered by the standard, and the Commission is retaining the existing consumer product safety standard. The revised voluntary standard will become the mandatory standard, effective 180 days after the Commission received notification of the revision (or a later date specified by the Commission in the Federal Register ). 15 U.S.C. 2056a(b)(4)(B). Table 3—Regulated Infant Sleep Products and Applicable Standards Product Voluntary standard Mandatory standard Bassinet/Cradle ASTM F2194-16ε1 22 16 CFR 1218. Full-Size Crib ASTM F1169-19 16 CFR 1219. Non-Full-Size Crib ASTM F406-19 16 CFR 1220. Play Yard ASTM F406-19 16 CFR 1221. Bedside Sleeper ASTM F2906-13 16 CFR 1222. Some products currently marketed or intended for infant sleep are not regulated by one of the five existing CPSC sleep standards. Additionally, new products continue to enter the market for infant sleep, but some are also not within the scope of an existing CPSC sleep standard. Such products may not follow safe sleep principles, and are not tested for compliance to a CPSC sleep standard. These unregulated sleep products collectively include products such as: Infant inclined sleep products, in-bed sleepers, baby boxes, compact/travel bassinets without handles or handholds, and infant travel tents. Hand-held bassinet/cradles are regulated as part of 16 CFR part 1225, Safety Standard for Hand-Held Infant Carriers, but part 1225 does not address hazards associated with infant sleep. Accordingly, hand-held carriers are unregulated if marketed or intended for infant sleep. 22 CPSC's mandatory standard, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, incorporates by reference ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and Cradles, with modifications to make the standard more stringent. In 2016, ASTM revised the voluntary standard to include the modifications set forth in the mandatory standard. Accordingly, ASTM F2194-16ε1 is substantially similar to the mandatory standard, and we assess this version of the voluntary standard in this preamble, to simplify our analysis. The final rule seeks to address hazards associated with infant sleep products, both inclined and flat. Products that already meet a CPSC sleep standard are, by definition, outside the scope of the rule. The final rule addresses hazards associated with infant sleep products by requiring them to meet the requirements of the bassinet and cradle standard, 16 CFR part 1218, including conforming to the definition of a “bassinet/cradle.” V. Voluntary Standards Overview—ASTM F3118 and ASTM F2194 A. Infant Inclined Sleep Products—ASTM F3118 1. History As a result of incidents associated with the use of inclined sleep products, the Commission directed CPSC staff to work with ASTM to develop voluntary requirements to address the hazard patterns related to the use of inclined sleep products. ASTM first approved ASTM F3118 on April 1, 2015, and published it in May 2015. Through the ASTM process, CPSC staff consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and members of the public. The current standard, ASTM F3118-17a, was approved on September 1, 2017, and published in October 2017. This is the fourth revision of the standard since it was first published in May 2015. ASTM F3118-17a states that it is intended to address hazards from falls, positional asphyxiation, and obstruction of nose and mouth by bedding. 2. Description The 2017 NPR described the key provisions of ASTM F3118-17, including: Scope, terminology, general requirements, performance requirements, test methods, marking and labeling, and instructional literature. 82 FR at 16967. The 2019 SNPR proposed to incorporate by reference the most recent version of the voluntary standard, ASTM F3118-17a, which is substantially the same as ASTM F3118-17, except that the “accessory” definition was updated to match the modification recommended in the 2017 NPR. Like the previous version, ASTM F3118-17a describes the scope of the voluntary standard, defines terms for various types of infant inclined sleep products, and sets out requirements for performance (such as for structural integrity and stability) and for warnings and instructions. As discussed elsewhere in this preamble, CPSC's final rule makes substantial modifications to ASTM F3118-17a. 3. CPSC Staff's Work Within the ASTM Process CPSC staff's work on the infant inclined sleep product voluntary standard arose from staff's work through the ASTM process on the voluntary standard for bassinets and cradles in approximately 2011, in preparation for a proposed rule on bassinets and cradles. ASTM began developing the infant inclined sleep products voluntary standard to address hammocks and inclined sleep products, whose product characteristics at that time did not appear to align with bassinets, because the bassinets standard requires a sleep surface of 10 degrees or less, while the inclined product category at that time included products with an incline of 10 to 30 degrees. Staff has been actively participating in the development of the voluntary standard for inclined sleep products since then. CPSC staff participated in the ASTM process by attending meetings, 23 working on task groups, commenting on ballots, 24 and providing incident data. CPSC staff provided incident data and hazard pattern analysis associated with inclined sleep products for the 2017 NPR and the 2019 SNPR, and updated this information in this final rule preamble. Additionally, staff last provided ASTM with incident data associated with inclined sleep products in May 2018. 23 Meeting logs detailing CPSC's work with ASTM on the infant inclined sleep product voluntary standard can be found here: https://www.cpsc.gov/Newsroom/FOIA/ReportList?field_nfr_date_value%5Bvalue%5D%5Bmonth%5D=&field_nfr_date_value_1%5Bvalue%5D%5Byear%5D=&field_nfr_type_value=meeting&title=incline&=Apply. 24 CPSC staff's correspondence with ASTM since issuing the 2017 NPR regarding these products can be found on www.regulations.gov under supporting materials: https://www.regulations.gov/docket/CPSC-2017-0020/document?documentTypes=Supporting%20%26%20Related%20Material. Since the SNPR published on November 12, 2019, ASTM has not updated ASTM F3118-17a to address hazards associated with inclined products. Staff's SNPR Briefing Package was posted on the Commission's website on October 16, 2019, before ASTM held fall meetings on voluntary standards for juvenile products, and before the Commission voted on the SNPR, so that ASTM members and other stakeholders could review the package, including the Mannen Study, before the ASTM meetings, and so that staff could discuss the package and the Mannen Study with ASTM members. The ASTM Agenda for Infant Inclined Sleep Products meeting that occurred on October 21, 2019, included a link to Staff's SNPR Briefing Package. CPSC staff discussed the 2019 SNPR Briefing Package at the ASTM meetings in October 2019, including the ASTM subcommittees for infant inclined sleep products, in-bed sleepers, and bassinets, discussing the Mannen Study findings, as well as addressing the fact that flat sleep products were covered by the SNPR. Dr. Mannen attended the subcommittee meeting for infant inclined sleep products via telephone, to discuss the Mannen Study and to answer questions. After the SNPR published in the Federal Register on November 12, 2019, CPSC staff urged the ASTM subcommittee for ASTM F3118 to meet and discuss how to address issues presented in the 2019 SNPR. However, the F3118 subcommittee did not meet again until August 26, 2020, following a July 16, 2020 letter from CPSC staff. 25 After staff's letter, the ASTM F3118 subcommittee established a task group to revise the infant inclined sleep standard's title, introduction, and scope, to be more in line with the proposal in the 2019 SNPR. In December 2020, the ASTM subcommittee introduced ballot F15-18 (20-1) to change the standard's title, introduction, and scope to include all infant sleep products (and not just inclined sleep products). The ballot sought to: 25 Available at: https://www.cpsc.gov/s3fs-public/IISPLettertoASTM-07162020.pdf?6ntZUkyau.r2mlrQnM31s0B3g1EkUg.9. • Remove the word “inclined” throughout the standard. • Include in the scope, products intended for infants up to 12 months old. • Include in the scope, products marketed or intended to provide sleeping accommodations. • Change the scope to include all infant sleep products that do not fall within the scope of an existing infant sleep product standard: Full-Sized Cribs (F1169) Bassinets (F2194) Bedside Sleepers (F2906) Non-Full-Size Cribs/Play Yards (F406) • Exempt crib mattresses from the scope of the standard. • Limit the sleep surface in all positions to be 10 degrees or less. However, in January 2021, the ballot did not pass due to six negative votes. The negative votes objected to a variety of different aspects of the ballot, including four broad categories: 1. That the proposal would discourage innovation and be too broad; 2. That the ballot appeared to allow products that fall under other sleep standards to opt to meet ASTM F3118 instead; 3. That the voter could not support changing the title, introduction, and scope without seeing the underlying requirements; and 4. Editorial comments. The ASTM F3118 subcommittee discussed the ballot results at a meeting on January 27, 2021. During this meeting, ASTM members disagreed on the intent and consequences of changes to the voluntary standard, and the meeting ended without a consensus on a path forward. However, CPSC staff participates on an ASTM task group to review safe sleep requirements across infant sleep product standards (the comparison task group), and reports that this task group has met at least four times since the January 27, 2021 meeting. Based on the ballot results and the discussions in these ASTM meetings, staff advises that it is unlikely that ASTM will be able to move forward with changes to ASTM F3118 that address safe sleep requirements in the near term. 26 26 The ASTM task group approach is different than CPSC's approach in this final rule, because ASTM is attempting to put safe sleep requirements in ASTM F3118, rather than rely on the performance and labeling requirements in the bassinets and cradles standard. The Commission determines in this final rule that the performance and labeling requirements in the bassinet standard are the minimum safe sleep requirements for infant sleep products. Thus, it remains unclear whether ASTM's approach can be successful. However, if the ASTM committee revises ASTM F3118-17a and notifies the Commission, the staff will evaluate the revised voluntary standard at that time. Recently, on April 22, 2021, at an ASTM task group meeting on the title, introduction, and scope of the voluntary standard, task group members discussed balloting the proposed regulatory text in the 2019 SNPR for the voluntary standard, to prevent the sale of infant inclined sleep products that purport to certify to ASTM F3118-17a, meaning products with an incline above 10 degrees, while ASTM works to revise the voluntary standard to be more in line with the 2019 SNPR. However, the task group does not plan to ballot the 2019 SNPR requirement that infant sleep products meet the requirements of the bassinet standard, because ASTM is working to create minimum safe sleep requirements in a revised ASTM F3118 standard. Staff is participating in this effort as well, but staff has advised the task group that staff's expertise does not suggest that requirements that are different and less stringent than the requirements in the bassinet standard will adequately address the risk of injury associated with infant sleep products. Additionally, staff's conclusion that the Safety Standard for Bassinets and Cradles contains the minimum safe sleep requirements for these products is supported by the assessment presented in Staff's Final Rule Briefing Package and in this final rule. B. Bassinets and Cradles—ASTM F3194 1. History and Description The voluntary standard for bassinets and cradles, ASTM F2194, was first approved and published by ASTM in 2002, as ASTM 2194, Standard Consumer Safety Specification for Bassinets and Cradles. The voluntary standard was revised several times between 2002 and CPSC's promulgation of a mandatory standard for bassinets in 2013. CPSC's mandatory standard for bassinets and cradles, codified at 16 CFR part 1218, incorporates by reference ASTM F2194-13, with the following modifications to the voluntary standard: 1. Clarify the scope of the standard to include multi-mode products in which a mode meets the definition of a “bassinet/cradle” (seat incline is 10 degrees or less from horizontal) 2. Modify the stability test procedure to require the use of a newborn CAMI dummy, rather than an infant CAMI dummy. 3. Add stability requirements for removable bassinet beds. 4. Add more stringent mattress flatness performance requirements to limit measured angle to 10 degrees (versus 14 degrees allowed in ASTM F2194-13). 5. Exempt bassinets that are less than 15 inches across from the mattress flatness requirement. In 2016, ASTM approved and published the most recent version of the standard, ASTM F2194-16ε1, with new requirements to bring the voluntary ASTM standard in line with the mandatory standard for bassinets in 16 CFR part 1218. In developing ASTM F2194-16ε1, ASTM harmonized the voluntary standard with all modifications specified in part 1218. In addition to including all modifications contained in part 1218, ASTM added: 1. Additional clarification that strollers with a removable bassinet must be tested to the bassinet standard, 2. Minor formatting and editorial changes, and 3. An additional warning statement to be applied to bassinet bed products that are removable from the base/stand without the use of tools and that contain a lock/latch mechanism that secures the bassinet bed to the base/stand. Staff assessed the additional changes to the voluntary standard, beyond harmonization with 16 CFR part 1218, and advises that the changes are either non-substantive, or an improvement in safety. We evaluate and discuss ASTM F2194-16ε1 in this preamble to the final rule, and CPSC will update the reference in part 1218 to ASTM F2194-16ε1 as soon as feasible. The more significant requirements of ASTM F2194 include: • Scope—describes the types of products intended to be covered under the standard. • Spacing of rigid-side components—is intended to prevent child entrapment between both uniformly and non-uniformly spaced components, such as slats. • Openings for mesh/fabric—is intended to prevent the entrapment of children's fingers and toes, as well as button ensnarement. • Static load test—is intended to ensure structural integrity even when a child three times the recommended (or 95th percentile) weight uses the product. • Stability requirements—is intended to ensure that the product does not tip over when pulled on by a 2-year-old male. • Sleeping pad thickness and dimensions—is intended to minimize gaps and the possibility of suffocation due to excessive padding. • Tests of locking and latching mechanisms—is intended to prevent unintentional folding while in use. • Suffocation warning label—is intended to help prevent soft bedding incidents. • Fabric-sided openings test—is intended to prevent entrapments. • Rock/swing angle requirement—is intended to address suffocation hazards that can occur when latch/lock problems and excessive rocking or swinging angles press children into the side of the bassinet/cradle. • Occupant restraints—is intended to prevent incidents where unused restraints have entrapped and strangled children. • Side height requirement—is intended to prevent falls. • Segmented mattress flatness—is intended to address suffocation hazards associated with “V” shapes that can be created by the segmented mattress folds. The voluntary standard also includes: (1) Torque and tension tests to prevent components from being removed; (2) requirements for several bassinet/cradle features to prevent entrapment and cuts (minimum and maximum opening size, small parts, hazardous sharp edges or points, and edges that can scissor, shear, or pinch); (3) requirements for the permanency and adhesion of labels; (4) requirements for instructional literature; and (5) corner post extension requirements intended to prevent pacifier cords, ribbons, necklaces, or clothing that a child may be wearing from catching on a projection. 78 FR 63019, 63020-21 (Oct. 23, 2013). 2. CPSC Staff's Work Within the ASTM Process CPSC has been working with ASTM on the voluntary standard for bassinets and cradles since before publication of the original voluntary standard in 2002. CPSC began rulemaking under section 104 of the CPSIA, to create a mandatory standard for bassinet and cradles based on the voluntary standard, in approximately 2009, following passage of the CPSIA. CPSC issued a notice of proposed rulemaking in 2010 (75 FR 22303 (Apr. 28, 2010)), a supplemental notice of proposed rulemaking in 2012 (77 FR 64055 (Oct. 18, 2012)), and a final rule in 2013 (78 FR 63019 (Oct. 28, 2013)). The final rule is codified at 16 CFR part 1218, Safety Standard for Bassinets and Cradles. The final rule incorporated by reference the then-current voluntary standard, ASTM F2194-13, with modifications to make the standard more stringent. CPSC staff has continually participated in the ASTM process, including attending subcommittee meetings, 27 participating in task groups, 27 commenting and voting on ballots to revise the voluntary standard, 28 and providing incident data, when requested. This has included ASTM's recent efforts to address hazards associated with currently unregulated flat sleep products, such as compact bassinets, baby boxes, and in-bed sleepers, since approximately 2015. ASTM has not yet been successful in adding any of these flat sleep products to the bassinet standard. 27 CPSC meeting logs associated with staff's work with ASTM can be found here: https://www.cpsc.gov/Newsroom/FOIA/ReportList?field_nfr_date_value%5Bvalue%5D%5Bmonth%5D=&field_nfr_date_value_1%5Bvalue%5D%5Byear%5D=&field_nfr_type_value=meeting&title=bassinet&=Apply . 28 CPSC correspondence with the ASTM Subcommittee for Bassinets and Cradles can be found here: https://cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI . CPSC staff's correspondence with ASTM states that staff is opposed to removing or reducing the requirements of the bassinet and cradle voluntary standard to create new requirements specifically for these products, when such requirements are inconsistent with safe sleep principles already required in the bassinet standard. Accordingly, for example, in a December 12, 2019 letter to both the inclined sleep and bassinet subcommittees, CPSC staff reiterated concerns with weakening the safe sleep requirements in the voluntary standard for bassinets and cradles in order to accommodate unregulated products, such as in-bed sleepers, compact bassinets, and baby boxes. 29 Additionally, on October 16, 2020, staff voted negatively on an ASTM ballot to modify the bassinet standard to include less stringent stability and side height requirements for compact bassinets, versus traditional bassinets. 30 To ensure safe sleep, staff's negative ballot vote urged ASTM to maintain the same side height and stability requirements for compact bassinets that are required of bassinets. 29 Available at: https://www.cpsc.gov/s3fs-public/LetterToASTMBassinet_IISP_121219.pdf?uMq_ImMYhtrDmFkoDH9I6vdwNI0hsm00 . 30 Available at: https://www.cpsc.gov/s3fs-public/VoteCommentToASTMBassinet_10162020.pdf?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI. CPSC's website, at https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards, contains information on staff activities as well as correspondence with voluntary standards organizations. In June 2019, ASTM began to develop a separate in-bed sleeper voluntary standard. Staff provided data to ASTM regarding in-bed sleepers in 2017, and has participated in ASTM meetings for in-bed sleepers since June 2019, as well as working with performance and labeling task groups. 31 Task groups working on the in-bed sleeper standard have been unable to reach consensus on performance requirements for in-bed sleepers, and have been focusing on developing warning labels for these products. CPSC staff continues to participate in all of these ASTM efforts, and to urge ASTM members to retain safe sleep principles in standards development. For example, in a July 8, 2020 letter to the Subcommittee Chairman for ASTM's in-bed sleeper committee, CPSC staff stated: 31 Meeting logs describing ASTM meetings are available on CPSC' website: https://www.cpsc.gov/Newsroom/FOIA/ReportList?field_nfr_date_value%5Bvalue%5D%5Bmonth%5D=&field_nfr_date_value_1%5Bvalue%5D%5Byear%5D=&field_nfr_type_value=meeting&title=in-bed&=Apply . We would like to be clear that based on our evaluation of incident data related to in-bed sleepers, we have great concerns regarding the safety of in-bed sleepers and the feasibility of developing any safety standard that fully addresses potential hazards. Based on the 12 deaths discussed with the In-bed Sleeper Data Task Group members, CPSC staff cannot foresee how these products can be designed and regulated to ensure safe use for infants. Staff is not confident that an in-bed sleeper voluntary standard that differs from the current bassinet standard will result in a safe sleep product. 32 32 See July 8, 2020 Letter from C. Kish to ASTM Subcommittee for In-bed Sleepers, available at: https://www.cpsc.gov/s3fs-public/InbedSleepers_07082020ASTM%20Letter.pdf?3SpzS3cG3zvPjCLFamcCz.9FxNjpUu2s . VI. Assessment of the Voluntary Standards To Address Identified Hazard Patterns Associated With Infant Sleep Products A. Inclined Sleep Products The 2019 SNPR assessed the adequacy of ASTM F3118-17a to address the risk of injury associated with inclined sleep products. 84 FR 60955-56. The assessment relied, in part, on the Mannen Study regarding the safety of inclined sleep surfaces for infant sleep, attached as Tab B to Staff's SNPR Briefing Package, and also summarized in the 2019 SNPR. Id. at 60954. Based on the Mannen Study, CPSC staff advised that a flat sleep surface, meaning one that does not exceed 10 degrees from the horizontal, is the safest sleep surface for infants. Id. Accordingly, the Commission proposed in the 2019 SNPR to remove the term “inclined” in CPSC's mandatory standard, and to require that all sleep products not otherwise subject to a CPSC sleep standard (full-size cribs, non-full-size cribs, play yards, bedside sleepers, and bassinets and cradles), meet the requirements of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, which, among other requirements, mandates a seat back/sleep surface angle intended for sleep to be 10 degrees or less from horizontal. Id. Here, we summarize the results of the Mannen Study again, summarize the assessment of ASTM F3118-17a in the 2019 SNPR, and update our assessment to determine whether the voluntary standards, ASTM F3118-17a, or ASTM F2194-16ε1, are adequate to address the incidents associated with inclined sleep products, including the 71 new incidents reported since the 2019 SNPR. Based on the following analysis, the Commission determines that ASTM F3118-17a is inadequate to address the risk of injury associated with inclined sleep products, and that more stringent requirements are necessary in the final rule to further reduce the risk of injury associated with infant inclined sleep products. Specifically, the Commission determines that the performance requirements in the mandatory standard, 16 CFR part 1218, Safety Standard for Bassinets and Cradles, would adequately address the risk of injury associated with these products. 1. Mannen Study Summary During the development of the 2019 SNPR, staff reviewed 450 incidents, 59 were deaths that occurred while in infant inclined sleep products. Commission staff contracted with Dr. Erin Mannen, Ph.D., a mechanical engineer with a biomechanics specialization, to conduct infant testing to evaluate the design of inclined sleep products. The Mannen Study examined how the degree of a seatback angle affects an infant's ability to move within the products and whether those designs directly impact safety or present a risk factor that could contribute to the suffocation of an infant. The testing compared infants' muscle movement and oxygen saturation on a flat crib mattress at 0 degrees, 10 degrees, and 20 degrees, versus seven different inclined sleep products. The Mannen Study concluded that none of the inclined sleep products tested were safe for infant sleep. Id. The Mannen Study concluded that muscle activity for infants who rolled over in inclined sleep products with a 20-degree incline sleep surface was significantly different than in products with a zero-degree incline surface. The increased demand on the abdominal muscles could lead to increased fatigue and suffocation if an infant is unable to reposition themselves after rolling from a supine to prone position. The Mannen Study also concluded that inclined sleep products with a 10-degree or less sleep surface incline do not significantly impact infant motion or muscle activity. Based on the Mannen Study, staff recommended that 10 degrees is the maximum sleep surface angle that should be allowed for any product intended for infant sleep, similar to the requirements found in the EN 1130:2019 children's cribs, EN 1466:2014 carry cots, and the AS/NZS 4385:96 infant rocking cradles international standards. Id. 2. Hazard Pattern Categories In the 2019 SNPR, CPSC reviewed 451 reported incidents involving inclined sleep products, which included 59 fatalities and 96 injuries. CPSC identified seven hazards that involved deaths and injuries (for this analysis, we did not consider patterns, such as consumer comments, that did not involve injuries or deaths): • Design issues (31 percent). This hazard involved 19 deaths, 17 resulting from infants rolling over into a prone (face down) position. An additional 71 injuries were reported in this category, including five hospitalizations and four emergency department visits. Thirty-three percent of the reported incidents involved infants rolling from their original supine (on their back) position. • Electrical issues (28 percent). This hazard involved no deaths and two reports of injuries. • Undetermined (8 percent). This hazard involved 28 deaths and six injuries. Among the 28 deaths, staff was unable to determine the product's role, but often unsafe sleep environment was cited as a co-contributing condition to sudden infant death syndrome (SIDS). • Structural Integrity (6 percent). This hazard involved no deaths and two injuries. • Insufficient information (4 percent). This hazard involved eight deaths and six injuries. The reports did not provide information on the circumstances of deaths and injuries involved unspecified falls. • Other Product-Related Issues (3 percent). This hazard involved no deaths and nine injuries. The category includes reports of instability (product tipping over) and inadequacy of restraints, and most of the injuries involved falls. • Infant placement issues (1 percent). This hazard involved four deaths and no injuries. Three of the four deaths involved infants placed in a prone position. Id. at 60952-53. Since the 2019 SNPR, CPSC received a total of 71 new incident reports related to inclined sleep products. While the distribution of the data in this update varies somewhat, staff advises that the broader hazard categories are very similar. The 71 new reports included 10 fatalities and 17 injuries. Of the 10 fatalities, three deaths involved an infant who rolled from a supine position, one death involved an overturned sleeper, one death involved an infant placed with a blanket, and five deaths without reports containing information on the circumstances of the death. Of the 17 injuries 12 involved design issues, two involved structural integrity, and two involved unspecified falls. 3. Assessment of ASTM Standards in Addressing Hazards Below we summarize the hazard patterns associated with deaths and injuries from all 522 incident reports related to inclined sleep products CPSC received and reviewed since the 2017 NPR. CPSC did not consider patterns, such as consumer comments, that did not involve injuries or deaths. The 522 incidents involved 69 deaths and 113 injuries. We assesses the adequacy of the voluntary standard for infant inclined sleep products (ASTM F3118) and the adequacy of the voluntary standard for bassinets (ASTM F2194) in addressing hazards associated with injuries and deaths. In the 2019 SNPR, CPSC determined that the voluntary standard for infant inclined sleep products, ASTM F3118-17a, is inadequate to address the risk of injury associated with the incline of sleep products, because the standard allows for products with a seatback angle greater than 10 degrees. Id. at 60955-56. The majority of deaths (in which the circumstances were known) were due to suffocation after the infant rolled over in the product, and the same hazard pattern was reported in nonfatal incidents. For the mandatory standard, CPSC proposed to modify ASTM F3118-17a to limit the seatback angle for all infant sleep products to 10 degrees or less, and to replace the performance requirements with the performance requirements in 16 CFR part 1218, Safety Standard for Bassinets and Cradles, which incorporates by reference ASTM F2194-13 Standard Consumer Safety Specification for Bassinets and Cradles, with modifications. With the modifications in the mandatory standard, the standard is substantially similar to ASTM F2194-16ε1, which we use for the assessment here. (a) Hazard: Design Issues When combining the data from the 2019 SNPR with new incident data received since the SNPR, the “design issues” hazard is associated with 22 deaths and 83 injuries. At least 20 deaths involved infants rolling into a prone position (face down) and suffocating. More than one-third of the incidents also reported that infants rolled over—fully or partially—from their original supine (on their back) position. In the 2019 SNPR, we concluded that a flat sleeping surface that does not exceed 10 degrees from horizontal offers infants the safest sleep environment. This conclusion was based on findings from the Mannen Study. 84 FR at 60955-56. Although some comments to the 2019 SNPR stated that more testing should be done to determine if the maximum angle for safe sleep may be between 10 degrees to 20 degrees, the Mannen Study suggested if future work were done on safe sleep angles, one area of study would be additional biomechanical testing to determine “which, if any, angles between 10- and 20-degrees may be safe for infant sleep.” The Mannen Study recommendations do not imply that an incline angle between 10 and 20 degrees may be safe for infant sleep, merely that if higher angles are considered, additional biomechanical testing is required. The Mannen Study also stated that its testing of awake infants was a limitation because “while the muscle use and motion may be similar, it is likely that infants who find themselves in a compromised position in an inclined sleep product during a nap or overnight sleep may not have enough energy or alertness to achieve self-correction and may succumb to suffocation earlier or more easily than infants who are fully awake.” Given the vulnerability of newborn infants and infant fatalities who were most likely asleep at the time of incidents in inclined products, we conclude that additional research of inclines above 10 degrees is unnecessary for the final rule. Based on the biomechanical results of the Mannen Study, and its conclusion that 10 degrees is likely a safe incline for infant sleep, which supports the 10 degrees stated in the scope of ASTM F2194-16ε1, the Commission concludes that 10 degrees is the maximum sleep surface angle that should be allowed for any product intended for infant sleep for young infants up to 5 months old. Additionally, other research 33 has demonstrated a discernable difference in infant ability between 5, 7, and 10 degrees in a side-to-side tilt, which formed the basis of the 7-degree maximum sleep surface angle in Health Canada's regulations. Staff advises that additional research at angles higher than 10 degrees is unlikely to alter their assessment that 10 degrees is the maximum safe incline for infant sleep. 33 Beal SM, Moore L, Collett M, Montgomery B, Sprod C, Beal A. The danger of freely rocking cradles. J Paediatr Child Health. 1995 Feb;31(1):38-40. doi: 10.1111/j.1440-1754.1995.tb02910.x. PMID: 7748688. The current voluntary standard for infant inclined sleep products, ASTM F3118-17a, defines an “inclined sleep product,” in part, as having a seatback angle greater than 10 degrees and not exceeding 30 degrees. Based on the Mannen Study and the other factors discussed above, we conclude that ASTM F3118-17a does not adequately address the risk of injury related to a sleep surface incline greater than 10 degrees, because the voluntary standard does not limit the sleep surface to a safe incline angle. In comparison, the voluntary standard for bassinets, ASTM F2194-16ε1, defines a sleep surface as being less than or equal to 10 degrees, and includes performance requirements for mattress flatness that limit measured angles to 10 degrees or less. 34 Therefore, for the mandatory standard specified in this final rule, with respect to sleep surfaces, all infant sleep products, including inclined sleep products, must meet the more stringent sleep surface angle requirement of the voluntary standard for bassinets, ASTM F2194-16ε1, as codified in 16 CFR part 1218, to further reduce the risk of death from suffocation. 34 In the final rule for bassinets, the Commission stated they intended to limit the scope of the bassinet standard to exclude all inclined products “when the incline is more than 10 degrees from horizontal.” 78 FR 63,021. (b) Hazard: Undetermined Product Issue This hazard category is associated with 28 deaths and six injuries. Among the 28 deaths and six injuries, staff was unable to determine the product's role. Without information on the product's role in deaths or injuries, we are unable to assess whether the voluntary standard for infant inclined sleep, ASTM F3118-17a, or the voluntary standard for bassinets, ASTM F2194-16ε1, would adequately address the hazards in this category. (c) Hazard: Insufficient Information This hazard category is associated with 13 deaths and eight injuries. The reports did not provide information on the circumstances of deaths and injury reports involving unspecified falls. Without information on the circumstances of deaths or injuries, staff is unable to assess if the voluntary standard for infant inclined sleep, ASTM F3118-17a, or the voluntary standard for bassinets, ASTM F2194-16ε1, would adequately address the hazards in this category. Falls are discussed in more detail in “Other Product-Related Issues,” below. (d) Hazard: Infant Placement This hazard category is associated with five deaths and no injuries. Three of the deaths involved infants placed in a prone position, and one death involved an infant placed in a supine position with a blanket covering the face. Based on the Mannen study, sleep surfaces with a 20-degree incline significantly increased the demand on abdominal muscles and could lead to increased fatigue and suffocation if an infant is unable to reposition themselves after rolling from a supine to prone position. In three of the deaths in this hazard category, the infant was placed in the prone position and the inclined sleep surface may have contributed to suffocation if the angle of the sleep surface led to fatigue that prevented the infant from rolling to a supine position. While infants can die in flat products when placed to sleep in the prone position, based on the Mannen Study, an inclined surface could further contribute to deaths in the prone position. A sleep surface limited to a 10-degree or less incline, as required in the bassinet standard (ASTM F2194-16ε1), could reduce the risk of injury associated with the prone position, when compared to an inclined sleep product. Therefore, with respect to sleep surfaces, for the mandatory rule, all infant sleep products, including inclined sleep products, must meet the more stringent sleep surface angle requirement of the voluntary standard for bassinets, ASTM F2194-16ε1, as set forth in 16 CFR part 1218, to further reduce the risk of death from suffocation. (e) Hazard: Other Product-Related Issues (Instability, Restraints, etc.) This hazard category includes reports of instability (product tipping over) and containment; the category is associated with one death and nine injuries. One death occurred when a foam-type reclined product tipped over and fell from the adult bed to the floor, trapping the infant underneath. Most of the injuries involved falls and at least 10 reports (with no injury reported) related to nearly or completely flipped over products. The death, and most likely the injuries, relate to the stability of the product and how easy it is to tip the product over into a hazardous situation. The voluntary standard for infant inclined sleep products, ASTM F3118-17a, includes two stability performance requirements that apply to “Compact Inclined Sleep Products” and “Infant or Newborn Inclined Sleep Products.” For the “Compact Inclined Sleep Products,” the product must remain upright when placed on a 20-degree inclined test platform. For the “Infant or Newborn Inclined Sleep Products,” a 23-lb. vertical force and 5-lb. horizontal force are applied to the product's side with a newborn CAMI dummy occupant to simulate an older sibling pulling up on the side to view the infant in the bassinet, and the product must remain upright containing the CAMI dummy. The “Compact Inclined Sleep Products” are exempt from the 23- and 5-pound force requirements, with the rationale that the compact products are intended to sit on a floor and are unlikely to have an older sibling attempt to pull up to see the infant inside. The current voluntary standard for bassinets, ASTM F2194-16ε1, includes an identical stability requirement that applies a 23-lb. vertical force and a 5-lb. horizontal force to the product with a newborn CAMI dummy occupant, and this requirement applies to all products; it does not provide exemptions for “Compact Inclined Sleep Products” to meet only the less stringent 20-degree inclined test platform test. The rationale in ASTM F2194 states the dual application of forces simulates a 2-year-old male pulling on the side of the product; staff advises that sibling interaction is a reasonable scenario which may cause the product to tip over. Due to the portability of some of the unregulated compact sleep products, incident data confirm that the products are used on raised surfaces from which infants and product may fall. Therefore, regarding the product's stability, in the final rule, all infant sleep products, including inclined products, must meet the more stringent stability requirement of the voluntary standard for bassinets, ASTM F2194-16ε1, as codified in 16 CFR part 1218, to further reduce the risk of injury from tip over of the product. (f) Hazard: Structural Integrity This hazard category includes reports of some component failures on the product such as buckles/straps, hardware coming loose, hub/rail/leg coming loose, or other unspecified components breaking. This hazard category involved no deaths and four injuries. All injuries were related to falls, and include one hospitalization and three emergency department visits. The voluntary standard for infant inclined sleep products, ASTM F3118-17a, includes performance requirements to assess the integrity of inclined sleep products. The requirements specify a dynamic test in which an 18-lb. load, consisting of a 6- to 8-inch steel shot bag, is dropped 50 times from a height of 1.0 inch onto the seat surface. The requirements also specify a static test in which a 50-lb. load or three times the product's maximum recommended weight, whichever is greater, is gradually applied through a 6-inch square wooden block to the seat surface for 60 seconds. The current voluntary standard for bassinets, ASTM F2194-16ε1, has a performance requirement to address structural integrity that specifies a static load test that applies a 54-lb. load or three times the manufacturer's recommended weight, whichever is greater, through a 6-inch aluminum block to the sleep surface for 60 seconds. The rationale in ASTM F2194 states 54 lbs. is three times the weight of the 95th percentile of a 3- to 5-month-old infant. Although the voluntary standard for infant inclined sleep products, ASTM F3118-17a, requires a dynamic test for structural integrity, its effectiveness in evaluating the product's strength is minimal, compared to the static test. The load in the dynamic test being one-third of the static load, the low drop height, short test timeframe, and presence of energy-absorbing material (shot bag and flexible product material), combine to minimize the effect of this test on the product's structural integrity. In contrast, the static test applies a much larger load, three times the heaviest infant in the product, with a rigid applicator applied continuously for 60 seconds. Therefore, staff advises that the static test is the more stringent evaluator of product integrity than the dynamic test. The static load in ASTM F2194-16ε1 is 54 lbs., which is a more stringent load compared to the static load of 50 lbs. in ASTM F3118-17a. Therefore, to further reduce the risk of injury associated with structural defects, for the final rule, the Commission concludes that the static load test in ASTM F2194 is adequate to assess structural integrity of infant sleep products, and is more stringent than the static load test in ASTM F3118-17a. The final rule requires that all infant sleep products, including inclined sleep products, meet the more stringent structural integrity requirement of the voluntary standard for bassinets, ASTM F2194-16ε1, as codified in 16 CFR part 1218. (g) Hazard: Electrical Issues This hazard category involved no deaths and two reports of injuries related to electric shock. Non-injury incidents reported overheating/melting of components and issues with batteries. As noted in the 2019 SNPR, the infant inclined sleep products standard, ASTM F3118-17a, does not include any performance requirements for electrical components. 84 FR at 60956. The voluntary standard for bassinets, ASTM F2194-16ε1, also does not address electrical hazards. However, CPSC staff advises that they raised this issue with ASTM, and that the ASTM Ad Hoc task group is developing performance requirements to address electrical hazards across juvenile products. As these electrical requirements are added during the ASTM voluntary standard updates, CPSC can review the updated voluntary standard pursuant to the update provision in Public Law 112-28, and determine whether to revise the mandatory standard based on a revised voluntary standard. 4. Assessment of International Standards (a) EN1466:2014 Carry Cots The BS EN 1466:2014 Child use and care articles—Carry cots and stands—Safety requirements and test methods European standard applies to products intended for carrying a child in a lying position using a handle or stand. This standard applies to children who cannot sit unaided or roll over or push up on their hands and knees and is a maximum weight of 19.84 pounds. i. Side Height For cots on a stand, EN 1466:2014 standard requires an internal height of at least 7.87 inches (200 mm) from the top of a mattress, compressed by a 19.84-pound (9kg) steel plate, to the lowest point of the upper edge of the [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2021-12723. Public record. Not legal advice.